Teva`s Olafsson starts global markets review

Transcription

14 November 2014
COMPANY NEWS
2
Hikma increases its forecast for 2014
2
US$4.5bn Omega buy gives
3
Perrigo OTC lift
Pharmstandard sees slide after OTC spin 4
Kabi calls time on its
5
venture in Russia
Teva hails European profit improvement 6
Global growth keeps India’s Lupin rising 8
Actavis aims to avoid hostile approaches 9
Jubilant falls despite Canadian launches 10
Sagent looks to buy amid delays at FDA 11
Latin America lifts Glenmark’s growth 12
Endo aims to expand US
13
generics business
MARKET NEWS
14
French body outlines nine key proposals 14
Industry urges ICH to
15
offer equal footing
NHS savings study welcomed by BGMA 16
PRODUCT NEWS
18
Takeda is denied bar on Hikma’s Mitigare18
EMA guideline allows
19
non-EEA comparator
Ranbaxy loses edge on
20
US valganciclovir
Canada’s top court to consider damages 21
Amgen sues Sandoz over filgrastim filing 23
FEATURES
US awaits biosimilar savings
26
By combining a review of existing studies on
potential US savings from biosimilars with
analysis of the latest sales data, RAND
Corporation has concluded that biosimilars
could save the country US$44 billion over
the next decade. David Wallace reports.
REGULARS
Pipeline Watch – Insulin glargine
Events – Our regular listing
Price Watch UK – Our in-depth
look at pricing trends in the UK
People – Actavis prefers Pepsi to
find finance head
22
24
25
27
Teva’s Olafsson starts
global markets review
T
eva has started a review of all markets in which its Generic Medicine business operates,
following the arrival of global head Siggi Olafsson four-and-a-half months ago. Olafsson
told investors the review would prioritise “how we want to play in different markets”,
as well as “what are the key therapeutic areas and dosage forms we want to offer, and
how can we differentiate ourselves from our competition?”
“We are a top-three company in close to 30 out of our 60 markets,” Olafsson noted. “We
are reviewing each of these markets and prioritising them on where we want to invest, what
markets we need to turn around, and where we might want to look for an alternative scenario.”
Olafsson revealed that he was aiming to lift the operating profit of Teva’s Generic
Medicine business by about six percentage points to 25%-26% by the end of 2017. Having
posted margins below 20% last year, the business improved its margin to 22.9% in the third
quarter of this year. “Teva’s generics focus is on growing the bottom line,” he stated, adding
that the firm would look to cut cost of goods, make its sales and marketing network more
efficient and shift its product mix towards more complex products with less competition.
In particular, he said, Teva was conducting “an in-depth strategy exercise” to define steps
needed to reach short-term and long-term goals in generics “growth markets” outside of North
America and Europe. “We have a relatively small business in Brazil which we want to grow
further, and the same applies to Mexico,” he said.
Declaring that he “felt more comfortable” about Teva pursuing acquisitions, chief executive
officer Erez Vigodman stated: “We might pursue generics businesses in emerging markets and
G
in the complex generics arena if we find the right ones.”
For a detailed review of Teva’s plans and performance, turn to page 6.
Kremers to be sold for US$1.5bn
K
remers Urban Pharmaceuticals (KU) – the US generics arm of Belgian biopharmaceutical
firm UCB – is to be sold to private-equity firms Advent International and Avista Capital
Partners for approximately US$1.53 billion in cash. The transaction – which is subject to
regulatory approvals and other closing conditions – has been unanimously approved by UCB’s
board of directors and is expected to close in the first quarter of next year.
KU, the private-equity firms said, had over the past seven years expanded its portfolio
from one key drug to more than twenty “high barrier to entry” generics – including “unusual
dosage forms” such as patches, liquids and injectables – in areas such as respiratory drugs,
antihypertensives and gastroesophageal reflux disease treatments. “KU is a strong, specialty
player in a rapidly growing and changing global generic industry,” commented Advent’s
managing director, John Maldonado, “and we believe it will thrive as an independent entity.”
As part of the deal, Avista healthcare industry executive Brian Markison – formerly
head of dermatology specialist Fougera – will take the helm as KU’s president and chief
executive officer. He will succeed George Stevenson, who will leave the New Jersey-based
firm to “pursue other interests”.
UCB – which acquired KU through its multi-billion dollar deal for German group Schwarz
Pharma Manufacturing eight years ago – said it would use the proceeds to reduce its debt and
expand its core pipeline in central nervous system and immunology drugs. “We believe Advent
and Avista are best positioned to drive KU’s growth to the next stage in the specialty generics
market,” asserted Roch Doliveux, UCB’s chief executive officer.
G
COMPANY NEWS
BUSINESS STRATEGY/THIRD-QUARTER RESULTS
RESULTS FORECAST
N
S
Norway’s Navamedic Hikma increases its
needs narrower niche forecast for 2014
avamedic says that “rapid market changes and strong price
pressure” mean that “a pure generics strategy no longer is
attractive” to the company. Noting that the generics market had changed
“fundamentally over a short period of time”, the Norwegian firm said
that “going forward, generic pharmaceuticals will be included in the
firm’s portfolio alongside other products only when found attractive”.
A “highly selective approach to portfolio expansion” – which will
focus on the five “strategic product groups” of female care, urology,
dermatology, oral medicine and medical nutrition – is in line with the
firm’s recently revised corporate strategy, under which it says it is
“actively pursuing products with attractive margin potentials within
a smaller number of strategic product groups”. Navamedic also said
that its core market would now be defined only as the Nordic region.
Pharma sales – including generics along with branded medicines
and medical devices – rose by 46% to NOK40.1 million (US$5.88
million) in the third quarter of 2014, accounting for just over twothirds of the company’s NOK58.8 million total. Consumer Care sales
more than trebled to NOK12.3 million and Medical Nutrition turnover
rose by more than a tenth to NOK6.5 million.
Navamedic’s Pharma segment contributed earnings before interest,
tax, depreciation and amortisation (EBITDA) that grew to NOK1.7
million from NOK0.2 million in the prior-year period. Group EBITDA
advanced from NOK0.8 million to NOK4.2 million.
G
2 GENERICS bulletin
14 November 2014
trong performances from its US Injectables and solid-dose
Generics operations have led Hikma Pharmaceuticals to raise its
growth forecast for group turnover this year from around 5% to 7%.
Last year, group sales rose by 23% to US$1.37 billion.
With the US Injectables operation continuing to “capture specific
market opportunities” – and having acquired Bedford Laboratories in
July, followed by the Ben Venue manufacturing site in September –
the Jordanian firm has increased its outlook for global Injectables
growth from “above 20%” to around 25%.
The rise comes despite its Portuguese injectables plant being
subject to a warning letter issued by the US Food and Drug
Administration (FDA) last month, following an inspection in March
(Generics bulletin, 3 November 2014, page 6).
Hikma said it anticipated a drop in European Injectables contractmanufacturing sales this year, but its operation in the Middle East and
North Africa (MENA) was “on track to deliver slight growth” in 2014.
Re-introducing drugs and capitalising on market opportunities
would give the US solid-dose Generics business a turnover of around
US$215 million this year, Hikma said. This sum, it noted, did not
include any contribution from its recently-approved colchicine 0.6mg
capsules, which are the subject of a legal battle (see page 18).
Hikma’s Branded operation in the MENA region is set for “low
single-digit” sales growth.
G
COMPANY NEWS
STRATEGIC ALLIANCES/THIRD-QUARTER RESULTS
MERGERS & ACQUISITIONS/FIRST-QUARTER RESULTS
H
U
Hospira gets sole US US$4.5bn Omega buy
rights to two mAbs gives Perrigo OTC lift
ospira says it now has “exclusive rights” to distribute its biosimilar
infliximab in the US and “a number of other major markets”
following an amendment to its existing agreement with Celltrion.
Having invested US$200 million in a five-year convertible bond
that was issued by its Korean partner, Hospira has modified its
distribution rights from “co-exclusive”. The US company said the new
arrangement would “further solidify our partnership with Celltrion
[and] support our efforts to enable improved access for patients”.
And Hospira – which markets the rival to Janssen’s Remicade
brand under the Inflectra name – has also through the arrangement
gained exclusive rights to trastuzumab in the US and a “number of
major markets”, along with “the majority of Western Europe”. The
US firm, which struck its initial agreement with Celltrion five years
ago (Generics bulletin, 16 October 2009, page 13), said it “was not
in a position” to share the financial changes to the agreement.
Separately, Hospira’s chief executive, Mike Ball, revealed the
firm had in late October responded with an action plan to the warning
letter issued by the US Food and Drug Administration (FDA) to the
company’s injectables manufacturing facility in Mulgrave, Australia
Third-quarter sales Reported Constant-currency
(US$ millions) change (%)
change (%)
Americas
EMEA
Asia-Pacific
Specialty Injectables
630
87
63
780
+16.7
+8.3
-2.2
+13.9
+16.9
+8.0
-2.3
+14.0
Devices
208
-1.1
-0.2
Other Pharma
163
+43.6
+42.9
1,151
+14.1
+14.3
Hospira
Figure 1: Breakdown by product type and region of Hospira’s sales in the third
quarter of 2014 (Source – Hospira)
(Generics bulletin, 17 October 2014, page 5). “Many of the response
commitments have already been completed or are in the process of
being completed,” he stated, reiterating that the letter did not restrict
production or shipments from the facility.
Improved supply, better product mix and improved pricing helped
Specialty Injectable Pharmaceuticals (SIP) sales in the Americas to
rise by 16.7% to US$630 million in the third quarter of the year. During
the quarter, Hospira faced US generic competition to its Precedex
(dexmedetomidine) brand from Mylan, Par and Sandoz after a court
lifted an injunction (Generics bulletin, 19 September 2014, page 15).
“While Precedex has been a nice financial driver for us, it is not one
of our longer-term strategic drivers,” Ball insisted.
SIP turnover in Europe, the Middle East and Africa (EMEA)
rising by 8.3% to US$87.1 million more than offset a 2.2% sales dip
to US$63.4 million in Hospira’s Asia-Pacific region (see Figure 1)
as global SIP turnover advanced by 13.9% to US$780 million. With
Other Pharma sales that advanced by more than two-fifths adding
US$163 million and pump-device sales of US$208 million, the US
firm’s group turnover increased by 14.1% to US$1.15 billion.
Meanwhile, selling its clinical surveillance software system,
TheraDoc, along with a surgical-suction product line for a combined
US$110 million helped Hospira to raise its operating profit by more
than seven-and-a-half times to US$228 million.
G
S OTC and generics specialist Perrigo is set significantly to
increase its presence in Europe’s consumer healthcare market by
snapping up Omega Pharma in a C3.6 billion (US$4.5 billion) cash,
shares and debt deal. Joe Papa, Perrigo’s chief executive officer, said
that acquiring the Belgian firm would provide Perrigo with “critical
mass” in all key European markets and complemented “Perrigo’s US
store-brand OTC and supply-chain and quality excellence with Omega’s
branded OTC expertise and European commercial infrastructure”.
Upon closing early next year, Omega will give Perrigo a diverse
range of OTC brands covering a number of categories – including
analgesics, cough, cold and allergy remedies, and dermatology – which
generated sales of US$1.6 billion in the year to September 2014.
Papa said Omega would give Perrigo a “direct commercial
presence in 35 European countries” and a sales team of 1,100 people
serving 211,000 pharmacists, 105,000 retail stores and 3,900
parapharmacies. Noting widespread restrictions on pharmacy ownership
and OTC sales channels in Europe, Papa commented: “There really is
not a store-brand opportunity in Europe, with the exception of the UK.”
The combined entity would be a “top-five player in the attractive
US$30 billion European OTC market”, he continued, with an annual
pro forma turnover of around US$5.7 billion, of which around 57%
will come from the group’s US operations. Top-line synergies include
using Perrigo’s roster of 3,000 products to add line extensions to
Omega’s brands as well as marketing the Belgian firm’s brands through
Perrigo’s operations in countries including Australia and Mexico.
Perrigo is buying Omega’s shares for C2.48 billion and assuming
C1.1 billion of debt. Omega’s founder and chief executive officer, Marc
Coucke, will receive 25% of the share purchase price and will also
join Perrigo’s executive committee.
In its financial first quarter ended 27 September 2014, Perrigo
increased its group turnover by 2% to US$952 million due to the addition
of US$91.9 million of Tysabri (natalizumab) royalties through Elan.
Prescription turnover fell by 4% to US$195 million on charges
linked to pricing programmes. New-product sales of US$8 million
and another US$4 million from acquired Fera products were offset
by US$11 million of discontinued products.
An 8% decline in Consumer Healthcare sales to US$493 million
was due in part to the US market absence of Perrigo’s generic version
of Mucinex (guaifenesin) 600mg extended-release tablets that the
firm is currently relaunching. Active pharmaceutical ingredient (API)
turnover slumped by 43% to US$25 million as Perrigo’s partner, Teva,
lost US generic exclusivity for temozolomide.
G
Business
segment
First-quarter sales Change
(US$ millions)
(%)
Operating
margin (%)
Consumer Healthcare
Prescription Pharma
Nutritionals
Specialty Sciences
API
Other
493
195
125
92
25
22
-8
-4
-3
–
-43
+14
13.2
33.3
6.8
16.2
28.3
4.0
Perrigo
952
+2
14.4*
* includes US$24.3 million of unallocated expenses
Figure 1: Breakdown by business segment of Perrigo’s sales and operating
margin in its financial first quarter ended 27 September 2014 (Source – Perrigo)
14 November 2014
GENERICS bulletin 3
COMPANY NEWS
MERGERS & ACQUISITIONS
NINE-MONTH RESULTS
L
L
India’s Laurus gains Pharmstandard sees
a Rs5.5bn injection slide after OTC spin
aurus Labs has received “the largest private-equity investment in
an Indian active pharmaceutical ingredient (API) manufacturer since
2004” after an affiliate of US-based Warburg Pincus invested Rs5.5
billion (US$89.6 million) in Laurus in return for a minority stake.
The Indian firm – which specialises in antiretroviral, oncology,
cardiovascular disease and diabetes APIs, and also has a “fast-growing”
contract-manufacturing business – said it was at “an important
juncture in its evolution”, and would use the cash to, amongst other
things, “foray into new business segments”.
“In addition to securing growth capital, we look forward to
leveraging Warburg Pincus’ deep domain expertise and global network
of relationships to help enter new markets and add to our customer
base,” said founder and chief executive officer, Satyanarayana Chava. G
MANUFACTURING/REGULATORY AFFAIRS
Canada bars Micro Lab lines
H
ealth Canada has restricted imports of products made at Micro
Labs’ Indian facilities in Bangalore, Goa and Hosur. The Canadian
regulator cited “data-integrity concerns identified in recent inspections
by international partners”.
None of the products barred from import into Canada qualify for
the “medically necessary” status that would allow import following
third-party testing (Generics bulletin, 3 November 2014, page 8).
Among the banned products are tramadol/acetaminophen that Micro
Labs supplied to Actavis, doxazosin and terbinafine marketed by Mylan,
and metformin sold under the Ranbaxy label. The ban also affects
drugs sold by ECL, Jamp, Marcan, Pharmascience, Septa and Vita.
Similar concerns over data-integrity have led Health Canada to
issue similar restrictions on imports from Indian facilities operated
by Apotex and Ipca.
G
14 November 2014
Issue 222
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4 GENERICS bulletin
14 November 2014
ower sales of OTC brands following the spin-off its OTCPharm
affiliate, as well as weaker revenues from distributed third-party
products, led Russia’s Pharmstandard to report a 15.5% decline in
group turnover to RUR24.8 billion (US$589 million) in the first nine
months of this year (see Figure 1).
Pharmstandard’s own sales of Prescription Products rose by 0.5%
to RUR4.57 billion, as turnover from its best-selling product,
Phosphogliv (glycyrrhizic acid) advanced by over a third to RUR1.10
billion, or almost a fifth of all Prescription turnover. Sales of Combilipen
(lidocaine) and Octolipen (alpha-lipoic acid) increased by a fifth to
RUR519 million and RUR254 million respectively.
However, the company’s OTC segment – led by the antiseptic
brand Ingalypt (norsulfazol sodium) – fell by 62.9% to RUR4.42
billion as several brands were transferred to OTCPharm. But
Pharmstandard generated RUR3.78 billion of turnover from supplying
finished goods and raw materials to OTCPharm.
Turnover from third-party products – which made up over a third of
the company’s total turnover – slipped by a fifth to RUR8.49 billion. G
Nine-month sales
(RUR millions)
Third-party products 8,487
Prescription
4,566
OTC
4,419
Drug substances
814
Pharmaceuticals
18,286
Change
(%)
Proportion of
total (%)
-20.5
+0.5
-62.9
+9.0
-34.4
34.3
18.4
17.8
3.3
73.9
Other
6,473
–
26.1
Pharmstandard
24,760
-15.5
100
Figure 1: Breakdown by business segment of Pharmstandard’s sales in the first
nine months of 2014 (Source – Pharmstandard)
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COMPANY NEWS
STRATEGIC ALLIANCES/NINE-MONTH RESULTS
E
F
Mylan turns its gaze Kabi calls time on
toward Latin America its venture in Russia
xpanding in emerging markets, “especially in Latin America”, is
on Mylan’s agenda as it continues to pursue acquisitions beyond
its US$5.5 billion deal for Abbott’s branded generics and mature
products business in developed markets other than the US.
“There are plenty of transactions out there that make strategic and
financial sense,” chief executive officer Heather Bresch told investors.
Rather than thinking in terms of generics or branded assets, Mylan was
looking to strengthen therapeutic franchises, such as in respiratory, she
explained, adding that the firm was “aggressively pursuing many things”.
Reviewing the strategic rationale for the Abbott deal, Bresch said
it would give the group “critical mass around the physician channel
throughout Europe” that would create “upside synergies” when
combined with Mylan’s strength in the pharmacy sector. “It doubles the
size in our top-10 markets outside of the US,” she pointed out.
Under the terms of a recently amended deal (Generics bulletin,
3 November 2014, page 3), Mylan will issue to Abbott 110 million
shares valued at around US$5.5 billion, while altered product-supply
Third-quarter sales Reported Constant-currency
(US$ millions)
change (%)
change (%)
North America
Europe
Rest of world
Generics
842
352
414
1,607
+19
+1
+19
+15
+20
+1
+18
+15
Specialty
462
+29
+29
Other
15
+29
–
Mylan
2,084
+18
+18
Figure 1: Breakdown by region and business of Mylan’s sales in the third quarter
of 2014 (Source – Mylan)
arrangements have reduced the multiple to adjusted earnings before
interest, tax, depreciation and amortisation (EBITDA) that Mylan
is paying from 6.6 to 6.4.
Higher volumes in France and Italy, along with recent launches,
helped to offset lower pricing as Mylan’s European Generics sales
edged ahead by 1% to US$352 million in the third quarter of this year.
North American Generics turnover climbed by almost a fifth to
US$842 million on recent launches and “capitalising quickly on
unanticipated market opportunities”. Among the firm’s recent US
launches were generic Combivir (lamivudine/zidovudine) tablets,
while Mylan has just added to its US antiretrovirals portfolio with
nevirapine extended-release tablets (see page 20).
“The US Food and Drug Administration (FDA) continues to
struggle to implement the Generic Drug User Fee Amendments
(GDUFA) and has simply been unable to perform efficiently as it
transforms,” Bresch asserted. “While we find the resulting lack of
transparency and timeliness of approvals frustrating, we continue to
benefit from our ability to successfully leverage our global network
to fill supply gaps resulting from market disruption.”
Recent launches helped to push up sales in Australia as Generics
sales in Mylan’s Rest of the World region increased by 19% to US$414
million. “Our business in Brazil is gaining traction,” Bresch noted.
Including US$462 million from the US Specialty segment, group
turnover grew by 18% to US$2.08 billion (see Figure 1). The group’s
operating profit increased by 46% to US$495 million.
G
resenius Kabi has agreed with its local partners to terminate a joint
venture in Russia that it formed earlier this year (Generics bulletin,
16 May 2014, page 7). The injectables specialist had intended to combine
its Russian business with Binnopharm’s operations in the Commonwealth
of Independent States (CIS), with Kabi to hold a 51% stake.
“Changing political and regulatory circumstances in the region
have made closing the joint venture more challenging than anticipated,”
Germany’s Kabi explained. “The company is committed to further
grow its business in the region, and is exploring other potential options
to cooperate with Binnopharm.”
Moscow-based injectables and infusion solutions specialist
Binnopharm – which operates two local manufacturing facilities –
achieved a turnover last year of US$104 million. In the same period,
Kabi’s Russian sales totalled US$73 million.
Separately, a recent US Food and Drug Administration (FDA)
inspection of Kabi’s injectables manufacturing facility in Grand
Island, New York, yielded “encouraging results”, the firm said. These
could result in the plant receiving voluntary action indicated (VAI)
status, opening the door for new product approvals.
Noting that the facility had received three ‘Form 483’ observations
following the inspection in October, Kabi pointed out that figure had
been eight, including four repeat observations, at the beginning of last
year, and 16 in July 2011. “[Zero] observations is very rare these days,
and it is common that the FDA audits conclude with a few observations,”
group chief executive officer Mark Schneider insisted to investors.
Current good manufacturing practice deficiencies (cGMP),
including insects found in sterile products and manufacturing areas,
led the FDA to issue Kabi’s Grand Island facility with a warning letter
at the beginning of 2012 (Generics bulletin, 9 March 2012, page 3).
In the first nine months of this year, Kabi’s global turnover stalled
at C3.76 billion (US$4.68 billion) as 3% organic growth and a one
percentage-point gain from acquisitions were cancelled out by a
four-point negative currency impact.
Single-digit sales growth in Kabi’s Asia-Pacific and Latin America
Africa regions to C723 million and C381 million respectively helped
to offset a 3% decline in North American turnover to C1.12 billion
(see Figure 1). European sales inched ahead by 1% to C1.54 billion.
Taken by product line, just over a third of sales came from Kabi’s
Intravenous Drugs business, where turnover rose on an organic basis
by 2% to C1.31 billion. Clinical Nutrition sales were up by 6% to
C1.02 billion, while the German firm's Infusion Therapy and Medical
Devices businesses added almost equal amounts: C724 million and
C704 million respectively.
Kabi's earnings before interest and tax (EBIT) slipped by 9%
to C634 million, cutting its EBIT margin by 1.7 points to 16.9%. G
Region
Nine-month sales Reported
(C millions)
change (%)
Organic
change (%)
Europe
North America
Asia-Pacific
Latin America/Africa
1,538
1,118
723
381
+1
-3
+5
+3
+2
±0
+7
+13
Fresenius Kabi
3,760
±0
+3
Figure 1: Breakdown by region of Fresenius Kabi’s sales in the first nine months
of 2014 (Source – Fresenius Kabi)
14 November 2014
GENERICS bulletin 5
COMPANY NEWS
THIRD-QUARTER RESULTS
Teva hails European profit improvement
A
“significant increase in European Union (EU) profitability” helped
Teva to increase the operating profit of its Global generics
business by 40% to US$556 million in the third quarter of this year.
A seven percentage-point margin improvement to 22.9% came on a
2% slide in Global Generics sales to US$2.43 billion.
“The profitability of the European generics business is significantly
better than a year ago,” pointed out Siggi Olafsson, who joined from
Actavis earlier this year to lead the Global Generics business. “We are
participating in fewer tenders in Germany and we are running the
business for the bottom line,” stated Olafsson, who is conducting a
global review of the group’s generics operations.
Teva attributed a 3% Generics turnover slide to US$757 million
in Europe mainly to “our strategy of pursuing profitable and sustainable
business in the region, with a significant decrease in Spain partially
offset by increases in certain other markets”.
A loss of exclusivity on generic Niaspan (niacin) contributed to
US Generics sales slipping by 1% to US$1.12 billion, as did lower
sales of generic Adderall (amphetamine salts). These negative impacts
were largely offset by recent introductions of generic Xeloda
(capecitabine) and Lovaza (omega-3 acid ethyl esters), as well as the
exclusive third-quarter launch of a generic rival to Bristol-Myers
Squibb’s Baraclude (entecavir) hepatitis C treatment (Generics
bulletin, 19 September 2014, page 14).
Olafsson insisted that Teva could offer a unique portfolio to an
increasingly consolidated US customer base that was eroding prices
for the firm’s base business.
Looking to expand US hospitals business
Among 14 US launches to date this year was the “important
milestone” of relaunching four injectables as the firm looked to expand
its hospitals business. Noting that the firm’s US injectables plant in
Irvine, California, was one of nine sites that Teva had slated for closure
– along with six others that the firm had already closed or divested –
Olafsson said Teva was looking for acquisition opportunities to fill
in gaps in its injectables offering.
The US operation had just filed for a generic version of
AstraZeneca’s Byetta (exenatide) injectable diabetes treatment, he
pointed out, while seven scheduled US launches by the end of this
year included a rival to Pfizer’s Celebrex (celecoxib) in mid-December.
A 3% Generics sales dip to US$551 million in Teva’s Rest of the
World region equated to a 4% local-currency rise on higher sales in
Canada and Latin America (see Figure 1).
“Latin America is a significant contributor,” Olafsson commented.
“We are a strong player in Chile and Peru, and we have a growing
business in Argentina. We have a relatively small business in Brazil,
which we want to grow further, and the same applies to Mexico.”
“We have a very significant business in Russia,” he continued,
adding that Teva was working to improve its local product pipeline.
“We see double-digit growth in that business, even though the market
is growing in high single digits.”
Rest of the World sales were largely responsible for Teva’s thirdparty active pharmaceutical ingredient (API) turnover – which was
reported as part of the US$2.43 billion Global Generics total – rising
by 9% to US$185 million.
The stronger API sales helped to push up the Global Generics
business’ gross profit by a tenth to US$1.08 billion, improving its gross
margin by 4.8 percentage points to 44.3%. A 13% rise in research and
development spending to US$134 million was more than balanced
out by a 17% cut in sales and marketing expenses to US$388 million.
This left the business with an operating profit – excluding amortisation
6 GENERICS bulletin
14 November 2014
Third-quarter sales Reported Local-currency
(US$ millions)
change (%) change (%)
US
Europe*
Rest of world
Generics
1,124
757
551
2,432
-1
-3
-3
-2
-1
-4
+4
-1
Specialty
2,176
+5
+5
450
-10
-7
5,058
±0
+1
OTC/Others
Teva
* European Union, Norway, Switzerland, Albania and Balkan states
Figure 1: Breakdown by business segment of Teva Pharmaceutical Industries’
sales in the third quarter of 2014 (Source – Teva)
and general and administrative expenses – 40% higher at US$556
million and an operating margin seven points stronger at 22.9%.
Teva’s group’s operating profit rose by 39% to US$1.11 billion on
static turnover of US$5.06 billion as the firm benefitted from a US$122
million pay-out from a paragraph IV patent litigation insurance policy.
Almost half – US$1.11 billion – of Specialty Medicine sales that
rose by 5% to US$2.18 billion came from the firm’s Copaxone
(glatiramer acetate) franchise. Teva is currently rolling out its 40mg
three-times-a-week formulation of the multiple-sclerosis treatment as
it tries to defend the 20mg strength from looming generic competition.
Following recent oral arguments in its case before the US Supreme
Court (Generics bulletin, 3 November 2014, page 21), the company
anticipates a ruling “late this year or in the first quarter of 2015”.
Specialty Medicine also included Oncology sales ahead by almost
a fifth to US$299 million after Teva’s recent launches of Granix
(tbo-filgrastim) and Lonquex (lipegfilgrastim). The Israeli firm said
Granix had captured more than a tenth of the US short-acting
granulocyte-colony stimulating factor (G-CSF) market within a year
of launch, while Lonquex had gained a similar share of the German
long-acting G-CSF market in just under 12 months.
Terminating development of balugrastim
However, Teva is shelving Oncology research and development
as it focuses its Specialty pipeline on central nervous system and
respiratory candidates (Generics bulletin, 17 October 2014, page 5).
While the company has announced it will terminate development of
the balugrastim long-acting G-CSF for US and EU markets by the
end of this year, it is not clear whether any biosimilars are among
the pipeline projects that the Israeli group has identified “for
discontinuation, divestment or partnership”.
Having expanded its European respiratory offering during the
quarter by introducing DuoResp Spiromax (budesonide/formoterol)
inhalers in Ireland, Norway, Sweden and the UK, Teva intends next year
to submit an EU application for a fluticasone/salmeterol metered-dose
inhaler for asthma and chronic obstructive pulmonary disorder (COPD).
The company also plans to file US new drug applications (NDAs) for
fluticasone and fluticasone/salmeterol pressurised metered-dose
inhalers as asthma treatments.
Announcing a US$3 million share buy-back, Teva’s chief executive
officer Erez Vigodman stressed that this did not preclude businessdevelopment moves. “I feel more and more comfortable with our level
of readiness for acquisitions in general,” he stated. “We might pursue
generics businesses in emerging markets and in the complex generics
arena if we find the right ones.”
G
COMPANY NEWS
Impax plans to cut
42 jobs in research
I
mpax Laboratories intends to slash 42 research and development
jobs – or around a quarter of its research team – as part of plans to
“to match resources to high-value projects” for its generic and branded
pipelines, and produce annual costs savings of around US$8.0 million.
Following the reorganisation – under which approximately 49 staff
in total will be made redundant – Impax’ generics development
operation will consist of 46 “high-value generic products”; 23
abbreviated new drug applications (ANDAs) pending US Food and
Drug Administration (FDA) approval; and a further 23 generic projects
under development. The generics unit will also be responsible for “earlystage development and analytical functions for all Impax products”.
The US firm said it would incur a charge of US$2.0 million in
association with the reorganisation, which will be partially offset by
saving US$1.5 million in the fourth quarter of this year.
Commenting on the amendments to its generics pipeline, the US
firm’s president and chief executive officer, Fred Wilkinson, told
investors that Impax had “looked at those products that have essentially
lost value or which the work to have them put through [the FDA] would
distract us from the quality-improvement activities that are a high
priority to us”. The firm, he added, had withdrawn several ANDAs
and “stopped work” on others.
Meanwhile, Impax said its branded division’s focus would be
narrowed to three candidates; the Parkinson’s disease treatment Rytary
(carbidopa/levodopa), along with two investigational candidates
consisting of a bupivacaine patch and a further Parkinson’s disease
drug. Furthermore, the branded research team will hold responsibility
for “existing late-stage opportunities” for all products, including
clinical trials and pharmacovigilance.
Generics sales rose by a quarter
In the third quarter of this year, launching ursodiol tablets in July
(Generics bulletin, 11 July 2014, page 3) – coupled with strong sales
of its authorised generic of Sanofi’s Renvela (sevelamer carbonate)
tablets – helped Impax’ Global Laboratories generics division to
increase its turnover by just over a quarter to US$146 million. The US
company recently bolstered its generics pipeline and manufacturing
space by agreeing to acquire US-based generics player CorePharma,
along with affiliates Amedra and Lineage, for US$700 million
(Generics bulletin, 17 October 2014, page 1).
A short time after that deal was announced, Global Laboratories
president Carole Ben-Maimon left the company (Generics bulletin,
3 November 2014, page 27). Wilkinson told investors that a “formal
search” had not begun for a new generics head, but asserted that
“this industry is small enough for us to know who is out there, who
is available, and who might be interested and might fit our profile”.
Wilkinson also said that operations at its Hayward, California,
and Taiwan facilities remained unchanged following Impax’ responses
to multiple ‘Form 483’ observations at the facilities in August. “Although
we have not received any official notification of any change in our
status, the ongoing dialogue with the FDA has been constructive,” he
insisted. “We’ve also committed to the agency that we will continue
to send them monthly updates on our remediation programmes as well
as our quality-improvement initiatives.”
Branded sales falling by 29% to US$12.1 million limited Impax’
turnover growth to a rise of just under a fifth to US$158 million. But
the higher sales helped Impax turn a prior-year operating loss of
US$0.19 million into a US$25.5 million operating profit.
G
8 GENERICS bulletin
14 November 2014
SECOND-QUARTER RESULTS
Global growth keeps
India’s Lupin rising
D
ouble-digit growth across all of Lupin’s global markets – except
in South Africa – helped the Indian firm to increase its formulations
sales by 19% to Rs28.0 billion (US$456 million) in its financial
second quarter ended 30 September 2014.
Formulations turnover in the US, which accounted for 45% of
these sales, rose by almost a quarter to Rs12.7 billion, as Lupin
launched three products during the quarter. The Indian firm now
boasts 75 products in its US portfolio, of which it said 31 were
market leaders, while 54 were in the top three by market share.
Managing director Nilesh Gupta said Lupin’s pipeline – which
includes 95 abbreviated new drug applications (ANDAs) pending
approval in the US – was “evolving well”. “We expect significant
developments in the dermatology and inhalation space in the quarters
to come,” he commented.
Meanwhile in India – where Lupin during the quarter reached an
agreement with Korea’s LG Life Sciences to distribute insulin glargine
under the fantasy name Basugine (Generics bulletin, 5 September
2014, page 20) – formulations sales grew by a fifth to Rs7.99 billion.
Turnover in Japan increased by 12% to Rs3.46 billion, and in
Europe by 11% to Rs876 million. South African growth was limited
in comparison, with sales rising through the firm’s Pharma Dynamics
business by 5% to Rs1.06 billion (see Figure 1). However, Lupin
pointed out, in constant-currency terms this translated to a 15% rise
to ZAR187 million (US$17.2 million).
In Lupin’s Rest of the World region, sales rose by 16% to Rs1.89
billion. Towards the end of the quarter, the Indian firm reached a deal
with Merck Serono to develop, manufacture and market a range of
“affordable, high-quality medicines” in emerging markets, including
in “major markets” such as Brazil, Mexico, Indonesia and the
Philippines (Generics bulletin, 19 September 2014, page 4).
Including global sales of active pharmaceutical ingredients (APIs)
that were ahead by 11% adding Rs3.18 billion, Lupin’s group turnover
increased by 18% to Rs31.2 billion. The Indian firm’s profit before
tax improved by almost a quarter to Rs8.32 billion.
G
Second-quarter sales Change
(Rs millions)
(%)
Proportion of
total (%)
US
India
Japan
South Africa
Europe
Rest of World
Formulations
12,716
7,990
3,459
1,057
876
1,887
27,985
+23
+20
+12
+5
+11
+16
+19
41
26
11
3
3
6
90
APIs
3,183
+11
10
Lupin
31,168
+18
100
Figure 1: Breakdown by region and business of Lupin’s sales in its financial
second quarter ended 30 September 2014 (Source – Lupin)
IN BRIEF
BEXIMCO PHARMACEUTICALS increased its sales by 8.5%
to BDT8.27 billion (US$107 million) in the first nine months of
this year. The Bangladeshi firm improved its operating profit by
6.9% to BDT1.77 billion.
G
COMPANY NEWS
BUSINESS STRATEGY/SECOND-QUARTER RESULTS
Habitrol will expand
Reddy’s OTC range
D
r Reddy’s is looking to widen its OTC offerings in the US after
agreeing to acquire the title and rights to Novartis’ Habitrol
(nicotine) smoking-cessation transdermal patch, subject to final US
Federal Trade Commission (FTC) review.
In its financial second quarter ended 30 September 2014, Reddy’s
improved its generics sales in North America by 8% to Rs14.3 billion
(US$233 million). This was thanks to improved market shares for
key products including decitabine, for which Reddy’s said it now
had a 70% market share, as well as azacitidine and ziprasidone.
The Indian firm during the quarter launched US rivals to
Sunovion’s Xopenex (levalbuterol) inhalation solution (Generics
bulletin, 3 October 2014, page 19), and also filed two abbreviated new
Second-quarter sales Change
(Rs millions)
(%)
Proportion of
total (%)
North America
India
Russia/CIS
Europe
Rest of world
Global Generics
14,293
4,799
4,798
1,434
3,545
28,868
+8
+14
-13
-19
+95
+9
40
13
13
4
10
80
Pharma Services, APIs
6,392
±0
18
618
-1
2
35,879
+7
100
Proprietary Products/other
Dr Reddy’s
Figure 1: Breakdown by region and business of Dr Reddy’s Laboratories’ sales in
its financial second quarter ended 30 September 2014 (Source – Dr Reddy’s)
drug applications (ANDAs) to take its total pending US Food and Drug
Administration (FDA) approval to 72. That pipeline included 45
ANDAs containing paragraph IV patent challenges and 11 first-to-file
opportunities, Reddy’s pointed out.
Meanwhile, Reddy’s said domestic turnover rising by 14% to
Rs4.80 billion represented its “highest ever quarterly revenue”, as the
firm launched two products during the quarter.
And “strong growth” in Venezuela – where turnover rose by
248% in constant-currency terms – helped almost double the firm’s
sales in its Rest of the World region where Reddy’s also launched
two products to Rs3.55 billion (see Figure 1).
However, these rises were partially offset by double-digit turnover
slips in Russia and the Commonwealth of Independent States (CIS)
and Europe. In the former region, sales fell by 13% to Rs4.80 billion,
as the devaluation of the rouble led Russian sales to slide by 11%
to Rs4.13 billion.
Reddy’s offered no explanation for its European turnover
dropping by almost a fifth to Rs1.43 billion. Nevertheless, the
firm’s Global Generics sales increased by 9% to Rs28.9 billion.
Sales from the firm’s Pharmaceutical Services and Active
Ingredients (PSAI) business stagnated at Rs6.39 billion as the company
submitted three drug master files (DMFs) in the US and made six
similar filings in Europe.
Proprietary Products turnover slipping by 1% to Rs618 million
limited Reddy’s’ overall growth, as the group’s total sales increased
by 7% to Rs35.9 billion.
A 37% hike in research and development spending to Rs4.11
billion cut the Indian firm’s pre-tax profit by a tenth to Rs6.94 billion. G
MERGERS & ACQUISITIONS/THIRD-QUARTER RESULTS
Actavis aims to avoid
hostile approaches
A
ctavis will aim to focus on “friendly deals” rather than hostile
takeovers, the group’s chief executive officer Brent Saunders stated
as media speculation linked the firm with a ‘white knight’ move to
rescue ophthalmics specialist Allergan from Valeant’s hostile attention.
“People have been trained to hate each other for months, and
perhaps years, during a hostile fight,” Saunders remarked. “The rhetoric
is ramped up and a lot of value can be destroyed.”
With Forest’s integration into Actavis well underway after a
US$30.9 billion deal was completed on 1 July, Saunders is looking
for further deals. “If it was the right strategic opportunity with strong
financial fundamentals that created long-term enduring growth for
our company, we would be very interested,” he stated. In the current
low-interest-rate environment, he added, “you are going to regret it if
you just used your money to buy shares and pay dividends”.
Meanwhile, Saunders pledged, Actavis would continue to invest
in respiratory and biosimilar development projects. “The next generics
frontier is respiratory, and after that it is biosimilars,” he stated.
Actavis is building inventory for generic Pulmicort (budesonide)
as it awaits the outcome of patent litigation, while it is working on
device-dependent targets such as Advair (fluticasone/salmeterol).
“Biologics are incredibly important to us on both the brand and
biosimilar side,” Saunders continued. Hailing Actavis’ alliance with
Amgen as “the smart way for us to enter the biosimilar arena”, he said
the firm would continue to invest in biosimilars, either by expanding
its relationship with Amgen or going it alone. Amgen has just revealed
it is working on nine biosimilar candidates (see page 20).
Among 228 abbreviated new drug applications (ANDAs) that
Actavis has pending US approval are 60 it says have first-to-file status.
“Strength in the base business” offset delayed launches and
additional competition to Actavis’ generic version of Lidoderm
(lidocaine) and its authorised generic of Concerta (methylphenidate)
as North American Generics sales stalled at US$980 million. In Canada,
the firm said its generics operation had “reached a top-five position”.
Total International turnover outside of North America – from
brands as well as generics – increased by 15% to US$661 million, as
contributions of US$67.5 million from Forest and US$45.2 million
from Warner Chilcott more than made up for the sales Actavis lost by
selling its Western European generics operations to Aurobindo. The UK
business benefitted from its “ability to identify product shortages”.
Including US$1.61 billion from the expanded North American
brands business and US$423 million from its US Anda Distribution
arm (see Figure 1), Actavis advanced its group turnover by 83% to
US$3.68 billion. But the group posted an operating loss of US$1.05
billion as amortisation and impairment charges added to research and
development investment of US$392 million – US$248 million for brands,
US$115 million for generics and US$28.5 million for biosimilars. G
Third-quarter sales Change
(US$ millions)
(%)
Proportion of
total (%)
North American Brands
North American Generics
International
Anda Distribution
1,619
980
661
423
–
±0
+15
+38
44
27
18
11
Actavis
3,683
+83
100
Figure 1: Actavis’ sales in the third quarter of 2014 (Source – Actavis)
14 November 2014
GENERICS bulletin 9
COMPANY NEWS
BUSINESS STRATEGY
Pfizer could divide
into two from 2017
P
fizer could split into two businesses, one covering mature products
and the other innovative and pipeline drugs, in 2017, the originator
has told investors. At around the same time, the company’s five
biosimilar candidates are slated to start reaching the market.
Chief financial officer Frank D’Amelio said by 2017 Pfizer would
have the separate financial records for its Global Established Products
(GEP) division that would be necessary for a public transaction such
as a spin-off or initial public offering (IPO), and would probably be
needed for a private deal like a divestment or joint venture.
In the meantime, chief executive officer Ian Read said, the GEP
division would continue to explore “a multitude of opportunities” for
business-development deals following its acquisition in September
of US generic injectables specialist InnoPharma for up to US$360
million (Generics bulletin, 8 August 2014, page 3).
Pfizer’s third-quarter GEP sales declined by 7% to US$6.24
billion – just over half of group turnover of US$12.4 billion – as the
firm’s Lipitor (atorvastatin) faced generic competition in the US and
Japan. “Increasing spending on biosimilar programmes” contributed
to the division’s operating profit dipping by 4% to US$3.99 billion.
At present, Pfizer is enrolling for or conducting Phase III clinical
trials for biosimilar infliximab, rituximab and trastuzumab. A Phase I
study for adalimumab is underway, while the firm has just completed
a Phase I trial for bevacizumab.
G
10 GENERICS bulletin
14 November 2014
Jubilant falls despite
Canadian launches
I
ntroducing finished-dose zolmitriptan and bulk quetiapine in Canada
failed to prevent a sales and profits decline by Jubilant Life Sciences’
Pharmaceuticals business segment in the Indian group’s financial
second quarter ended 30 September 2014. Canada accounted for two
of the 15 solid-dose formulations approvals that Jubilant obtained
during the quarter, as well as one of the six active pharmaceutical
ingredients (APIs) filings it made during the three-month period.
Higher sales of “key radiopharmaceutical products” helped to offset
the impact of a production shut-down at the contract manufacturing
unit’s sterile injectables facility in Spokane, US, as the firm worked
to resolve problems identified in a warning letter issued by the US
Food and Drug Administration (FDA).
Pharmaceuticals turnover fell by 11% to Rs6.14 billion (US$100
million). The segment’s earnings before interest, tax, depreciation and
amortisation (EBITDA) margin tumbled by just over 14 percentage
points to 11.3%, which Jubilant blamed on the Spokane warning letter,
a postponed solid-dose order in Japan and delays in US approvals.
The group’s Life Science Ingredients segment overcame additional
competition and “changes in regulatory requirements for aqueous
paraquat” in China to post a 2% turnover increase to Rs7.57 billion,
albeit at an EBITDA margin that halved to 8.2%. As a result, the
group’s EBITDA margin almost halved to 10.0% on turnover down
by 5% to Rs13.7 billion.
G
COMPANY NEWS
MANUFACTURING/SECOND-QUARTER RESULTS
W
S
Import alerts remain Sagent looks to buy
on Wockhardt plants amid delays at FDA
ockhardt was able to offer little news on tackling the import alerts
imposed by the US Food and Drug Administration (FDA) on its
Indian facilities in Chikalthana and Waluj as the company reported
US sales down by more than half in its financial second quarter ended
30 September 2014. “The status of the import alerts on the Chikalthana
and Waluj facilities remains unchanged,” Wockhardt stated. “The
company’s efforts to put remediation measures in place continues.”
Having seen its Waluj plant get an alert midway through last year
(Generics bulletin, 7 June 2013, page 5), the Indian company got a
similar ban on exporting finished drugs from its Chikalthana site to the
US around 12 months ago (Generics bulletin, 6 December 2013, page 3).
These import bans were reflected in the firm’s second-quarter US
sales plummeting by 56.3% – equivalent to a 56.7% local-currency
drop – to Rs2.28 billion (US$37.1 million). The US business – which
has 75 abbreviated new drug applications (ANDAs) pending approval –
Region
Second-quarter sales
(Rs millions*)
Change
(%)
Proportion
of total (%)
India/Emerging
3,960
+14.9
39
UK
France
Ireland
Other
Europe
2,300
420
380
140
3,240
-3.8
+45.3
+14.5
–
-2.1
22
4
4
1
31
US
2,280
-56.3
22
810
–
8
10,290
-14.0
100
Litigation compensation
Wockhardt
* rounded to the nearest Rs10 million
Figure 1: Breakdown by region of Wockhardt’s sales in its financial second
quarter ended 30 September 2014 (Source – Wockhardt)
accounted for 22% of group turnover that declined by 14.0% to Rs10.3
billion, even including an Rs810 million boost from litigation
compensation (see Figure 1).
Launching 17 products in its domestic market helped Wockhardt
to increase its sales in India and Emerging Markets by 14.9% to
Rs3.96 billion. European turnover slipped slightly to Rs3.24 billion
on a 3.8% slide to Rs2.30 billion in the UK, where sales fell by 11.7%
on a local-currency basis. That fall was offset in part by 14.5% sales
growth to Rs380 million in Ireland, and by a 45.3% recovery to Rs420
million in France.
Higher staff and research and development costs contributed to
Wockhardt’s pre-tax profit decreasing by 36.4% to Rs820 million. G
IN BRIEF
IDT AUSTRALIA has agreed to pay up to US$18.0 million to acquire
23 previously marketed US generics from undisclosed vendors. The
firm plans to transfer production of the 23 tablets and capsules –
which include antidepressants and antihypertensives, as well as antiinfectives and Parkinson’s disease drugs – to its Melbourne facility, with
launches targetted for the first half of 2016. “Discussions have already
commenced with potential distribution partners,” IDT revealed. G
agent Pharmaceuticals will look to follow up its US$85.3 million
deal for Canada’s Omega Laboratories with further acquisitions
as generic approval rates by the US Food and Drug Administration
(FDA) remain “dismally low”, according to the US-based injectables
specialist’s chairman and chief executive officer, Jeff Yordon.
While Sagent would continue to file at least 15 dossiers per year
with the FDA, Yordon said the company could not rely on timely
approvals, so acquisitions would become “more important”. “We have
no visibility, we cannot interact with the FDA to get information
about anything related to approvals,” he complained, adding that since
the agency had implemented fully a system of communicating mainly
through complete response letters, average approval times had risen
from about 31 to nearer 40 months.
Discussing potential acquisition targets, Yordon acknowledged a
“general consensus that the market in emerging countries for injectable
generics is going to be very attractive”. However, he stressed, Sagent’s
focus would be less on geographic expansion than on buying assets
that were financially accretive, added manufacturing capabilities and
offered attractive baskets of approved products.
“You have to kiss 100 frogs to find a prince,” he commented,
adding that financial capacity was not necessarily a limiting factor on
deals. “As long as you are disciplined, investors in the debt market
will be willing to go along for the ride.”
Having spent around US$85 million in cash on Omega at the
start of October, the company has agreed a US$80 million loan facility
with JPMorgan Chase to fund further acquisitions and investment
in its Sagent China Pharmaceuticals (SCP) facility that holds FDA
approval for carboplatin and is scheduled to have its lyophilisation
line inspected by the US agency early next year. Revealing plans to
install a second line at SCP next year, Yordon said the firm had started
to transfer products to the site using the FDA’s CBE-30 process that
required three months of stability data.
Omega offers 26-product pipeline
Yordon said Montreal-based Omega offered a broad portfolio
of sterile injectable vials such as antiseptics and oncology drugs,
with leading positions in molecules including furosemide,
glycopyrrolate, neostigmine and octreotide. The Canadian firm
marketed its portfolio of 93 products in more than 40 countries,
including in Asia and Africa, and had a pipeline of 26 generics set
for launch between 2014 and 2019 (Generics bulletin, 17 October
2014, page 3). Integration was underway, he added.
Excluding Omega, Sagent ended the third quarter of this year with
43 products – represented by 67 abbreviated new drug applications
(ANDAs) – pending FDA review, and another three products across
nine ANDAs approved and awaiting launch. A further 19 products
spread across 29 ANDAs were in pre-filing development.
Launching 11 products in 29 presentations since 30 September
2013 contributed US$12.8 million to Sagent’s third-quarter turnover
that increased by 7%, or by US$4.5 million, to US$65.4 million. The
launches more than offset an US$8.0 million decline in sales of older
products, largely due to lower prices for docetaxel and zoledronic
acid. Third-quarter turnover was split almost equally between antiinfectives, oncology and critical-care drugs.
Price declines cut the firm’s gross margin by 1.8 percentage
points to 28.7%. But lower product-development spending helped
Sagent to improve its operating profit by 30% to US$4.04 million. G
14 November 2014
GENERICS bulletin 11
COMPANY NEWS
Latin America lifts
Glenmark’s growth
L
atin America sales more than doubling to Rs2.31 billion (US$37.6
million) helped Glenmark offset a turnover dip in the US, as the
Indian group’s sales increased by 14.9% to Rs16.8 billion in its financial
second quarter ended 30 September 2014.
“The environment continues to be tough, especially in the US,”
commented Glenmark’s chairman and managing director, Glenn
Saldanha. “US product approvals have slowed down considerably, and
the channel consolidation has impacted overall sales.” Product approvals
were limited to two – for rivals to Boehringer Ingelheim’s Micardis
(telmisartan) tablets and Valeant’s Vanos (fluocinonide) cream (Generics
bulletin, 8 August 2014, page 23) – as the firm’s US turnover fell by
9.0% to Rs5.08 billion. The Indian firm said those approvals left 72
abbreviated new drug applications (ANDAs) pending FDA approval,
of which 30 contained paragraph IV certifications.
In Latin America, sales soared by 139% thanks to Glenmark’s
turnover in Mexico and Venezuela trebling and quadrupling respectively.
In the former, the Indian firm said sales had been bolstered thanks to
the launch of two oncology drugs during the quarter, while in Venezuela
the firm received approvals for three products. Glenmark reported
“moderate growth” of 12% for its subsidiary in Brazil, where the
Indian firm received one approval during the quarter.
Indian sales rose by 14.5%
Meanwhile, the Indian firm’s domestic turnover rose by 14.5%
to Rs4.78 billion, as the company increased its share for cardiovascular
and respiratory disease treatments, as well as for its anti-infectives,
diabetes drugs and gynaecology products. Conversely, the firm’s
market share for its dermatology portfolio fell.
Furthermore, the Indian firm pointed to strong sales in Eastern
Europe – in particular, Poland – as its overall sales in the continent
rose by a quarter to Rs1.31 billion. Admitting that the business
environment in Romania had been “extremely challenging”, Glenmark
said it had on the other hand improved its sales in the UK by “over
50%”, despite pricing pressure and “a lack of new launches”.
Active pharmaceutical ingredient (API) sales leaping by almost
three-fifths to Rs1.60 billion more than offset Glenmark’s turnover in
its Rest of the World business stagnating at Rs1.74 billion (see Figure 1).
But the Indian firm anticipates “good growth” in Russia during its next
financial year ending 30 March 2016 as sales of its recently launched
Kerwort (imiquimod) and Sertamykol (sertaconazole) “ramp up”.
“These are two important product launches,” Glenmark asserted. The
Indian group’s pre-tax profit was unmoved at Rs2.20 billion.
G
Region
Second-quarter sales
(Rs millions)
Change
(%)
Proportion
of total (%)
US
India
Latin America
Rest of world
Europe
APIs
5,076
4,782
2,309
1,740
1,306
1,595
-9.0
+14.5
+139.0
±0.0
+25.1
+57.9
30
28
14
10
8
9
Glenmark
16,807
+14.9
100
Figure 1: Breakdown by business segment and region of Glenmark Pharmaceuticals’
sales in its financial second quarter ended 30 September 2014 (Source – Glenmark)
14 November 2014
IN BRIEF
SIEGFRIED has received operating approval for an initial phase
at the active pharmaceutical ingredients (APIs) facility it recently
finished building in Nantong, near Shanghai, China. Having started
construction midway through last year, the Swiss group is starting
to make pilot validation batches (Generics bulletin, 19 September
2014, page 8). Siegfried plans in the second quarter of 2015 to
produce its first commercial batches at the Nantong site.
NEULAND LABORATORIES overcame a “2% increase in rawmaterial costs” to post a 61% rise in pre-tax profit to Rs75.1 million
(US$1.22 million) in its financial second quarter ended 30 September
2014. The Indian active pharmaceutical ingredients (APIs) producer
– which has just raised around Rs250 million through a share
offering – increased its turnover by 16% to Rs1.21 billion.
JGL is setting up its own operations in Belarus through an office in
Minsk. Having previously worked with a local partner for the past
three years, the Croatian firm expects to increase its exports to
Belarus by a half to C1.5 million (US$1.9 million) next year as it
expands its product range, especially with nasal sprays and travelsickness remedies. To date, JGL has registered 15 products in Belarus,
including the seawater-based Aqua Maris line. In addition, the nasal
decongestant Rinomaris (xylometazoline) and the rosacea treatment
Rozamet (metronidazole) are currently pending authorisation.
ORIOLA KD is considering divesting its Russian operations as it
explores the “strategic options” for the businesses. The Finnish
wholesaler said it had appointed a financial advisor to “investigate
the conditions” for selling its Russian pharmaceutical wholesale and
retail businesses and had already “conducted negotiations”. Oriola’s
Russian operations – which consist of 229 pharmacies in the Moscow
region, a logistics hub in Moscow and 12 regional distribution
centres – made an operating loss of C31.0 million (US$38.6 million)
on a turnover of C558 million in the first nine months of this year.
ROCHEM INTERNATIONAL has moved into renovated 5,600 sq m
headquarters in Hauppauge, New York. The raw-materials sourcing
specialist – which was previously based in nearby Ronkonkoma –
said the move would allow it to consolidate its East Coast inventory
into a single warehouse next to administrative offices, thereby
offering “better control, additional cost savings and expedited
shipments to customers”.
DIVI’S LABORATORIES increased its turnover by 47% to Rs8.33
billion (US$135 million) in the three months ended 30 September
2014. But higher raw-material costs limited to 12% the Indian firm’s
pre-tax profit improvement to Rs2.93 billion.
EL KENDI intends by 2016 to open a biosimilars manufacturing
facility in Algeria. The Jordanian company plans to produce mainly
cancer treatments at the plant.
DSM said its DSM Sinochem Pharmaceuticals (DSP) joint venture
contributed C99 million (US$123 million) to its turnover in the third
quarter of this year. This represented an increase of 15%.
GVK BIOSCIENCES has agreed to acquire Chennai-based toxicology
testing specialist Vanta Bioscience for an undisclosed fee. By midNovember, the European Medicines Agency (EMA) intends to have
gathered responses from national regulatory agencies about which
products relied on bioequivalence studies conducted at a GVK site
in Hyderabad, India (see page 14). The agency said an inspection
had raised concerns about the reliability of such studies.
G
COMPANY NEWS
Endo aims to expand US generics business
E
ndo is looking at “new platforms and new verticals” for its US
generics business from which the firm would be able to “benefit
from better competitive dynamics and better margin profiles”, according
to president and chief executive officer Rajiv De Silva. “Areas like semisolids, ophthalmics and injectables continue to be of interest,” he said.
With Endo having closed its US$600 million deal for US generics
player Dava Pharmaceuticals in August (Generics bulletin, 11 July
2014, page 3), De Silva added that the firm would “certainly” be
looking to conduct more generic transactions following its agreement
for branded specialty company Auxilium Pharmaceuticals (Generics
bulletin, 17 October 2014, page 4). That transaction is set to close in
the first half of next year.
“The US generics business has been a substantial growth driver,”
De Silva insisted. “We think it is a very attractive asset and we intend
to build upon it.” The US firm – which has also this year bought US
niche generics specialist Boca for US$225 million – pointed out that
it had already completed its annual target of eight abbreviated new
drug application (ANDA) filings, leaving 70 ANDAs pending US
Food and Drug Administration (FDA) approval.
Bolstered by the addition of sales from Dava and Boca, in addition
to the “continued success” of its authorised generic of the US firm’s
own Lidoderm (lidocaine) patch, Endo’s US generics sales soared by
almost three quarters to US$319 million in the third quarter of this year
(see Figure 1). “The hydrocodone/acetaminophen 300mg combination
we got from Boca is a very important contributor for this year, and
I would say Dava is off to a reasonable start,” De Silva commented.
Business
unit
Third-quarter sales
(US$ millions)
Change
(%)
Proportion of
total (%)
US Generics
US Brands
Devices
International
319
241
110
94
+74
-34
-1
–
42
32
14
12
Endo
764
+16
100
Figure 1: Breakdown by business unit of Endo Health Solutions’ sales in the third
quarter of 2014 (Source – Endo)
Excluding inorganic effects, Endo said its base generics business
had grown by 13% thanks to increased sales of controlled substances.
International sales added US$94 million to group turnover, as the
US firm at the end of the quarter appointed Norbert Oppitz to head its
Latin America, Africa and Export Markets business (Generics bulletin,
8 August 2014, page 13). This operation includes – in addition to
Canada through Paladin – locations in South Africa through Paladin’s
controlling stake in Litha Healthcare and in Mexico through generics
player Somar, which Endo bought earlier this year for an undisclosed
sum (Generics bulletin, 16 May 2014, page 3).
The US Generics and International sales combined more than
overcame a sales slump of a third to US$241 million from Endo’s US
brands as group turnover rose by 16% to US$764 million. But Devices
sales continued to struggle, slipping by 1% to US$110 million. G
14 November 2014
MARKET NEWS
REGULATORY AFFAIRS/BIOLOGICAL DRUGS
French body outlines
nine key proposals
A
nine-point plan detailing measures that would help to develop
France’s biosimilars market has been published by local generics
industry Gemme. The plan follows an event held by Gemme in
conjunction with the European Generic medicines Association (EGA)
in October aimed at fostering growth and raising awareness of
biosimilars (Generics bulletin, 17 October 2014, page 10).
Creating a “climate of trust” by publishing “official and objective”
information on biosimilars for healthcare professionals and patients
is Gemme’s first recommendation. The association also suggests
creating a reference list of similar biologic medicines – as defined by
local medicines agency ANSM – to provide doctors with “complete
information on possible therapeutic alternatives”.
Promoting the early provision of biosimilars and establishing a
specific and “simplified” evaluation process for biosimilars by
effectiveness body HAS are also among Gemme’s recommendations,
along with having HAS formulate “medico-economic” recommendations
to encourage the most efficient use of medicines that offer the same
therapeutic benefits. HAS should also set prescribing targets for
biosimilars in each product class, Gemme suggests, and include these
targets as part of contracts with healthcare establishments.
French authorities should also encourage hospitals to reference at
least one biosimilar medicine in each product class, Gemme proposes.
Finally, the association says the country must reinvest part of the
savings generated by biosimilars into research and training.
“Biological drugs represent more than 25% of spending on
medicines in France,” Gemme stated, noting that seven of the country’s
top 10 medicines in terms of annual cost were biologicals. In the next
five years, the association noted, several oncology and auto-immune
biologics – representing spending of more than C1 billion (US$1.26
billion) annually – would lose patent protection in France.
G
China invites biosimilar input
I
nterested parties have until 29 November to comment on the first
draft biosimilars guideline published by China’s Center for Drug
Evaluation (CDE). The Center – which forms part of the country’s
State Food and Drug Administration (SFDA) – said it had started
writing the ‘biosimilar drug-development and evaluation technical
guideline’ in January this year.
Among the topics covered in the draft guideline are pharmacological
assessment as well as pre-clinical and clinical studies, according to law
firm Ropes & Gray. The guideline defines a biosimilar as a therapeutic
biologic that is similar to an approved original biologic in quality,
safety and efficacy, and that has the same amino-acid sequence.
Original reference products must be approved in China, while
– as is common in other jurisdictions – biosimilars cannot serve as
reference drugs. European and US standards are also reflected in the
Chinese guideline adopting a “stepwise approach” to demonstrating
biosimilarity based on comparative safety, effectiveness and quality
data. Such data, the guideline notes, can be drawn from in vitro
analytical studies, animal studies or human clinical trials.
Extrapolation of indications, Ropes & Gray notes, may be
permitted where the mechanism of action is the same for treating
the indicated diseases.
G
14 November 2014
IN BRIEF
US SENATORS Amy Klobuchar and Chuck Grassley have called
upon the US Federal Trade Commission (FTC) to publish data for
the past two years on ‘pay-for-delay’ or reverse-payment patentlitigation settlements. “The 2013 and 2014 numbers will help
Congress understand whether the [Supreme] Court’s decision in
Actavis vs. FTC has altered the behaviour of drug manufacturers,
and what legislative reforms are needed,” argued the senators, who
are co-sponsoring legislation aimed at combating such settlements.
CGPA – the Canadian Generic Pharmaceutical Association – has
donated C$25,000 (US$22,000) to local information provider
Care-Ring Voice Network to help caregivers hold online training
workshops on the safe use of medications. The association said the
workshops would “provide an opportunity for caregivers to learn,
get answers and share their experiences with the medication taking
habits of seniors”. “Too often, caregivers are under-supported and
don’t have enough information regarding the proper use of medications,
the compliance with prescriptions and the prevention of risks related to
interactions or side effects,” commented CGPA president Jim Keon.
THE EUROPEAN COMMISSION has launched a public consultation
on patents and standards. Open until 31 January 2015, the
consultation is aimed at gathering “information and views on the
interplay between standardisation and intellectual-property rights
such as patents”. In particular, the Commission will focus on how the
current standardisation framework for patents performs, and how
it should evolve to remain efficient.
RUSSIA’s private healthcare market is expected to grow between
10% and 12% between 2015 and 2019, according to a report by
market researcher PMR. While growth in 2013 had been “at a slightly
less rapid rate than in the previous years because of the deterioration
in the economic situation of the country”, the growth between 2015
and 2019 would be driven by “growing prices for medical services
and the gradual recovery of personal insurance budgets of employees
of large companies”.
OIG – the Office of Inspector General within the US Department
of Health and Human Services – plans to investigate US Food
and Drug Administration (FDA) inspections of generics firms
by the end of the US fiscal year ending 30 September 2015. “We
will determine the extent to which FDA conducts inspections of
generic drug manufacturers,” the OIG states in a ‘work plan’
document. “We will also describe the results of such inspections
and the enforcement actions taken by the FDA in response to
shortcomings or deficiencies.”
EMA – the European Medicines Agency – has released a timetable
indicating that the agency’s committee for human medicinal products
(CHMP) will in late November publish a list of outstanding
issues or CHMP opinion on bioequivalence studies carried out by
GVK Biosciences. Earlier this year, companies with products that
were approved in Europe on the basis of clinical work carried out
by GVK were asked to notify regulators (Generics bulletin, 8
August 2014, page 15).
MCC – South Africa’s Medicines Control Council – has validated two
electronic common technical document (eCTD) submissions using
software firm Extedo’s reviewing and validation tool. “The
successful registrations – of a new chemical entity and a generic drug
– mark an important milestone in MCC’s efforts to introduce the
eCTD standard to South Africa,” Extedo said, adding that the process
would help the MCC to “dramatically reduce registration times”. G
MARKET NEWS
PRICING & REIMBURSEMENT
REGULATORY AFFAIRS/INDUSTRY ASSOCIATIONS
T
I
Teva tops Germany’s Industry urges ICH
GWQ tender winners to offer equal footing
eva and its Ratiopharm affiliate proved most successful in capturing
supply contracts in the 10th tender round run by Germany’s GWQ
ServicePlus alliance of 43 health funds insuring around 7 million
Germans. Stada’s Aliud Pharma and Sandoz’ Hexal and 1A Pharma
were also major winners.
With 95 of more than 500 individual supply contracts awarded,
Teva/Ratiopharm led the field, followed by Aliud with 79 and Hexal/1A
Pharma with 57. Zentiva/Sanofi picked up 40 contracts, Berlin-based
Aristo Pharma 38 and Torrent’s Heumann/Heunet 36, while the former
Actavis business now owned by Aurobindo secured 21 supply deals.
GWQ said the 226 active ingredients or combinations, spread
across 342 bidding lots, had an annual retail value through its partner
funds of around C430 million (US$538 million). Almost two-thirds –
221 – of the bidding lots were awarded on an exclusive basis, while
the other 121 were divided between three suppliers. Most of the
contracts start on 1 February next year and end on 31 December 2016.
Among the molecules supplied by the three companies will be
atorvastatin, bisoprolol, candesartan, clopidogrel, ibuprofen and
omeprazole, as well as three that are among around 70 ingredients
covered by a GWQ tender for the first time – capecitabine, telmisartan
and telmisartan/hydrochlorothiazide.
G
INTELLECTUAL PROPERTY
Call to de-link access from IP
A
recently established US-India intellectual property (IP) working
group should “engage in dialogue that would de-link access to
medicines from IP”, originator group Biotechnology Industry
Organization (BIO) has suggested in its response to an out-of-cycle
review of Indian IP policy that is being conducted by the US Trade
Representative (Generics bulletin, 3 November 2014, page 11).
“The Indian government has several mechanisms for improving
affordability and accessibility of medicines without resorting to
compulsory licences or revocation of patents,” BIO contends.
Describing compulsory licences as “the greatest concern of the
global biotechnology industry”, the originators’ body says the position
of India’s new Modi government is unclear. However, it welcomes
the Indian Department of Industrial Policy and Promotion (DIPP)
deferring a decision on granting such a licence for dasatinib.
Another US brand body, PhRMA, wants the Modi government to
disband the previous regime’s committee for considering compulsory
licences and clarify that it will never issue such a licence “on the basis
that a company has failed to demonstrate why the product has not
been produced locally”.
But the secretary-general of the Indian Pharmaceutical Alliance
(IPA), Dilip Shah, points out: “The only compulsory licence granted
so far [in India] is for Bayer’s Nexavar (sorafenib).” In upholding that
licence, he observes, the Mumbai High Court had found that Nexavar
was “not available at a reasonably affordable price” and clarified that
a patent holder could satisfy Indian authorities why the patented product
could not be manufactured locally, thereby meeting the requirement
that the drug was ‘worked’ in India.
“Difficulties in obtaining injunctions as well as apprehensions
about the lack of patent linkage have been overstated to the US Trade
Representative,” the IPA’s Shah maintains.
G
GPA – the International Generic Pharmaceutical Alliance, representing
the global generics industry – has met with the steering committee
of the International Conference on Harmonisation (ICH) to lobby for
ICH executive board membership. The request follows a letter sent
to the steering committee by the IGPA earlier this year insisting that
the generics industry should have equal status to the originator
industry within the ICH, which develops global quality, safety and
efficacy standards (Generics bulletin, 5 September 2014, page 1).
“Having participated in ICH since 1997,” the IGPA said, “we have
the utmost respect for ICH and what it has accomplished.” Noting that
the executive board would perform the ICH’s executive function, the
IGPA noted that this function had “historically been performed by
global regulators and brand pharmaceutical industry representatives,
without the beneficial input that the generics industry can provide”.
“Even administrative decisions can significantly impact the outcome
of a proceeding,” the IGPA stated, adding: “We believe the generics
industry should be a full part of those discussions and decisions.”
“If IGPA is permitted to join the executive board, it would fully
participate in all decisions relating to ICH management and
harmonisation of global drug quality, safety and efficacy standards,”
the generics association promised. “We would like to be full participants,”
the IGPA said, “so that we can help ICH to represent public health
in the 21st century.”
Representing the IGPA, David Gaugh – the US Generic
Pharmaceutical Association’s (GPhA’s) vice-president for sciences and
regulatory affairs – told a meeting of the ICH’s steering committee in
Lisbon, Portugal, on 9 November that it was “essential for the generic
and biosimilar medicines industry to partner with ICH in global
harmonisation and quality efforts impacting public health”.
“ICH guidelines are being broadly and increasingly applied to
generic and biosmilar industries by regulators,” Gaugh said,
emphasising that “with one set of standards, it is imperative that all
key industry sectors have an equal voice”.
‘Interested party’ is too limiting
Limiting the IGPA’s role to that of an ‘interested party’ would
exclude the generics industry association from important discussions,
Gaugh said. These covered issues including the structure and
administrative policies and procedures of ICH, as well as the selection
of topics for harmonisation.
Interested parties were also “outnumbered on expert working
groups” and were often viewed as “optional attendees to the working
group meetings”, Gaugh observed, adding that they were also excluded
from being rapporteurs, topic leaders and deputy topic leaders.
The opportunity for equal input was therefore “limited in some
cases, resulting in no or restricted generic perspectives”, Gaugh said,
noting that the number of IGPA experts in working groups was largely
limited to one, compared to two for other industry associations. In
spite of these limitations, however, Gaugh insisted that the IGPA
had a “consistent history of contributions”.
“Excluding a major stakeholder from administrative processes
results in a lack of transparency and representation,” Gaugh concluded,
insisting that it was “time to create a space for generic and biosimilar
producers’ inclusion in dialogue with regulators at the global level”.
Urging ICH to “enter a new phase where the rules that apply to all
of industry are no longer made by the few”, Gaugh said this change was
“necessary in order to support ICH’s future strength and credibility”. G
14 November 2014
MARKET NEWS
REGULATORY AFFAIRS
Italy’s biosimilars
low on ADR reports
A
“low proportion of adverse drug reactions (ADR) reports concern
biosimilars” in Italy, according to a study published by the US
National Center for Biotechnology Information (NCBI). Analysing
the Italian spontaneous reporting system database, the study found
that just 0.2% – or 298 – of the 171,201 ADR reports collected during
the study period related to biosimilars. And of these, only “a low
proportion” – 10.1% – indicated drug ineffectiveness, the study found.
Biological drugs as a whole – including branded biologics and
biosimilars – accounted for 5.6% of the ADR reports, the study found,
adding that these reports were mainly issued by hospital-based
physicians. Two-thirds of the biologicals reports involved monoclonal
antibodies and fusion proteins.
95% of reports included product name
“In terms of traceability, 94.8% of biological-related reports
included an identifiable product name, whilst only 8.6% indicated the
corresponding batch number,” the study noted.
Meanwhile, Italian generics association Assogenerici has held an
event in Rome, Italy, at the start of November “to discuss the
challenges and opportunities offered by biosimilar medicines in Italy”.
The event – held in collaboration with the European Generic medicines
Association’s (EGA’s) European Biosimilars Group (EBG) –
“highlighted the essential role of biosimilar medicines” to attending
industry stakeholders. This included presenting the findings of a
sustainability study undertaken by market researcher GfK on behalf
of the EGA earlier this year (Generics bulletin, 20 June 2014, page 1).
EGA director-general Adrian van den Hoven said Italy was
“playing a leading role in biosimilar medicines uptake across Europe”,
insisting that the country’s health service “cannot miss the opportunity
for greater access to the new biosimilar medicines coming to market,
which will be key drivers of sustainability in healthcare”.
The EGA also recently collaborated with the Polish Generic
Medicines Association, the PZPPF, to host a similar event in Warsaw,
Poland, on 28 October. Highlighting the findings of the GfK study,
the Polish association called for “a multi-stakeholder approach”. G
India issues patent guideline
F
inal guidelines for examining pharmaceutical patent applications
have been issued by India’s office of the controller-general of
patents, designs and trademarks. The document follows draft guidelines
published earlier this year (Generics bulletin, 21 March 2014, page 15).
Under section 3(d) of India’s Patents Act, the guideline states,
non-patentable inventions include “the mere discovery of a new form
of a known substance which does not result in the enhancement of the
known efficacy of that substance”. The guidance explains that “salts,
esters, ethers, polymorphs, metabolites, pure form, particle size,
isomers, mixtures of isomers, complexes, combinations and other
derivatives of the known substance shall be considered to be the same
substance, unless they differ significantly with regard to efficacy”.
A section on prior-art searching has been modified following
stakeholder comments on the draft guideline. The guidance now no
longer requires applicants to disclose the international non-proprietary
name (INN) of the pharmaceutical substance.
G
14 November 2014
PUBLICATIONS
NHS savings study
welcomed by BGMA
A
report by the UK’s Academy of Medical Royal Colleges that
identifies nearly £2 billion (US$3.2 billion) of cost savings the
National Health Service (NHS) could make by providing more
appropriate care in 16 areas of clinical practice has been welcomed
by the British Generic Manufacturers Association (BGMA).
BGMA director-general Warwick Smith said using generics
“already saves the NHS in England over £12 billion per year”. And
“every further 1% swing to the use of generic medicines saves a
further £160 million and promotes innovation by competing with
established treatments”.
In a section on waste, the report says treating gastro-oesophageal
reflux disease with an off-patent proton-pump inhibitor is a “cheap,
effective way to reduce symptom burden and disease progression”,
as well as “a high-value intervention with little potential waste”.
“Whilst we support the take-up of new medicines where they offer
more cost-effective treatment for patients,” the BGMA said, “the use
of generic medicines where they are the cost-effective alternative
remains crucial to reduce the NHS drugs bill.” Using generics, the
association insisted, “allows financial headroom to enable the NHS to
afford newer treatments, as well as providing competition to incentivise
the development of innovative medicines”.
Meanwhile, the BGMA noted that auditing was the theme of the
most recent ‘quality forum’ meeting that the association held with the
UK’s Medicines and Healthcare products Regulatory Agency (MHRA)
on 12 November. Launched earlier this year (Generics bulletin, 2
May 2014, page 10), the forum meets three times annually.
G
UPC aims to avoid conflict
L
egal actions that are either pending before, or have been concluded
by, the planned European Unified Patent Court (UPC) will preclude
any opt-out from the pan-European system, the legal group of the
UPC’s preparatory committee has clarified in the 17th draft of the
court’s rules of procedure.
“The risk that the UPC and national courts deal one after the other
with the same European patent – and reach diverging decisions – can
thus be reduced,” explained the committee. Similarly, once an action
on a European patent or application subject to an opt-out is pending
or completed before a national court, that opt-out cannot be reversed
to obtain a ruling from the UPC.
Other amendments in the 17th draft include rules on languages,
such as where more than one language is used in proceedings.
A hearing on the rules of procedure will take place in Trier,
Germany, on 26 November. A preparatory committee meeting held
in Brussels, Belgium, on 4 November heard that several contracting
member states “hope to be able to ratify [the UPC] in the course of
2015”. Training of candidate judges will begin early next year. G
IN BRIEF
EMA – the European Medicines Agency – has made available a new
bulk-update management tool to help marketing-authorisation
holders to edit information in the agency’s XEVMPD database. G
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PRODUCT NEWS
ANTIHYPERTENSIVES
GOUT TREATMENTS
A
T
Apotex confirms win Takeda is denied bar
over UK perindopril on Hikma’s Mitigare
UK appeals court was right to reverse an earlier patents court ruling
that prevented Apotex from recovering damages from Servier due
to an interim injunction barring the generics firm from selling a rival
to Coversyl (perindopril) during an ultimately unsuccessful patentinfringement lawsuit, the country’s Supreme Court has confirmed.
Servier had in 2008 been ordered by a UK high court to pay
Apotex £17.5 million (US$28.0 million) for delaying competition
through the interim injunction (Generics bulletin, 17 October 2008,
page 15). But in 2010, a Patents Court judge told Apotex to repay the
damages because its tablets would have been made in Canada using
a process that infringed a Canadian patent (Generics bulletin, 9 April
2010, page 18).
Subsequently, however, the Court of Appeal ruled that the principle
of Servier’s ‘illegality defence’ depended on the circumstances of
individual cases, and did not apply in the case of perindopril tablets
manufactured by Apotex in Canada and imported into the UK
(Generics bulletin, 18 May 2012, page 19).
Dismissing Servier’s appeal against the most recent ruling, the
Supreme Court’s panel of five judges agreed that the originator’s
defence did not apply to Apotex’ actions. “In this appeal, Servier is
attempting to extend the doctrine of illegality beyond any previously
reported decision,” stated Lord Toulson. “I see no good public policy
reason to do so.”
G
14 November 2014
akeda has been denied a preliminary injunction against Hikma in
the US over the generics firm’s Mitigare (colchicine) 0.6mg capsules.
However, a Delaware district court said it would extend a temporary
restraining order against Hikma to allow the originator to make an
immediate appeal, provided Takeda posted a substantial bond.
Delaware District Judge Sue Robinson recently issued the temporary
restraining order on the basis that Hikma’s product – approved by
the US Food and Drug Administration (FDA) as a 505(b)(2) hybrid
new drug application using data from Takeda’s Colcrys original –
would infringe all five US method-of-use patents protecting the gout
flare treatment (Generics bulletin, 17 October 2014, page 19).
However, reviewing Takeda’s demand for a preliminary injunction,
Robinson said that the originator’s claim of a specific intent on Hikma’s
part to induce an infringing use of Mitigare “cannot be inferred from
the knowledge – actual or based on ‘market realities’ – that a generic
product may be used in infringing ways”. There must be “affirmative
evidence of specific intent and action to induce infringement.”
“The question remains whether the proposed label is a sufficient
catalyst to constitute active steps to encourage direct infringement,”
Robinson found, concluding: “Takeda has not carried its burden of
persuasion in this regard.”
Hikma has announced that its financial forecast for 2014 “does
not reflect any contribution from colchicine” (see page 2).
G
PRODUCT NEWS
ANTI-INFLAMMATORY DRUGS
A
B
Canadian court finds EMA guideline allows
Celebrex patent valid non-EEA comparator
potex and Mylan have failed to persuade Canada’s Federal Court
of Appeal to overturn a ruling that prevents the generics firms from
obtaining a notice of compliance (NOC), or marketing authorisation,
for celecoxib until Canadian patent 2,177,576 expires on 14 November.
Federal Judge Sean Harrington had previously found in separate cases
for Mylan (Generics bulletin, 7 March 2014, page 18) and Apotex
(Generics bulletin, 2 May 2014, page 17) that the patent protecting
Pfizer’s Celebrex brand was not invalid due to a lack of utility.
Both firms had failed to convince Harrington that the ‘576 patent
promised to reduce side effects in humans compared to other nonsteroidal inflammatory drugs (NSAIDs). Moreover, Apotex had
unsuccessfully argued that the patent promised to reduce side effects
in humans, with Harrington determining that the use of the word
“subjects” did not extend to cover humans: “That may have been a
wish, an aspiration, a goal, a target or an advantage,” he said, but
“there was no actual promise”.
On appeal, Judge Marc Noël “found no error” in Harrington’s
“exercise of discretion” in either case, especially concerning his
interpretation of the patent’s alleged promises. “The promise doctrine
will hold an inventor to an elevated standard only where a clear and
unambiguous promise has been made,” he said.
“Where the validity of a patent is challenged on the basis of an
alleged unfulfilled promise,” Nöel stated, “the patent will be construed
in favour of the patentee where it can reasonably be read by the
skilled person as excluding this promise.”
“It becomes clear that no explicit promise of treatment in humans
was made. Apotex itself recognises that the claims speak only of
subjects,” he stated. “In my view, the Federal Court judge correctly
held that the promise of the patent did not extend to humans.”
Furthermore, Noël concluded, “not one case cited by Apotex stands
for the proposition that a promise, once made and shown not to have
been met, must be construed as invalidating the invention as a whole”. G
ANTIDEPRESSANTS
Mylan loses Australian appeal
M
ylan’s Alphapharm has failed to convince the High Court of
Australia to overturn a lower court’s ruling on a patent-term
extension for Lundbeck’s Lexapro (escitalopram) antidepressant.
Australia’s Commissioner of Patents, the High Court said in a split
decision, had been justified in granting Lundbeck a three-and-a-half
year patent-term extension running until December 2012.
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ANTIRETROVIRALS
Silarx comes first on Epivir
S
ilarx Pharmaceuticals has become the first company to secure US
approval for a generic version of Viiv’s Epivir (lamivudine)
10mg/ml oral solution. By challenging Viiv’s US patent 6,004,968 –
which expires on 20 September 2018 – without triggering patent
litigation that could have blocked approval, Silarx secured 180-day
generic market exclusivity that will start when it launches the
antiretroviral drug.
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iosimilar applicants in the European Union (EU) can now use a
comparator product authorised outside of the European Economic
Area (EEA) for their clinical development after the European Medicines
Agency (EMA) adopted a revised overarching guideline on biosimilars.
While the revised guideline officially comes into force on 30 April
2015, the EMA said “applicants can apply some or all provisions of
this guideline from today”.
“This new concept is expected to facilitate the global development
of biosimilars and to avoid unnecessary repetition of clinical trials,”
the EMA stated. Any non-EEA approved comparator drug used for
clinical trials or in vivo non-clinical studies has to be “authorised by
a regulatory authority with similar scientific and regulatory standards
as EMA”, such as by International Conference on Harmonisation
(ICH) countries, the guideline dictates. The applicant is responsible
for establishing that the comparator is representative of the reference
medicine authorised in the EEA.
Bridging data to the EEA-authorised reference products will always
include analytical studies comparing the biosimilar, EEA-authorised
original and non-EEA-authorised comparator, the guideline lays out,
adding that it may also include clinical pharmacokinetic or
pharmacodynamic studies.
Congratulating the EMA on adopting the revised guideline, the
European Generic medicines Association (EGA) and its affiliated
European Biosimilars Group (EBG) said the update was “an important
step forward in facilitating the global development of biosimilar
medicines while avoiding unnecessary repetition of clinical trials across
geographic boundaries”.
In particular, the EBG welcomed the addition of a scientific
definition that biosimilars must show “similarity to the reference
medicinal product in terms of quality characteristics, biological activity,
safety and efficacy based on a comprehensive comparability exercise”.
Scientific principles for such comparability exercises are, the
guideline explains, “based on those applied for evaluation of the impact
of changes in the manufacturing process of a biological medicinal
product”, as outlined in the ICH’s Q5E chapter on comparability of
biological products subject to changes in their manufacturing process.
Clinical trials “may not be necessary” if similar efficacy and safety
can be deduced from other data.
Active substances in biosimilars and reference biologics must
share the same amino-acid sequence, the guideline continues, while
the “posology and route of administration” should also be the same.
Deviations from the original, such as in terms of strength, pharmaceutical
form or excipients must be justified, including through additional data
where necessary. While changes to improve efficacy would preclude
a biosimilar approach, alterations to enhance safety – such as lower
levels of impurities or immunogenicity – “may not preclude
biosimilarity”, the EMA states.
“If biosimilarity has been demonstrated in one indication,
extrapolation to other indications of the reference product could be
acceptable with appropriate scientific justification,” the guideline
clarifies. On pharmacovigilance, it recommends that any biological
drug linked to an adverse reaction report be clearly identified “with
due regard to its brand name and batch number”.
Absent from the overarching guideline are any recommendations
on interchangeability between biosimilars and reference products.
“Substitution policies are within the remit of the EU member states,”
it points out.
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14 November 2014
PRODUCT NEWS
ANTIVIRAL DRUGS
Ranbaxy loses edge
on US valganciclovir
R
anbaxy must forfeit its 180-day exclusivity for a generic version
of Roche’s Valcyte (valganciclovir) 450mg tablets in the US, the
Indian firm has been told by the US Food and Drug Administration
(FDA). A communication from the agency said that its original
decisions granting tentative approval for Ranbaxy’s abbreviated new
drug application (ANDA) for the antiviral – as well as tentative
approvals for ANDAs for esomeprazole 20mg and 40mg tablets – were
“in error because of the compliance status of the facilities referenced
in the ANDAs at the time the tentative approvals were granted”.
“FDA has rescinded the previously-granted tentative approvals
for Ranbaxy’s ANDAs,” the company confirmed. The firm said it was
“disappointed with this development and is actively evaluating all
available options to preserve its rights”.
Moreover, Ranbaxy observed, the FDA said it had determined
that the company’s esomeprazole and valganciclovir ANDAs “did
not have any data-integrity issues”.
The FDA has now granted Dr Reddy’s and Endo final approvals
for rivals to Valcyte, which Endo said had US sales of around US$440
million in the year ended September 2014, according to IMS Health.
Follows manufacturing setbacks
Ranbaxy has suffered a series of setbacks linked to manufacturing
and data-integrity deficiencies detected by the FDA. Last year,
Ranbaxy’s plant in Mohali, India, was placed under import alert and
subjected to certain terms of an FDA consent decree (Generics bulletin,
20 September 2013, page 3), which had previously been applied to
the company’s sites in Dewas and Paonta Sahib, India (Generics
bulletin, 13 January 2012, page 3). Earlier this year, the firm’s Toansa
facility in Punjab, India, was also subjected to certain terms of the
decree (Generics bulletin, 3 February 2014, page 3).
Connecticut attorney general George Jepsen recently filed a citizen
petition urging the FDA to waive Ranbaxy’s right to launch the first
US rival to AstraZeneca’s Nexium (esomeprazole) with 180-day
exclusivity unless the agency was prepared to immediately approve
the ANDA (Generics bulletin, 19 September 2014, page 21).
Under the terms of a 2008 agreement, Ranbaxy had agreed to drop
litigation with AstraZeneca in return for the right to launch the first US
Nexium rival on 27 May 2014, with 180-day exclusivity (Generics
bulletin, 2 May 2008, page 11).
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BIOLOGICAL DRUGS
Amgen pipeline grows to nine
A
mgen has expanded the pipeline of biosimilars it is developing
from six to nine programmes. The firm’s general manager for
biosimilars, Scott Foraker, said biosimilars were “a good strategic fit”
for the biologics specialist and represented “a compelling growth
opportunity with the potential to deliver more than US$3 billion in
annual revenues”.
While Amgen has already disclosed its initial six biosimilar
monoclonal antibody candidates – infliximab and rituximab that are
at the “clinical ready phase”, as well as adalimumab, bevacizumab,
cetuximab and trastuzumab – it has not identified the three programmes
it has just added to its roster. The US company expects to launch its
first biosimilar in 2017, with four more to follow through to 2019. G
14 November 2014
IN BRIEF
LUPIN has been awarded final US Food and Drug Administration
(FDA) approval for its generic rival to Pfizer’s Celebrex (celecoxib)
50mg capsules. The Indian firm – which also received a tentative
nod from the agency for 100mg, 200mg and 400mg strengths –
joins Mylan and Teva in having received approval for the lowest
strength of the blockbuster analgesic (Generics bulletin, 6 June
2014, page 18). Only Teva has received final approvals for all four
strengths. Under separate settlement agreements reached with the
originator, Teva, Mylan and Actavis may launch versions of the
analgesic – which had US sales of US$2.44 billion for the 12
months ended June 2014 – from December.
APOTEX has withdrawn its appeal to Canada’s Supreme Court over
Sanofi’s Plavix (clopidogrel). The Supreme Court had allowed the
appeal earlier this year (Generics bulletin, 14 February 2014, page
15), following a 2013 appeals court decision that overturned an earlier
ruling that Apotex version of the drug did not infringe Canadian
patent 1,336,777 (Generics bulletin, 9 August 2013, page 18).
EDENBRIDGE PHARMACEUTICALS plans in the near future to
start shipping the first generic rival to Merck & Co’s Stromectol
(ivermectin) 3mg tablets in the US. The anthelmintic agent marks
the New Jersey-based company’s first abbreviated new drug
application (ANDA) approval.
PHARMAC – New Zealand’s Pharmaceutical Management Agency
– has published the results of its latest pharmaceutical tender. Included
are sole-supply deals for Mylan’s Dicarz (carvedilol) 6.25mg, 12.5mg
and 25mg tablets, ezetimibe 10mg tablets and Zimybe (ezetimibe/
simvastatin) 10mg/10mg, 10mg/20mg, 10mg/40mg and 10mg/80mg
tablets, as well as for Apotex’ amlodipine 5mg and 10mg tablets.
DR REDDY’S has received US Food and Drug Administration (FDA)
approval for the first US rival to Pfizer’s Rapamune (sirolimus).
The Indian firm’s version of the immunosuppressant is available
as 1mg and 2mg tablets.
IMPAX has submitted a marketing-authorisation application for
its ‘IPX066’ carbidopa/levodopa extended-release capsules to the
European Medicines Agency (EMA). The company said it had
“initiated a process to find a partner” to market the Parkinson’s
Disease treatment in territories outside the US.
FDA – the US Food and Drug Administration – has published updated
draft guidance on bioequivalence requirements for methylphenidate
extended-release oral formulations. The guidance sets out details
of two recommended studies – one fed, one fasting – for the attention
deficit hyperactivity disorder drug.
STADA has launched paracetamol efferverscent 1g tablets in
Spain. The rival to Bristol-Myers Squibb’s Efferalgan is available
in 20- and 40-tablet packs.
MYLAN has launched a US rival to Boehringer Ingelheim’s
Viramune XR (nevirapine) 400mg extended-release tablets
following US Food and Drug Administration (FDA) approval.
BIOOUTSOURCE says it has expanded its research and development
capabilities “to leverage rapid growth in the biosimilars market”.
Among the development targets for the UK-based contract-testing
and characterisation specialist are Actemra (tocilizumab), Orencia
(abatacept), Stelara (ustekinumab), Synagis (palivizumab) and
Yervoy (ipilimumab).
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PRODUCT NEWS
RESPIRATORY DRUGS
ANTIHYPERTENSIVES
S
I
Baltic states approve Canada’s top court
AirFluSal for Sandoz to consider damages
andoz has received approval for its AirFluSal Forspiro (fluticasone/
salmeterol) inhaler in Estonia, Latvia and Lithuania. The Baltic states
granted marketing authorisations for the 50µg/250µg and 50µg/500µg
strengths of the rival to GlaxoSmithKline’s Seretide brand, for patients
with asthma and/or chronic obstructive pulmonary disease (COPD).
“We look forward to launching this important new product in the
Baltics in the near future and making it available to a steadily growing
number of people suffering from asthma and COPD,” stated Sandoz’
global respiratory head, Jan-Torsten Tews.
Including the three Baltic states, Sandoz noted that AirFluSal
Forspiro had now been approved in 13 European countries, as well as
in South Korea. The respiratory treatment has also received approval
in Mexico, where it will be sold as IrFlosol Forspiro (Generics bulletin,
5 September 2014, page 18).
Sandoz has so far rolled out AirFluSal Forspiro in five countries.
After introducing the drug in Denmark at the start of this year (Generics
bulletin, 3 February 2014, page 15), launches followed in Germany,
Norway and Sweden (Generics bulletin, 11 July 2014, page 21), as
well as in South Korea (Generics bulletin, 6 June 2014, page 16).
The firm recently overcame legal challenges to AirFluSal launched
by GlaxoSmithKline in Germany – over the use of the colour purple,
similar to the originator’s Viani Diskus device – as well as in Norway
and Denmark (Generics bulletin, 17 October 2014, page 18).
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ssues around damages owed to generics companies in Canada
through the country’s Patented Medicines (Notice of Compliance),
or PM(NOC), patent-linkage litigation system will be considered by
the Supreme Court of Canada. The court has granted Sanofi leave to
appeal against a series of Court of Appeal rulings that clarified the
ability of Apotex and Teva to claim damages over delays to marketing
generic versions of Sanofi’s Altace (ramipril) antihypertensive due to
an invalid patent (Generics bulletin, 4 April 2014, page 15).
Apotex and Teva had previously successfully defended themselves
over Sanofi’s appeal against a 2009 Canadian Federal Court ruling
that several claims of Altace’s Canadian patent 1,341,206 were invalid
(Generics bulletin, 18 November 2011, page 18). However, while in
progress, the lawsuit had prevented them from marketing their versions.
Earlier this year, the Federal Court of Appeal dismissed as “largely
speculative” an attempt by Sanofi to assert that – in the hypothetical
market that had to be established in order to calculate compensation
for the generics firms – Canadian firm Pharmascience would have
been first to enter the generic ramipril market.
While Sanofi had argued that section eight of the PM(NOC)
regulations – covering delays to generic market entry caused by patent
litigation – should not, “as a matter of jurisdiction”, allow compensation
for lost sales for unauthorised indications, the appeals court said the
originator had “referred to no authority to support its submission”. G
14 November 2014
PIPELINE WATCH
Gate opens for insulin glargine in Europe
S
anofi’s Lantus (insulin glargine) blockbuster could soon face
biosimilar competition in Europe as November brings the expiry
of supplementary protection certificates (SPCs) attached to the European
molecule patent EP0,368,187 in Norway and Switzerland.
However, six-month paediatric SPC extensions protect the long-acting
basal insulin analogue until next year in most of Europe’s largest markets.
In September this year, the European Commission approved Eli
Lilly’s and Boehringer Ingelheim’s Abasria rival to Lantus as Europe’s
first biosimilar insulin (Generics bulletin, 19 September 2014, page 1).
Lantus is Sanofi’s highest-selling drug, generating global sales of
C4.57 billion (US$5.67 billion) in first nine months of 2014, C643 million
of which came from Western Europe and C3.03 billion from the US.
Ark Patent Intelligence notes that while Lantus’ US molecule
patent is set to expire in February 2015, Sanofi triggered a 30-month
stay on approval for Lilly and Boehringer’s hybrid 505(b)(2) version
by suing for alleged infringement of a patent protecting the marketed
dosage formulation. The stay runs until mid-2016.
October and November bring SPC expires for two antipsychotics,
Otsuka’s Abilify (aripiprazole) and Janssen’s Invega (paliperidone).
SPC expiries in October/November
INN
Country
October
Aripiprazole
France, Germany*, Italy*, Netherlands*,
Romania* Spain, Sweden, Switzerland,
UK*
Paliperidone
Austria, Belgium, Cyprus, France,
Germany, Greece, Italy, Luxembourg,
Netherlands, Romania, Spain, Sweden,
UK
November
Artemether/Lumefantrine
Spain
Bupropion
Ireland
Irbesartan/Hydrochlorothiazide Portugal
Icatibant
Austria, Belgium, Cyprus, France,
Germany, Greece, Hungary, Italy,
Luxembourg, Netherlands, Portugal,
Spain, Sweden, UK
Insulin glargine
Norway, Switzerland
Nevirapine
Portugal
Paliperidone
Denmark, Finland, Ireland, Norway
Selamectin
Austria, Belgium, Denmark, Finland,
France, Germany, Greece, Hungary,
Ireland, Italy, Luxembourg, Netherlands,
Norway, Portugal, Slovenia, Spain,
Sweden
* indicates that the paediatric extension to the SPC remained an application at expiry
Figure 1: Molecules for which supplementary protection certificates (SPCs) expire in
key markets during October and November 2014 (Source – Ark Patent Intelligence)
In several European countries, Otsuka had applied for paediatric
extensions to European patent EP0,367,141. These have since been
rejected in France and Sweden, and are still in the application stages
in Germany and the Netherlands (see Figure 1). Invega’s SPCs were
based on European patent EP0,368,388. However, Ark points out, data
exclusivity has to date constrained generic competition. While Abilify’s
data exclusivity expired in June 2014, allowing generic approvals two
years later, Invega’s eight-year term runs until mid-2015, and a oneyear extension for a new indication could bar generics until mid-2018.
As Figure 2 shows, eight-year data exclusivity ends in November
for drugs including AstraZeneca’s Byetta (exenatide) diabetes drug. G
Data exclusivity expiries in October/November
INN
Country/Region
October
Almotriptan
Argatroban
Switzerland
Belgium, France, Germany, Italy,
Luxembourg, Netherlands, Sweden, UK
Cinacalcet
European Union
Darifenacin
European Union
Delapril/Manidipine
Emtricitabine
Switzerland
Ethinylestradiol/Levonorgestrel Belgium, France, Germany, Italy,
Firocoxib
Switzerland
Mannitol
Olmesartan/Hydrochlorothiazide Canada*
Pazopanib
US
November
Amotosalen plasma
European Union
Anagrelide
European Union
Capsaicin
US
Dasatinib
European Union
Dibotermin alfa
Switzerland
Exenatide
European Union
Golimumab
Australia
Melagatran
Switzerland
Melatonin
Australia
Romidepsin
US
Technetium (99mtc) mertiatide Belgium, France, Germany, Italy,
Ximelagatran
Switzerland
* This will be followed by a no-marketing period of two years during which a notice of
compliance will not be granted to a generic manufacturer. In addition, a further six
months of data protection will be added to the eight-year term for studies of olmesartan
in paediatric populations.
Figure 2: Molecules for which data exclusivity expires in key markets during
October and November 2014 (Source – Ark Patent Intelligence)
This monthly update of key patent, SPC and data exclusivity data is extracted from Ark Patent Intelligence Expiry Database. Covering 50
countries and over 1,600 INNs, Ark Expiry Database contains watertight data teamed with the ultimate in generic launch analysis.
For further information, visit www.arkpatentintelligence.com, or contact:
Europe: +44 870 879 0081. North America: +1 704 665 1986.
Or e-mail: [email protected].
14 November 2014
PRODUCT NEWS
IN BRIEF
SANDOZ is claiming the first launch of a generic rival to Baxter’s
Cytoxan (cyclophosphamide) in the US. The oncology injectable –
developed by Sandoz’ partner and abbreviated new drug application
(ANDA) holder Jiangsu Hengrui Medicine – is available in 500mg,
1g and 2g single-dose vials. Citing IMS Health data for the year
ended September 2014, Sandoz said cyclophosphamide injectables
had US sales of around US$420 million.
FARMAK has extended its portfolio in Ukraine by launching
citicoline in 30ml and 60ml oral solutions. The firm had previously
offered the cardiovascular treatment – which is being marketed under
the name Lira – as 500mg/4ml and 1,000mg/4ml injectables. In
addition, the company has also introduced Ototon (phenazone/
lidocaine) 16mg/ml ear drops, indicated for treating otitis.
HOSPIRA has introduced US rivals to AbbVie’s Zemplar
(paricalcitol) for injection 2µg/1ml, 5µg/1ml and 10µg/2ml multidose vials following final US Food and Drug Administration (FDA)
approval. The treatment for secondary hyperparathyroidism in
patients with chronic kidney disease would “increase dosing
efficiency and reduce waste to healthcare providers in the renal dialysis
and hospital dialysis markets”, Hospira commented.
NHS – the UK’s National Health Service – could save around £1.1
billion (US$1.8 billion) over the next five years by systematically
switching HIV treatment from patented to generic antiretrovirals
(ARVs), according to research conducted by local health researchers
from Liverpool and London. “Similar savings are feasible for other
European countries, given parallel patent-expiry dates,” the researchers
said at an HIV Drug Therapy Congress in Glasgow, Scotland.
BRECKENRIDGE says it is finalising plans to launch a US rival
to AstraZeneca’s Seroquel (quetiapine) tablets. The firm said the
schizophrenia and bipolar disorder drug would be supplied by
abbreviated new drug application (ANDA) holder Alembic in 25mg,
50mg, 100mg, 200mg, 300mg and 400mg strengths.
ANSM – France’s medicines agency – has added Inopharm’s rivals
to UCB’s Atarax (hydroxyzine) 25mg tablets to the country’s
répertoire of generic equivalents. Inopharm’s versions are available
under the molecule name and four fantasy names. Aguettant has a
listing for a rival to GlaxoSmithKline’s Levophed (noradrenaline)
8mg/4ml injectable solution, while Ipsen has added an authorised
generic of its own Smecta (diosmectite) 3g oral solution.
MYLAN has started shipping its generic version of Warner Chilcott’s
Loestrin 24 Fe (norethindrone/ethinylestradiol) 1mg/0.2mg tablets
in the US, after receiving final approval from the US Food and Drug
Administration (FDA). Citing IMS Health data for the year ended
September 2014, Mylan said Loestrin 24 Fe had annual US sales of
around US$24.4 million. Last year, Amneal Pharmaceuticals struck
a deal with Actavis to acquire a version of the oral contraceptive
as a condition of Actavis securing US Federal Trade Commission
clearance for its acquisition of Warner Chilcott (Generics bulletin,
4 October 2013, page 5).
PHARMA ACTION has opened a plant in Rheda-Wiedenbrueck,
Germany, dedicated to producing crude heparin that the firm claims
will have the capacity to process “around 60% of Europe’s traceable
heparin raw material”. Production at the facility – which has a
3,500 sq m production area and was constructed with joint venture
partner Tönnies (Generics bulletin, 18 October 2013, page 4) – is
due to start by the end of the year.
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BIOLOGICAL DRUGS
Amgen sues Sandoz
over filgrastim filing
S
andoz has not met its obligations under the US biosimilars filing
framework in seeking approval for a rival to Amgen’s Neupogen
(filgrastim), according to a lawsuit filed by the originator in a California
district court. In late July, Sandoz’ application became the first US
biosimilar filing to be accepted by the US Food and Drug Administration
(FDA) for review (Generics bulletin, 8 August 2014, page 1).
Noting that the Biosimilars Price Competition and Innovation Act
(BPCIA) requires biosimilar applicants to disclose their applications
and manufacturing information to the originator within 20 days of
filing, Amgen’s lawsuit says Sandoz has “refused to provide Amgen
with the Biologics Licence Application (BLA) and manufacturing
information in a timely manner”. The decision on Sandoz’ part to “follow
only those parts of the BPCIA they consider helpful, and to flaunt
the part they consider unhelpful to them” is unlawful, Amgen maintains.
The disclosure of the BLA and manufacturing information required
by the BPCIA “allows the innovator to assess which patents the
biosimilar applicant’s activities could infringe and critically, to start a
process that will allow the innovator to bring its patent claims before
the applicant can begin selling an infringing product and thereby
irreparably damage the market,” Amgen stated.
By not providing this information, Sandoz was attempting “to
prevent Amgen from learning the details of their processes for
manufacture, to avoid patent-infringement litigation on any manufacturing
patents and to avoid the patent exchanges required by the statute, and
instead go directly to litigation”, the originator believes.
Claiming that Sandoz’ failure to follow the statutory framework
was “part of a carefully orchestrated scheme to deprive Amgen of the
substantive and procedural benefits of the BPCIA”, the originator
insisted that “this lawsuit is necessary because [Sandoz] refuse to follow
the rules”. Amgen is seeking a declaration that Sandoz has engaged in
unfair competition, along with an injunction to prevent the generics
firm from marketing its filgrastim as well as “compensatory damages”.
A spokesperson for Sandoz said that Amgen’s lawsuit “comes as
no surprise”. “As Sandoz is the first company using the pathway to
bring cost-effective biosimilars to market in the US,” Sandoz told
Generics bulletin, “it is understandable that Amgen and Sandoz might
take a different view of the BPCIA provisions. We look forward to
the court’s resolution of this matter and Sandoz will not comment
further on the litigation at this stage.”
Amgen has also filed a citizen petition urging the FDA to require
that all biosimilar applications contain a certification from the applicant
that it will provide a copy of the application to the sponsor of the
reference product, as well as “information that fully describes the
manufacture of the proposed biosimilar product”, within 20 days of the
FDA accepting the application for review. “This certification should
be required for all biosimilar applications that have not been accepted
for review by the FDA,” Amgen insists.
Celltrion recently revealed that it had initiated the filing process
for its Remsima (infliximab) rival to Janssen’s Remicade brand
(Generics bulletin, 5 September 2014, page 17).
The South Korean firm had said that it expected Remsima to be
the first biosimilar monoclonal antibody to be accepted for filing by
the FDA, having previously filed a lawsuit against Janssen that
challenged the originator’s patents to clear the way for Celltrion to
launch its version (Generics bulletin, 18 April 2014, page 19).
However, Celltrion recently withdrew the litigation (Generics bulletin,
3 November 2014, page 1).
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14 November 2014
EVENTS
DECEMBER
19-21 November 2014
■
2-4 December
■
Miami, USA
This three-day event is being organised by the US Generic Pharmaceutical
Association (GPhA) and is the global event of the worldwide generics industry. It is the
annual joint meeting of the Canadian, European, Japanese, South African and US
generics industry associations, the CGPA, EGA, JGA, NAPM and GPhA. Topics covered
will include market trends, regulatory developments and intellectual property. There will
be speakers from companies such as Actavis and Mylan along with opportunities to network.
CPhI & P-MEC India
Mumbai, India
This is a three-day exhibition and
networking event which will also provide
technical and educational seminars.
Contact: UBM.
Tel: +31 2040 99544.
E-mail: [email protected].
Website: www.cphi.com.
Contact: Jennifer Nguyen, GPhA. Tel: +1 202 249 7127.
E-mail: [email protected]. Website: www.gphaonline.org.
10 December
■
FEBRUARY
CRED Generics
9-11 February
London, UK
This is a course run by Topra looking at
regulatory affairs in the generics industry.
The course will cover issues including
legislation relating to abridged applications
and bioequivalence studies.
■
GPhA 2015 Annual Meeting
21 January
MARCH
8th EGA Pharmacovigilance
Discussion Forum
Contact: Lucia Romagnoli, GPA Conferences.
Tel: +44 7562 876 873.
Register online at www.egagenerics.com or
www.egaevents.org.
APRIL
9-10 March
■
London, UK
This European Generic medicines
Association (EGA) event will take the
form of a discussion forum with speakers
from the industry as well as from agencies.
EuroPLX 57
Cascais, Portugal
This meeting provides a forum for
business-development decision makers to
discuss and negotiate agreements, inlicensing, marketing and distribution of
patented medicines, generics, biosimilars,
OTC products, medical devices and
food supplements.
Tel: +44 7562 876 873.
www.egaevents.org.
14th EGA Regulatory &
Scientific Affairs Conference
London, UK
This two-day conference will follow the
EGA’s Pharmacovigilance Forum. Both
events are at the same venue in London.
Topics covered at both meetings will include
risk-management plans, periodic safety
update reports, joint studies and inspections.
Tel: +44 7562 876 873.
www.egaevents.org.
13-15 April
■
12-13 March
■
7th Pharmeet
DIA 27th Annual
EuroMeeting
Paris, France
Issues to be covered at this three-day event
include innovation, clinical trials legislation
and medical devices. There will be speakers
from firms including Amgen and Sanofi.
Contact: DIA.
Tel: +41 61 225 5151.
Website: www.diaeurope.org.
Contact: Raucon.
Tel: +49 6222 9807 0.
Website: www.europlx.com.
22-23 January
10th EGA Legal
Affairs Forum
Brussels, Belgium
This is a two-day event organised by the
EGA which will look at issues including
litigation, regulatory matters and patent
settlements. The forum will also offer
networking opportunities.
Contact: GPhA.
Tel: +1 202 249 7127.
Website: www.gphaonline.org.
JANUARY
■
18-19 March
■
Miami, US
This is a three-day meeting of the US
Generic Pharmaceutical Association
(GPhA) which will look at regulatory issues
and opportunities for the industry. There
will also be networking opportunities.
Contact: Topra.
Tel: +44 (0) 207 510 2560.
Website: www.topra.org.
■
17th IGPA Annual Conference
23-24 April
■
Mallorca, Spain
This two-day event is designed to offer
delegates the opportunity to network as
well as the chance to strike licensing
deals for a wide range of products
including biosimilars.
Contact: PharMeet.
Tel: +34 91 637 0660.
Website: www.pharmeet.com.
SAVE THE DATE ...
13th EGA International
Biosimilars Conference
London, UK
This meeting is organised by the EGA
and will cover topics including industry
developments and regulatory issues for
the biosimilars industry.
Tel: +44 7562 876 873.
www.egaevents.org.
The Global Generics & Biosimilars Awards
2015 will be held in Madrid, Spain on
Tuesday 13 October 2015.
14 November 2014
For more information on how to
enter, sponsor and attend,
contact Natalie Cornwell on
+44 (0) 1564 777550 or
email: [email protected]
PRICE WATCH ............ UK
Forecasting the need for price concessions
■ For further information see www.bppi.co.uk.
Alternatively, contact Charles Joynson at
WaveData Limited, UK. Tel: +44 (0)1702 425125.
profitability
Retail
+"'&&8
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+, 0
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Figure 1: Average trade, Drug Tariff and Concession prices for 21-tablet packs of
co-amoxiclav 250mg/125mg, showing dispensing losses (Source – WaveData)
Average
Concession
(%$%%
40
profitability
Retail
Tariff
Drug
( "$%%
35
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Oct 14
£37.95
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Figure 2: Average trade, Drug Tariff and Concession prices for 30-tablet packs of
exemestane 25mg, showing dispensing losses (Source – WaveData)
Average
Retail
profitability
Tariff
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Figure 3: Average trade and Drug Tariff prices for 28-tablet packs of bicalutamide
150mg, showing dispensing profit declining into losses (Source – WaveData)
Average
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Please specify the product and period of time you would like to
investigate and email your request to [email protected].
Drug
Tariff
Jul 14
Long-term product price trends or other price analyses are available.
Average
Nov 12
Dec 12
Jan 13
Feb 13
Mar 13
Apr 13
May 13
Jun 13
Jul 13
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Sep 13
WANT MORE LIKE THIS?
Concession
10
+ &'&&
Price (£)
ore frequent adjustments to reimbursement prices are currently
being considered by the English authorities, which want to make
the funding system for community pharmacy more responsive and
account for “all margin within the annual sum” (Generics bulletin,
17 October 2014, page 25). Meanwhile, however, the Pharmaceutical
Services Negotiating Committee (PSNC) – the body representing
community pharmacists’ interests – continues to negotiate monthly price
concessions from the authorities for products whose trade prices in the
marketplace exceed those in the official Drug Tariff of reimbursement
prices. Nine ingredients in 12 presentations were granted price
concessions last month, which was somewhat below the usual number.
At present, actual trade prices are collected quarterly to arrive at
category M reimbursement prices in the Drug Tariff, which usually
have a three-month lifespan. A shorter timescale would clearly make
the funding system more responsive. Meanwhile, pharmacists are
dispensing some products at a loss.
Charles Joynson, WaveData’s managing director, says that analysis
has shown that low prices do not drive availability issues. Neither has
any association been found between the direct-marketing activities of
wholesalers and product availability.
What is apparent, however, is that retail profitability – the
difference between Drug Tariff and average trade price – is a significant
factor in whether there are any common features in the trade-price
histories of products granted concessionary prices, and whether
there are any earlier, telltale signs that pharmacists are likely to be
dispensing products unprofitably. Products for which a price concession
is eventually granted experience some months of declining retail
profitability, and eventually dispensing losses, before the concessionary
price is granted. Typical examples are 21-tablet packs of co-amoxiclav
250mg/125mg (see Figure 1) and 30-tablet packs of exemestane
25mg (see Figure 2).
Of the 49 products granted concessionary prices, 34 exhibited this
pattern, according to Joynson. Of the rest, 13 were already receiving
price concessions at the start of the two-year period studied and the
remaining handful failed to show any period of profit decline. Of the
34 concessionary products, 41% gave more than three months warning
of impending losses, but another 32% lost profitability more quickly.
Another 43 products, however, were not granted a price concession
and yet also experienced profit declines turning into dispensing losses
during the period. Bicalutamide and esomeprazole were typical of
this group (see Figures 3 and 4). “The main difference between the
two groups was that products granted price concessions would have
generally resulted in far greater financial losses for pharmacists than
the others,” comments Joynson, who adds that 94% of all products
that caused dispensing losses were in category M.
Pharmacists would have lost as much as £5.90 (US$9.36) on
average for dispensing co-amoxiclav in April 2014 without the monthly
price concession, while the loss would have been £6.77 on average
for exemestane last month. The comparable losses for dispensing
bicalutamide and esomeprazole without price concessions were £1.08
and £3.40, respectively, both in November 2013.
G
Price (£)
M
Figure 4: Average trade and Drug Tariff prices for 28-capsule packs of esomeprazole
40mg, showing dispensing profit declining into losses (Source – WaveData)
14 November 2014
MARKET RESEARCH
US awaits biosimilar savings
By combining a review
of existing studies on
potential US savings
from biosimilars
with analysis of the
latest sales data,
RAND Corporation
has concluded that
biosimilars could
save the country
US$44 billion over
the next decade.
David Wallace reports.
Study
E
ver since 2009’s Biosimilars Price Competition
and Innovation Act (BPCIA) set out the US
regulatory framework, there has been anticipation
of significant savings once biosimilars enter the market.
Market researcher RAND Corporation has reviewed
a series of previous savings studies, in tandem with
2013 sales data, to provide the latest estimate.
“We predict that biosimilars will lead to a US$44.2
billion reduction in direct spending on biologic drugs
from 2014 to 2024, or about 4% of total biologic
spending over the same period,” the RAND report
states, acknowledging that the final figure could fall
between US$13 billion and US$66 billion.
“Our estimate,” RAND states, “uses recent data and
transparent assumptions” while combining prior research
(see Figure 1) with 2013 US sales data on more than
100 biologics, including all blockbuster biologics.
RAND noted that its forecast assumed year-onyear originator growth of 10%, as well as an increase
in the share of originator sales exposed to biosimilar
competition from 10% in the first year to 20% in the
tenth. It also assumes biosimilar market penetration
of 60%, and a biosimilar price discount of 35%.
These “informed guesses” were also used to
estimate the way the projected overall savings would
be split between different product classes (see Figure 2).
The report finds that US cost savings from
biosimilars will be influenced by four main drivers:
safety and efficacy; payment; acceptability; and
competition. While these drivers build on each other,
the report notes, “a single strong driver can lead to
significant cost savings even with lacklustre results
elsewhere in the framework”.
“We caution against expecting savings similar to
those from small-molecule generics for biosimilars,
Other
Non-interferon
immunostimulants
Anti-TNF
Erythropoetins
Interferons
Colonystimulating
factors
Longacting
insulins
Fastacting
insulins
mAb antineoplastics
Figure 2: Breakdown by product type of potential US cost
savings from biosimilars (Source – RAND Corporation)
but rather view those as an upper bound of the potential
savings,” the study states. “Details on interchangeability,
naming conventions, market exclusivity for originators
and clinical research requirements will have a direct
impact on biosimilar competition and uptake, and
therefore on cost savings.”
Ralph Neas, president and chief executive officer
of the US Generic Pharmaceutical Association (GPhA),
said there was “unanimous agreement that biosimilars
will promote competition, enable significant savings,
and provide millions of patients with alternatives to
costly biologic drugs”.
“It is an exciting time for the industry,” Neas stated,
“and recent FDA actions constitute major steps forward.
We look forward to witnessing the transformative
potential of these innovative therapies as they are
integrated into the American health system.”
G
Approach
Scope
Time frame
Price reduction
Saving
Grabowski et al., 2007 as
applied in Goodman et al.,
2009 (base case)
Economic model
6 major categories of
biologics, top 20 biologics
by sales only, all payers
2009-2019
12% to 20%
varies by product
US$10 billion
Grabowski et al., 2007 as
applied in Goodman et al.,
2009 (sensitivity analyses)
Economic model
6 major categories of
biologics, top 20 biologics
by sales only, all payers
2009-2019
12% to 40%
varies by product
US$1 billion to
US$44 billion
Ahlstrom et al., 2007
(Avalere Health)
Actuarial model
Federal payers only
2008-2017
10% to 51%
varies by product
and increasing over time
US$3.6 billion
Engel and Novitt, 2007
Actuarial model
Excludes Enhanced Primary
Care, Medicare Part B only
(office-based, physicianadministered biologics)
2007-2016
Unknown
US$14.4 billion
Miller and Houts, 2007
(Express Scripts)
Actuarial model
Select markets, all
commercial players
2007-2016
25%
US$71 billion
CBO, 2008
Actuarial model
All biologics
2009-2018
20% to 40%
varies by product
and increasing over time
US$25 billion
Shapiro et al., 2008
Actuarial model
Top 12 biologic classes
2010-2019
25% to 35%
varies by assumption
US$67 billion to
US$108 billion
Figure 1: Select estimates of potential US cost savings from biosimilars (Source – RAND Corporation)
14 November 2014
PEOPLE
APPOINTMENTS
Camargo’s Castillo
leads development
C
amargo – the US-based 505(b)(2) hybrid new drug application
(NDA) specialist – has named Steven Castillo as its vice-president
of drug development. During a 25-year career that has included roles
with GlaxoSmithKline (GSK) and Novartis’ Alcon unit, Castillo has,
according to Camargo, amassed a “broad therapeutic expertise” in
areas including infectious diseases, oncology, ophthalmology,
dermatology and biological drugs.
“Steven is a tremendous asset to our team,” commented president
and chief executive officer Ken Phelps. “His experience in each stage
of drug development, combined with outstanding leadership qualities,
strengthens our team and will better support the success of our clients.” G
APPOINTMENTS
Mendonça moves to Mylan
M
ylan has appointed Victor Mendonça as vice-president of
global policy and market access in Europe.
Mendonça previously oversaw market access at the European
Generic medicines Association (EGA), having previously served as
an advisor to the board of Portuguese regulatory agency Infarmed.
He has also worked for Boehringer Ingelheim as a product
manager in Portugal.
G
IN BRIEF
PERRIGO has hired Adriane Siefert as senior legal counsel, based
at the group’s US headquarters in Allegan, Michigan. She will work
on issues including drafting and negotiating commercial contracts.
AKRIKHIN has appointed Irina Redzyuk as its vice-president of
regulatory affairs. She previously served in similar roles with
firms including Ferring and Teva Russia.
EAASM – the European Alliance for Access to Safe Medicine – has
promoted its board member Cathalijne van Doorne as chairperson.
She takes over the role at the anti-counterfeiting body from Jim
Thomson, who remains on its board.
G
APPOINTMENTS
Actavis prefers Pepsi
to find finance head
A
ctavis has announced that Pepsi’s Maria Teresa Hilado will
join the company on 8 December to succeed Todd Joyce as the
firm’s chief financial officer. Joyce – who has served in the role
since October 2009, having initially taken it up on an acting basis
in July of that year – will, however, remain with the firm until
“early 2015” to “support the transition”.
Hilado will join Actavis from PepsiCo, where she currently serves
as senior vice-president of finance and treasurer. Previously, she worked
in the same role with Schering-Plough. “Tessa is an experienced
finance leader whose nearly three decades in financial leadership
roles at some of the world’s leading multinational corporations will
be invaluable to Actavis as we continue our evolution,” said president
and chief executive officer Brent Saunders.
Joyce will depart the company after a 17-year association, having
joined Watson Pharmaceuticals in 1997 as corporate controller before
being promoted and adding the role of treasurer to his responsibilities
around four years later.
Commenting on Joyce’s retirement, Actavis’ executive chairman
Paul Bisaro stated: “Todd has been an integral part of the executive
leadership team that has reshaped our company from a US-centric
generic company into a truly global, specialty pharma leader.” G
APPOINTMENTS
Gehler heads Siegfried sites
S
iegfried’s chief communications officer, Peter Gehler, has from
1 November taken on “management and coordination” of the Swiss
group’s industrial site in Zofingen, Switzerland, along with the
committees that represent four other companies at the site. The Swiss
group said the site was to be “further developed in the coming years”
under the Pharmapark Siegfried Zofingen name “to develop an attractive
and competitive location for Siegfried and other companies in the
pharmaceutical field”.
Subsequent to taking on the role, Gehler has stepped down from
Siegfried’s executive committee; however, he has retained his
responsibilities as chief communications officer – a position he has
held since 2000 – and will also continue to manage the Swiss group’s
manufacturing facilities in Zofingen.
G
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Teva`s Olafsson starts global markets review

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