Financ - Boehringer Ingelheim

Transcription

Financial Highlights
Boehringer Ingelheim group of companies
2006
2005
change
10,574
9,535
11 %
Europe
31 %
33 %
Americas
51 %
48 %
Asia, Australasia, Africa
18 %
19 %
96 %
96 %
4 %
4 %
Research and development
1,574
1,360
16 %
Personnel costs
2,836
2,671
6 %
38,428
37,406
3 %
2,140
1,923
11 %
20.2 %
20.2 %
Amounts in millions of EUR, unless otherwise indicated
Net sales
by region
by business area
Human Pharmaceuticals
Boehringer Ingelheim
Animal Health
Operating income
Operating income as % of sales
Annual Report 2006
Income after taxes
1,729
1,514
16.4 %
15.9 %
5,175
4,609
37.4 %
34.2 %
2,317
2,069
12 %
Investments in tangible assets
596
532
12 %
Depreciation of tangible assets
419
439
-5 %
Income after taxes as % of sales
Annual Report 2006
www.boehringer-ingelheim.com
Average number of employees
Shareholders’ equity
Return on shareholders’ equity
Cash flow
14 %
12 %
Value through Innovation
Top 5 products — Prescription Medicines
Net sales 2006
spiriva®
micardis®
nopq
Top 5 products — Consumer Health Care
in millions of EUR
change
Net sales 2006
in millions of EUR
change
1,381
45.2 %
dulcolax®
122.0
6.2 %
967
33.6 %
mucosolvan®
108.3
18.6 %
flomax®
922
27.8 %
pharmaton®
95.6
8.2 %
combivent®
671
19.6 %
buscopan®
71.2
19.6 %
mobic®
579
-31.8 %
bisolvon®
67.1
0.4 %
2006
2005
change
10,574
9,535
11 %
Europe
31 %
33 %
Americas
51 %
48 %
18 %
19 %
96 %
96 %
4 %
4 %
1,574
1,360
16 %
Personnel costs
2,836
2,671
6 %
38,428
37,406
3 %
2,140
1,923
11 %
20.2 %
20.2 %
Net sales
by region
by business area
Animal Health
Operating income
Annual Report 2006
Income after taxes
1,729
1,514
16.4 %
15.9 %
5,175
4,609
37.4 %
34.2 %
2,317
2,069
12 %
596
532
12 %
419
439
-5 %
Annual Report 2006
Cash flow
14 %
12 %
Net sales 2006
spiriva®
micardis®
nopq
in millions of EUR
change
Net sales 2006
in millions of EUR
change
1,381
45.2 %
dulcolax®
122.0
6.2 %
967
33.6 %
mucosolvan®
108.3
18.6 %
flomax®
922
27.8 %
pharmaton®
95.6
8.2 %
combivent®
671
19.6 %
buscopan®
71.2
19.6 %
mobic®
579
-31.8 %
bisolvon®
67.1
0.4 %
Contents
Comparison of Balance Sheets/
Financial Data 1997—2006 (in millions of EUR)
“There is help“
1 Value Through Innovation
In Kenya, about 50,000 newborn babies a year are estimated to acquire HIV from their infected mothers.
Worldwide UNAIDS talks of 2.3 million cases of AIDS-diseased children. [page 10]
2 The Shareholders’ Perspective
4 Key Aspects of 2006
Assets (as of 31.12.)
Intangible assets
Tangible assets
Financial assets
Fixed assets
Inventories
9 Our Caring Culture
Accounts receivable (incl. deferred charges and deferred taxes)
1997
1998
1999*
2000
2001
2002
2003
2004
2005
2006
508
452
400
344
322
302
242
267
233
554
1,612
1,739
1,992
2,217
2,467
2,840
2,767
2,712
2,900
2,886
757
731
849
1,135
1,008
1,689
2,462
2,756
3,396
3,043
2,877
2,922
3,241
3,696
3,797
4,831
5,471
5,735
6,529
6,483
794
806
944
1,021
1,014
971
1,000
1,085
1,229
1,280
1,211
1,255
1,870
1,938
2,314
2,360
2,537
2,477
3,013
3,137
10 “There is help”
Cash and cash equivalents (incl. securities)
134
299
459
477
1,002
1,055
1,134
1,333
1,247
945
14 Our People
Current assets
2,139
2,360
3,273
3,436
4,330
4,386
4,671
4,895
5,489
5,362
18 Caring for our Neighbours
Total assets
5,016
5,282
6,514
7,132
8,127
9,217
10,142
10,630
12,018
11,845
1997
1998
1999*
2000
2001
2002
2003
2004
2005
2006
399
441
332
211
200
178
178
178
178
178
22 Our Environment & Employee Safety
27 Our R & D Drive
28 Targeting tomorrow’s therapies
32 Our R & D Strategy
Targeting tomorrow’s
therapies
38 Our Expertise in Landmark Studies
40 From Mind to Man – The R & D Process
42 New Biological Entities (NBE)
Liabilities and equity (as of 31.12.)
Shareholders’ capital
Reserves (incl. currency conversion difference)
Focusing on both biopharmaceutical and
small molecule drugs, Boehringer Ingelheim
has embarked on a major drive to discover
and develop new cancer drugs. [page 28]
43 Biomarker & Pharmacogenetics
45 Serving Patients *
1,461 1,651 1,982 2,362 2,753 2,818 3,139
3,297
2,940
3,275
Net income
212
229
320
379
401
537
529
888
1,491
1,722
Total equity
2,072
2,321
2,634
2,952
3,354
3,533
3,846
4,363
4,609
5,175
0
0
0
0
1
203
188
193
216
188
Minority interests
46 “I wake up refreshed ...”
Group equity
2,072
2,321
2,634
2,952
3,355
3,736
4,034
4,556
4,825
5,363
49 Human Pharmaceuticals
Provisions (incl. deferred taxes)
1,982 2,012 2,631 2,932 3,150 3,568 3,963 4,172
4,958
4,641
60 “My recovery came fast”
Liabilities (incl. deferred charges)
962 949 1,249 1,248 1,622 1,913 2,145
1,902
2,235
1,841
78 “Now I know how to keep them under control”
Total liabilities
2,944
2,961
3,880
4,180
4,772
5,481
6,108
6,074
7,193
6,482
80 From Plant to the Pharmacy – The buscopan® Story
Total liabilities and equity
5,016
5,282
6,514
7,132
8,127
9,217
10,142
10,630
12,018
11,845
81 Consumer Health Care
84 Our friend Tom
87 Animal Health
91 Our Customer Orientation
Summary of selected financial data
1997
1998
1999*
2000
2001
2002
2003
2004
2005
2006
92 Biopharmaceuticals – How Innovations are Made
Net sales
4,201
4,474
5,086
6,188
6,694
7,580
7,382
8,157
9,535
10,574
95 Pharmaceuticals Production and Pharma Chemicals
97 Counterfeits – A Real Threat for Patients
99 Group Management Report
115 Consolidated Financial Statements 2006
116 Overview of the Major Consolidated Companies
118 Consolidated Balance Sheet
119 Consolidated Profit and Loss Statement
120 Cash Flow Statement
121 Statement of Changes in Group Equity
122 Notes to the Consolidated Financial Statements 2006
140 Auditor’s Report
“Now I know
Our friend Tom how to keep
Every year, about 10 % of them under
all horses suffer from equine colic, a disease that
control”
can prove life-threatening. [page 84]
Abdominal pains and cramps,
a widespread ailment, is
more common in women
than in men and can affect
people still in their teens. [page 78]
“My recovery
came fast”
Stroke is a serious disease.
It is the third leading cause
of death after heart disease
and cancer and the most important reason for
medical disability. [page 60]
“I wake up
refreshed ...”
Operating income
Hypertension is not only an
unpleasant condition that
keeps people from doing
what the things they like.
It is also a serious cardio
vascular risk that can be
the precursor to stroke and
heart attack. [page 46]
350
336
655
800
980
1,082
901
1,372
1,923
2,140
8.3
7.5
12.9
12.9
14.6
14.3
12.2
16.8
20.2
20.2
Income after taxes
212
229
320
379
401
551
537
908
1,514
1,729
5.0
5.1
6.3
6.1
6.0
7.3
7.3
11.1
15.9
16.4
Return on equity (in %)
11.4
11.0
13.8
14.4
13.6
16.0
15.0
23.1
34.2
37.4
Own capital resources (in %)
41.3
43.9
40.4
41.4
41.3
38.3
37.9
41.0
38.4
43.7
561
595
737
791
1,117
1,049
1,059
1,430
2,069
2,317
722
858
1,055
1,094
1,645
2,645
3,516
4,015
4,585
3,934
1,270
1,409
1,527
1,749
1,916
2,175
2,252
2,443
2,671
2,836
30.5
29.9
28.0
26.8
34,221 35,529
37,406
38,428
Cash flow
Financial funds
Personnel expenditure
Personnel expenditure as % of sales
Average numbers of employees
Research and development costs
Flap Comparison of Balance Sheet / Financial Data 1997–2006
* The patient reports are authentic reports which refer to personal
experience only. Please acknowledge that other patients may experience
different treatment results. Individual treatment schemes have always to
be discussed between patient and physician case by case.
please turn over
31.5
30.0
28.3
28.6
28.7
25,927
26,448
27,325
27,980
31,843
771
812
826
968
1,019
1,304
1,176
1,232
1,360
1,574
18.4
18.1
16.2
15.6
15.2
17.2
15.9
15.1
14.3
14.9
455
421
377
497
548
634
516
427
532
596
189
211
256
288
305
340
354
377
439
419
R&D as % of sales
142 Glossary
30.2
24,860
*As of the comparative financial statement
1999, accounting and evaluation methods were
brought closer into line with International
Accounting Standards (IAS), particularly with
regard to deferred taxes and provisions for
pensions.
Our vision drives us forward. It helps us to
foster value creation through innovation
throughout our company and to look to the
future with constantly renewed commitment
and ambition.
Boehringer Ingelheim is a research-driven group of companies
dedicated to researching, developing, manufacturing and marketing
pharmaceuticals that improve health and quality of life.
Our business consists largely of Prescription Medicines, Consumer
Health Care, Biopharmaceuticals and Animal Health. We focus on the
production of innovative drugs and treatments that represent major
therapeutic advances.
Excellence in innovation and technology guides our actions in all
areas. Our products have long been highly successful in the treatment
of respiratory, cardiovascular, central nervous system, urological and
virological disorders. In addition we have intensified our research
into the immune system, metabolic diseases and oncology.
Boehringer Ingelheim, which currently has more than 38,400
employees, has 137 affiliated companies spread around the globe.
We have research and development facilities in ten countries and
production plants in more than 20.
Our Human Pharmaceuticals research and development in our
Prescription Medicine spending corresponds to about 18 % of net
sales in this business.
Our headquarters is at Ingelheim, the German town where the
company was founded in 1885.
The Shareholders’ Perspective
Dear Reader,
Family-owned companies such as Boehringer
years of research and development. The develop-
Ingelheim are attracting considerable interest
ment of innovative substances with an efficacy
these days. As their strategy and investments are
superior to those already available will be crucial
often directed towards ensuring the continuation
to our success in the future.
of the company in the long term, family-owned
companies have often proved to be particularly
The market demands that productivity be
stable and crisis-resistant, especially in the
constantly raised throughout the value chain.
volatile market conditions of recent years.
Our employees are the driving force behind
the innovations required at any one stage of our
The success of value-based family-owned com-
complex processes. We rely on their integrity
panies is also confirmed by various surveys and
and commitment. It is also important for us
indices comparing family-owned companies
to remain an employer of choice for our own
with listed ones. It is borne out by our own
employees and for people outside the company.
success as well. Boehringer Ingelheim’s sales
That Boehringer Ingelheim, as numerous
growth this past financial year exceeded the
external comparisons have shown, is one of
market average for the seventh year in a row,
the most interesting and desirable employers
allowing us to improve our world market share
in many countries is a source of great pride.
yet again. Benchmarking operating margins
Boehringer Ingelheim certainly has the corporate
also show Boehringer Ingelheim to be well
culture, the size and the structure to enable us
positioned. That our commercial success has
to identify with a common strategy and to help
also allowed the corporation to take on more
shape it, too. Such an environment is essential
employees is particularly gratifying. Over
to innovation and excellence. We believe that
the past ten years, Boehringer Ingelheim has
our corporate culture, with its focus on how we
increased its personnel capacity by 5 % per
work together in a ‘great team’, is a significant
annum on average.
prerequisite for motivating our employees
to achieve still more innovative solutions for
We are a research-driven pharmaceutical com-
patients, progress and economic success.
pany. The guiding principles in our Leitbild give
top priority to the development of innovative
The year 2006 was again one of market consoli-
medicines for the benefit of patients worldwide.
dation in the pharmaceutical industry. And this
The same applies to our endeavours in animal
trend with mergers and acquisitions is most
health as well. Innovation and the quality of our
likely to continue. The main reason for this is a
products drive our success and materialise many
very simple one: lack of productivity in R&D.
Boehringer Ingelheim A n n u a l R e p o r t 2 0 0 6
Christian Boehringer,
Chairman of the
Shareholders’ Committee
Boehringer Ingelheim’s shareholders have set the
We are confident of the continued motivation
course for the future in such a way that we can
and loyalty of our employees, the expertise and
continue to build on the successful development
experience of the Board and constructive com-
of recent years as an independent company. This
mitment of our Advisory Board in the future. On
applies not only to the corporate strategy decided
behalf of the shareholders of Boehringer Ingel-
jointly with the Board of Managing Directors,
heim, allow me to congratulate all those I have
but also to the make-up of both the Board and
mentioned on the very successful financial year
the Shareholders’ Committee. After 32 years of
2006. Thank you all for your tremendous efforts.
highly successful commitment to Boehringer
We look forward to continuing to work closely
Ingelheim, as Chairman of the Board of
with our employees, the Board of Managing
Managing Directors, and since 2001 as Chairman
Directors and the Advisory Board for the good
of the Shareholders’ Committee too, Dr Heribert
of Boehringer Ingelheim as a whole. Despite what
Johann took well deserved retirement as of
is sometimes a difficult economic and political
31 December 2006. Dr Johann played a key role
environment, and some highly competitive
in shaping our company’s strategic development
markets, we are confident that we are set to
over the past 15 years and we are profoundly
remain one of the world’s leading pharmaceu-
grateful to him for his unflagging commitment
tical companies.
to Boehringer Ingelheim.
The commitment of the owner-family to
Christian Boehringer
Boehringer Ingelheim, meanwhile, has been
Chairman of the Shareholders’ Committee
further strengthened by two important decisions
taken in 2006: the move of family member
Hubertus von Baumbach to the Board of
Managing Directors at the beginning of 2009
and the increased involvement of other family
members in the Shareholders’ Committee,
which is now chaired again by a family member
representing the increased commitment of the
fourth generation of shareholders.
The Shareholders’ Perspective
Key Aspects of 2006
2006 was again a rewarding year for Boehringer
Success in serving patients
Ingelheim. We grew faster than the market
Boehringer Ingelheim is a pharmaceutical
average for the seventh year in succession.
company that generates almost 80 % of its net
While the global pharmaceutical markets are
sales with prescription medicines. Yet we do
changing and mergers and consolidation efforts
not measure our success in financial key figures
continue, we again maintained our successful
alone, but also, and of equal importance, in
course as an independent and dynamically
terms of the acceptance of our products and
growing pharmaceutical company. We are proud
programmes. For instance, in conjunction with
that we once again achieved our overall goal
our donation programme for the anti-AIDS
of helping people by making our medications
product viramune®, we have so far succeeded
available to patients through researching and
in providing medication for almost 1 million
developing new and innovative drugs. Our
mother-child pairs in around 60 countries for
economic success in recent years mirrors the
the prevention of mother-to-child transmission
value of our medications for patients.
of HIV. About six million patients benefited from
our product spiriva® for chronic obstructive
Market analyses by the healthcare information
pulmonary disease (COPD). The number of
provider IMS confirm that our +8.4 % growth
patients using our anti-hypertension medicine
rate was appreciably healthier than that of the
micardis® amounted to more than four million
pharmaceutical market in general (+6.1 %).
in 2006.
Although our growth curve flattened out as a
result of the generic competition that our anti-
rheumatic drug mobic® has been facing in the
Naturally, the success of our products is reflected
USA since summer 2006, we increased our
in our business results. In 2006, our net sales
market share in 2006 worldwide and in the
across all business areas grew by 11 % to
USA to about 2 %. Overall, we are happy
almost EUR 10.6 billion. We were also pleased
with our 2006 results.
that we were able to increase the number of our
employees by 3 % to 38,428 and so offer more
than 1,000 new and qualified jobs around the
world.
Members of the Board
of Managing Directors:
Dr Hans-Jürgen Leuchs
Dr Andreas Barner
Dr Alessandro Banchi
Prof. Marbod Muff
(from left to right)
The Prescription Medicines business area, which
Well-filled pipeline
grew by 15 % to EUR 8.3 billion (compared to
Our product pipeline has further improved and
2005) made the greatest contribution to sales
is being progressively filled with substances from
growth. The most important products driving
our research. We focus on respiratory and cardio-
this growth included our leading product
vascular diseases, virology, central nervous
spiriva®, with sales up 45 % to EUR 1.4 billion,
system, immunology, metabolic diseases and
micardis® which grew by 34 % to EUR 967
oncology. In this last therapeutic area, for exam-
million, and flomax®/alna®, for benign
ple, three anti-cancer drug candidates are now
prostatic hyperplasia, which grew by 28 %
in clinical phase II development. Our projects
to EUR 922 million. In US dollar terms,
are complemented by strategic alliances and the
micardis® and flomax® thus represent two
in-licensing of new compounds and technolo-
more Boehringer Ingelheim blockbusters
gies.
alongside spiriva®.
Our late-stage pipeline also progressed well in
In 2006, we were granted marketing authorisa-
phase III, and we were able to file the first indi-
tion for sifrol® in the indication restless legs
cations of our lead anti-thrombotic compound
syndrome (RLS), both in Europe and the USA.
dabigatran for registration in Europe at the
Important and innovative clinical studies (phase
beginning of 2007.
I-IV) continued successfully, involving about
90,000 patients worldwide. These included
Investments in research and development in
the ontarget™ study (micardis®), uplift®
our prescription medicines increased again
(spiriva®) and profess® (aggrenox®/
in 2006, up by 16 % to about EUR 1.5 billion;
micardis®).
this corresponds to around 18 % of sales in
this business area.
Overall, our Consumer Health Care (CHC) business showed good development, in spite of an
increase in sales of only 1 % to EUR 1.1 billion.
Key Aspects of 2006
This growth was clearly restrained by the
chronic heart disease in dogs, as well as the pig
weakness of the Japanese market, where we
vaccines enterisol® ileitis (against diarrhoea)
generate almost 30 % of our CHC business.
and ingelvac® prrs (against porcine reproduc-
Excluding Japan, we achieved strong growth
tive and respiratory syndrome).
of about 9 %.
The outlook remains good
Our international core brands, in particular
The picture seen in recent years has not changed.
dulcolax®, pharmaton® and buscopan®,
Boehringer Ingelheim’s growth in 2006 was
showed wholly positive development. As an
excellent across all regions of the world. The
outstanding complement to our gastrointestinal
Americas region grew very well in spite of the
disease business, we successfully acquired
sales decrease of mobic® due to generic compe-
zantac® (for heartburn) for the important US
tition in the USA, with sales rising by 18 % to
market. Our CHC business accounted for about
EUR 5.4 billion. But not only the USA (+20 % to
10 % of our total net sales.
4.5 billion) performed well. Other countries, in
particular Mexico, with its vigorous 27 % growth
Our Biopharmaceuticals business segment,
(to EUR 300 million), put in an excellent per-
which embraces contract manufacture and
formance, too. Europe showed a rather gratifying
development for our international customers,
development, growing by 6 % to EUR 3.3 billion.
declined by 8 % to EUR 503 million. This devel-
France (+19 % to EUR 263 million), the Regional
opment was expected, despite plant running at
Center Vienna with its expanding East European
full capacity, as the 2005 business year benefited
business (+13 % to EUR 362 million) and Spain
from extraordinary effects caused by special
(+10 % to EUR 349 million) developed very well.
projects that helped boost sales by 40 %.
That Germany, on the other hand, stagnated
in 2006 (+1 % to EUR 822 million) was a result
Boehringer Ingelheim is not only strategically
of the expiry of our patent on alna® on top
committed to the Human Pharmaceuticals
of the very difficult pharmapolitical impacts.
business but also to Animal Health. Here, sales
In the Asia, Australasia, Africa (AAA) region,
in 2006 rose by 4 % to about EUR 374 million,
Japan is showing encouraging signs of growth
giving growth above the market average.
(currency adjusted +6 % to EUR 1.2 billion).
Adjusted for extraordinary and currency effects
In Japan, we were for the second year in a row
the Animal Health business grew by 8 %. Accord-
the fastest growing company among the top 25
ing to the market research institute Wood Mac-
in prescription medicines; we would like to pay
Kenzie, Boehringer Ingelheim, with a market
a special tribute to our Japanese employees.
share of about 3 %, ranks 10th in the international ranking of animal health companies.
Gratifying growth and effective cost manage-
The most important products in this business
ment led to increased operating income for the
area include the anti-inflammatory product
company, as reflected in our results. Operating
metacam®, vetmedin®, a product for treating
income rose by 11 % to over EUR 2.1 billion.
This corresponds to a return on sales of 20.2 %.
The outlook for further business development at
However, our major products still have high
Boehringer Ingelheim remains good. Drugs with
growth potential. We also hope that 2007 will
patent protection or exclusivity will continue
see registration granted in Europe for our
to be our main growth drivers. These products
new and, for patients, innovative device, the
are expected to account for more than 60 % of
respimat® Soft Mist™ Inhaler, for our most
net sales in 2007. We also expect to grow in line
important product spiriva®.
with the market in 2007 due to the generic
competition of mobic® in the USA, which will
And more importantly, we rely on top-class
put pressure on our growth rate for the first
worldwide teams of highly committed and skilled
half of the year.
employees. In spite of the increasing health
policy restrictions in many countries, we continue to look towards the future with optimism.
Dr Andreas Barner
Prof. Marbod Muff
Key Aspects of 2006
Advisory Board
Board of Managing Directors
Dr Heribert Johann
Prof. Michael Hoffmann-Becking
(until 31. 12. 2006)
Attorney at Law, Düsseldorf
Corporate Board Division
Chairman of the
Chairman of the Advisory Board
Chairman of the Board
Dr Rolf-E. Breuer
Pharma Marketing and Sales
Christian Boehringer
Chairman of the Supervisory Board
(from 1. 1. 2007)
Deutsche Bank AG,
Dr Andreas Barner
Chairman of the
Frankfurt (Main)
Vice-Chairman of the Board
Albert Boehringer
Christoph Boehringer
Ferdinand von Baumbach
Hubertus von Baumbach
Dr Mathias Boehringer
Prof. Fredmund Malik
Managementzentrum
St. Gallen Holding AG
Prof. Axel Ullrich
(until 30. 6. 2006)
Director of the Max Planck Institute
for Biochemistry, Martinsried
Dr Heinrich Weiss
SMS AG, Düsseldorf
Pharma Research,
Development and Medicine
Operations
Animal Health
Prof. Marbod Muff
Finance
Human Resources
Our caring culture
“There is help”
“The woman who came to my hospital was pregnant. Her husband accompanied her. And
she had AIDS. When I asked her how she had acquired the disease she just turned to her
husband and glanced at him. He lowered his head and looked at the ground.” Dr Charles
Wanyonyi, Medical Director of Pumwani Maternity Hospital in Nairobi, Kenya, has seen many
patients like this woman. Promiscuity, carelessness, superstition or lack of information and
education contribute to the spread of the deadly disease. Stigma and discrimination also
have a persistent, negative impact in many countries.
In Kenya, about 50,000 newborn babies are estimated to acquire HIV from their infected
mothers every year. Worldwide, UNAIDS talks of 2.3 million cases of AIDS-diseased children.
Most of them will die before they are five years old. Hence the forceful call from former
UN Secretary-General Kofi Annan, a man deeply committed to the struggle against AIDS:
“We must prevent the cruellest, most unjust infections of all – those that pass from mother
to child.”
The infection does not necessarily occur only in the womb during pregnancy. The baby may
also come into contact with the mother’s infected body fluids during labour and delivery.
Finally, they may acquire the virus from their HIV-positive mother’s breastmilk. Without
treatment, around 15–30 % of babies born to HIV-positive women will become infected with
HIV during pregnancy and delivery. A further 5–20 % will become infected through breast
feeding.
There is help. Adelaide Moraa Ayiechad, a midwife from Dr Wanyonyi’s hospital in Kenya,
says: “A baby can be protected from contracting HIV by using nevirapine, so long as the
medication is given in time.” Nevirapine, marketed by Boehringer Ingelheim worldwide
under the tradename viramune®, has proven to significantly reduce the transmission of the
virus from mother to child. Just one tablet taken by the mother during labour and a dose
of viramune® suspension given to the baby within the first 72 hours after birth can reduce
the rate of transmission by about 50 %, as demonstrated in clinical studies.
Saving hundreds of thousands of lives
In its commitment to expanding access to antiretroviral therapy for developing countries,
Boehringer Ingelheim has since 2000 been giving free access to nevirapine through
the viramune® Donation Programme (VDP). The company currently donates the product
to 156 programmes in 59 countries in Africa, Asia, Latin America and Eastern Europe.
continued on page 12
Examination at Pumwani Maternity Hospital, Nairobi, Kenya,
where HIV-infected women and their babies receive treatment
with nevirapine to prevent mother-to-child transmission of HIV.
A Kenyan mother, having just delivered
twins, undergoes HIV counselling
and testing under the prevention of
mother-to-child transmission
programme at Pumwani Hospital,
Nairobi.
continued from page 10
So far, a total of almost one million mother-and-child pair doses have been supplied free of
charge, with the greatest proportion directed to sub-Saharan Africa, epicentre of the AIDS
pandemic. The VDP continues to develop and the numbers still receiving the medication are
rising.
The programme is open to any government, NGO, charitable organisation or other healthcare
providers actively involved in the prevention of mother-to-child transmission (MTCT) based
on local government approval and registration, according to World Health Organization
(WHO) donation guidelines. Boehringer Ingelheim has contracted Axios International,
a distributor of healthcare supplies in the developing world, to provide technical assistance
to support the implementation of the VDP.
“Provided free of charge by Boehringer Ingelheim, nevirapine is straightforward to use
and ideally should be part of a full treatment schedule. But if this is not possible, it can also
be used alone. I feel tremendously privileged to have participated in the discovery and
development of a drug that is having the impact that nevirapine is having throughout the
world,” says Professor John L. Sullivan from the University of Massachusetts Medical School,
who has made a decisive contribution to the viramune® clinical trials.
The single-dose nevirapine regimen has won the support of the public health and HIV/AIDS
treatment communities as, in some countries, it may be the only therapy available for
preventing HIV transmission to infants during birth. Although the most recent WHO guidelines (2006) continue to recommend single-dose nevirapine use as a practical option in
resource-limited settings, there is general agreement that whenever possible single-dose
nevirapine should be used in combination with short courses of other antiretroviral drugs
to decrease the development of resistance.
In addition to the VDP programme, Boehringer Ingelheim has granted in the past years local
and internationally operating manufacturers licenses to produce and sell nevirapine for use
in anti-HIV combination therapy for the sub-Saharan Africa.
Boehringer Ingelheim has now expanded its access policy which will make it easier for local
and internationally operating manufacturers to produce and sell nevirapine for treatment
in anti-HIV combination therapy for the whole of Africa and least developed countries,
according to the World Bank and UNDP standard. This new access policy is made available
for all producers of nevirapine containing products pre-qualified by the WHO, irrespective
of local patent issues or place of production.
12
our caring culture
Mothers deliver healthy babies
Interview with Dr Charles Wanyonyi
What is the situation in your area in terms of the HIV infection
rate? The rate of HIV-infected people has gone down from 13 %
in 2003 to at the moment 8 - 9 % of Kenya’s population. This drop
is showing that the rate is now stabilising and is being brought
under control.
How long have you been using nevirapine at your hospital?
We introduced a prevention of mother-to-child transmission
programme in 2003, the aim of which was to inform HIVpositive expectant mothers about how to protect a baby from
contracting the virus. They are also told of the importance of
using nevirapine and we have been using it since then.
How many mother-child pairs have been treated with
nevirapine so far? Since we started the programme, we have
handled approximately 4,500 cases.
What is your opinion of nevirapine in terms of its efficacy
and safety? Nevirapine is very effective and has helped many
HIV-positive mothers deliver healthy babies. I must say that there
has been a drastic drop of mother-to-child transmission during
delivery. I have seen the drug work in a baby whose blood had
been in contact with the virus during birth and where a dose of
nevirapine had been given, which had then caused the virus to
be wiped out and the antibodies to disappear.
Consultant obstetrician and gynaecologist
Dr Charles Wanyonyi is Medical Director of
Pumwani Maternity Hospital (PMH), the largest
maternity institution in the East and Central Africa
region. Located in Nairobi, the Kenyan capital,
it is the most active site in Kenya for preventing
mother-to-child transmission (PMTCT) of HIV.
Dr Wanyonyi oversees the day to day running of
PMH which provides antenatal, delivery and postnatal services, midwife training, research activities
and healthcare programmes, such as PMTCT.
VIRAMUNE® Donation Programme
13
Our people
In pursuing our vision to create “Value through Innovation”, we build on the
inspiration, expertise and dedication of our more than 38,400 people around
the world. Their striving for continuous innovation and discovery of novel
solutions enable us to maintain our growth, to sustain high-level performance
and prepare for future challenges.
Supported by our Leitbild (guiding principles)
surveys increasingly place us among the most
and our long-term strategic direction, we con-
preferred employers, giving us a competitive
tinue to focus on core issues for enhancing our
advantage in recruiting and retaining the best
people’s capabilities and their passion to pursue
talent. In 2006, Boehringer Ingelheim was listed
our vision everywhere we operate. A key element
No. 2 among the top 20 employers of scientists
of our sustained success at Boehringer Ingelheim
in a respected survey among researchers in the
is the way we work together. Guided by funda-
USA and Europe (see page 15).
mental questions contained in Lead & Learn,
our common cultural understanding, we are
Preparing for the future
individually and collectively called on to shape
To ensure our sustained, positive development, a
an environment where creativity, challenge,
number of our organisations devoted substantial
team-spirit, respect and fairness flourish. Inter-
attention in 2006 to capitalising on opportunities
disciplinary teams throughout our organisations
to improve business and operating efficiency
continue to support this aspiration with uncon-
beyond existing continuous improvement.
ventional and inspirational ways of questioning,
Hence, processes have been launched in which
sharing and learning from each other.
our employees have contributed powerful
insights into how we can reinvent ourselves,
Preferred employer recognition
create structures and processes for better serving
The strength of our distinctive working culture
the marketplace, reducing costs and redundan-
is winning wide acknowledgement from
cies, as well as working more efficiently and
prestigious, independent workplace surveys (see
securing breakthroughs.
page 17). We regard these awards as an affirmation of our success in establishing a demanding
yet highly attractive working environment. The
14
our caring culture
2006
Personnel costs in millions of EUR
2,836
Personnel costs as % of net sales
Number of employees (incl. apprentices)
2005
2,671
2004
2003
2002
2,443
2,252
2,175
26.8
28.0
29.9
30.5
28.7
38,428
37,406
35,529
34,221
31,843
As many of our country organisations will be
from everyone at Boehringer Ingelheim that will
challenged by an increasingly ageing workforce
benefit all.
and shortage of qualified new entrants, we have
set out to emphasise the options available and
A model of our successful adaptation to changing
the opportunities to be seized in this develop-
employment requirements is offered by
ment. While measures promoting lifelong learn-
Boehringer Ingelheim Germany. With kinder
ing for all, diversity management, enabling better
gartens on two sites, educational supervision for
work-life balance, maintaining and enhancing
schoolchildren during the summer holidays and
physical, mental and social well-being are well
interns for employee children, flexible working
anchored and the scope for improvement con-
times, more than 100 varying part-time working
tinuously scrutinised, we have now embarked on
models and access to elderly care services as well
a course designed to prompt ideas and actions
as emergency caring arrangements, the organi-
The No. 2 for scientists
Its clear orientation towards values makes Boehringer
Hans-Joachim Geppert, Head of Corporate
Ingelheim a top employer in the pharmaceutical
Division Human Resources at Boehringer Ingelheim
industry, according to a web-based Science survey
says: “We try to provide a working environment for
from October 2006. In particular, it found that the
our employees where they can challenge assumptions,
respectful treatment of employees, their loyalty and
make decisions and where they find the freedom to
the social orientation of the company rank Boehringer
implement innovations.”
Ingelheim the second most attractive employer (from
number 8 last year) to scientists in the USA and
Western Europe.
In other categories, such as “clear vision to the future”
or “innovative leader in the industry”, Boehringer
Ingelheim also ranked top. The 656 respondents
were mainly employed in the biopharmaceutical
and biotechnology sector (67 %), where Boehringer
Ingelheim is one of the leading international
companies. Two thirds of the respondents held Ph.D.s.
Our people
15
“We believe the center will stand out noticeably among the
many other outstanding benefits we offer, such as our excellent
relocation policy,” David Nurnberger, Senior Vice-President
Human Resources, says. “It might even be one of the main
reasons a candidate would choose to work at Ridgefield, since
working people with children can readily appreciate its value
and convenience.”
At full capacity, the center will have about 35 teachers, all
of whom must have a degree in either education or human
service. The learning center is headed by Katrina Maloney,
who has a degree in early childhood education and has worked
with children for over 17 years. “We are an early learning
center; we’re not babysitting children all day. We have very
specific curricula, from infants all the way up to the oldest
children at the center,” Ms Maloney says.
A group has one or more rooms to itself, with the distribution
dependent on the numbers enrolled in the various groups.
The center, which assigns two teachers to every room, also
provides private kindergarten and after-school care. It also
has a drop-off programme.
Company childcare enters new territory
In an old orchard on Boehringer Ingelheim’s sprawling US
Boehringer Ingelheim provides childcare at several of its sites,
focusing primarily on the pre-school age group. In Germany,
campus in Ridgefield, Connecticut, a long, one-story building
the company’s Ingelheim and Biberach sites run all-day crèches
fits discretely into its surroundings. This is the Apple Blossom
for very young children (both in cooperation with external
Children’s Learning Center, an exciting new venture in company
partners), taking employees’ children and children from the
childcare provision. The building reflects the architectural
surrounding community. The company’s kindergarten provision
language of the site, Boehringer Ingelheim’s US headquarters,
is also conducted in cooperation with the local authorities at
where some 2,200 people are employed, many in research and
the Italian sites, Milan and Florence. In Spain, for example,
development.
The Apple Blossom Center, inaugurated in September 2006,
will take care during the week of up to 156 children from only
six weeks old up to 12 years of age. It is open from 6.30 a.m.
to 6.30 p.m.
16
the company runs an annual summer camp in which about
120 children took part in 2006.
our caring culture
sation received highly esteemed certification for
Our biannual International Management
its achievements and commitment to making the
Development Programme is one of our popular
employment conditions more family-friendly
leadership enhancement schemes and is the
(see page 16). Our German operating unit further-
object of external industry benchmarking and
more had 667 apprentices in 2006 (+2.6 %), again
research. Our international and interdisciplinary
exceeding the previous year’s total engaged in
development approach involves around 100
internal vocational programmes.
potentials learning and working on stretching
topics of strategic relevance over 14 months.
Enhancing our capabilities
To enhance the knowledge of our employees and
International projects and assignments continue
support life-long learning, the Boehringer
to be at the core of our global capability develop-
Ingelheim Academy, with its many options from
ment strategy. Placements lasting up to two years
vocational subjects to leadership development,
have increased considerably. The aim of all these
offers all employees a unique source of informa-
measures is to assign individuals to tasks in
tion about available qualification and updating
which their skill sets are most required and can
opportunities.
best benefit the business, and to enable them to
gain international experience in dealing successfully with different economies cultures, and
business practices, while appreciating the rich
diversity of our corporation.
Awards 2006
Country
Argentina
Austria
Ranking Survey
8 Best Employers in Argentina (Apertura Business Magazine)
23 Great Place to Work: The best companies to work for in Austria
Belgium
Brazil
The fastest growing large companies
among Top 10
Brazil
Denmark
Great Place to Work: The best companies to work for in Latin America
7 Denmark’s Best Workplaces
Finland
France
Great Place to Work: The best companies to work for in Finland
12 Great Place to Work
Netherlands
Netherlands
United Kingdom
USA (Ben Venue)
USA/Europe
Great Place to Work: The best companies to work for in Brazil
The 49 Preferred Employers in the Netherlands
bronze
Great Place to Work
40 100 Best Companies to Work for (Sunday Times)
among Top 100
North Coast 99 Award
2 Science Survey
“Great Place to Work”®, USA, is an international initiative that has been undertaken for many years
in various countries to evaluate the world of work and employee satisfaction.
Our people
17
Caring for our neighbours
We are fundamentally committed to fostering economic and social well-being
in the countries and communities where we operate. Both as a company and
as individuals, we seek in a people-orientated and inspirational way to deliver
value through innovation in all we do. We contribute actively to communities,
charitable organisations and projects in research, science, education, healthcare, culture and environmental protection.
Our commitment to our neighbours was again
Our Australian operation supported projects in
demonstrated across the world in 2006 in a
other parts of the region, participating in the
broad range of activities involving thousands of
Collaboration for Health in Papua New Guinea
our employees and substantial company
Project and in the design and implementation of
resources, expressing our adherence to the
a pilot scheme to train healthcare workers in the
principles of social responsibility in both devel-
treatment of people affected by HIV/AIDS.
oping and developed economies.
Substantial charitable activities continued in
Australia, including funds donated to the
Our employees’ enthusiasm for making personal
Innisfail Hospital after the area was struck by
contributions is noteworthy. Their contributions
Cyclone Larry.
range from regularly giving part of their income
to good causes to using their spare time to engage
In South Africa, where we provided the prime
both at home and abroad in hands-on projects,
funding for the country’s first lung institute,
such as building homes for the poor.
the company also sponsors children in a Johannesburg childrens’ home as one of its many
activities. In Botswana, the Boehringer
Our subsidiary in Indonesia, which in 2005
Ingelheim Training and Facilitation Centre
provided immediate support to victims of the
in Gabarone continued in 2006 to facilitate
tsunami that devastated coastal regions in South-
important conferences and educational events
East Asia, held its third annual healthcare pro-
for healthcare professionals and government
gramme at its Bogor plant in 2006. The company
officials, especially related to AIDS (“Turning
gave free treatment and medicines for almost 250
the Tide” training programme). The year also
local people, with 20 Boehringer Ingelheim
saw the first pharmacy student commence
employees, three doctors and two nurses dis-
studies at Rhodes University under a Boehringer
pensing healthcare.
Ingelheim-funded programme agreed with the
Botswana government. Pharmacists on the
In the Philippines, we joined forces with Gawad
programme are bonded to take up service in the
Kalinga (GK – “To give care”) as a corporate
public sector after completing their studies.
donor to build homes for less fortunate Filipinos.
Boehringer Ingelheim employees will help build
Americas
homes for the local community over the next
In North and South America, our company
three years.
and employees were engaged in a comprehensive
range of activities. In the USA, this involved
18
our caring culture
Open Day 2006 in Germany
draws record attention
Boehringer Ingelheim holds open days for employees’ families
Open Day 2006 was designed to provide insight into the key
and friends, and the general public. The 2006 events in mid-
technologies for the discovery, development and production of
September at the main German sites, Ingelheim and Biberach,
innovative drugs. There were also guided tours through a range
attracted a record number of visitors keen to find out more
of state-of-the-art buildings, including the company’s plant for
about the research-based company. The opportunity to take a
worldwide production of pharmaceutical substances and the
look behind the scenes in areas normally only accessible to the
new biopharmaceutical production unit.
workforce drew a combined total of almost 25,000 people.
Broader interests were accommodated, too. Those interested
The visitors, many of them enthusiastic children, came to the
familiarised themselves with the company’s own power
Boehringer Ingelheim sites to spend a day meeting the staff,
plant, the water purification plant and the on-site firefighters.
seeing the research and manufacturing facilities and learning
Information on the wide choice of career opportunities at
about the many-sided nature of pharmaceuticals.
Boehringer Ingelheim was naturally provided as well. The
events at Ingelheim and Biberach formed part of the nationwide initiative ‘Responsible Care®’, organised by the National
Federation of the Chemical Industry.
19
In Latin America, our Mexican subsidiary in
2006 concluded its support programme for
educating 6,370 poor children in schools
in Xochimilco (Mexico City) by installing
media rooms.
Our Brazilian company was committed in the
social responsibility programme, “Conectar”,
designed to help disabled people to prepare for
the jobs market, using our human resources
professionals in cooperation with other organisations. It also supported Associação Aliança
pela Vida (Alliance for Life Association (ALIVI))
that provides shelter and care to adults and
Children from St Margaret Clitherow Primary School
children living with AIDS.
receiving their prizes – one first prize and two runner-up
awards – in the 2006 Environmental Art Competition,
Europe
an annual event in which children develop artwork
In Germany, the scope of our community
reflecting the theme of recycling. Run by Boehringer
involvement is very broad, embracing kinder
Ingelheim UK for 10 year-old pupils, the competition
garten provision and assistance for the aged
fosters environmental awareness and supports the
and disabled.
national curriculum for this age group. Five schools in
the county of Berkshire took part in the competition.
The latest cooperation project between our
Biberach site and the charitable organisation
Heggbacher Einrichtungen provided two disabled
volunteering by our employees. A “Day of Car-
people with much needed home improvements.
ing” gave employees at our site in Ridgefield,
Employees of the company’s health and safety
Connecticut, the opportunity to volunteer for
section volunteered their free time to refurbish
tasks to help the aged and deprived. Our US
an apartment.
employees also participated in many sponsored
events to raise funds for good causes.
In the United Kingdom, we have developed
close partnerships with local schools. Our UK
The Boehringer Ingelheim Cares Foundation
employees also donate money to charitable
Patient Assistance programme makes our
causes under a payroll giving scheme and get two
products, worth millions of dollars, available to
days off a year to work on community initiatives.
US patients who are without pharmaceutical
Our Portuguese subsidiary is engaged with an
insurance coverage and who meet certain house-
NGO to support HIV-positive people.
hold income levels. This is geared toward helping
provide medication to those who need them
most, including senior citizens and families
on limited incomes.
20
our caring culture
Modern patronage
Interview with Dr Patricia Rochard
For almost five decades, the Internationale Tage (International
Days) in Ingelheim have offered art enthusiasts a special insight
into different world cultures, the works of individual artists and
important art movements. Exhibitions on specific themes, such
as the art of the South Seas, Japanese woodcuts, Fauvism and
Expressionism, Viennese Biedermeier or the spirit of the 50s
in Paris, not only fired visitors’ enthusiasm with the displayed
works, but also through their conception and educational
qualities.
It all started with the idea of offering people a chance to get
to know the life and culture of other nations and peoples in
an international company setting. The central theme of
cultural openness and continuing education prompted Dr Ernst
What demands do you make of your exhibitions? First of all,
Boehringer, co-owner of the family-owned Boehringer
they must be consistent with the basic idea behind the Inter-
Ingelheim, to stage an annual cultural festival in 1959. The
national Days. That means we can’t make arbitrary choices or
International Days team was subsequently led for almost three
play catch-up, according to events, splendour or fashion trends.
decades by Dr François Lachenal of Switzerland (1918–1997).
On the other hand, we can’t choose subjects that are only acces-
Dr Patricia Rochard, a Frenchwoman who has been managing
address both a wide audience interested in art and the profes-
sible to a small circle of connoisseurs. The primary goal is to
the International Days since 1988, has worked for the
sionals. It’s not always easy to find the right balance, but we
programme since 1975.
make every effort to do so by setting a high standard of quality
Dr Rochard, in 2006 the International Days were devoted to
exhibits.
when preparing the concept and selecting and presenting the
the works of Andy Warhol. How did the exhibition handle the
artist? By bringing together familiar and known dimensions
Has Boehringer Ingelheim some special motivation for
in surprising contexts. This altered perspective highlighted un-
supporting the International Days? The history of the Inter-
familiar and unknown aspects of his work.
national Days is the history of a commitment to culture that is
steeped in tradition, the purpose of which is neither to achieve
Your choice of subjects is extremely varied. Do you have an
short-lived impact nor economic success. This is wholly in
overall concept for the International Days? Rather than an
keeping with the spirit of modern patronage which also enjoys
overall concept, I’d prefer to describe it as a basic or central
the support of the fourth generation of company owners.
idea. As sponsor and patron of the International Days, the owner
family was, and still is, interested in conveying humanistic and
What is the theme of the exhibition in 2007? Picasso – Varia-
cultural values. Thus, diversity, openness, education and insight
tion & Metamorphosis. After Tinguely 2005 and Warhol, the aim
are some of the crucial elements, or main pillars, of this idea.
here is again to highlight a known aspect of Picasso’s work while
The International Days used to be devoted to country-specific
attempting to gain “new” insights into the artist’s approach to
themes. Due to increased mobility in our society and the wealth
work and lifestyle post-1945 by focusing strictly and specifically
of information available, the image of the International Days has
on a few themes and variations on them.
changed considerably since its early days. In recent years, the
focus has increasingly been on themes intrinsic to art.
21
Our environment & employee safety
According to the guiding principles (Leitbild) of Boehringer Ingelheim, the
health and safety of its employees and the protection of the environment has
a very high priority, a fact also underlined by our “Principles on Safety, Quality
and Environmental Protection.” Compliance with company-wide global
standards is regularly checked in audits – a total of 13 in 2006 – by Corporate
Headquarters. Agreed annual targets support the implementation of our
environment health and safety (EHS) policy, which includes the commitment to
the principles of Responsible Care®, a global initiative of the chemical industry.
A corresponding management system ensures
that new, and often highly potent, active ingredi-
not only that legal requirements are satisfied, but
ents with very low exposure limits, can be
also that continuous improvements in EHS are
handled safely without the need for respiratory
achieved at all production sites. In 2006, our
protection.
chemical site in Fornovo, Italy, and the pharmaceutical site in Yamagata, Japan, were certified
But technical measures are not the only way
by external institutions according to the inter-
of protecting the health of personnel. In fact,
national standard ISO 14001.
a review of our accident statistics shows that
the majority of work accidents were not related
For further details of our EHS management
to activities specific to the chemical or pharma-
system please visit www.boehringer-ingelheim.
ceutical industry, but that one third of the
com/ehs
cases involved slips, trips and falls. Our sites in
Germany have addressed this seemingly trivial
The following current examples show how we
problem by initiating a large-scale campaign –
put our policies into practice:
Responsibility for our employees
Highly potent substances that represent a benefit
to patients at low doses, can pose a health risk to
employees in production or development when
inhaled as dust. We therefore set exposure limits
Work accidents
■ Frequency rate =
accidents x 1 million hours / total labour hours
■ Severity rate =
lost labour days x 1 million hours / total labour hours
for all our substances in order to ensure that
none of our employees are exposed to excessive
80
concentrations. During the past year, techno-
70
logical solutions implemented at, for example,
60
our sites in Biberach, Germany; Ridgefield, USA;
50
and Kawanishi, Japan, were designed to ensure
40
4
3
2
1
’02
22
’03
’04
’05
’06
our caring culture
“Boehringer Ingelheim geht sicher” (Boehringer
Product responsibility
Ingelheim walks safely) – that includes a
One of the ways in which we fulfil our obliga-
physical training course. This successful model
tions in respect of product responsibility is
will also be introduced in other countries.
through environmental risk assessments for our
drugs. Product responsibility in the wider sense
Our business partners
also includes the implementation of the Registra-
We do not just focus on Boehringer Ingelheim
tion, Evaluation and Authorisation of Chemicals
personnel. As we have observed that the accident
(REACH) regulation, a cornerstone of the future
rate among the large number of employees from
EU chemicals policy. Over the past year, we
outside companies at our plants is distinctly
started preparing all our European sites for the
higher than for our own employees, we have
implementation of REACH. The objective of the
focused our attention even more closely than
regulation is to enhance the safety of all those
hitherto on the safety of this group of workers.
involved along the product chain and to protect
A revised global policy specifies the ground rules
both consumers and the environment. In future,
for ensuring that these companies endanger
companies will only be permitted to use or
neither themselves nor others. Accordingly, even
market correspondingly registered products.
before an order is placed, as well as during its
execution, we scrutinise the companies to deter-
Minimising environmental impact
mine if they can satisfy our requirements for safe
The importance of reducing carbon dioxide (CO2)
working.
emissions in the future was again highlighted
We have also revised our business process for
November 2006.
at the World Climate Conference in Nairobi in
the qualification of suppliers and third party
manufacturers and expressed clear requirements
Since 2005, Boehringer Ingelheim has managed
related to EHS and social standards.
to improve its own CO2 balance by a quarter,
Energy
■ Energy consumption (in millions of gigajoules)
■ Energy consumption index (in %)
Water
■ Water consumption (in millions of m3)
■ Water consumption index (in %)
120
120
100
100
80
10
60
80
5
8
4
6
3
4
2
2
1
’02
’03
’04
’05
’06
’02
’03
’04
’05
’06
23
thanks to the use of the wood-fired power station
allow us to react quickly and appropriately to
in Ingelheim, Germany. In addition to power
different incidents. Last year, we established
generation, energy efficiency is considered in the
an additional crisis management plan to be
construction of new buildings. A recent example
prepared in case of pandemics.
is the new pharmaceutical development building
in Biberach, which opened in 2006 and opti-
In this report we can highlight only a proportion
mises energy efficiency through heat recovery and
of the variety of our EHS activities. We con-
other measures. The latest illustration of this
stantly deal with further topics, which are
approach is provided by a new administration
described on our website at www.boehringer-
building currently under construction in Ingel-
ingelheim.com/ehs
heim. The building’s energy needs will be met by
an environment-friendly geothermal system: the
Awards
energy will be obtained by means of 32 brine-
Our site activities yet again received external
filled earth probes inserted into 100-metre-deep
recognition in 2006: the chemical site in Malgrat
shafts.
was awarded by the Spanish chemical industry
Crisis preparedness / incidents
programme. The US pharmaceutical site in
association for its successful accident prevention
Boehringer Ingelheim does everything in its
Bedford, Ohio, was rated among the top “Healthy
power to avoid incidents. Indeed, no major in-
50 companies” in Ohio. The Animal Health
cidents were reported in 2006. However, should
site in St. Joseph, Missouri, USA, received an
a crisis occur, there are plans in place which
award for exemplary wastewater treatment.
Carbon dioxide (CO)
■ CO2 by energy purchased (in 1,000 tonnes)
■ CO 2 by process emissions (in 1,000 tonnes)
■ CO2 emissions index, direct emissions (in %)
(without company car fleet)
Volatile organic carbon (VOC)
■ VOC emissions, non-halogenated (in tonnes)
■ VOC emissions, halogenated (in tonnes)
■ VOC emissions index (in %)
120
120
100
100
80
80
500
60
400
800
300
600
200
400
100
200
’02
24
1,000
’03
’04
’05
’0
60
’02
’03
’04
’05
’0
our caring culture
The pharmaceutical site in Shanghai, China,
information, we will show on our website the
was presented with an award for its exemplary
contributions made by our individual business
segments – Chemicals, Biopharmaceuticals and
energy-saving efforts.
Pharmaceuticals Production – to the respective
Facts and figures
indicators.
The graphs on these pages show our performance
figures for the last five years.
Over the last few years, most indicators have
reached a stable level because many previous
The key parameter for our performance in
technical or organisational improvements
occupational safety is the accident rate relative
resulted in an already high performance stand-
to hours worked. As the graph shows, this
ard. Many of our ongoing efforts are no longer
has remained at the same level as in previous
reflected in our performance data as clearly as
years and is well below the average of about
during the earlier years. In 2006, we observed
seven accidents/million hours worked for the
a noticeable increase in hazardous waste and a
European chemical industry.
decrease in the recycling rate. This effect can be
Our environmental impacts are shown both as
wood-burning in the Ingelheim power plant.
absolute values and relative to production –
While in the past the slag could be reused for
represented in our production index. The calcu-
filling salt deposits, it is now brought to landfill
mainly ascribed to the disposal of the slag from
lation of the index was slightly revised in 2006.
sites. For a more detailed explanation of the
Our new baseline year is 2000. As additional
individual graphs, please visit www.boehringeringelheim.com/ehs
Disposed waste
■ Domestic waste (in tonnes)
■ Hazardous waste (in tonnes), incl. pharmaceutical waste
■ Disposed waste index (in %)
■ Recycling rate (in %)
Wastewater — chemical oxygen demand (COD)
■ COD load before treatment (in tonnes)
■ COD load after treatment (in tonnes)
■ COD load (after treatment) index (in %)
80
100
60
90
40
20
80
25,000
8,000
20,000
6,000
15,000
4,000
10,000
2,000
5,000
’02
’03
’04
’05
’0
70
’02
’03
’04
’05
’06
25
Our goals
An additional state-of-the art treatment step will
We shall continue to invest in closed systems in
make the process more effective, will increase
order to protect our employees handling highly
nitrogen removal by improving the nitrification/
potent substances. Corresponding modifications
denitrification process, and will also target the
in the two pharmaceutical sites in the USA, as
specific halogen-containing wastewater which is
well as in Ingelheim, are planned for 2007/08.
difficult to treat when using only conventional
technology.
There is also potential for the reduction of emissions of volatile solvents (VOC) to the air. We are
Energy savings represent another priority issue:
making changes at our chemical site in Spain,
the new laboratory and administration building
where VOCs will be eliminated in future through
at our production site in Bedford, Ohio, will be
thermal oxidation rather than by scrubbing with
constructed in accordance with the Leadership
aqueous media. In Ingelheim, too, additional
in Energy and Environmental Design (LEED)
plants are to be connected to the existing incin-
standards, a recognised rating system for envi-
erator. Our goal for 2008 is to halve our VOC
ronment-friendly and cost-effective buildings.
emissions.
The goal is to obtain the LEED certification.
In order to adapt our wastewater treatment to
increasing loads, we started a major investment
in our Ingelheim wastewater treatment plant.
26
Our R & D drive
Targeting tomorrow’s therapies
The evolution of concepts for cancer treatment into targeted therapies has changed the
chances for some cancer patients drastically. New cancer treatment options may help to
transform an acute, deadly disease into a chronic one. There is hope that in future more
and more patients will at least be able to live with their cancer and survive into old age.
“Patients and their doctors have many new opportunities and there are some excellent drugs
available and even better ones under development,” says Professor Aimery de Gramont of
the Hôpital Saint-Antoine, Paris, an internationally recognised centre for cancer treatment.
In research, change is already taking place, with a movement away from concentrating on
tumour types, such as breast, lung or colorectal cancer, towards tumour-specific targets
that can be identified and treated with small molecules or monoclonal antibodies in a variety
of tumour types. Additionally, the combination of cancer medicines seems to be a key to
even better treatment results. Indeed, it looks as if the time for cancer drug development
has never been better, as genomics, proteomics and biomedical analysis have prepared
the ground for tomorrow’s therapies.
By focusing on both biopharmaceuticals and small-molecule drugs, Boehringer Ingelheim
has embarked on a major drive to discover and develop new cancer drugs. “Particularly in
the last few years, Boehringer Ingelheim has become a serious player in the area of oncology,
with a whole range of interesting molecules,” Prof. de Gramont, one of the world’s leading
experts in oncology, says.
As one of the main international cooperation partners for oncology, the Hôpital SaintAntoine conducts clinical studies in cancer patients for Boehringer Ingelheim’s new potential
cancer treatments. The substances belong to the group of small molecules which effectively
target specific enzymes (kinases) that play an important role in tumour growth. Although
oncology is a highly competitive field in which no company has exclusivity for a target, and
there are always several companies working on the same target, Boehringer Ingelheim has
advanced three unique molecules into phase II clinical trials.
BIBF 1120 is a novel triple angiokinase inhibitor. It differentiates from other compounds
of this kind, as it works on three tumour growth factors simultaneously. The compound
inhibits the development of new blood vessels to the tumour (tumour angiogenesis) and in
consequence stops the tumour from growing.
continued on page 30
Professor Aimery de Gramont, Hôpital St-Antoine, Paris, France,
internationally renowned for his expertise in the field of cancer research.
“Boehringer Ingelheim has become
a serious player in the area of oncology,
with a whole range of interesting
molecules,” Professor Aimery de
Gramont.
continued from page 28
BIBW 2992 is a novel dual kinase inhibitor which irreversibly blocks the activity of two
growth factor receptors (EGFR and HER 2). Due to its irreversible binding, BIBW 2992 holds
promise for activity against receptors that have become resistant to first-generation
reversible inhibitors.
BI 2536 is a novel inhibitor of the cell cycle of a cancer cell. Polo-like kinase 1 (Plk-1) is a cell
cycle switch, a kinase enzyme with an important role for guiding proliferating cells through
the cell cycle. BI 2536 inhibits Plk-1 and causes “polo-arrest”, interrupting cell division, thus
causing cancer cell death.
The cooperation between Boehringer Ingelheim and the Hôpital Saint-Antoine is aimed at
optimising the process of drug development in oncology and thus to improve the speed of
clinical development.
“Boehringer Ingelheim is much newer to oncology than other companies we work with,
but the interaction is very meaningful and effective. Decisions can be made quickly and
suggestions are taken up very effectively,” Prof. de Gramont observes about the cooperation.
“Boehringer Ingelheim shows strong commitment to research programmes and long-term
partnerships. This commitment is beneficial for our work and – in the long run – beneficial
for patients.”
30
our r & d drive
One key for three locks
Interview with Dr Chooi Lee
Oncologist Dr Chooi Lee was involved in the clinical phase
I development of one of Boehringer Ingelheim’s promising
potential cancer treatments, encoded as BIBF 1120, when
a research fellow at the Royal Marsden Hospital in London.
Dr Lee, you have worked with BIBF 1120, one of the new
compounds from Boehringer Ingelheim’s research. How would
you describe the effect that the molecule actually has? BIBF
1120 limits nutrition provided to cancer cells by inhibiting the
development of blood vessels to the tumour (tumour angio
genesis). By inhibiting this process, the tumour’s blood supply
can be suppressed which stops the tumour from growing. Some
studies have shown that the tumour is actually dying in the centre
because of starvation due to a lack of nutrition as a result of
decreased blood supply to the tumour.
How exactly does BIBF 1120 work? BIBF 1120 is a so-called
The formation of new blood vessels (angiogenesis) plays a
critical role in tumour growth. Beyond a diameter of about
2 mm tumours are dependent on an adequate blood supply
through newly formed vessels. Inhibition of angiogenesis
via specific pathways thus represents an important strategy in
inhibiting cancer growth and causes the tumour to regress.
triple angiokinase inhibitor which means that it inhibits receptors
that are relevant in angiogenesis and hence in tumour growth.
out there, for example in terms of lower incidents of hypertension
BIBF 1120 inhibits not only one growth factor receptor, but three:
and bleeding complications which are common side effects of
the VEGF, FGF and PDGF receptors. The Boehringer Ingelheim
other antiangiogenic drugs.
compound has therefore a broader range of targets compared to
others in this area.
Do you think that with BIBF 1120 disease progression could
What has been investigated in phase I clinical trial? It was a
patients, who already had standard treatment for their cancer,
dose escalation phase I study to look at the maximum tolerated
and did not have any further treatment options left for their
dose of the drug to evaluate safety and tolerability.
advanced disease, experienced stabilisation of their disease,
actually be stopped? Yes, during Phase I, more than 50 % of the
which is very promising.
In general, the principle of inhibiting angiogenesis is already
known to be effective against cancer, so such a drug would
not be the first on the market. What makes this compound
BIBF 1120 is now in phase II clinical development.
BIBF 1120 so special? It is certainly very special that BIBF 1120
is targeting three growth factor receptors at once, instead of
just one. The data have shown that BIBF 1120 has a unique and
favourable toxicity profile, which is different to the other drugs
Targeting tomorrow’s therapies
31
Our R & D strategy
Research and development has been the foundation of Boehringer
Ingelheim’s success and continues to be the major driver of innovative,
new medicines. One key element of the strategy is to expand the discovery
and development portfolio into new biological entities (NBEs see page 42),
derived out of internal research as well as out of in-licensing efforts
without neglecting to foster internal new chemical entities (NCE) R&D
capabilities. These NBEs are planned to be co-developed with and produced
by our Biopharmaceuticals Division. We have therefore continued to build
up dedicated resources, predominantly in Vienna and Biberach.
Today, we carry out drug discovery in seven
Our licensing functions along the value chain
major therapeutic areas allocated to four major
are supported by interdisciplinary, therapy-area-
R&D sites. Our R&D sites maintain strong
specific advisory and project teams ensuring
responsibility and accountability for their thera-
speed and diligence in objective evaluations, and
peutic areas locally and deploy their innovation
seamless incorporation of partnered projects.
and flexibility. International scientific reviews
and portfolio management ensure a sustainable,
competitive and risk-balanced discovery pipeline.
scientists, technicians and support personnel
To further strengthen our R&D organisation we
in preclinical R&D. They are complemented
have implemented international skill centres to
by about 2,300 clinical monitors, statisticians
improve efficiency and to secure equal access to
and data managers in clinical development
state-of-the-art technologies and informatics
and medical departments.
platforms for all sites.
Boehringer Ingelheim recognises in-licensing
and partnering as a key component of our drive
to deliver novel therapeutics to the market.
While our major licensing focus is in our strategic
therapeutic areas, we very successfully develop
and market products outside these areas as well.
32
Worldwide, we employ more than 3,300
our r & d drive
Our R & D sites
Biberach and Ingelheim,
Germany
CNS, respiratory, metabolism,
non-clinical development
In our largest R&D center in Biberach, more than
1,600 scientists from about 20 nations energise
our research and development while nourishing
the interdisciplinary scientific exchange as on a
research campus. Biberach is the competence
centre for several therapeutic areas: central
nervous system (CNS), metabolic and respiratory
diseases. Furthermore, our Human Pharmacological Center, in operation since 2004, secures an
important link to the clinical investigation of
compounds.
Projects in Biberach benefit from the open and
constructive interaction among our scientists, as
well as with academia and biotech companies,
with whom numerous scientific collaboration
agreements have been signed.
Since developmental aspects are considered early
during drug discovery, the high attrition rate
during the process could be reduced. The
challenges of target validation and clinical proof,
however, remain, but are now actively addressed
by dedicated technology-driven expert groups at
the Boehringer Ingelheim Global Skill Centers
“The key to success is ‘never stop striving for more!’,” comments
Dr Michel Pairet, Senior Vice-President Research in Biberach, on the
ambitious goals for the upcoming year. “We want to see one or two of
our compounds achieving clinical proof of concept, and three to four
compounds to successfully complete phase I clinical trials. What’s
more, we plan to bring four or five new high-quality compounds into
preclinical development. And more: Boehringer Ingelheim regards
it a critical endeavour to fully integrate new biological entities in its
project portfolio.”
Dr Pairet forecasts a busy year of R&D at Biberach: seven new
compounds which have been added to the preclinical portfolio last
year will now have to be further characterised. “In addition, we are
looking forward to having the first compounds coming out of collaborative research with academic groups or biotechs.”
The research teams’ outstanding efficiency is attributed to two main
factors – the company’s size and the fact that Boehringer Ingelheim
is family-owned: “Our scientists have the spirit of freedom to work
and think in the long term, concentrating on true medical need and
compound safety, rather than on glossy presentations to investors.”
For the future, teams will prepare to enter new therapeutic areas for
which there is a high unmet medical need. “With the new structure
we are well prepared for future tasks, since we allocate development
resources on a global basis jointly with our colleagues in Ridgefield.
Germany will, furthermore, be the link between research and
manufacturing, since we have the late stage chemistry manufacturing
and control responsibility for the entire portfolio. Last but not least,
the excellent exchange with our colleagues from research and
medicine position us well for the challenges of a full portfolio,” says
Dr Wolfgang Baiker, Senior Vice-President Development in Germany.
(GSCs).
Development efforts in Germany support the
research centres in Biberach and Vienna with
all early and late development functions. For
increased efficiency, the late chemistry, manufac-
Dr Wolfgang Baiker,
Dr Michel Pairet,
Senior Vice-President
Development,
Research, Germany
Germany
turing and control, as well as the development of
inhalation devices, have been centralised in
Germany for compounds stemming from all
research sites.
Our R & D sites
33
Ridgefield, USA
Cardiovascular, immunology
and inflammation, non-clinical
development
Research and Development at Boehringer Ingelheim Pharmaceuticals, Inc. was established in
1979 and was built up as a centre for immune &
inflammatory diseases. Only a few years ago, in
2003, it also became the R&D competence centre
for cardiovascular diseases.
In the area of cardiovascular diseases, chronic
heart failure, atherosclerosis, hypertension and its
sequelae are targeted. In immunology & inflammation, Boehringer Ingelheim’s focus is on
autoimmune diseases such as rheumatoid arthritis, psoriasis and multiple sclerosis. In the last
three years, the Ridgefield site has seen major
investments in staff and facilities with the aim of
strenghtening the previously mentioned key indication area pipeline.
In order to strengthen our early development
capabilities, a new physical science building has
been erected and is about to be opened. It will
provide a state-of-the-art facility for analytical
science and chemical development.
“My most interesting and satisfying experiences have been seeing the
fruits of our research tested in patients for the first time,” says Paul
Anderson, Senior Vice-President Research at the US R&D centre.
“That is what our work is all about.” Dr Anderson outlines that apart
from the classical research another focus of the efforts in Ridgefield is
the build-up of a pipeline of NBEs (see page 42). Capitalising on the
expertise of the Biopharmaceuticals business, the teams will be able
to advance innovative NBE projects in areas where biological therapeutics can provide important advances.
The confidence in the success is based on solid ground. “The distribution of our seven therapeutic areas to specific sites among our four
major drug discovery centers allows each site to focus, with a critical
mass, on the therapeutic areas under its responsibility, and gives each
site the focus and autonomy of a biotech company with the resources
and backing of a major international pharmaceutical company,” he
stresses.
There is a positive picture for what is to come: “In recent years, we
have successfully built a truly globalised development structure which
has strengthened our non-clinical development in Ridgefield. Our
new physical science building adds an important capability to achieve
our goal of supporting research in Ridgefield and Laval, but also adds
the needed capacity in development worldwide. Our experience in
working closely with research colleagues provides an important advantage and drives the rapid and efficient development of compounds in
our therapeutic areas,” notes Dr Peter Farina, Senior Vice-President
Development at Boehringer Ingelheim, Ridgefield.
With the aim of benefitting all of our global
research sites, Boehringer Ingelheim has recently
established global skill centers (GSCs) to strengthen
its position in technology areas of strategic importance. Ridgefield has established the GSC for high
Dr Paul Anderson,
Senior Vice-President Research, USA
throughput cloning and expression and shares
responsibility for the alternative lead identification and compound pool optimisation the GSCs
Dr Peter Farina,
with Biberach, Germany.
Development, USA
34
our r & d drive
Laval, Canada
Virology
Boehringer Ingelheim’s Research Center in Laval
is one of Canada’s largest pharmaceutical research
sites. Located near Montreal, over 130 scientists
and their complementing support staff are
Boehringer Ingelheim’s experts for discovering
potential treatments for chronic and acute viral
diseases for which either no vaccine exists or
current therapy is lacking or unsatisfactory. The
teams in Laval are dedicated to advance therapeutics for diseases caused by the hepatitis C virus
and the human immunodeficiency virus (causing
AIDS).
HIV research in Laval aims to complement
Boehringer Ingelheim’s portfolio of existing HIV
treatments, e. g. viramune® (nevirapine, a nonnucleoside reverse transcriptase inhibitor) and
aptivus® (tipranavir, a protease inhibitor). Further
compounds under development will be added to
the armentarium of drugs to treat HIV-positive
patients, particularly those where prior therapy
has failed due to development of a resistance.
State-of-the-art technology in the key areas chemistry and biological sciences, such as the nuclear
magnetic resonance (NMR) and X-ray technology,
as well as computer-aided image analysis, push
projects forward.
“What is most rewarding in my position is to receive
the positive response from collaborators regarding our
scientists and projects – and it’s humbling. Universally,
I hear our scientists’ high level of motivation, and the
obvious excitement they get from the science that they
do is unique,” relates Dr Michael Cordingley, Senior VicePresident Research, about the teams in Laval.
By capitalising on research with first molecules in
hepatitis C in recent years and by implementing even better
technology to ferret out bad actors early, the teams will
continue to consolidate the strong position in hepatitis C
virus protease inhibitor and polymerase inhibitor development in 2007. “We will also strengthen our activities
within our collaborative programme, for example with the
Australian biotech Biota Holdings, for additional complementary targets.”
The work is far from done in the HCV area. Current treatment options still carry the serious safety and tolerability
problems associated with the standard care. “Our aspiration therefore is to introduce oral combination therapy
which will deliver patients effective and well tolerated
oral treatments, rather than inconvenient injectables.”
The focus in Laval is on discovering antivirals with complementary mechanisms suitable for use together to combat
resistance and provide durable efficacy and safety. “Overall,
we aim for nothing less than providing safe and effective
novel oral medicines to improve treatment outcomes for
HCV and HIV-infected patients,” emphasises Dr Cordingley.
The increase in the number of research projects in
Laval are being complemented by the extension of
the research facility to about double the size. The
building is planned to be inaugurated in early
2008.
Dr Michael Cordingley,
Senior Vice-President Research,
Canada
Our R & D sites
35
Vienna, Austria
Oncology
Boehringer Ingelheim’s dedicated drug discovery
center for innovative cancer medicines is located
in Vienna. Oncology was created as a new therapeutic area at Boehringer Ingelheim in response
to the substantial unmet medical needs of cancer
patients and the tremendous advances in understanding cancer biology, fuelled by the human
genome project, with new insights into cancer
genes and the biochemical signalling pathways
gone awry in malignant cells.
Research in Vienna reveals that scientific excellence and the ambition to discover and develop
new medicines are not limited by national borders:
the more than 200 researchers in Boehringer
Ingelheim’s laboratories come from more than a
dozen countries worldwide. Together with the
global development center in Biberach and colleagues in Medical, the discovery teams are committed to new treatment choices for patients (with
locally advanced or metastatic cancers).
The oncology research campus is part of the
Regional Center Vienna, which has business
responsibility for Austria and twenty-nine
countries in Central and Eastern Europe. From
Of the nearly 25 million people diagnosed with malignant
cancers worldwide, more than half can be treated today
with long-lasting benefit; however, “close to seven million
cancer deaths per year are simply not acceptable,” explains
Dr Wolfgang Rettig, Senior Vice-President Research in Vienna.
“Available treatment options, particularly surgical inter
ventions, are least promising when the cancer has spread to
distant organs, and at this stage of the disease the need for
more effective, targeted therapies with fewer side effects
becomes plainly visible. One in every three women and one
in every two men will be diagnosed with a malignant cancer
during their lifetimes, and this is a challenge we take very
personally,” Dr Rettig states.
The time for finding better cancer medicines has never been
better for Boehringer Ingelheim, since the company can build
on a very strong scientific foundation provided by academic
research centers worldwide. “Nevertheless, the road ahead is
long and arduous,” Dr Rettig forecasts. Boehringer Ingelheim has entered the field of oncology with the persistence
and long-term vision possible for a family-owned group
of companies, and the outlook for patients is therefore
promising. Already, some cancer types are being treated
very effectively with targeted drugs, although not all
patients benefit equally. According to Dr Rettig: “With many
additional drugs in development, this trend will improve,
and we will continue to change the face of cancer, turning it
into a chronic disease with improved quality of life, one
step at a time.”
2000 to 2007, a highly modern, state-of-the-art
research infrastructure has been built up at the
Regional Center. Only recently, a new biology
research building has been opened, which
complements the chemistry research building
inaugurated in 2002. Within a very short timespan, innovative drug candidates from in-house
research – both small-molecule chemicals and
human monoclonal antibodies – have been
advanced into development, including three
compounds currently in phase II clinical trials.
Dr Wolfgang Rettig,
Research, Vienna
36
our r & d drive
Our support centres
Kawanishi, Japan
Molecular biology,
non-clinical development
One of Boehringer Ingelheim’s centres for molecular cell biology is located in Kawanishi, Japan.
Kawanishi is specialised in membrane receptor
targets providing dedicated support for drug
discovery activities. International development is
supported by early pharmaceutical work and analytical sciences. Furthermore, Kawanishi serves as
a skill center to characterise how drugs interact
with transporter molecules in the body.
Research Institute of Molecular Pathology
(IMP), Vienna, Austria – an independent
basic research institute
The bridge between our R&D people and academia is rein-
Milan, Italy
Chemical synthesis
forced by the strong link to the renowned Research Institute
of Molecular Pathology (IMP) in Vienna. IMP scientists are at
the forefront of discovery defining fundamental processes
of cell division and differentiation in healthy and diseased
The Chemistry Research Center Milan, Italy, with
states. In 2001, collaboration started between the IMP and
about 30 employees, contributes to advancing
the Institute of Molecular Biotechnology Austria (IMBA),
research at an important stage of the process,
which added a new dimension to our academic network.
namely by providing expertise in synthesis in
exploratory projects and lead optimisation projects
for Biberach.
Buenos Aires, Argentina
Non-clinical development
Our support center in Buenos Aires operates in
close cooperation with the Ridgefield development site and also provides assistance to production plants in Argentina, Brazil, Colombia and
Mexico. From Buenos Aires comes added support
on drug formulation and the manufacture of
medication for clinical trials.
Our R & D sites
37
Our expertise in landmark studies
Landmark studies are large-scale, randomised, controlled clinical trials for thousands
of patients recruited from a great number of sites around the world. Results have a
potential to broadly impact on clinical practice. All in all, in the last decade Boehringer
Ingelheim conducted or sponsored some 1,400 studies involving approximately
1.2 million patients in 59 countries in all regions of the world.
Among these studies, the ontarget™/
The largest secondary stroke prevention study
transcend®, profess®, uplift® and
profess® exceeded its recruitment target and
re-volution® trial programmes are land-
has now enrolled 20,333 patients. The primary
mark studies. They progressed according
endpoint of this trial is time to first recurrent
to plan in 2006.
stroke. profess® compares the efficacy and
The ontarget™ trial programme, the cardiovas-
extended-release dipyridamole) with clopidogrel,
cular protection study with micardis® (telmisar-
and additionally of micardis® (telmisartan) with
tan), our angiotensin II receptor blocker, had
a placebo. First results are expected in 2008.
safety of aggrenox® (25 mg ASA/200 mg
recruited over 31,000 patients by 2004, the end
of the recruitment interval. Since then, patients
have been followed up with regular clinical
examinations and are now in the last year of
observation. The primary target of the study is
Every single step matters
Interview with Dr Salim Yusuf
to determine if the combination of micardis®
What will the landmark trial ONTARGET™ mean for patients?
and the angiotensin-converting enzyme (ACE)
The ONTARGET ™ trial programme is set up to investigate the
inhibitor ramipril is more effective in reducing
potential benefits of the combination of the angiotensin-II
myocardial infarction, stroke, heart failure and
receptor blocker telmisartan (ed: MICARDIS®) and the ACE
cardiovascular death compared with ramipril
inhibitor ramipril in reducing myocardial infarction, stroke, heart
alone, and, if micardis® 80 mg is at least as
failure and cardiovascular death. We also have a parallel study
effective as ramipril 10 mg daily.
called TRANSCEND® where people who can’t take ramipril receive
either telmisartan or placebo. So between these two trials we
Among the secondary endpoints are newly
will learn whether telmisartan is at least as good as ramipril,
diagnosed congestive heart failure, the need
and whether the combination is more effective. This is important
for cardiovascular revascularisation procedure,
because ramipril has some side effects and a significant propor-
newly diagnosed diabetes, cognitive decline and
tion of people can’t tolerate it. If telmisartan is as good as rami-
dementia. The transcend® trial with micardis®
pril, but is tolerated better, that is a positive finding for patients.
versus a placebo looks into the same endpoints
The second possibility is that telmisartan when added to ramipril
but is focused on patients who cannot tolerate
will have more benefit than either drug alone. That would be the
an ACE inhibitor and may benefit from an angio
most exciting finding if confirmed.
tensin II receptor blocker instead. Results are
expected in 2008.
38
our r & d drive
uplift® is our 6,000-patient, long-term outcome
re-volution®, the clinical trial programme in
study with spiriva® (tiotropium bromide), a
thrombo-embolic disease, involves more than
novel once-daily inhaled anticholinergic for the
27,000 patients and investigates dabigatran
maintenance treatment of chronic obstructive
etexilate, an orally available thrombin inhibitor
pulmonary disease (COPD). The trial has been
for the prevention and treatment of thrombo-
set up to prospectively confirm that spiriva® has
embolic diseases. Studies cover the prevention
the potential to positively influence the progres-
of deep vein thrombosis following orthopaedic
sion of COPD over time. The primary endpoint
hip or knee replacement surgery, as well as
is the rate of decline in forced expiratory volume
treatment of thromboembolism, secondary
during the first second of exhalation (FEV1)
prevention of thromboembolism and stroke
over four years in COPD patients. This study is
prevention in atrial fibrillation. The studies are
explored to be completed in 2008 as well.
scheduled for completion between 2006 and
2009.
Do you think that patients will understand the importance of a
McMaster University to make this an efficient process managing
“prevention treatment”, i.e. taking tablets for a condition which
some one and a half to two million pages of data every year. With
does not hurt before infarction or stroke may occur?
ONTARGET ™ we will publish a large number of scientific paper
The people in ONTARGET ™ have all had a heart attack or stroke,
and analysis will go on for many years after the first announce-
coronary disease or diabetes or some complications, or are
ments of data in 2008.
at high risk of developing these. These are patients who need
multiple approaches to prevent cardiovascular disease. Think of
Salim Yusuf, Professor of Epidemiology and Cardiology at
it like climbing a staircase: every step matters. One step alone
McMaster University in Hamilton, Ontario, Canada, leads
won’t do.
the research team for Boehringer Ingelheim’s ONTARGET™
trial programme. Here he discusses the long-term project.
How is the flood of information in this trial processed?
We have more than 700 trial centres in 41 countries. Data comes
in on 40 fax lines open to receive data continuously day and
night. The data are automatically screened and scanned by an
intelligent optical recognition system which enters them into a
special software for a first-level data check. Next, our specialists
check to see if there are things the computer missed. Some 180
individuals, research assistants, research coordinators, medical
officers, statisticians, programmers and administrative staff
collaborate here at The Population Health Research Institute at
Our expertise in landmark studies
39
From mind to man – the R & D process
It seems almost as impossible as finding a needle in a haystack.
Target validation
From more than one million screened molecules, only one
To select targets most likely to be useful for the treatment of a
will eventually enter the market as an approved medication.
disease, researchers compare each drug target to others based
Drug discovery, pre-clinical and clinical development take
on their association with a specific disease and their ability to
about 12 years and an average investment of USD 800 million.
regulate biological processes in the body. Tests confirm that
The development of a drug from mind to market has to
interactions with the drug target effect the desired change in
successfully pass through the stages described below.
the behaviour of the diseased cells.
Lead identification
Research
Laboratory assays are developed that allow a rapid screening
of small molecules or proteins. Screening of chemical libraries
Target identification
representing larger or smaller cellections of molecules that
Drugs usually act on cellular proteins, such as enzymes or
with drug-like properties will identify leads, compounds that
receptors, known as drug targets, which are believed to be
specifially bind to the desired target.
associated with a disease. Scientists use a variety of molecular,
genetic or pharmacological techniques to identify a target
Lead optimisation
and learn more about how it influences the disease.
Improvement of the properties of the identified leads in order
to support the selection of those compounds with the greatest
potential to be developed into safe and effective medicines.
The best lead compounds are studied for their therapeutic
effects and how they are absorbed, metabolised and excreted
in living organisms.
research
basic research (academia)
and exploratory research
(industry)
years ›
development
target
target
identification validation
1
2
pre-clinical
development
phase I
lead
lead
identification optimisation
3
4
5
6
phase II
7
8
our r & d drive
Phase III
Development
Phase II results on efficacy and safety are refined and
confirmed in larger patient numbers (several thousands) and
Pre-clinical development
Profiling of the drug candidate with regard to safety according
to regulatory requirements prior to first use in humans is per-
surveillance of long-term treatment as appropriate for the
indication.
formed. A chemical synthesis is developed and scaled up to
provide the necessary drug quantities for further development
and testing. The best dosage form for administration to patients and a suitable pharmaceutical formulation are identified.
Registration / life cycle management
Regulatory approval
After clinical studies, results are submitted to regulatory agen-
Phase I
Clinical trials, normally performed in healthy volunteers,
provide results on the absorption, distribution in the human
body and excretion of an investigational compound, and on
short-term tolerability and safety, in order to determine a
preliminary dose range. Boehringer Ingelheim has two Human
Pharmacological Centers in operation in Germany (Ingelheim
and Biberach).
cies. Independent experts give their opinion on whether or not
the drug product should be approved.
Phase IV (life cycle management)
The product is further profiled for more general and broader
real-life usage, in special patient subgroups and in the context
of an even broader concomitant therapeutic environment.
These trials may be extremely large (10,000—30,000 patients)
and therefore can better identify even rare adverse reactions.
Phase II
Efficacy and safety in the target indication is established with
up to several hundred patients usually treated for several weeks
or a few months. These studies allow the determination of the
potential therapeutic dose range.
registration
regulatory
approval
phase III
9
10
11
12
phase IV (life cycle management)
13
14
15
New biological entities (NBE)
Boehringer Ingelheim is widely recognised as a
Our current NBE discovery programme includes
world leader in all aspects of biopharmaceutical
some ten projects, a first step towards a steady
manufacturing, from early process development
stream of innovative NBE therapeutics in
to large-scale commercial manufacturing in
our development pipeline. Good progress was
microbial as well as mammalian expression
achieved during 2006 with several projects
systems. Combined with our disease expertise,
across multiple therapeutic areas moving to the
our strategy is to create a comprehensive and
lead optimisation and pre-development stages.
proprietary NBE programme, thus addressing
We are also pursuing a number of biotechnology
unmet medical needs in several indication areas
collaborations to sustain and strengthen future
and expanding our proprietary NBE product
delivery of quality NBEs. With FivePrime Thera-
portfolio beyond actilyse®, metalyse®, imukin®
peutics we are conducting a high-throughput
and beromun®.
functional screen of their proprietary library
of secreted proteins and receptor ectodomains
To fully exploit our internal synergistic potential,
to identify novel NBE targets for rheumatoid
we have established expertise in human antibody
arthritis. We are also currently looking into
drug discovery facilitated by in-licensing key
new alliances on technologies that will help
technologies from MorphoSys (phage display)
us develop high-quality NBEs as a complement
and Medarex (genetically modified mice). We
to our successful alliances with Medarex and
have also strengthened our protein technology
MorphoSys.
infrastructure and allocated dedicated biology
resources.
One of the fastest drug developers
Pharmaceutical companies that develop and launch new
them to ever more complex studies, and were better at setting
products faster than their competitors perform consistently
resource priorities, the survey revealed.
better across a number of dimensions, earn higher revenues,
and have lower development costs. These findings were
reported in a newly-completed analysis of the period 2000 to
2005 from the Tufts Center for the Study of Drug Development,
based in Boston, USA.
“We have in the last few years noted an increase in our R&D
productivity, as measured by increased output of compounds,
better project success rates and a growing R&D portfolio.
The Tufts survey addresses speed as yet another productivity
parameter. The data further supports the notion that our
Boehringer Ingelheim was represented amongst a group of
international R&D strategy is on the right track,” says
the fastest pharmaceutical companies. All of the fastest
Dr Mikael Dolsten, Executive Vice-President Pharma Research
companies shortened their development and regulatory cycles
by as much as 17 months, compared to average-performing
of Boehringer Ingelheim. “In view of the very high R&D costs
– one reckons presently with more than EUR 800 million for
drug developers. They had far less development and regulatory
the development of a new drug – the speed to get valuable
time variability, stopped projects sooner, instead of moving
drugs to the market is crucial, and may give us another competitive edge over other pharma companies.”
42
our r & d drive
Biomarker and pharmacogenetics
Realising the importance of biomarkers and
In pharmacogenetics the genetic variation
pharmacogenetics from early discovery phase
between patients is studied in order to explain
to post-launch in delivering more and safer
potential differences in the response to drugs.
medicines with good and predictable efficacy
This area is becoming increasingly important for
to patients, this area receives particular attention
understanding efficacy and side effects for the
in Boehringer Ingelheim. Biomarkers give an
individual patient, with a particular focus on
objective read-out for drug target binding,
polymorphisms (i. e. having multiple alleles of a
immediate downstream physiological effects
gene within a population) in the drug target itself,
(pharmacodynamic biomarkers), pathological
as well as in drug metabolising enzymes and
processes (disease biomarkers) or drug-induced
drug transporters. In 2006 Boehringer Ingelheim
side effects (safety biomarkers). This is
started to put in place a strong infrastructure to
particularly helpful in early clinical development
support our clinical development project teams
as a tool to obtain an early indication of drug
to efficiently use biomarkers and pharmaco
effectiveness and safety. Biomarkers are typically
genetics. The newly built function includes
recorded by clinical chemistry measurements
laboratories for clinical chemistry and pharma-
or physiological responses in animal models
cogenetic analyses, and will provide capacity for
and patients. Boehringer Ingelheim is increas-
fully automated long-term storage of several
ingly exploring cutting-edge technologies
million anonymised DNA samples obtained from
for biomarker assessment, including imaging,
patients during clinical development. The new
expression profiling and proteomics in our
function also includes a state-of-the-art sample
discovery and early development projects.
logistics infrastructure and data mining and
modelling capabilities.
New biological entities (NBE) / Biomarker and pharmacogenetics
43
The development of
our businesses
We have committed ourselves to the goal
of serving mankind through research into
diseases and the development of new drugs
and therapies in the areas of human pharmaceuticals and animal health. Our businesses
follow our patient-orientated approach. They
are divided into two main business areas:
Human Pharmaceuticals, that accounts for
96 % of our business, and Animal Health that
accounts for 4 % of our business.
Net sales (in EUR million)
2006
2005
Growth
in %
10,200
9,174
1,026
11 %
Prescription Medicines
8,311
7,247
1,064
15 %
– Branded Prescription Medicines
7,654
6,712
942
14 %
– Generic Prescription Medicines
657
535
122
23 %
1,064
1,052
12
1 %
809
847
-38
-5 %
Consumer Health Care
Industrial Customer
— Pharma Chemicals
— and Pharmaceuticals Production
306
299
7
2 %
— Biopharmaceuticals
503
548
-45
-8 %
Others
Animal Health
Total
44
16
28
-12
-43 %
374
361
13
4 %
10,574
9,535
1,039
11 %
Serving patients
Rin Fujima, Kyoto, Japan, suffers from high blood pressure,
a serious risk for the brain, heart and kidneys.
“I can do so much by exercising and
having a healthy life style, but I also
need effective medicine to lower my
blood pressure,” Rin Fujima
“I wake up refreshed ...”
“When I woke up in the morning, I no longer felt refreshed from sleep. I went to my doctor Haruteru
Hasuo who found that my blood pressure was far too high. Fortunately, apart from high blood
pressure, my checkup revealed no other disorders, such as hyperlipidaemia or diabetes,” recalls
Rin Fujima, a 60-year-old housewife living near Kyoto. She was prescribed an angiotensin-II-receptorblocker to control her blood pressure. “I now measure my blood pressure before taking my
medication every morning. I’ve seen great improvement.” After taking the medication things got
back to normal for her.
However, high blood pressure or hypertension is not only an unpleasant condition. It is possibly also
the first sign of a serious cardiovascular risk that can be the precursor to stroke and heart attack.
Uncontrolled, this 24-hour condition can cause damage to vital organs, such as the heart, kidneys or
brain, over the long term. Sharp rises in blood pressure occur in the early hours, coinciding with an
increase in life-threatening heart attacks and strokes.
“We know that more than half of the patients who appear to have well-controlled blood pressure
are not effectively protected when their blood pressure is measured over a 24-hour period,” notes
Professor Toshiro Fujita, chairman of the department of internal medicine at the graduate school
of medicine and faculty of medicine, University of Tokyo. “There is a need for patients to receive
powerful blood pressure lowering treatments that work over the full 24-hour period,” he urges.
“I can do so much by exercising and having a healthy life style,” says Rin, “but I also need effective
medicine to lower my blood pressure. I’m convinced that my new treatment and my new way of life
now complement each other. And I wake up refreshed like I used to.”
Cardiovascular disease remains the No. 1 cause of death globally and is responsible for every one in
three deaths worldwide – an estimated 17 million people a year. It is also a major cause of disability,
and contributes significantly to the escalating costs of healthcare.
48
serving patients
Branded prescription
medicines
Respiratory diseases
Respiratory diseases have long been a major focus
Boehringer Ingelheim is recognised as an innova-
area for Boehringer Ingelheim and we dedicate
tive company which discovers, develops and mar-
ample resources to research in this field. Our main
kets new medications. We focus on the therapeutic
objective in pulmonary research is to further
needs of our ultimate customer, the patient.
improve treatment options for chronic obstructive
pulmonary disease (COPD) and asthma.
During 2006, we continued to build and
strengthen our clinical development programme
by including nearly 40,000 patients in (Good
COPD and asthma
Clinical Practice) clinical trials of phase I to IV.
COPD is currently the fourth most common cause
With these new patients included the number of
of death, yet up to three-quarters of sufferers in
patients actively engaged in clinical trials exceeded
Europe and 45 % in the USA go undiagnosed. This
50,000 patients on average every day throughout
suggests a major unmet need for treatment for
the year.
this debilitating lung disease.
Currently, our focus is on the following therapeu-
The major xxxx
cause ofofCOPD
tobacco smoking. The
USA
which:is
Americas
tic areas: respiratory diseases, central nervous
xxxx with an ongoing decline in
disease is progressive
system (CNS) diseases, virology, cardiovascular
lung function, which results in increasing breath-
diseases, immunology/inflammation, oncology,
lessness, reduction in the capacity to exercise, and
metabolic diseases and urology.
a subsequent diminishment of quality of life.
Top products
Branded prescription medicines
Net sales 2006
Sales of branded prescription medicines
by therapeutic area
in millions of EUR
change
1,381
+45.2 %
micardis®
967
+33.6 %
flomax®
922
+27.8 %
combivent®
671
+19.6 %
mobic®
579
-31.8 %
sifrol®
536
+23.4 %
spiriva®
viramune®
276
-4.1 %
atrovent®
263
+5.4 %
aggrenox®
225
+30.9 %
catapresan® 217
+23.7 %
Gastrointestinal/
metabolic 3.0 % Others 1.9 %
HIV 4.4 %
Central nervous system
9.8 %
Respiratory
37.1 %
Muscoloskeletal/
rheumatology
7.7 %
Urology
12.6 %
Cardiovascular
23.5 %
49
Boehringer Ingelheim’s respiratory portfolio con
Our clinical studies in respiratory diseases
sists of major COPD and asthma products:
The year 2006 was highlighted by several import-
spiriva® (tiotropium bromide), combivent® (ipra
ant successes in the spiriva® clinical trial pro
tropium bromide / salbutamol) and atrovent®
gramme. The importance of spiriva® for the
(ipratropium bromide).
treatment of COPD was focused on by over 70
publications, including review articles and
spiriva® is a once-daily inhaled medicine recom
abstracts. Several publications from primary and
mended for first-line regular treatment of COPD.
secondary data analyses were issued, including
It contains an anticholinergic agent which acts on
the publication of the one-year mistral® trial in
airway constriction, a dominant mechanism in
France in which spiriva® demonstrated signifi
COPD. It opens the narrowed airways of COPD
cant reductions in COPD exacerbations.
patients for a full 24 hours to help patients to
breathe more easily, thereby positively impacting
Important clinical trial data presented in 2006
the clinical course of COPD and helping to change
also demonstrated significant improvements in
the way patients live with their disease. It is the
lung function in patients with milder disease
first inhaled treatment to provide significant and
symptoms and those diagnosed with both COPD
sustained improvement in lung function with
and asthma. Both patient populations are consid
once-daily dosing.
ered important patient groups who may be under
treated with required inhaled anticholinergics.
In 2005, spiriva® became Boehringer Ingelheim’s
first blockbuster medicine, that is one with annual
uplift®, the global 6,000-patient landmark study
turnover exceeding USD 1,000 million. spiriva®
with spiriva®, is investigating the drug’s potential
to impact the course of the
posted growth in net sales
to EUR 1,400 million, or
USD 1,700 million, in 2006.
spiriva®
expanded
its
position as a global medi
cation for COPD. With the
successful launch of the
product in France in 2006,
spiriva®, which is globally
co-promoted with Pfizer
Inc., is now available to
spiriva® is a novel anti
cholinergic medicine
recommended for first-line
regular treatment of COPD.
It is the first inhaled treatment
to provide significant and
sustained improvement in
lung function over 24 hours
with once-daily dosing.
disease by slowing the
decline
in
pulmonary
function, which is one of
the devastating conse
quences of COPD. All
parameters of good clini
cal trial conduct indicate
that this study will suc
cessfully enter its last full
year of follow-up in 2007
patients in most countries
and be completed in
of the world. About six
2008.
million patients affected
by COPD worldwide have
On the basis of excellent
been treated with spiriva®
clinical study results, the
in 2006. This reflects
European
the benefits spiriva®
spiriva®
provides
was extended to include
to
COPD
patients.
50
label
for
HandiHaler®
the improvement of physi
serving patients
“I feel now like another man”
“I have smoked for 30 years which has left me with chronic
obstructive pulmonary disease,” says seventy-year-old Frenchman
Jacques Luchier, a retired food industry bacteriologist. “The first
time I met my pulmonary specialist and he told me I had very
severe COPD, I was caught completely off guard. I was scared,
as you think about death and that you’ll end up in a hospital bed
with tubes everywhere to keep you alive.”
COPD causes significant deterioration of lung function resulting
in breathlessness, activity limitation and associated disability.
Some 600 million people currently live with COPD, and the
disease is projected to be the world’s third leading cause of death
by 2020.
Jacques Luchier started treatment with a novel bronchodilator.
He also undertakes respiratory rehabilitation which consists of
regular supervised exercise, education on COPD and its treatment, breathing techniques, as well as nutritional and psychological support.
“The respiratory rehabilitation is very hard to cope with at the
start. You have to really make an effort,” Jacques says. “But you
get to improve your quality of life by inhaling the bronchodilator.
You feel relief, you breathe better, you feel more yourself, you
recover your spirits”. And he adds: “Now I feel like another man.
I feel distinctly better. I feel less handicapped.”
cal exercise capacity and the reduction of exacer-
of the drug in the lungs is improved and less
bations in COPD. spiriva® is now the first COPD
deposition occurs in the mouth and throat com-
drug which incorporates information about exac-
pared to pressurised metered dose inhalers. Atti-
erbations and exercise in a broad population of
tudes of patients show a high level of satisfaction
COPD patients on its label.
with this device.
spiriva® is currently delivered to patients via our
After completion of the pivotal studies for spiriva®
HandiHaler® device. In future, patients will also
in our propellant-free respimat® SMI we have
be able to benefit from spiriva® delivered via
submitted a registration file in the EU under the
Boehringer Ingelheim’s respimat® Soft Mist™
“decentralised procedure” and in addition in sev-
Inhaler (SMI), a novel propellant-free, multi-dose,
eral other countries around the world. The com-
inhaler that generates a slow-moving, long-last-
pletion of the US submission will be one of our
ing cloud (the soft mist) with a high fine particle
key activities for 2007.
fraction (less than 5.8 μm). As a result, deposition
51
Our R & D for respiratory diseases
Our worldwide launch of spiriva® (tiotropium)
provided a medication to improve COPD therapy
and strengthened our leading position in this field.
We are striving for further innovations by developing bronchodilators with alternative mechanisms. These new bronchodilators are being formulated in innovative inhalation devices.
In addition, Boehringer Ingelheim in 2006 entered
into a worldwide collaboration, development and
licence agreement with the British company
Vectura. The aim of the collaboration is to develop
a multi-dose dry powder inhaler as a Boehringer
Ingelheim branded device, to deliver a range of
proprietary Boehringer Ingelheim respiratory
products, mainly for the treatment of COPD and
asthma. We currently have numerous broncho
dilator programmes in development, six of them
in clinical studies.
Extending our product portfolio to drugs that
target treatment of the underlying inflammation
and the tissue remodelling process are further key
goals in our COPD research. Inflammation in
COPD patients is provoked by an infiltration of
the lungs by macrophages and neutrophils.
This is only poorly controlled by current, widelyused anti-inflammatory drugs, such as corticos-
severe asthma, where mucous plugging is considered the main cause of death.
Our research in asthma is aimed at new mechanisms and immunological paradigms that would
allow us to replace or reduce the doses of inhaled
steroids by providing anti-inflammatory therapy
better tolerated by patients. Another goal is to
provide a new treatment for specific syndromes
with high, unmet medical need, such as severe,
steroid-resistant asthma.
teroids. We are therefore working on alternative
anti-inflammatory mechanisms, specifically targeting macrophage and neutrophil-driven inflammation.
In addition, we aim at preventing or delaying tis-
52
Diseases of the
central nervous system
According to World Health Organization (WHO)
sue remodelling that is induced by chronic inflam-
predictions, diseases of the central nervous system
mation by targeting lung growth factors. Two
will constitute an increasing medical need in this
first-in-class mechanisms targeting mucous
century, attributable to an exponential increase of
hyperplasia and fibrosis are being tested clinically.
these diseases in patients beyond 65 years of age,
Beyond COPD, such new mechanisms have a
combined with an aging population. To date,
therapeutic potential in idiopathic pulmonary
available therapeutic treatments are still unsatis-
fibrosis (IPF), a life-threatening disease, and in
factory for the majority of CNS diseases.
serving patients
“Like a great round of golf“
“When in 2003 I faced my diagnosis of Parkinson’s disease, I tried to deal with it with the spirit of a true competitor,”
says Cherie Zaun, a professional golfer from Glendale, California, USA. “Despite at first feeling helpless, I read up on
everything about how to live with the disease and set out to battle it. I was still only in my early 50s.”
“Today, I’m able to teach and play golf again. Living with Parkinson’s is not all that different from doing a great
round of golf – it takes practice and determination,” Cherie explains. She is mother of three and former winner of
the Virginia State Amateur Championship, former member of the Duramed Future Tour and one-time head coach
for the University of Southern California Women’s Golf Team. She is still playing in some West Coast tournaments
and qualifiers. For three years she has been taken a dopamine agonist for the treatment of Parkinson’s disease.
“I’m exercising, too, finding yoga and golf especially helpful. But I do not want to just focus on my own health,”
Cherie comments. “I’ve decided to take an active role in patient education. Together with Boehringer Ingelheim
I’ve developed patient materials specifically for people who have been recently diagnosed with Parkinson’s.
And I act as spokeswoman for ‘Planning Your Course’, a patient education programme supported by Boehringer
Ingelheim and the US National Parkinson’s Foundation (NPF).”
Diseases of the central nervous system (CNS) are
Pramipexole has significant efficacy on the key
one of the most important therapeutic areas for
symptoms of restless legs syndrome (RLS) and
Boehringer Ingelheim. Our product portfolio con-
beneficial effects on the symptoms frequently
sists of drugs for the treatment of Parkinson’s
affecting RLS patients, such as daytime sleepiness,
disease and restless legs syndrome (RLS), as well
mood disturbance, and overall reduced quality of
as for treatment of major depressive disorder
life. Patients often have difficulties in describing
(MDD) and diabetic peripheral neuropathic pain
their symptoms, with sleep disturbance often
(DPNP).
being the most frequent reason why people with
RLS seek medical advice. We expect that the
impressive efficacy of RLS as shown in our clini-
Parkinson’s disease and restless legs syndrome
cal trial programme will favourably impact and
sifrol® / mirapexin® / mirapex® (pramipexole),
strengthen the market position of sifrol®.
a product from Boehringer Ingelheim research, is
a dopamine agonist that was first approved in
sifrol® / mirapexin® / mirapex® continued to
1997 for the treatment of the signs and symptoms
show strong growth in 2006 in the Parkinson’s
of idiopathic Parkinson’s disease (PD), as mono-
disease indication, too. At the end of October
therapy or in combination with levodopa.
2006, the brand ranked No. 6 among Boehringer
Ingelheim’s best-selling products, with total net
After a decade of treatment for Parkinson’s
sales of EUR 536 million, up 23 % against the
patients, a new key milestone was achieved with
same period in 2005. It is the world’s best-selling
the approval of sifrol® / mirapexin® / mirapex®
dopamine agonist, with a market share of more
for the symptomatic treatment of moderate to
than 22 %. The estimated cumulative worldwide
severe idiopathic restless legs syndrome (RLS) in
exposure since 1997 is 2.2 million patient years.
2006, both in the European Union and the USA.
53
Our clinical studies in Parkinson’s disease
Depression and diabetic peripheral
and RLS
neuropathic pain
The continued research interest in sifrol®/
Major depressive disorder (MDD), a common dis-
mirapexin® / mirapex® is reflected in a compre-
order of complex, often recurring symptoms
hensive phase IV clinical trials programme that is
affecting the mind and body, can be life-threaten-
underway in both indications, PD and RLS, com-
ing and certainly disabling, according to WHO
prising more than 2,800 patients. It will investi-
research. The neuropathology of depression is not
gate additional aspects of these diseases in an
fully understood, but the two neurotransmitters,
effort to provide data on the effects of sifrol® /
serotonin and noradrenalin, seem to play a major
mirapexin® / mirapex® in improving the quality
role in the development and course of the disease.
of life in patients with these conditions. A study
recently reported (Barone P. et al., J Neurol 253,
cymbalta®/xeristar® (duloxetine hydrochloride)
601–607 [2006]) highlights the positive effects of
is a potent and balanced dual reuptake inhibitor
sifrol® on depressive symptoms in patients with
of both serotonin and noradrenalin that provides
PD which we plan to confirm in further studies.
rapid, sustained relief of the emotional and
painful physical symptoms of depression and
Boehringer Ingelheim is directing
major efforts into its research
and development of drugs for the
treatment of diseases of the central
nervous system. The most recent
indication for which we gained
market approval for our medication mirapex®/sifrol® was RLS.
Characterised by a distressing urge
to move the legs, RLS is usually
associated with uncomfortable or
sometimes painful sensations in
the legs, with symptoms being
worse at night and while at rest.
54
serving patients
gives patients a better chance of getting well and
staying well. A recently completed placebocontrolled study with duloxetine showed clear
therapeutic effects of the drug on painful body
symptoms in patients suffering from depression.
This favourable profile of duloxetine can help to
address an important aspect of the clinical
symptoms of depression.
Serotonin and noradrenalin also play a major role
in the neuronal modulation of pain signals, suggesting a role for duloxetine. Through its extensive clinical programme, duloxetine has also been
successfully developed for the treatment of
diabetic peripheral neuropathic pain (DPNP), and
in 2006 was launched in Germany, Mexico and
Brazil in the DPNP indication.
Depression is one of the most
frequent psychiatric disorders,
but is often undiagnosed or is
under-treated. This may be
because up to about 70 % of
patients later diagnosed with
depression cite physical symptoms as the reason they initially
visited their primary care
physican. New data shows that
cymbalta® (duloxetine hydrochloride) significantly reduced
both painful and emotional
symptoms of depression,
resulting in an increased likelihood for patients to reach
remission.
In November 2002, Eli Lilly and Company and
Boehringer Ingelheim signed a long-term agreement to jointly develop and commercialise
Female hypoactive sexual desire
duloxetine. At year-end 2005, cymbalta® had
disorder (FHSDD)
been successfully launched in more than 20 co-
Hypoactive sexual desire disorder (HSDD), a con-
promotion countries worldwide. In Germany,
dition in which patients suffer from their decreased
cymbalta® has been the most successful anti-
sexual desire, is the most common form of female
depressant launch in the country to date. During
sexual dysfunction. It is an important and defined
2006, cymbalta® was launched in 11 additional
medical condition that can be identified and diag-
countries in Europe, Latin America and Asia. Key
nosed. Epidemiological studies indicate that up to
2006 milestones include Boehringer Ingelheim’s
one in five women suffer from decreased sexual
successful launch of xeristar® in the co-market-
desire.
ing countries of Italy, Spain and Greece.
Over 60 % of the patients are moderately to
To support continued medical education concern-
extremely distressed because of their low desire.
ing these important and potentially debilitating
Flibanserin, a centrally active compound with a
diseases, Boehringer Ingelheim and Lilly hosted a
unique mechanism of action, is a novel approach
series of educational events to raise awareness
for the treatment of decreased sexual desire in pre-
and understanding of depression and pain man-
menopausal women. The medical definition for
agement in Europe, Latin America and Asia.
the condition is hypoactive sexual desire disorder
(HSDD) with marked distress and or interpersonal
cymbalta® and xeristar® generated combined
difficulties. Thus focusing on this condition, four
revenues of EUR 53 million, more than 100 %
phase III studies have been initiated. One of them
growth over 2005.
has already fully recruited more than 1,000
55
patients. High interest to participate in these
(GPCRs), which are involved in pain transduction
studies supports our understanding that there is
pathways and have been validated in neuropathic
substantial medical need and patient demand. We
and inflammatory pain models, form the basis for
expect the phase III programme to run until 2008
our drug discovery efforts in the chronic pain
and provide us with pivotal results for registra-
indication. Our drug discovery activities in the
tion.
indication migraine address a new mechanism of
action to interfere with cerebral vasodilatation for
which we were the first research group to obtain
Our R & D in CNS
clinical proof of concept.
Our research in CNS diseases focuses on novel
treatment concepts for the major neurodegenerative disorders, Alzheimer’s and Parkinson’s
disease, both being prominent consequences of
Virology
the ageing population. Our research efforts to
interfere with disease progression in Alzheimer’s
Antiviral therapies for many serious, life-threat-
and Parkinson’s disease focus on targets estab-
ening chronic and acute viral diseases are lacking
lished by pathohistology and genetics.
or are unsatisfactory. New antiviral therapeutics
for the treatment of the human immunodeficiency
Moreover, we are investigating approaches for
virus type 1 (HIV-1) and the hepatitis C virus
reducing treatment-induced motor complications
(HCV) are therefore in the focus. These two patho-
(dyskinaesias), a major medical problem for patients
gens have each emerged epidemically in recent
with late stage Parkinson’s disease. Our activities
decades, infecting millions of people globally.
in Alzheimer’s disease are, for example, aimed at
reducing amounts of the amyloid-beta peptide,
the major mediator of this fatal disorder, and
HIV/AIDS
additionally searching for pro-cognitive therapies
In 2006, the AIDS pandemic continued to grow.
beyond acetylcholine restoration in this disease.
Now about 40 million people are infected with
HIV. Boehringer Ingelheim aims at improving
In order to expand these approaches, we have
HIV/AIDS therapy by providing physicians and
entered into an exclusive worldwide collaboration
patients with innovative antiretroviral (ARV)
and license agreement with the Belgian company
drugs.
Ablynx to discover and develop new therapies for
Alzheimer’s disease, using Nanobodies®, a novel
aptivus® (tipranavir), a non-peptidic protease
class of therapeutic proteins.
inhibitor, blocks the viral protease, an enzyme
needed to complete HIV replication. In co-admin-
An additional focus lies on chronic pain, a condi-
56
istration with low dose ritonavir, aptivus® is
tion for which medical attention is sought most
indicated for combined antiretroviral treatment of
frequently, yet satisfactory treatment options are
HIV infection in highly treatment-experienced
still limited. New molecular targets, such as ion
(HTE) patients with resistance to multiple pro-
channels and G-protein coupled receptors
tease inhibitors (PI).
serving patients
aptivus® was launched in the USA in July 2005
the HIV transmission rate. This simple and effec-
and in the EU in November 2005, reaching net
tive treatment, also tested successfully in combi-
sales of EUR 53 million in 2006.
nation with zidovudine/lamivudine, has particular value in the healthcare setting of developing
viramune® (nevirapine), which posted net sales
countries, and as such is recommended by the
of EUR 276 million in 2006, was the first com-
WHO (see also page 10).
pound of the class of non-nucleoside reverse
transcriptase inhibitors (NNRTI) to be launched
in 1996 as a powerful component of combination
For more information, please visit the website
therapy of HIV-1 with a favourable long-term
www.pmtctdonations.org
tolerability. This product is now available in some
100 countries, making it one of the most widely
used compounds in chronic HIV-1 therapy world-
Our clinical studies and R & D in virology
wide.
After the worldwide introduction of aptivus®,
viramune® has also been demonstrated to be
HIV patients with highly resistant virus. The super-
beneficial alone as a single oral dose in preventing
iority of aptivus® over a group of comparator PI’s
transmission of HIV-1 from the infected mother
in our resist™ trials was the basis for accel-
physicians had a powerful therapeutic to treat
to the newborn. A single dose administered to the
erated, conditional approval in the
mother during labour and a single dose to the
USA and the EU in 2005. In
infant after birth has shown to significantly reduce
the meantime, long-term
Since the introduction of HAART (highly active
antiretroviral
retroviral therapy) in the late 1990s, mortality
due to AIDS has been dramatically reduced in
the western world. In these countries HAART –
normally a combination therapy consisting of
three antiretroviral drugs – has transformed
formed the
life-threatening disease into a chronic illness.
Thus the goal of the therapy can be now
defined as: prolonging the patient’s life, while
maintaining
taining the best possible quality of health
and life. However, up to now it has not been
possible to eradicate the virus from the body.
The patient therefore has to undergo a lifelong
treatment.
maintenance data with controlled observation of
Our R&D activities in HIV aim at developing new
up to 96 weeks have become available. The supe-
treatment options for all HIV patients, but espe-
rior efficacy over the ongoing comparator treat-
cially those who have failed prior therapy due to
ment is fully maintained both for aptivus® with
the development of drug resistance. Our research
two other active antiretroviral drugs and aptivus®
in this area has identified a new NNRTI as a fol-
in combination with new drugs as for example
low-up to our existing HIV treatment viramune®.
the injectable enfurvitide. Both in the USA and in
Moreover, our discovery efforts are addressing
Europe we have submitted long-term follow-up
several novel targets for future HIV therapy.
data together with additional phase IV study
results and expect traditional approval in the USA
Our hepatitis C virus research is directed toward
in 2007.
identifying inhibitors targeting essential viral
“I just cannot believe it ...
... I didn’t think I would survive the year,” says Meike Nörder
(right), a 41-year-old former cook from the north German
town of Oldenburg.
“I’ve been HIV-positive for 16 years. The debilitating effects
ness. But the side effects are all tolerable and bearable,”
she notes. “The rapid recovery of my immune system was
a real surprise for me and brought to halt an HIV-specific
encephalopathy, unlike in the previous two winters when
my immune cell levels were low and made me susceptible
of the infection, and long-term multiple resistance to drug
to infections. My CD4 T-lymphocyte cell count went from
treatments, have made normal life impossible for me, but
13 % in February 2006 immediately before the new treat-
I still keep home for my partner and our teenage son,” says
ment began to 18 % in May. By September it was up to
Meike about her situation. “Over the years, I’ve taken a
24 %. Over the same period my viral load dropped from
number of different treatment regimens which did not
32,600 to below 47.”
sufficiently control my viral load to an undetectable level
and have rendered the virus resistant to many anti-HIV
medications.”
Meike says: “I’ve not only found renewed hope concerning
my own health. I’m also actively promoting AIDS awareness, visiting schools and other institutions in my region
In 2006, she began to take a novel protease inhibitor. Her
to tell of my own experiences of living with HIV and drug
new HIV treatment – in conjunction with other anti-AIDS
resistance.”
drugs – brought significant improvement in key virus
counts. “Within a month, my viral load dropped below
the measurable limit for the first time. When I heard this
news I was speechless.”
58
“Naturally, I do experience side effects, including tired-
serving patients
enzymes, such as the HCV serine protease and
viral principle and have one other compound in
RNA polymerase. Such new mechanisms offer the
clinical phase I.
potential for new therapies with improved safety
and efficacy compared to current treatments of
Our ongoing activities in HCV continue to exploit
chronic hepatitis C.
these antiviral targets together with other novel
approaches and are complemented by partnering
Our virology drug discovery group in Laval has
efforts. In 2006, we initiated a collaboration with
developed compounds with an alternative mode
the Australian company Biota to jointly discover
of action for the treatment of HCV infection. In
and develop Biota’s novel nucleoside analogues
clinical trials in infected patient volunteers, we
designed to treat HCV infections and other
established the short-term-efficacy for a new anti-
diseases.
59
Top Story: Actilyse
Børge Madsen, Copenhagen, Denmark.
Thanks to rapid treatment he fully recovered from a stroke.
“I was fortunate to get the right treatment
promptly and efficiently at the local hospital.
My recovery came fast. Only three days after
being admitted, I was able to leave hospital.”
Børge Madsen
“My recovery came fast”
“I was making a cup of coffee in my kitchen on 1 May 2006 when I had a stroke. Luckily,
my wife Lis came home a little later with the grandchildren. She found me paralysed and
unable to speak. Straight away she called the emergency services and an ambulance
quickly transferred me to the local hospital,” says Børge Madsen, a 64-year-old retired
schoolteacher from Copenhagen. After a neurological examination and an immediate brain
scan, he was given a thrombolytic therapy to treat the stroke.
An ischaemic stroke occurs when a blood clot blocks a blood vessel in the brain, interrupting
blood flow to an area of the brain, killing cells in the immediate vicinity from within minutes
to a few hours after the stroke. The time it takes to transport stroke patients to hospital
is decisive to their recovery, or even their survival. But the administration of a thrombolytic
agent is only the first step. Careful further treatment and therapy in a hospital also has a
crucial impact on the health and recovery of the patient.
“I was fortunate to get the right treatment promptly and efficiently at the local hospital,”
Børge says. “My recovery came fast. By around noon, I felt I was regaining the ability
to move my fingers. Later that day, I was able to write. It was fantastic. Only three days
after being admitted, I was able to leave hospital.”
“My relatively good health played a significant role,” Børge says. “I’ve been physically active
all my life and always played football, most recently with the old boys. And I used to work
as a voluntary sports journalist for the local newspaper. Okay, I was a bit overweight and my
blood pressure was a little too high. But otherwise I was fit. And I always have been. The
doctors also tell me that this has helped me.”
62
serving patients
Cardiovascular diseases
Beyond antihypertensive treatment, the aim of
additional cardiovascular protection requires
treatment of all identified risk factors and associ-
Despite significant advances in the understanding
ated clinical conditions accessible by therapeutic
and treatment of cardiovascular disease, it remains
approaches and/or changes in lifestyle.
the leading cause of premature death in western
societies and is predicted to become the most
With micardis® (telmisartan), our angiotensin II
common cause of premature death worldwide
receptor blocker (ARB), and micardisplus®/
within the next decade.
micardis® hct (telmisartan in a fixed dose combination with the diuretic hydrochlorothiazide),
Our product portfolio consists of drugs for the
Boehringer Ingelheim offers two innovative
treatment of hypertension, acute myocardial
options and flexibility for the treatment of essen-
infarction and treatment of acute massive pul-
tial hypertension. micardis® has the longest half-
monary embolism, as well as stroke treatment and
life in the ARB class and a high affinity for the
prevention.
angiotensin-I receptor, providing powerful blood
pressure control over 24 hours with a once-daily
dosage, including the early morning hours when
Hypertension and cardiovascular protection
blood pressure surges.
Hypertension is a major risk factor for cardiovascular morbidity and mortality. The organs at risk
micardis® / micardisplus® / micardis® hct
are primarily the heart, the main blood vessels,
generated net sales of EUR 967 million in 2006,
the brain and the kidneys. Furthermore, it is
representing growth of 34 %. This made it our
strongly linked to stroke and heart attack as well
second biggest prescription medicine and secured
as other associated clinical conditions.
it blockbuster status.
Approximately 1 billion people are affected by
hypertension worldwide. The prevalence of essen-
Our clinical studies in hypertension
tial hypertension increases steadily with age. As
and cardiovascular protection
the population as a whole ages, the prevalence of
The micardis® landmark trials in cardiovascular
hypertension will increase even further.
protection,
ontarget™
and
transcend®,
The primary goal of antihypertensive treatment is
to reduce the long-term total risk for cardiovascular morbidity and mortality. To achieve this,
current evidence suggests that blood pressure
values should be targeted as low as possible.
micardis® offers powerful 24-hour
blood pressure control. Despite
treatment options, some 80 % of
hypertensive patients in the USA and
Western Europe remain untreated.
continued to perform according to our best expec-
actilyse® (alteplase) is also indicated for the
tations with excellent patient retention and no
thrombolytic treatment in AMI as well as in
concern from safety review board assessments.
thrombolytic treatment in acute massive
For both trials we are setting up all necessary
pulmonary embolism with haemodynamic
logistics to recruit more than 30,000 cardiovascu-
instability. actilyse® is also approved for the
lar high-risk patients within a short time period at
treatment of acute ischaemic stroke.
the end of 2007 and in early 2008.
In 2006, both products continued to be leaders
In parallel to the ongoing ontarget™ and
in their class and posted combined net sales of
transcend® studies, the protection® programme
EUR 159 million.
was concluded in hypertension. amadeo™ was
the last in a series of studies involving 6,500
patients in 32 countries. All studies were positive
Stroke treatment and prevention
and the protection® programme showed a bene-
Stroke is one of the leading causes of death
ficial effect of micardis® and micardisplus®/
and disability in the developed world. The
micardis® hct on renal organ protection in
WHO estimates that 5.1 million people die
hypertensive patients, also when compared to
from stroke each year.
other established therapies.
Almost one in four men and one in five women
aged 45 can expect to have a stroke, if they live
Acute myocardial infarction
to their 85th year. A stroke occurs when a
Every year, approximately three million people
blood clot blocks an artery in the brain (ischae-
worldwide suffer from acute myocardial infarc-
mic stroke), or when a blood vessel ruptures
tion (AMI), or heart attack. However, only about
(haemorrhagic stroke), interrupting blood flow
47 % are diagnosed and treated. The most impor-
to an area of the brain. A stroke kills brain
tant factor for a successful treatment of AMI is
cells in the immediate area beginning a few
time to treatment. Thrombolytic therapy is estab-
minutes after onset.
lished as one of the most successful modern
AMI treatment options, in particular in patients
in whom percutaneous transluminal coronary
angiography (PTCA) cannot be performed within
90 minutes after first medical contact.
metalyse® (tenecteplase) is the only thrombolytic
to be administered as a single bolus for the thrombolytic treatment in AMI for patients, in whom a
coronary intervention cannot be performed. With
its ease of administration, thrombolysis with
metalyse® is very well suited for pre-hospital and
in-hospital thrombolysis to keep the time from
the onset of symptoms to effective treatment as
short as possible.
Boehringer Ingelheim A n n u A l R e p o R t 2 0 0 6
metalyse® is indicated for the
treatment of acute mycardial
infarction. It is in particular
suitable for patients in whom
a coronary intervention can
not be performed. It can also
be administered as a prehospital lysis in the ambulance.
serving patients
“I didn’t let a stroke stop me”
“I suffered the first stroke in 2003 at a training camp in Tashkent,
Uzbekistan. Two more followed in Germany. I was paralysed on one
side and I couldn’t speak,” recounts German national wrestling team
trainer Alexander Leipold. The former national, European and world
title-holder says with good humour: “When fate strikes, it often picks
me out. But I wasn’t going to let a stroke stop me from leading an
active life.”
After rehab at the Medical Park Bad Rodach and treatment with a
medication for reducing the risk of further strokes, Alexander, at 35,
resumed his wrestling career in 2003, winning acclaim from leading
German sportsmen. In 2005, he won the world masters title for
wrestlers over 35 years of age in Teheran, Iran. The same year, he also
switched to his current role as trainer.
Alexander lives with his wife and two children in the German state of
Bavaria. “But apart from my sport, I’m also keen to help others fight
strokes, too”, he says. “This is the reason why I work as an ambassador
for German Stroke Aid.”
actilyse® is the first and only thrombolytic indi-
acute stroke treatment as demonstrated in the
cated for treatment of acute ischaemic stroke
previous pooled randomised trials. This was pub-
within three hours after symptom onset. Addi-
lished in the Lancet at the beginning of 2007.
tionally, the company is currently investigating
the efficacy of actilyse® within the 3 –4.5 hour
aggrenox®/asasantin® retard/(extended
time window through the ecass 3 trial which, if
released dipyridamole + acetyl salicylic acid (ASA))
positive, will allow a larger proportion of patients
is indicated to reduce the risk of secondary stroke
to benefit from treatment.
in patients who have had a transient ischaemic-
Boehringer Ingelheim is also the sole sponsor of
thrombosis. It generated net sales of EUR 225 mil-
sits-most. This is the largest international stroke
lion in 2006 with a growth of 31 %.
attack (TIA) or completed ischaemic stroke due to
registry with the objective of optimising the
thrombolytic treatment of acute stroke and pro-
The use of aggrenox®/asasantin® retard as a
viding a benchmarking tool for best practice for
first-line treatment for secondary stroke preven-
treating stroke patients worldwide. The laudable
tion is recommended in many international
results of the sits-most study, which enrolled
guidelines, such as those issued by the European
6,483 patients from 285 European centres, have
Stroke Initiative (EUSI), the UK’s National
confirmed the safety and efficacy of actilyse® for
Institute of Health and Clinical Excellence (NICE),
65
the American College of Chest Physicians (ACCP),
as well as the recently issued joint guidelines of
the American Heart and Stroke Association (AHA/
ASA).
Promising new drug
for blood clot prevention
Therapeutic options for preventing thrombo-embolic diseases
remain limited, despite their being among the most common
For more information please visit the website:
causes of death in the aging societies of the industrialised
www.stroke-forum.com
world.
The anticoagulant dabigatran etexilate, a new direct thrombin
Our clinical studies in stroke prevention
profess®, one of Boehringer Ingelheim’s landmark studies, has concluded recruitment with
inhibitor discovered and developed by Boehringer Ingelheim,
holds out the promise of a new drug to fulfil the unmet
therapeutic need.
20,300 patients enrolled. It had been designed to
The most commonly used oral anticoagulant has been
confirm the efficacy, and potentially demonstrate
warfarin. Dabigatran etexilate specifically and reversibly
the superiority, of aggrenox® over clopidogrel
inhibits thrombin, one of the key enzymes for blood clot
prove as well as to the additional protective ben-
formation. It is administered in a fixed dose and has a rapid
efits of our ARB micardis® in the prevention of
onset of action, providing a consistent anticoagulation
secondary stroke. As profess® is proceeding to
effect without the need for time-consuming coagulation
plan, we foresee final recruitment of patients and
monitoring and dose adjustment.
availability of results in 2008.
The independent esprit study (European/
Australasian Stroke Prevention in Reversible
Ischaemia Trial) on prevention of secondary
stroke was published in Lancet, 2006; 367: 1665–
Major indication areas will be stroke prevention in atrial
fibrillation, the most common form of cardiac arrhythmia,
prevention of deep vein thrombosis (DVT) after hip or knee
replacement surgery, acute DVT treatment and secondary
prevention of DVT.
1673. It found superior efficacy of dipyridamole
extended release in combination with ASA versus
deep vein thrombosis (DVT) after hip or total knee
ASA alone. These results with a 20 % risk reduc-
replacement, the treatment of acute DVT, the
tion for stroke over ASA alone in the ESPRIT
secondary prevention of DVT and the long-term
study are in line with our own ESPS 2 results and
prevention of thrombo-embolic events (stroke) in
support our expectation in favour of a positive
patients with atrial fibrillation. The phase III trial
outcome of profess®.
programme has been initiated with a group of
studies combined under the umbrella of the
re-volution® programme. With more than
Treatment and prevention of thrombo-embolic
27,000 patients re-volution® is the largest
diseases
clinical trial programme in thrombo-embolic
Our presently largest phase III programme is for
disease.
dabigatran etexilate, an oral direct thrombin
66
inhibitor that we are developing for the preven-
With studies in all indications successfully imple-
tion and treatment of thrombo-embolic disease.
mented, the two indications we advanced most
Dabigatran is the frontrunner of all new oral anti-
were the post-surgery prevention of DVT and
coagulants currently being developed, and is
stroke prevention in atrial fibrillation. We have
being investigated in the primary prevention of
launched a 15,000-patient study (rely™) in atrial
serving patients
fibrillation in some 40 countries involving almost
discovery in these therapeutic areas places an
1,000 study centres. By the end of 2006, more
emphasis on gaining a mechanistic understanding
than 8,000 patients have been recruited, exceed-
of rheumatoid arthritis, multiple sclerosis and
ing our plan by far.
psoriasis disease processes.
For the prevention of DVT post-orthopaedic surgery pivotal studies have been completed and the
Rheumatic arthritis / osteoarthritis
first submission for Europe has been completed.
Rheumatoid arthritis is an autoimmune disease
Additional study results will become available
that affects the body as a whole and may lead to
during 2007 to complement the dataset for a later
joint destruction. Osteoarthritis is the most
US submission file.
commonly diagnosed degenerative disease affecting the joints, especially in elderly people. Signs
and symptoms of osteoarthritis can include joint
Our R & D in cardiovascular diseases
stiffness, often with a sensation of grinding in the
Continuing research efforts in the thrombo-
affected joint.
embolic area resulted in compounds with alternative anti-thrombotic mechanisms, which also
mobic®/mobec® (meloxicam) is indicated for the
recently entered clinical development where their
symptomatic treatment of osteoarthritis and
efficacy-safety profile is being compared to that of
rheumatoid arthritis as well as ankylosing spon-
direct thrombin inhibitors. We will continue to
dylitis (Morbus Bechterew).
develop our cardiovascular research platform in
the area of atherothrombosis and widen our
The patent exclusivity period in the USA for the
research to include heart failure.
drug ended in July 2006, and the market entry of
These research programmes are facilitated by the
product. mobic®/mobec® generated net sales of
use of in vivo imaging studies and enhanced by
EUR 577 million in 2006.
generics resulted in major sales losses for this
external collaborations with academic and biotechnology industry partners.
Our R & D in immunologic
Our cardiovascular research programmes also
and inflammatory diseases
benefit from close collaboration with scientists
Together with experts in the field, we are gaining
working in related therapeutic areas, such as
greater insights into the biology of autoimmune
metabolic diseases and immunology and inflam-
diseases with a view to identifying novel drug
mation, in order to increase the opportunities for
targets. For example, certain cells play a key role
developing novel therapeutic agents for the fight
in perpetuating the inflammation and resulting
against cardiovascular disease.
tissue destruction observed in the joints of
rheumatoid arthritis patients by secreting
Immunologic /
inflammatory diseases
cytokines and other inflammatory mediators.
As a means to identify key pathways operating in
these cells, we have established collaborations to
Despite advances in treatment, there remains a
screen for modulators which may be drug targets
large unmet medical need for safe and efficacious
that could form the basis of novel therapies.
treatments for autoimmune diseases. Our drug
Current approaches targeting autoimmune disease
67
include diverse mechanisms that are being
addressed with both small molecules as well as
protein-based therapeutics.
Our activities in the area of new biological entities
(NBEs) have been further strengthened by entering into a collaborative research and licence
Urology
In 2006, Boehringer Ingelheim’s product portfolio in urologic diseases consisted of drugs to
treat benign prostate hyperplasia (BPH) and stress
urinary incontinence.
agreement with the US-based biotech company
FivePrime Therapeutics with the goal of discover-
Benign prostate hyperplasia
ing novel therapeutic protein products to treat
Lower urinary tract symptoms (LUTS) suggestive
rheumatoid arthritis and other inflammatory
of BPH are the most common urological condi-
diseases. Promising new small molecule therapies
tion in older men. BPH is characterised by the
are currently being tested in clinical trials to
presence of several urinary symptoms that can be
establish their effectiveness for psoriasis and mul-
related to bladder emptying (voiding or obstruc-
tiple sclerosis. By gaining a mechanistic under-
tive symptoms) or filling (storage or irritative
standing of immune disease, we can identify those
symptoms).
mechanisms that are also relevant for the pathology of other diseases and thus expand the
Typical voiding symptoms are hesitancy, weak
promise of new immunological therapies to addi-
stream and intermittency. Typical storage symp-
tional medical conditions.
toms are increased daytime frequency, nocturia
and urgency. Nocturia, i.e. awakening one or more
The combination of our current focus on disease
times at night for voiding, reduces the quality of
mechanisms, our efforts directed to the identifica-
sleep of the patient and has a significant negative
tion of novel drug targets and our expansion into
impact on how the patient feels the next day in
protein-based therapeutics is maximising our
terms of energy level/fatigue, concentration and
ability to deliver promising new therapeutic
mood (sometimes the patient may even get
options for patients suffering from autoimmune
depressed) and ultimately his overall well-being
diseases.
and quality of life.
The incidence of benign prostate hyperplasia (BPH)
increases with age. Symptomatic BPH in general occurs
in approximately 25 % of men over 40 and in one of
every three men over 65. flomax®/alna® (tamsulosin),
an alpha receptor blocker that has been established
as a standard first-line treatment of BPH symptoms,
is the most widely prescribed medication for them.
serving patients
Treatment modalities used to relieve bothersome
Stress urinary incontinence
LUTS/BPH are designed to reduce the static and/
Stress urinary incontinence (SUI) is the involun-
or dynamic component of obstruction and to
tary loss of urine on effort or exertion, or on
improve the quality of life.
sneezing or coughing. Around 97 % of SUI patients
are female, but less than half of the women suf-
Pharmacological therapy with flomax®/alna®
fering from this condition seek treatment.
(tamsulosin), an α1-receptor antagonist, is
indicated for the treatment of this condition and
yentreve®/ariclaim®, with the active ingredient
provides effective and well-tolerated improve-
of duloxetine, is approved in the EU for the treat-
ment of the symptoms. It relieves obstruction by
ment of women with moderate to severe SUI. In
relaxing smooth muscles in the prostate and
2006, it was jointly commercialised in several
urethra improving voiding symptoms. It also
European countries and Mexico by Eli Lilly and
improves storage symptoms in which bladder
Company and Boehringer Ingelheim. yentreve®/
instability plays an important role.
ariclaim® generated revenues of EUR 4 million
in 2006.
After the launch of the 0.4 mg capsule in 1996,
Boehringer Ingelheim and its partner Astellas
Boehringer Ingelheim and Eli Lilly and Company
developed a new tablet formulation using the
(USA) jointly decided in February 2006 to change
technology ocas® (Oral Controlled Absorption
the contractual agreements for yentreve®/
System) to further optimise pharmacological
ariclaim®. Eli Lilly and Company took over sole
therapy for LUTS/BPH.
worldwide commercialisation rights for the medi-
This system provides effective symptom control
incontinence indications, effective as of 15 Janu-
during daytime and nighttime, a very good toler-
ary 2007.
cation for SUI and potential future, related urinary
ability and excellent convenience for the patient
(e.g. once-daily dosing without the need of dose
adjustment, medication intake independent of
meals).
Oncology
flomax®/alna®, using the ocas® technology, has
Every year, more than ten million people find
been available since 2005 in Germany, Spain and
themselves grappling with the medical uncertain-
Switzerland. In 2006, it was launched in Portugal,
ties and emotional upheaval of a newly diagnosed
France, Canada and Greece.
cancer. Fortunately, an increasing number of
patients benefit from surgery, radiation and
The capsule formulation started to lose patent
pharmacological medicines, with a complete cure
protection in several countries in March 2006. In
possible in about 60 % of cases. If the cancer has
the USA, patent protection will continue until
spread throughout the body, the hurdles for
October 2009. flomax®/alna® capsules and
effective therapies become higher, but even then
ocas® tablets generated net sales of EUR 922
cure or disease modification with longer survival
million, an increase of 28 % over 2005, placing the
and better quality of life is possible with innova-
medication third in Boehringer Ingelheim’s
tive, targeted medicines that offer more efficacy
Human Pharmaceuticals sales ranking.
and better tolerability to patients.
69
Cell-cycle kinases are cellular
proteins that promote the
process of cell division.
Boehringer Ingelheim’s first-inclass investigational compound
BI 2536 (light blue) seems to
effectively block such a cell-cycle
kinase (the polo-like kinase,
Plk-1) at its active site, leading
to tumour growth inhibition
and tumour regression.
Our clinical studies in oncology
2007 and that the innovative features of our mol-
We have embarked on the discovery and develop-
ecules, once confirmed in phase III trials, will
ment of innovative medicines for some of the most
offer improved treatment choices to cancer
common cancers. Since 2000, research conducted
patients.
at Boehringer Ingelheim Austria has resulted in
promising drug candidates moving into advanced
clinical development. We are conducting clinical
Our R & D in oncology
studies of phase II for compounds interfering
The sequencing of the human genome and detailed
with essential drivers of tumour growth: A) aber-
studies of genetic changes in human cancer cells,
rant growth signalling through activity of epider-
known as oncogenome signature typing, have
mal growth factor receptor (EGFR) and human
accelerated the identification of mutations and
epidermal growth factor (HER 2), B) supply of
the knowledge of the faulty cellular circuitry that
oxygen and nutrients to cancer cells by the devel-
underlie the aberrant growth, invasion and metas-
opment of new blood vessels to the tumour (neo-
tasis of cancerous tissues in the body. Moreover,
angiogenesis), and C) targeting inhibition of the
they provide important clues to new drug targets
uncontrolled cell division (mitosis).
and the best match-up of new drugs with the
patients whose cancers are most likely to respond
Current phase I / II target indications for our oral
to the drugs, a process called biomarker-guided
compounds in antiangiogenesis and signal trans-
drug development or customised cancer therapy.
duction, and our intravenous cell-cycle inhibitor,
include non-small-cell lung cancer, breast cancer,
New further compounds have entered develop-
colorectal cancer, prostate cancer, ovarian cancer,
ment to strengthen our emerging oncology
leukaemia and lymphomas.
pipeline and we are continuing our efforts to
develop monoclonal antibody-based drug candi-
70
We are confident that the continued good patient
dates. As part of our strategic collaboration with
accrual into our phase II studies will allow us to
MorphoSys on human antibodies, we have exer-
establish first proofs of efficacy towards the end of
cised an option for optimising a therapeutic
serving patients
HuCAL antibody directed against a cancer-related
The second compound in phase I is a first-in-class,
target molecule and have acquired an exclusive
new development, which may offer improved
licence for this project.
options for treatment of diabetes mellitus. It has
already established pharmacodynamic effects of
Metabolic diseases
the mode of action and will enter phase II in
patients in 2007. With additional preclinical
development candidates and follow-up com-
Health authorities and governments have been
pounds expected to enter the clinic, our metabolic
alarmed by recent epidemiological data suggest-
clinical pipeline will grow and gain further attrac-
ing that metabolic diseases, including diabetes
tiveness in the near future.
mellitus type II, obesity and dyslipidaemia, will
grow worldwide by a much greater extent than
previously expected. This has been identified as a
Our R&D in metabolic diseases
major health problem, not only for western coun-
New therapeutic approaches for the treatment of
tries, but also in, for example, South America,
diabetes type II have the potential of delaying or
India and China. Particularly worrisome is the
even inhibiting the progression of the disease.
increasing prevalence of obesity in children
Several research projects even offer the possibility
together with the onset of type II diabetes in
of preventing manifestation of the illness. We
young adults. This disturbing fact leads to the
have been successful in entering development
forecast that today’s children may have a lower
with several of our research projects with a variety
life expectancy than their parents. We are there-
of new mechanisms.
fore putting great efforts into the metabolic disease field with particular focus on diabetes type II,
In obesity there is a great need for new drugs that
obesity and dyslipidaemia. Many diabetic patients
are more efficacious than the existing ones while
are overweight or obese and also suffer from dys-
providing a high level of patient safety. Research
lipidaemia, features of the metabolic syndrome.
in that area is directed both at a reduction of appetite and food intake as well as increasing the
metabolism of energy carriers. We have estab-
Our clinical studies in metabolic diseases
lished state-of-the-art technologies to carefully
We were particularly pleased with promising first
profile advanced compounds in vitro and in vivo.
clinical results of compounds with two different,
We also see opportunities to explore the combin-
but complementary, mechanisms, one that stimu-
ation of various mechanisms.
lates insulin secretion and another that facilitates
the renal excretion of glucose.
Despite efficacious treatment for the lowering
The first compound with an already established
60–70 % of cardiovascular events still cannot be
of low-density lipoprotein (LDL) cholesterol,
mode of action is entering phase IIb after very
prevented. The role of low levels of high-density
encouraging four weeks’ results in diabetes type II
lipoprotein (HDL) cholesterol and malfunction of
patients. We believe that during later phase III this
the reverse cholesterol transport are hence areas
compound has the potential to develop into a best-
of increasing research interest. We have started
in-class drug providing improved efficacy and
several new research projects to address this
convenience.
therapeutic need.
71
Our regions
The economic situation in Latin America stabilised in 2006. Mexico, our largest operating unit
in Latin America, developed very positively, with
Americas
a growth rate of 35 % compared with 2005. The
main growth drivers were flomax®, micardis®,
buscopan®, combivent® and some local key
In our Americas region, 2006 saw continued
products. Sales of major drugs, such as spiriva®
strong development of our product portfolio. Net
and cymbalta®, are growing strongly.
sales in our Presciption Medicines business
reached EUR 4,460 million.
Our South American operating unit, which combines the management of all Spanish-speaking
The USA remains the main driver of pharmaceuti-
countries in the region, enjoyed its first full year in
cal growth and is the largest contributor to
2006. Greater efficiencies are being generated and
Boehringer Ingelheim’s sales and profits. The US
marketing efforts simplified by combining strate-
market, a highly competitive environment which
gies and resources across the whole regional unit.
underwent significant changes in 2006, grew by
A cross-country (CN) management structure has
8.2 %. Boehringer Ingelheim continued to develop
been established and regional centres of excel-
above the market average. micardis®, spiriva®,
lence developed for products in our portfolio. Our
flomax® and aggrenox® were the main growth
Brazilian company celebrated its 50th anniversary
drivers in the USA and compensated for lost sales
in 2006. Development here was seen across our
of mobic® due to the launch of generic competi-
portfolio, with particular success for mirapex®/
tors in July.
sifrol®, the most prescribed drug of its class for
Parkinson’s disease. mirapex® for RLS was
For the first time, US citizens above 65 years of
launched in September, reinforcing its market
age, regardless of income, were given access to
position. Main drivers of growth were micardis®,
prescription drug coverage by Medicare. This new
mirapex® and buscopan®.
coverage (Medicare Part D) began on 1 January
2006. Boehringer Ingelheim ensured that it was
well positioned in the plans to enable a greater
Europe
number of US citizens access to our portfolio of
innovative medicines.
Despite an extremely challenging market environ-
In Canada, new regulations on intellectual prop-
7 % growth in 2006. Our three main patent-pro-
ment, our net sales in the Europe region achieved
72
erty came into law. This established eight years of
tected products, spiriva®, micardis®/micardis-
data exclusivity for a molecule from the date of its
plus® and sifrol®/mirapexin®, met strong
approval, further protecting the intellectual rights
demand, posting double-digit growth rates. New
of the research-driven pharmaceutical industry.
product introductions contributed positively to
But 2006 also saw the proposal and implementa-
the growth. xeristar®, an innovative antidepres-
tion of tighter pricing and reimbursement policies
sant, was successfully launched in Italy, Greece
mainly affecting the two major provinces Ontario
and Spain. Our new protease inhibitor aptivus®
and Quebec. This will further limit patient access
is now available in almost all markets. spiriva®
to innovative drugs.
was successfully launched in France. On the other
serving patients
hand, the end of exclusivity in Europe for mobic®
underfunded. Accordingly, governments through-
and alna®/pradif®/josir® affected sales signifi-
out Europe are reducing consumption volume by
cantly.
restricting patient access to innovative medicines
and demanding lower prices.
In Italy and France, we grew faster than the overall market. In the UK, we matched overall market
In 2006, the Italian government, for instance,
growth, but in Germany we were unable to keep
secured a 10 % cut in retail prices. Newly intro-
up with the market due to the loss of alna® sales
duced products, which naturally post above-
to generic competition. In contrast to Western
average growth rates, were even subjected to an
European markets, Eastern Europe showed
additional price reduction. France’s Social
dynamic economic growth. This was evident in
Security Financing Law and Germany’s Economic
the prescription medicines markets, especially in
Optimisation of Pharmaceutical Care Act have
Russia, where a newly introduced federal pro-
also contributed to market stagnation.
gramme reimburses ‘essential medicines’ to
selected patients. Across Eastern Europe strong
Price referencing has become common practice
demand for our respiratory products and for
across Europe, with price reductions in one
mobic® enabled us to achieve 27 % growth.
country leading to reductions elsewhere, inducing
a downward spiral. An increasing number of
The healthcare market, in particular the market
companies will be forced to refuse such significant
for prescription medicines, remains very difficult
price reductions to avoid this vicious circle. The
in most European countries. While demand is
result will be the withdrawal of hitherto
increasing due to demographic developments and
reimbursed medicines, less access to drugs and
the use of innovative products with real benefits
higher financial contributions from patients.
to patients, most healthcare systems are chronically
Overall, the outlook for the European prescription
The USA remained by
far the most important
market for our drugs.
Prescription Medicines (PM)
– which accounted for
79 % of our net sales –
had a turnover of more
than EUR 8.3 billion
to which US sales
contributed 46 %.
The Europe region
achieved 26 % of PM
net sales.
Europe
,10
Americas
,0
of which:
USA branded
3,174
USA generics
657
of which: Germany
446
Asia, Australasia,
Africa
1,9
of which: Japan
849
Net sales Prescription Medicines, excl. licences (in millions of EUR)
73
medicines market is far from encouraging and any
reimbursement. Such deliberations, all being part
fresh investment in this region needs to be evalu-
of cost containment measures and governmental
ated with particular care.
restrictions, feature throughout the region. Price
cuts in Taiwan and Indonesia in 2006 caused
Asia, Australasia,
Africa (AAA)
particular concern in the pharmaceutical
industry.
In South Africa and neighbouring countries our
In our AAA region, 2006 was characterised by
growth rate has slowed. This development must,
continued strong growth in local currency terms.
however, be seen in conjunction with our decision
Our PM business in the AAA region is heavily
to grant voluntary licences for viramune® in
dominated by the performance of Japan which
South Africa (and also in Egypt, Nigeria, Kenya)
contributes more than 59 % to regional sales and
so that generic manufacturers can offer our
earnings. Nippon Boehringer Ingelheim was, for
antiretroviral drug at generic prices. In fact, in
the second year running, the fastest growing busi-
order to make viramune® more readily available
ness among the leading 20 pharmaceutical com-
we announced measures to encourage even more
panies in Japan. In nearly all the other AAA
generic manufacturers to avail themselves of the
countries we outpaced the market. Locally
opportunity of offering medicines containing the
achieved sales growth was, however, not fully
active ingredient nevirapine to the countries of
reflected in euro terms, as most of the region’s
the developing world, including the whole of
major currencies weakened against the euro dur-
Africa.
ing the reporting period.
In China, the pharmaceutical market is neither
The Japanese market for prescription products
transparent nor easy, and is in fact dominated by
remained sluggish. Net sales of our prescription
healthcare reform and generics. Although last
products increased by 16 % in local currency (by
year our Chinese business accounted for only 3 %
7 % in euro terms) and by the end of the year our
of our PM sales in the AAA region, we remain
market share reached 1.7 %, despite a government-
confident that the huge Chinese market will
imposed price cut in April, averaging 5.6 % for our
gradually make a more significant contribution to
business.
our worldwide business. In 2006, we completed
the formalities to purchase the outstanding 5 % of
Australia, our second most important AAA market,
shares in our joint venture, which will give
achieved net sales of EUR 118 million and market
Boehringer Ingelheim a wholly owned enterprise
share of over 2.3 %. We achieved significant sales
in China in 2007.
and established a respectable market share of
1.5 % in Turkey, making it our third most impor-
Our strong growth in nearly all the AAA countries
tant country in the AAA region.
reflects continuing field force efficiency initiatives
and also the robust development of our core prod-
74
In South Korea, where we have a joint venture
ucts micardis®, spiriva® and sifrol®. Some
with a local partner, sales growth exceeded 24 %.
well-established products, such as buscopan®,
Here we closely follow ongoing governmental
combivent® and mucosolvan® also produced
deliberations on positive listing for drug
an upward sales trend in some countries.
serving patients
Generic Prescription
Medicines
from Europe and Asia. This increase in the number
of competitors, along with the cost-focused
pharmacopolitical environment, is exerting
continued pressures on margins.
The US generic industry posted revenues in excess
of USD 47 billion in 2006 and the market is
As the size of the generic market continues to
expected to grow by 6 % annually over the next
grow, there is also increased competition for
five years. Drivers of this growth include the aging
revenues from brand pharmaceutical companies
population, government cost reduction measures,
which show a renewed interest in generics.
increased generic utilisation, blockbuster patent
Additionally, large multinational generic com-
expirations, and the emergence of biogenerics or
panies, which have grown through merger and
copies of biopharmaceuticals (biosimilars).
acquisition, and companies from India, Eastern
Europe and China are playing key roles in this
Boehringer Ingelheim’s Generic Prescription
market.
Medicine (GPM) business in the USA, which
consists of Roxane Laboratories and BenVenue
Roxane Laboratories
Laboratories with its unit Bedford Laboratories,
Roxane Laboratories focuses on developing
generated net sales of USD 825 million (EUR 657
manufacturing and marketing a broad line of oral
million), approximately 17 % of overall USA
solid and liquid medications and intranasal
Prescription Medicines sales in 2006.
products. The year 2006 was one of dramatic
growth in which the company achieved net sales
Business Environment
of USD 328 million (EUR 261 million) compared
The US generic market was shaped by many
with USD 242 million (EUR 194 million) in 2005
factors in 2006. There was significant consolida-
(+ 35 % in USD terms). Leading this growth
tion due to mergers and acquisitions, at the same
was the launch of fluticasone proportionate
time as new international competitors emerged
nasal spray, a generic version of GSK’s flonase.
Driven by demographic factors, government’s assumption of the
responsibility for healthcare needs of the uninsured, and efforts to reduce
spiraling costs, the US generic pharmaceutical market will continue its
rapid growth in the coming years. It is anticipated that in 2007 the market
will grow by 15 % to USD 62 billion, versus USD 54 billion in 2006.
Boehringer Ingelheim, by virtue of its US Generic Prescription Medicine
(GPM) subsidiaries Bedford Laboratories and Roxane Laboratories, is poised
to benefit from this growth. By the year 2010, our combined multisource
companies are expected to reach USD 1 billion in sales.
Generic Prescription Medicines
75
Fluticasone is the first Roxane product to exceed
Roxane
Boehringer Ingelheim Roxane and Roxane Laboratories
are located in Columbus, Ohio, and are subsidiaries of
Boehringer Ingelheim Corporation (Ridgefield, Connecticut). These subsidiaries are recognised leaders in
researching, manufacturing and packaging brand name
and generic medications, including oral liquids, tablets
and capsules.
the USD 100 million threshold. In 2006, Roxane
submitted 16 abbreviated new drug applications
(ANDAs) to the US Food & Drug Administration
(FDA), received ten tentative approvals (TAs) and
launched seven new products.
Bedford Laboratories
Bedford Laboratories posted net sales of USD 497
million ( EUR 396 million) in 2006, a growth rate
Boehringer Ingelheim Roxane (BIRI) is the manufacturing
of 17 %. Key products for the year included
arm of Boehringer Ingelheim Corporation. It functions as
propofol, octreotide, glucagen®, paclitaxel,
a primary site for prescription and multisource pharma-
adriamycin®, midazolam and polymyxin B.
ceutical manufacturing in North America. In addition,
Three new products were launched in 2006,
BIRI is one of Boehringer Ingelheim’s two product launch
including ciprofloxacin, an anti-infective; loraze
sites.
pam, an anaesthesia adjunct, and mitoxantrone,
Roxane Laboratories is the research and development
and sales and marketing arm of our multi-source business. It offers development services for new products
and formulas, oversees the manufacturing process for
its customers, and develops analytical test methods for
potential new products.
an oncology product. With these three new products, Bedford continues to consolidate its position
in the generic market and remains one of the largest US suppliers of speciality injectable pharmaceuticals to hospitals and clinics.
Bedford currently offers 90 injectable products in
Roxane started in 1885 as Columbus Pharmacal, a small,
254 different configurations, covering a wide
regional pharmaceutical manufacturer. In 1978, it was
variety of therapeutic classes, mainly in the areas
acquired by Boehringer Ingelheim. Roxane has about
of oncology, cardiology, anaesthesia, anti-infec-
1,000 employees. The sales increased over the past five
tive and antipsychotics. It will continue to file ten
years by about 13 % per year, totalling EUR 261 million in
to twelve ANDAs each year to create a pipeline of
2006.
products that will allow it to maintain a leadership position in the generic injectable market.
76
serving patients
Ben Venue – a world leader in sterile injectable pharmaceuticals
Ben Venue Laboratories (Bedford, Ohio), is part of the Boehringer Ingelheim group of
companies and a leading producer of sterile injectable pharmaceutical products. Also the
oldest and largest contract manufacturer of sterile injectable products in the USA, it has
with an impressive track record. Ben Venue works with some of the largest pharmaceutical
and biopharmaceutical companies, along with mid-size and virtual pharmaceutical and
biopharmaceutical companies which bring their products for development and manufacturing of clinical and commercial supply. Ben Venue has established a reputation for expertise in lyophilisation, or freeze drying, which remains a primary speciality.
Freeze drying (above) extends the shelf life of a product, makes it more stable and allows it
to be stored at room temperature. When its latest expansion is completed, Ben Venue will
have 27 freeze-driers with 718 square meters of lyophilising chamber space. It offers the
ability to support batch sizes from 1 litres to 2,000 litres, from clinical to commercial. Ben
Venue markets its own line of generic injectables to hospitals in North America through
its Bedford Laboratories division, currently offering 90 drugs with 254 configurations,
including oncology, cardiovascular, anaesthesia, antipsychotic and other miscellaneous
products to hospitals and alternate care markets.
Generic Prescription Medicines
77
“Now I know how to keep
them under control”
“When I moved from my home town of Pico in La Pampa to study communication science at the
University of Buenos Aires in the Argentinian capital, I found the change very hard. Pressure from
exams made things even worse,” Mara Lovera, a 25-year-old student, explains. “Every time I had to
take a test I experienced strong discomfort and abdominal pain, which on some occasions forced
me to skip exams.”
Abdominal pain and cramps, a widespread ailment around the world, is more common in women
than in men and can affect people still in their teens. The ailment can strike sufferers at any time and
is one of the most common causes of absence from work. It can also have significant impact on selfconfidence, social life and day-to-day living.
“As the discomfort and pain was constantly disrupting my studies, I went my doctor to find out what
could be done to help me. He explained that what I had were spasms produced by stress and nerves,”
Mara says. The doctor recommended an antispasmodic which suppresses and relieves painful muscle
spasms.
“Since the moment I started taking the medication my problem was solved,” Mara says. “Nowadays,
the pain is not so frequent, but every time my stomach starts to hurt, I know how to treat it and keep
the spasms under control.”
New data presented at the international gastroenterology congress, the Digestive Disease Week,
Los Angeles, in 2006, showed that the prevalence and severity of abdominal cramping, pain and
discomfort have been globally underestimated. A global epidemiological study showed that one in
four people around the world suffer from this troublesome and sometimes debilitating ailment.
Two- thirds of all sufferers indicated they experience sudden abdominal attacks that begin without
warning. On average, more than one-third of these sufferers experience at least one fierce attack
every week.
Professor Guido N. J. Tytgat, from the Academisch Medisch Centrum of the University of Amsterdam,
comments: “This ailment is classified as a functional gastrointestinal disorder, which means that the
abdomen appears normal, but does not function properly. Despite the painful symptoms associated
with this ailment, proactive management and treatment can significantly improve a sufferer’s quality
of life.”
Mara Lovera, Buenos Aires, Argentina, went through
hard times because of abdominal pain.
From plant to the pharmacy – the buscopan® story
The buscopan® story starts in Ingelheim,
acts directly on the muscle contractions from
Germany, where elite Duboisia plants are grown
within the digestive tract, causing them to relax,
in greenhouses. These plants are bred to be
thus relieving the pain and allowing normal
resistant against nematodes and beetles. The best
functioning.
seeds are harvested and then delivered to the
company’s plantations in South America and
Abdominal cramping, pain and discomfort is a
Australia for further on-site selection. Here, the
functional gastrointestinal disorder which can
shrubs grow on a large scale. The pharmaceut-
be painful, embarrassing and often debilitating.
ically important alkaloid scopolamine which is
Whilst mild symptoms can be annoying and
contained in the dried leaves and stalks is iso-
unpleasant, severe ones can be unbearable.
lated and purified. Finally, the active precursor
Anyone can suffer from abdominal cramping,
substance scopolamine is converted in a single
pain and discomfort at any time and for any
chemical process into hyoscine butylbromide,
reason. It affects almost a quarter of the general
the active ingredient of buscopan®.
population worldwide, with women being more
likely to suffer than men (31 % vs. 22 %). Whilst
Boehringer Ingelheim’s buscopan® is an
effective over-the-counter medicine which
offers relief from abdominal pain
and discomfort by targeting the
source of the problem. It suppresses
and relieves painful muscle
spasms by travelling directly to
the gastrointestinal tract. It does
not enter the bloodstream, but
0
there is no difference in the prevalence of the
ailment between different age groups, the
initial onset of symptoms usually
occurs between 27 and 31 years of age.
The causes are manifold and often
difficult to
determine.
serving patients
Our Consumer Health Care (CHC) business segment achieved net sales of
EUR 1.1 billion in 2006 (+1.1 % against the previous year). All regions of the
CHC business, except Japan, achieved strong growth supported by positive
exchange rate developments. Boehringer Ingelheim is ranked No. 8 worldwide among CHC companies and defended its position in 2006, primarily
through launching new line extensions and switching prescription-only
medicines to over-the-counter (OTC) products. Our key international brands
continued to develop very positively.
dulcolax® – our leading laxative brand – main-
Development by brand
tained its position as the No. 1 laxative worldwide
and is now marketed in over 100 countries. Posi-
buscopan® – positioned as the specialist treat-
tive performances were achieved in 2006 in
ment for abdominal cramping, discomfort and
Europe, Asia and the Americas, where our strong
pain – extended its worldwide No. 1 antispasmodic
category position was reinforced. In order to con-
brand position, according to IMS data. The
tinually strengthen our brand worldwide, a
buscopan® franchise produced strong double-
number of key line and brand extensions are being
digit growth in 2006. In Argentina, Colombia and
developed in order to reinforce dulcolax®’s
Paraguay the most recent buscopan® line exten-
global position.
sion, buscapina® fem, was successfully introduced for treatment against menstrual pain.
Globally aligned international packaging has now
antistax® – our brand for the prevention and
been introduced in all major countries such as
treatment of chronic leg vein insufficiency –
Argentina, Brazil, Mexico, Germany and Italy a
succeeded in delivering another year of growth in
step towards building a contemporary and com-
2006. Driven by strong double-digit growth in
pelling global OTC brand.
Italy, Belgium and Russia, antistax® is well on its
way to becoming a leading international player in
the treatment of chronic venous insufficiency.
With a new brand positioning and worldwide
Top products Consumer
��
Health Care
rollout plans in place, antistax® is set to continue
Net sales in millions of EUR
change
playing a central role in delivering positive busi-
dulcolax®
122.0
+ 6.2 %
ness growth for our CHC business in the coming
mucosolvan®
108.3
+ 18.6 %
pharmaton®
95.6
+ 8.2 %
buscopan®
71.2
+ 19.6 %
years.
bisolvon®
67.1
+ 0.4 %
mucoangin® – our sore throat brand – achieved
thomapyrin®
34.2
+ 14.2 %
satisfactory growth in the major markets of
laxoberal®
34.0
+ 6.9 %
Germany and Mexico. A new product launch was
antistax®
23.2
+ 2.7 %
made in the Netherlands.
81
zantac® – an excellent strategic fit
Regions
Boehringer Ingelheim’s Consumer Health Care (CHC)
Europe
business made an important strategic move in October
In 2006, the region reported sales growth of more
2006 with the acquisition of US rights to the over-the-
than 5 % compared to the previous year, this in
counter (OTC) brand zantac® (ranitidine), an H2 blocker
spite of low incidence in coughs and colds and
for treating the common disorders heartburn and acid
strong negative business impact caused by the
indigestion.
delisting activities by the authorities in France.
“Our CHC business ranks as the eighth largest supplier of
self-medication products worldwide, and the well-known
consumer brand zantac® will further strengthen its
presence in the key US market,” says Hans V. Regenauer,
Corporate Senior Vice-President Marketing & Sales
of Boehringer Ingelheim’s CHC business. The zantac®
rights, acquired under an agreement between Boehringer
Ingelheim Pharmaceuticals, Inc., Johnson & Johnson
and Pfizer, add to the US portfolio a strong consumer
brand that combines well in terms of retailing and sales
and promotion with the flagship brand dulcolax®,
Boehringer Ingelheim’s worldwide leading laxative brand.
“zantac® is an excellent strategic fit that comple-
Strong growth was provided by our flagship
brands dulcolax® and buscopan® which
together posted a growth of almost 20 % against
the previous year.
Together with several small countries, Spain, Italy
and Russia were prime drivers of the positive
development.
Americas
The year 2006 was again positive for the CHC
business in the Americas region, which achieved
growth of 10 % against the previous year. All inter-
ments our existing OTC franchise and provides us with
national core brands developed positively. The
two leading brands in the two largest gastrointestinal
main growth drivers were the USA, Mexico,
categories – acid reducers and laxatives,” says J. Martin
Argentina and Venezuela.
Carroll, president and CEO of Boehringer Ingelheim’s
US Corporation.
mucosolvan® – the world’s leading cough expectorant – maintained its No. 1 position in 2006 and
achieved good growth performances in Russia,
Mexico and Brazil. New marketing campaigns
were launched in Germany and Russia, as well as
in China and France, where mucosolvan® was
targeted at consumers for the first time.
bisolvon® – the cough remedy – strengthened its
position as one of the leading brands in the world
cough remedies category as a result of new product upgrades and product launches.
mucosolvan® has
proven to be a very
reliable, trusted
and strong
expectorant for
the treatment of
productive cough.
It is one of the
leading therapies
for cough and is
available around
the world.
serving patients
Switching reinforces the trend towards
self-medication
Switching – the reclassification of prescription-only
medicines to over-the-counter (OTC) products needing
no prescription – is reinforcing the growing trend towards
self-medication.
Throughout the developed world the explicit policy
adopted by many health authorities in licensing and
reclassifying medicines, is that they should be made
freely available to patients, unless a case can be made
for availability being restricted.
Making medicines more widely available at the pharmacy
On the road for leg vein health
as OTC products provides consumers with the oppor-
Boehringer Ingelheim’s antistax® camper van is a well-
tunity to buy a wider range of medicinal products. This
established mobile consulting room. It tours Italy to raise
deregulation of medicines comes against a background
public awareness about chronic vein insufficiency.
of pressure on the drugs bill in many countries.
Some governments are already committed to expanding
the range of medicines available for self-medication
The tour is conducted in cooperation with the scientific institute San Raffaele in Milan under the slogan
“Benessere delle Gambe” (Well-being for legs). In 2006,
towards longer-term chronic conditions and preven-
the van visited 13 cities from Como to Naples, giving
tive therapies. zantac®, for which Boehringer Ingelheim
access to the public, in order to provide them a free
recently purchased the USA rights, is a great example of
leg-vein check, conducted by a specialist. About 3,000
a brand which was a prescription blockbuster for many
people, mainly women but also some men, visited the van
years, but has now successfully switched globally with
for a free consultation, to find out if they suffered from
equal OTC success.
chronic venous insufficiency, an ailment which can be
In addition, Boehringer Ingelheim’s self-medication
associated with heavy, tired, achy and swollen legs.
portfolio also includes other highly successfully switched
Boehringer Ingelheim’s antistax®, a natural food supple-
products, such as the antispasmodic buscopan® and
ment can help to maintain leg vein health. It contains the
mucosolvan®, the cough expectorant.
unique extract of red vine leaf, AS195®.
Asia, Australasia, Africa (AAA)
SSP Co. Ltd. – the No. 3 OTC company in Japan,
whose major shareholder is Nippon Boehringer
Ingelheim Co. Ltd. – defended its position in a
highly competitive market environment. The AAA
region, excluding Japan, achieved strong growth
of 26 % against the previous year. Our international core brands pharmaton®, bisolvon® and
dulcolax® showed overall sales growth of 10 %.
83
Top Story: Metacam®
Alexander (left) and Christopher playing together with Tom, a Fjord gelding
which is part of their therapy. The horse had to be treated for colic.
Fatima, a 30-year-old Anglo-Arabian mare, and
Miriam who takes care of the horse, still an
important member of the team. And the children
are happy to work with her.
Our friend Tom
Alexander and Christopher, both nine years old, are two cheerful, outgoing young boys. They love
playing football and computer games. But Fridays are always special for the twins: that is when they go
to see Tom. Tom, a 12-year-old Fjord gelding, is their friend. “He’s so big and blond and soft,” says
Christopher, his eyes gleaming. Riding and handling the horse, feeding and looking after it, is extremely
important for the children’s development, as their health has been impaired since birth.
For about three years Alexander and Christopher have had regular training once a week at the
therapeutic riding centre in Flörsheim-Dalsheim, a town south-west of Frankfurt in Germany. Tom
has been part of the team there now for many years and has been specially trained for the job. The
rhythmic movement of the horse and the therapeutic exercises during a ride relieve Alexander’s
spasticity. The elevated position and being able to move without a wheelchair give him an immense
feeling of freedom. And Christopher finds the horse has a calming effect, particularly the close
physical contact with the animal. Christopher suffers from attention deficit disorder (ADD).
“The most vital aspect of the therapy is the trust between the horse and client,” explains Nora Ringhof,
the boys’ therapeutic riding instructor. “The animal becomes an important partner and friend. Building
trust, through eye-to-eye contact, for instance, is of decisive importance and is only possible over a
long period of time,” she says.
This kind of therapy normalises muscle tone, helps clients control their upper body and head, improves
balance and helps them learn how it feels to move. It is indicated in the case of cerebral movement
disorders, regardless of the cause or severity, multiple sclerosis, spina bifida, postural defects, or lowback syndromes. Furthermore, the improvement of social skills forms an important part of riding
therapy.
When Tom suddenly developed colic one day, he was given immediate relief by administration of
metacam®, an analgesic and anti-inflammatory drug from Boehringer Ingelheim. Their very long
intestine makes horses very prone to colic, a disease that can prove life-threatening. Every year about
10% of all horses across the world suffer from equine colic. Many horses can be helped with drug
therapy while others have to undergo intensive surgery in special clinics. Recent research results from
the USA show that metacam® is highly effective in the treatment of this disease. Ms Ringhof adds:
“The children are delighted that Tom found help so quickly and that he’s ready for them again.”
86
serving patients
Animal Health
The sound progress of our core business segments in Animal Health, namely
swine and small animals, is a key characteristic of the year 2006. On the
whole, our global Animal Health business has concluded another successful
year with a growth of 4 %. Adjusted for extraordinary and currency effects,
the business grew by 8 %. This again compares favourably to the industry’s
excellent growth of 6 %.
Overall, we increased sales to EUR 374 million
Emerging markets
and have hence continued to strengthen our
The Animal Health business area extended its
position in the global market. With a global mar-
global presence in 2006. We commenced market-
ket share of 3 %, in 2006 we once again ranked
ing our porcine vaccine portfolio through our own
among the top ten animal health companies in
organisation in Brazil, one of the world’s largest
the world.
pig markets. In addition, we reorganised our
South American activities with a regional sales
Regions
organisation in September. Our teams now very
effectively serve the markets in Argentina, Chile,
Paraguay, Uruguay and the Andean Pact coun-
Growth was relatively balanced across all regions
tries.
and exceeded our expectations everywhere in
2006. Once again, Europe brought very gratifying
By newly establishing a sales organisation in
news, since all countries developed positively
South Africa, we emphasised the geographic
compared to the previous year, showing overall
expansion of our business activities in sub-Saha-
growth of 10 %. The NAFTA region achieved con-
ran Africa. Furthermore, our new subsidiary in
siderable growth over 2005. Our market leadership
Dubai is to supply the demanding Arab markets,
in the porcine vaccine sector was extended further
especially in the small animal, equine and poultry
and, in the first full financial year with our own
segments.
independent companion animal team, we achieved
marked sales growth for several products. We
In Europe too, additional efforts are dedicated to
celebrated the 25th anniversary of Boehringer
opening up new markets, especially in Eastern
Ingelheim Vetmedica, Inc. in St. Joseph, Missouri,
Europe. Most recently, all our operations for Aus-
our global research and production site.
tria and Eastern Europe have been bundled and
are now conducted from a regional centre in
In Asia, our country organisations, in particular in
Vienna, which will be fully operational by the first
China, Thailand and South Korea, achieved
quarter of 2008. In summary, 2006 was dedicated
exceptional growth figures, a result of the strin-
to accessing emerging markets and to introducing
gent focus on pig vaccines in these markets. Japan
and marketing our product portfolio in new
showed far-reaching progress in increasing prof-
regions – a strategy we intend to continue to pur-
itability and improving the product portfolio.
sue in the future.
Animal Health
87
Food-producing animals
Swine
Our support for US search dogs
“Over the past decade, we’ve found out about the vital role
The global launch of enterisol® ileitis was one
rescue dogs play when properly trained with a skilled fire-
of the highlights of 2006 in the swine segment.
fighter to save lives. This is the human-animal bond at its most
With the market introduction of this innovative
profound. Over the years, the canines and their firefighter
vaccine in most European countries, in Brazil,
partners have responded to national and local disasters such
Australia and in New Zealand it grew by 33 %.
as 9/11, Hurricane Katrina and many other regional and state
However, it became evident that many farmers
disasters. We thank Boehringer Ingelheim for their belief in
still consider the concept of disease prevention to
our mission and for their support in being part of the search,”
be a major change of standard practice. The
says Wilma Melville, founder of the National Disaster Search
acceptance and implementation at farm level will
Dog Foundation (NDSDF).
therefore take longer than anticipated. However,
forecast trends indicate that enterisol® ileitis
will already be our biggest selling pig vaccine in
2007. In July 2006, a survey of participants at the
Congress of the International Pig Veterinary
The mission of the NDSDF is to produce the most highly trained
canine search and rescue teams in the USA. In response to
the shortage of such teams, Boehringer Ingelheim Vetmedica
is enabling a greater number of search and rescue dogs to be
Society (IPVS) in Copenhagen confirmed that
ileitis is currently seen as the most important subclinical disease in pigs. The unmet therapeutic
need is obviously substantial. But substantial too
and effectively respond to emerging diseases by
is the economic advantage that the use of
supplying medical innovations and economically
enterisol® ileitis brings to pig farmers.
beneficial solutions to pig producers.
Further highlights of 2006 included the market-
As to the future, we are confident that we will be
ing authorisation of our new vaccine ingelvac®
able to maintain strong growth in the swine seg-
circoflex™ which was granted approval in the
ment and aim to become the global No. 1 in pig
USA in October, and in Canada in November. This
vaccines in the near future. Fiftyfive scientific
highly efficacious vaccine protects against porcine
publications presented at the 2006 IPVS congress
circovirus, PCV-2, currently considered to be one
have substantiated our market and opinion-lead-
of the greatest unsolved problems in pig produc-
ing position.
tion. This insidious disease dramatically weakens
the animals’ immune system, leaving them
Cattle
susceptible to infection. The one-shot vaccine
The cattle segment also posted
ingelvac® circoflex™, which was developed in
significant growth in 2006.
record time, is an antigen that effectively controls
Our traditional mastitis
this disease in affected herds. Products, such
products
as enterisol® ileitis and ingelvac®
enjoy great popularity in
circoflex™, have demonstrated that Boe-
the market due to their
hringer Ingelheim Animal Health can rapidly
88
continue
outstanding
to
efficacy.
serving patients
located, trained and placed with fire departments under a
three-year partnership deal.
In return, the NDSDF has given the company exclusive affiliation with a search dog, Lola, a Black Labrador (right) handled
by Johnny Subia of the Seaside Fire Department in California.
She was selected as the metacam® search dog.
In metacam®, Boehringer Ingelheim offers a medication that
benefits canines (and other animals) suffering from osteoarthritis, the most common cause of impaired mobility in dogs.
One of a new generation of effective non-steroidal antiinflammatory drugs, it reduces within hours inflammation and
relieves pain associated with osteoarthritis, while minimising
the side effects seen with less selective substances.
Encouraging growth rates for these products, for
instance mamyzin® and benestermycin®, have
supported our decision to make additional investments in this segment. In January 2006, we
acquired the mastitis product line of Leo Animal
Health in the United Kingdom and Ireland.
Productivity in the cattle business – as in many
other Animal Health areas – is closely linked to
animals’ well-being. Consequently, efficient treatment of pain and inflammation will increase
productivity. With growth of over 10 %, metacam®
again made strong inroads into this market. In
addition, the cattle vaccines business in the USA
developed very well in 2006. At the same time,
the divestment of our ectoparasite portfolio has
further streamlined our product segment in the
US and facilitates our global focus on vaccines, mastitis products and pharmaceutical
specialties.
Companion animals
Small animals
The positive trend in our business in the small
animals segment continues apace. Due to the
strong brand awareness, highly efficacious products and successful marketing strategies, we can
look back on another record-breaking year in the
companion animals segment. In 2006, we focused
on the long-term treatment of dogs and cats with
osteoarthritis and other painful locomotor diseases. Not only did we make impressive gains in
this sector with our top brand metacam®, but we
also responded to the wishes of veterinarians and
dog owners for a new dosage form by launching
metacam® chewable tablets for short-term postoperative treatment in Europe and Australia.
Additional synergy effects were clearly apparent for metacam® injectable solution.
Animal Health
89
serving patients
Our second flagship product for companion ani-
solution for pain relief in equine colic was another
mals, vetmedin®, a product based on pimobendan,
landmark accomplishment, providing an essential
secured further market shares in 2006 in the
component for the treatment of gastrointestinal
fiercely competitive small animal market. The
diseases and supplementing buscopan®, sedivet®
outstanding efficacy of this drug in endocardiosis
and pronutrin®. Hence, the ground is prepared
in dogs was recently underlined by a scientific
for further growth in the equine sector in the
study called Vetscope. By dilating the blood ves-
future.
sels and increasing the contractility of the heart
muscle, the animals not only lived much longer
than after treatment with angiotensin-converting
enzyme (ACE) inhibitors, but also significantly
Research and
development
showed fewer symptoms – a clear indication of
improved quality of life. Thus, it is no surprise that
For many years, Boehringer Ingelheim Animal
vetmedin® more than surpassed our expectations
Health has been investing a high percentage of its
in the reporting year, achieving growth of over
sales in research and development. In 2006, it
20 %. We plan to increase market penetration even
totalled around 13 % of our net sales. Innovation
further over the next few years to be able to offer
is the imperative basis of our organic growth
vetmedin® across the globe.
strategy. Consequently, we commit ourselves to
further substantial investment in our global R&D
Horses
infrastructure and in a European vaccines research
Our company’s global equine business has clearly
and development centre in the years ahead. We
followed the positive trend of all other business
also note with considerable optimism the sound
areas. Milestone achievements were the launch of
progress in our product pipeline and the high level
the metacam® oral suspension for musculoskele-
of expertise in the control of emerging diseases
tal diseases in horses in Europe, as well as
as well as the expertise in developing novel
the market introduction of equitop gonex®
chemical formulations. Through the discovery of
in Germany, a product available without pres-
new pharmaceutical solutions, molecules or
cription for regulating and stabilising joint
vaccines we can offer added value to
and connective tissue metabolism. Furthermore,
veterinarians and animal owners, thus
the European marketing authorisation for
benefiting mankind.
metacam® injectable
90
Our CustomerOur
Orientation
customer orientation
How innovations are made
The world of biopharmaceutical production has in the last five years grown
immensely due to ever-increasing market demand for monoclonal antibodies
(MAbs) and other therapeutic proteins. As many antibody-based therapies are
applied in high doses – for example in oncology – there is a need to ensure
high production capacity with high yield. Boehringer Ingelheim is meeting this
need by continuously improving biopharmaceutical production of therapeutics
derived from mammalian cell culture (Biberach, Germany) and bacterial
fermentation (Vienna, Austria). For gene therapeutics and DNA products
Boehringer Ingelheim’s expertise is increasingly in demand too.
At our biopharmaceutical site in Vienna we have
For some years now, Boehringer Ingelheim Pharma
developed a fusion protein technology which uses
in Biberach has had an international reputation
the bacteria E. coli to produce efficiently thera-
as a reliable contract developer and manufacturer
peutic proteins. E. coli serves as a bacterial
of biopharmaceuticals from mammalian cells and,
expression system and core of a process which
as such, has cultivated a long-standing and syner-
ultimately delivers a therapeutic protein yield that
gistic relationship with highly respected compa-
is four times that of current industrial standards.
nies in the biopharmaceutical arena.
This achievement will further strengthen the
company’s competitiveness in the area of production of therapeutics of bacterial origin. Due to the
creativity and know-how of our teams in process
development and manufacturing, Boehringer
Ingelheim offers very economic, high-yield
processes performed in our modern facilities.
In 2000, Boehringer Ingelheim Austria entered
the area of plasmid DNA products, an important
therapeutic molecular structure which helps to
develop gene therapeutics and vaccines. During
the last five years, Boehringer Ingelheim has
advanced its plasmid DNA product yields from 50
mg/l to 2,000 mg/l – a 40-fold yield increase.
After the successful validation of the new Vienna
plant, Boehringer Ingelheim became the preferred
partner for the immediate uptake of late-stage and
commercial products to be produced in E. coli and
yeast. These include therapeutic proteins, antibody fragments, protein scaffolds and plasmid
DNA products.
92
Recombinant proteins are manufactured by means
of fermentation in bioreactors. Cultivation depends
here on optimal conditions for cell growth and
production of the drug substance. The organisms
used (cell cultures or bacteria) are highly sensitive
to any changes such as temperature, pH, oxygen
and carbon dioxide saturation, length of the
process or excipients used. Biopharmaceutical
Process Development in Biberach tests and evaluates at once the different cultivation conditions for
mammalian cell cultures (e.g. CHO cells) on a small
scale. These tests make it possible to determine the
optimal growth conditions for the cells which will
later be implemented in the large-scale bioreactors for market production. This important part of
development is essential for the economic production of drug substances with high-yield processes.
our customer orientation
On a biopharmaceutical compound’s way from
In Biberach, Boehringer Ingelheim has also devel-
mind to market there are many hurdles to over-
oped a high expression system (bi-hex) which
come. The Biberach teams have successfully
uses mammalian cell cultures (CHO cells) to
addressed these challenges and many projects
obtain a high yield of the therapeutic protein of
have been advanced into late stages: three new
interest. The bi-hex platform meets demands for
cell culture products in oncology and in respira-
shorter development times of a new biological
tory diseases have recently been transferred from
medicine and follows the paradigm do-it-right-
the small-scale process development level to the
the-first-time to avoid unnecessary costs and
large-scale production level. This is one step
delays. The bi-hex system has a four-fold higher
further on our way to be able to finally apply for
yield from mammalian cells than the current
international marketing authorisation.
industrial standard.
Furthermore, Boehringer Ingelheim successfully
Since most modern biopharmaceutical treatments
entered the Japanese oncology business by signing
cannot be taken in tablet form, patients have to
a manufacturing agreement with a major Japanese
inject the medication using a syringe. With pre-
pharmaceutical company for a monoclonal anti-
filled syringes the convenience for patients can be
body in the field of oncology.
increased usually resulting in a better compliance
How innovations are made
93
and treatment success. The worldwide need for
Confirming our leading position in biopharma-
such devices is constantly on the increase.
ceuticals development and manufacture, we have
Boehringer Ingelheim established a new aseptic
extended our resources for cell line development
filling line for pre-filled syringes in Biberach for
services for third parties and have established a
this therapeutic need.
global manufacturing network with collaboration
partners in manufacturing in Asia, Europe and
Our biopharmaceutical activities also support the
the USA.
development of Boehringer Ingelheim’s Animal
Health product pipeline. The support focuses on
Our biopharmaceutical Industrial Customer
R&D activities, such as the evaluation of anti
business is not only growing faster than the mar-
microbial peptides, for the treatment of chronic
ket average but is at the same time adding value to
bacterial infections that cannot be efficiently
research and development activities within the
controlled by conventional antibiotics, and the
company to ensure a sustained biological product
investigation of the safety and efficacy of recom-
pipeline with the aim of developing innovative
binant cytokines for the treatment of certain
therapeutic proteins that ultimately benefit
canine tumours in a new galenic formulation.
patients.
New biotechnology course started
October 2006 saw the first 35 students begin a pioneering degree course in pharmaceutical biotechnology at the School of Technology, Biberach, the German town that is home to Boehringer Ingelheim’s
main biopharmaceuticals site. Studies started only days after the inauguration of a EUR 8.6 million
faculty building.
“This project is of great importance beyond the region for the competitiveness of biopharmaceuticals
in Germany, as well as for patients who attach new hopes to this technology for treatment of their
diseases. Every third medicine being approved today is of biopharmaceutical origin,” Professor Rolf
Werner, Senior Vice-President, Corporate Division Biopharmaceuticals, Boehringer Ingelheim, said.
The 3.5-year course, which leads to a bachelor’s degree, concentrates on biopharmaceutical production processes and is more focused than previous study options serving the industry.
Boehringer Ingelheim’s Biberach site houses the largest biopharmaceutical production facility in
Europe. The new specialised faculty, set up by Boehringer Ingelheim in partnership with the local,
regional and federal authorities, as well as commercial partners, represents an important investment
in ensuring the future skills base.
94
Pharmaceuticals
Production
Pharma Chemicals
The sales figures of our worldwide Pharma Chemicals business developed very well. Consolidated
Our Pharmaceuticals
Division
sales amounted to EUR 158 million in 2006,
launches and produces Boehringer Ingelheim’s
Production
clearly exceeding the 2005 level (EUR 140 mil-
own drugs in a globally coordinated production
lion). The importance of the US market increased
network. Each site has a distinctive strength
further.
focusing on launch or seamless supply. Production sites are competitive centres of business proc-
The excellent positioning of our large established
ess excellence with distinctive competencies in
line products also contributed to the gratifying
managing, for example, new technologies and
sales development. The phenylephrine business
product life cycle.
continued growing at a high level, guaifenesin
In 2006, major investments, such a that for the
very well, especially in Japan. The development in
sales doubled and ketoprofen volumes developed
respimat®, dabigatran or the LogiPack Center in
the new business development area was also
Ingelheim, were made.
favourable. A couple of very promising projects
will ensure future growth.
Ben Venue, Bedford, Ohio, USA, one of the world’s
largest sterile injectables manufacturers, also
invested more than USD 50 million in a new
manufacturing facility which will come on line in
2007. For the mid-term, Boehringer Ingelheim
plans to invest a total of more than EUR 1.3 billion
for new products, mainly in Germany and the
USA. Optimising the assets of Boehringer Ingelheim’s corporate network will further contribute
to increasing efficiency.
Pharmaceuticals Production also offers its capabilities and capacities to our Industrial Customer
business. Boehringer Ingelheim produces for key
clients, such as Pfizer, Sanofi, GlaxoSmithKline,
Novartis, Bristol Myers Squibb, Sankyo, Sagmel
and Valeant.
Pharmaceuticals Production / Pharma Chemicals
95
Our investments in 2006
As a result of dynamic business growth, global investments in tangible fixed assets at Boehringer
Ingelheim increased significantly in 2006. They totalled EUR 596 million, which is an increase of 12 %
on the previous year.
Major investment projects that began in 2006 included expansion of the chemical production facilities
in Petersburg, Virginia, USA, and Fornovo, Italy. With an investment volume totalling more than EUR
170 million, these projects will ensure a long-term supply of active pharmaceutical ingredients (APIs)
for pharmaceutical production.
An especially important investment project is the expansion of the production facilities of Boehringer
Ingelheim microParts at the site in Dortmund, Germany, where production capacity for respimat®
devices is set to double by 2009 through expansion of the on-site production area and systems. This
will be accompanied by an increase in the number of employees in Dortmund from approximately
350 to 500 by 2010.
In addition to the opening of a new biology research centre in Vienna, Austria, a new centre for
pharmaceutical research and development was inaugurated in Biberach, Germany, in 2006 (right).
With an investment of approximately EUR 50 million, this new building provides a modern working
environment for around 130 employees for administering and applying new active ingredients.
96
Counterfeits – a real threat
for patients
According to World Health Organization (WHO) figures,
controlled by inspections and not well protected against
about 10 % of all pharmaceuticals are counterfeit, are fakes
penetration of faked products. New distribution channels
or substandard drugs. People in developing countries are
like the internet are not yet sufficiently controlled either.
regularly confronted with this problem, also developed
countries too are increasingly affected by this kind of crimi-
“One company alone cannot solve the problem,” says
nal activity. The main sources for counterfeit drugs are in
Dr Thomas Zimmer, Head of Corporate Safety, Quality
Asia and Latin America.
& Environmental Protection. Dr Zimmer represents
Boehringer Ingelheim in the European Federation of
Boehringer Ingelheim products were also subject to this
Pharmaceutical Industries Associations (EFPIA) as the
criminal activity. Since 2001, when the Corporate reporting
chairman of the anticounterfeiting ad hoc group and
system was installed, over 100 cases had been reported from
as a member of the WHO taskforce IMPACT.
inside or outside the Corporation.
The strategy for combating counterfeits in the developed
There are several reasons for the rise of counterfeit
world involves a couple of different approaches: a tamper-
medications: weak regulatory oversight, missing legal
resistant package, which is combined with a two-dimen-
framework for prosecution and penalisation, untrained
sional randomised barcode specific to one individual pack-
customs and a supply chain which is not sufficiently
age, and a database to support the authentication process of
products as close to the customer as possible, ideally in
pharmacies. In the USA, other techniques, such as radio
frequency identification (RFID) labels are currently being
discussed as too are so-called “pedigrees” which document
each stop a product has made in the supply chain. To
specifically address the Latin American market Boehringer
Ingelheim founded an internal taskforce intended to
collaborate with other companies and local agencies to
contribute to respective solutions.
“But the solution is not only a technical one,” Dr Zimmer
says. “There is in general an over-reliance on technology.
Communication with the public is needed.”
It is a fight which requires patience, persistence and sustained effort. “This battle can be won, but you can only
Two-dimensional barcodes are small and can store much
win it step by step,” underlines Dr Zimmer.
more information than older one-dimensional barcodes.
They are therefore useful for pharma packages. To give
the maximum protection for the patient they should be
combined with tamper-resistant closures.
Investments / Counterfeits
97
98
Group Management Report 2006
Group Management Report
Business and operating
environment
for 2007, led to extensive purchases of durable
Overview
The pleasing development in 2006 also extended
tax increase, from 16 % to 19 %, announced
consumer goods being brought forward.
The world economy in 2006 maintained the
to the labour market. The number of unemployed
positive development of the previous year.
fell distinctly and the number of people in
Economic growth was broadly based. The
employment rose further.
primary contributors to this were the economies
of East Asia, the United States and the euro zone
The favourable economic development can,
too, which in 2006 showed a strong increase in
however, only to a very limited extent be applied
its real gross domestic product (GDP).
to the research-driven pharmaceutical industry.
The growth rate for the world pharmaceutical
In Germany too economic development in
industry, discounting currency effects, slowed
2006 was favourable. With a growth rate of
again in 2006 – already the third year in succes-
2.7 %, real GDP was higher than it had been
sion.
since 2000. In contrast to the previous years,
domestic demand, alongside continued, strong
The reasons for this development are various. In
exports, also contributed decisively to this
first place is certainly the fact that a number of
gratifying development. In particular, the sales
important products from leading pharmaceutical
Net sales by businesses 2006
(in millions of EUR)
Net sales by region 2006
Netmillions
sales byof
region
(in
EUR) 2006
7,247
8,311
1,052
1,064
Biopharmaceuticals
548
503
Pharma Chemicals and
Pharmaceuticals Production
299
306
Animal Health
361
374
’05 ’06
100
Americas
Americas
4,559
4,559
5,388
5,388
Europe
Europe
3,117
3,117
3,295
3,295
Asia, Australasia,
Asia, Australasia,
Africa
Africa
1,891
1,859
1,859 ’05 ’06 1,891
’05 ’06
Total
Total
9,535
9,535
10,574
10,574
companies lost their patent protection. Due to
the subsequent generic competition, these
Net sales
2006
2005
Change
products were sold at substantially lower prices.
8,311
7,247
+15 %
On the other hand, it is becoming increasingly
1,064 1,052
+1 %
difficult to close the sales gaps caused by
Biopharmaceuticals
503
548
Pharma Chemicals and
and Pharmaceuticals
Production
306
299
+2 %
Animal Health
374
361
+4 %
expiring patent protection with new products.
The number of new registrations still trails
behind the high points of previous years.
-8 %
Nor was Boehringer Ingelheim able to avoid the
worldwide trend of declining growth rates in the
Borne by growth in all three regions, group net
industry. Following turnover growth, according
sales were increased by 10.9 % to almost EUR
to the healthcare information provider IMS
10.6 billion. The favourable development of the
Health, of 24 % in 2005, discounting currency
business in the last few years (2005: +17 %, 2004:
effects, primarily borne by innovative launches
+10.5 %) has thus continued. As in 2005, exchange
(spiriva® and micardis®) and extraordinary
rate developments in 2006 had no decisive impact
effects (mobic®), growth of only 8.4 % was
on turnover growth. The Japanese yen only lost
achieved in 2006. However, as in the last seven
some 6% of its value compared with the previous
years, this exceeded overall market growth
period, which only had an effect of less than -1 %
(6.1 % in 2006). A significant cause of the slowed
on group net sales.
growth at Boehringer Ingelheim is that our antirheumatic mobic®, as expected, faced generic
Boehringer Ingelheim’s most important sales
competition in the USA from summer 2006
segment is the Prescription Medicines (PM)
and compared to 2005 experienced a decline
business that again in 2006 developed very
in turnover of EUR 250 million.
favourably, with an increase of 15 %.
Boehringer Ingelheim’s growth in 2006 was
Net sales by region
2006
Americas
5,388 4,559
Europe
3,295
1,891 1,859
again borne by all three regions, each of which
surpassed its respective market growth. This
testifies to the international orientation and
strength of our group. The strongest growth was
achieved in the Asia, Australasia, Africa (AAA)
2005
3,117
region, with 15 % at constant exchange rates
according to IMS Health. In the Americas region
turnover growth was 9 %, discounting currency
effects. In Europe we posted market growth of
4.6 % at comparable exchange rates.
101
In our Animal Health business, with growth of
tations and we assume that it has further growth
10 %, we further reinforced our No. 10 position
potential that can gain additional momentum on
internationally and thereby secured a market
publication of the results of the ontarget™
share of 3 % in this highly competitive market.
study in 2008. flomax®/alna®, a medication for
We considered growth of 1 % for our Consumer
the treatment of benign prostatic hyperplasia
Health Care (CHC) as unsatisfactory. The main
(BPH), achieved sales growth of 28 %. This
reason lies in the restrained development of our
growth is primarily attributable to its market
business in Japan, which, in addition, suffered
success in the USA, where it holds a market share
from the marked depreciation of the Japanese
of around 57 %. We expect another important
yen. We expect the acquisition at the end
turnover driver from the 2006 market approval
of 2006 of the medication zantac® in the USA
for sifrol®/mirapex® in the indication restless
to give us strong growth in CHC business in
legs syndrome (RLS) in both Europe and the USA.
this market in 2007.
The generic competition for our mobic® in the
USA had been anticipated, but some months later
We anticipated the 8 % decline in turnover in
than it actually happened. For the first time, the
the Biopharmaceuticals segment, as the previous
US Food and Drug Administration (FDA) granted
period had been positively affected by certain
market approval to 14 applicants simultaneously,
extraordinary factors (2005 growth in this
which immediately after they entered the market
segment amounted to 40 %).
led to a dramatic decline in prices.
In the business area PM we further extended
As in previous periods, the positive influence of
the market position of our main sales generators
our concepts Value through Innovation (VTI)
spiriva®, flomax® and micardis®. In these
and Lead & Learn was of importance in 2006.
products Boehringer Ingelheim now has three
Both have continued to play a decisively
medications with sales volumes exceeding
formative role in our corporate culture and are
USD 1 billion. spiriva®, one of the most pre-
a significant basis for successful cooperation at
scribed medications for the treatment of chronic
Boehringer Ingelheim. With a series of projects
obstructive pulmonary disease (COPD), achieved
we have ensured that these principles will
the strongest growth with a 45 % increase on the
continue to be translated into reality so that
previous year. micardis®, a medication for the
we can thereby also successfully meet the
treatment of hypertension, achieved growth of
challenges of the future.
34 %, which underlines the strength of this
medication in this highly contested market
segment. micardis® has thereby met our expec-
102
To summarise, we see the success of 2006 once
Boehringer Ingelheim spent EUR 1,574 million
again as confirmation of our business efforts.
in this business area, thereby increasing our
In the business areas Research and Development,
R&D expenditure by 15.7 % against the previous
Production, Marketing and Sales we regard
period and again investing 14.9 % of our net sales
ourselves as well-equipped and look to the future
in our own R&D activities.
with confidence.
In our Human Pharmaceuticals business, R&D
The most important figures for earnings for 2006
expenditure as a share of net sales was 15.0 %
are as follows:
(2005: 14.4 %). We have distributed our global
research activities to our sites in Germany, the
Net sales
Operating income
Return on net sales (as %)
2006
2005
Change
10,574 9,535
+10.9 %
2,140
1,923
20.2
20.2
+11.3 %
USA, Austria and Canada. In addition to each
site’s focussing on certain fields of research,
numerous international project teams ensure
that necessary know-how concerning successful
project management is available. Boehringer
Ingelheim has concentrated its R&D on seven
Research and Development
therapeutic areas:
Boehringer Ingelheim has firmly anchored
• respiratory diseases
in its guiding principles (Leitbild) the mission
• virology
of helping people suffering from diseases by
• oncology
researching innovative medicines. Against this
• metabolic diseases
background, the worldwide deployment of
• cardiovascular diseases
resources in research and development are of
• central nervous system diseases
prime importance. In the reporting period,
• immunology and inflammation
2006
2005
2004
2003
2002
Total expenditure (in millions of EUR)
1,574
1,360
1,232
1,176
1,304
14.9
14.3
15.1
15.9
17.2
1,527
1,318
1,195
1,140
1,264
15.0
14.4
15.3
16.1
17.4
6,003
5,678
5,471
5,362
5,205
125
116
97
93
97
– as % of net sales
Human Pharma. expend. (in millions of EUR)
– as % of HP net sales
Investments in tangible assets (in millions of EUR;
without investments in infrastructure)
103
Our medications spiriva®, combivent® and
of our therapy area cardiovascular diseases. We
atrovent® have for many years given us a
assume that the presentation of the results of the
leading position in the treatment of COPD.
large-scale studies ontarget™ and transcend®
spiriva®, our first blockbuster medication, is one
(together including more than 30,000 patients)
of the medicines that is most often prescribed for
at the beginning of 2008 will show that the
this indication. The product, co-promoted with
spectrum for using micardis® can be further
Pfizer, Inc., was also launched in France in 2006
widened substantially. The clinical study
and is now available in most countries. We
profess®, with over 20,000 patients, to demon-
assume that the clinical study uplift®, the
strate the efficacy of aggrenox® in secondary
outcome of which we expect in 2008, will further
stroke prevention, will be concluded in 2008.
reaffirm the medicinal efficacy of spiriva® with
Here too we expect an outcome that promises
additional favourable results.
success. In dabigatran we have a highly
promising substance in clinical phase III in the
In the therapeutic area of central nervous system
therapeutic area cardiovascular diseases for the
diseases we have in the dopamine agonist
prevention and treatment of thrombo-embolic
sifrol®/mirapex® (pramipexole) a successful
diseases.
medication for the treatment of Parkinson’s
disease. In 2006, pramipexole was also given
In the urology area Boehringer Ingelheim
market approval by the EU and the FDA for the
markets flomax®/alna®, a medication
treatment of RLS. Together with Lilly, Boehringer
in-licensed from Astellas, for the treatment
Ingelheim has developed the antidepressant
of benign prostate hyperplasia (BPH).
cymbalta® that has already been introduced in
more than 20 countries. In Germany cymbalta®
In the areas oncology and metabolic diseases,
has developed into the most successful intro-
newer research areas for Boehringer Ingelheim,
duction of an antidepressant.
we have some interesting development products
in clinical phase II.
In the area of virology Boehringer Ingelheim has
had for years, with the medication viramune®, a
Our own previously mentioned research efforts
successful drug in the non-nucleoside reverse
are complemented by strategic alliances and
transcriptase inhibitor (NNRTI) class. The intro-
in-licensing. Here we can note our exemplary
duction of aptivus® in 2005 complemented our
cooperation with Ablynx for researching and
portfolio of treatments for the immune deficiency
developing new forms of therapy for Alzheimer’s
disease AIDS. A further focus in virological
disease based on Nanobodies® developed by
research is in the area of the hepatitis C virus.
Ablynx.
With growth of more than 30 % in 2006,
With several compounds in clinical phases II
micardis® (angiotensin II receptor blocker) is
and III, and a number of substances in the
one of the fastest growing Boehringer Ingelheim
pre-clinical phase, we will be able to ensure
products. The medication has developed highly
the flow of new products.
successfully since launch and is a cornerstone
104
Production
capacity in which Boehringer Ingelheim is estab-
Production sites belonging to the Boehringer
lished and recognised as a leading manufacturer.
Ingelheim group of companies produce the
company’s own pharmaceutical products within
Environmental and employee protection
the framework of a global network. Catchphrases
The safety of employees and protection of the
like “Business Process Excellence” and
environment play a central role for Boehringer
“Customer Relation Excellence” characterise the
Ingelheim at all of our sites. This high priority is
management culture at these sites. Compliance
also expressed by the fact that this aspect is
and optimisation are among the main focus
written down in our Leitbild. Our aim is to avoid
areas when new products or technologies are
damaging impact on the environment and to
implemented.
conserve natural resources in conducting our
Significant investments in 2006 were at the
respect and adhere to the legal requirements in
activities. For us, it goes without saying that we
site at Cleveland, Ohio, USA to expand our
the respective countries. Indeed, we also go
production capacity (> EUR 50 million) and
beyond the legally defined demands, where we
in our LogiPack-Center (packaging facility)
regard it as purposeful. Our established processes
at the site in Ingelheim, Germany.
in the field of environmental, health and safety
(EH&S) are the foundation for the successful
With an investment volume of more than
implementation of the basic principles of
EUR 250 million in our production plants over
environmental policy. Here our objective is
the next few years we will establish the basis to
to scrutinise our existing procedures in a
be able to meet future demands on capacity and
continuous process of improvement constantly
fulfil the ever-growing regulatory requirements
in search of improvement potential. We ensure
of the authorities.
consistent groupwide adherence to these
standards through environmental audits at our
In the area of chemical production we will in
sites (2006: 13 environmental audits). Within the
the next few years invest a total of over EUR 150
framework of our participation in “Responsible
million at the sites Petersburg, Virginia, USA and
Care”, the global initiative of the chemical
Fornovo, Italy. With these plants and the existing
industry, we have also committed ourselves to its
capacity at Ingelheim and Malgrat, Spain we will
basic principles.
guarantee active substance supply for
our pharmaceutical products, and with a view
The certification of our sites at Fornovo, Italy
to our planned launches, on a lasting basis.
and Yamagata, Japan, by external inspectors in
At both of our biopharmaceutical production
internal standards. In this we also see an
accordance with ISO 14001 confirmed our high
sites, Biberach, Germany and Vienna, Austria,
incentive to build on our excellent position in
capacity was expanded markedly over the past
these areas.
few years. We consider ourselves very wellequipped for the next few years, underpinned
by continued strong demand for biotechnological
105
Employee reporting
In addition, an important part of our human
The sustained, positive development of our
resources work is our commitment to education.
business has led to a further expansion of the
In the reporting period, we offered apprentice-
number of our employees. Averaged over the year,
ships to 667 young people in Germany, thereby
Boehringer Ingelheim in 2006 employed 38,428
raising the previous year’s level once again. In
people. This corresponds to growth of 3 %,
the years before, we had already at the Biberach
following 5 % growth in 2005.
and Ingelheim sites taken account of the social
challenge of creating a better work-life balance
In the reporting year, we, through a series
and, in cooperation with the local communities,
of programmes and events, intensified and
promoted and supported the establishment of
established as a central element of our working
day-care centres for children.
culture, the Lead & Learn concept that has
been implemented since 2005. In this we see a
In 2006, a childcare centre with 130 places was
significant basis to further create Value through
also built at our site at Ridgefield, Connecticut,
Innovation in order to face the challenges ahead.
USA.
An important goal of our human resources work
Social responsibility
is to recruit and retain the best people on a lasting
Boehringer Ingelheim has for more than 100
basis. Boehringer Ingelheim offers talented
years taken care of its social responsibility in a
employees various paths to personal and leader-
very extensive and highly attentive manner. Our
ship development in order to develop further
understanding is that our responsibility applies
their abilities. We are convinced that our remu-
to our patients, our employees and their families
neration schemes also put us in a very good,
as well as the communities and countries in
competitive position. Our system of financial
which we operate (Good Corporate Citizenship).
rewards provides, in addition to a basic marketorientated salary, for a variable salary element
that essentially follows company success and the
achievement of personal targets. Alongside this,
basic principles of “corporate governance” and
“corporate social responsibility”, as proposed
our extensive social contributions play an impor-
by various international organisations (United
tant role in the overall remuneration concept.
Nations, World Health Organization, Organisa-
As in previous years, Boehringer Ingelheim
tion for Economic Cooperation and Development
in 2006 again received recognition in many
and the EU). These principles are employed in
countries in conjunction with opinion polls to
our strategic deliberations, our corporate culture
find the best employers. Part of our fundamental
and our daily business.
beliefs is not to rest on our laurels. In 2007,
we will conduct a group-wide opinion survey
among our employees. From the results of this
survey we will access further improvement
potential.
106
Boehringer Ingelheim orientates itself after the
In the area of HIV/AIDS therapy, we have for
years considered it our duty to undertake the
special social task of making our medication
viramune® available to patients who would
otherwise receive an inadequate supply of
medicine. Through our donation programme
we support activities that clearly reduce the risk
of transmission of HIV from mother to child
during birth using an antiretroviral therapy. For
this purpose we make our AIDS medication
viramune® available free of charge. In 2006,
we in addition reduced the price for viramune®
for some developing countries and within the
framework of the Accelerating Access Initiative
(AAI) programme we offer these countries considerable price reductions. Furthermore, we have
in the meantime granted seven manufacturing
licences that allow generic production in the
developing countries concerned.
At the same time in 2006, we sought through
numerous clinical studies with aptivus® and
viramune® to gain further insights into the
treatment and therapy of AIDS.
Another given for our social responsibility as
a company is, where possible, to encourage
and support the voluntary commitment of our
employees. Many of our employees engage
voluntarily in their free time in social projects
and make a decisive contribution where help
is called for.
Results from operations,
financial position and
net assets
Results from operations
Independent market data show that Boehringer
Ingelheim again grew faster than the overall
market in 2006. We thereby gained market share
for the seventh consecutive year. This success
was all the more remarkable, as Boehringer
Ingelheim achieved this growth essentially with
its own resources, i.e. with products from its own
research. According to current market data,
Boehringer Ingelheim ranks 15th among the
world’s largest pharmaceutical companies, with
a market share of 2 %.
Boehringer Ingelheim increased its net sales by
10.9 % in 2006 to EUR 10,574 million. Exchange
rate movements, compared to the previous period
2005, had a slightly negative impact (-1 %) on
this development. When analysing our growth, it
must be noted that changes in the consolidation
were negligible. The acquisition of the product
zantac® in the USA took place at the end of
2006 and has not yet affected our turnover
development.
Boehringer Ingelheim is divided into the businesses Human Pharmaceuticals and Animal
2006
2005
2004
2003
2002
Price/quantity/new introductions
12.1
17.4
16.1
7.8
10.1
Acquisition and sale of businesses
–0.3
–0.5
–0.5
–0.2
7.1
Currency effect
–0.9
0
–5.1
–10.2
–4.0
Components of growth in net sales (as %)
107
Health. The Human Pharmaceuticals business
loss of exclusivity for mobic® in the USA in 2006,
encompasses the segments PM, CHC as well
we had, as already mentioned, to take a drop in
as Industrial Customers. In 2006, this business
net sales of this product exceeding EUR 250
achieved net sales of EUR 10,200 million,
million which will be even greater in the 2007
corresponding to growth of 11 %. The Human
period.
Pharmaceuticals business thereby accounted
for 96 % of group net sales.
The overwhelmingly strongest region in the
PM segment is the Americas, with a 54 % share
of group net sales. With only a very modest
PM is by far the most important segment in
foreign exchange influence, growth of 8.9 % was
our Human Pharmaceuticals business. In 2006,
achieved, discounting currency effects. Growth
net sales of EUR 8,311 million were achieved,
of 8.5 % in the pharmaceutical market was
corresponding to growth of 14.7 % compared
thereby surpassed once again. Net sales for the
to the previous year (2005: EUR 7,247 million).
region amounted to EUR 4.5 billion. As a single
The significance of this segment is evident in
market, the USA was the largest and most impor-
that it accounts for 81 % of our Human Pharma-
tant country for Boehringer Ingelheim, with an
ceuticals business.
86 % share of net sales. In the US market the
products spiriva®, micardis® and flomax®
This gratifying development was borne by our
showed very gratifying development, all achiev-
strategic products which all showed marked
ing double-digit growth.
growth:
In the Europe region a net sales volume of
EUR 2,180 million was achieved, giving the
Net sales
2006
2005
Growth
spiriva®
1,381
951
45 %
micardis®
967
724
34 %
aggrenox®
225
172
31 %
flomax®
922
721
28 %
sifrol®/mirapex®
536
434
23 %
region a share of 26 % in this segment. Market
growth of 3.9 % in the region was exceeded
slightly. The country in this region with the
biggest turnover was Germany, which contributed EUR 446 million to total net sales. This
represented a 2 % decline in net sales in our
home market compared to the previous period.
Our businesses in Eastern Europe showed very
spiriva® continued to develop favourably and
pleasing development, with many countries
is our fastest growing product. For the products
achieving double-digit growth.
micardis® and aggrenox® we also expect
further growth in the next few years, supported
Exchange rate movements, particularly that of
by the outcomes of clinical studies. In 2006,
the Japanese yen, had a negative impact on net
our medication sifrol®/mirapex® was granted
sales development in the AAA region. At constant
market approval in the indication RLS, so we
exchange rates, we grew 15 %, markedly above
can also expect further growth from the
the overall market that had a growth rate of
extended spectrum of use in 2007. Due to the
108
only 2 %. The region’s overall net sales reached
Industrial Customers
EUR 1,379 million, with Japan in the leading
In our Industrial Customers business we have
position with a 62 % share of net sales. In 2006,
brought together the third party business of
Japan’s total net sales in PM amounted to EUR
Pharmaceuticals Production, the Pharma
849 million.
Chemicals area and our contract manufacturing
three business areas in 2006 amounted to EUR
In the business segment CHC we increased
809 million, thereby falling below the figure for
our net sales to EUR 1,064 million, a rise of 3 %
the previous year. It must be noted that the 2005
of Biopharmaceuticals. Total net sales for these
compared to the previous year, discounting
figures contained favourable, one-off effects in
currency effects. We continue to pursue our
Biopharmaceuticals. Contract manufacture of
strategic orientation with a focus on defined key
biotechnologically produced medications takes
brands. In 2006, we distinctly strengthened our
the most important place.
presence on the over-the-counter (OTC) market
in the USA by acquiring the product zantac®.
Animal Health
Together with our product dulcolax® we
In the global markets in animal health products,
now have a strong position there in the gastro-
Boehringer Ingelheim is in No. 10 position, with
intestinal medications segment.
a market share of 3 %. Compared to the previous
year, net sales were increased in 2006 by 4 %,
despite the sale in 2005 of some non-strategic
The most important product groups in this
product groups. On the basis of comparable
segment in 2006 were:
underlying business, growth in 2006 was 8 %
Net sales
in local currency terms. Net sales amounted to
2006
2005
Growth
dulcolax®
122
115
6 %
mucosolvan®
108
91
19 %
pharmaton®
96
88
9 %
buscopan®
71
59
20 %
Business development was very different from
region to region. While the Americas (+ 10 %)
and Europe (+ 5 %) marked increases in net sales,
turnover in the AAA region (- 9 %) declined. The
EUR 374 million.
Worldwide growth was achieved by the following
product groups in particular:
Net sales
2006
2005
Growth
enterisol ileitis®
22
17
29 %
vetmedin®
19
16
19 %
metacam®
75
68
10 %
reason for the weak development in the AAA
region was the depreciation of the Japanese yen
against the euro.
109
From a regional point of view, Europe showed
shareholders may not be shown as tax expenses.
marked growth. With an increase of 10 %, net
These are presented as withdrawals from accu-
sales reached a volume of EUR 179 million.
mulated group equity.
Development in the other two regions showed a
slight decline. In the Americas region this was
Taking this extraordinary effect into considera-
attributable to the sale of certain product groups,
tion, the actual tax ratio is markedly higher than
while in AAA the currency effect of the Japanese
the value shown in the profit and loss statement.
yen had a negative impact.
To sum up, net income rose to EUR 1,722 million.
Expenditure and income
This signifies a EUR 231 million increase
Total operating costs were 5.5 % higher than in
compared to 2005.
2005 and reached EUR 8,848 million. In 2005,
they amounted to EUR 8,388 million. Personnel
Financial position
costs rose by 6 % in 2006 to EUR 2,836 million,
Boehringer Ingelheim’s financial management
which reflects an increase in the average head-
instruments and methods are aligned with
count by 1,022 employees.
international standards for a modern
industrial company. The goal of the financial
Depreciations remained at the 2005 level at
management is to support the business strategy
EUR 530 million. Other operating expenses rose
of our company by providing or investing finan-
by EUR 425 million (+ 12 %). Overall, operating
cial assets, taking account of the foreign
income increased by EUR 217 million compared
exchange risk.
to 2005 and now amounts to EUR 2,140 million.
The return on net sales was maintained at the
As a result of Boehringer Ingelheim’s interna-
2005 level of 20 %.
tional orientation, exchange rate fluctuations
have a considerable impact on the measure of
The financial income in the reporting period
the company’s success. Here, the exchange rate
amounted to EUR 102 million and was
development of the US dollar represents the
significantly affected by the sale of a number
highest single risk. Within the framework of
of financial assets. Borne by increase in income
group-wide financial reporting, foreign exchange
from operations, income before taxes rose to
risk is regularly investigated and analysed. To
EUR 2,243 million and was thereby EUR 355
secure against this risk, particularly from goods
million, or 19 %, distinctly higher than in 2005.
and services, derivative financial instruments are
employed. The manner and extent of these
Tax expenses amounted to EUR 514 million,
measures are regulated by the relevant group
corresponding to a tax ratio of 23 % (2005: 20 %).
guideline.
Here, it must be taken into consideration that due
110
to regulations of the German commercial code,
Boehringer Ingelheim’s good economic develop-
personal taxes on group activities levied on the
ment in 2006 is also reflected in the development
of the cash flow, which rose by EUR 248 million
Net assets
compared to 2005 to EUR 2,317 million (+ 12 %).
Total assets in 2006 stood at EUR 11,845 million,
The cash flow from operating activities is EUR
the same level as in the previous year. Tangible
1,500 million, clearly exceeding funds used for
and intangible assets are covered by Boehringer
investment activities. In 2006, we increased
Ingelheim’s total equity.
our investment efforts again (+ EUR 64 million)
and entered an investment volume of EUR 596
By actively managing the days of sales outstand-
million in tangible assets. There was an addition
ing of our receivables, we achieved an increase of
of EUR 451 million to the intangible assets,
the receivables, discounting currency effects, that
essentially due to the acquisition of the product
was disproportionately small relative to the
zantac® in the USA. Securities and liquid funds
expansion of our business.
stood at EUR 3,934 million at year-end.
Due to the transfer of liquid funds into the
To summarise, it can be noted that, because
financial assets, liquid assets declined, compared
of existing liquidity, the given capital structure
to the previous year, to EUR 866 million (2005:
and the available funding potential, the financial
EUR 1,167 million).
preconditions for successfully realising our
strategy remain in place.
Group equity increased compared to the
In Germany the new galenics building in
EUR 4,825 million) because of the favourable
previous year to EUR 5,363 million (2005:
Biberach and the new packaging facility
business development. Long-term disposable
(LogiPack-Center) in Ingelheim were completed.
capital (equity, pension provisions and long-term
Furthermore, a number of new investment
liabilities) amounted to EUR 7,450 million,
projects were started in Germany. Particularly
corresponding to 63 % of the balance sheet total.
noteworthy are the expansion of our production
This year again, this item covers all the intangi-
plants at the Dortmund site (BI microParts),
ble and tangible assets, inventories and liabilities
the new chemical laboratory and a new works
as well as almost half the liquid assets.
canteen in Ingelheim. In Biberach additional
investments in the biotechnical active ingredient
production facilities were started.
The balance sheet and the related balance sheet
ratios round off the altogether favourable picture
that the earnings and financial position have
In Italy we laid the foundation stone for a new
already drawn.
chemical synthesis facility at the Fornovo site.
In addition, we have commenced activities
The combined evaluation of the net assets,
for building a new synthesis plant in Petersburg,
financial position and results of operations
Virginia, USA. It was also decided to expand
shows that Boehringer Ingelheim is a soundly
production capacity at the Ben Venue site in
financed and profitable company. In 2006, we
Cleveland, Ohio. In the USA construction was
created a firm basis for our further business
also started at the site at Ridgefield, Connecticut
development.
on a laboratory building in order to increase
our research capacity.
111
Report on post-balance
sheet date events
Within the framework of the audit plan approved
by the Board of Managing Directors, internal
auditing conducted routine and extraordinary
audits worldwide during the reporting year.
Since the end of the financial year 2006, we
The focus was the efficiency of structures and
have not become aware of any events that are of
processes, securing assets, adherence to legal
material significance to the group of companies,
requirements and guidelines, the functionality
or could lead to a reappraisal of its asset, finan-
of systems and the effectiveness of internal
cial or earnings position.
controls.
Currency and interest rate risks, which arise
because of our group’s international business
Risk report
The Boehringer Ingelheim group’s risk management system has proved effective over recent
years and the concept was unchanged in the
reported period.
With the participation of the country organisations, and the inclusion of various function
holders, business-specific risks are systematically
reported and monitored.
Our strategy and planning processes, which
focus over several years, also form a significant
element of our active risk management. Hereby,
we ensure that all risks known to us are reported,
thoroughly analysed and evaluated. Following
the appropriate classification, counter-measures
are commenced and their implementation
consistently monitored.
relationships, are constantly examined and
limited by appropriate hedging strategies. From
the portfolio of receivables and liabilities on
trade accounts no risk arose for the Boehringer
Ingelheim group which exceeds the industry
norm. This equally applies to the default risks
that are mainly secured against economic and
political uncertainties.
Risks in the area of environmental health and
safety are minimised preventively by adherence
to our own very high safety standards. For
possible incidents appropriate emergency plans
are in place that are regularly tested and trained.
Furthermore, Boehringer Ingelheim has
risk-adjusted insurance coverage.
In addition to the general business risks associated with the industry, we are not currently
aware of any risks that substantially threaten the
further development of Boehringer Ingelheim’s
business.
112
Report on expected
developments
The spiriva® respimat® Soft Mist™ Inhaler
(SMI) was filed for registration with the European authorities in 2006. For 2007, it is planned
to put together the documentation for filing
The good results of the financial year 2006
with the US authorities. Studies confirm that
confirmed our internal planning parameters.
the SMI is preferred by our patients compared
Our businesses and functions have, within the
to other dosage forms. This gas propellant-free
framework of our planning processes, in the
mist generation achieves improved uptake of
reporting period adapted their multi-year
the active ingredient via the lungs.
planning on the basis of current development.
The insights gained from this essentially
At the beginning of 2006, we began
confirm our strategic parameters and targets.
re-volution®, the largest clinical study
programme to date in thrombo-embolic diseases,
For our key brands spiriva®, micardis®,
in which 27,000 patients worldwide will take
flomax® and sifrol® we foresee further
part. It will investigate dabigatran, a novel, orally
growth potential in 2007. For spiriva® and
available thrombin inhibitor researched and
micardis® we expect positive outcomes in
developed by Boehringer Ingelheim for the
the next two years from various clinical studies,
prevention and treatment of thrombo-embolic
such as uplift® (spiriva®) and ontarget™ and
conditions.
transcend® (both micardis®). For the product
flomax® we anticipate further market growth in
Other important development projects are in
the relevant indication, especially in the impor-
phases II and III. For flibanserin a number of
tant US market, from which our product will
phase III studies were commenced in 2006.
benefit. The market approval received from the
Flibanserin is a novel treatment approach for the
European authorities and the FDA in 2006
treatment of hypoactive sexual desire disorder
for our product sifrol® in the indication RLS
(HSDD). In the oncology area, one of our newer
will further reinforce the development of this
fields of research, we have developed some prom-
product. We expect the results in 2008 of the
ising approaches in cancer therapy. Several
profess® study on micardis® and aggrenox®,
clinical phase II studies were initiated in 2006.
a medication to prevent the risk of secondary
We expect their outcomes in 2007.
stroke.
113
For the financial year 2007, we assume turnover
innovative research long term and thereby be
growth in single figures. One reason for this is
able to guarantee the necessary flow of new
the loss of exclusivity for our product mobic®
products in the future.
in the USA in 2006. For this product alone we
estimate that we will have a decline in net sales
Although further concentration occurred in the
of more than EUR 350 million in 2007. The fact
pharmaceutical industry in 2006, especially in
that we, in spite of everything, expect growth in
the German market, our declared goal remains
net sales exceeding 5 %, is testimony to the
to manage Boehringer Ingelheim long term as
strength and balance of our portfolio.
an independent, family-owned company. Our
endeavour in this context is to achieve above-
On the basis of current planning, we expect net
average growth in the market that will deliver
sales of more than EUR 11 billion in 2007. For
a corresponding increase in the value of the
2008, we plan to exceed the EUR 12 billion mark
company. To this end, we will also continue to
for the first time.
keep a close eye on the profitability of our group.
With approximately EUR 700 million we will
With the success of the year 2006 we were able
again increase our investment expenditure
to link up with the very good figures of the
in 2007 compared to the previous year. Our
previous year and further improve our turnover
investments will be concentrated in the areas of
and net income. This confirms our strategic
production and research. Major projects in the
orientation and gives us confidence that we can
chemicals area to ensure that we can meet future
reach our demanding goals in the future too. We
active ingredient demand were approved with a
will continue to take every measure in order for
total investment volume of more than EUR 160
Boehringer Ingelheim to be able to successfully
million. In the research area projects for modern-
develop further. We consider this a duty towards
ising and expanding our capacity at our German
all stakeholders, primarily towards all patients
and US sites have been decided. With these
for whom we wish to make effective and safe
investments we will establish the necessary
medicines available in the future.
preconditions to also be able to conduct
114
Consolidated
Financial Statements 2006
Overview of the major consolidated companies
C. H. Boehringer Sohn*
Boehringer Ingelheim GmbH
Europe GmbH
International GmbH
Germany
Finland
Austria
Argentina
Pharma GmbH & Co. KG,
Ingelheim
Finland Ky, Espoo
Forschungsinstitut für Molekulare
Pathologie Gesellschaft mbH,
Vienna
Boehringer Ingelheim S.A.,
Buenos Aires
Belgium
Boehringer Ingelheim Pty. Ltd.,
North Ryde
Vetmedica GmbH, Ingelheim
Norway
Norway KS, Asker
SCS Boehringer Ingelheim
Comm. V., Brussels
China
International Trading (Shanghai)
Co. Ltd., Shanghai
Boehringer Ingelheim Shanghai
Pharmaceuticals Co. Ltd.,
Shanghai
Australia
Austria
Boehringer Ingelheim Austria
GmbH, Vienna
Pharma Ges.m.b.H., Vienna
Brazil
Philippines
Boehringer Ingelheim do Brasil
Quimica e Farmaceutica Ltda.,
São Paulo
Boehringer Ingelheim (Phil.) Inc.,
Manila
Solana Agro Pecuaria Ltda.,
Arapongas
South Korea
Canada
Boehringer Ingelheim Korea Ltd.,
Seoul (50 %)
Boehringer Ingelheim (Canada)
Ltd., Burlington
Boehringer Ingelheim Vetmedica
Korea Ltd., Seoul
Chile
Boehringer Ingelheim Ltda.,
Santiago de Chile
Colombia
Boehringer Ingelheim S.A., Bogotá
Czech Republic
Boehringer Ingelheim s.r.o.,
Prague
Denmark
Distribution
Production
Ecuador
Research
Boehringer Ingelheim del Ecuador
Cia. Ltda., Quito
*sole general partner:
Boehringer AG
116
Boehringer Ingelheim Danmark
A/S, Copenhagen
Boehringer Ingelheim a n n u a l r e p o r t 2 0 0 6
C. H. Boehringer Sohn Grundstücksverwaltung GmbH & Co. KG
Auslandsbeteiligungs GmbH
France
South Africa
Pharma Investment Ltd.,
France S.A.S., Paris
Boehringer Ingelheim (Pty.) Ltd.,
Randburg
Burlington, Canada
Investment Ltd.,
Labso Chimie Fine S.A.R.L.,
Blanquefort
Ingelheim Pharmaceuticals (Pty.)
Ltd., Randburg
USA
Greece
Spain
Boehringer Ingelheim Ellas AE,
Athens
Boehringer Ingelheim España S.A.,
Barcelona
Indonesia
Boehringer Ingelheim S.A.,
Barcelona
PT Boehringer Ingelheim
Indonesia, Jakarta
Italy
Boehringer Ingelheim Italia S.p.A.,
Reggello
Bidachem S.p.A.,
Fornovo S. Giovanni
Europharma S.A., Barcelona
Laboratorios Fher S.A., Barcelona
Sweden
Boehringer Ingelheim AB,
Stockholm
Switzerland
Istituto De Angeli srl,
Reggello
(Schweiz) GmbH, Basel
Japan
Pharmaton S.A., Lugano
Nippon Boehringer Ingelheim
Co. Ltd., Kawanishi
Taiwan
SSP Co. Ltd., Tokio (57 %)
Boehringer Ingelheim Taiwan Ltd.,
Taipei
Vetmedica Japan Co. Ltd.,
Kawanishi
Seiyaku Co., Ltd., Yamagata
Netherlands
Boehringer Ingelheim B. V.,
Alkmaar
Poland
Boehringer Ingelheim Sp.zo.o.,
Warsaw
Portugal
Boehringer Ingelheim Lda.,
Lisbon
Burlington, Canada
Boehringer Ingelheim Corp.,
Ridgefield, Connecticut
Pharmaceuticals, Inc.,
Ridgefield, Connecticut
Mexico
Promeco S.A. de C.V., Mexico City
Boehringer Ingelheim Vetmedica
S.A. de C.V., Guadalajara
Ben Venue Laboratories, Inc.,
Bedford, Ohio
Roxane Laboratories, Inc.,
Columbus, Ohio
Vetmedica, Inc.,
St. Joseph, Missouri
Roxane, Inc., Columbus, Ohio
Chemicals, Inc.,
Petersburg, Virginia
Thailand
Boehringer Ingelheim (Thai) Ltd.,
Bangkok
Turkey
Boehringer Ingelheim Ilac
Ticaret A.S., Istanbul
United Kingdom
Boehringer Ingelheim Ltd.,
Bracknell
Venezuela
Boehringer Ingelheim C.A.,
Caracas
Unilfarma Lda., Lisbon
Overview of the major consolidated companies
117
C. H. Boehringer Sohn, Ingelheim
Consolidated balance sheet
Assets (in millions of EUR)
Notes1)
31.12.2005
Intangible assets
(3.1)
554
233
Tangible assets
(3.2)
2,886
2,900
Financial assets
(3.3)
Fixed assets
3,043
3,396
6,483
6,529
Inventories
(3.4)
1,280
1,229
Accounts receivable
(3.5)
2,333
2,143
79
80
Securities
Cash and cash equivalents
866
1,167
Current assets
4,558
4,619
Deferred taxes
746
821
58
49
11,845
12,018
31.12.2006
31.12.2005
178
178
3,415
3,001
-140
-61
Deferred charges and prepaid expenses
Total assets
Liabilities and equity (in millions of EUR)
Notes1)
Group reserves
Balance sheet currency conversion difference
Net income
1,722
1,491
Equity
5,175
4,609
188
216
5,363
4,825
4,459
4,754
Minority interests
Group equity
Provisions
(3.6)
Accounts payable
(3.7)
Liabilities
Deferred taxes
Deferred charges
1)
118
31.12.2006
For explanation, see relevant section in the Notes to the Consolidated Financial Statements.
1,774
2,174
6,233
6,928
182
204
67
61
11,845
12,018
Consolidated profit and loss statement
Notes1)
Net sales
(4.1)
Changes in inventories
Other internal work performed and capitalised
Other operating income
Total revenues
2006
2005
10,574
9,535
40
175
4
3
370
598
10,988
10,311
Material costs
(4.2)
-1,484
-1,613
Personnel costs
(4.3)
-2,836
-2,671
Amortisation of intangible and depreciation of tangible assets
(4.4)
-530
-531
Other operating expenses
(4.5)
-3,998
-3,573
2,140
1,923
102
-35
Operating income
Financial income
(4.6)
Holding income
(4.7)
Income before taxes
Taxes2)
(4.8)
Income after taxes
Third-party share
Net income
1)
(4.9)
1
0
2,243
1,888
-514
-374
1,729
1,514
-7
-23
1,722
1,491
For explanation, see relevant section in the Notes to the Consolidated Financial Statements.
2)
D ue to legal requirements the disclosure of the shareholders’ personal taxes arising from
consolidated business activities as tax expenses is not allowed. These taxes are shown as
withdrawals from the accrued group capital.
Consolidated balance sheet / Consolidated profit and loss statement
119
Cash flow statement
Income after taxes
Write-downs/write-ups on fixed assets
1)
Change in provisions for pensions
Cash flow
Change in other provisions
Other non-cash income and expenses
2005
1,729
1,514
527
529
61
26
2,317
2,069
-184
561
-5
43
Gain on disposals of fixed assets
-30
-4
Increase of inventories
-99
-90
Increase of accounts receivable and other assets not related to
investing or financing activities
-302
-385
Decrease/increase of trade accounts payable and other liabilities
not related to investing or financing activities
-197
196
1,500
2,390
Cash flow from operating activities
Investments in intangible assets
-451
-57
Investments in property, plant and equipment
-596
-532
Investments in non-current financial assets1)
-11
-6
Proceeds from disposals of intangible assets
2
2
92
43
Proceeds from disposals of property, plant and equipment
Proceeds from disposals of non-current financial assets
13
21
–951
–529
-1,088
-1,360
-96
26
–1,184
–1,334
-635
527
0
0
-16
43
Securities and liquid funds 2) as of 1. 1.
4,585
4,015
Securities and liquid funds as of 31. 12.
3,934
4,585
1)
Cash flow from investing activities
Cash payments to shareholders and minority shareholders
Cash proceeds from borrowings/repayments of loans
Cash flow from financing activities
Change in liquid funds from cash relevant transactions
Changes in liquid funds due to changes in scope of consolidation
Changes in liquid funds due to exchange rate movements
2)
excl. fixed-asset securities
2)
liquid funds, securities within fixed and current assets
(+) = source of funds, (–) = use of funds
1)
120
2006
Statement of changes in group equity
Shareholders’
capital1)
Accrued
group
capital
thereof
currency
effects
Equity
Minority
interests
thereof
currency
effects
Group
equity
Group Equity
178
4,185
–168
4,363
193
–29
4,556
Contributions
Balance as of 31. 12. 2004
0
0
0
0
0
0
0
Withdrawals
0
–1,352
0
–1,352
0
0
–1,352
Net income
0
1,491
0
1,491
23
0
1,514
Change of scope of consolidation
0
0
0
0
7
0
7
Other changes
0
107
107
107
–7
2
100
178
4,431
–61
4,609
216
–27
4,825
Contributions
0
0
0
0
0
0
0
Withdrawals
0
-1,077
0
-1,077
0
0
-1,077
Net income
0
1,722
0
1,722
7
0
1,729
Change of scope of consolidation
0
0
0
0
0
0
0
Other changes
1)
0
-79
-79
-79
-35
-24
-114
178
4,997
-140
5,175
188
-51
5,363
Cash flow statement / Statement of changes in group equity
121
T he shareholders’ capital consists of the equity of C. H. Boehringer Sohn and C. H. Boehringer Sohn Grundstücksverwaltung
GmbH & Co. KG. It consists only of capital of the limited partners. The shareholders’ personal taxes arising from consolidated
business activities are shown as withdrawals from the accrued group capital.
Notes to the consolidated financial statements 2006
1 Principles and methods
1.1 General principles
The consolidated financial statements of Boehringer Ingelheim for the fiscal year 2006 have been
prepared pursuant to section 264a German Commercial Code (HGB) by applying the group accounting
regulations of section 290 to 314 HGB.
In accordance with section 297, paragraph 1 HGB, the consolidated financial statements are composed
of the consolidated balance sheet, the consolidated profit and loss statement, notes to the consolidated
financial statements, the consolidated cash flow statement and the statement on changes in equity.
1.2 Companies included in the consolidation
The ultimate parent of Boehringer Ingelheim is C. H. Boehringer Sohn. Boehringer AG is the sole
unlimited managing partner of this company.
Besides C. H. Boehringer Sohn there is C. H. Boehringer Sohn Grundstücksverwaltung GmbH &
Co. KG whose unlimited partner is under the unified management of C. H. Boehringer Sohn.
The Boehringer Ingelheim Group of companies consists of 137 affiliated companies in and outside
Germany. In addition to C. H. Boehringer Sohn and C. H. Boehringer Sohn Grundstücksverwaltung
GmbH & Co. KG, a further 104 companies in which C. H. Boehringer Sohn holds directly or indirectly
the majority of voting shares are included in the consolidated financial statements.
29 companies were not consolidated in the reporting year, as the net assets, financial position and
results of operations of these companies were insignificant to Boehringer Ingelheim. Combined they
represent less than 1 % of the Group’s net sales, equity and net profit.
A further two companies are subject to bylaws containing enduring restrictions.
Compared to the previous year, the total number of affiliated companies was reduced by six:
• five companies were closed down,
• a further three companies were dissolved due to mergers and
• two companies were established
A separate statement of interests held by Boehringer Ingelheim will be submitted to the authority
operating the German Federal Gazette in order to place it in the Register of Companies.
122
The following subsidiaries were exempted from the reporting and disclosure obligations in accordance
with section 264, paragraph 4 HGB in conjunction with section 264, paragraph 3 HGB:
• Boehringer Ingelheim GmbH, Ingelheim
• Boehringer Ingelheim International GmbH, Ingelheim
• Dr. Karl Thomae GmbH, Biberach
• Boehringer Ingelheim Europe GmbH, Ingelheim
• Boehringer Ingelheim Vetmedica GmbH, Ingelheim
• Boehringer Ingelheim Secura Versicherungsvermittlungs GmbH, Ingelheim
• Boehringer Ingelheim Grundstücks-GmbH, Ingelheim
• Boehringer Ingelheim Finanzierungs GmbH, Ingelheim
Exempted from reporting and disclose obligations of annual financial statements according to HGB
regulations for joint stock companies under section 264b HGB are:
• C. H. Boehringer Sohn, Ingelheim
• C. H. Boehringer Sohn Grundstücksverwaltung GmbH & Co. KG, Ingelheim
• Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim
1.3 Consolidation methods
For inventories, accounts receivable and payable, and the income and expense items, business
transactions between the companies consolidated were eliminated as part of the debt consolidation,
according to section 303 HGB, the elimination of inter-company profits according to section 304 HGB,
and the income and expense consolidation according to section 305 HGB.
The purchase method of accounting was used for the capital consolidation of those subsidiaries that
were included for the first time in the consolidated financial statements. First-time consolidation takes
place at the time of the respective company becoming a subsidiary.
The goodwill of two major companies wholly acquired in 1997 was amortized according to plan over
10 years (last portion in 2006).
Credit balances from capital consolidation primarily represent retained earnings during group
membership; they therefore have the characteristics of equity and are included in group reserves.
123
1.4 Currency conversions
The financial statements prepared in foreign currencies were translated into euros, the functional
currency of the group parent company, C. H. Boehringer Sohn, according to the year-end method.
All assets and liabilities have been converted at the year-end rate. The profit and loss statement and,
consequently, net income, were converted at the average annual rate for the reporting year.
Translation differences due to the conversion of foreign currencies are shown as a balancing item in
the equity without impact on income.
The functional currency of subsidiaries is the respective local currency. Annual financial statements in
high inflation countries are in principle drawn up in accordance with German Accounting Standard
14 (GAS 14); in the financial year 2006, no group company was affected by the high inflation
accounting. All positions in individual financial statements drawn up in prior years in hard currencies
(in US dollars or euros), were translated into the new functional currency on 1 January 2006 at the
respective spot rate.
The most important currencies for Boehringer Ingelheim reflect the following changes in the reporting
year (base 1 euro):
year-end rate
US dollar
Japanese yen
124
average annual rate
31.12.2006
31.12.2005
2006
2005
1.32
1.18
1.26
1.24
156.93
139.90
146.06
136.87
Pound sterling
0.67
0.69
0.68
0.68
Canadian dollar
1.53
1.37
1.42
1.51
2 Accounting and evaluation methods
2.1 Fixed assets
Intangible and tangible assets are shown at purchase or manufacturing cost, net of regular straightline depreciation, according to the technical and economic situation. The following periods of use
were applied:
Buildings
20 years
Technical facilities and machinery
10 years
Other facilities, operating and business equipment
3 to 10 years
Diverging from the declining-balance method of depreciation applied in the individual financial
statements of C. H. Boehringer Sohn the straight-line method of depreciation is used in the consolidated financial statements for the purpose of uniformity in group-wide measurement. Anticipated
long-term losses in the value of investments were accounted for by unscheduled write-offs. Cost
of direct material and production as well as appropriate portions of material and production overheads were taken into consideration for the determination of manufacturing costs. Fully amortised
goodwill that is more than five years old, or is materially insignificant, is shown under disposals.
All capitalised intangible assets have a limited useful life.
The financial assets were valued at the lower of either purchase cost, present value or fair market
value.
2.2 Current assets
Inventories are valued at purchase or manufacturing cost using the weighted average cost flow
method as the group-wide uniform method of measurement, whereas C. H. Boehringer Sohn applies
the LIFO Method in its individual financial statements. Appropriate portions of material and
production overheads were taken into consideration for the determination of the manufacturing
costs. Necessary reductions were made for inventory risks.
Accounts receivable were stated at their nominal value net of any individual valuation allowances
required. The general credit risk was covered by a general valuation allowance for bad debt.
Other assets were stated at the lower of either purchase cost or fair market value.
Foreign currency items were recorded at the year-end rate of exchange.
125
2.3 Group reserves
Group reserves include the retained earnings of the consolidated subsidiaries from prior years,
consolidation entries that affect earnings and credit balances arising from capital consolidation,
where they respectively relate to prior years.
2.4 Provisions
The provisions include amounts necessary to cover any perceptible obligations and risks, including
provisions for contingent losses from pending contracts. The valuation is made on the basis of
reasonable commercial judgement. Provisions with an implied interest are shown on a discounted
basis (e. g. certain personnel provisions).
2.5 Liabilities
Liabilities are shown in the balance sheet at the repayable amount. Liabilities in foreign currencies
were recorded at the year-end rate of exchange.
2.6 Deferred taxes
The deferred tax assets and liabilities represent the tax deferral in accordance with section 274
and 306 HGB, which arise because of temporary differences between the tax balance sheets of
the individual companies and the consolidated balance sheet (including differences arising from
adjustments for conformity in group-wide reporting and evaluation as well as consolidation
measures). Quasi-permanent differences between the consolidated balance sheet and the tax
balance sheet are treated as temporary differences in accordance with German Accounting Standard
10 (GAS 10). Deferred tax assets and liabilities are offset in accordance with GAS 10.
In the individual balance sheets (i.e. the financial statements II) the consolidated companies made
use of their option to capitalise assets to the amount of probable tax relief in the following years in
accordance with section 274, paragraph 2 HGB. The calculation of deferred taxes is based on the
tax rates that are expected to be valid at the time of their realisation.
The capitalisation of deferred tax assets on tax loss carry-forwards is carried out if it is sufficiently
probable that the tax benefits can be realised.
126
3 Notes to the consolidated balance sheet
3.1 Intangible assets
Concessions/
Similar rights
Goodwill
Advance
payments
Total
526
11
816
3
1,345
3
0
14
Procurement/manufacturing costs
Currency conversion difference
Additions due to first consolidation
0
0
0
0
Additions
50
0
7
57
Disposals
-18
-13
0
-31
4
0
-4
0
573
806
6
1,385
-30
0
0
-30
0
0
0
0
Additions
443
0
8
451
Disposals
-18
0
0
-18
Reclassifications
Reclassifications
7
0
-3
4
975
806
11
1,792
Accumulated depreciations
357
721
0
1,078
9
2
0
11
0
0
0
0
44
48
0
92
Additions
Write-ups
0
0
0
0
Disposals
-16
-13
0
-29
Reclassifications
0
0
0
0
394
758
0
1,152
-10
0
0
-10
0
0
0
0
Additions
63
48
0
111
Write-ups
0
0
0
0
Disposals
-15
0
0
-15
0
0
0
0
432
806
0
1,238
Book value as of 31. 12. 2005
179
48
6
233
543
0
11
554
Reclassifications
127
3.2 Tangible assets
Land and
Technical
buildings facilities and
machines
Other
Advance
facilities/
payments/
operating construction
equipment
in progress
Total
2,022
1,982
1,312
270
5,586
96
82
61
15
254
3
2
2
0
7
Additions
37
77
140
278
532
Disposals
-31
-42
-89
-8
-170
56
98
49
-203
0
2,183
2,199
1,475
352
6,209
-115
-81
-56
-17
-269
0
0
0
0
0
Reclassifications
Additions
54
70
164
308
596
Disposals
-78
-57
-82
-2
-219
Reclassifications
66
107
89
-266
-4
2,110
2,238
1,590
375
6,313
933
1,030
911
0
2,874
42
43
40
0
125
2
1
2
0
5
125
163
151
0
439
Additions
Write-ups
0
-2
0
0
-2
Disposals
-13
-37
-82
0
-132
Reclassifications
0
0
0
0
0
1,089
1,198
1,022
0
3,309
-58
-45
-38
0
-141
0
0
0
0
0
Additions
83
172
164
0
419
Write-ups
-1
-1
-1
0
-3
Disposals
-36
-48
-73
0
-157
-1
1
0
0
0
1,076
1,277
1,074
0
3,427
1,094
1,001
453
352
2,900
1,034
961
516
375
2,886
Reclassifications
128
3.3 Financial assets
Investments
in affilated
companies
Loans
to affiliated
companies
Investments
in related
companies
Loans to
related
companies
Investment
securities
Other loans
Total
21
8
10
6
2,686
41
2,772
0
0
0
0
3
0
3
0
0
0
0
0
0
0
Additions
0
1
0
0
674
5
680
Disposals
-1
0
0
0
-7
-21
-29
Reclassifications
0
0
0
0
0
0
0
20
9
10
6
3,356
25
3,426
-2
-1
-1
0
-9
0
-13
0
0
0
0
0
0
0
Additions
0
0
7
0
603
4
614
Disposals
0
0
-6
0
-911
-6
-923
Reclassifications
0
0
0
0
0
0
0
18
8
10
6
3,039
23
3,104
3
0
3
3
4
3
16
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Additions
0
0
0
0
14
0
14
Write-ups
0
0
0
0
0
0
0
Disposals
0
0
0
0
0
0
0
Reclassifications
0
0
0
0
0
0
0
3
0
3
3
18
3
30
0
0
-1
0
0
0
-1
0
0
0
0
0
0
0
Additions
0
0
0
0
38
0
38
Write-ups
0
0
0
0
-1
0
-1
Disposals
0
0
0
0
-5
0
-5
Reclassifications
0
0
0
0
0
0
0
3
0
2
3
50
3
61
17
9
7
3
3,338
22
3,396
15
8
8
3
2,989
20
3,043
129
As in the previous year, the item “other loans” includes no loans to the shareholders.
3.4 Inventories
31.12.2006
31.12.2005
Raw materials and supplies
224
225
Unfinished products
549
537
Finished products and goods for resale
201
460
6
7
1,280
1,229
Advance payments to suppliers
3.5 Accounts receivable
Trade accounts receivable
Receivables from affiliated companies
Receivables from related companies
Other assets
31.12.2006
Residual term
over 1 year
31.12.2005
Residual term
over 1 year
1,937
2
1,854
71
7
0
2
0
6
0
5
0
383
19
282
12
2,333
21
2,143
83
The item “other assets” contains receivables from the shareholders amounting to EUR 64 million
(2005: EUR 0 million).
3.6 Provisions (in millions of EUR)
31.12.2006
31.12.2005
Pension provisions
2,062
2,035
382
548
2,015
2,171
4,459
4,754
Tax provisions
Other provisions
130
Pension provisions
Boehringer Ingelheim’s pension schemes are based on various defined contribution plans as well as
defined benefit plans.
Pension obligations arising from direct or indirect defined benefit plans are determined on the basis of
the projected unit credit method, taking future salary and pension increases into consideration.
The actuarial calculation of the pension obligation from defined benefit plans is based on countryspecific biometric data (e. g. in Germany the “generation tables” issued in 2005 by Professor Klaus
Heubeck) and actuarial assumptions. The main countries applied the following parameters:
Germany
Parameter (in %)
Discount rate
USA
Japan
2006
2005
2006
2005
2006
2005
4.5
4.1
5.8
5.5
1.5
1.5
Expected return on plan assets
6.0
6.0
8.0
8.0 2.2-3.0 2.2–3.0
Salary increase
3.5
2.5
5.5
5.5 2.4-3.0 2.4–4.7
Pension increase
1.7
1.7
3.0
3.0
0.0
0.0
At the balance sheet date, the present value of the expected pension obligation was netted with the fair
value of the respective pension plan assets (funded status).
Based on this, pension provisions are determined by deducting unrealised transition amounts as well
as unrealised actuarial gains and losses from the funded status. Based on the “corridor approach”,
unrealised gains and losses are amortised over the expected average service periods of the respective
active employees. At balance sheet date, pension commitments (including total unrealised transition
amounts and actuarial gains and losses) of EUR 498 million (2005: EUR 698 million) were not recognised as part of pension provisions.
In conjunction with defined contribution plans, group companies paid contributions to state or
private insurers on the basis of legal or contractual regulations. On payment of the contributions the
companies no longer have any performance obligations. Contributions are recognised as personnel
costs.
131
3.7 Accounts payable
Bank loans
Residual term
less than 1 year
Residual term
1–5 years
Residual term
over 5 years
31.12.2006
Residual term
31.12.2005 less than 1 year
225
116
25
366
480
216
1,280
128
–
1,408
1,694
1,549
696
–
–
696
775
775
56
–
–
56
45
45
– Notes payable
7
–
–
7
14
14
– Accounts payable to
affiliated companies
9
–
–
9
8
8
Other accounts payable
of which:
– Trade accounts payable
– Advance payments
– Accounts payable to
related companies
– Other liabilities (*)
1
–
–
1
1
1
511
128
–
639
851
706
1,505
244
25
1,774
2,174
1,765
(*) of which:
– taxes
68
24
– social security contributions
13
22
There were no liabilities secured by mortgages or similar rights on the balance sheet date consistent
with the previous year.
At year-end, there were no liabilities due to shareholders (2005: EUR 215 million).
Payments received from the Asset-Backed-Security partners in conjunction with the ABS transaction
are shown as short-term loans under “other liabilities” until the underlying accounts receivable are
paid off.
132
4 Notes to the consolidated profit and loss statement
The consolidated profit and loss statement is presented in line with the total cost method.
4.1 Net sales by business and business segment (in millions of EUR)
2006
2005
10,200
9,174
of which: Prescription Medicines
8,311
7,247
1,064
1,052
Industrial Customer
809
847
Other sales
16
28
374
361
10,574
9,535
by geographic region (in millions of EUR)
2006
2005
Europe
3,295
3,177
Animal Health
of which: Germany
822
816
Americas
5,388
4,559
of which: USA/Canada/Mexico
5,039
4,219
Asia/Australasia/Africa
1,891
1,859
of which: Japan
1,227
1,232
10,574
9,535
2006
2005
Costs of raw material, supplies and goods for resale
1,219
1,351
265
262
1,484
1,613
2006
2005
Salaries and wages
4.2 Material costs
Expenditure on services
4.3 Personnel costs
2,217
2,087
Social benefits and retirement benefits
619
584
of which: retirement benefits
231
155
2,836
2,671
The interest component with respect to the increase in pensions and similar obligations is included in
financial income rather than in personnel costs and is, therefore, not included in the operating result
of the company.
133
Average headcount
Production
Administration
Marketing and Sales
Research and Development
Apprentices
2006
2005
12,380
12,044
4,972
4,742
14,368
14,257
6,003
5,678
705
685
38,428
37,406
4.4 Amortisation of intangible and depreciation of tangible assets
The amortisation of intangible assets and depreciation of tangible assets includes unscheduled
write-offs of EUR 21 million (2005: EUR 2 million).
4.5 Other operating expenses
Other operating expenses include third-party services in research, development, medicine, and
marketing, further administration costs, fees, contributions, non-income-related taxes, commissions,
rents, freight costs, and expenses for third-party repairs as well as expenses incurred by restructuring
measures.
4.6 Financial income
Interest expense relating to pensions and similar obligations
Other interest expense and similar expenditure
2005
-100
-108
-53
-70
-153
-178
Amortisation of other financial assets and short-term investments
-38
-14
Income from other investment securities and from long-term loans
226
110
Interest expense and similar expenditure
Other interest income and similar proceeds
134
2006
67
47
102
-35
4.7 Holding income
Gains from the sale of investments
2006
2005
1
0
2006
2005
4.8 Taxes
Income taxes
501
504
Deferred taxes
13
-154
Other taxes
–
24
514
374
As of the reporting year, other taxes are treated as operating expenses and have correspondingly
reduced operating income.
By concluding profit transfer agreements, significant German corporations have since 1 January 2004
belonged to the trade and corporate taxation group of integrated companies of the parent company
C. H. Boehringer Sohn. As income tax levied on taxable income allocated to the shareholders of
C. H. Boehringer Sohn may not be shown in the consolidated profit and loss statement, only the trade
tax of the relevant companies is shown as a tax expense.
In the effective tax-rate reconciliation the expected tax expense for Boehringer Ingelheim is calculated
on the profit tax rate for corporations (corporate tax, solidarity levy and trade tax). As in the profit and
loss statement tax expenses related to the income tax for partnerships and integrated companies of
C. H. Boehringer Sohn are limited to showing trade tax, the expected tax expense in the effective
tax-rate reconciliation is in this respect adjusted for fictive current and deferred corporate tax expenses
in order to link to the profit tax expense shown in the profit and loss statement. This elimination of
fictive corporate tax (including the solidarity levy) is shown in the items Fictive Corporation.
135
The expected tax expense derived by using a fictive tax rate of 37.1 % (average tax rate for a German
corporation at a municipal trade tax levy rate of 340 %; 2005: 360 %) can be related to the actual tax
expense as follows:
2006
Income before taxes minus other taxes
2005
2,243
Expected tax expense (current and deferred)
1,864
832
Decrease/increase in expected tax expense by
–Fictive Corporation current taxes
37.1 %
701
37.6 %
-284 -12.7 %
-378
-20.3 %
–Fictive Corporation deferred taxes
-25
-1.1 %
49
2.6 %
–Local tax rate divergences
-28
-1.2 %
-34
-1.8 %
–Non-taxable income
-26
-1.2 %
-6
-0.3 %
–Non-tax-deductible expenses
59
2.6 %
34
1.8 %
–Taxes related to prior periods
-10
-0.4 %
-35
-1.9 %
–Amortisation of goodwill
18
0.8 %
18
1.0 %
–Changes in applicable tax rates
-5
-0.2 %
7
0.4 %
5
0.2 %
20
1.1 %
-39
-1.7 %
-19
-1.0 %
17
0.7 %
-7
-0.4 %
514
22.9 %
350
18.8 %
–Withholding taxes not subject to tax credits
–Tax credits for research activities
–Other effects
Actual tax expense (current and deferred)
The deferred taxes can be attributed to the following balance sheet items:
31.12.2006
Liabilities
9
2
7
2
Tangible assets
32
122
32
132
Financial assets
13
17
15
24
116
14
104
19
Intangible assets
Inventories
Receivables
Assets
Liabilities
21
9
38
9
511
16
600
16
Liabilities
17
2
14
2
Tax loss carryforwards and tax credits
27
0
11
0
746
182
821
204
Provisions
136
31.12.2005
Assets
Other mandatory disclosures according to GAS 10.39:
2006
2005
-5
7
5
5
Deferred tax expense from changes in law
Deferred tax expense relating to the write-off of deferred tax assets
in fiscal year
The absence of changes in accounting and evaluation methods results, as in the previous year,
in no deferred tax income.
The valuation allowances relating to deferred tax assets amount to EUR 10 million.
Unused tax loss carryforwards, on which no deferred tax assets are recognized in the balance
sheet, amount to EUR 29 million at year-end, EUR 24 million of which expire in five years and
EUR 5 million expire in 10 years at the latest.
4.9 Net income
Net income for the year 2006 includes operating income unrelated to the accounting period
(mainly the release of other provisions) amounting to EUR 136 million (2005: EUR 81 million).
Operating expenditure unrelated to the accounting period amounted to EUR 17 million
(2005: EUR 27 million).
137
5 Notes to the cash flow statement
The cash flow statement shows how the total liquid funds (liquid assets and securities in fixed and
current assets) of the Boehringer Ingelheim Group have changed during the reporting year through
inflow and outflow of cash and cash equivalents. In accordance with German Accounting Standard
No. 2 (GAS 2), Cash Flow Statements, cash flows are classified by operating, investing or financing
activities.
Changes reported by consolidated companies are converted at the average annual rate. Liquid funds
are converted, as shown in the balance sheet, according to the year-end rate method. The influence
of exchange rate changes on liquid funds is provided separately.
6 Other information
6.1 Derivative financial instruments
Boehringer Ingelheim is, due to its extensive international structure, highly dependent on the
development of the major world currencies and interest rates. In order to hedge against the risks,
particularly those inherent in supplies and services and financial funding, use is generally made
of foreign exchange forward contracts in the case of currency risks. Regarding interest rate risks,
use is made of interest rate swaps and interest rate options.
The use of derivative financial instruments and the organisational procedure are laid down in internal
guidelines. Trade, processing, documentation, and control are kept strictly separate.
The risk positions are recorded, analyzed and assessed regularly in a special consolidated financial
report. The items are periodically re-evaluated and monitored. Derivative financial instruments are
only agreed on with banks of sound financial standing.
As of 31 December 2006, the nominal value of all foreign currency and interest rate hedging
transactions amounted to EUR 2,506 million (2005: 3,618 million). The corresponding market values
amounted to EUR +103 million (2005: EUR -63 million).
138
Derivative financial instruments at year-end were as follows:
Nominal value
Market value
31.12.2006
31.12.2005
31.12.2006
31.12.2005
2,448
3,355
103
–62
58
263
0
–1
Foreign exchange forward contracts
Interest instruments
The nominal value is the sum of all purchases and sales. The market value is calculated on the basis of
quoted prices or derived values for derivative instruments.
6.2 Contingent liabilities to the benefit of third parties (in millions of EUR)
Liabilities from guarantees, guarantees for bills and cheques,
warranties and provisions of collateral for third-party liabilities
31.12.2006
31.12.2005
12
176
31.12.2006
31.12.2005
967
741
6.3 Other financial obligations
To third parties
At year-end, other financial obligations included capital investments of EUR 665 million (2005:
EUR 552 million). Furthermore, EUR 195 million (2005: EUR 182 million) from renting and leasing
contracts are included, of which EUR 82 million concern long-term rent contracts with subsidiaries
not included in the consolidation.
6.4 Research and development expenses
2006
2005
Expenditures for Research and Development
1,574
1,360
139
Auditor’s Report
We have audited the consolidated financial
We conducted our audit of the consolidated
statements prepared by the C. H. Boehringer
financial statements in accordance with § 317
Sohn, Ingelheim – comprising the balance sheet,
HGB (German Commercial Code) and German
the income statement, statement of changes in
generally accepted standards for the audit of
equity, cash flow statement and the notes to the
financial statements promulgated by the Institut
consolidated financial statements – together
der Wirtschaftsprüfer (Institute of Public
with the group management report for the
Auditors in Germany) (IDW). Those standards
business year from 1 January to 31 December
require that we plan and perform the audit such
2006. The preparation of the consolidated finan-
that misstatements materially affecting the
cial statements and the group management
presentation of the net assets, financial position
report in accordance with German commercial
and results of operations in the consolidated
law is the responsibility of the Management
financial statements in accordance with
Board of the Managing Corporate Partnership-
(German) principles of proper accounting and in
AG. Our responsibility is to express an opinion
the group management report are detected with
on the consolidated financial statements and the
reasonable assurance. Knowledge of the business
group management report based on our audit.
activities and the economic and legal environment of the Group and expectations as to possible misstatements are taken into account in the
determination of audit procedures. The effectiveness of the accounting-related internal control
system and the evidence supporting the
disclosures in the consolidated financial
statements and the group management report
are examined primarily on a test basis within
the framework of the audit. The audit includes
assessing the annual financial statements of the
companies included in consolidation, the determination of the companies to be included in
consolidation, the accounting and consolidation
principles used and significant estimates made by
the Management Board of the Managing Corporate Partnership-AG, as well as evaluating the
overall presentation of the consolidated financial
statements and the group management report.
We believe that our audit provides a reasonable
basis for our opinion.
140
With the following exception, our audit has not
led to any reservations: Contrary to § 314 paragraph 1 number 6 HGB compensation of the
members and the former members of the board
of managing directors have not been disclosed.
In our opinion based on the findings of our audit,
the consolidated financial statements with the
exception mentioned comply with the legal
requirements. The consolidated financial statements give a true and fair view of the net assets,
financial position and results of operations of
the Group in accordance with German principles
of proper accounting. The group management
report is consistent with consolidated financial
statements that comply with the legal requirements and as a whole provides a suitable view
of the Group’s position and suitably presents the
opportunities and risks of future development.
Frankfurt am Main, 16 February 2007
PricewaterhouseCoopers
Aktiengesellschaft
Wirtschaftsprüfungsgesellschaft
(E.-W. Frings)
(P. Marshall)
Wirtschaftsprüfer
Wirtschaftsprüfer
(German Certified
(German Certified
Public Accountant)
Public Accountant)
Auditor’s Report
141
Glossary
Product name
142
Active ingredient
Indication
actilyse®
alteplase
Fibrinolytic treatment of acute myocardial
infarction, acute massive pulmonary embolism
and ischaemic stroke.
aggrenox®
asasantin®
persantin®
persantine®
persantina®
ASA / dipyridamole
extended release
Prevention of stroke following a first stroke
or for transient ischaemic attacks.
As above and adjunct to coumarin anti-coagulants
in the prevention of postoperative thrombo-
embolic complications of cardiac valve
replacement.
alesion®
flurinol®
talerc®
epinastine
Antiallergic agent
antistax®
quantified red wine leaf
extract AS195 ®
Prevention and treatment of symptoms of chronic
venous insufficiency; varicosis veins, leg edema,
painful swollen legs, tickling itching legs,
tired and heavy legs.
Product name
Active ingredient
Indication
aptivus®
tipranavir
Available as capsules for adults –
used co-administered with 200 mg of ritonavir,
is indicated for combination antiretroviral treat-
ment of HIV-1-infected adult patients with
evidence of viral replication, who are highly
treatment-experienced or have HIV-1 strains
resistant to multiple protease inhibitors.
atrovent®
ipratropium bromide
Bronchodilator for maintenance treatment
of bronchospasm associated with chronic
obstructive pulmonary disease, including
chronic bronchitis, emphysema and asthma.
berotec®
dosberotec®
fenoterol
a) Symptomatic treatment of acute asthma attacks
b) Prophylaxis of exercise induced asthma
c) Symptomatic treatment of bronchial asthma
and other conditions with reversible airway
narrowing e.g. chronic obstructive bronchitis.
Concomitant anti-inflammatory therapy should be
considered for patients with bronchial asthma and
steroid responsive chronic obstructive pulmonary
disease (COPD).
bisolvon®
bromhexine
Mucolytic for the treatment of acute and chronic
bronchopulmonary diseases associated with
impaired formation and transport of mucus.
Glossary
143
144
Product name
Active ingredient
Indication
buscopan®
buscapina®
butylscopolamine
Treatment of abdominal discomfort and pain
associated with intestinal cramps.
catapresan®
catapres®
catapressan®
atensina®
clonidine
All forms of high blood pressure,
unless caused by phaeochromocytoma.
combivent®
ipratropium bromide /
salbutamol
Treatment of bronchospasms associated with
reversible obstructive airway diseases in patients
requiring more than one bronchodilator.
cymbalta®
xeristar®
duloxetine
Major depressive disorder (MDD),
diabetic peripheral neuropathic pain (DPNP)
Product name
Active ingredient
Indication
dulcolax®
bisacodyl (tablets,
suppositories),
sodium picosulphate
(drops, pearls)
Laxative for use in patients suffering from
constipation. In preparation for diagnostic
procedures, in pre- and postoperative treatment
and in conditions, which require defecation
to be facilitated.
duovent®
bronchodual®
berodual®
fenoterol /
ipratropium bromide
For prevention and treatment of symptoms in
chronic obstructive airway disorders with
reversible bronchospasm such as bronchial
asthma and especially chronic bronchitis with
or without emphysema.
flomax®
alna®
josir®
pradif®
secotex®
urolosin®
tamsulosin
Lower urinary tract symptoms (LUTS) associated
with benign prostatic hyperplasia (BPH).
flomax® cr
alna® ocas®
pradif® t
urolosin® ocas®
tamsulosin,
orally controlled
absorption system
Lower urinary tract symptoms (LUTS) associated
with benign prostatic hyperplasia (BPH).
Glossary
145
Product name
146
Active ingredient
Indication
inflammide®
budesonide
Chronic control of symptoms and signs of
bronchial asthma.
laxoberal®
laxoberon®
dulcolax® pico
sodium picosulphate
(drops, pearls, tablets)
Laxative for use in cases of constipation and
in conditions which require defecation to
be facilitated.
lendormin®
lendorm®
lindormin®
sintonal®
brotizolam
Short-term treatment of disorders of initiating and
maintaining sleep.
metalyse®
tenecteplase
Fibrinolytic treatment of acute myocardial
infarction.
Product name
Active ingredient
Indication
mexitil®
mexitilen®
mexiletine
Serious symptomatic ventricular tachycardic heart
rhythm disturbances.
micardis®
micardisplus®
micardis® plus
micardis® hct
co-micardis®
telmisartan
telmisartan / hydro
chlorothiazide
Treatment of essential hypertension.
mobic®
mobec®
movalis®
movatec®
meloxicam
Symptomatic treatment of rheumatic diseases.
motens®
caldine®
tens®
midotens®
lacidipine
Treatment of essential hypertension.
Glossary
147
Product name
148
Active ingredient
Indication
mucoangin®
frubizin® akut
ambroxol (lozenges)
Pain relief in acute sore throat.
mucosolvan®
motosol®
mucosan®
surbronc®
vaksan®
ambroxol
Mucolytic treatment of acute and chronic
bronchopulmonary diseases associated with
impaired formation and transport of mucus.
pharmaton®
pharmaton® capsules
geriavit pharmaton®
pharmaton® caplets
standardized ginseng
extract G115®,
vitamins, minerals,
trace elements
To improve physical and mental performance
and well-being.
sifrol®
mirapex®
mirapexin®
pramipexole
Symptomatic treatment of idiophathic
Parkinson’s disease,
symptomatic treatment of idiophathic
Restless Legs Syndrome.
Product name
Active ingredient
Indication
silomat®
clobutinol
Symptomatic treatment of irritable,
non-productive cough.
spiriva®
tiotropium bromide
Maintenance treatment of patients with
COPD (chronic obstructive pulmonary disease,
including chronic bronchitis and emphysema),
the maintenance treatment of associated
dyspnoea and for prevention of exacerbations.
thomapyrin®
ASA, paracetamol,
coffeine
Mild to moderate pain.
viramune®
nevirapine
Available as tablets for adults and suspension
for children – for the combination therapy
of HIV infection and for the prevention of
mother-to-child transmission of HIV.
Glossary
149
Animal Health
Product name
150
Active ingredient
Indication
enterisol® ileitis
attenuated
live vaccine (Lawsonia
intracellularis)
For active immunisation of pigs to reduce intes-
tinal lesions caused by Lawsonia intracellularis
infection and to reduce growth variability and loss
of weight gain associated with the disease.
express®
attenuated live vaccine For prevention of reproductive and respiratory
(IBRV, BVDV, PI3V, BRSV) diseases in cattle.
ingelvac® circoflex™
recombinant vaccine
(Porcine Circovirus
Type 2, PCV2)
For the active immunisation of swine against
porcine circovirus type 2.
ingelvac® m.hyo
inactivated vaccine
(Mycoplasma
hyopneumoniae)
For the active immunisation of swine to reduce
lung lesions following infection with Mycoplasma
hyopneumoniae.
Product name
Active ingredient
Indication
ingelvac® prrs mlv
attenuated live vaccine
(PRRS virus)
For the active immunisation of clinically healthy
swine against the respiratory and
reproductive form of PRRS virus infection (porcine
reproductive respiratory syndrome).
mamyzin®
penethamate
hydroiodide
For the treatment of mastitis caused by
Gram-positive pathogens.
metacam®
meloxicam
Dog, horse: alleviation of pain and inflammation
associated with acute or chronic musculo-skeletal
disorders
Cat, dog: reduction of postoperative pain
Cattle: respiratory infection, diarrhoea, mastitis
Swine: non-infectious locomoter disorders,
mastitis-metritis-agalactia-syndrome,
Horse: for the alleviation of pain in the event of
colic.
ventipulmin®
clenbuterol
Bronchodilator for the treatment of acute and
chronic obstructive airway disease in horses.
vetmedin®
pimobendan
For the treatment of congestive heart failure
in dogs.
Glossary
151
If you have any queries or comments, please contact us:
Binger Strasse 173
55216 Ingelheim
Germany
Telephone + 49 / 6132 / 77-0
Fax + 49 / 6132 / 77-3000
Contacts
CD Communications
Telephone + 49 / 6132 / 77-2012
Fax + 49 / 6132 / 77-6601
Internet www.boehringer-ingelheim.com
Issued by
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Neufrankfurt Corporate Design GmbH, Offenbach am Main
[email protected]
Printed by
Süddeutsche Verlagsgesellschaft, Ulm
Copyright
© Boehringer Ingelheim GmbH, 2007
All rights reserved. No part of this Annual Report 2006
may be reproduced or transmitted in any form or
by any means, electronic or photocopy, without permission
in writing from Boehringer Ingelheim GmbH.
Figures from third parties used in the annual report are based
on data available at the time the financial statement was drawn up.
Contents
Comparison of Balance Sheets/
Financial Data 1997—2006 (in millions of EUR)
“There is help“
1 Value Through Innovation
In Kenya, about 50,000 newborn babies a year are estimated to acquire HIV from their infected mothers.
Worldwide UNAIDS talks of 2.3 million cases of AIDS-diseased children. [page 10]
2 The Shareholders’ Perspective
4 Key Aspects of 2006
Assets (as of 31.12.)
Intangible assets
Tangible assets
Financial assets
Fixed assets
Inventories
9 Our Caring Culture
Accounts receivable (incl. deferred charges and deferred taxes)
1997
1998
1999*
2000
2001
2002
2003
2004
2005
2006
508
452
400
344
322
302
242
267
233
554
1,612
1,739
1,992
2,217
2,467
2,840
2,767
2,712
2,900
2,886
757
731
849
1,135
1,008
1,689
2,462
2,756
3,396
3,043
2,877
2,922
3,241
3,696
3,797
4,831
5,471
5,735
6,529
6,483
794
806
944
1,021
1,014
971
1,000
1,085
1,229
1,280
1,211
1,255
1,870
1,938
2,314
2,360
2,537
2,477
3,013
3,137
10 “There is help”
Cash and cash equivalents (incl. securities)
134
299
459
477
1,002
1,055
1,134
1,333
1,247
945
14 Our People
Current assets
2,139
2,360
3,273
3,436
4,330
4,386
4,671
4,895
5,489
5,362
18 Caring for our Neighbours
Total assets
5,016
5,282
6,514
7,132
8,127
9,217
10,142
10,630
12,018
11,845
1997
1998
1999*
2000
2001
2002
2003
2004
2005
2006
399
441
332
211
200
178
178
178
178
178
22 Our Environment & Employee Safety
27 Our R & D Drive
28 Targeting tomorrow’s therapies
32 Our R & D Strategy
Targeting tomorrow’s
therapies
38 Our Expertise in Landmark Studies
40 From Mind to Man – The R & D Process
42 New Biological Entities (NBE)
Liabilities and equity (as of 31.12.)
Reserves (incl. currency conversion difference)
Focusing on both biopharmaceutical and
small molecule drugs, Boehringer Ingelheim
has embarked on a major drive to discover
and develop new cancer drugs. [page 28]
43 Biomarker & Pharmacogenetics
45 Serving Patients *
1,461 1,651 1,982 2,362 2,753 2,818 3,139
3,297
2,940
3,275
Net income
212
229
320
379
401
537
529
888
1,491
1,722
Total equity
2,072
2,321
2,634
2,952
3,354
3,533
3,846
4,363
4,609
5,175
0
0
0
0
1
203
188
193
216
188
Minority interests
46 “I wake up refreshed ...”
Group equity
2,072
2,321
2,634
2,952
3,355
3,736
4,034
4,556
4,825
5,363
49 Human Pharmaceuticals
Provisions (incl. deferred taxes)
1,982 2,012 2,631 2,932 3,150 3,568 3,963 4,172
4,958
4,641
60 “My recovery came fast”
Liabilities (incl. deferred charges)
962 949 1,249 1,248 1,622 1,913 2,145
1,902
2,235
1,841
78 “Now I know how to keep them under control”
Total liabilities
2,944
2,961
3,880
4,180
4,772
5,481
6,108
6,074
7,193
6,482
80 From Plant to the Pharmacy – The buscopan® Story
5,016
5,282
6,514
7,132
8,127
9,217
10,142
10,630
12,018
11,845
81 Consumer Health Care
84 Our friend Tom
87 Animal Health
91 Our Customer Orientation
Summary of selected financial data
1997
1998
1999*
2000
2001
2002
2003
2004
2005
2006
92 Biopharmaceuticals – How Innovations are Made
Net sales
4,201
4,474
5,086
6,188
6,694
7,580
7,382
8,157
9,535
10,574
95 Pharmaceuticals Production and Pharma Chemicals
97 Counterfeits – A Real Threat for Patients
99 Group Management Report
115 Consolidated Financial Statements 2006
116 Overview of the Major Consolidated Companies
118 Consolidated Balance Sheet
119 Consolidated Profit and Loss Statement
120 Cash Flow Statement
121 Statement of Changes in Group Equity
122 Notes to the Consolidated Financial Statements 2006
140 Auditor’s Report
“Now I know
Our friend Tom how to keep
Every year, about 10 % of them under
all horses suffer from equine colic, a disease that
control”
can prove life-threatening. [page 84]
Abdominal pains and cramps,
a widespread ailment, is
more common in women
than in men and can affect
people still in their teens. [page 78]
“My recovery
came fast”
Stroke is a serious disease.
It is the third leading cause
of death after heart disease
and cancer and the most important reason for
medical disability. [page 60]
“I wake up
refreshed ...”
Operating income
Hypertension is not only an
unpleasant condition that
keeps people from doing
what the things they like.
It is also a serious cardio
vascular risk that can be
the precursor to stroke and
heart attack. [page 46]
350
336
655
800
980
1,082
901
1,372
1,923
2,140
8.3
7.5
12.9
12.9
14.6
14.3
12.2
16.8
20.2
20.2
Income after taxes
212
229
320
379
401
551
537
908
1,514
1,729
5.0
5.1
6.3
6.1
6.0
7.3
7.3
11.1
15.9
16.4
Return on equity (in %)
11.4
11.0
13.8
14.4
13.6
16.0
15.0
23.1
34.2
37.4
Own capital resources (in %)
41.3
43.9
40.4
41.4
41.3
38.3
37.9
41.0
38.4
43.7
561
595
737
791
1,117
1,049
1,059
1,430
2,069
2,317
722
858
1,055
1,094
1,645
2,645
3,516
4,015
4,585
3,934
1,270
1,409
1,527
1,749
1,916
2,175
2,252
2,443
2,671
2,836
30.5
29.9
28.0
26.8
34,221 35,529
37,406
38,428
Cash flow
Financial funds
Personnel expenditure
Personnel expenditure as % of sales
Average numbers of employees
Research and development costs
Flap Comparison of Balance Sheet / Financial Data 1997–2006
* The patient reports are authentic reports which refer to personal
experience only. Please acknowledge that other patients may experience
different treatment results. Individual treatment schemes have always to
be discussed between patient and physician case by case.
please turn over
31.5
30.0
28.3
28.6
28.7
25,927
26,448
27,325
27,980
31,843
771
812
826
968
1,019
1,304
1,176
1,232
1,360
1,574
18.4
18.1
16.2
15.6
15.2
17.2
15.9
15.1
14.3
14.9
455
421
377
497
548
634
516
427
532
596
189
211
256
288
305
340
354
377
439
419
R&D as % of sales
142 Glossary
30.2
24,860
*As of the comparative financial statement
1999, accounting and evaluation methods were
brought closer into line with International
Accounting Standards (IAS), particularly with
regard to deferred taxes and provisions for
pensions.
2006
2005
change
10,574
9,535
11 %
Europe
31 %
33 %
Americas
51 %
48 %
18 %
19 %
96 %
96 %
4 %
4 %
1,574
1,360
16 %
Personnel costs
2,836
2,671
6 %
38,428
37,406
3 %
2,140
1,923
11 %
20.2 %
20.2 %
Net sales
by region
by business area
Animal Health
Operating income
Annual Report 2006
Income after taxes
1,729
1,514
16.4 %
15.9 %
5,175
4,609
37.4 %
34.2 %
2,317
2,069
12 %
596
532
12 %
419
439
-5 %
Annual Report 2006
Cash flow
14 %
12 %
Net sales 2006
spiriva®
micardis®
nopq
in millions of EUR
change
Net sales 2006
in millions of EUR
change
1,381
45.2 %
dulcolax®
122.0
6.2 %
967
33.6 %
mucosolvan®
108.3
18.6 %
flomax®
922
27.8 %
pharmaton®
95.6
8.2 %
combivent®
671
19.6 %
buscopan®
71.2
19.6 %
mobic®
579
-31.8 %
bisolvon®
67.1
0.4 %

Financ - Boehringer Ingelheim

Transcription

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