Ping An Romania Why the

Good Doctor primed for flu season

prepares IPO self-care matters
page 4 page 15 page 20

Contents FDA takes action on

loperamide abuse
16 February 2018
Issue Number 497

COMPANY NEWS
Investors question
Nestlé CHC move
3 T he US Food and Drug Administration
(FDA) is set to limit the number of doses
of loperamide per pack in OTC versions of the
dose could “cause serious heart problems that
can lead to death”.
Despite the additional warning label, the FDA
Sanofi remains 5 drug, following continued reports of the anti- said it had continued to “receive reports of serious
open to deals diarrhoea medication being misused by people heart problems and deaths with loperamide”,
GSK silent on link with Pfizer 6 addicted to opioids. particularly among people “who are intention-
International growth 7 Noting that loperamide – the active ingredi- ally misusing or abusing high doses”.
boosts Pfizer sales ent in Johnson & Johnson’s (J&J’s) Imodium
A-D brand and numerous OTC store-brand and Bulk online sales
Japan sales slide at Taisho 8
generic anti-diarrhoea products – was safe and In addition to working with manufacturers,
Bigger brands 9 effective when taken at the correct dosage, the the regulatory body said it was reaching out to
key for Prestige FDA said that it had requested that packs con- e-commerce providers of Imodium by explaining
China’s By-Health 10 tained only a “limited amount of loperamide the risks of selling loperamide in bulk quantities.
grabs Life-Space appropriate for the treatment of short-term diar- The agency noted that consumers often pur-
rhoea according to the product label”. chased large quantities of OTC medicines online
GENERAL NEWS Explaining the reason for the clamp down, for convenience, and that loperamide was com-
BAH slams attack by 11 the FDA said loperamide was “seen by those monly sold over the internet in “large bottles”.
consumer watchdog suffering from opioid addiction as a potential Moreover, the FDA said it was engaging with
alternative to manage withdrawal symptoms” healthcare professionals to explain the risks of
Green scrips 14
growing steadily or to achieve euphoric effects. loperamide abuse and to advise prescribing
In June 2016, the FDA added a warning to the medication for much shorter periods.
MARKETING NEWS OTC and prescription loperamide products stat- The FDA has requested feedback on the issue
ing that taking a higher than recommended by 16 March 2018. OTC
NAD questions Xyzal claims 16
Femibion backs 17
working mums
P&G takes ZzzQuil 18
Australia keeps ibuprofen access
into supplements
BioGaia expands 18 A n Australian scheduling delegate has issued
an interim decision recommending that
ibuprofen remain available to buy through gro-
The delegate’s recommendations came after
an application was made to the Therapeutic Goods
Administration (TGA) to reduce pack sizes and
Swedish portfolio
cery stores due to the drug’s good safety profile. remove them from general sale.
REGULARS Ibuprofen is currently the only unscheduled Explaining its reasoning for the changes, the
oral non-steroidal anti-inflammatory drug (NSAID) applicant pointed to a number of recent studies
Events – Our regular listing 19 available in Australia. The delegate also recom- linking ibuprofen to various health problems, as
People – Goldschmidt joins 23 mended maintaining the 100-dosage unit pack well as to the recently implemented ban on OTC
Stada as new chief size for 200mg ibuprofen available in pharmacies. Continued on page 23

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With a little creativity and a lot of
understanding, good things can happen.

At Hamell, we are passionate about people. And passionate about health.

We know that with award-winning creative solutions, fuelled by a deeper
understanding of human behaviour, we can motivate and empower people
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or phone 020 7978 5206. for good

Business Strategy
Hisamitsu in Investors question
Hong Kong
Nestlé CHC move
J apan’s Hisamitsu Pharmaceutical is establish-
S
ing a new wholly-owned subsidiary in Hong
Kong, in a move the firm says will “strengthen”
its OTC business in the Chinese territory.
Describing Hong Kong as an “important mar-
ket”, Hisamitsu said it had invested ¥10 million
(C0.08 million) to set up Hisamitsu Hong Kong,
which would be based in the Kowloon area of
the territory.
Explaining the rationale for establishing the
subsidiary, Hisamitsu said that having a direct
presence in Hong Kong would help to grow its
OTC business in the territory and specifically
drive up sales of its Salonpas and Mohrus OTC
analgesic patches.
The topical analgesic specialist made the an-
nouncement shortly after reporting the results
of its third-quarter ended 30 November 2017.
Hisamitsu reported turnover at its OTC busi-
ness up by 13% to ¥35.8 billion in the three
months, thanks to the performance of Salonpas.
The analgesic patch posted sales up by 23%
to ¥21.4 billion, due primarily to a double-
digit increase in turnover in overseas markets.
Hisamitsu noted it had expanded its OTC
offering in the third quarter with the launches
of the NobiNobi Salonsip analgesic patches and
Allegra FX Junior allergic rhinitis product in
its domestic market.
Despite strong growth in its OTC segment,
total group sales fell by 18% to ¥135.9 billion,
as turnover fell at its dominant prescription phar-
maceuticals business. OTC
Editor: Matt Stewart
Deputy Editor: Tom Gallen
Associate Editor: David Ridley
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16 February 2018 OTC bulletin
Business Strategy
wiss food and drinks giant Nestlé should
“better explain to shareholders the ration-
ale behind expanding further into consumer
healthcare”, says major shareholder Third Point.
Investment firm Third Point, which holds
a 1.3% stake in Nestlé worth around US$3.5
billion (C2.9 billion), claims that the recent ac-
quisition of Canadian dietary supplements spe-
cialist Atrium Innovations, combined with “rum-
ours the company is bidding on larger assets”
in the consumer healthcare market, has “left some
shareholders confused”.
Nestlé is set to pay US$2.3 billion to acquire
Atrium – and its leading Garden of Life organic
supplements range – in a move the firm says
supports its “pursuit of growth opportunities in
consumer healthcare” (OTC bulletin, 15 Decem-
ber 2017, page 3).
Following the deal for Atrium, and com-
ments from chief executive Mark Schneider last
year that Nestlé was committed to expanding
its presence in consumer healthcare (OTC bul-
letin, 21 July 2017, page 7), rumours have swirled
that the firm is set to make a serious play in
the market by snapping up the for sale Merck
KGaA Consumer Health business (OTC bul-
letin, 12 January 2018, page 3).
While Third Point does not directly criticise
the Atrium deal, it questions Nestlé’s ongoing
investment in its Skin Health unit, which houses
prescription and OTC skin-care products.
“Forays into skin health seem unrelated to
Assistant Editor: Rachael Walker
Production Editor: Jenna Meredith
Editor-in-Chief: Aidan Fry
Managing Director: Phil Jarvis
16 February 2018 | Number 497
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COMPANY NEWS OTC
Nestlé’s core business and like a costly mistake
which should be unwound,” Third Point insists.
“Nestlé defines itself as a company focused
on ‘nutrition, health and wellness’, but many of
its assets do not align with that vision,” the inves-
tor argues. “We believe Schneider has an oppor-
tunity to better align the company’s strategy
with its stated objective by addressing these and
other inconsistencies.”
Skin Health, by Schneider’s own admission,
has “underperformed” in recent years. The firm
is now working to “aggressively right-size” the
operation, according to Schneider, as the business
is suffering from a host of self-inflicted issues,
including an “over aggressive expansion” into
OTC skin-care products (OTC bulletin, 6 Octo-
ber 2017, page 5).
Rather than continuing to invest in the OTC
market, Third Point believes that Nestlé should
“move faster to increase its exposure to the
high-growth categories of coffee, pet care, water
and nutrition”.
Despite questioning areas of Schneider’s strat-
egy, Third Point says that he has “begun to take
the needed steps to move the firm forward”.
This is not the first time Third Point has called
into question Nestlé’s strategic direction. In June
last year, the company insisted that “reshaping
the portfolio” was among the changes needed
at Nestlé to reverse a “recent history of mean-
ingful underperformance versus peers” (OTC
bulletin, 30 June 2017, page 6). OTC
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3
 OTC COMPANY NEWS
Business Strategy
All change Ping An Good Doctor
at Dr Pfleger prepares China IPO
B y developing new products and strength-
C
ening existing brands, German pharma-
ceutical manufacturer Dr Pfleger Arzneimittel’s
recently-appointed managing director Günter
Auerbach said he would lead the company “suc-
cessfully” forward.
Alongside Ralf Will – who joined Dr Pfleger
as chief operating officer in 2016 – Auerbach
revealed the new leadership team had “concrete
plans” to further advance the charity-run firm by
implementing a “modern orientation” strategy.
Change at the top management level was key
to its modernisation strategy, the company said,
with Auerbach – previously chief executive of-
ficer at Germany-based OTC specialist bene-
Arzneimittel – bringing “extensive leadership
and industry experience” to the firm.
Auerbach will be supported in the role by
industry veteran Will, who joined Dr Pfleger in
September 2016, after heading up supply-chain
operations for seven years at German herbal
medicines manufacturer Bionorica.
Introduce new brands
“Part of the new strategy is to further in-
crease our innovation power,” Auerbach noted.
“We want to strengthen our existing prescription-
only and OTC indication areas, while expanding
our offering through new, strong brands.”
Dr Pfleger pointed to its “most successful”
OTC brands as those with the greatest potential
for development, including the Neuralgin and
Godamed analgesics, Bio-H-Tin range of hair
and nail supplements and Ipalat cold remedy.
At the heart of its product development plan
was the recently built “state-of-the-art” produc-
tion facility in Bamberg, the firm commented,
where the company has been based since its found-
ing in 1945 by namesake Dr Robert Pfleger.
While the appointments of Auerbach and Will
marked a “generational change” in the company
and a shift in strategy, Dr Pfleger insisted that
it would continue to perate as a not-for-profit,
with 100% of its C78.6 million “record sales”
in 2017 going to its charitable owner, the Robert
Pfleger Foundation.
As a charity-owned company, this meant that,
alongside the “entrepreneurial” goals of its new
strategy, the firm was also committed to address-
ing “current issues of healthcare in Germany”.
One important move it said it could make
was protecting the role of traditional pharmacies
in securing the comprehensive supply of medi-
cines in the country, especially in rural areas. OTC
4 OTC bulletin 16 February 2018
Business Strategy
hinese conglomerate Ping An Insurance is
seeking to take a larger slice of China’s
healthcare market by launching an initial pub-
lic offering (IPO) for its Ping An Good Doc-
tor subsidiary.
Ping An Good Doctor operates an online doc-
tor consultation service for Chinese consumers,
plus an e-commerce platform selling a range
of healthcare products, including OTC medi-
cines. A health check-up service is also offered
by the company, through which consumers can
receive self-care advice.
By operating Ping An Good Doctor as an in-
dependent company and listing on the Hong
Kong Stock Exchange, Ping An Insurance said
it hoped to unleash the business’ “growth poten-
tial”. While the firm has not disclosed the pric-
ing for the IPO, it is expected to generate up
to US$1.0 billion (C810 million).
The funds from the IPO, Ping An Insurance
says, will be used to expand the reach of Ping
An Good Doctor in China, and into neighbour-
ing markets – through acquisitions and strategic
alliances – and for research and development
purposes to improve its information technology
and artificial intelligence (AI) capabilities.
According to Ping An Insurance, Ping An
Good Doctor is the “world’s leading health-
care portal in terms of traffic”, with over 190
million registered users and more than 30 mil-
lion monthly active users. In 2016, Ping An Good
Doctor generated sales of CNY602 million (C77.8
million), up from CNY279 million in the prior
year. Total sales reached CNY1.02 billion in the
opening nine months of 2017.
In its IPO prospectus, Ping An Good Doc-
tor describes itself as a “one-stop healthcare plat-
form that delivers an integrated suite of services”.
“We are cultivating a network nationwide
and globally that connects our users with our
online healthcare platform, as well as third-party
healthcare service providers, such as hospitals,
health check-up centres, pharmacies and physio-
therapy centres,” the firm points out. “We provide
IN BRIEF
AMAZON, Berkshire Hathaway and JP
Morgan Chase & Co are “partnering on ways
to address healthcare for their US employees,
with the aim of improving employee satisfac-
tion and reducing costs”. The firms said they
our users with access to a wide spectrum of med-
ical and wellness product offerings, as well as
personalised wellness contents and programmes
for maintaining a healthy lifestyle.”
The company organises its business in four
distinct segments: Family Doctor Services; Con-
sumer Healthcare; Health Mall; and Health Man-
agement and Wellness Interaction.
Family Doctor Services, Ping An explains,
consists “primarily of online consultation, hos-
pital referral and appointment, inpatient arrange-
ment and second opinion services” delivered
by the firm’s in-house medical team and exter-
nal doctors. The team’s work is supported by
Ping An’s AI-Assistant, the firm notes, which
“enhances the efficiency and accuracy” of care
to the users of the service.
The AI Assistant can also “standardise and
automate care in a common clinical scenario”,
PingAn points out, as well as “record and transmit
a user’s history, condition and/or responses”.
Distinct from, but complementary to, the
Family Doctor Services operation, the Health
Mall segment operates an e-commerce platform
providing consumers with “diversified and evolv-
ing product offerings, including healthcare prod-
ucts, such as OTC medicines, dietary supplements
and medical devices”.
As well as direct sales to consumers, Ping
An’s e-commerce platform also facilitates trans-
actions between third-party vendors and consum-
ers. These vendors consist primarily of pharmacy
chains – such as Beijing Guotaiyongkang Big
Pharmacy and Guangdong Jianke Pharmaceuti-
cal – and overseas shopping service providers.
In addition to its Health Mall and Family
Doctor businesses, Ping An offers through its
Consumer Healthcare segment “standardised
packages of healthcare services” – provided by
third-parties – such as health check-ups and
genetic testing. Meanwhile, the Health Manage-
ment and Wellness Interaction segment curates
“wellness programmes, tools and activities to help
consumers maintain a healthy lifestyle”. OTC
would “bring their scale and complementary
expertise to this long-term effort”, which would
be conducted through an “independent com-
pany that is free from profit-making incentives
and constraints”. OTC
 COMPANY NEWS OTC

Business Strategy/Annual Results

Sanofi remains open to deals

S anofi “continues to look at potential oppor-
tunities” to expand its Consumer Healthcare
business through acquisitions, according to the
Region

Emerging Markets
Annual sales
(C millions)
1,616
Change (%)
CER*
+31.3
Change
CER/CS** (%)
+3.0
firm’s chief executive officer Olivier Brandicourt. Europe 1,422 +62.0 +2.0
Asked by analysts if the France-based phar-
US 1,133 +22.5 +1.3
maceuticals giant had an “interest” in further
OTC deals, Brandicourt said he remained open Rest of World 661 >100 –
to opportunities to add to Consumer Healthcare, Total Consumer Healthcare 4,832 +46.3 +2.1
which was a “very important business” for Sanofi. * CER is constant exchange rates
** CER/CS compares sales in 2017 to sales in 2016 adjusted to include turnover from Boehringer Consumer Health
While he declined to comment on the types Care and sales from the terminated Sanofi Pasteur MSD joint venture
of assets Sanofi was interested in, Brandicourt Figure 1: Sanofi’s Consumer Healthcare sales in 2017 by region (Source – Sanofi)
pointed out that the firm had only recently sig-
nificantly expanded Consumer Healthcare by ness operating income margin at Consumer Consumer Healthcare’s sales had grown by 2.1%,
acquiring Boehringer Ingelheim Consumer Healthcare in 2018 “and beyond”. the company noted, thanks to a better perform-
Health Care, in a deal which had added more Meanwhile, Sanofi Consumer Healthcare ance in Europe and the US.
than C1.0 billion in sales to its OTC operation reported sales up by 46.3% at constant exchange The addition of the Boehringer brands pushed
(OTC bulletin, 13 January 2017, page 1). rates to C4.83 billion in 2017, thanks primarily to up sales in Europe by 62.0% at constant ex-
Commenting on the integration of Boehring- the addition of Boehringer Consumer Health change rates to C1.42 billion (see Figure 1). At
er Consumer Health Care, Alan Main, head Care to the portfolio. constant exchange rates and constant structure,
of Sanofi Consumer Healthcare, said the firm At constant exchange rates and constant sales had improved by 2.0%, the firm noted,
was “right on track” to deliver the cost synergies structure – comparing sales in 2017 including thanks to the performance of its Pain brands.
it expected from the deal. The firm remained Consumer Health Care with 2016 sales adjusted In the US, turnover increased by 22.5% at
committed, Main said, to achieving a 30% busi- to also include Consumer Health Care – Sanofi constant exchange rates to C1.13 billion. Better
sales of allergy brands and the Gold Bond skin-
Business Annual sales Change Change care line lifted turnover at constant exchange
(C millions) CER*(%) CER/CS** (%)
rates and constant structure by 1.3%, Sanofi said.
Doliprane 323 +5.5 +5.5
Turning to Emerging Markets, Sanofi report-
Buscopan 191 – – ed sales up by 31.3% at constant exchange
Pain 1,258 +45.9 +5.7 rates – 3.0% at constant exchange rates and
Allegra 423 +2.4 +2.4 constant structure – to C1.62 billion, as turno-
Mucosolvan 125 – –
ver improved at a double-digit rate in its Pain
and Nutritionals categories.
Xyzal 65 – –
Rest of World sales more than doubled to
Allergy, Cough and Cold 1,226 +56.6 +3.2 C661 million at constant exchange rates in the
Dulcolax 211 – – 12 months. Sanofi did not comment on the re-
Enterogermina 168 +6.9 +6.9 gion’s performance at constant exchange rates
Essentiale 150 +0.7 +0.7 and constant structure.
On Consumer Healthcare’s category perform-
Zantac 117 – –
ance, the addition of Buscopan helped to lift
Digestive 930 +79.5 -0.8
turnover in the Pain category by 45.9% at con-
Pharmaton 100 – – stant currencies to C1.26 billion (see Figure
Nutritionals 652 +44.9 -2.7 2). At constant structure and constant curren-
Gold Bond 201 +5.6 +5.6 cies, Pain sales advanced by 5.7%, Sanofi pointed
Other 766 +11.2 +2.5
out, reflecting increased demand for Doliprane.
Allergy, Cough and Cold turnover had grown
Total Consumer Healthcare 4,832 +46.3 +2.1
by 56.6% at constant currencies to C1.23 bil-
General Medicines and Emerging Markets 14,048 -1.0 -3.1 lion, Sanofi noted, thanks to Boehringer’s Muco-
Diabetes & Cardiovascular 5,400 -14.3 -15.6 solvan and better sales of Allegra.
Genzyme/Specialty Care 5,674 +15.1 +13.1 Digestive sales had improved by 79.5% at
Total Pharmaceuticals 29,954 +4.2 +2.4 constant currencies to C930 million, due to the
Vaccines 5,101 +14.5 +11.4
addition of Dulcolax, the firm noted, while Nu-
tritionals sales had risen by 44.9% at constant
Total Sanofi 35,055 +5.6 +3.6 currencies to C652 million, thanks to Pharmaton.
* CER is constant exchange rates
** CER/CS compares sales in 2017 to sales in 2016 adjusted to include turnover from Boehringer Consumer Health
Consumer Healthcare accounted for 13.8%
Care and sales from the terminated Sanofi Pasteur MSD joint venture of Sanofi’s total sales in 2017, which rose by 5.6%
Figure 2: Sanofi’s sales in 2017 broken down by business (Source – Sanofi) at constant exchange rates to C35.1 billion. OTC

16 February 2018 OTC bulletin 5

 OTC COMPANY NEWS

Business Strategy/Annual Results

GSK silent on link with Pfizer

G laxoSmithKline’s (GSK’s) chief execu-
tive officer Emma Walmsley has refused
to be drawn on press speculation that the firm
Business

Wellness
Annual sales
(£ millions)
4,001
£
+7
Change (%)
CER*
+2
is one of only two remaining bidders – along Oral health 2,466 +11 +6
with Reckitt Benckiser (RB) – for Pfizer’s Con- Nutrition 680 +1 -5
sumer Healthcare unit.
Skin health 603 +6 –
Asked by analysts if the company had sub-
mitted a non-binding bid for Pfizer’s OTC busi- Total Consumer Healthcare 7,750 +8 +2
* Constant exchange rates
ness, Walmsley said she would not “comment
specifically” on whether GSK was involved in Figure 1: GSK Consumer Healthcare’s sales in 2017 by business unit (Source – GSK)

the bidding process “and certainly not on the something that we need to do.” GSK reported Consumer Healthcare turnover
media commentary either”. Bloomberg reported this month that GSK up by 8% to £7.75 billion (C8.86 billion) in 2017,
Reiterating comments made at the JP Mor- and RB were the only companies to have sub- thanks to higher sales in its Wellness and Oral
gan Healthcare Conference last month (OTC mitted non-binding bids for Pfizer Consumer health categories, and positive currency effects.
bulletin, 2 February 2018, page 4), Walmsley Healthcare after rival candidates walked away, At constant currencies, sales advanced at the
described Pfizer Consumer Healthcare as an citing people familiar with the matter. slower rate of 2%.
“attractive business”, adding: “You would ex- Johnson & Johnson (J&J) confirmed it was “Strong growth above market levels” by its
pect us to take a serious look at any major assets out of the running earlier this month, telling ‘power brands’ had been partially offset by a
that come up in the market.” Reuters it refuted “assertions” that it was “in weak cough and cold season and “competitive
“We are a world leader in consumer health- negotiations for Pfizer’s consumer business” pressures” in the allergy category, GSK noted.
care and we have a good track record of inte- (OTC bulletin, 2 February 2018, page 1). Expanding on the performance of Consumer
grating businesses effectively,” Walmsley in- Pfizer announced in October last year that Healthcare’s individual categories, GSK reported
sisted, “but our first priority remains Pharma- it was reviewing “strategic alternatives” for Wellness sales up by 7% to £4.0 billion (see
ceuticals. We will not do anything that cuts across Consumer Healthcare, including the potential Figure 1). Adjusted for currency effects, sales
that priority.” sale of the unit, as part of the firm’s “continuing improved by 2%.
“Most importantly, we’re very happy with efforts to allocate resources and capital to best “Strong broad-based growth” from Otrivin
our Consumer Healthcare business and it’s pro- serve patients and maximise value for sharehold- and Theraflu, particularly in Europe, had driven
gress and momentum,” Walmsley stated, “so ers” (OTC bulletin, 20 October 2017, page 1). up sales in Wellness’ respiratory segment, GSK
[acquiring Pfizer Consumer Healthcare] is not Walmsley made her comments on Pfizer as reported. This had been partially offset by lower
sales of Flonase, the firm added, with the brand
Region Annual sales Change (%)
(£ millions) £ CER* hit by competitive pressures from private-label
International 3,564 +9 +4
products in the US allergy category.
Pain-relief brands had recorded double-digit
Europe 2,360 +9 +3
growth in the 12 months, GSK said, “driven
US 1,826 +4 -1 significantly” by Voltarol, which had performed
Total Consumer Healthcare 7,750 +8 +2 well “across all regions”. The brand had ben-
* Constant exchange rates efitted from “strong momentum” behind its 12-
Figure 2: GSK Consumer Healthcare’s sales in 2017 by region (Source – GSK)
hour product, as well as “strong in-store mar-
keting activation”.
Annual sales Change 2016/2017 Proportion Away from Wellness, Oral health turnover
(£ millions) £ CER* of total (%) advanced by 11% – 6% at constant currencies –
Core sales to £2.47 billion, with Sensodyne recording
Pharmaceuticals 17,276 +7 +3 57 double-digit growth globally.
Consumer Healthcare 7,750 +8 +2 26 Sales of Paradontax had also “continued to
Vaccines 5,160 +12 +6 17
grow strongly”, GSK explained, thanks to a
“brand reset”, increases in dentist recommen-
Total core sales 30,186 +8 +3 100
dations, and its launch in the US during the open-
Core operating profit ing three months of the year.
Pharmaceuticals 5,927 +8 +1 66 Meanwhile, sales in the Nutrition category
Vaccines 1,644 +15 +11 18 edged up by 1% to £680 million, due entirely
Consumer Healthcare 1,373 +23 +11 15 to positive currency effects. At constant cur-
rencies, Nutrition sales slipped back by 5%.
Total core operating profit** 8,944 +11 +4 100
* Constant exchange rates
“Continued competitive pressures” on Hor-
** Excluding corporate and other unallocated costs of £376 million licks in India, combined with the implementation
Figure 3: GSK’s ‘core’ sales and operating profit in 2017. Core results exclude amortisation, goodwill, of the Goods and Services Tax (GST) in the
restructuring costs, legal charges and other items (Source – GSK) country during the year, had been to blame for the

6 OTC bulletin 16 February 2018


slide in Nutrition turnover, the company said.
This had been compounded, the firm added, by
the sale of GSK’s Nigerian drinks business to
Japan’s Suntory Beverage & Food in 2016 (OTC
bulletin, 21 October 2016, page 6).
Skin health sales advanced by 6% to £603
million in the 12 months, again due entirely to
positive currency effects. At constant curren-
cies, sales were flat.
A “strong” performance by Fenistil in Europe
– following digital activity and new marketing
campaigns – had been offset by lower sales of
Physiogel and Lamisil, GSK reported, with both
brands suffering from increased competition.
Turning to the regional performance, posi-
tive currency effects and a strong showing from
Wellness brands helped push up International
turnover by 9% – 4% adjusted for currency
effects – to £3.56 billion (see Figure 2).
Sales in Europe had also improved by 9%
to £2.36 billion, GSK pointed out, thanks to a
combination of positive currency effects and the
growth of the Oral health category and a strong
showing from pain-relief lines. At constant ex-
change rates, sales moved forward by 3%.
In the US, sales advanced by 4% to £1.83
billion, due entirely to positive currency effects.
At constant currencies, turnover had actually
slipped back by 1%, GSK said, as a result of pri-
vate-label competition in the allergy category.
Consumer Healthcare accounted for 26%
of GSK’s total sales in 2017, which increased
by 8% to £30.2 billion (see Figure 3).
Consumer Healthcare reported operating profit
up by 23% to £1.37 billion in the 12 months,
thanks to a combination of “power brand growth
and strong cost control”, as well as positive cur-
rency effects. At constant currencies, operating
profit advanced by 11%. OTC
Licensing Agreements
BioGaia makes
China move
B ioGaia’s Protectis probiotics will soon be
available in China after the Swedish firm
signed a licensing deal with Abbott Laboratories.
Under the exclusive agreement, Abbott has
been granted the rights to commercialise Bio-
Gaia Protectis in China.
Expected to be launched in 2018, the chew-
able probiotic tablets would be co-branded by
the companies, BioGaia reported.
Explaining the rationale behind the deal,
BioGaia’s managing director, Axel Sjöblad, said
the firm had a strong focus on “growing our
Asian business”, adding that he looked forward
to working withAbbott on the “successful launch”
of its Protectis tablets in China. OTC
16 February 2018 OTC bulletin
COMPANY NEWS OTC
Annual Results
International growth
boosts Pfizer sales
B etter sales in its International segment helped
to push up Pfizer’s Consumer Healthcare
turnover by 2% to US$3.47 billion (C2.79 bil-
the firm “continues to review strategic options
for Consumer Healthcare”.
“This could include anything from a full or
lion) in 2017. partial separation of the business, to ultimately
International turnover had improved by 9% deciding to retain the business,” Read pointed
to US$1.62 billion in the 12 months, the US- out. “We expect to make a decision during 2018.”
based pharmaceuticals giant noted, thanks to Asked late last year whether Pfizer would
growth in its Developed Europe, Developed Rest consider offloading Consumer Healthcare through
of World and Emerging Markets regions. an asset swap, Read said the company was rul-
Meanwhile, turnover in the US had fallen ing nothing out (OTC bulletin, 24 November
by 3% to US$1.85 billion, the company said, due 2017, page 7).
to the impact of hurricane Maria in Puerto Rico, “We have for some time been looking and
which had disrupted production at its local seeking strategic deals for our Consumer busi-
manufacturing plant. ness…perhaps involving asset swaps,” he noted.
Consumer Healthcare accounted for 6.6% “I think this process we’re going to take in the
of Pfizer’s total sales in 2017, which declined strategic review may shake loose more alter-
by 1% to US$52.5 billion (see Figure 1). natives in that respect.”
Pfizer is currently reviewing “strategic alter- According to Bloomberg, GlaxoSmithKline
natives” for its Consumer Healthcare business, (GSK) and Reckitt Benckiser (RB) are the only
a process which began last year (OTC bulletin, companies to have submitted non-binding bids
20 October 2017, page 1). for Pfizer Consumer Healthcare after rival can-
Commenting on the process, Pfizer’s chief didates walked away, citing people familiar with
executive officer, Ian Read, told investors that the matter (see page 6). OTC
Business Annual sales Change Proportion
(US$ millions) 2016/2017 (%) of sales (%)
Internal medicine 9,684 +9 18
Oncology 6,056 +33 12
Vaccines 6,001 -1 11
Inflammation & Immunology 3,968 +1 8
Consumer Healthcare 3,472 +2 7
Rare Diseases 2,240 -5 4
Innovative Health 31,422 +8 60
Essential Health 21,124 -11 40
Total Pfizer 52,546 -1 100
Figure 1: Pfizer’s sales in 2017 broken down by business (Source – Pfizer)
IN BRIEF
HEVERT ARZNEIMITTEL is offering gang Hevert, as well as promote scientific re-
C10,000 to the winner of this year’s biennial search in holistic medicine – will be judged
Dr Wolfgang Hevert Prize, which is open to according to four general criteria: originality;
“scientific and non-commercial research” pub- quality; relevance; and usability of the com-
lished in German or English that attempts to pleted research. The deadline for submissions
“clarify questions in the fields of European natu- is 30 June 2018. Previous years’ prizes were
ral medicine and associated therapies such as ho- awarded to research on the use of homoeopathic
moeopathy”. The competition – which Hevert therapy with children, the role of vitamin C in
said was designed to celebrate the “work and cancer treatment, and the effect of clay packs
vision” of the Germany-based company’s for- on the quality of life of patients with chronic
mer managing director and founder Dr Wolf- venous insufficiency (CVI). OTC
7
 OTC COMPANY NEWS

Nine-Month Results

Japan sales slide at Taisho

D omestic turnover at Taisho’s Self-Medi-
cation unit slipped back by 0.4% to ¥115.3
billion (C868 million) in the nine months ended
Business

Lipovitan D
Nine-month
sales (¥ billions)
28.7
Change Forecast sales Change
(%)
-5.8
(¥ billions) (%)
35.2 -5.3
31 December 2017, as sales of the Japanese Other Lipovitan 15.4 -9.0 19.8 -6.7
company’s core Lipovitan brand and Livita food Total Lipovitan 44.1 -6.9 55.1 -5.8
products declined.
Cold remedies (Pabron brand) 20.9 +10.9 28.0 +6.5
“Lackluster” demand for energy drinks in
Japan during the period had caused sales of Hair treatments (RiUP brand) 12.3 +0.3 16.2 +1.1
Lipovitan to drop by 6.9% to ¥44.1 billion, Biofermin 6.5 -2.8 8.7 -2.2
Taisho reported. Livita series 2.6 -9.3 3.5 -9.0
Turnover from Lipovitan D fell back by 5.8% Gastrointestinal treatments 3.0 -0.5 3.9 -0.6
to ¥28.7 billion, while sales of other Lipovitan
Laxatives (Colac brand) 2.5 -2.5 3.3 +1.2
products slumped by 9.0% to ¥15.4 billion
Analgesics (Naron brand) 2.4 -8.7 3.1 -8.6
(see Figure 1).
Sales of Livita tumbled by 9.3% to ¥2.6 bil- Cold remedies (Vicks brand) 3.1 +7.9 4.1 +12.2
lion, while turnover from Naron analgesics de- Other Self-Medication products 2.1 +0.4 2.7 -1.9
clined by 8.7% to ¥2.4 billion. Total Domestic Self-Medication 115.3 -0.4 149.9 +0.1
On a more positive note, domestic sales of
Figure 1: Breakdown of Taisho Pharmaceutical’s Self-Medication sales in Japan in the nine months
Pabron cold remedies advanced by 10.9% to ended 31 December 2017. Forecasted sales are for the year ending 31 March 2018 compared with
¥20.9 billion in the nine months, Taisho pointed actual sales in the financial year ended 31 March 2017 (Source – Taisho Pharmaceutical)
out, thanks to new product launches.
At the start of its financial year, Japan’s demand”, the company explained. would work to “strengthen” its product develop-
largest OTC player said it was crucial for the Meanwhile, overall turnover at Taisho’s Self- ment capabilities and invest to bolster newly-
firm to “further strengthen” its domestic business Medication division edged up by 1.9% to ¥140.9 acquired brands.
in the face of “intensified” competition (OTC billion in the nine-month period, as a notable Furthermore, the company would strive to
bulletin, 26 May 2017, page 4). rise in international turnover offset the fall in expand further the footprint of the internation-
Enhancing consumer communications, dev- domestic sales. al business across South-East Asia, Taisho com-
eloping new products and introducing innova- Total international sales jumped by 15.4% mented, and into other regions where it iden-
tive line extensions to key ranges would help to ¥23.5 billion, with Other sales generating tified “high growth potential”.
Taisho to drive growth in Japan, the firm noted. ¥2.1 billion (see Figure 2). To that end, Taisho in 2016 acquired a
Following the release of its nine-month re- International sales of the division’s OTC 24.5% stake in Vietnamese OTC and prescrip-
sults, the company reiterated it was “focusing on drugs improved by 9.6% to ¥13.8 billion. In- tion medicines manufacturer Duoc Hau Giang
enhancing direct communication with consum- ternational turnover from energy drinks advanced Pharmaceutical (DHG).
ers by expanding into new channels, such as by 18.3% to ¥8.5 billion, while other sales gen- Describing DHG as the “largest Vietnamese
mail order”. erated ¥1.2 billion. domestic-invested pharmaceutical company”,
In addition, Taisho was working hard to re- Taisho noted that during the nine months Taisho said at the time that its investment was in
spond to growing “health consciousness” among the firm had continued to “actively develop” its line with its strategy of “enhancing” its business
the Japanese population by “stepping up prod- international business, particularly in Asia. in the “continuously expanding” Asian market
uct development to create new products that Commenting last year on its plans to grow (OTC bulletin, 22 July 2016, page 5). OTC
satisfy consumer needs and also generate new the business further, the Japanese firm said it

Business Nine-month sales

(¥ billions)
Change
(%)
Forecast sales
(¥ billions)
Change
(%)
IN BRIEF
Japan 115.3 -0.4 149.9 +0.1 ASPEN PHARMACARE is reviewing
International OTC drugs 13.8 +9.6 18.6 +8.2 “strategic options” for its global Nutritionals
International energy drinks 8.5 +18.3 10.8 +15.9 business.A range of options would be considered,
International other 1.2 – 1.5 –
the South-African company said, “including,
inter alia, the introduction of a strategic part-
International 23.5 +15.4 30.9 +12.3
ner that could unlock appropriate value”. The
Others 2.1 +0.4 2.7 -1.9 Nutritionals unit – which houses the firm’s in-
Total Self-Medication 140.9 +1.9 183.5 +1.9 fant milk formula brands – had a “particular
Prescription operations 74.9 -4.2 96.0 -3.8 focus on emerging markets”, Aspen pointed out,
Total Taisho 215.8 -0.3 279.5 -0.1 with “well-established businesses and leading
brands in Asia Pacific, Sub-Saharan Africa and
Figure 2: Taisho Pharmaceutical’s sales in the nine months ended 31 December 2017. Forecasted
sales are for the year ending 31 March 2018 compared with actual sales in the year ended 31
Latin America, and a growing presence in the
March 2017 (Source – Taisho Pharmaceutical) Middle East and China”. OTC

8 OTC bulletin 16 February 2018

 COMPANY NEWS OTC

Business Strategy/Third-Quarter Results

Bigger brands key for Prestige

“F ocused efforts on long-term brand build-
ing” are helping to position Prestige
Brands for long-term success in a “challenging
environment”, according to the firm’s chief ex-
ecutive officer Ron Lombardi.
Speaking as the US-based OTC and house-
hold products player announced the results
of its third quarter ended 31 December 2017, Lom-
bardi said building consumer healthcare brands
through innovation was one of Prestige’s key
tools for driving sales.
Prestige’s goal was to develop new products
that helped “grow both our brand and the cat-
egory”, Lombardi explained. Leading this ef-
fort, the firm’s “strong in-house new product
development (NPD) team” was charged with
understanding, and addressing, “unmet consum-
er needs in a variety of ways”, he noted.
“Our brand building methods are wide rang-
ing,” Lombardi insisted, “and we apply any num-
ber [of different approaches] from our tool kit
to drive growth.” Developing “consumer insights”
was key, he said, as was capitalising on “new
channel development opportunities”.
Commenting on some of Prestige’s recent
successes, Lombardi said the Simply foaming
wash line extension to its Summer’s Eve fem-
inine hygiene range appealed to the ‘millennial’
consumer’s desire for simple ingredients that
were free of harsh chemicals.
New flavour introductions – such as Red
Hot Cinnamon – to its Luden’s throat lozeng-
es brand met consumer’s desires for “exciting
flavour profiles”, he said, while the introduc-
tion of BC Sinus, Congestion and Pain ex-
tended the well-known BC pain-relief brand
into the sinus congestion category.
“Our consistent pipeline of new products
helps differentiate our brands in the market-
place and drive category growth, which is im-
portant for both us and our retail partners,”
Lombardi insisted.
“All of our efforts are showing results,”
Lombardi claimed. “Driven by our brand-
building efforts over the past five years, our
core portfolio has outpaced growth in the cat-
egories in which we compete.”
“This success is a clear reminder of the
power of brands and the benefits that they
can have to retailers,” Lombardi insisted. “As
many retailers continue to struggle to gener-
ate revenue growth, our brand strategy offers
high growth, innovative products.”
Turning to Prestige’s third-quarter results,
Lombardi said “strong consumption trends”
across its portfolio had helped push up Prestige’s
group sales by 24.8% in the three months.
The firm’s third-quarter turnover of US$271
million (C218 million) had been driven primar-
ily by its acquisition of CB Fleet last year (OTC
Prestige’s BC sinus congestion product
bulletin, 13 January 2017, page 3), Lombardi
noted, with the company also benefitting from
“continued solid consumption” in the three months.
These strong consumer-consumption levels
across Prestige’s “core OTC brands”, Lombardi
added, demonstrated the success of the firm’s
“brand building efforts and portfolio evolution”.
Sales at Prestige’s core North American
OTC Healthcare business jumped by 27.3% to
US$226 million in the three months, driven pri-
marily by the Fleet acquisition.
Meanwhile, incremental revenues from some
of the acquired Fleet brands, plus the growth
of the company’s “legacy OTC brands”, helped
lift third-quarter turnover at Prestige’s Inter-
national OTC Healthcare division by 39.3%
to US$25.7 million.
OTC sales accounted for 93% of Prestige’s
total third-quarter sales, with the remainder gen-
erated by the Household Cleaning segment. OTC

Business Strategy

Hermes ready for

Russian production
H ermes Pharma’s two production plants
in Wolfratshausen, Germany, and Wolfs-
berg, Austria, have been deemed compliant with
good manufacturing practice (GMP) follow-
ing inspections by Russian authorities.
As a result of the inspections, both the Ger-
man and the Austrian facilities are now author-
ised to manufacture granules and lozenges, as
well as effervescent and chewable tablets.
We support healthcare companies with innovative products in internationalising their business
Plant optimised in Europe and the UK, and focus on CE Medical Devices, Nutraceuticals, Dermocosmetics and
OTC products:
The Wolfratshausen plant – which has a foot-
print of 12,400 sq m – is optimised for produc- n To help innovative healthcare companies to extend the market window
ing moisture-sensitive effervescent tablets, and n To open business opportunities by linking partners
manufactures 800 million effervescent and chew- n To offer attractive health problem solutions, e.g. for cough & cold, baby colics, nail fungal,
able tablets annually. pain management, IBS, cancer integrative care, wound management and many other topics
Meanwhile, the Wolfsberg facility covers
We offer you product opportunities for certain countries/territories, mainly for Europe please
an area of 12,500 sq m, encompassing an 8,000
find some under www.medserva.eu or contact us per e-mail marketing@medserva.com
sq m clean room and a fully automated high-
rack warehouse. OTC

16 February 2018 OTC bulletin 9

 OTC COMPANY NEWS
Annual Results
Nutraceutix
boosts Probi
P robi recorded double-digit growth at its Con-
sumer Healthcare business in 2017 as it con-
tinued to reap the benefits of acquiring US-based
contract manufacturer and supplier Nutraceutix.
Thanks to a full year of sales from Nutra-
ceutix – which Probi snapped up for US$105
million (C85.6 million) in 2016 (OTC bulletin,
17 June 2016, page 7) – the Swedish probiotics
specialist posted Consumer Healthcare sales up
by 42% to SEK578 million (C15.9 million) in
the 12 months.
Noting that Nutraceutix had now been fully
integrated into the company, Probi said that go-
ing forward it would operate the business as a
distinct division, Probi USA.
Distribution to expand
Through the division, Probi had signed an
agreement with a new partner to introduce its
FerroSorb probiotic – marketed as a supplement
to improve iron absorption – in North America,
the company pointed out.
Furthermore, the Swedish manufacturer said
it had secured the first purchase orders for its
Probi Select range of immune and digestive health
probiotics in the US market.
Excluding the impact of the Nutraceutix deal,
Probi noted that Consumer Healthcare’s turnover
had actually fallen in 2017, as a result of con-
tinued destocking by an unnamed customer.
The expected detrimental effects of destock-
ing on the company’s 2017 sales had been moot-
ed by Probi’s chief executive officer, Peter Nähl-
stedt, following publication of the company’s
nine-month results (OTC bulletin, 24 Nov-
ember 2017, page 5).
Consumer Healthcare sales accounted for
94% of Probi’s total annual turnover, which
rose by 38% to SEK612 million.
Group earnings before interest, tax, depre-
ciation and amortisation (EBITDA) grew at
the slower rate of 3.1% to SEK157.3 million,
reflecting the impact of destocking.
Turning to its Functional Food business
– which accounted for 5.6% of Probi’s total
2017 turnover – the firm reported sales down
by 2.2% to SEK34.2 million.
Despite falling sales at Functional Foods,
the Swedish firm said it had reason to be op-
timistic about the unit’s growth prospects af-
ter securing a deal with an unnamed “global
fast moving consumer goods” firm to launch
in North America next year a functional food
product containing Probi’s proprietary bacte-
ria for gut health. OTC
10
Mergers & Acquisitions
China’s By-Health
grabs Life-Space
C hinese dietary supplements specialist By-
Health is poised to expand substantially
its product portfolio and geographic reach by
snapping up Australian probiotics manufacturer
Life-Space Group. Subject to shareholder and
regulatory approval, the transaction implies an
enterprise value for Life-Space of “up to A$690
million (C440 million)”.
Noting that Life-Space had a presence in
China, North America and Europe, as well as
its domestic market, By-Health said the acqui-
sition represented a “natural progression” to-
wards the Chinese firm becoming a “globally
recognised” supplements player.
The “Australian probiotic market leader”,
Life-Space, By-Health noted, operated the Evo-
lution Health and Ultramix supplements busi-
nesses, and also owned the Life-Space product
range, which was popular in China andAustralia.
In addition, Life-Space distributes the Healthy
Essentials, Elmore Oil and Corams lines, de-
scribed by By-Health as a “diverse brand port-
folio in the natural health; joint and muscular
pain-relief; and infant and baby-care categories”.
While Life-Space had a strong presence in
its domestic market, By-Health pointed out that
the firm’s brands had become “highly recog-
nised by Chinese consumers”, thanks to their
“quality and attributes”. Since entering China
in 2014, Life-Space’s sales in the country had
“rapidly expanded”, By-Health noted.
“As a part of By-Health’s strategy, the ac-
quisition of Life-Space is an important step for
the continuing large-scale development of the
company,” commented By-Health’s chief execu-
tive officer Zhicheng Lin.
“The probiotics market is one of the fastest-
growing supplement segments,” Lin pointed out.
“Life-Space has received public praise for its
online experience and brand, and meets the re-
IN BRIEF
BOIRON – the French homoeopathy spe-
cialist – posted turnover up by 0.5% to C618
million in 2017, as sales rose in its domestic
market and North America. Turnover in France
had increased in the 12 months by 2.1% to C378
million, Boiron pointed out, thanks to better sales
of its OTC Specialties. Meanwhile, Boiron said
higher sales in the US had helped to lift turn-
over in North America by 5.6% to C68.6 million.
Life-Space’s eponymous probiotics line
quirements to become a global probiotics leader.”
By owning Life-Space and its brands, By-
Health would have more opportunities to “de-
velop new product categories and channels”,
Lin insisted. Furthermore, Life-Space would be
able to “take advantage of By-Health’s market-
ing network and channels”, he said, “to improve
its own presence in China and continue its strong
growth momentum”.
“Together,” Lin added, “the two companies
will generate synergies at both a product and
business level and explore new growth oppor-
tunities in the market.”
Commenting on the deal, Ben McHarg, Life-
Space’s managing director, said By-Health was
the “most natural owner” for the company and
the best “home for our brands”.
“By-Health shares many of the same values
that we feel are vital in building our own busi-
ness,” McHarg insisted, “and we look forward to
a long and successful future together.”
Established in 1995, and listed on the Shenz-
hen Stock Exchange, By-Health claims to be a
“leading” player in the Chinese supplements
market. Its brands include Keylid, GymMax
and Naturone, as well as its eponymous line.
By-Health also operates a joint venture in
China with US-based The Nature’s Bounty Co.
Through the venture – established in 2016 (OTC
bulletin, 25 March 2016, page 3) – By-Health
distributes Nature’s Bounty’s own-brand and
Mex-Rx product ranges. OTC
On a more negative note, the firm posted turnover
in Europe, excluding France, down by 5.3% to
C155 million, as sales fell in Russia. Turning to per-
formance by product category, Boiron posted
sales of its OTC Specialities up by 2.0% to C306
million. Turnover from Non-proprietary Homoeo-
pathic Medicines slipped back by 0.9% to C311
million, while sales of ‘Other’ products fell by
4.0% to C1.4 million. OTC
OTC bulletin 16 February 2018
 GENERAL NEWS OTC

Regulatory Affairs Industry Associations

HTA proposal BAH slams attack by

is welcomed
A proposal to boost cooperation between consumer watchdog
European Union (EU) member states for
assessing health technology has been cautiously
welcomed by the Association of the European
G erman industry association, the BAH, has
slammed a recently-released list of 35
OTC brands which consumer watchdog Stiftung
these well-known brands.
“Even the most popular OTC medicines
requested by patients receive the mark ‘not suita-
Self-Medication Industry, the AESGP. Warentest claimed were “unsuitable”. ble’ in the report,” commented Weiser. “Those
The European Commission (EC) proposal Stiftung Warentest – a product-testing organi- medicines are popular for a reason. They ob-
aimed to formalise over 20 years of voluntary sation founded by the German government – rated viously fulfil patients’ expectations.”
cooperation between member states in the health 35 leading OTC brands as “poorly performing”, Weiser emphasised that the OTC medicines
technology assessment (HTA) area and build due to a lack of effectiveness, unwanted side named in the list had been through clinical trials,
upon the work carried out by the HTA network effects or unnecessary combination of active a strict approval process, and were tried and
established in 2013, the EC said, which had ingredients (see Figure 1). tested by pharmacists and patients.
developed a “solid knowledge base on methodol- “Stiftung Warentest completely ignores these
ogies and information exchange with regards List of big brands criteria,” he argued. “Like all medicines in Ger-
to the assessment of health technologies”. In the majority of cases, the list – which in- many, OTC medicines have been authorised
Under the proposed regulation of HTA, mem- cludes well-known brands such as Procter & by a competent authority and tested for quality,
ber states would be able to use common HTA Gamble’s (P&G’s) Wick range of decongestants, safety and efficacy.”
tools, methodologies and procedures across the Pfizer’s line of Spalt analgesics and Reckitt
EU, the EC said, on four main areas: Joint clini- Benckiser’s (RB’s) Gaviscon Advance Heart- Safe for consumers
cal assessments focusing on the most innovative burn Relief Liquid – suggested patients should “Most of them have been marketed for many
health technologies with the most potential for turn to non-branded, single-ingredient prod- years, and due to their particularly positive ben-
patients; joint scientific consultations whereby ucts in their place. efit-risk ratio are available without a prescrip-
developers can seek advice from HTA authorities; Martin Weiser, BAH director general, told tion,” Weiser added.
identification of emerging health technologies OTC bulletin that Stiftung’s “sweeping assess- “If a physician or a pharmacist recommends
to identify promising technologies early on; and ment” had neglected the positive experiences an OTC medicine, patients can usually take it
continuing voluntary cooperation in other areas. patients, doctors and pharmacists had had with without hesitation,” he insisted. OTC
EU member states, the EC pointed out, would
Product Criticism Alternative
continue to be responsible for assessing non-
clinical – economic, social and ethical – aspects Wick DayMed Kombi Not a meaningful combination Individual cold symptoms
Cold Capsules of painkiller, cough expectorant – such as pain, cough and
of health technology and for making decisions Procter & Gamble and stimulating agent. runny nose – would be better
on pricing and reimbursement. paracetamol, guaifenesin, treated separately.
The AESGP welcomed the proposal’s efforts and phenylephrine
to foster better cooperation on clinical assess-
Grippostad C Capsules Not a sensible combination For pain and fever, use
ments, while also maintaining the individual
Stada Arzneimittel of a painkiller and an paracetamol on its own.
rights of EU member states to oversee pricing paracetamol, antihistamine. In the case of a cold,
and reimbursement. chlorphenamine, the short-term use of
However, while the proposal allowed for caffeine and vitamin C decongestant nasal sprays or
the involvement of pharmaceutical firms, as well drops is more tolerable.
as patients, clinical experts and other stakehold- Aspirin Complex Not a sensible combination of For pain and fever, use
ers, the association called for a more transparent Granulat a painkiller and a stimulant. acetylsalicyclic acid on
mechanism on how patient or physician engage- Bayer its own. In the case of a
acetylsalicyclic acid cold, the short-term use of
ment was organised by the HTA network.
and pseudoephedrine decongestant nasal sprays or
Some improvements had been made on the hydrochloride drops is more tolerable.
involvement of external experts, the AESGP
said, but there needed to be a more “structured Gaviscon Advance That the combination of Active ingredients such as
Heartburn Relief Liquid active ingredients work better hydrotalcite, magaldrate,
and transparent process”. Reckitt Benckiser than when taken individually ranitidine, omeprazole and
“Therefore, the pharmaceutical industry sup- potassium bicarbonate is not proven. Potassium pantoprazole are also suitable.
ports the development of a transparent and ef- and sodium alginate bicarbonate can cause
fective criteria framework,” the association add- stomach discomfort.
ed, “in order to ensure adequate involvement Spalt Pain-Relief Tablets The combination of For pain, a suitable painkiller
from stakeholders and to consider input from Pfizer acetylsalicylic acid and on its own, for example
all members of the HTA network.” acetylsalicylic acid paracetamol offers no acetylsalicylic acid,
The proposal will now be discussed by the and paracetamol additional therapeutic paracetamol or ibuprofen, if
benefits, and also carries the more suitable.
European Parliament and Council of Ministers.
risk of side effects.
Once adopted and it enters into force, it will be-
come applicable three years later. OTC Figure 1: Examples of the products reviewed and criticised by Stiftung Warentest (Source – Stiftung Warentest)

16 February 2018 OTC bulletin 11

 MAKE YOUR MARK

O
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Supported by
 OTC GENERAL NEWS
Market Research
Green scrips growing steadily
G erman doctors continued to recommend
non-prescription medicines to patients using
‘green’ prescription pads in 2017, with the num-
ber of such prescriptions growing steadily ac-
cording to IQVIA market data.
Introduced in response to Germany’s delist-
ing from reimbursement of most non-prescrip-
tion medicines in 2004, the grüne rezept – or
green prescription – scheme enabled doctors
to write recommendations for non-reimburs-
able medicines on green notes designed to look
like prescribing pads (OTC bulletin, 17 March
2010, page 12).
Green prescriptions were intended to boost
consumer confidence in buying non-prescription
medicines for themselves and reassure patients
that the non-prescription medicines they were
buying were approved and were needed.
This innovation acted to sustain the non-pre-
scription market that had been devastated by de-
reimbursement, contributing to the 38% growth
recorded by the self-medication market in Ger-
many between 2004 and 2016 (OTC bulletin,
26 May 2017, page 24).
According to the latest IQVIA figures, green
prescriptions as a proportion of all prescriptions
issued by doctors in Germany increased from
1.2% to 6.3% during the same period.
Last year the number of green prescriptions
issued in Germany continued to grow steadily,
increasing by 7.7% to 47.3 million in the year
ended 30 September 2017 (see Figure 1).
Just over a quarter of green prescriptions were
for cough and cold medicines in the 12 months
– growing by 13.5% to 12.6 million – almost five
times the next category, pain-relief, which jump-
ed by 9.8% to 2.8 million.
The strongest rise came from the throat-pain
category, with doctors writing 2.2 million green
prescriptions for such products, an increase of
19.6%. Vitamins and the anti-diarrhoea, oral
Regulatory Affairs
UK and China expand cooperation
T he UK’s Medicines and Healthcare prod-
ucts Regulatory Agency (MHRA) and the
China Food and Drug Administration (CFDA)
have signed a Memorandum of Understanding
(MoU) outlining new areas of cooperation be-
tween the two agencies.
Building on the MoU signed in 2014 – which
focused on exchanging safety information on
medicines and medical devices – the latest agree-
ment covers an exchange of learning from the
14
Category Number of green
prescriptions (millions)
Change
(%)
Cough and cold 12.6 +13.5
Pain-relief 2.8 +9.8
Anti-diarrhoea, oral electrolytes, digestive health 2.8 +14.6
Throat-pain remedies 2.2 +19.6
Blood-thinning agents 2.1 +2.3
Antacids, anti-flatulence and ulcer therapies 1.8 +9.3
Constipation and colonic irrigation aids 1.7 -1.3
Antifungals for dermatological use 1.6 ±0.0
Vitamins 1.5 +17.5
Allergy remedies 1.2 +0.2
Topical analgesics 1.1 -1.4
Intimate health 1.0 -2.7
Total top-12 32.4 +8.8
Other 15.0 –
Total green prescriptions 47.3 +7.7
Figure 1: Number of green prescriptions issued in Germany in the year ended 30 September 2017
broken down by product category (Source – IQVIA)
electrolytes, digestive health categories were product and Bayer’s Iberogast herbal gastro-
the next fastest growing, with both outpacing intestinal oral liquid.
the total green prescription market rate with ad- Sinupret and Iberogast were also the second
vances of 17.5% and 14.6% respectively. and third overall best-selling OTC medicines
However, not all categories improved, with respectively through German pharmacy during
the number of green prescriptions for intimate the same period, according to Insight Health
health products dropping by 2.7% to 1 million (OTC bulletin, 24 November 2017, page 14).
in the 12 months, while green prescriptions for Cough and cold remedies dominated the green
topical analgesics fell by 1.4% to 1.1 million. prescription top 10, with six brands being either
Turning to the brands, IQVIA noted that cold remedies or nasal sprays.
the top-10 OTC brands prescribed by doctors Commenting to OTC bulletin on the “suc-
accounted for around a fifth of all green pre- cess story” of its green prescription initiative,
scriptions in the 12 months. the German manufacturers’association, the BAH,
Bionorica’s Sinupret herbal cold remedy said the move had allowed German doctors to
was the brand most prescribed using green pre- continue to recommend OTC medicines, despite
scription in 2017, IQVIA added, followed by limitations imposed by de-reimbursement.
Pohl-Boskamp’s GeloMyrtol sinusitis and cough Information gathered via green prescriptions
had also enabled physicians to “gain an over-
view” of what medicines patients were taking,
the association added, preventing problems aris-
ing from “interactions with other medicines”.
Patients benefitted from the scheme, the
UK’s accelerated access review system and
also how to effectively regulate online sales
of medicines.
BAH argued, as each green prescription was
printed with the most important information about
OTC medicines “at a glance”. Furthermore, many
Commenting on the MoU, Ian Hudson, the statutory health insurance companies were now
MHRA’s chief executive officer, pointed out that willing to reimburse OTC medicines if prescribed
China was a “world leader” in supplying raw via green prescriptions.
materials for the pharmaceutical industry and “Green prescription is well established with-
that closer collaboration between the two agencies in the German health care system,” the BAH
would “support the promotion of innovation, concluded. “It is accepted by patients and streng-
good practice and protect UK patients”. OTC thens the role of pharmacists.” OTC
OTC bulletin 16 February 2018

Market Research
Romania primed for self-care
“T he Romanian self-care market is devel-
oping rapidly and there are numerous
opportunities for the companies operating in this
sector,” according to the Romanian Association
of the Self-Care Industry (RASCI).
However, there remained legislative and regu-
latory challenges that needed to be addressed,
the association told OTC bulletin, and that was
what RASCI was geared up to do.
Established in July 2016, RASCI – a member
of the Association of the European Self-Med-
ication Industry, the AESGP – had brought a
“powerful, competent and unitary voice” to the
self-care sector in Romania, commented its chief
executive officer Diana Mereu.
Formed by local and international companies
– including Bayer, GlaxoSmithKline (GSK)
Consumer Healthcare, Johnson & Johnson (J&J),
Reckitt Benckiser (RB) and Sanofi – RASCI
was founded in response to a bill which passed
through Romania’s lower house of parliament in
2015 that would have banned advertising for
OTC medicines on television and radio.
Industry players pulled together and – aided
by the AESGP – lobbied for the bill to be vot-
ed down. In late 2016, the country’s Senate over-
RASCI is educating Romanians on self-care
Regulatory Affairs
NICE backs OTCs for sore throats
O TC medicines rather than antibiotics should
be the first line of defence for patients in
England suffering from acute sore throat, accord-
ing to the National Institute for Health and Care
Excellence (NICE).
In its recent guidance – ‘Sore throat: anti-
microbial prescribing’– NICE encouraged health-
care professionals to prescribe fewer antibiotics
for cases of acute sore throat and to instead rec-
ommend patients to use OTC medicines to help
manage their symptoms.
16 February 2018 OTC bulletin
whelmingly rejected the ban after Romania’s
President Klaus Iohannis ordered a review of the
bill (OTC bulletin, 4 November 2016, page 18).
Just over a year after seeing off the advert-
ising ban, RASCI had turned its attention in
part to educating Romanians about the benefits of
self-care, Mereu said, by launching a “long-term
educational campaign” targeting consumers,
called ‘Despre sănătate, cu responsabilitate’ –
or ‘About Health, With Responsibility’.
Launched with a debate between representa-
tives of healthcare authorities, institutions and
professionals, and joined by the pharmaceutical
industry and media representatives, the ongoing
campaign, Mereu explained, had been widened
to include a website featuring advice on self-care,
along with television advertising and promo-
tional materials distributed to pharmacies and
clinics across the country.
Consumer campaign in 2018
The campaign would continue throughout
2018 with activity on “all relevant communica-
tion channels”, she added, noting that the initi-
ative had garnered support from the Ministry
of Health, the National Agency for Medicines
and Medical Devices, the Romanian National
Society of Family Medicine, the Romanian Col-
lege of Pharmacists and the Romanian Adver-
tising Council.
On the industry front, Mereu pointed out
that there were still challenges, primarily the
need for the “development, adoption and imple-
mentation of a transparent and predictable legisla-
tive framework” that was in line with European
and international regulations and best practices.
One step in this direction, she explained, was
a bill that was currently being discussed by
committees within the Romanian parliament to
regulate food supplements.
Non-prescription analgesics, such as paracet-
amol and ibuprofen, NICE pointed out, could
treat common sore throat symptoms.
Medicated OTC treatments – including loz-
enges and throat sprays containing either a local
anaesthetic, antiseptic or non-steroidal anti-in-
flammatory drug (NSAID) – could also be recom-
mended to sore-throat sufferers, NICE suggested.
Explaining the reasons for issuing the guid-
ance, NICE said antibiotics made “little differ-
ence” to how long symptoms of sore throat lasted
GENERAL NEWS OTC
Dermatologicals
Vitamins, 8.0% Others
minerals & 2.5%
supplements
Lifestyle
12.6%
OTCs
Analgesics 22.2%
13.4%
Cough, cold,
Gastrointestinals and allergy
19.8% 21.5%
Figure 1: Breakdown of the Romanian self-care
market – worth €680 million – in 2017 by
category (Source – Cegedim)
Furthermore, RASCI would continue to keep
an “open dialogue” with competent authorities
at both a national and regional level, she said, to
ensure that consumer advertising and commu-
nications were fair and not misleading.
In terms of the Romanian self-care market
– which was worth around C680 million in
2017 – OTC drugs accounted for around two
thirds of sales, with supplements (including
medical devices) making up the remainder.
So-called ‘lifestyle’ OTC products account-
ed for 22.2% of the market, RASCI revealed,
followed by cough, cold and allergy products
with 21.5% (see Figure 1).
Gastrointestinal products, together with an-
algesics, accounted for a further 33.2%, the
association said, while vitamins, minerals and
supplements (VMS) took a 12.6% share and
dermatologicals another 8%.
Looking ahead, Mereu said that RASCI’s
efforts to educate consumers about self-care while
at the same time developing stronger regula-
tory frameworks, meant that the “rapidly” devel-
oping Romanian OTC market was well posi-
tioned for a sustainable future. OTC
but were prescribed in 60% of cases when a pa-
tient visited a general practitioner (GP) for advice.
Welcoming the guidance, the Proprietary As-
sociation of Great Britain (PAGB) said it support-
ed campaigns to “reduce unnecessary prescribing
of antibiotics”.
NICE’s recommendations drew attention to
OTC alternatives to antibiotics for sore throat suf-
ferers, the association pointed out, and highlighted
the value of self-care in the healthcare system.
In addition to its advice on curbing unnec-
essary use of antibiotics, NICE also emphasised
the importance of educating the public on their
health and empowering them to self-care. OTC
15
 OTC MARKETING NEWS
Advertising Complaints
NAD questions Xyzal claims
T he US National Advertising Division (NAD)
has told Sanofi Consumer Healthcare’s
Chattem subsidiary to discontinue claims that
the “smart” or “wise” design of its Xyzal Allergy
24HR product made it better than Johnson &
Johnson’s (J&J’s) rival Zyrtec allergy product.
J&J challenged numerous claims made by
Chattem in the marketing materials for Xyzal
(levocetirizine) targeting healthcare professionals,
which featured a “wise” owl and a number of
statements alluding to the product’s supposed
benefits compared to competing allergy brands.
Consumer advertising for Xyzal has consist-
ently used the image of a wise owl dressed as a
professor to convey the message that the brand
is a “wise” choice for allergy sufferers, with a
current YouTube advertisement on the brand’s
website using an animated owl – sporting an
English accent – to explain the benefits of the
product and signing off with the tagline: “Be
wise all, take Xyzal.”
Explaining its rationale for recommending
Chattem stop using certain claims made in Xyzal
healthcare professional advertising, the NAD
said it had considered whether the advertising
at issue implied that Xyzal offered a “product
performance benefit over Zyrtec and other OTC
oral antihistamines or that Xyzal has the same
efficacy as Zyrtec with half the medicine”.
Noting that the challenged advertisements
appeared on Xyzal’s healthcare professional
website and featured the “image of an owl in a
labcoat alongside a blackboard, with scientific
drawings, a comparison chart and references
to various aspects of Xyzal Allergy 24HR’s
Marketing Campaigns
Em-eukal returns to German screens
D r C Soldan’s Em-eukal cough drops have
returned to German television screens for
the third year running, with a new creative high-
lighting the brand’s natural ingredients.
Using the tagline “so gentle, so juicy, so
fruity” the creative shows dramatic close ups
of the key ingredients in the brand’s wild cherry
Television spots for Em-eukal focus on flavour
16
pharmacological makeup as compared to that
of Zyrtec – which were characterised as being
“wise” and “smart” – the NAD said that de-
spite the light-hearted tone of the advertising,
certain claims implied that Xyzal was “better
or more efficacious than Zyrtec because of its
pharmacological design”.
“The use of a wise owl and the advertising’s
emphasis on a smart design help convey the
message that Xyzal is superior to Zyrtec in a
meaningful way,” the NAD concluded, “and
Chattem was not merely informing healthcare
providers about the design differences in the
products, but conveying the message that Xyzal
is superior to Zyrtec so that healthcare provid-
ers will recommend Xyzal Allergy 24HR in-
stead of competing OTC oral antihistamines
(including Zyrtec) to their patients.”
“While advertisers are free to highlight mean-
ingful differences between their product and
a competing product,” the NAD said, “the high-
lighted differences should be truthful and pro-
vide meaningful benefits.”
Discontinue claims
Following its review of the evidence in the
record, the NAD recommended that Chattem
discontinue the following claims:
“A smart formulation is now a wise OTC
choice for allergy sufferers”
“See why a smart molecule matters”
“Delivers potency with a smart design”
“Potent proof that not all OTC oral anti-
histamines are built the same”.
Furthermore, the NAD recommended that
and sage-flavoured gummy drops.
Against a colourful backdrop, sage leaves
move through the air, before a wild cherry is
hit by an Em-eukal gummy drop and explodes
dramatically. The gummy drop – now infused
with the wild cherry flavour – hits a bag of sage
and wild cherry Em-eukal gummy drops and
falls to the floor revealing a shot of the range
of Em-eukal gummies and hard candies.
Running until early March, the commercial
will be broadcast on a number of major German
television channels and during coverage of the
PyeongChang 2018 Olympic Winter Games .
Furthermore, a sampling programme was un-
derway, Soldan said, covering 14 German cities
until the end of March. OTC
The NAD questioned Chattem’s‘wise’claims for Xyzal
Chattem discontinue the claims: “Xyzal Allergy
24HR provides the same relief as Zyrtec, with
half the medicine”; and “Xyzal has the same
efficacy as Zyrtec with half the medicine”.
However, it said that Chattem had provided
a reasonable basis to support the standalone
claim: “Xyzal delivers efficacy in a 5mg tablet.”
The NAD also recommended that a num-
ber of claims related to the pharmacological
design of the product be modified, however
it ruled that three of the challenged claims –
“Xyzal works differently from other oral anti-
histamines”; “Active enantiomer of Zyrtec with
no dextrocetirizine”; and “potent H1 blocker” –
had been substantiated by Chattem.
Pointing out that whilw Chattem could “high-
light pharmacological differences between oral
antihistamines which may cause them to dif-
fer from a potential toxicity perspective for
individuals in certain risk groups and which
may not be included in OTC labelling”, the regu-
latory body warned the company to “avoid mak-
ing any express or implied claims about Xy-
zal – including comparative claims – that are
clinically irrelevant”.
In its response to the NAD’s ruling, Chat-
tem said it had agreed to comply with the recom-
mendations, although it noted that it disagreed
with the NAD’s position that “healthcare practi-
tioners or consumers would be misled by Chat-
tem’s other advertising”.
“Out of respect for the NAD,” Chattem said,
“the company will take the decision into con-
sideration in future advertising.”
The NAD noted that during the course of the
investigation, Chattem had chosen to “perma-
nently discontinue” patient satisfaction claims
initially challenged by J&J.
A recommendation by the NAD to modify
or discontinue a claim, the body added, was not
a “finding of wrongdoing” and an “advertiser’s
voluntary discontinuance or modification of
claims should not be construed as an admission
of impropriety”. OTC
OTC bulletin 16 February 2018

Marketing Campaigns
Femibion backs working mums
M otherhood should be celebrated as a way
of furthering a career, rather than por-
trayed as a roadblock to getting ahead, accord-
ing to a new campaign by Merck Consumer
Health for its Femibion supplement range.
Building on a survey conducted by the Ger-
man firm revealing that 62% of women believe
having children halts or delays career pro-
gression, the online MumPlus campaign for
Femibion – a multivitamin for pregnancy –
utilises the LinkedIn career-focused social net-
work in an attempt to change attitudes towards
working mothers and to allow women to list
motherhood as part of their career history.
There was a need for a “fundamental change
of narrative in the workplace”, Merck insisted,
to one where motherhood was “rightly valued”
and seen as something to be proud of.
While 94% of women agreed that mother-
hood needed to be recognised as a positive in the
workplace, many said that the reality did not
meet their expectation, the company added.
By utilising Femibion’s core audience of moth-
ers, Merck has created a series of videos. The firm
said these videos shared the “reassuring message
that it should be a dualism of ‘motherhood and
career’, and not an ‘either/or’ decision”.
A MumPlus campaign page had been
launched on LinkedIn, Merck said, to “inspire
women to show support for the campaign and
encourage employers to think differently about
the working mothers around them”.
To further carry the campaign’s message a
LinkedIn ‘badge’ had been developed, the com-
pany explained, for working mothers to display
on their profiles.
A video on the campaign page shows a work-
ing mother explaining her frustration that she
cannot put motherhood on her CV, despite the
role being “one of the hardest jobs, and one of
the best jobs in the world”.
The creative goes on to explain that Femibion
believes that motherhood is a “qualification
to be proud of” and that the skills mums learn
are a “great addition to any career”.
The latest Vigantolvit campaign
16 February 2018 OTC bulletin
MARKETING NEWS OTC
A short tutorial on how to add the MumPlus
badge to a LinkedIn profile follows, with the
creative ending with a call to action for women
to share the video on LinkedIn and YouTube
and “support working mums everywhere”, along
with a link to the MumPlus page on the Femi-
bion website.
Describing LinkedIn as a “crucial platform
for working mums who are building their pro-
fessional profile”, Merck noted by using the plat-
form, Femibion was leading the digital trans-
formation of the Merck Consumer Health busi-
ness, and engaging with consumers online as
a key part of its marketing strategy.
Meanwhile, Merck has also launched a part-
nership programme with pharmacists in the UK
off the back of the company’s WE100 move-
ment, which aims to “prepare society for a new
era of humans living 100 healthy years”.
Having launched last year a report under the
WE100 banner on what could be done to put
children on the right path towards living for a
century and being as healthy as possible for as
long as possible (OTC bulletin, 11 August 2017,
page 20), Merck has released its “Young for
Old, Old for Young” pharmacist training pro-
gramme to begin “bridging the gap between
living longer and living longer and healthier”.
Focused on supporting pharmacists to tackle A video shows how to add a MumPlus badge
to a LinkedIn profile
specific challenges faced by ageing consumers,
such as poor nutrition, the programme, Merck many for its recently launched Vigantolvit vita-
said, would improve pharmacists’ skills when min D supplement.
it came to providing appropriate health and nu- Centred on a 60-year old grandmother who
tritional advice. continues to go surfing alongside her daughter
Commenting on the Young for Old, Old and granddaughter, the campaign, Merck said,
for Young campaign, Uta Kemmerich-Keil, illustrated the “desire of Vigantolvit to help
Merck Consumer Health’s chief executive of- bring generations together” by encouraging a
ficer, said that the programme illustrated that the healthy lifestyle for consumers of all ages.
WE100 movement was “rooted in the belief” that OTC
as people lived longer lives, doing so as healthily
as possible needed to be the “top priority for IN BRIEF
all generations”.
Reinforcing the company’s desire to help BEST CHOLINE has launched its Choline
maintain the health of all generations, Merck Gummies for Children and Adults in the US.
has also rolled out a consumer campaign in Ger- Claiming that choline was essential for brain
development, organ function and memory, the
firm said the citrus-flavoured gummies – avail-
able in bottles of 90 – specifically targeted the
cognitive development of unborn and school-
aged children. Drawing on research, that high-
lighted the risks of not consuming choline during
pregnancy, the firm claimed that consumption
of choline by pregnant women supported brain
development. “The amount of Choline consumed
during pregnancy affects learning potential for
Merck is offering training on elderly nutrition a lifetime,” the company said. OTC
17
 OTC MARKETING NEWS
Cuderm Gel Wash is the latest addition to Synergy
Biologics Cuderm moisturising skin-care range,
which was launched in the UK last year.
A soap- and alcohol-free gel wash, with oatmeal
extract, Cuderm Gel Wash was designed “for those
who want a gentle but effective face and body
cleanser”, Synergy said,“that doesn’t contain harsh
ingredients that can dry and irritate the skin”.
“For those with dry or sensitive skin, finding the
right soap or shower gel can be a complex game
of trial and error,” the company claimed.“Many
soaps and shower gels contain unnecessary
chemicals that can strip the skin of its essential
oils which, over time, can leave it dry and irritated.”
Cuderm Gel Wash delivered “great skin care”
but didn’t ignore the “luxurious aspects of bubbles
and a little fragrance” which made bath and
shower time such a pleasure, Synergy claimed.
The product also helped to “naturally cleanse and
moisturise dry and sensitive skin, while maintaining
the skin’s natural pH balance” the firm added.
Available in pharmacies now, Cuderm Gel
Wash has a retail price of £5.49 (C6.19). OTC
An “effortless way” to consume probiotics is
how Otsuka Pharmaceuticals is positioning its
Body Mainté Drink liquid supplement in Japan.
Sitting alongside Otsuka’s existing Body Mainté
Jelly nutritional food, Body Mainté Drink was
a “physical conditioning beverage”, the firm
claimed, targeted at those consumers who made
an effort to maintain “optimum physical condition
among the routine risks of every day life”.
Both Body Mainté Drink and jelly contained
Otsuka’s proprietary lactic acid bacteria B240,
the firm pointed out, which supported the “main-
tenance of physical condition”.
The Body Mainté liquid supplement also
comprised electrolytes for hydration, had a
“pleasant green citrus flavour”, and was a
low-calorie option, Otsula explained.
The beverage has a recommended retail price
of ¥154 (€1.12). OTC
IN BRIEF
KLOSTERFRAU has launched the D-man-
nose food supplement for cystitis in pharma-
cies across Germany. OTC
18
Product Launches
P&G takes ZzzQuil
into supplements
“H elps regulate your sleep cycle without
next day grogginess” is the promise to
US consumers from Procter & Gamble (P&G)
with the latest addition to its Vicks ZzzQuil
sleep-aid range, ZzzQuil Pure Zzzs gummies.
A melatonin-based supplement, Pure Zzzs
is the first non-medicine to be added to the estab-
lished ZzzQuil line, which already includes the
diphenhydramine-based ZzzQuil liquids and
ZzzQuil liquicaps.
Designed to corner the US natural sleep-aid
market, according to P&G’s chief financial offic-
er Jon Moeller (OTC bulletin, 2 February 2018,
page 5), Pure Zzzs was “naturally free from arti-
ficial flavours, gluten, lactose and gelatine”.
Pure Zzzs featured the “optimal level of mela-
tonin” to regulate users’ sleep cycles, P&G
claimed, without causing grogginess the next day.
Users were further helped to “fall asleep
naturally and wake refreshed”, the company said,
by the product’s “fusion of lavender, chamomile,
lemon balm and valerian”.
The product is set to be launched online at
the end of February and will be rolled out in
stores during March.
Taking ZzzQuil into the supplements space
was a reaction, Moeller said in January, to the
growing demand for more natural offerings.
The company was continuing to “develop
Product Launches
BioGaia expands Swedish portfolio
P
robiotics specialist BioGaia has grown its
presence in Swedish pharmacies by introduc-
ing chewable tablets containing the company’s
patented lactobacillius reuteri Protectis pro-
biotic with vitamin D.
Available now in three Swedish pharmacy
chains – Apoteket AB, Apotek Hjärtat and
Apotea – BioGaia Protectis with vitamin D was
designed to not only maintain a healthy gut, the
BioGaia Protectis with vitamin D
Vicks ZzzQuil Pure Zzzs contain melatonin
new natural offerings to increase the relevance”
of its brands and products with the “naturals
consumer”, Moeller admitted, and the “increas-
ingly environmentally concerned shopper”.
Preference for natural products spread across
a wide demographic, he insisted, and included
both ‘baby-boomer’ and ‘millenials’.
P&G expanded the Vicks cold brand into the
sleep-aid category in 2012 when it launched
ZzzQuil with the tag line: “It’s not for colds, it’s
not for pain, it’s just for sleep” (OTC bulletin,
15 June 2012, page 11).
Branded as being “From the makers of Vicks
NyQuil”, ZzzQuil has performed strongly since
its launch, breaking the US$100 million (C81.7
million) sales barrier in 2013 (OTC bulletin,
7 April 2017, page 21). OTC
company said, but also to help tackle the prob-
lem of vitamin D deficiency in Sweden.
Axel Sjöblad, BioGaia’s managing director,
pointed out that vitamin D deficiency was a
common problem in Sweden, especially during
the winter, so it was logical to bring to the mar-
ket a product which combined vitamin D with
the firm’s patented probiotic formulation.
Launched in association with sales and mar-
keting services company MedHouse, BioGaia
Protectis with vitamin D is available in two
strengths, one containing 10µg of vitamin D
per chewable tablet – the recommended daily
dose in Sweden for people under 75 years –
and a higher strength version which contains
20µg of vitamin D for those aged over 75 years,
for adults with limited exposure to sunlight,
or in other circumstances that prevent natural
vitamin D absorption. OTC
OTC bulletin 16 February 2018
 EVENTS OTC

MARCH 26-27 February

AESGP Conference with the
1-2 March
European Union Medicines Agencies
Capitalising on Change Lisbon, Portugal
Through OTC Innovation ‘Public and consumer health: Future priorities for European Union (EU) Medicines Agencies’ is
and Business Development the theme of this two-day event organised by the Association of the European Self-Medication
London, UK Industry, the AESGP, with the EU Heads of Medicines Agencies (HMA).
A two-day conference and networking event There will be sessions on ‘Self-care as the first choice in healthcare – which issues need to
organised jointly by OTCToolbox and the be addressed by medicines agencies?’; ‘Regulatory optimisation’; and ‘The impact of new
Pharmaceutical Licensing Group (PLG). medical device regulation’.
Contact: OTCToolbox. Speakers will include: Zaide Frias of the European Medicines Agency (EMA); Andrzej Rys of
Tel: +44 121 314 8757. the European Commission; Klaus Cichutek of the HMA; Ian Hudson and John Wilkinson of the
Email: deborah.wilkes@otctoolbox.com. UK’s Medicines and Healthcare products Regulatory Agency (MHRA); and Karl Broich of the
Website: plg-group.com/events/3rd-otc-event. federal institute for drugs and medical devices, BfArM.
1-2 March Contact: AESGP. Tel: +32 2 735 51 30. Email: info@aesgp.eu. Website: aesgp.eu/lis18.
Pharmaceutical Regulatory
Affairs in Russia and Contact: Forum Institut für Management. 30 April 2018
the Eurasion Union Tel: +49 6221 500 696. Pharmacovigilance
London, UK Email: j.jegodka@forum-institut.de. London, UK
Countries covered at this two-day meeting in- Website: forum-institut.de. A one-day course focusing on pharmacovigi-
clude Armenia, Belarus, Russia and Ukraine. lance and regulatory requirements.
11-14 March
Contact: Management Forum. Contact: Management Forum.
CHPA Annual Tel: +44 20 7749 4730.
Tel: +44 20 7749 4730.
Executive Conference Email: info@management-forum.co.uk.
Email: info@management-forum.co.uk.
Florida, US Website: management-forum.co.uk.
Website: management-forum.co.uk.
The annual meeting of the US Consumer
5-6 March Healthcare Products Association (CHPA).
EuroPLX 66 Contact: CHPA. MAY
Lisbon, Portugal Tel: +1 202 429 9260.
This two-day meeting will provide a forum Email: amamone@chpa.org. 8-11 May
for business development decision makers Website: chpa.org/aec. Digital Healthcare Asia
for discussing and negotiating collaborative Singapore
agreements in licensing, marketing, and dis- APRIL A four-day summit amalgamating the views
tribution of patented medicines, generics, bio- of medical professionals and IT experts.
similars, OTC products, medical devices and 17-19 April Contact: IBC Asia.
food supplements. Tel: +65 6508 2401.
DIA 30th Annual EuroMeeting
Contact: RauCon. Email: register@ibcasia.com.sg.
Basel, Switzerland
Tel: +49 6221 426 2960. Website: digitalhealthcareasia.com.
‘Join us at the crossroads of healthcare’ is
Email: meetyou@europlx.com.
the theme of this three-day meeting organised 15-17 May
Website: europlx.com.
by the Drug Information Association (DIA). Vitafoods Europe
7-11 March Contact: DIA. Geneva, Switzerland
Engredea Tel: +41 61 225 5151. A three-day exhibition and conference focus-
California, US Email: emea.exhibition@diaglobal.org. ing on nutraceuticals, and functional foods
A five-day event looking at natural and org- Website: diaglobal.org/europe2018. and drinks.
anic health products. 22-23 April Contact: Informa.
Contact: Engredea. Tel: +44 20 7017 6297.
Natural & Organic
Tel: +1 866 458 4935. Email: aimee.went@informa.com.
Email: tradeshows@newhope.com.
Products Europe
Website: vitafoods.eu.com.
London, UK
Website: engredea.com/en18.
This two-day event is described as Europe’s
8-9 March biggest trade show for natural products. JUNE
Pharmacovigilance in Europe Contact: Diversified Communications.
Amsterdam, the Netherlands Tel: +44 1273 645 126. 5-7 June
Drug safety, regulations and guidelines will Email: cdunning@divcom.co.uk. 54th AESGP Annual Meeting
be discussed at this two-day seminar. Website: naturalproducts.co.uk. Amsterdam, the Netherlands
‘Connecting the smart consumer’ is the theme
8 March of this three-day annual meeting of the As-
OTC Marketing Awards 2018 sociation of the European Self-Medication
London, UK Industry, the AESGP. Topics to be discussed
Organised by OTC bulletin, these Awards recognise the best of include sustainable healthcare systems, the
the British OTC industry. Join the party and celebrate all of your changing OTC marketplace, switches, the
achievements at the OTC industry’s most talked about and most MARKETING AWARDS digital revolution and artificial intelligence.
Recognising the best of the British OTC Industry
glamorous night of the year. 2018 Contact: AESGP.
Contact: OTC bulletin. Tel: +32 2 735 51 30.
Tel: +44 1564 777 550. Email: awards@otc-bulletin.com. Website: otc-bulletin.com/awards. Email: info@aesgp.eu.
Website: aesgp.eu/events/.

16 February 2018 OTC bulletin 19

 OTC MARKET RESEARCH
Why the flu season matters
T
he 2017/2018 cough, cold and
flu season has been more vis-
ible than ever, with news outlets
around the world running head-
lines warning of deadly strains of flu
and claiming that it has never been
this bad before.
While a severe cough, cold and flu season
is bad news on a personal level, for the OTC
industry it can have a positive impact on sales
of products to treat the symptoms people suf-
fered from during the cold winter months.
Predicting the severity of a cough, cold and
flu season is notoriously tricky, vexing even tech-
nology giants such as Google, who have tried
and failed to accurately predict where an out-
break might hit and how bad it could be.
Keena Roberts, Euromonitor’s consumer
health industry analyst, pointed out that while
predictions could be inaccurate, one way of
increasing the chances of successfully forecast-
ing the severity of season was to take a look
at how close the approved vaccines for flu for
a particular season matched the strains of the
illness circulating at that time.
Typically, each spring the World Health Org-
anization (WHO) received flu samples from
around the world and determined the chemical
make-up of the coming season’s vaccine, Rob-
erts pointed out.
“Experts agree,” Roberts said, “that a vaccine
that matches the circulating strain well usually
means a poor season in sales for OTC flu prod-
ucts, while a vaccine that matches the circulating
strain poorly is likely to result in people rushing
to the pharmacy for flu-related OTC products.”
20
This created an inverse relationship between
how closely the vaccine matched the circulating
strain and how well OTC product for coughs,
colds and flu would sell, she added, so it was
worth industry paying close attention to the
components of the vaccine and its administra-
tion – which is generally determined by national
governments – when it came to setting expecta-
tions for an upcoming season.
“Seasonal flu has a significant and immediate
impact on the sale of a variety of consumer
healthcare products,” Roberts pointed out, “from
cough- and cold-relief products to facial tissues
and hand sanitisers.”
Disparate seasons of flu
Despite similarities in seasonality and vi-
ral strains, the two largest economic regions
in the northern hemisphere – North America
and Western Europe – Roberts noted, often ex-
perienced disparate seasons of flu.
In the US, Roberts pointed out, the flu vac-
cine was easy to access and was offered every-
where from pharmacies to airports.
Furthermore, the lack of universal healthcare
in the US, coupled with around a third of Amer-
icans not getting paid when off work sick, Rob-
erts said, were all motivating factors for people
to go and get vaccinated.
However, according to a 2015 NPR-Truven
HealthAnalytics Health Poll, only 62% ofAmeri-
cans said they had been vaccinated or intended
to get vaccinated against the flu, Roberts pointed
out, a number which had been largely the same
for more than 10 years, despite public health
education campaigns and recommendations
The cough, cold
and flu season is crucial
for the OTC industry,
with sales of many of the
sector’s biggest brands
rising and falling
depending on its severity.
Matt Stewart takes a look at
this important time of year.
from the Centers for Disease Control and Pre-
vention (CDC) that all Americans should get
vaccinated, regardless of their relative risk of
getting sick.
It should be pointed out, Roberts explained,
that as healthcare in the US was an out-of-
pocket cost, and could be prohibitively expen-
sive, many Americans ignored their illnesses,
and/or treated themselves with cheaper OTC
products, rather than seeking clinical care.
By contrast in Western Europe, vaccination
of the general population was not recommend-
ed by any country and could only be adminis-
tered by a healthcare professional, but it was
promoted for the most-at-risk populations such
as the elderly and young children, Roberts said,
although each country across the region had
its own policy on vaccination.
Furthermore, while most European countries
had much more generous leave policies com-
pared to the US, she added, and offered some
form of universal healthcare – subsidised by the
government or an employer – it was generally
much cheaper than that in the US, which of-
ten meant European consumers sought medical
care more readily than Americans.
So what impact can a severe cold and flu
season have on sales of OTC products? Rob-
erts pointed to historical data from Germany,
which showed that even after consecutive de-
clines in year-on-year sales in the cough, cold
and allergy category, one strong flu season could
return the category to growth.
“Though OTC products continue to be
popular in Germany, sales in many cough, cold
and allergy categories declined between 2013
OTC bulletin 16 February 2018
 MARKET RESEARCH OTC

and 2014, as consumers shifted towards more Category Annual sales Change
natural methods of health improvement, in- (US$ millions) (%)
cluding meditation and healthy eating habits,” Combination products – cough, cold and allergy remedies 11,362.6 +3.2
Roberts explained. “Nationally, retail sales of
Cough remedies 5,798.8 +2.7
cough, cold and allergy remedies dropped back
from US$1.8 billion (C1.5 billion) in 2013 to Medicated confectionery 5,403.5 +2.0
US$1.7 billion in 2014.” Antihistamines/allergy remedies (systemic) 4,414.0 +7.7
However, the flu season of 2014/2015 re-
Decongestants 4,314.8 +4.2
versed this trend, she pointed out, as consumers
again turned to OTC cough, cold and allergy Sore-throat treatments 3,192.8 +4.0
products to combat a flu outbreak, resulting in Paediatric cough, cold and allergy remedies 2,220.4 +3.1
sales increases of Germany’s most popular cough,
cold and allergy products. Worldwide cough, cold and allergy market 36,706.9 +3.6
“Retail sales of Dr Willmar Schwabe’s gerani- Figure 1: Breakdown of the cough, cold and allergy market worldwide in 2017 (Source – Euromonitor)
um-based cough syrup Umckaloabo increased Category Annual sales Change
by US$4 million from 2014 to 2015,” Roberts (US$ millions) (%)
revealed, “while sales of Stada Arzneimittel’s
Combination products – cough, cold and allergy remedies 3,477.4 +1.7
Grippostad grew by US$9 million and Procter
& Gamble’s (P&G’s) Wick by US$10 million Antihistamines/allergy remedies (systemic) 2,659.6 +10.8
over the same period.” Decongestants 1,256.0 +4.8

Cough remedies 1,081.6 +3.6

Rise of combinations
The greatest increase was seen in sales of
cough, cold and allergy combination products,
which rose from US$261 million in 2014 to
US$286 million in 2015, she noted, represent-
ing year-on-year growth of around 10%.
Furthermore, sales of cough remedies also
grew significantly in the 12 months, Roberts
said, advancing by 8%, with total retail sales
increasing by US$24 million from the previ-
ous year.
More recent Euromonitor data shows a
mixed picture for the cough, cold and allergy
category over 2017, which takes in the final
three months of the 2016/2017 season and the
opening months of the 2017/2018. It must also
be noted that the summer is a key selling period
for allergy products within the segment.
Globally in 2017, retail sales of cough, cold
and allergy remedies as defined by Euromonitor
increased by 3.6% to US$36.7 billion from
US$35.4 billion (see Figure 1).
Outside of products designed to treat aller-
gies, decongestants was the fastest-growing
segment, with retail sales improving by 4.2% to
US$4.3 billion. Although it must be noted that
these can also be used to treat allergy symptoms.
Of the product segments most directly re-
lated to coughs, colds and flu, the sore-throat
segment grew quickest, with sales rising by 4.0%
to US$3.2 billion. Cough remedies and medi-
cated confectionary were the slowest movers,
improving by less than the category as a whole.
Looking at North America and Western Eu-
rope, the cough, cold and allergy category in
the two markets moved – in dollar terms at
least – in different directions.
According to Euromonitor data, sales of
cough, cold and allergy products in North Amer-
ica advanced by 5.0% to US$10.3 billion, driven
Medicated confectionery 851.8 +6.0
Paediatric cough, cold and allergy remedies 775.2 +3.3
Sore-throat treatments 219.5 +2.3
North America’s cough, cold and allergy market 10,321.1 +5.0
Figure 2: Breakdown of the cough, cold and allergy market in North America 2017 (Source – Euromonitor)
Category Annual sales Change
(US$ millions) (%)
Medicated confectionery 1,624.6 -1.8
Cough remedies 1,328.8 -2.6
Decongestants 1,216.4 -0.6
Combination products – cough, cold and allergy remedies 1,118.8 +0.6
Sore-throat treatments 859.3 +0.6
Antihistamines/allergy remedies (systemic) 422.7 -0.9
Paediatric cough,cold and allergy remedies 173.0 -0.6
Western Europe’s cough, cold and allergy market 6,743.6 -1.0
Figure 3: Breakdown of the cough,cold and allergy market in Western Europe in 2017 (Source – Euromonitor)
primarily by a 10.8% jump in sales of allergy decline, according to Euromonitor’s figures, with
products to US$2.7 billion (see Figure 2). cough remedies – which globally and in North
Decongestants performed well in NorthAmer- America struggled for growth – falling back
ica with sales up by 4.8% to US$1.3 billion, by 2.6% to US$1.3 billion.
while in the categories most directly focused The only two categories to improve over the
on cough, cold and flu symptoms, medicated 12 months were sore-throat treatments – which
confectionary was the fastest growing, with advanced by 0.6% to US$859 million in 2017
sales up by 6.0% to US$852 million. from US$854 million in 2016 – and combination
Cough remedies edged up by 3.6% to just cough, cold and allergy products, which also
over US$1 billion, with sore-throat products posted sales up by 0.6% to US$1.1 billion.
moving ahead by 2.3% to US$220 million. As the 2017/2018 cough, cold and flu sea-
son comes to a head, preliminary studies have
Decline in Western Europe shown that this season’s vaccine was only 10%
By contrast to the growth in North America, effective against the strain circulating when it
sales in the cough, cold and allergy category in was used during the Australian winter. If cor-
Western Europe slipped by 1.0% in US dollar rect, industry could be in for a bumper season
terms to US$6.7 billion in 2017 (see Figure 3). when it comes to sales of its key OTC cough,
Almost every category posted a very slight cold and flu remedies. OTC

16 February 2018 OTC bulletin 21

OTC DISTRIBUTION IN EUROPE
I TIO C E T E I IE

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Wholesalers & Retailers
Changes
at Phoenix
P an-European wholesaler and retailer Phoe-
nix has expanded its management team.
Frank Große-Natrop has been appointed
as co-chairman of the firm’s German executive
board, joining existing chairman Marcus Freitag,
who has led the board for the past year.
In his new role, Große-Natrop would take
over responsibility for Phoenix’ operations in
Germany from Stefan Pflug, the company noted,
while retaining his place on the Phoenix Group’s
executive board.
Pflug, Phoenix said, had taken over leader-
ship of Phoenix’ Europe-wide Pharma Services
and Group Sourcing divisions together with
Stefan Jung. OTC
Regulatory Affairs
Australia keeps
ibuprofen access
Continued from front page
sales of codeine.
The applicant claimed that the codeine ban
would lead to an increase in the use of ibuprofen
as people sought other OTC alternatives. Low-
ering the doses and restricting access, the ap-
plicant said, would reduce the risk of people
using too much ibuprofen.
However, the scheduling delegate recom-
mended maintaining ibuprofen’s current sched-
uling designation – which allowed the drug to
be sold outside of pharmacy in packs of up to
25 dosage units at a strength of 200mg – as there
was no evidence of excessive use. Furthermore,
the delegate added, there was no new evidence
of safety concerns surrounding proper use of OTC
doses of ibuprofen.
Meanwhile, the Australian Self Medication In-
dustry (ASMI) insisted that consumers could be
confident that OTC oral analgesics such as diclo-
fenac, ibuprofen and paracetamol were safe for
short-term use, following media reports that the
drugs could cause harm.
Noting that the media reports were based on a
study into long-term use of paracetamol and other
NSAIDs at high doses, the association said that
in the wake of codeine being made prescription-
only at the start of the year, it was important for
consumers to understand that the study was not
applicable to OTC oral analgesics, which re-
mained a “safe and effective means of relief
from acute pain when used short-term and ac-
cording to the instructions”. OTC
16 February 2018 OTC bulletin
Manufacturers
Goldschmidt joins
Stada as new chief
S tada has named Peter Goldschmidt – US
president of Novartis’ Sandoz subsidiary – as
its chief executive officer.
Effective from September 2018, Goldschmidt
will replace Claudio Albrecht, who was placed
in charge of the German firm in September last
year (OTC bulletin, 6 October 2017, page 27)
after it was acquired by private equity firms Bain
Capital and Cinven (OTC bulletin, 8 September
2017, page 1).
Albrecht – who advised Bain and Cinven on
the takeover – was expected to serve as chief on
an interim basis while the firms found a per-
manent chief to “lead Stada in the long run”.
Thanking Albrecht for making “tremendous
progress” during his short time at the helm,
chairman of Stada’s supervisory board, Günter
von Au, said the industry veteran would con-
tinue to implement reforms throughout the course
of the year, before transitioning to a non-exec-
utive position at the end of the year.
Stada now had a “clear, long-term perspec-
tive” for the leadership of the company, Al-
brecht enthused, and was “laying the founda-
Manufacturers
Davy gets new ASMI position
T he Australian Self Medication Industry
(ASMI) has promoted Brenda Davy to
the position of director of business development,
with immediate effect.
Davy, currently ASMI’s strategy manager of
Complementary Medicines, replaces Filomena
Maiese, who has led the association’s business
development activities for the past seven years.
Stakeholder outreach
In her new role, Davy will be responsible
for managing the ASMI’s events and services,
its outreach with stakeholders as well as its
marketing and ethics subcommittee.
IN BRIEF
CVS HEALTH has placed its executive
vice-president of retail pharmacy and supply,
Kevin Hourican, in temporary charge of the
company’s CVS Pharmacy retail division in the
US while it searches for a replacement for the
recently-departed Helena Foulkes.
PEOPLE OTC
tion” for its “continued growth”.
Describing Goldschmidt as an “experienced
manager in the OTC and generic drug segments”
Stada said he would build on the “successful
course of renewal and growth” that had been ini-
tiated by Albrecht.
Prior to his current role as president of Sandoz
USA and head of North America, Goldschmidt
held multiple leadership positions at Novartis in
Europe, Asia and the US, in a career at the Swiss
pharmaceutical giant spanning 28 years.
During his time as global executive member
for Central and Eastern Europe (CEE), Gold-
schmidt had led Sandoz to a market leadership
position in the generics sector, Stada noted, and
had grown strongly the firm’s OTC business.
Commenting on his appointment, Goldschmidt
said it was evident that Stada had “recently ex-
perienced a healthy shake-up” through which
“many new initiatives were launched”.
Stada had “enormous potential”, Gold-
schmidt said, adding that he looked forward
to fully exploiting the “growth opportunities
in the market”. OTC
Previously, Davy spent 15 years in senior man-
agement positions at US giant Procter & Gam-
ble (P&G), as well as three years at Australian
health supplements firm Blackmores.
Meanwhile, Maiese leaves the ASMI to take
on the role of executive director of portfolio and
innovation at Australian-based iNova Pharmaceu-
ticals, where she will be responsible for devel-
oping new “product and innovation pipelines”.
Commenting on Maiese’s departure, the ASMI
said she had been “instrumental” in the success-
ful advancement of “key strategic industry ini-
tiatives” such as prescription-to-OTC switching
and advertising of Schedule-3 medicines. OTC
ALBERTSONS – the US grocery chain –
has named Susan Morris as executive vice-
president and chief operating officer. Morris
– who has been with the firm for over 30 years –
will take over from Wayne Denningham, who
will retire at the end of March. OTC
23
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