OTC Bulletin PDF

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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COMPANY NEWS OTC
Business Strategy 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”
wiss food and drinks giant Nestlé should
“better explain to shareholders the ration-
Nestlé’s core business and like a costly mistake
which should be unwound,” Third Point insists.
its OTC business in the Chinese territory. ale behind expanding further into consumer “Nestlé defines itself as a company focused
Describing Hong Kong as an “important mar- healthcare”, says major shareholder Third Point. on ‘nutrition, health and wellness’, but many of
ket”, Hisamitsu said it had invested ¥10 million Investment firm Third Point, which holds its assets do not align with that vision,” the inves-
(C0.08 million) to set up Hisamitsu Hong Kong, a 1.3% stake in Nestlé worth around US$3.5 tor argues. “We believe Schneider has an oppor-
which would be based in the Kowloon area of billion (C2.9 billion), claims that the recent ac- tunity to better align the company’s strategy
the territory. quisition of Canadian dietary supplements spe- with its stated objective by addressing these and
Explaining the rationale for establishing the cialist Atrium Innovations, combined with “rum- other inconsistencies.”
subsidiary, Hisamitsu said that having a direct ours the company is bidding on larger assets” Skin Health, by Schneider’s own admission,
presence in Hong Kong would help to grow its in the consumer healthcare market, has “left some has “underperformed” in recent years. The firm
OTC business in the territory and specifically shareholders confused”. is now working to “aggressively right-size” the
drive up sales of its Salonpas and Mohrus OTC Nestlé is set to pay US$2.3 billion to acquire operation, according to Schneider, as the business
analgesic patches. Atrium – and its leading Garden of Life organic is suffering from a host of self-inflicted issues,
The topical analgesic specialist made the an- supplements range – in a move the firm says including an “over aggressive expansion” into
nouncement shortly after reporting the results supports its “pursuit of growth opportunities in OTC skin-care products (OTC bulletin, 6 Octo-
of its third-quarter ended 30 November 2017. consumer healthcare” (OTC bulletin, 15 Decem- ber 2017, page 5).
Hisamitsu reported turnover at its OTC busi- ber 2017, page 3). Rather than continuing to invest in the OTC
ness up by 13% to ¥35.8 billion in the three Following the deal for Atrium, and com- market, Third Point believes that Nestlé should
months, thanks to the performance of Salonpas. ments from chief executive Mark Schneider last “move faster to increase its exposure to the
The analgesic patch posted sales up by 23% year that Nestlé was committed to expanding high-growth categories of coffee, pet care, water
to ¥21.4 billion, due primarily to a double- its presence in consumer healthcare (OTC bul- and nutrition”.
digit increase in turnover in overseas markets. letin, 21 July 2017, page 7), rumours have swirled Despite questioning areas of Schneider’s strat-
Hisamitsu noted it had expanded its OTC that the firm is set to make a serious play in egy, Third Point says that he has “begun to take
offering in the third quarter with the launches the market by snapping up the for sale Merck the needed steps to move the firm forward”.
of the NobiNobi Salonsip analgesic patches and KGaA Consumer Health business (OTC bul- This is not the first time Third Point has called
Allegra FX Junior allergic rhinitis product in letin, 12 January 2018, page 3). into question Nestlé’s strategic direction. In June
its domestic market. While Third Point does not directly criticise last year, the company insisted that “reshaping
Despite strong growth in its OTC segment, the Atrium deal, it questions Nestlé’s ongoing the portfolio” was among the changes needed
total group sales fell by 18% to ¥135.9 billion, investment in its Skin Health unit, which houses at Nestlé to reverse a “recent history of mean-
as turnover fell at its dominant prescription phar- prescription and OTC skin-care products. ingful underperformance versus peers” (OTC
maceuticals business. OTC “Forays into skin health seem unrelated to bulletin, 30 June 2017, page 6). OTC
Editor: Matt Stewart Assistant Editor: Rachael Walker Advertising Controller: Debi Robinson
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Associate Editor: David Ridley Editor-in-Chief: Aidan Fry Group Sales Manager: Rob Coulson
Contributing Editor: David Wallace Managing Director: Phil Jarvis Awards Manager: Natalie Cornwell
16 February 2018 | Number 497

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16 February 2018 OTC bulletin 3

OTC COMPANY NEWS
Business Strategy 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
hinese conglomerate Ping An Insurance is
seeking to take a larger slice of China’s
our users with access to a wide spectrum of med-
ical and wellness product offerings, as well as
recently-appointed managing director Günter healthcare market by launching an initial pub- personalised wellness contents and programmes
Auerbach said he would lead the company “suc- lic offering (IPO) for its Ping An Good Doc- for maintaining a healthy lifestyle.”
cessfully” forward. tor subsidiary. The company organises its business in four
Alongside Ralf Will – who joined Dr Pfleger Ping An Good Doctor operates an online doc- distinct segments: Family Doctor Services; Con-
as chief operating officer in 2016 – Auerbach tor consultation service for Chinese consumers, sumer Healthcare; Health Mall; and Health Man-
revealed the new leadership team had “concrete plus an e-commerce platform selling a range agement and Wellness Interaction.
plans” to further advance the charity-run firm by of healthcare products, including OTC medi- Family Doctor Services, Ping An explains,
implementing a “modern orientation” strategy. cines. A health check-up service is also offered consists “primarily of online consultation, hos-
Change at the top management level was key by the company, through which consumers can pital referral and appointment, inpatient arrange-
to its modernisation strategy, the company said, receive self-care advice. ment and second opinion services” delivered
with Auerbach – previously chief executive of- By operating Ping An Good Doctor as an in- by the firm’s in-house medical team and exter-
ficer at Germany-based OTC specialist bene- dependent company and listing on the Hong nal doctors. The team’s work is supported by
Arzneimittel – bringing “extensive leadership Kong Stock Exchange, Ping An Insurance said Ping An’s AI-Assistant, the firm notes, which
and industry experience” to the firm. it hoped to unleash the business’ “growth poten- “enhances the efficiency and accuracy” of care
Auerbach will be supported in the role by tial”. While the firm has not disclosed the pric- to the users of the service.
industry veteran Will, who joined Dr Pfleger in ing for the IPO, it is expected to generate up The AI Assistant can also “standardise and
September 2016, after heading up supply-chain to US$1.0 billion (C810 million). automate care in a common clinical scenario”,
operations for seven years at German herbal The funds from the IPO, Ping An Insurance PingAn points out, as well as “record and transmit
medicines manufacturer Bionorica. says, will be used to expand the reach of Ping a user’s history, condition and/or responses”.
An Good Doctor in China, and into neighbour- Distinct from, but complementary to, the
Introduce new brands ing markets – through acquisitions and strategic Family Doctor Services operation, the Health
“Part of the new strategy is to further in- alliances – and for research and development Mall segment operates an e-commerce platform
crease our innovation power,” Auerbach noted. purposes to improve its information technology providing consumers with “diversified and evolv-
“We want to strengthen our existing prescription- and artificial intelligence (AI) capabilities. ing product offerings, including healthcare prod-
only and OTC indication areas, while expanding According to Ping An Insurance, Ping An ucts, such as OTC medicines, dietary supplements
our offering through new, strong brands.” Good Doctor is the “world’s leading health- and medical devices”.
Dr Pfleger pointed to its “most successful” care portal in terms of traffic”, with over 190 As well as direct sales to consumers, Ping
OTC brands as those with the greatest potential million registered users and more than 30 mil- An’s e-commerce platform also facilitates trans-
for development, including the Neuralgin and lion monthly active users. In 2016, Ping An Good actions between third-party vendors and consum-
Godamed analgesics, Bio-H-Tin range of hair Doctor generated sales of CNY602 million (C77.8 ers. These vendors consist primarily of pharmacy
and nail supplements and Ipalat cold remedy. million), up from CNY279 million in the prior chains – such as Beijing Guotaiyongkang Big
At the heart of its product development plan year. Total sales reached CNY1.02 billion in the Pharmacy and Guangdong Jianke Pharmaceuti-
was the recently built “state-of-the-art” produc- opening nine months of 2017. cal – and overseas shopping service providers.
tion facility in Bamberg, the firm commented, In its IPO prospectus, Ping An Good Doc- In addition to its Health Mall and Family
where the company has been based since its found- tor describes itself as a “one-stop healthcare plat- Doctor businesses, Ping An offers through its
ing in 1945 by namesake Dr Robert Pfleger. form that delivers an integrated suite of services”. Consumer Healthcare segment “standardised
While the appointments of Auerbach and Will “We are cultivating a network nationwide packages of healthcare services” – provided by
marked a “generational change” in the company and globally that connects our users with our third-parties – such as health check-ups and
and a shift in strategy, Dr Pfleger insisted that online healthcare platform, as well as third-party genetic testing. Meanwhile, the Health Manage-
it would continue to perate as a not-for-profit, healthcare service providers, such as hospitals, ment and Wellness Interaction segment curates
with 100% of its C78.6 million “record sales” health check-up centres, pharmacies and physio- “wellness programmes, tools and activities to help
in 2017 going to its charitable owner, the Robert therapy centres,” the firm points out. “We provide consumers maintain a healthy lifestyle”. OTC
Pfleger Foundation.
As a charity-owned company, this meant that,
alongside the “entrepreneurial” goals of its new IN BRIEF
strategy, the firm was also committed to address-
ing “current issues of healthcare in Germany”. AMAZON, Berkshire Hathaway and JP would “bring their scale and complementary
One important move it said it could make Morgan Chase & Co are “partnering on ways expertise to this long-term effort”, which would
was protecting the role of traditional pharmacies to address healthcare for their US employees, be conducted through an “independent com-
in securing the comprehensive supply of medi- with the aim of improving employee satisfac- pany that is free from profit-making incentives
cines in the country, especially in rural areas. OTC tion and reducing costs”. The firms said they and constraints”. OTC
4 OTC bulletin 16 February 2018

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

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

COMPANY NEWS OTC
slide in Nutrition turnover, the company said. Annual Results
International growth
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
boosts Pfizer sales

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
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
campaigns – had been offset by lower sales of lion) in 2017. partial separation of the business, to ultimately
Physiogel and Lamisil, GSK reported, with both International turnover had improved by 9% deciding to retain the business,” Read pointed
brands suffering from increased competition. to US$1.62 billion in the 12 months, the US- out. “We expect to make a decision during 2018.”
Turning to the regional performance, posi- based pharmaceuticals giant noted, thanks to Asked late last year whether Pfizer would
tive currency effects and a strong showing from growth in its Developed Europe, Developed Rest consider offloading Consumer Healthcare through
Wellness brands helped push up International of World and Emerging Markets regions. an asset swap, Read said the company was rul-
turnover by 9% – 4% adjusted for currency Meanwhile, turnover in the US had fallen ing nothing out (OTC bulletin, 24 November
effects – to £3.56 billion (see Figure 2). by 3% to US$1.85 billion, the company said, due 2017, page 7).
Sales in Europe had also improved by 9% to the impact of hurricane Maria in Puerto Rico, “We have for some time been looking and
to £2.36 billion, GSK pointed out, thanks to a which had disrupted production at its local seeking strategic deals for our Consumer busi-
combination of positive currency effects and the manufacturing plant. ness…perhaps involving asset swaps,” he noted.
growth of the Oral health category and a strong Consumer Healthcare accounted for 6.6% “I think this process we’re going to take in the
showing from pain-relief lines. At constant ex- of Pfizer’s total sales in 2017, which declined strategic review may shake loose more alter-
change rates, sales moved forward by 3%. by 1% to US$52.5 billion (see Figure 1). natives in that respect.”
In the US, sales advanced by 4% to £1.83 Pfizer is currently reviewing “strategic alter- According to Bloomberg, GlaxoSmithKline
billion, due entirely to positive currency effects. natives” for its Consumer Healthcare business, (GSK) and Reckitt Benckiser (RB) are the only
At constant currencies, turnover had actually a process which began last year (OTC bulletin, companies to have submitted non-binding bids
slipped back by 1%, GSK said, as a result of pri- 20 October 2017, page 1). for Pfizer Consumer Healthcare after rival can-
vate-label competition in the allergy category. Commenting on the process, Pfizer’s chief didates walked away, citing people familiar with
Consumer Healthcare accounted for 26% executive officer, Ian Read, told investors that the matter (see page 6). OTC
of GSK’s total sales in 2017, which increased
Business Annual sales Change Proportion
by 8% to £30.2 billion (see Figure 3). (US$ millions) 2016/2017 (%) of sales (%)
Consumer Healthcare reported operating profit
Internal medicine 9,684 +9 18
up by 23% to £1.37 billion in the 12 months,
thanks to a combination of “power brand growth Oncology 6,056 +33 12
and strong cost control”, as well as positive cur- Vaccines 6,001 -1 11
rency effects. At constant currencies, operating Inflammation & Immunology 3,968 +1 8
profit advanced by 11%. OTC
Consumer Healthcare 3,472 +2 7
Rare Diseases 2,240 -5 4
Licensing Agreements Innovative Health 31,422 +8 60
BioGaia makes Essential Health 21,124 -11 40
Total Pfizer 52,546 -1 100

China move Figure 1: Pfizer’s sales in 2017 broken down by business (Source – Pfizer)
B ioGaia’s Protectis probiotics will soon be

available in China after the Swedish firm
signed a licensing deal with Abbott Laboratories. IN BRIEF
Under the exclusive agreement, Abbott has
been granted the rights to commercialise Bio- HEVERT ARZNEIMITTEL is offering gang Hevert, as well as promote scientific re-
Gaia Protectis in China. C10,000 to the winner of this year’s biennial search in holistic medicine – will be judged
Expected to be launched in 2018, the chew- Dr Wolfgang Hevert Prize, which is open to according to four general criteria: originality;
able probiotic tablets would be co-branded by “scientific and non-commercial research” pub- quality; relevance; and usability of the com-
the companies, BioGaia reported. lished in German or English that attempts to pleted research. The deadline for submissions
Explaining the rationale behind the deal, “clarify questions in the fields of European natu- is 30 June 2018. Previous years’ prizes were
BioGaia’s managing director, Axel Sjöblad, said ral medicine and associated therapies such as ho- awarded to research on the use of homoeopathic
the firm had a strong focus on “growing our moeopathy”. The competition – which Hevert therapy with children, the role of vitamin C in
Asian business”, adding that he looked forward said was designed to celebrate the “work and cancer treatment, and the effect of clay packs
to working withAbbott on the “successful launch” vision” of the Germany-based company’s for- on the quality of life of patients with chronic
of its Protectis tablets in China. OTC mer managing director and founder Dr Wolf- venous insufficiency (CVI). OTC

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

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

OTC COMPANY NEWS
Annual Results Mergers & Acquisitions
Nutraceutix China’s By-Health

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

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)

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2018
GALA DINNER & AWARDS PRESENTATION
SHERATON GRAND PARK LANE HOTEL,
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THURSDAY 8TH MARCH
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-
Category Number of green
prescriptions (millions)
Change
(%)
Cough and cold 12.6 +13.5
ber of such prescriptions growing steadily ac-
Pain-relief 2.8 +9.8
cording to IQVIA market data.
Introduced in response to Germany’s delist- Anti-diarrhoea, oral electrolytes, digestive health 2.8 +14.6
ing from reimbursement of most non-prescrip- Throat-pain remedies 2.2 +19.6
tion medicines in 2004, the grüne rezept – or Blood-thinning agents 2.1 +2.3
green prescription – scheme enabled doctors
to write recommendations for non-reimburs- Antacids, anti-flatulence and ulcer therapies 1.8 +9.3
able medicines on green notes designed to look Constipation and colonic irrigation aids 1.7 -1.3
like prescribing pads (OTC bulletin, 17 March Antifungals for dermatological use 1.6 ±0.0
2010, page 12).
Vitamins 1.5 +17.5
Green prescriptions were intended to boost
consumer confidence in buying non-prescription Allergy remedies 1.2 +0.2
medicines for themselves and reassure patients Topical analgesics 1.1 -1.4
that the non-prescription medicines they were
Intimate health 1.0 -2.7
buying were approved and were needed.
This innovation acted to sustain the non-pre- Total top-12 32.4 +8.8
scription market that had been devastated by de- Other 15.0 –
reimbursement, contributing to the 38% growth
Total green prescriptions 47.3 +7.7
recorded by the self-medication market in Ger-
many between 2004 and 2016 (OTC bulletin, Figure 1: Number of green prescriptions issued in Germany in the year ended 30 September 2017
broken down by product category (Source – IQVIA)
26 May 2017, page 24).
According to the latest IQVIA figures, green electrolytes, digestive health categories were product and Bayer’s Iberogast herbal gastro-
prescriptions as a proportion of all prescriptions the next fastest growing, with both outpacing intestinal oral liquid.
issued by doctors in Germany increased from the total green prescription market rate with ad- Sinupret and Iberogast were also the second
1.2% to 6.3% during the same period. vances of 17.5% and 14.6% respectively. and third overall best-selling OTC medicines
Last year the number of green prescriptions However, not all categories improved, with respectively through German pharmacy during
issued in Germany continued to grow steadily, the number of green prescriptions for intimate the same period, according to Insight Health
increasing by 7.7% to 47.3 million in the year health products dropping by 2.7% to 1 million (OTC bulletin, 24 November 2017, page 14).
ended 30 September 2017 (see Figure 1). in the 12 months, while green prescriptions for Cough and cold remedies dominated the green
Just over a quarter of green prescriptions were topical analgesics fell by 1.4% to 1.1 million. prescription top 10, with six brands being either
for cough and cold medicines in the 12 months Turning to the brands, IQVIA noted that cold remedies or nasal sprays.
– growing by 13.5% to 12.6 million – almost five the top-10 OTC brands prescribed by doctors Commenting to OTC bulletin on the “suc-
times the next category, pain-relief, which jump- accounted for around a fifth of all green pre- cess story” of its green prescription initiative,
ed by 9.8% to 2.8 million. scriptions in the 12 months. the German manufacturers’association, the BAH,
The strongest rise came from the throat-pain Bionorica’s Sinupret herbal cold remedy said the move had allowed German doctors to
category, with doctors writing 2.2 million green was the brand most prescribed using green pre- continue to recommend OTC medicines, despite
prescriptions for such products, an increase of scription in 2017, IQVIA added, followed by limitations imposed by de-reimbursement.
19.6%. Vitamins and the anti-diarrhoea, oral 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,
Regulatory Affairs the association added, preventing problems aris-
UK and China expand cooperation ing from “interactions with other medicines”.
Patients benefitted from the scheme, the
T he UK’s Medicines and Healthcare prod-

ucts Regulatory Agency (MHRA) and the
China Food and Drug Administration (CFDA)
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
have signed a Memorandum of Understanding Commenting on the MoU, Ian Hudson, the statutory health insurance companies were now
(MoU) outlining new areas of cooperation be- MHRA’s chief executive officer, pointed out that willing to reimburse OTC medicines if prescribed
tween the two agencies. China was a “world leader” in supplying raw via green prescriptions.
Building on the MoU signed in 2014 – which materials for the pharmaceutical industry and “Green prescription is well established with-
focused on exchanging safety information on that closer collaboration between the two agencies in the German health care system,” the BAH
medicines and medical devices – the latest agree- would “support the promotion of innovation, concluded. “It is accepted by patients and streng-
ment covers an exchange of learning from the good practice and protect UK patients”. OTC thens the role of pharmacists.” OTC

GENERAL NEWS OTC
Market Research
Romania primed for self-care

“T he Romanian self-care market is devel- whelmingly rejected the ban after Romania’s Dermatologicals
Vitamins, 8.0% Others
oping rapidly and there are numerous President Klaus Iohannis ordered a review of the minerals & 2.5%
opportunities for the companies operating in this bill (OTC bulletin, 4 November 2016, page 18). supplements
Lifestyle
12.6%
sector,” according to the Romanian Association Just over a year after seeing off the advert- OTCs
of the Self-Care Industry (RASCI). ising ban, RASCI had turned its attention in Analgesics 22.2%
However, there remained legislative and regu- part to educating Romanians about the benefits of 13.4%
latory challenges that needed to be addressed, self-care, Mereu said, by launching a “long-term
the association told OTC bulletin, and that was educational campaign” targeting consumers,
what RASCI was geared up to do. called ‘Despre sănătate, cu responsabilitate’ –
Established in July 2016, RASCI – a member or ‘About Health, With Responsibility’.
Cough, cold,
of the Association of the European Self-Med- Launched with a debate between representa- Gastrointestinals and allergy
ication Industry, the AESGP – had brought a tives of healthcare authorities, institutions and 19.8% 21.5%
“powerful, competent and unitary voice” to the professionals, and joined by the pharmaceutical Figure 1: Breakdown of the Romanian self-care
self-care sector in Romania, commented its chief industry and media representatives, the ongoing market – worth €680 million – in 2017 by
category (Source – Cegedim)
executive officer Diana Mereu. campaign, Mereu explained, had been widened
Formed by local and international companies to include a website featuring advice on self-care, Furthermore, RASCI would continue to keep
– including Bayer, GlaxoSmithKline (GSK) along with television advertising and promo- an “open dialogue” with competent authorities
Consumer Healthcare, Johnson & Johnson (J&J), tional materials distributed to pharmacies and at both a national and regional level, she said, to
Reckitt Benckiser (RB) and Sanofi – RASCI clinics across the country. ensure that consumer advertising and commu-
was founded in response to a bill which passed nications were fair and not misleading.
through Romania’s lower house of parliament in Consumer campaign in 2018 In terms of the Romanian self-care market
2015 that would have banned advertising for The campaign would continue throughout – which was worth around C680 million in
OTC medicines on television and radio. 2018 with activity on “all relevant communica- 2017 – OTC drugs accounted for around two
Industry players pulled together and – aided tion channels”, she added, noting that the initi- thirds of sales, with supplements (including
by the AESGP – lobbied for the bill to be vot- ative had garnered support from the Ministry medical devices) making up the remainder.
ed down. In late 2016, the country’s Senate over- of Health, the National Agency for Medicines So-called ‘lifestyle’ OTC products account-
and Medical Devices, the Romanian National ed for 22.2% of the market, RASCI revealed,
Society of Family Medicine, the Romanian Col- followed by cough, cold and allergy products
lege of Pharmacists and the Romanian Adver- with 21.5% (see Figure 1).
tising Council. Gastrointestinal products, together with an-
On the industry front, Mereu pointed out algesics, accounted for a further 33.2%, the
that there were still challenges, primarily the association said, while vitamins, minerals and
need for the “development, adoption and imple- supplements (VMS) took a 12.6% share and
mentation of a transparent and predictable legisla- dermatologicals another 8%.
tive framework” that was in line with European Looking ahead, Mereu said that RASCI’s
and international regulations and best practices. efforts to educate consumers about self-care while
One step in this direction, she explained, was at the same time developing stronger regula-
a bill that was currently being discussed by tory frameworks, meant that the “rapidly” devel-
committees within the Romanian parliament to oping Romanian OTC market was well posi-
RASCI is educating Romanians on self-care regulate food supplements. tioned for a sustainable future. OTC
Regulatory Affairs but were prescribed in 60% of cases when a pa-
NICE backs OTCs for sore throats

tient visited a general practitioner (GP) for advice.
Welcoming the guidance, the Proprietary As-
O TC medicines rather than antibiotics should

be the first line of defence for patients in
England suffering from acute sore throat, accord-
Non-prescription analgesics, such as paracet-
amol and ibuprofen, NICE pointed out, could
treat common sore throat symptoms.
sociation of Great Britain (PAGB) said it support-
ed campaigns to “reduce unnecessary prescribing
of antibiotics”.
ing to the National Institute for Health and Care Medicated OTC treatments – including loz- NICE’s recommendations drew attention to
Excellence (NICE). enges and throat sprays containing either a local OTC alternatives to antibiotics for sore throat suf-
In its recent guidance – ‘Sore throat: anti- anaesthetic, antiseptic or non-steroidal anti-in- ferers, the association pointed out, and highlighted
microbial prescribing’– NICE encouraged health- flammatory drug (NSAID) – could also be recom- the value of self-care in the healthcare system.
care professionals to prescribe fewer antibiotics mended to sore-throat sufferers, NICE suggested. In addition to its advice on curbing unnec-
for cases of acute sore throat and to instead rec- Explaining the reasons for issuing the guid- essary use of antibiotics, NICE also emphasised
ommend patients to use OTC medicines to help ance, NICE said antibiotics made “little differ- the importance of educating the public on their
manage their symptoms. ence” to how long symptoms of sore throat lasted health and empowering them to self-care. OTC

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
pharmacological makeup as compared to that
of Zyrtec – which were characterised as being
“wise” and “smart” – the NAD said that de-
the “smart” or “wise” design of its Xyzal Allergy spite the light-hearted tone of the advertising,
24HR product made it better than Johnson & certain claims implied that Xyzal was “better
Johnson’s (J&J’s) rival Zyrtec allergy product. or more efficacious than Zyrtec because of its
J&J challenged numerous claims made by pharmacological design”.
Chattem in the marketing materials for Xyzal “The use of a wise owl and the advertising’s
(levocetirizine) targeting healthcare professionals, emphasis on a smart design help convey the
which featured a “wise” owl and a number of message that Xyzal is superior to Zyrtec in a
statements alluding to the product’s supposed meaningful way,” the NAD concluded, “and The NAD questioned Chattem’s‘wise’claims for Xyzal
benefits compared to competing allergy brands. Chattem was not merely informing healthcare
Consumer advertising for Xyzal has consist- providers about the design differences in the Chattem discontinue the claims: “Xyzal Allergy
ently used the image of a wise owl dressed as a products, but conveying the message that Xyzal 24HR provides the same relief as Zyrtec, with
professor to convey the message that the brand is superior to Zyrtec so that healthcare provid- half the medicine”; and “Xyzal has the same
is a “wise” choice for allergy sufferers, with a ers will recommend Xyzal Allergy 24HR in- efficacy as Zyrtec with half the medicine”.
current YouTube advertisement on the brand’s stead of competing OTC oral antihistamines However, it said that Chattem had provided
website using an animated owl – sporting an (including Zyrtec) to their patients.” a reasonable basis to support the standalone
English accent – to explain the benefits of the “While advertisers are free to highlight mean- claim: “Xyzal delivers efficacy in a 5mg tablet.”
product and signing off with the tagline: “Be ingful differences between their product and The NAD also recommended that a num-
wise all, take Xyzal.” a competing product,” the NAD said, “the high- ber of claims related to the pharmacological
Explaining its rationale for recommending lighted differences should be truthful and pro- design of the product be modified, however
Chattem stop using certain claims made in Xyzal vide meaningful benefits.” it ruled that three of the challenged claims –
healthcare professional advertising, the NAD “Xyzal works differently from other oral anti-
said it had considered whether the advertising Discontinue claims histamines”; “Active enantiomer of Zyrtec with
at issue implied that Xyzal offered a “product Following its review of the evidence in the no dextrocetirizine”; and “potent H1 blocker” –
performance benefit over Zyrtec and other OTC record, the NAD recommended that Chattem had been substantiated by Chattem.
oral antihistamines or that Xyzal has the same discontinue the following claims: Pointing out that whilw Chattem could “high-
efficacy as Zyrtec with half the medicine”. “A smart formulation is now a wise OTC light pharmacological differences between oral
Noting that the challenged advertisements choice for allergy sufferers” antihistamines which may cause them to dif-
appeared on Xyzal’s healthcare professional “See why a smart molecule matters” fer from a potential toxicity perspective for
website and featured the “image of an owl in a “Delivers potency with a smart design” individuals in certain risk groups and which
labcoat alongside a blackboard, with scientific “Potent proof that not all OTC oral anti- may not be included in OTC labelling”, the regu-
drawings, a comparison chart and references histamines are built the same”. latory body warned the company to “avoid mak-
to various aspects of Xyzal Allergy 24HR’s Furthermore, the NAD recommended that ing any express or implied claims about Xy-
zal – including comparative claims – that are
clinically irrelevant”.
Marketing Campaigns In its response to the NAD’s ruling, Chat-
Em-eukal returns to German screens tem said it had agreed to comply with the recom-
mendations, although it noted that it disagreed
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-
and sage-flavoured gummy drops.
Against a colourful backdrop, sage leaves
move through the air, before a wild cherry is
with the NAD’s position that “healthcare practi-
tioners or consumers would be misled by Chat-
tem’s other advertising”.
lighting the brand’s natural ingredients. hit by an Em-eukal gummy drop and explodes “Out of respect for the NAD,” Chattem said,
Using the tagline “so gentle, so juicy, so dramatically. The gummy drop – now infused “the company will take the decision into con-
fruity” the creative shows dramatic close ups with the wild cherry flavour – hits a bag of sage sideration in future advertising.”
of the key ingredients in the brand’s wild cherry and wild cherry Em-eukal gummy drops and The NAD noted that during the course of the
falls to the floor revealing a shot of the range investigation, Chattem had chosen to “perma-
of Em-eukal gummies and hard candies. nently discontinue” patient satisfaction claims
Running until early March, the commercial initially challenged by J&J.
will be broadcast on a number of major German A recommendation by the NAD to modify
television channels and during coverage of the or discontinue a claim, the body added, was not
PyeongChang 2018 Olympic Winter Games . a “finding of wrongdoing” and an “advertiser’s
Furthermore, a sampling programme was un- voluntary discontinuance or modification of
derway, Soldan said, covering 14 German cities claims should not be construed as an admission
Television spots for Em-eukal focus on flavour until the end of March. OTC of impropriety”. OTC

MARKETING NEWS OTC
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-
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
ing to a new campaign by Merck Consumer to share the video on LinkedIn and YouTube
Health for its Femibion supplement range. and “support working mums everywhere”, along
Building on a survey conducted by the Ger- with a link to the MumPlus page on the Femi-
man firm revealing that 62% of women believe bion website.
having children halts or delays career pro- Describing LinkedIn as a “crucial platform
gression, the online MumPlus campaign for for working mums who are building their pro-
Femibion – a multivitamin for pregnancy – fessional profile”, Merck noted by using the plat-
utilises the LinkedIn career-focused social net- form, Femibion was leading the digital trans-
work in an attempt to change attitudes towards formation of the Merck Consumer Health busi-
working mothers and to allow women to list ness, and engaging with consumers online as
motherhood as part of their career history. a key part of its marketing strategy.
There was a need for a “fundamental change Meanwhile, Merck has also launched a part-
of narrative in the workplace”, Merck insisted, nership programme with pharmacists in the UK
to one where motherhood was “rightly valued” off the back of the company’s WE100 move-
and seen as something to be proud of. ment, which aims to “prepare society for a new
While 94% of women agreed that mother- era of humans living 100 healthy years”.
hood needed to be recognised as a positive in the Having launched last year a report under the
workplace, many said that the reality did not WE100 banner on what could be done to put
meet their expectation, the company added. children on the right path towards living for a
By utilising Femibion’s core audience of moth- century and being as healthy as possible for as
ers, Merck has created a series of videos. The firm long as possible (OTC bulletin, 11 August 2017,
said these videos shared the “reassuring message page 20), Merck has released its “Young for
that it should be a dualism of ‘motherhood and Old, Old for Young” pharmacist training pro-
career’, and not an ‘either/or’ decision”. gramme to begin “bridging the gap between
A MumPlus campaign page had been living longer and living longer and healthier”.
launched on LinkedIn, Merck said, to “inspire Focused on supporting pharmacists to tackle A video shows how to add a MumPlus badge
to a LinkedIn profile
women to show support for the campaign and specific challenges faced by ageing consumers,
encourage employers to think differently about such as poor nutrition, the programme, Merck many for its recently launched Vigantolvit vita-
the working mothers around them”. said, would improve pharmacists’ skills when min D supplement.
To further carry the campaign’s message a it came to providing appropriate health and nu- Centred on a 60-year old grandmother who
LinkedIn ‘badge’ had been developed, the com- tritional advice. continues to go surfing alongside her daughter
pany explained, for working mothers to display Commenting on the Young for Old, Old and granddaughter, the campaign, Merck said,
on their profiles. for Young campaign, Uta Kemmerich-Keil, illustrated the “desire of Vigantolvit to help
A video on the campaign page shows a work- Merck Consumer Health’s chief executive of- bring generations together” by encouraging a
ing mother explaining her frustration that she ficer, said that the programme illustrated that the healthy lifestyle for consumers of all ages.
cannot put motherhood on her CV, despite the WE100 movement was “rooted in the belief” that OTC
role being “one of the hardest jobs, and one of as people lived longer lives, doing so as healthily
the best jobs in the world”. as possible needed to be the “top priority for IN BRIEF
The creative goes on to explain that Femibion all generations”.
believes that motherhood is a “qualification Reinforcing the company’s desire to help BEST CHOLINE has launched its Choline
to be proud of” and that the skills mums learn maintain the health of all generations, Merck Gummies for Children and Adults in the US.
are a “great addition to any career”. 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
The latest Vigantolvit campaign Merck is offering training on elderly nutrition a lifetime,” the company said. OTC

OTC MARKETING NEWS
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)
Cuderm Gel Wash is the latest addition to Synergy with the latest addition to its Vicks ZzzQuil
Biologics Cuderm moisturising skin-care range, sleep-aid range, ZzzQuil Pure Zzzs gummies.
which was launched in the UK last year. A melatonin-based supplement, Pure Zzzs
A soap- and alcohol-free gel wash, with oatmeal
extract, Cuderm Gel Wash was designed “for those is the first non-medicine to be added to the estab-
who want a gentle but effective face and body lished ZzzQuil line, which already includes the
cleanser”, Synergy said,“that doesn’t contain harsh diphenhydramine-based ZzzQuil liquids and
ingredients that can dry and irritate the skin”.
“For those with dry or sensitive skin, finding the ZzzQuil liquicaps.
right soap or shower gel can be a complex game Designed to corner the US natural sleep-aid
of trial and error,” the company claimed.“Many Vicks ZzzQuil Pure Zzzs contain melatonin
market, according to P&G’s chief financial offic-
soaps and shower gels contain unnecessary
chemicals that can strip the skin of its essential er Jon Moeller (OTC bulletin, 2 February 2018, new natural offerings to increase the relevance”
oils which, over time, can leave it dry and irritated.” page 5), Pure Zzzs was “naturally free from arti- of its brands and products with the “naturals
Cuderm Gel Wash delivered “great skin care” ficial flavours, gluten, lactose and gelatine”. consumer”, Moeller admitted, and the “increas-
but didn’t ignore the “luxurious aspects of bubbles
and a little fragrance” which made bath and Pure Zzzs featured the “optimal level of mela- ingly environmentally concerned shopper”.
shower time such a pleasure, Synergy claimed. tonin” to regulate users’ sleep cycles, P&G Preference for natural products spread across
The product also helped to “naturally cleanse and claimed, without causing grogginess the next day. a wide demographic, he insisted, and included
moisturise dry and sensitive skin, while maintaining
the skin’s natural pH balance” the firm added. Users were further helped to “fall asleep both ‘baby-boomer’ and ‘millenials’.
Available in pharmacies now, Cuderm Gel naturally and wake refreshed”, the company said, P&G expanded the Vicks cold brand into the
Wash has a retail price of £5.49 (C6.19). OTC by the product’s “fusion of lavender, chamomile, sleep-aid category in 2012 when it launched
lemon balm and valerian”. ZzzQuil with the tag line: “It’s not for colds, it’s
The product is set to be launched online at not for pain, it’s just for sleep” (OTC bulletin,
the end of February and will be rolled out in 15 June 2012, page 11).
stores during March. Branded as being “From the makers of Vicks
Taking ZzzQuil into the supplements space NyQuil”, ZzzQuil has performed strongly since
was a reaction, Moeller said in January, to the its launch, breaking the US$100 million (C81.7
growing demand for more natural offerings. million) sales barrier in 2013 (OTC bulletin,
The company was continuing to “develop 7 April 2017, page 21). OTC
Product Launches
An “effortless way” to consume probiotics is
how Otsuka Pharmaceuticals is positioning its
BioGaia expands Swedish portfolio
P
Body Mainté Drink liquid supplement in Japan. robiotics specialist BioGaia has grown its company said, but also to help tackle the prob-
Sitting alongside Otsuka’s existing Body Mainté
Jelly nutritional food, Body Mainté Drink was presence in Swedish pharmacies by introduc- lem of vitamin D deficiency in Sweden.
a “physical conditioning beverage”, the firm ing chewable tablets containing the company’s Axel Sjöblad, BioGaia’s managing director,
claimed, targeted at those consumers who made patented lactobacillius reuteri Protectis pro- pointed out that vitamin D deficiency was a
an effort to maintain “optimum physical condition
among the routine risks of every day life”. biotic with vitamin D. common problem in Sweden, especially during
Both Body Mainté Drink and jelly contained Available now in three Swedish pharmacy the winter, so it was logical to bring to the mar-
Otsuka’s proprietary lactic acid bacteria B240, chains – Apoteket AB, Apotek Hjärtat and ket a product which combined vitamin D with
the firm pointed out, which supported the “main-
tenance of physical condition”. Apotea – BioGaia Protectis with vitamin D was the firm’s patented probiotic formulation.
The Body Mainté liquid supplement also designed to not only maintain a healthy gut, the Launched in association with sales and mar-
comprised electrolytes for hydration, had a keting services company MedHouse, BioGaia
“pleasant green citrus flavour”, and was a
low-calorie option, Otsula explained. Protectis with vitamin D is available in two
The beverage has a recommended retail price strengths, one containing 10µg of vitamin D
of ¥154 (€1.12). OTC per chewable tablet – the recommended daily
dose in Sweden for people under 75 years –
and a higher strength version which contains
IN BRIEF 20µg of vitamin D for those aged over 75 years,
KLOSTERFRAU has launched the D-man- for adults with limited exposure to sunlight,
nose food supplement for cystitis in pharma- or in other circumstances that prevent natural
cies across Germany. OTC BioGaia Protectis with vitamin D vitamin D absorption. OTC

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: [email protected]. 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: [email protected]. 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: [email protected]. 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: [email protected].
Email: [email protected].
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: [email protected]. 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: [email protected].
Basel, Switzerland
Tel: +49 6221 426 2960. Website: digitalhealthcareasia.com.
‘Join us at the crossroads of healthcare’ is
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: [email protected]. 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: [email protected].
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: [email protected]. 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: [email protected]. Website: otc-bulletin.com/awards. Email: [email protected].
Website: aesgp.eu/events/.

OTC MARKET RESEARCH
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.
Why the flu season matters

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

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

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PEOPLE OTC
Wholesalers & Retailers Manufacturers
Changes Goldschmidt joins

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

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Ping An Romania Why the

Good Doctor primed for flu season

Contents FDA takes action on

Connect with us on: Twitter LinkedIn OTC-bulletin.com

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

To find out more, contact Fiona Hammond at [email protected] Changing behaviour

Business Strategy Business Strategy

Hisamitsu in Investors question

16 February 2018 | Number 497

16 February 2018 OTC bulletin 3

Business Strategy Business Strategy

All change Ping An Good Doctor

4 OTC bulletin 16 February 2018

Business Strategy/Annual Results

Sanofi remains open to deals

16 February 2018 OTC bulletin 5

Business Strategy/Annual Results

GSK silent on link with Pfizer

6 OTC bulletin 16 February 2018

slide in Nutrition turnover, the company said. Annual Results

boosts Pfizer sales

BioGaia makes Essential Health 21,124 -11 40

Total Pfizer 52,546 -1 100

B ioGaia’s Protectis probiotics will soon be

16 February 2018 OTC bulletin 7

Japan sales slide at Taisho

Business Nine-month sales

8 OTC bulletin 16 February 2018

Business Strategy/Third-Quarter Results

Bigger brands key for Prestige

Hermes ready for

16 February 2018 OTC bulletin 9

Annual Results Mergers & Acquisitions

Nutraceutix China’s By-Health

10 OTC bulletin 16 February 2018

Regulatory Affairs Industry Associations

HTA proposal BAH slams attack by

16 February 2018 OTC bulletin 11

Green scrips growing steadily

T he UK’s Medicines and Healthcare prod-

14 OTC bulletin 16 February 2018

Romania primed for self-care

Regulatory Affairs but were prescribed in 60% of cases when a pa-

NICE backs OTCs for sore throats

O TC medicines rather than antibiotics should

16 February 2018 OTC bulletin 15

NAD questions Xyzal claims

D r C Soldan’s Em-eukal cough drops have

16 OTC bulletin 16 February 2018

Femibion backs working mums

16 February 2018 OTC bulletin 17

P&G takes ZzzQuil

18 OTC bulletin 16 February 2018

MARCH 26-27 February

16 February 2018 OTC bulletin 19

The cough, cold

Why the flu season matters

20 OTC bulletin 16 February 2018

Cough remedies 1,081.6 +3.6