Fate of Rule 21 in balance as med devices talks begin

Transcription

23 October 2015
COMPANY NEWS
3
Mid Europa Partners set
to take control of Walmark
Perrigo strikes deal with Flamel
J&J ready to pursue
OTC opportunities
Shionogi forms
OTC subsidiary
23andMe gets investment
to grow global operations
Nestlé to open research facility
Genomma on the look out
for brands to grow portfolio
IPO on the cards
for AFT Pharma
Boiron hit by lower sales
in key European markets
3
GENERAL NEWS
9
ASMI wants better
codeine measures
PAGB lends its support
to NHS winter campaign
Foreign traditions challenge HMPC
US slow to adopt
digital health tech
9
3
4
5
6
6
7
7
8
10
10
11
MARKETING NEWS
14
Vicks makes its debut in
“connected health space”
GSK teams with X Factor
in Australia
Sanofi promotes Doliprane
for French self-medication
Infirst Healthcare prepares
to launch UniCough in UK
Covonia grows with
hot dose variant
Dolormin capsules aim to
relieve pains in the neck
Pregnacare Liquid is
said to be UK’s first
14
FEATURES
20
Pharmacy needs to
adapt to flourish
20
14
15
16
17
18
18
REGULARS
Events – Our regular listing
People – Oschmann to replace
Kley as head of Merck in 2016
19
23
Fate of Rule 21 in balance
as med devices talks begin
R
ule 21 was on the table when talks began last week on the fate of the European Union’s (EU’s) proposed medical device legislation.
The rule – proposed by the Commission,
rejected by the Parliament, and expanded by
the Council – will determine whether self-care
medical devices have a future, according to
speakers at a meeting organised by the Association of the European Self-Medication Industry, the AESGP, last week.
Mairead McGuinness, vice-president of the
European Parliament, said that while the first
round of trialogue discussions had been positive
– with a decision made to try and complete the
work by the end of the year – there had been
no movement on the future of the legislation’s
controversial Rule 21.
If implemented, Rule 21 could see a raft of
self-care medical devices, such as nasal sprays,
removed from the market.
In June, the Council expanded the scope
of Rule 21 in Annex VII of the proposed legislation to cover “all devices that are introduced
into the human body via body orifice or applied
on skin”. The AESGP said at the time that this
new language would mean numerous self-care
devices would unnecessarily be classified in the
highest risk category – class III (OTC bulletin,
24 July 2015, page 1).
Commenting on the first trialogue discussions on the proposed legislation between the
Council of Health Ministers, the European
Commission and the European Parliament –
which were held on 13 October – McGuinness said that “it was not clear if there is an
acceptable compromise”.
“That is not to say that things might not
evolve and move on before our next meeting,”
McGuinness added. “This is not a race to the
end. Let’s not rush; let’s do the right thing.”
The AESGP meeting clearly showed the
scale of the task facing the self-care industry
in convincing member states to delete Rule 21.
Vincent Houdry, health advisor for the permanent representation of France to the EU, simply stated that if a product fell under the def-
inition of Rule 21, France was “quite happy to
have these products in class III”.
However, Houdry did leave some room for
compromise noting that France was not happy
with the current language of Rule 21 and conceded that the legislation might be “excessive
for some products”, and that France was “happy
to work on this topic”.
Adopting a similar view, Matthias Neumann,
of Germany’s Ministry of Health, said that his
country felt the rule was needed, but that the
Council’s current text was ill-defined. To find
a compromise, the language needed to be revisited, he argued.
Meanwhile, John Wilkinson, from the UK’s
Medicines and Healthcare products Regulatory
Agency (MHRA), said the agency’s position
had been laid out in 2012 and had not changed –
orally ingested, inhaled, rectal and vaginal products were all medicines if absorbed or dispersed.
“Caution is needed here,” he warned. “There
is potential for a wide open door that a load
of stuff goes through which was not intended, and nobody wants that.”
“No rationale” for Rule 21
Facing such entrenched positions, GlaxoSmithKline’s (GSK’s) Andrew Wilson, speaking in his capacity as a member of the AESGP’s
Committee on Medical Devices, argued that
there was “no rationale” for Rule 21.
“We have heard it said that member states
are concerned about ingested medical devices.
Yet we’ve not seen any data to support this concern,” he claimed. “But if there is, let’s reach
a conclusion on it.”
“Then if action is needed, let’s make provision in a delegated act,” Wilson urged. “Let’s
write a technical specification for ingested medical devices and the standards they should meet.”
“It will be clear, understandable, actionable
and easier to reach alignment on than a general
rule,” Wilson added.
“The regulation has the tools to do this already and because of this we would urge the
trialogue discussions to come out in line with
the Parliament position and delete Rule 21.”
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COMPANY NEWS OTC
Mergers & Acquisitions
Perrigo strikes Mid Europa Partners set
deal with Flamel to take control of Walmark
P
P
errigo has struck an exclusive deal to license
Flamel Technologies’ LiquiTime drug-delivery technology to develop a range of products
for the US OTC market.
Noting that LiquiTime permitted extendedrelease of liquid medicines – such as ibuprofen
or guaifenesin – the US store-brand specialist
said the technology would be “utilised in the
development of a portfolio of extended-release
suspension products”.
Commenting on the agreement, Perrigo’s
chairman, president and chief executive officer,
Joseph Papa, said the partnership with Flamel
for its “innovative” LiquiTime technology demonstrated the firm’s “continued focus on its
growth strategy”.
“This is yet another excellent example of
Perrigo’s commitment to providing quality affordable healthcare products for our customers
across the globe,” Papa insisted.
Michael Anderson, Flamel’s chief executive
officer, said the company “looked forward to
continued successful development programmes
and commercial launches with Perrigo”.
Perrigo is currently the target of a hostile
takeover bid from Mylan, which the generics
giant made directly to the firm’s shareholders
on 14 September (OTC bulletin, 25 September
2015, page 3).
OTC
23 October 2015
Number 451
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23 October 2015 OTC bulletin
rivate-equity firm Mid Europa Partners is
set to take full control of family-owned
Czech dietary supplements and natural products company Walmark.
Under the terms of the deal, Mid Europa
will acquire the 50% of Walmark that it does
not already own from the founding Walach
family. Mid Europa first snapped up a 50%
stake in Walmark in December 2012.
Commenting on the agreement, Adam Walach, member of Walmark’s board, said that the
Walach family had concluded that the time was
right to sell the business.
“After 25 years of building Walmark, we
have decided to pursue other interests and new
investment opportunities, capitalising on our experience,” Walach explained.
Enjoyed an excellent partnership
Michelle Capiod, a partner at Mid Europa,
said the private-equity company had enjoyed an
“excellent partnership” with the Walach family
for the past three years.
“We have jointly transformed Walmark from
the leading dietary supplements business in Central and Eastern Europe (CEE) into a focused
consumer healthcare platform with an exciting
pipeline of new products,” Capiod insisted.
“We are delighted to continue our active supIndividual subscriptions
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port of the management in their execution of
this successful strategy,” she added.
Echoing Capiod’s comments, Jorge Manuel,
Walmark’s chief executive officer, insisted that
this “evolution in Walmark’s ownership” would
not alter the firm’s “strategy and priorities”.
“I and the whole Walmark team remain highly motivated to materialise the value-creation
opportunities ahead of us,” Manuel stressed,
“through our commitment to consumer insightled innovation and brand-equity building in partnership with pharmacists and other healthcare
professionals across the CEE region.”
Established in 1990, Walmark claims to
be the “fastest growing healthcare company”
across the CEE region. The firm’s portfolio includes the Benosen sleep-aid, Pneumolan respiratory health products, Septofort sore-throat
line and Spektrum multivitamins.
Walmark expanded its product portfolio earlier this month by acquiring Czech dietary supplements and natural products firm Valosun for
an undisclosed sum (OTC bulletin, 9 October
2015, page 3).
Describing Valosun as the “leading probiotic
player in the Czech Republic and Slovakia”,
Walmark said the deal would “further strengthen” its position in both “key” markets.
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3
OTC COMPANY NEWS
Third-Quarter Results
J&J ready to pursue OTC opportunities
J
ohnson & Johnson is on the look out for
acquisitions to grow its OTC and certain
other Consumer businesses, according to the
firm’s chief financial officer Dominic Caruso.
Speaking as the US pharmaceutical giant
announced its third-quarter results, Caruso said
Johnson & Johnson would pursue acquisitions
to expand its OTC, Oral Care and Skin Care
businesses if the right opportunities came along.
The company would look to add scale to these
three businesses in particular, Caruso said, as
they constituted Johnson & Johnson’s “core
platforms” within its Consumer unit.
Not averse to big deals
Commenting on the size of any potential
deal, Caruso insisted that the company was not
“averse to large mergers and acquisitions”. However, such a transaction had to drive “long-term,
value-creating growth”, he stressed.
Turning to the manufacturing issues that
have blighted the company’s US OTC business
over the past few years, Caruso noted that the
majority of the brands that had been withdrawn
were now back on the market. “We are back
to a consistent cadence of new products as we
Business
continue to reintroduce products to shelves,”
he pointed out.
All three of the firm’s US OTC manufacturing plants operating under a consent decree (OTC bulletin, 17 March 2011, page 1)
have now passed US Food and Drug Administration (FDA) inspections (OTC bulletin, 11
September 2015, page 11).
Despite receiving FDA certification for all
three plants, Johnson & Johnson will continue
to operate under the consent decree for a further
five-year period.
The firm was issued with the consent decree for failing to comply with good manufacturing practice (GMP) requirements at its Fort
Washington facility in Pennsylvania, US and
its Las Piedras site in Puerto Rico.
A string of product recalls by Johnson &
Johnson’s OTC business during 2010 and 2011
prompted a government investigation and the
closure of the Fort Washington facility. Manufacturing problems at Fort Washington led to
the withdrawal of the bulk of Johnson & Johnson’s OTC portfolio in the US.
Johnson & Johnson’s OTC brands returning
to shelves in the third quarter of 2015 helped
to lift its US OTC sales by 22.4% to US$383
million (C338 million).
Growth had been recorded by the firm’s US
analgesics brands, Johnson & Johnson noted,
with the company singling out the “positive
contributions” of Motrin and Tylenol.
Johnson & Johnson’s share of the US adult
analgesics market in the quarter had reached
12.5%, the company pointed out, up from 11%
in the prior-year period.
In addition, the firm noted that it had taken
a 44.5% share of the paediatric analgesics market, up from 41% in the third quarter of 2014.
US OTC sales had also benefitted from
seasonal inventory build-up for Zyrtec and initial stocking for a number of relaunched d igestive-health products, the company added.
Outside the US market, international OTC
sales slumped by 17.8% to US$580 million, as
an operational fall of 0.7% was compounded
by a 17.1% negative currency effect.
Johnson & Johnson blamed the operational
fall on the “timing of the seasonal inventory
build-up for upper respiratory products”, noting
that the build-up had occurred earlier than in
the prior year.
Third-quarter sales
(US$ millions)
Change
2014/2015 (%)
Operational
change (%)
Currency
effect (%)
OTC – US
OTC – International
Total OTC
383
580
963
+22.4
-17.8
-5.5
+22.4
-0.7
+6.3
–
-17.1
-11.8
Skin Care – US
Skin Care – International
Total Skin Care
435
428
863
+8.8
-17.7
-6.2
+8.8
-2.3
+2.5
–
-15.4
-8.7
Baby Care – US
Baby Care – International
Total Baby Care
103
403
506
+1.0
-12.6
-10.1
+1.0
+2.1
+2.0
–
-14.7
-12.1
Oral Care – US
Oral Care – International
Total Oral Care
154
224
378
+4.1
-14.2
-7.6
+4.1
+3.2
+3.5
–
-17.4
-11.1
Women’s Health – US
Women’s Health – International
Total Women’s Health
6
304
310
-25.0
-4.1
-4.6
-25.0
+14.2
+13.3
–
-18.3
-17.9
Wound Care/Other – US
Wound Care/Other – International
Total Wound Care/Other*
196
98
294
-3.0
-35.1
-16.7
-3.0
-23.9
-11.9
–
-11.2
-4.8
Total Consumer
3,314
-7.7
+3.1
-10.8
Consumer – US
Consumer – International
1,277
2,037
+8.9
-15.7
+8.9
+0.4
–
-16.1
* Now includes Nutritionals, which was previously grouped with OTC
Figure 2: Breakdown of sales by Johnson & Johnson’s Consumer division in the third quarter of 2015 (Source – Johnson & Johnson)
4
OTC bulletin 23 October 2015
COMPANY NEWS OTC
Business
Third-quarter
Change
sales (US$ millions)
(%)
Operational
change (%)
Currency
effect (%)
Pharmaceutical
7,694
-7.4
-0.3
-7.1
Medical Devices
6,094
-7.3
+0.9
-8.2
Consumer
3,314
-7.7
+3.1
-10.8
Total Johnson & Johnson
17,102
-7.4
+0.8
-8.2
Consumer
19%
US$3.3 billion
Pharmaceutical
45%
US$7.7 billion
Medical
Devices
36%
US$6.1 billion
Figure 3: Johnson & Johnson’s sales in the third
quarter of 2015 – US$17.1 billion – broken down by
business segment (Source – Johnson & Johnson)
declined by 7.6% to US$378 million, as a 4.1%
rise in US sales was held back by a 14.2%
drop in international turnover.
Operationally, international Oral Care sales
had advanced by 3.2%, the company said,
thanks to better sales of the Listerine mouthwash brand following new product launches.
The Women’s Health unit posted worldwide
sales down by 4.6% to US$310 million, following the sale of its North American sanitary
protection product unit.
The sell-off contributed to a 25.0% slump
in Women’s Health turnover in the US during
the three months, while international sales declined by 4.1% due to negative currency effects.
Turning to Consumer’s Wound Care/Other
unit, Johnson & Johnson reported worldwide
sales at the business down by 16.7% to US$294
million, as the divestment of Benecol in November 2014 had caused international turnover
to slump by 35.1% to US$98 million. US sales
fell back at a slower rate, sliding by 3.0% to
US$196 million.
The Consumer division accounted for 19.4%
of Johnson & Johnson’s worldwide sales in
the third-quarter (see Figure 3), which dropped
by 7.4% to US$17.1 billion.
OTC
Help Net to acquire
Centrofarm stores
R
said the deal would enhance Hi-Tech’s “industry-leading sports-nutrition position” by expanding “market opportunities”. “We will have an
even larger product portfolio, broader geographic
reach and enhanced scale,” Wheat claimed.
OTC
OTC
IN BRIEF
apan’s Shionogi is set to spin off its consumer healthcare business into a wholly-owned
subsidiary in response to rising demand for
its OTC products.
Scheduled to begin operations in April 2016,
the new subsidiary would be named Shionogi
Healthcare, the company noted, and be led by
Itaru Hirano, currently vice-president of the
firm’s existing Consumer Health Care division.
Explaining the rationale behind the move,
Shionogi said that in Japan, self-medication was
“becoming more and more important”.
The new subsidiary would help the firm to
increase its “focus” on consumer healthcare,
Shionogi claimed, while also facilitating “quick
decision making”.
Shionogi Healthcare would concentrate its
efforts on providing consumers with “highquality healthcare products” to help “extend
healthy life expectancy”, the firm noted.
Shionogi’s OTC product portfolio – which
includes the Popon multivitamin range, Pylon
cold remedies and the Sedes analgesic – generated sales of ¥4.6 billion (C34 million) in 2014.
The firm’s total 2014 turnover amounted to
¥274 billion from sales of prescription medicines and medical devices, as well as OTC lines.
omania’s competition authority has given
the go-ahead to pharmacy chain Help Net
Farma’s acquisition of 19 stores from local rival Centrofarm.
The country’s Consiliul Concurentei said its
investigations had concluded that the deal “does
not raise significant obstacles to competition”
in the Romanian pharmacy market.
By adding 19 Centrofarm outlets to its network, Help Net would not “create a dominant
position” in the market, the authority judged.
Under the terms of the agreement – announced in June – Help Net has acquired for
an undisclosed sum 19 Centrofarm pharmacies
located in 10 cities across Romania, including
the country’s capital city, Bucharest.
Help Net currently operates more than 190
pharmacies in its domestic market.
OTC
■ HI-TECH PHARMACEUTICALS – the
US-based sports-nutrition firm – has grown its
brand portfolio by buying iForce Nutrition and
its range of sports-nutrition and bodybuilding
products for an undisclosed sum. Jared Wheat,
Hi-Tech’s president and chief executive officer,
Shionogi forms
OTC subsidiary
J
Figure 1: Johnson & Johnson’s sales in the third quarter of 2015 (Source – Johnson & Johnson)
Worldwide OTC sales fell back by 5.5%
to US$963 million, as an operational gain of
6.3% was held back by an 11.8% negative currency effect.
The decline at the OTC business contributed
to an overall slump in sales at Johnson & Johnson’s Consumer division, which reported worldwide turnover down by 7.7% to US$3.31 billion (see Figure 1).
A rise in US Consumer sales of 8.9% to
US$1.28 billion failed to offset a 15.7% drop
in international turnover to US$2.04 billion.
Operationally, international sales edged up by
0.4%, but this gain was wiped out by a 16.1%
negative currency effect (see Figure 2).
Excluding divestments, Johnson & Johnson
said worldwide Consumer sales had improved
operationally by 4.0%, with US sales increasing by 8.9% and international turnover advancing by 1.5%.
Along with the OTC unit, all of Johnson &
Johnson’s other Consumer businesses reported a
drop in sales in the three months.
Skin Care posted worldwide turnover down
by 6.2% to US$863 million, as a 17.7% fall
in international sales held back an 8.8% rise in
the US. The international decline had been due
to a combination of negative currency effects
and “soft sales” in China, the firm noted.
Johnson & Johnson attributed the increase
in US Skin Care turnover to market share gains
for Aveeno and Neutrogena in the country.
Consumer’s Baby Care business reported a
10.1% drop in worldwide sales to US$506 million, due to a 12.6% fall in international turnover.
US Baby Care sales had edged up by 1.0%
to US$103 million, the firm pointed out, with
gains from new product launches. However,
this progress has been “partially offset” internationally by a poor performance in China.
Meanwhile, worldwide Oral Care turnover
Business Strategy
5
OTC COMPANY NEWS
Business Strategy
Business Strategy
estlé Health Science is investing US$70
million (C62 million) to open a research
and development facility in New Jersey, US, in
a move the firm claims will help it to develop
“innovative nutritional solutions”.
Scheduled to open in 2016, the Nestlé Product Technology Center (NPTC) would focus on
“applied research and innovative product development” and provide “technological knowhow in packaging”, the Swiss firm explained.
Greg Behar, chief executive officer of Nestlé
Health Science, said the investment reflected
the firm’s “commitment to leading the development of innovative nutritional therapies”.
The NPTC would use the “latest technologies” to “accelerate the quality and speed to
market of Nestlé Health Science’s innovations”,
Behar added.
Nestlé Health Science focuses on “deepening the role of nutrition in healthcare” and sits
alongside Nestlé Skin Health in the company’s
Nutrition and Health Science business unit.
S OTC genetic testing firm 23andMe has
secured US$115 million (C102 million) of
capital to help grow its presence in its domestic market and abroad.
Noting that the funds had been generated
during a recent round of financing, 23andMe
said the investment would enable the company
to “expand its operations and maximize the
potential of its direct-to-consumer product in
the US and abroad”.
23andMe currently markets an ‘at home’
genetic testing kit in Canada, the US, UK and
a number of other European countries. The kit
offers consumers access to health, ancestry and
genetic data.
However, the kit is sold in the US without
the health test component after the Food and
Drug Administration (FDA) in 2013 banned
this part of the product for violating the Food,
Drug and Cosmetic Act.
The firm revealed in May that it was “act-
Nestlé to open 23andMe gets investment
research facility to grow global operations
N
U
ively working” with the FDA to return the
health element of the kit to the market.
Expanding on its plans for the investment,
23andMe said the funding would help the company to launch a “new user experience” for the
kit, plus “enhanced tools and functionality by
the end of the year”.
“The financing will also provide capital for
strategic infrastructure,” 23andMe explained,
“including new laboratory space for therapeutic research and a next-generation sequencing
laboratory, as well as other investments in longterm growth.”
Andy Page, 23andMe’s president, said the
firm would use the investment to further its
“vision for long-term growth” in its consumer
and therapeutic businesses.
Page noted that earlier this year 23andMe
had achieved its initial goal to “reach and serve
one million individuals” and was now “focused”
on expanding further its customer base.
OTC
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N
G
ew Zealand’s AFT Pharmaceuticals has
revealed it is “considering” an initial public offering (IPO) to help the firm accelerate its
international growth.
Hartley Atkinson, AFT’s chief executive officer, said the “time was right” for the company
to consider an IPO and listing on the NZX Main
Board and the Australian Securities Exchange
(ASX) in order to raise capital and “embark
on the next phase of global growth”.
AFT exports prescription and OTC medicines – including the Histaclear allergy relief
product, Hylo-Forte eye drops, Maxiclear cold
and flu brand, and the Maxigesic analgesic –
to more than 40 countries worldwide and generated sales of NZ$76 million (C45 million)
in 2014.
“Raising new capital is really about taking
this business to the next level,” Atkinson explained, “and advancing our portfolio of innovative development products.”
Claiming that AFT was “set up to perform
well on the world stage,” Atkinson noted that
the firm had developed a “good track record”
in terms of product development, regulatory
approvals, licensing and distribution.
“Our first patented development product,
Maxigesic, is already approved and licensed in
multiple European countries,” Atkinson said.
AFT pointed out that a final decision on
launching the IPO had not yet been made, but
potential investors were able to register “preliminary indications of interest” with investment company First NZ Capital.
OTC
IN BRIEF
■ GLAXOSMITHKLINE (GSK) Consumer
Healthcare is investing US$11 million (C9.7 million) in expanding its manufacturing plant
in Buenos Aires, Argentina to increase production of its Corega denture care brand. Corega
– also known as Poligrip in some markets – was
GSK Consumer Healthcare’s biggest-selling
brand in Argentina, the firm noted, and was one
of the company’s seven global ‘power brands’.
Expanding the Buenos Aires site would allow
GSK Consumer Healthcare to produce 16 million tubes of Corega denture-adhesive cream
annually by 2017, the firm explained, to supply
10 markets across South America, including
Argentina, Brazil, Colombia and Venezuela.
OTC
enomma Lab is “always” seeking opportunities to acquire OTC and personal-care
brands to grow its presence in the US and
Latin America, according to the firm’s chief
executive officer Maximo Juda.
Speaking at a recent analysts’ day, Juda –
who was recently promoted from the position
of chief operating officer to lead Genomma
(OTC bulletin, 14 August 2015, page 27) – revealed that the Mexican firm was “always willing to take opportunities” to buy both OTC and
personal-care products to expand its portfolio.
Open to potential deals
While Genomma had no specific targets in
mind, Juda said the company was open to deals
that fitted with the firm’s strategy.
“When buying a brand, we will take into
consideration how that brand aligns with the
long-term strategy of the company and our existing portfolio,” Juda explained.
If an opportunity came along to acquire an
OTC or personal-care brand that had a “potential upside in terms of sales and margin”, Genomma would definitely consider it, Juda insisted.
“If a brand appears for two-times sales, is
a crown jewel, and makes a lot of sense for us
and our investors, we will consider it, analyse
it and then buy it,” he said.
As well as brand acquisitions, Genomma
would be interested in licensing products from
other companies if attractive opportunities came
along, Juda noted, adding that such deals would
be carefully “analysed” by the firm’s board.
While Genomma was looking to add brands
to its portfolio, the firm was not averse to offloading products that did not fit with the company’s plans, Juda noted.
“If a brand doesn’t make sense for us in the
long run we will engage in discussions to sell
that brand,” he explained.
Genomma’s OTC range includes the Alliviax
analgesic, Gargax sore-throat treatment, Nasalub nasal-spray and Oxigricol allergy brand.
The firm reported 2014 sales up by 1.6% to
MXN11.5 billion (C703 million) thanks to better
sales of both OTC and personal-care products.
Genomma is currently plotting its expansion
into Europe, and has plans to launch its OTC
and personal-care products into a small number
of markets in the region next year (OTC bulletin, 20 March 2015, page 1).
OTC
Oriola-KD hit by fine over Russian sale
O
riola-KD has been fined by the Helsinki
stock exchange for breaching the rules of
the exchange in connection with the sale of its
Russian businesses in December last year.
Issuing the Finnish firm with a C50,000 fine,
the Nasdaq Helsinki disciplinary committee said
Oriola had breached the rules “regarding the
obligation to maintain adequate administrative
procedures and to disclose corrected information in connection with the sale of its Russian
businesses without undue delay”.
Oriola had announced on 8 December 2014
it had completed the sale of the businesses to
Russia’s Pharmacy Chain 36.6 (OTC bulletin,
12 December 2014, page 9), the committee
pointed out, and had stated that it expected to
record a loss of C26 million related to the deal.
The committee noted that in a stock exchange
release almost two months later, on 2 February
2015, Oriola had revised the amount of the loss
to C147.7 million.
As a result, the amount of the estimated loss
disclosed by Oriola on 8 December had “proven
to be erroneous to a substantial degree”, the
committee insisted. From the “market’s perspective” the amount of the loss was “not insignificant”, it added.
“Detecting the final losses only in connection with the financial statement process, and
the materiality of the errors, prove that the financial administration of the company has not acted
in a sufficiently compliant manner,” the committee ruled.
Noting that the firm always aimed to “follow
all the rules of the exchange”, Oriola claimed
that the revised loss had been published “as
soon as the loss was verified in connection with
the annual closing process”.
The firm said it had already “implemented
corrective actions to avoid similar situations
in the future”.
OTC
7
OTC COMPANY NEWS
Valeant reports Boiron hit by lower sales
double-digit rise
in
key
European
markets
V
F
aleant Pharmaceuticals posted third-quarter sales up by 36% to US$2.79 billion
(C2.45 billion), driven by a double-digit gain
in its Developed Markets region.
In the Canadian firm’s Developed Markets,
turnover increased by 54% to US$2.32 billion.
Valeant said the rise was thanks to “strong
volume organic growth” across its OTC, dermatology and ophthalmology portfolios.
Noting that 85% of Developed Markets
sales had been generated in the US, Valeant
commented that it had enjoyed “exceptional
growth” in the country during the three months.
Sales in the US had jumped by 81% to US$1.97
billion, the company noted, driven by the performance of its dermatology products and the
Bausch & Lomb eye-care business.
Valeant snapped up global eye-health specialist Bausch & Lomb from private-equity
firm Warburg Pincus in 2013 in a deal that
gave the Canadian firm a number of prescription and non-prescription pharmaceuticals and
a wide-ranging vision-care portfolio (OTC bulletin, 31 May 2013, page 1).
Meanwhile, Valeant’s growth in the thirdquarter was held back by the performance of
its Emerging Markets region.
Turnover had slipped back by 15% to
US$466 million in Emerging Markets, Valeant
noted, due to a “difficult” quarter in Russia.
The Russian business had been hit by the
“economic slowdown” of the country’s pharmaceutical market, Valeant explained, as well
as the “sharp drop” in the value of the rouble
versus the US dollar.
On a more positive note for its Emerging
Markets business, Valeant said its operations
in China had continued to perform well, with
the company seeing “very strong growth” in
the three months.
OTC
IN BRIEF
■ MYLAN has made a fresh appeal to Perrigo’s, shareholders restating its intention to
run the company as a subsidiary if it takes control of 50% or more of the firm’s shares but is
unable to gain over 80%. Mylan launched its
formal offer to the Perrigo shareholders on 14
September (OTC bulletin, 11 September 2015,
page 3) and has since attempted to convince
them of the merits of the deal.
OTC
8
rench homoeopathy specialist Boiron reported turnover down by 2.4% to C168 million in the third quarter of 2015, as sales fell
in a number of its key European markets.
Sales in Europe, excluding France, had
dropped in the three months by 19.4% to C50.6
million, Boiron pointed out, due “mainly” to the
firm’s performance in Russia. Turnover in the
region had also been held back by lower sales
in both Italy and Poland, the company added.
Sales in Other countries also declined in the
period, slipping back by 4.9% to C3.59 million
(see Figure 1).
On a more positive note, Boiron said that
Business
sales in France had increased by 5.7% to C97.8
million, while turnover in North America had
jumped by 22.5% to C16.1 million.
Turning to the firm’s performance by product
category, Boiron said sales by its OTC Specialities had fallen by 4.7% to C94.3 million.
The majority of the company’s turnover
came from its non-proprietary homoeopathic
medicines, with sales of these products moving
forward by 1.0% to C73.7 million.
Commenting on the firm’s strategy for its
homoeopathic products, Boiron said it was committed to continuing its “involvement in the development of homoeopathy around the world”.
Third-quarter sales
(C millions)
Change 2014/2015
(%)
Proportion
of total (%)
France
Europe*
North America
Other countries
97.8
50.6
16.1
3.6
+5.7
-19.4
+22.5
-4.9
58
30
10
2
Total Boiron
168.0
-2.4
100
OTC Specialties
Non-proprietary
Other
94.3
73.7
0.03
-4.7
+1.0
-80.8
56
44
>1
* Excluding France
Figure 1: Breakdown of Boiron’s sales in the third quarter of 2015 (Source – Boiron)
OTC
Licensing Agreements
Probi set to expand reach in Asia-Pacific
P
robi is set to grow the reach of its probiotics in South Korea, after signing a licensing deal with Seoul Milk.
Under the terms of the agreement, Probi said
its Lactobacillus plantarum 299v probiotic strain
would be included in Seoul Milk’s product
range by the end of the year.
Noting that Seoul Milk was the largest supplier of milk products in Korea, Probi pointed
out that the firm’s portfolio also included fruit
juices and “other types of beverages”.
Peter Nählstedt, Probi’s chief executive officer, said the company was “looking forward to
the first launch of a food product containing
Probi’s probiotics in the important and growing Asia region”.
“We are increasing our business development activities in functional food,” Nählstedt
explained, “and Asia-Pacific, with its high con-
sumer acceptance for probiotics, is a very interesting area for expansion.”
Nählstedt pointed out that Probi had already
established, through its partners, a presence
in the Korean dietary supplements market.
In April last year, Probi signed up Korea’s
Dongkook Pharmaceutical to launch its guthealth probiotic Probi Mage in the country
(OTC bulletin, 11 April 2014, page 9).
Later that month, Probi secured a deal with
Sanofi to add its Probi Digestis probiotic to
the French firm’s Cenovis vitamins minerals
and supplements brand in Korea (OTC bulletin,
25 April 2014, page 3).
Speaking at the time of the deal, Nählstedt
noted that with a market value of around US$54
million (C47 million), Korea was now the thirdlargest probiotic supplements market in Asia.
OTC
GENERAL NEWS OTC
Regulatory Affairs
ASMI wants better codeine measures
R
eclassifying all OTC medicines containing
codeine to prescription-only status in Australia will not adequately address issues of misuse and addiction, according to the Australian
Self-Medication Industry (ASMI).
Responding to a proposal to reverse-switch
all OTC codeine medicines by the country’s
Therapeutic Goods Administration (TGA) earlier this month (OTC bulletin, 9 October 2015,
page 1), the ASMI said that only a package of
“targeted measures” would find the “correct
balance” between the risks and benefits of access
for the vast majority of consumers who used the
medicines “safely and effectively”.
In its supplementary submission to the Federal government, the ASMI also argued for the
decision on rescheduling OTC codeine to be
deferred for 12 months to “allow time for the
implementation and impact assessment of a
real-time monitoring system in pharmacy”.
Steve Scarff, the ASMI’s director of regulatory and scientific affairs, said such a system
would help pharmacists to determine if supply of
a codeine-containing medicine was appropriate.
Furthermore, real-time monitoring would
help pharmacists to “identify at-risk consumers,
facilitate access to educational material, and
support referral to a pain specialist when necessary”, he claimed.
“The industry and consumer groups have
jointly developed a prototype,” Scarff revealed,
“which could be quickly implemented in community pharmacies nationally.”
Ideally, this system would form part of a
package of measures, he continued, including
front-of-pack warnings about the risk of codeine addiction, training for pharmacists and
information for consumers.
“This conclusion applies equally well to the
products intended for treating coughs and colds,
and those intended for the treatment of pain,”
the agency explained.
A final decision on the scheduling of OTC
codeine products is set to delivered in “late
November 2015”.
“The earliest possible implementation for
any final decision is from 1 June 2016,” the
agency pointed out. “The availability of any
OTC products containing codeine will not change
before then,” it added.
Move codeine to schedule 4
Announcing its review of codeine in April,
the TGA said it was inviting comments on its
proposal to delete the current schedule 3 – or
pharmacist-only – entry for codeine and reschedule the medicine as a schedule 4, or prescription-only, product.
The agency noted that it had been prompted to act by “potential issues of morbidity, toxicity and dependence”.
Concerns over the safety of codeine have
not been limited to Australia, with regulators in
Europe and the US recently conducting reviews
of the medicine.
Cough and cold medicines containing codeine are currently under investigation by the
US Food and Drug Administration (FDA) due
to the potential for serious side effects – including slowed or difficult breathing – in children
aged under 18 years (OTC bulletin, 24 July
2015, page 11).
The FDA announced the safety assessment
shortly after the European Medicines Agency’s
(EMA’s) Coordination Group for Mutual Recognition and Decentralised Procedures – CMDh –
supported recommendations by the agency’s
Pharmacovigilance Risk Assessment Committee
(PRAC) that children and adolescents between
12 and 18 years who had breathing problems
should not use codeine as a cough or cold treatment (OTC bulletin, 1 May 2015, page 10).
The CMDh also backed the PRAC’s recommendation that codeine should not be used to treat
coughs and colds in those aged under 12 years.
OTC
Call for impact assessment
In its submission, the ASMI also called for
a “comprehensive examination of the impacts
of the scheduling decision in the form of a Regulation Impact Statement”, along with a “reform
of the current Scheduling Policy Framework to
address its well-documented limitations”.
The TGA made its proposal after conducting a review of the scheduling of codeine in
Australia – announced in April (OTC bulletin,
17 April 2015, page 12) – and claiming that codeine appeared to be “an unsuitable candidate
for OTC availability”.
The recommendation was based on an “assessment of many issues”, the regulator said, “including risk of dependence and adverse events,
compared to safer products also available OTC”.
9
OTC GENERAL NEWS
Regulatory Affairs
Foreign traditions
challenge HMPC
H
armonised standards for all traditional
medicines sold in the European Union
(EU), regardless of origin, are needed “to protect public health”, according to Werner Knöss,
chair of the Herbal Medicinal Products Committee (HMPC) of the European Medicines
Agency (EMA).
Knöss told a recent meeting of the EMA’s
management board that traditional medicines
of non-European origin were presenting challenges for the HMPC.
“Chinese and Indian herbal substances are
already a reality in the EU market,” Knöss
pointed out. “We need harmonised standards
to protect public health and the Committee is
working towards this aim.”
Commenting on the HMPC’s recent work
in this area, Knöss noted that working party
discussions had been held during the first half of
2015 on setting European standards for herbal
combination products originating from nonEuropean traditional systems – including standards for tea combinations – with these talks expected to continue in the second half of the year.
In addition, a meeting of the EU-India joint
working group had been held in May, Knöss
explained, which had led to an agreement to invite an expert in the field from India to attend
an HMPC meeting at the end of 2015 or the
beginning of 2016.
Earlier this year, Knöss admitted that the rise
in popularity of traditional medicines could pose
problems, especially around definitions of traditional use and how these products were distributed (OTC bulletin, 12 June 2015, page 11).
Addressing delegates at the 51st Annual
Meeting of the Association of the European
Self-Medication Industry, the AESGP, in Barcelona, Spain, Knöss said that there were many
areas to discuss, including the transfer of product indications and access to supporting data.
Furthermore, the HMPC had to consider how
much these treatments were designed to support
self-medication, Knöss explained.
“The starting point for using a traditional
Chinese medicine (TCM) or an Indian Ayurvedic product is normally a very careful diagnosis by a specialist,” he noted. This was followed by a “very individual prescription”.
Despite these questions, the HMPC’s basic
position was clear, Knöss pointed out, and that
was that these products had to meet the same
standards as any herbal medicinal product valid
in the EU.
OTC
10
Trade Associations
PAGB lends its support
to NHS winter campaign
T
he Proprietary Association of Great Britain
(PAGB) – the UK OTC industry association – has partnered with National Health Service (NHS) England and Public Health England on a national campaign to educate people
on staying healthy this winter.
‘Stay Well This Winter’ was the theme of the
campaign, PAGB explained, which would communicate messages on using NHS services appropriately. It would encourage people to visit
a pharmacist for winter ailments, and promote
the flu vaccination service pharmacies offer.
John Smith, PAGB chief executive, said the
association was “delighted” to be a partner in
the campaign, which would “deliver a clear message to people about self-care and managing
winter ailments”.
Speaking to OTC bulletin earlier this year,
Smith – along with Helen Darracott, his deputy
chief executive – revealed that the association’s
focus in the three years ahead of its centenary
in 2019 would be on ensuring that the British
public were receiving a “consistent, single message on self-care” from the UK government
down (OTC bulletin, 14 August 2015, page 15).
Pointing out that one message “consistently
delivered at the national and local level” was
more effective than “numerous different” campaigns trying to communicate the same point,
Smith said PAGB was not running the ‘Treat
Yourself Better’ campaign this year.
Launched in 2013 with community pharmacy association Pharmacy Voice, the Treat
Yourself Better campaign initially urged people to self-treat winter ailments, rather than
using antibiotics prescribed by a doctor (OTC
bulletin, 29 November 2013, page 17).
This was adapted last year to encourage
consumers suffering with colds and flu to “treat
yourself better with pharmacist advice” (OTC
bulletin, 10 October 2014, page 13).
Instead, Smith explained, PAGB had been
working with Public Health England to ensure
the experience and lessons from Treat Yourself Better had “informed the development”
PAGB has partnered with NHS England and Public
Health England for the ‘Stay Well This Winter’ campaign
PAGB has developed a leaflet that offers advice on
common winter ailments as part of the ‘Stay Well
This Winter’ campaign in association with NHS
England and Public Health England
of the Stay Well This Winter campaign.
The association had also created a leaflet
– entitled ‘When will I feel better?’ – Smith
pointed out, to explain how long people could
expect cough and cold symptoms, including
sore throats and nasal congestion, to last.
In addition, the leaflet outlined what consumers could do to feel better, Smith said, as well
as highlighting the warning signs that meant
they might need to seek professional advice.
PAGB member companies would be encouraged to “get behind the campaign and increase
its reach”, Smith added, by using the supporting Stay Well This Winter logo in advertising
and marketing materials for relevant products.
OTC
IN BRIEF
■ CASH-BACK COUPONS and on-pack
promotions for OTC medicines should be
banned by German legislators, according to
the country’s pharmacists. Noting the increasing prevalence of such offers, German pharmacists during their Expopharm convention passed
a resolution that alleged such promotions trivialised medicines and triggered purchase impulses that “undermine the professional health
duties of pharmacists”.
OTC
GENERAL NEWS OTC
Market Research
US slow to adopt digital health tech
D
espite the need for consumer engagement
in healthcare having never been higher,
nearly half of all Americans have used only
one, or have never used any, of the services
available across the major consumer digitalhealth categories, according to a new survey
from Rock Health.
Questioning 4,017 internet-connected adults,
the survey covered six main categories of consumer digital health: online health information;
online health reviews; mobile health tracking;
wearables; genetic services; and telemedicine.
Most Americans – 80% – had used at least
one of the digital-health categories studied for
the survey, the US-based venture capital company pointed out, but 48% of people – dubbed
‘non-adopters’ – had used zero or just one of
the technologies listed.
At the other end of the spectrum, only 2%
of people had used five or six of the technologies and could be referred to as ‘super-adopters’, Rock pointed out.
While these figures might initially seem to
be low, Rock claimed that the slow rate of adoption and lack of an “iconic company” in the
consumer digital-health space represented “one
of the largest opportunities” in the digitalhealth arena.
Searching online for health information was
the most well-adopted digital-health category,
the firm noted, with 71% of people using the
internet to search for information on prescription drugs, diagnosis, dietary supplement products or treatment options (see Figure 1).
Six out of 10 people had searched for information on prescription drugs, the survey found,
making it the highest-ranked search category,
while just under half had searched for treatment options (see Figure 2).
SEARCHED FOR INFORMATION (%)
Prescription
drugs
Information about prescription drugs
or side effects
Diagnosis
57%
A diagnosis based on your symptoms
52%
Information about
dietary supplements
Treatment
options
Online health reviews
Historical use of online or mobile
resources to find reviews of
healthcare services
Mobile health tracking
Current use of a mobile health
application to track one or more
health-related factors
Wearables
Ownership of wearable
devices that help track key
health-related factors
Genetic services
Consumer-driven historical use of
genetic-based services including
family planning and personal DNA
Telemedicine
Historical use of video-based
technologies to receive medical
care or advice from a
healthcare professional
Figure 1: The top-six categories in the US consumer digital-health space in terms of popularity (Source – Rock Health)
The survey also asked whether those that
had searched for health information online had
presented their findings to their physician, or in
the case of supplements had purchased, or discontinued use of, a product.
About 40% of people who had searched had
taken action, the company noted, with 45% of
those who had sought an online diagnosis presenting it to their doctor.
Those taking action, represented approximately 15%-20% of the US adult population and
could be described as “highly-activated consumers, hungry for information and confident enough
to discuss it with their doctors”.
However, there was still “significant work
to be done by health information websites” to
fully convince consumers to trust them, Rock
pointed out, as people still ranked health websites, mobile health apps and social-media/online communities behind physicians and family/friends when it came to trustworthiness.
49%
Treatment options based on
your diagnosis
Asked his or her physician to
prescribe a specific drug or asked
to discontinue taking a specific drug
OTC
Be active
65%
Lose weight
Proposed own diagnosis of his or
her physician
Purchased or discontinued use
of a dietary supplement
Proposed a treatment to
your physician
Figure 2: Breakdown of health-related internet searches carried out by US consumers along with a breakdown of
the most popular uses of this information for each search (Source – Rock Health)
Looking at some of the less well-adopted
areas of consumer digital health, Rock’s survey found that of the 12% of respondents who
said they had a wearable health device, threequarters had only begun using the product in
the past 12 months.
Nearly two-thirds of individuals with wearables had purchased them for themselves, the
company pointed out, with most citing becoming more active or losing weight as the primary
reasons for purchasing wearable digital-health
devices (see Figure 3).
There was also a shift in who was buying
these products, Rock noted. Those that had purchased a wearable in the past three months were
more likely to be less healthy than early adopters and were more likely to have been hospitalised in the previous 12 months, the firm
said, countering the “popular narrative of only
healthy individuals purchasing wearables”.
ACTED UPON INFORMATION (%)
As a percentage of those who had sought information
60%
Supplements
Online health information
Historical use of online or mobile
resources to search for specific
health topics
42%
As an
experiment
Improve sleep
Social reasons
25%
21%
14%
Figure 3: Reasons for consumers purchasing wearable
digital-health devices (Source – Rock Health)
11
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OTC MARKETING NEWS
Product Launches
Vicks makes its debut in
“connected health space”
T
Italian pharmaceutical firm Angelini has bolstered its
Juanola Jalea Real (Royal Jelly) range in Spain with
two food-supplement syrups for children.
Both royal jelly-based syrups – an option for
immune-system support and a variant to stimulate
appetites – are suitable for those aged from two years.
Juanola Jalea Real Vitalidad Y Defensas combined
royal jelly, echinacea, propolis and prebiotics to
“reinforce” the body’s natural defences, the firm
pointed out, while Juanola Jalea Real Apetito was
formulated with royal jelly, propolis, B vitamins and
vitamin D, as well as quinine, to stimulate the desire
to eat in those with reduced appetites.
Angelini noted that the recommended dosage for
both syrups was 5ml a day for children aged between
two and five years, while this was doubled in those
aged over five.
The Juanola Jalea Real range also includes Plus,
Energy Plus and Defences options.
Other products available under the wider
Juanola brand umbrella include herbal candies and
liquorice-based pastilles, as well as the Propolis
range of lozenges, mouth sprays and syrups.
OTC
he Vicks decongestant brand has entered
into the “connected health space” for the
first time through the US launch of a SmartTemp wireless smartphone thermometer.
Manufactured and distributed under licence
from Procter & Gamble (P&G) by Kaz – a
subsidiary of US consumer products firm Helen
of Troy – the Bluetooth-enabled Vicks SmartTemp thermometer is said to make it easier for
parents to “take and track temperature readings
for the entire family” when used alongside the
Vicks SmartTemp app.
The thermometer took “professionally accurate” oral, rectal or under-arm readings in eight
seconds, Kaz claimed, which were automatically
sent via Bluetooth to the user’s Apple or Android device to help parents “monitor the progress” of their child’s fever.
Individualised profiles could be created for
each family member to “store their detailed
temperature history”, the company noted. Other
features of the app included ‘Fever InSight’
guidance – which turned the smartphone screen
a different colour depending on the thermometer’s reading – and a symptom tracker, Kaz
Readings from the Vicks SmartTemp thermometer
are sent to mobile devices via Bluetooth
explained, while users could also set up reminders to recall the last temperature reading
or medicine dosage.
Temperature readings and symptoms could
also be exported via email for “simple sharing”
with medical professionals, the firm noted.
Available nationwide in “major pharmacy
and baby retailers” – including Toys R Us –
Vicks SmartTemp has a recommended retail
price of US$24.99 (C21.99).
Helen of Troy also holds the rights to manufacture and market in the US the Vicks VapoPads and VapoSteam products.
OTC
Marketing Campaigns
GSK teams with X Factor in Australia
A
A giant anthropomorphic smiling strawberry is the
bold image that Ipsen has chosen to promote its new
strawberry flavour of diarrhoea treatment Smecta.
Accompanied by a slogan announcing that “the
new strawberry flavour has arrived!”, pharmacy-press
advertising for Smecta Fraise also sets out the
indications of the diosmectite-based remedy, which can
also be used to treat painful symptoms associated
with oesophageal-gastric and intestinal diseases.
Smecta Fraise is available in 3g packs of 12
powder sachets to be diluted in water before use.
Infants under one year of age suffering from
diarrhoea should use two sachets per day for three
days, followed by one sachet per day. For older
children, this should be raised to four sachets per day
for three days followed by two sachets, and for adults
around three sachets per day.
OTC
14
ustralians have the opportunity to win
A$300,000 (C190,000) through GlaxoSmithKline’s (GSK’s) sponsorship of television
show the X Factor to promote its Panadol
Rapid analgesic.
To enter the “achieve your dreams faster”
competition – which ends on 20 November –
consumers should watch the show to discover
a nightly code word that appears during the
programme, the firm explained.
This code word can then either be submitted
via the Panadol Australia Facebook page; the
official X Factor Australia website; through an
Singer and X Factor judge Dannii Minogue is
promoting the “achieve your dreams faster”
competition on television and through social media
online smartphone page; or by text message.
Eight winners would receive a A$500 ‘Wish’
gift card for the retail group Woolworths, as
well as an entry into the grand prize draw.
For extra chances to win, GSK noted, potential entrants could purchase from Woolworths
a pack of Panadol Rapid, which combines
500mg paracetamol with sodium bicarbonate
per caplet, and is claimed to be absorbed twice
as fast as regular Panadol tablets.
By entering the code on the pack – along
with the last two digits of the Woolworths purchase number – via text or online, entrants have
the opportunity to win one of 100 ‘Wish’ gift
cards worth A$1,000. One winner would also
be entered into the grand prize draw.
Television advertisements featuring singer
and X Factor judge Dannii Minogue were currently running exclusively on Channel 7 – which
airs the X Factor show – to promote the competition, GSK pointed out.
OTC
MARKETING NEWS OTC
Product Launches
Product Launches
Luminarie set to Sanofi promotes Doliprane
launch PoxClin for French self-medication
L
S
uminarie is set to enter the A$13 million
(C8.2 million) Australian OTC anti-itch
market with the PoxClin Sensitive duo product
for chicken pox in children.
Scheduled for launch on 1 November, PoxClin Sensitive combined the original CoolMousse – which is already available in markets
including Spain, Russia and the UK – with a
gel for use on more sensitive areas such as the
face, the Australian firm explained.
A class 1 medical device, PoxClin sensitive
is said to provide “rapid relief” from symptoms
such as irritation, itching and sensitivity by
cooling, soothing and moisturising the skin.
The CoolMousse’s ‘2QR complex’ – a “patented bacterial blocker” derived from the aloe
barbadensis plant – is also said to prevent secondary infection and scarring on scratched skin.
The mousse should be applied three times
daily or whenever relief was needed, Luminarie
said. One drop of gel should be applied to a
sensitive area once the mousse had evaporated,
the firm added, to provide further relief.
Luminarie said it would spend A$50,000
over the next 12 months to promote PoxClin
Sensitive, with marketing activity scheduled to
begin in November.
“Because itching is not fun” would be the
tagline of the campaign, the company pointed
out, which would include a collaboration with
online parenting community bubhub.com.au.
This partnership would encompass blogs
and posts on the Bubhub Facebook page and
inclusion in newsletters to Bubhub members.
PoxClin Sensitive would also be promoted
in pharmacy catalogues and through consumer brochures at the point of sale, Luminarie
noted, as well as through the brand website,
poxclin.com.au, and communications to schools
and day-care centres.
Luminarie told OTC bulletin it aimed to
sell 40,000 units within the first year of PoxClin Sensitive’s launch, equating to turnover
of around A$500,000.
The firm obtained the marketing and distribution rights to the PoxClin brand in Australia
and New Zealand in May this year from Netherlands-based YouMedical, which itself was recently acquired by Swedish OTC firm Trimb
(OTC bulletin, 11 September 2015, page 4).
PoxClin Sensitive would be available in
New Zealand from the first quarter of 2016,
Luminarie revealed.
OTC
anofi’s Doliprane paracetamol-based pain
remedies have been launched in France as
a non-reimbursable range of self-medication
treatments. The non-reimbursable line would
“complement the existing reimbursable range”,
Sanofi noted, adding that the reimbursable Doliprane range was more geared towards sufferers
of chronic pain requiring long-term treatment.
Comprising eight presentations of Doliprane,
Sanofi’s non-reimbursable self-medication line
includes 1g and 500mg tablets and 500mg orodispersible tablets, as well as tablets including
500mg paracetamol with 150mg vitamin C and
paracetamol/codeine 400mg/20mg tablets. The
range also includes 1g capsules, along with sachets of 200mg and 300mg sugar-free oral suspension under the Doliprane Liquiz name.
Retail prices including tax for these presentations are C1.94 for 16-tablet packs of the
500mg tablets and for eight-count packs of the
1g tablets or 1g capsules; C2.45 for 12 orodispersible tablets or 16 tablets with vitamin C;
C3.45 for the oral suspensions; and C3.95 for
the tablets that include codeine.
Five of the eight presentations – all except
the oral suspensions and tablets containing codeine – are available for self-selection through
France’s ‘free access’ scheme (OTC bulletin,
31 July 2008, page 17).
Insisting that the presentations were “adapted to patients’ needs”, Sanofi said the liquid
sachets were easily portable while the film-
Sanofi’s non-reimbursable Doliprane range includes a
liquid suspension and 1g capsules
coated tablets helped to “reduce the bitterness”
of paracetamol. “Self-medication is the first
step for patients in taking care of pain,” the
French company stated.
Isabelle Van Rycke, director of Sanofi Consumer Healthcare in France, said the new range
“responds to the desire of patients to become
more active in managing their own health”.
While the introduction reinforced “Sanofi’s
support for responsible self-medication”, she
insisted, the company was still committed to
helping doctors treat chronic pain through its
reimbursable range.
Emphasising that patient safety was the “number-one priority for Sanofi”, the company said
it was issuing guidance aimed at the general
public to inform them of the correct use of
paracetamol for pain management, including
a brochure to be distributed through pharmacies and a dedicated website.
OTC
Marketing Campaigns
Hypermarcas enlists chef for Vitasay push
C
elebrity chef Olivier Anquier is the star of
Brazilian firm Hypermarcas’ latest domestic television campaign for its Vitasay Stress
multivitamin supplement.
The 30-second spot showed Anquier travelling the world in search of ingredients for his
dishes, Hypermarcas said, to highlight that “even
enjoyable activities can lead to physical and emotional exhaustion that needs to be treated”.
Targeted at consumers aged over 30 years,
the spot signed off with the message: “Vitasay,
sua dose diária de vitalidade”, or “vitasay, your
daily dose of vitality,” the firm pointed out.
The television campaign would run until the
end of November 2016, Hypermarcas noted.
It would be supported by online content on
Facebook and Instagram from next month,
the company added.
There would also be print advertisements in
“major magazines”, the firm said, as well as
radio jingles and out-of-home advertising.
Meanwhile, Hypermarcas has created a
social-media presence for its Doril acetylsalicylic acid-based analgesic brand with the launch
of a DorilOficial page on Twitter.
The company said it had “identified an opportunity” to “reinforce the brand’s presence”
with a more light-hearted and relaxed approach
and language.
OTC
15
OTC MARKETING NEWS
Product Launches
Sanofi launches
DioraleZe caps
S
anofi is leveraging the strength of its Dioralyte rehydration brand in the UK with
DioraleZe capsules, the local firm’s first antidiarrhoeal medication.
Containing 2mg loperamide hydrochloride
per capsule, the product is said to stop the symptoms of diarrhoea in one dose.
The general-sale list (GSL) capsules will
take on established brands in the UK market
such as McNeil’s Imodium, Reckitt Benckiser’s
(RB’s) Diocalm and Galpharm’s Entrocalm.
Suitable for those aged 12 years, DioraleZe
joins the existing Dioralyte and Dioralyte Relief rehydration powders, along with the Oralyte hydration drink.
The capsules could be taken with the standard Dioralyte sachets to aid a faster recovery
time, Sanofi pointed out.
A consumer media and digital advertising
campaign would begin in 2016 to back the
launch of DioraleZe, the firm revealed.
In the meantime, the capsules were being
Sanofi is promoting DioraleZe alongside its Dioralyte
rehydration powders at the point of sale
supported through “detailing to healthcare professionals” and “strong” public-relations activity, Sanofi explained, as well as point-of-sale
materials that promoted both DioraleZe and
Dioralyte together.
The main message to consumers was that
they could “stop diarrhoea with DioraleZe and
rehydrate with Dioralyte”, the company said.
In addition, a brand website, dioraleze.co.uk,
had been launched, Sanofi noted, which also
featured the Dioralyte range.
DioraleZe has a recommended retail price
of £3.49 (C4.74) for a pack of six capsules.
OTC
IN BRIEF
■ POHL-BOSKAMP has extended its sponsorship of German football team FC St Pauli
to include promotion for its GeloRevoice Halstabletten medical device lozenges.
OTC
16
Product Launches
Infirst Healthcare prepares
to launch UniCough in UK
I
nfirst Healthcare is set to make its debut in the
European consumer healthcare space next
month with the UK launch of its UniCough
chocolate-flavoured cough liquid.
Scheduled for launch in Boots and independent pharmacies, the pharmacy-only (P), “cocoarich” oral solution contains 135mg ammonium
chloride, 14mg diphenhydramine hydrochloride
and 1.1mg levomenthol per 5ml.
Indicated for the symptomatic relief of common coughs associated with upper respiratory
tract congestion, UniCough’s “unique” cocoa
formulation formed a “soothing film over the
mucous membrane” in the buccal cavity and
throat, noted Manfred Scheske, the firm’s chief
executive officer, adding that it could help prevent sleep disruption.
UniCough was a “special product” in the
crowded UK cough and cold market, Scheske
pointed out, as it had been clinically proven to
reduce cough frequency “versus an active comparator product”.
Claiming that there was a general lack of
evidence regarding consumer cough and cold
products, Scheske said the firm – which has
recently received £13.2 million (C11.6 million)
in funding from Invesco Asset Management –
was “spending way more money upfront” on
“intense development and regulatory work”
than anybody else to create products backed
by clinical evidence.
Although Scheske would not comment on
marketing plans for UniCough, he said Infirst
had worked “very hard” on developing a “superior product” and would be “very focused” on
making sure that both pharmacists and consumers were aware of the supporting evidence.
Also launching ibuprofen capsules
Scheske added that the UK would also be
the first market to see the launch of the firm’s
Flarin 200mg ibuprofen soft-gel capsules, following the results of a clinical trial.
Like UniCough, Flarin had been derived
from Infirst’s “portfolio of patented technologies”, Scheske noted.
Formulated in the company’s patent-protected “lipid excipient matrix”, Flarin – also a P
product – was expected to be introduced “in the
first half of 2016”, he pointed out, and would
be positioned for the relief of rheumatic or muscular pain, as well as pain caused by “nonserious arthritic conditions”.
UniCough’s cocoa-rich formulation is said to be
clinically proven to reduce cough frequency
The firm’s focus on science-backed offerings
would set the company apart from its competitors, Scheske maintained, although he said
Infirst was “focusing more on execution than
from whom we’ll be taking market share”.
“We cannot compete with the big players
in terms of budgets or shelf space – nor do we
intend to,” Scheske insisted. “We need to make
sure that we operate in smaller markets and with
products that are actually backed by evidence.”
Infirst had started “regulatory and geographical expansion into Europe” for Flarin, he noted,
pointing out that it already had licences in Scandinavian markets and Holland.
The UK was a “prototype” of sorts, Scheske
said. “We want to make sure that we get the
first market right and then apply the model in
other countries.”
Turning to the US – where Infirst made its
global debut last year with the Dr Cocoa chocolate-flavoured cough-remedy brand for children
(OTC bulletin, 15 August 2014, page 19) –
Scheske said the company’s reinvigoration of
Johnson & Johnson’s digestive-health brands
Mylanta and Mylicon was also underway.
Infirst agreed a fixed-term licensing deal
earlier this year for Mylanta and Mylicon, which
had been absent from the market while Johnson
& Johnson dealt with a number of manufacturing issues which led to the bulk of its US
OTC portfolio being withdrawn (OTC bulletin, 20 March 2015, page 3; OTC bulletin,
17 March 2011, page 1).
Mylicon had returned to shelves in July,
Scheske noted, while the Mylanta liquid antacid was set to be relaunched in early 2016.
Both brands were “extremely well known”
and still had “quite strong residual awareness,
loyal followers and lots of professional endorsement”, Scheske insisted.
OTC
MARKETING NEWS OTC
Product Launches
Covonia grows with hot dose variant
A
cough and cold syrup positioned to be
taken hot at night is the latest addition
to Thornton & Ross’ Covonia cough-remedy
brand in the UK.
Containing 20mg dextromethorphan hydrobromide and 30mg diphenhydramine hydrochloride per 15ml, Covonia Hot Dose Cough &
Cold Syrup is said by the company to provide
“night-time relief for troublesome dry cough
and congestion from colds” in consumers aged
over 12 years.
Noting that a Night Time formula with the
same active ingredients was already available
under the Covonia brand umbrella, Thornton
& Ross said the new pharmacy-only (P) Hot
Dose option was intended to be mixed with
15ml hot water, rather than taken as a syrup
alone, to provide the “warm comfort that some
consumers desire”.
Covonia Hot Dose Cough & Cold’s syrup
format meant the product fully dissolved when
mixed with hot water, the firm added, rather
than leaving “unpleasant granules” at the bottom
of the cup, which could “sometimes happen
with powder sachets”.
The 30ml dose should be consumed “within
10 minutes for the full effect” and could be repeated after six hours if required, pointed out
Thornton & Ross, which was acquired by Germany’s Stada in 2013 (OTC bulletin, 23 August 2013, page 1).
Covonia Hot Dose Cough & Cold would be
supported as part of an overall marketing campaign for the brand worth over £4 million (C5.4
million), the firm said. This would feature “elements of the entire Covonia range”.
The range comprises a range of syrups, as
well as lozenges and a throat spray.
Marketing activity would include a national
television commercial that would air from November, Thornton & Ross pointed out, as well
as online advertising. This would include the
CovoniaUK Facebook page and brand website feelitworking.com.
Public-relations activity would place a “big
Thornton & Ross says 15ml of Covonia Hot Dose Cough
& Cold Syrup should be mixed with 15ml of hot water
focus” on the Hot Dose line extension, which
would be supported further through “ongoing
outreach with health and lifestyle publications”,
the company added.
Covonia Hot Dose Cough & Cold has a
recommended retail price of £5.49 for 150ml.
OTC
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A clear nose in less than three minutes is the
promise behind GlaxoSmithKline (GSK) Consumer
Healthcare’s latest extension to its Otriven
nasal-spray range in Germany.
Otriven Meerwasser mit Eukalyptus is said to
contain “100% pure sea water” from the French
Atlantic coast that includes minerals and trace
elements as well as eucalyptus for a fresh fragrance.
GSK says the spray has a “natural decongestant”
effect through its 2.2% salt content and helps to
remove excess mucus from the nose.
A 20ml bottle of Otriven Meerwasser mit
Eukalyptus has a recommended retail price of C6.25.
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OTC
17
OTC MARKETING NEWS
Line Extensions
Dolormin capsules aim to
relieve pains in the neck
A
“Still got it! Perfect!” is the strapline of Merck KGaA’s
UK print campaign for its recently-expanded Perfect 7
anti-ageing supplement range.
Featuring two glamorous older women taking a photo
of themselves, the advertisement includes the original
Perfect 7 product and recently-launched Prime variants.
The campaign was running in women’s monthly
consumer magazines such as InStyle, Good
Housekeeping, and Prima, the firm pointed out, as
well as in weekend supplements of newspapers, such
as Guardian Weekend, Stella and You.
Pointing out that the original Perfect 7 – launched
last year (OTC bulletin, 24 October 2014, page 20) –
had been created for men and women to tackle the first
signs of ageing and catered for their different needs
as they got older, the company said Perfect 7 Prime
addressed a “key need” of “mature” consumers, which
was an improvement in mental cognitive function.
The range – which also comprises separate
gender-specific formulas – did this, Merck claimed, by
combining natural-source marine oil with omega-3 and
ginkgo biloba, as well as zinc, in a one-a-day capsule.
Both Prime products also contain folic acid for
energy and vitamin B12. The variant for men contains
selenium for immunity, and the version for females is
formulated with iodine to “help maintain normal skin”.
Pointing out that the Prime variants were
available exclusively in Boots until March 2016,
Merck said the differences between the two Perfect
7 ranges would be highlighted in store.
OTC
rock singer who is determined to continue
the show despite a sore neck is the star of
a launch television campaign for Dolormin
400mg Weichkapseln soft-gel capsules, the latest addition to Johnson & Johnson’s ibuprofenbased analgesic brand in Germany.
Launch trade-press advertising depicts the
rock star grimacing above a banner that proclaims the liquid-filled capsules, each containing 400mg of ibuprofen, are a new treatment
for muscle pain that ensures “the show goes on”.
Johnson & Johnson claims the line extension is Germany’s “first ibuprofen soft-gel capsules for muscle pain”. The company says the
analgesic offers relief from muscle pain such
as stiff necks for up to eight hours.
The pharmacy-only medicine’s liquid formulation, Johnson & Johnson states, “allows
absorption into the body twice as quickly as
classic ibuprofen”.
A dolormin.de website includes a video of
exercises to alleviate aching necks and shoulders, in addition to advice leaflets to download.
Johnson & Johnson is also providing pharmacy staff with online product training.
OTC
18
Predominantly green and white, Dolormin
400mg Weichkapseln packs carry a strapline
stating that the medicine is for both headaches and muscle pain. The medicine is indicated for adults and children weighing over
40kg or older than 12 years.
A pack of 10 Dolormin soft-gel capsules
has a recommended retail price of C6.19.
Johnson & Johnson – which is using Patheon Softgels in the Netherlands as a contract
manufacturer – also holds marketing authorisations for the liquid-filled capsules in Austria,
Belgium and the UK.
OTC
Line Extensions
Pregnacare Liquid is said to be UK’s first
U
Laboratorios Heel – the Spanish arm of German
homoeopathic firm Biologische Heilmittel Heel –
claims to have bridged “the therapeutic gap between
corticosteroids and emollients” with its Dermaveel
cream for atopic dermatitis.
Comprising a “unique combination” of ingredients
– including ectoin, jojoba seed oil, panthenol and
butyrospermum parkii butter (shea butter) – the steroidfree medical device was indicated to relieve symptoms
of mild-to-moderate forms of the condition, the firm
pointed out, such as itching, swelling and dry skin.
The cream – which is suitable for use on children
– is said by Heel to reduce inflammation and protect
skin cells against dehydration, as well as strengthening
and maintaining the skin’s “barrier functions”.
Dermaveel should be applied twice daily to the
affected areas, the firm advises, or as often as needed.
Dolormin 400mg Weichkapseln is said to be Germany’s
first ibuprofen soft-gel capsule line for muscle pain
K supplements firm Vitabiotics claims its
Pregnacare Liquid is the first-ever liquid
multivitamin supplement for pregnant women
in its domestic market.
Pointing out that some women experienced
greater sensitivity to taste and swallowing when
pregnant, the company said the orange-flavoured
liquid had been created for those who might
have difficulty in swallowing tablets, or simply
preferred an alternative format.
Containing 18 vitamins and minerals, Pregnacare Liquid provided “a comprehensive formula for during pregnancy”, Vitabiotics noted.
The product provided folic acid and vitamin
D at the levels recommended by the UK Department of Health (DoH) – 400µg and 10µg
respectively – the firm pointed out, as well as
vitamin B12, iron and zinc, in a format that
was “gentle on the stomach”.
Vitabiotics said the liquid variant would
feature as part of an ongoing marketing campaign for Pregnacare.
Marketing activity included press advertising
in publications such as Mother&Baby, OK and
Prima, the firm noted, as well as digital promotion on websites such as Babycentre and Bounty.
Outdoor advertising would also feature,
Vitabiotics pointed out, while a television commercial would air from November.
Featuring the Pregnacare Conception, Original and Breastfeeding supplements, the 30-second creative – which aired last year as the first
ever television campaign for the brand (OTC
bulletin, 9 May 2014, page 17) – showed the
path of a couple’s pregnancy journey, from trying for a baby, during pregnancy, to seeing
their child take its first steps, the firm explained, highlighting that Pregnacare supported
mothers “every step of the way”.
A 200ml bottle of Pregnacare Liquid has a
recommended retail price of £7.95 (C10.72).
The company revealed that it planned to
launch the product into overseas markets.
OTC
EVENTS OTC
NOVEMBER
10-12 November
■
■
An Introduction to
the Medical Devices
Directives
ities of the European Medicines
Agency (EMA) and national agencies that work within the European
regulatory system is being run by
The Organisation for Professionals
in Regulatory Affairs (TOPRA).
Contact: TOPRA.
Tel: +44 20 7510 2560.
Email: [email protected].
Website: topra.org.
11 November
ASMI Annual Conference
Sydney, Australia
A one-day conference organised
by the Australian Self-Medication
Industry (ASMI).
Contact: ASMI.
Tel: +61 2 9922 5111.
Fax: +61 2 9959 3693.
Website: asmi.com.au/events/.
European Consumer
Healthcare Strategy
Forum: Pricing
Excellence 2.0
Frankfurt, Germany
‘Taking pricing to the next level for
consumer healthcare companies’
is the theme of this one-day event,
which will highlight key trends and
challenges in the consumer healthcare industry, provide an insight into
trade spend optimisation and cover
the best practices of leading consumer healthcare and fast-moving
consumer-goods (FMCG) firms.
Contact: Simon Kucher & Partners.
Tel: +49 89 544793 10.
Fax: +49 89 544793 50.
Website: simon-kucher.com/
consumerhealthforum.
Regulatory Compliance
and GMP Compliance
Frankfurt, Germany
Regulatory affairs will be discussed at this one-day seminar.
Contact: Forum Institut
für Management.
Tel: +49 6221 500 680.
Fax: +49 6221 500 555.
Website: forum-institut.com.
19-20 November
■
EMA Review of the Year
London, UK
This two-day review of the activ-
1 December
■
Advertising
Medicinal Products
Bonn, Germany
A one-day seminar focusing on advertising medicinal products, run
by Germany’s medicines manufacturers’ association, the BAH,
and conducted in German.
Contact: BAH.
Tel: +49 228 95745 0.
Fax: +49 228 95745 90.
Website: bah-bonn.de.
Ukrainian
Pharmaceutical Forum
Kiev, Ukraine
Speakers from GlaxoSmithKline,
Pfizer, Sanofi Aventis and Takeda
will attend this two-day event.
Contact: Adam Smith Conferences.
Tel: +44 20 3377 3182.
Fax: +44 20 7017 7447.
Email: nataliapr@adamsmith
conferences.com.
Website: ukrainianpharma.com.
13 November
■
DECEMBER
24-25 November
■
Pharmaceutical
Regulatory Affairs
in China
1-2 December
■
Regulatory Affairs
in Latin America
London, UK
A two-day workshop that can be
tailored for your company and delivered in-house.
Contact: Pharmaceutical Training
International (PTI).
Tel: +44 20 7017 7481.
15-16 February
■
AESGP Conference
Amsterdam, Holland
This two-day conference is being organised by the Association of the
European Self-Medication Industry, the AESGP with the EU Heads of
Medicines Agencies (HMA) during the Dutch Presidency.
Contact: AESGP.
Tel: +32 2 735 51 30. Fax: +32 2 735 52 22.
Email: [email protected]. Website: aesgp.eu/events/Amsterdam2016/.
Pharmacovigilance
London, UK
A three-day course discussing drug
safety monitoring in the European
Union (EU), Japan and the US.
Contact: Management Forum.
Tel: +44 1483 730071.
Website: management-forum.co.uk.
8-11 December
■
Basel, Switzerland
Regulatory requirements in countries such as China, Hong Kong,
Macau and Taiwan will be covered
at this two-day conference.
Tel: +44 1483 730071.
EuroPLX 59
Athens, Greece
This two-day meeting will provide a forum for business development decision makers for discussing and negotiating collaborative agreements in licensing, marketing, and distribution of patented
medicines, generics, biosimilars,
OTC products, medical devices
and food supplements.
Contact: RauCon.
Tel: +49 6221 426 2960.
Fax: +49 6222 9807 77.
Website: europlx.com.
7-9 December
■
26-27 November
■
23-24 November
■
12 November
■
10th Ceuta International
Alliance conference
Istanbul, Turkey
Delivering a solution to your international market management support
or expansion plans. This unique event brings together leading health
and beauty, OTC and diagnostic manufacturers, key industry opinion
leaders, retailers and outsource solution distributors from over 100 global
markets, giving delegates an opportunity to meet like-minded people.
Contact: Ceuta Healthcare.
Tel: +44 1202 449 709. Email: [email protected].
Website: ceutahealthcare.com.
London, UK
This three-day seminar will discuss the European medical device
legislation and give advice on how
to apply for a CE mark.
Tel: +44 1483 730071.
■
Fax: +44 20 7017 7823.
Website: pti-global.co.uk/latin.
3-5 November
GDP and GMP Symposium
London, UK
Day one of this two-day meeting –
organised by the UK Medicines
and Healthcare products Regulatory Agency (MHRA) – will cover
good distribution practice (GDP),
while day two will look at good
manufacturing practice (GMP). The
two days will then be repeated.
Contact: Glasgows.
Tel: +44 1772 767 715.
Website: mhragmdp.co.uk.
JANUARY 2016
20-21 January
■
Social Media in the
Pharmaceutical Industry
London, UK
Pharmacovigilance, digital marketing and social-media trends will be
examined at this two-day seminar.
Contact: SMi Group.
Tel: +44 20 7827 6000.
Fax: +44 20 7827 6001.
Website: smi-online.co.uk.
MARCH
3-4 March
■
Business Development
and Innovation
Opportunities in
Consumer
Healthcare/OTC
London, UK
This two-day conference and networking event will include sessions
on ‘The Future of OTC Medicines – Consumer Healthcare in a
Changing Environment’ and ‘Business Development Deal Trends’.
Contact: Pharmaceutical Licensing
Group (PLG).
Tel: +44 1737 356 391.
Fax: +44 1737 379 802.
Website: plg-group.com/events/
bdconsumerhealthcareotc/.
19
OTC DISTRIBUTION
Pharmacy needs to adapt to flourish
Driven by consolidation and regulatory shifts, pharmacy across Europe is
having to adapt to new supply-chain structures as well as increasing
competition from non-pharmacy channels. Matt Stewart reports.
T
he European pharmacy sector is facing
twin challenges: a consumer healthcare industry undergoing a period of
consolidation that is globalising supply networks; and greater non-prescription segment deregulation that is opening up the market
to non-pharmacy channels, according to a new
report published by James Dudley Management.
OTC strategist James Dudley told OTC bulletin that these trends had led to a “clear drift”
by independent pharmacies across Europe towards virtual pharmacy chains. Meanwhile,
major retail pharmacy players were developing
multi-channel offerings spanning wholly-owned
outlets, affiliates, franchises and the internet.
The growth of virtual pharmacy chains was
to be expected, he claimed. These collectives
gave independent pharmacies access to the procurement and marketing services they needed
to stay competitive in a globalised environment,
while maintaining their independence.
According to the Dudley report, only 10%
of the 145,143 pharmacies in the 20 countries
studied are part of chains comprising more than
50 pharmacies. The vast majority – 85% – are
independent pharmacies that are owner-managed
businesses (see Figure 1).
There are approximately 14,514 pharmacies
in wholly-owned chains across the 20 countries
Company/brands
studied, notes the report, and around a further
4,354 in chains of between five and 50 stores.
Only a limited number of countries in Europe
– including Belgium, the Czech Republic, Ireland, the Netherlands, Norway, Poland, Romania, Slovakia, Sweden, Switzerland and the
UK – allow companies to own significant chains.
In Poland, the law restricts the number of
pharmacies that one owner can have to just 1%
of the total number of pharmacies in a province, the report points out, but this law has been
ignored by a few chains.
However, since the start of 2015, the authorities in Poland have started cracking down on
the offending firms, it says, with some chains
being refused new licences in some provinces.
Some countries restrict ownership of pharmacies to pharmacists, and some allow pharmacists themselves to own chains but restrict the
size to two, three or four branches.
Norway and the UK have the highest proportion of their pharmacies in wholly-owned
chains, the Dudley report points out, at 86.0%
and 78.6% respectively (see Figure 2).
Commenting on virtual pharmacy chains,
the Dudley report points out that there has
been a “phenomenal” growth in these voluntary
groupings of pharmacies and concludes that
virtual chains will expand across the whole con-
Number of
wholly-owned pharmacies
OTC market strategist James Dudley says
Europe’s pharmacy sector is facing challenges from
consolidation and new channels
tinent by the end of the decade.
Around 53,900 pharmacies in the 20 countries – over a third of the total – are affiliated
in some way, says the study.
Although significant pharmacy chains are
not permitted in France and Germany, observes
the Dudley report, the majority of pharmacies
in these countries do participate in virtual chains
(see Figure 3).
According to the Dudley report, the three
largest pharmacy chains in Europe are owned
by Walgreens Boots Alliance, Celesio and Phoenix (see Figure 4).
Together, these three companies have direct ownership of a large proportion of pharma-
Territories and affiliates
Country
of origin
US
Walgreens Boots Alliance
2,843
Ireland, Lithuania, the Netherlands, Norway, and the UK
Affiliated partner pharmacies in Czech Republic, France,
Germany, Italy, the Netherlands, Russia, Spain and the UK
Celesio/Lloyds
2,184
Belgium, Germany, Ireland, Italy, Norway, the UK,
plus a joint venture in the Netherlands
Affiliated partner pharmacies in France, Germany and Norway
Phoenix/Rowlands/
Benu/Apteka 1
1,646
Baltic States, Hungary, Italy, Norway, Poland, Serbia,
the UK and investments in Austria
Affiliated partner pharmacies in France, Hungary, Italy, Norway,
the UK and a pharmacy management concept in Germany
Germany
Penta/Dr Max
850
Czech Republic, Poland and Slovakia
Czech Republic/
Slovakia
Bestway Group/
Well Pharmacy
779
UK
UK
Doz/
Dbam o Zdrowie –
I Care for My Health
600
Baltic States, Poland and the UK
Affiliated partner pharmacies include 320 franchise outlets
and 87 partner pharmacies
Netherlands
Fildes/Catena
500
Romania
Romania
Figure 4: Europe’s leading retail pharmacy chains as they currently stand (Source – James Dudley Management)
20
DISTRIBUTION OTC
StateMinor chains owned
(5-50 branches) 2% Co-ops
3%
<1%
Major chains
(>50 branches)
10%
13.3
Total
Norway
86.0
UK
78.6
Sweden
56.6
Switzerland
31.6
24.3
Netherlands
23.2
Slovakia
Romania
21.7
Czech Republic
19.2
10.9
Poland
Affiliated
independents
36%
Unaffiliated
independents
49%
Figure 1: Pharmacies in 20 European countries by
ownership (Source – James Dudley Management)
cies in major chains, the report notes, as well as
having a hand in 33% of all pharmacies affiliated to virtual pharmacy chains.
This embrace of virtual pharmacy chains by
Europe’s three key pharmacy players reflects
the “growing determination among more progressive companies to develop large groupings
of pharmacies as multi-channel brands”, the
Dudley report points out.
“A few innovators in this space have gone
even further by creating mixed ownership entities,” the report adds, “made up of wholly-owned
pharmacies, affiliated independent pharmacies
and, increasingly, franchise outlets.”
“While these groups can exploit economies
of scale to strengthen their competitiveness
in terms of procurement, pharmacy management, efficiencies and marketing,” the Dudley
report claims, “there are tremendous advantages from building a strong retail brand across
all types of outlets.”
However, while building strong multi-channel networks allows the major chains to improve margins, this will be achieved against
decreasing sales values, the Dudley report says,
unless all European pharmacy players pay more
attention to non-prescription products.
The current average turnover of a pharmacy
in Europe is approximately C944,000, the report
notes, down by 9% since 2012.
At the root of the decline in average turnover is the dependence pharmacies have on
social funding, the Dudley report says, noting
that 73% of turnover on average across the countries studied is derived from prescription-only
medicines and other social health services, funded primarily by statutory healthcare providers.
As a consequence, such products and services
are generally price-regulated and subject to price
and margin controls, the report adds, and there is
a “distinct trend” for fund holders to drive down
prices and fees across the 20 countries studied.
Pharmacies sell a wide range of non-medicinal lines other than prescription and OTC medi23 October 2015 OTC bulletin
9.4
Belgium
8.8
Bulgaria
Hungary
Finland
Italy
7.0
2.1
1.2
0
20
40
60
Share of pharmacies (%)
8
0
100
Figure 2: Proportion of pharmacies in wholly-owned retail chains (Source – James Dudley Management)
35.7
Total 20 countries*
95.0
Denmark
85.0
Germany
78.3
Netherlands
71.0
Slovakia
France
68.0
Finland
47.0
Switzerland
40.0
36.0
Bulgaria
Czech Republic
UK
30.0
Hungary
Italy
Sweden
Belgium
Spain
0
35.0
23.0
20.0
Poland
Norway
59.4
3.3
12.3
12.0
10.2
20
40
60
Share of pharmacies (%)
8
0
100
* Total includes countries not included in this chart
Figure 3: Proportion of pharmacies in virtual retail chains (Source – James Dudley Management)
cines, the report points out, including nutritional
and baby products, health-related and premium
personal-care items, cosmetics, nursing aids,
hygiene products and medical devices.
Together these represent 16% of the turnover of an average pharmacy in Europe, the
report adds, but as attractive as these lines are
in terms of prices and margins, pharmacy has
no monopoly on them and has to compete with
mass-market channels in these categories.
However, consumer purchases of OTC medicines represent only 11% of sales turnover of
the average pharmacy, the Dudley report reveals,
“despite the fact that the pharmacy is the natural channel for consumer healthcare”.
“It is in the interests of both pharmacies and
suppliers further to develop OTC medicines in
pharmacy in most European countries, especially
those in Northern Europe,” the report insists.
While acknowledging that there is competition in the OTC medicines space in a number
of markets from non-pharmacy channels and
the internet, the report points out that 85% of
the licensed consumer healthcare products in
the 20 countries under study are delivered
through pharmacies.
Furthermore, there are categories within the
non-prescription market which will remain exclusively in the pharmacy, due to the regulatory status of the products, it adds.
OTC medicines provide pharmacies with
a big opportunity to shield themselves against
price and margin cuts to prescription products,
the report notes, but pharmacy needs to address the category properly, or as deregulation
opens up the category to non-pharmacy competitors, it could lose out.
OTC
21
All that’s happening in
generics and biosimilars
Written by generics specialists from a generics industry perspective
The best decision-makers in the generics industry don’t have the time to go looking for
good information. They let it come to them. They subscribe to Generics bulletin.
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are already benefitting from commercial intelligence about business opportunities in
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with no postal delay. It also comes – at NO EXTRA CHARGE – as an app for mobile
access by tablet and smartphone.
Generics bulletin-i subscribers also get access to a fully-searchable archive. This
contains over five years of generics news and analysis in more than 100 back issues.
These offer an invaluable resource for researching marketing opportunities,
benchmarking competitive strengths, evaluating regulatory changes and assessing
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Existing subscribers can get 20% OFF when they upgrade their subscriptions to
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Take out a subscription TODAY at
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Bulletin Publishing Group, OTC Publications Ltd, 4 Poplar Road, Dorridge, Solihull B93 8DB, UK. (Tel: +44 (0)1564 777550; Fax: +44 (0)1564 777524).
Registered in England No: 2765878. VAT No: GB 608 0432 69
PEOPLE OTC
Manufacturers
BioGaia appoints
managing director
S
wedish probiotics specialist BioGaia has
named Axel Sjöblad as its managing director. He replaces Peter Rothschild, who has
been promoted to group president.
Sjöblad will join BioGaia on 1 March 2016
from Getinge Sverige, where he currently serves
as managing director and vice-president of the
sterilisation company’s North and Central Europe region.
He has also held a number of roles within
medical technology company Gambro, which
is now part of Baxter International.
BioGaia said Sjöblad had “extensive experience of, and a track record in, the healthcare
and life sciences area” and that he was “ideally
suited to take over management of the company’s operations, initially with a special focus
on marketing and sales”.
Meanwhile, Rothschild’s new role would
see him retain overall responsibility for BioAxel Sjöblad
Gaia’s research and development activities, the
firm noted, and remain chairman of the company’s CapAble, IBT and TwoPac subsidiaries.
In addition, Rothschild would support the
development of BioGaia’s Japanese division,
the company pointed out, and remain as the
chairman of scientific research company MetaboGen, in which BioGaia invested last year
(OTC bulletin, 12 December 2014, page 4).
BioGaia said the organisational change
would enable the company to “reinforce its
sales capabilities and geographic expansion”.
The firm would also be able to “increase the
focus on its subsidiaries and associated companies”, it noted, as well as to realise its “major development potential”.
OTC
IN BRIEF
■ GENERINOBEL – the German drug development firm – has recruited Dr Wolfgang
Bäurle as its managing director.
OTC
Manufacturers
Oschmann to replace Kley
as head of Merck in 2016
S
tefan Oschmann will assume the role of
Merck KGaA’s chief executive officer and
chairman of the executive board on 29 April
2016, the company has announced.
Currently deputy chairman of the German
firm’s board – and deputy chief executive officer – Oschmann will replace Karl-Ludwig Kley,
who will retire after nine years at the helm.
A member of Merck’s executive board since
2011, Oschmann is also president of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and vicepresident of the European Federation of Pharmaceutical Industries and Associations (EFPIA).
Johannes Baillou, chairman of the board of
partners at Merck, said Oschmann’s strategic
foresight and strong leadership had turned
Merck back into “a respected player in the pharmaceutical industry”.
Commenting on Kley’s departure, Baillou
pointed out that Merck had gone through the
“biggest transformation in its almost 350-year
history” under Kley’s leadership.
This included “building and expanding no
fewer than three strong global businesses” –
healthcare, life sciences and performance materials – he noted.
Kley has also recently overseen a “complete
overhaul” of Merck’s brand identity, including a
new company logo.
As part of the firm’s “Fit for 2018” efficiency
programme, Merck said it had undertaken a
Merck KGaA said its new logo reflected its position
as a “global science and technology company”
Stefan Oschmann
“fundamental revision” of its “visual appearance”
and introduced a logo which reflected its “transformation” from a “classic supplier of pharmaceuticals and chemicals” into a “global science
and technology company”.
Furthermore, the previously independent
Merck Serono and Merck Millipore brands had
been “eliminated” as part of the rebranding exercise, the company noted.
Going forward, Merck Serono would operate
as the biopharmaceutical division of Merck, the
firm noted, while the Millipore division would
be incorporated into the life sciences business.
Merck holds the rights to the Merck name
and brand globally, with the exception of Canada and the US. In these two countries, the
company would continue to operate as EMD
Serono in the biopharmaceutical business, as
EMD Performance Materials in the high-tech
materials business, and as EMD Millipore in the
life sciences business, up until the planned acquisition of Sigma-Aldrich had been completed.
To create a “strong visual link” with its
Canadian and US businesses, a “striking, multicoloured” ‘M’ which mirrored the new group
identity had been added to the EMD logo, the
company noted.
OTC
Consultants
Leyers joins Diapharm’s regulatory unit
D
iapharm – the Germany-based pharmaceutical services provider – has appointed Dr Stefan Leyers as its senior regulatory
affairs manager.
A registered pharmacist, Leyers had “many
years of experience”, Diapharm noted, having
held positions in the regulatory departments of
Johnson & Johnson’s German business, as well
as at the family-owned pharmaceutical com-
pany Medice Arzneimittel Pütter.
He had also previously worked as an assessor
at BfArM, the German Federal Institute for
Drugs and Medical Devices.
Meanwhile, Dr Jan Winters has joined the
company as senior manager of regulatory affairs
for food supplements. He will advise firms
about foods with additional health benefits.
OTC
23
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Fate of Rule 21 in balance as med devices talks begin

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