Contents Pfizerconsidering saleofConsumer...AESGP Meeting coverage pages8-10 Brazilians switching...

Contents20 October 2017Issue Number 491

COMPANY NEWSDamier grows with 3Belgium's PurasanaKaro secures Weifa deal 3Ponroy grabs ERSA 4to expand in FranceBayer is seeking out 5self-care innovationOxford suffers UK setback 5

GENERAL NEWSMake reflections on science, 8says AESGPBotanicals issue nears end 10EMA seeks temporary staff 11PAGB seeks 14self-care strategyHomoeopathy needs controls 15

MARKETING NEWSGSK to ease 16the world’s painDermalex to make 17the UK feel goodRB to pay A$3.5m 18for Nurofen claimsP&G settles Align lawsuit 18

REGULARSEvents – Our regular listing 19People – Gelbert leads R&D 23at Nature's Bounty

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Pfizer is reviewing “strategic alternatives”for its Consumer Healthcare business,including the potential sale of the unit, aspartof thefirm’s“continuingefforts toallocateresources and capital to best serve patientsand maximise value for shareholders”.

A range of options would be considered forConsumer Healthcare, the US-based pharma-ceuticals giant explained, including a “full orpartial separation” of the business from Pfizer“through a spin-off, sale or other transaction”.

“Pfizer may ultimately determine to retainthe business,” the firm pointed out.

Noting that it “expected” to make a decisionon Consumer Healthcare’s future “during 2018”,Pfizer said it did not intend to “make any fur-ther statements” about the process “until a de-cision has been reached or upon the completionof the strategic review”.

Ian Read, Pfizer’s chief executive officer,said exploring strategic options would help thefirm “evaluate how best to fuel the future suc-cess and expansion” of Consumer Healthcare,“while simultaneously unlocking potential valuefor shareholders”.

“Although there is a strong connection be-tween Consumer Healthcare and elements of ourcore biopharmaceutical business,” commentedRead, “it is also distinct enough from our corebusiness that there is potential for its value to bemore fully realised outside the company.”

Pfizer Consumer Healthcare was a “leadingplayer in the largest OTC categories”. The for-mer Wyeth franchise was a business with “iconicbrands, robust retail partnerships, global reach

and strong fundamentals”, Read pointed out.Pfizer Consumer Healthcare generated sales

of US$3.41 billion (C2.89 billion) in 2016 – flatas reported, but 5% ahead operationally – witharound 56% of this total coming from its USoperation (OTC bulletin, 17 February 2017,page 4). The remainder was generated by itsInternational operation, which is divided intothree segments: Emerging Markets, DevelopedEurope, and Developed Rest of World.

Emerging Markets is the largest of thesesegments – posting sales of US$802 millionin 2016 – and covers countries such as Brazil,China, India and Russia.

Consumer Healthcare accounted for 6.5%of Pfizer’s total sales in 2016, which advancedby 8% to US$52.8 billion.

Consumer Healthcare’s portfolio boasted 10brands with annual sales in excess of US$100million, Pfizer noted, with its Centrum multivi-tamins and Advil analgesics lines among the

Continued on page 8

Pfizer consideringsale of Consumer

AESGPMeetingcoveragepages 8-10

Braziliansswitchingto chainspage 20

Ian Read

GSK tapsinto thesensespage 6

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COMPANY NEWS OTC

Damier grows withBelgium’s Purasana

Mergers & Acquisitions

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Karo securesWeifa deal


Damier – the investment fund led by YvanVindevogel – has expanded its portfolioby snapping up Belgian dietary supplementsand health foods specialist Purasana for an un-disclosed sum.

Describing Purasana as the “Belgian mar-ket leader in high-quality health foods, foodsupplements and organic products”, Damiernoted that the company currently marketed itsportfolio in 15 European countries “with exportsales continuously increasing”.

Distributed through“specialisedhealthshops”,Purasana’s portfolio includes a wide range ofown-brand vitamins, minerals and supplements(VMS), as well as protein powders and shakes,and ‘superfoods’.

Under the termsof theagreement,Purasana’sfounder and chief executive officer, Raf DeJonckheere, will remain in his current role andreinvest a “portion” of the proceeds from thesale into the company.

Vindevogel – co-founder of Belgium’s OmegaPharma – said acquiring Purasana was “in linewith Damier’s strategy to further consolidateits leading presence in the areas of functionalfoods and VMS in Europe”.

Purasana would take Damier a step closerto its ambition of reaching C100 million in an-nual sales “in the near future”,Vindevogel added.

“The acquisition of Purasana complementsthe strategy we have set for Damier,” he insisted.“After the acquisition of Flinndal and Bärbel

Drexel, Damier continues to actively developits platform in the growing and underdevel-opedVMS market, which still offers great poten-tial for consolidation.”

“With its high quality and ethical prod-uct range, Purasana will contribute to the de-velopment of the group’s other companies,”Vindevogel insisted, “whilst benefitting fromDamier’s intimate market knowledge and ex-pertise in the sector.”

Damier acquired Belgian VMS player BärbelDrexel earlier this year (OTC bulletin, 16 June2017, page 3), having snapped up VMS e-tailerFlinndal in 2015 (OTC bulletin, 3 April 2015,page 4).

Purasana’s De Jonckheere said joining forc-es with Damier represented a “great opportunity”for his company to reach its potential.

“Damier’s direct-to-consumer approach, com-bined with our continuous active support to-wards our professional customers, will proveto be valuable to Purasana going forward,” DeJonckheere insisted. OTC

Sweden’s Karo Pharma said it had becomea “leading player” in Norway’s consumerhealthcare market after completing its acqui-sition of Weifa.

Following its NOK35 (C3.76) per share of-fer – which valued Weifa at around NOK1.28billion – Karo said 97.2% of Weifa’s shares hadbeen tendered by the 3 October deadline, sur-passing theminimumacceptance thresholdof90%.

On 12 October, Karo carried out a compulsoryacquisition of the remaining shares and announc-ed its intention to “pursue a delisting of the sharesin Weifa from the Oslo Stock Exchange”.

Attractive cash premiumAnnounced in August (OTC bulletin, 8 Sept-

ember 2017, page 3), the deal recognisedWeifa’s“strategic value”, the Norwegian firm’s boardsaid at the time, and delivered an “attractive cashpremium to our shareholders”.

Commenting on the offer, Karo’s chairman,Anders Lönner, said the takeover of Weifawas“based on strong commercial grounds”.

“The two companies are highly complement-ary in terms of both product portfolio and geo-graphy,” Lönner insisted, “and therefore wesee [the potential for] important synergies.”

Acquiring Weifa would “strengthen” Karo’sNordic operations, while giving the firm a “lead-ing position” in the Norwegian market, Lönnerstated. “A strong and profitable home marketprovides better opportunities for taking the nextsteps towards new markets and co-operationsoutside the Nordic region,” he added. OTC

Purasana’s portfolio includes protein shakes

4 OTC bulletin 20 October 2017

OTC COMPANY NEWS


Ponroy grabs ERSAto expand in France

Business Strategy

Jacobson getsfunds for M&AHong Kong’s Jacobson Pharma has struckdeals with investors to raise HK$500 mil-lion (C54.2 million) for future acquisitions byissuing convertible notes.

Private-equity firm Dragons 615 will takeHK$280 million of Jacobson’s bonds, while HHInRe JP will take HK$220 million.

Commenting on its plans for the proceeds,Jacobson said it would use the cash to fund pot-ential acquisitions or to form “strategic alliances”in the Asia-Pacific region, “with a view to ex-panding the company’s geographical reach andmarket presence” in the OTC and generic medi-cines industries.

The funds would also be used to invest in“bio-pharmaceutical projects”, Jacobson added.

Derek Sum, Jacobson’s chairman and chiefexecutive officer, said the firm was pleased tohave “gained the trust and support of two repu-table investors”.

“We see it as a vote of confidence in ourproven business strategy and in the growth pros-pects of Jacobson as a whole,” Sum insisted.

“Having secured a sound financial position,we will seek to accelerate our growth moment-um by contemplating an expansion of our busi-ness portfolio through strategic acquisitionsor alliances both vertically and horizontally.”

Jacobson expanded its Chinese consumerhealthcare portfolio earlier this year by acquir-ing three OTC brands from Ling Chi Medicinefor an undisclosed sum (OTC bulletin, 3 Feb-ruary 2017, page 2).

All three brands – Saplingtan, Shiling Oiland Col-gan – were “highly complementary” toJacobson’s existing consumer healthcare offering,the firm said at the time, and would “open up newopportunities” for the company to “strengthen”its presence in the OTC market. OTC

Ponroy Santé has bolstered its dietary supple-ments portfolio by snapping up France’sERSA Group for an undisclosed sum. The dealis Ponroy’s first since its takeover by private-equity firm 3i Group (OTC bulletin, 25 Nov-ember 2016, page 5).

Acquiring ERSA and its range of “premium”supplements would “strengthen Ponroy’s pres-ence in the pharmacy channel”, the companysaid, which represented “more than half of thefood supplement market in France”.

ERSA’s portfolio comprises its Aragan, Erb-alab and Syn-Actifs supplement brands. TheErbalab line consists of herbal supplement oralgels with ingredients including echinacea andSt John’s wort (OTC bulletin, 9 December 2016,page 8). Ersa’s Syn-Actifs range focuses onhealthy ageing, while its Aragan brand offers“high end” supplements in a number of cate-gories including digestive health.

Noting that the combined group would bea “leading player” in France’s “natural” con-sumer healthcare market, with sales “in excessof C200 million”, Ponroy said it would use itsinternational presence to expand ERSA’s foot-print outside its domestic market for the first time.

Commenting on the deal, Remi Carnimolla,3i France’s managing director, said the private-equity firm was “delighted to support Ponroy’sfirst acquisition since our investment”.

“The acquisition of ERSA confirms Ponroy’sambitious growth plans,” Carnimolla insisted,“in line with the strategy for the company wehave set out.”

“ERSA is very complementary to Ponroy,”he pointed out, “and we look forward to support-ing the combined business to continue its in-ternational growth, and further strengthen itsposition in the pharmacy channel in France.”

Moreover, the deal would enable Ponroy tofurther “take advantage of the rise in natural con-

sumer healthcare”, Carnimolla said, “which isa mega consumer trend in food and cosmetics”.

Nicolas Brodetsky, ERSA’s chief executiveofficer, said joining forces with Ponroy markeda “key step” in his company’s development.

“New and exciting challenges lie ahead forERSA,” Brodestky insisted, “and I am delight-ed to join with Ponroy to establish a leader inthe food supplements market with high poten-tial for international growth.”

Snapping up a controlling stake in Ponroylate last year, 3i said the French firm had “con-siderable potential for future organic and ex-ternal growth due to global mega trends in natu-ral healthcare and wellbeing”.

“We will support Ponroy’s management teamto build on the company’s strength in Europe,”continued 3i, “and further develop its globalpresence by expanding into other markets, espe-cially Asia, with the support of our co-investorCathay Capital.”

Headquartered in Boufféré, Ponroy manufac-tures a wide range of natural health and personal-care products such as food supplements, naturalcosmetics and hygiene products for babies andwomen. Its brands include the Biolane mother andbaby line, Vitarmonyl supplements range, Ultra-biotique probiotic and Naturé Moi cosmetics. OTC

ERSA’s Erbalab line consists of herbal supplements


Riverside snaps up Spain’s Probelte

Private-equity firm The Riverside Companyhas expanded its Euromed manufacturingplatform by snapping up dietary supplementsingredients producer Probelte Biotecnología foran undisclosed sum.

The deal for Spain’s Probelte, Riverside said,offered a “number of exciting opportunities”

for herbal extracts manufacturer Euromed, whichthe firm acquired from Meda in 2015 (OTCbulletin, 11 December 2015, page 5).

“This combination will bring more productsto Euromed’s well-developed international mar-kets, and boost its considerable research and dev-elopment capabilities,” Riverside insisted. OTC

ELI CONSUMER HEALTHCAREhas raised US$2.6 million (C2.2 million) frominvestors – including an “industry-leading OTCdrug company” – to grow its TummyZen OTCheartburn-relief product. The proceeds, Eli said,would be used to expand TummyZen’s distri-bution to over 18,000 retail stores across theUS, including CVS, Rite Aid and Target. “Weare on track to add thousands of additional storesover the next six months as retailers roll outtheir 2018 product resets,” commented Eli’s chair-man Peter Mann. OTC

IN BRIEF


COMPANY NEWS OTC

Bayer is seeking outself-care innovation

Business Strategy

Bayer is looking to work more closely withUS-based entrepreneurs who are develop-ing innovative self-care products and solutions.

Through its Grants4Apps Generator pro-gramme – scheduled to start in “early 2018” –Bayer said it wanted to “collaborate with like-minded healthcare innovators” to help the firmto “fulfil the potential of self-care”.

“Our Grants4Apps Generator is looking todevelop a network of collaborators who enableself-care by addressing the common barriersthat prevent individuals from living better, health-ier lives,” commented the company.

Exclusive self-care focusThe Generator is the latest addition to Bayer’s

global Grants4Apps programme, through whichthe firm invests in emerging healthcare technol-ogies. However, it is the first time that Bayerhas focused exclusively on start-ups working onself-care solutions.

Launched in 2013, Grants4Apps – whichruns in markets such as Germany, Singaporeand the US – provides financial support toboth entrepreneurs and start-ups for software,hardware and technology projects which “con-tribute to improving health outcomes or phar-maceutical processes”.

Expanding on its plans for the Generator,Bayer said it welcomed applications from “uniquestart-ups” developing products to “meet emerg-ing consumer needs” in four key self-care cate-gories: nutrition support; external pain manage-ment; digital health solutions; and skin andsun protection.

For nutrition support, the firm said it was in-terested in innovations that addressed the “nu-

tritional needs” of ‘millennials’ – those bornbetween the early 1980s and the late 1990s.

Skin and sun protection solutions were be-ing sought, Bayer said, that could “deliver abetter consumer experience”.

On digital health solutions, the firm said itwanted to support innovations that helped con-sumers to “simplify and better manage theirunique daily regimens”.

External pain-management solutions designedto support consumers “through the day and night”were also sought by the company, Bayer said.

Across all four categories, Bayer said it want-ed to identify innovations that made self-care“easy, convenient, accessible, and personalised”for consumers.

Entrepreneurs and start-ups interested in part-icipating in the Grants4Apps Generator can signup for more information at g4agenerator.com.

Bayer is the latest in a long line of consumerhealthcare players seeking to work more closelywith innovative start-ups.

Johnson & Johnson’s (J&J’s) Innovationsubsidiary regularly launches ‘challenges’ tofind innovative consumer healthcare products(OTC bulletin, 7 April 2017, page 7), whileReckitt Benckiser (RB) has partnered with UScrowdfunding website Indiegogo to help entre-preneurs specialising in “health and wellbeing”(OTC bulletin, 9 December 2016, page 5).

Pfizer also offers support to start-ups throughits ‘Health and Wellness Innovation Program’(OTC bulletin, 30 June 2016, page 7). OTC

Bayer’s Grants4Apps Generator

Business Strategy

Oxford suffersUK setback

Business Strategy

P&G rejects move by investorProcter & Gamble (P&G) has vowed to pressahead with its existing strategy after anactivist investor failed to win a seat on the com-pany’s board.

Announcing the preliminary results of a voteto select its board, P&G said in re-electing all11 existing members, shareholders had reject-ed activist investor Trian Fund Management’sbid for a seat.

“We are encouraged that shareholders rec-ognise P&G is a profoundly different, much

stronger, more profitable company than justa few years ago,” commented the firm. “Thechanges the company has made are broad-basedand delivering results.”

Trian – one of P&G’s largest shareholders– hadbeen seeking a seat to help the firm to “addressthe challenges it is facing” (OTC bulletin, 8September 2017, page 6).

P&Ghad in thepast10years“underperformedrelative to its peers”, Trian claimed, and had “lostmarket share across most of its categories”. OTC

Oxford Pharmascience’s efforts to commer-cialise its OXPzero ibuprofen asset as anOTC medicine in the UK have suffered a set-back after the firm received negative feedbackfrom the country’s Medicines and Healthcareproducts Regulatory Agency (MHRA).

While the MHRA confirmed that Oxfordcould submit a marketing authorisation appli-cation for OXPzero ibuprofen using the hybridroute – relying in part on the results of pre-clin-ical trials for a reference product and in parton new data – the agency said further clinicalsafety and efficacy data would be required to getthe product approved.

OXPzero, the MHRA said, was not bioequiv-alent to the unnamed reference product, due to“faster time to maximum concentration”.

“The requirement for further clinical andsafety data,” commented Oxford, “may affect theeconomic viability of the programme.”

Noting that the company was yet to decidewhether to invest in additional clinical work orto “embark on other further development to matchthe reference within the required range for bio-equivalence”, Oxford said it would first seekfurther regulatory advice from the US Food andDrug Administration (FDA) and Sweden’s Medi-cal Products Agency (MPA).

Oxford said it would also seek advice fromother European Union (EU) national regulators“if considered necessary”.

A strategic review had been launched, Oxfordnoted, to assess “how best to realise the valueof the company’s assets at the present time and/or how to best obtain better value from theseassets over time”.

Marcelo Bravo, Oxford’s chief executive of-ficer, said that while the firm had received “verypositive consumer research results” on its OTCOXPzero programme, Oxford needed to “bet-ter understand the regulatory pathway to prod-uct approval” before proceeding with furtherproduct development.

Oxford is already having difficulties in se-curing OTC approval for OXPzero in the US.Earlier this year, the FDA told the firm that inorder to market OXPzero with a gastrointes-tinal safety claim, an outcomes-based phase IIIstudy would be required (OTC bulletin, 26 May2017, page 6).

“Such a study,” commented Oxford at thetime, “would be take a significant period of timeand require a very large sample size relativeto those originally envisaged by the companyusing endoscopic data.” OTC


OTC COMPANY NEWS

By harnessing the senses of touch, taste,smell and sight, GlaxoSmithKline (GSK)Consumer Healthcare is striving to stay ahead ofthe competition in the race to develop the next“breakthrough” consumer healthcare product.

Inviting OTC bulletin into its newly-openedConsumer Sensory Lab (CSL) – housed along-side its Shopper Science Lab (SSL) at the firm’sheadquarters in London, UK – GSK revealsit has assembled a panel of “highly trained”sensory testers to rank – on a 100-point scale – thesensory attributes of the company’s productsand, importantly, the products of its competitors.Through this process, it hopes to spot gaps in themarket for potential new product development.

Each product’s sensory properties – such asits colour, taste and texture – can be plotted ona principal competent analysis (PCA) map, GSKnotes, for detailed analysis by its sensory scien-tists, who oversee the sensory testers.

“The PCA map allows us to distinguish whereour products sit versus those of our competitors,”explains Marie Richardson, GSK ConsumerHealthcare’s principal sensory scientist.

Noting that each coloured dot on the maprepresents a product, Richardson says the dot’sposition is determined by the product’s key sen-sory attributes. Two products close together sharesimilar attributes, she says, while two that arefar apart will be noticeably different in their taste,texture, smell and appearance.

The PCA map reveals that the sensory prop-erties of GSK’s Sensodyne mouthwash are indistinct contrast to the properties of Johnson &Johnson’s (J&J’s) Listerine Cool Mint product.

“While Listerine Cool Mint is extremelymenthol and spicy – containing cardamom andginger notes – Sensodyne is much sweeter,” Rich-ardson explains.

Once GSK has plotted each product on thePCA map it can perform a “gap analysis”, shesays, “to understand what [type of product] ismissing [from the market]”.

In addition to the PCA map, GSK can alsoplot the data on a ‘spider map’, Richardson ob-serves, which allows the company to “dissectmore specifically one product versus another foreach attribute”.

“The spider map can give us a quick snap-shot of the similarities and differences betweenproducts,” she explains.

“By using different types of analytical meth-ods, we can extract as much information aspossible to compare our products with the com-petition,” Richardson adds.

Exploring the sensory properties of exist-ing products is just one way GSK is using itsnew sensory laboratory in London to shake upthe product development process for its globalskin-care and oral-care brands, according to SallyLoughlin, GSK Consumer Healthcare’s seniordirector of consumer and sensory innovation.

Similar sensory analysis for GSK’s Well-ness product development process is performedat the firm’s existing CSL in the US, whichopened last year. Research at the US lab hasalready led to changes across a range of GSK’sproduct lines.

The CSL in the US identified that consumersexperienced a burning sensation when they hadheartburn and desired a cooling effect to soothethe sensation. Using this insight, the companydeveloped cooling technologies that could beused in an antacid.

The findings, the company notes, fed directlyinto the development of ENO Cooling Powder– available in both Latin America and Asia –which now delivers on strong sensory-basedclaims such as “fast/instant cooling”.

Back at the London facility, Loughlin notesthat once GSK has spotted a gap in the mar-ket, the firm can invite consumers from thelocal area to the CSL, which is packed with“state-of-the-art technology” for sensory test-ing. It can then hone in on exactly what con-sumers want from a new product.

“If we want to create a new toothpaste, forexample, we need to understand exactly whatconsumers are looking for,” she explains. “Wemight ask consumers what texture in their mouthdo they want [the product to have], how longdo they want the cooling sensation to last, whattype of flavour do they want.”

Observe consumers’ reactionsUsing the technology at the CSL and the

adjacent SSL – such as facial and skin biometricmonitoring systems – GSK can also observeconsumers’ reactions to both new product con-cepts and existing lines, she notes.

Based on the sensory and consumer feed-back, the company’s product development teamcan create a new product, Loughlin explains,which matches exactly the desired sensory attrib-utes, such as sweet and spicy.

Newly-developed products can then be sentto the CSL for further sensory analysis and con-sumer feedback to ensure the product is right.According to Loughlin, the CSL will enableGSK to offer products which meet the needsof consumers “in a way that simply wasn’t pos-sible before”.

GSK’s work at the CSL is dependent on itspanel of sensory testers and its numerous con-sumer panels, Loughlin explains.

Whittled down from more than 400 appli-cants, GSK’s 24 sensory testers have been sel-ected for their “elite sensory perception”, Lough-lin notes. Each panellist has undergone sixmonths of training to ensure they can provide“detailed feedback on the taste, texture, smell,and other properties of everyday healthcare prod-ucts, such as toothpaste”.

The consumer panels are distinct from thesensory testers, Loughlin points out. If GSKis looking to develop a new toothpaste target-ing sensitivity, it can work with its market-re-

GSK taps into the sensesBusiness Strategy

GSK can observe consumers in the sensory booths using a one-way mirror

Sally Loughlin


COMPANY NEWS OTC

search partners to assemble a panel of consum-ers with sensitive teeth, she explains.

Expanding on the sensory technology housedat the CSL, Loughlin notes that the centre-piece of the facility is a bank of 12 individual‘sensory booths’.These cubicles are where GSK’spanel of sensory testers sit to assess the proper-ties of existing and newly-developed products.

“Each booth is fully equipped with state-of-the-art technology for sensory testing,” Lough-lin explains, including an iPad, recording equip-ment and adaptive lighting.

“By changing the lighting we can eliminatedifferences in colour between samples, so pan-ellists can focus absolutely on the taste, smelland texture of the product,” she notes.

“Each member of the panel works completelyindependently,” Loughlin points out, “to ensurethey accurately measure the sensory propertiesof products.”

Once inside a booth, a panellist is given asample – of an existing or newly-developedproduct – through a small hatch. Using the iPad,the panellists are asked a range of questions relat-ing to the sensory properties of the product. Eachproperty is given a score on a 100-point scale.

“Everything is broken down to measure theexact attributes of the product,” explains ChloeGuariglia, GSK Consumer Healthcare’s sen-sory panel leader. “With oral-care lines, such astoothpaste, we break [the product’s attributes]down by how much peppermint there is, howmuch menthol, whether it is bitter or sweet,and what mouth effects it produces, such as cool-ing, tingling or numbing.”

“For example, a panellist might score a prod-uct as 35 peppermint, 25 sweet and 65 cooling,”she explains.

“Whether that score is a good or bad thing isnot up to the panellist to decide,” Guariglia says.“That’s just what it is and that is the result wefeed back [to the product development team].”

“In order to get good results from our pan-ellists that are easy to interpret, we train themto perceive samples in the same way, and to think

the same way,” Guariglia explains.“One of the ways we do that is with refer-

ences for specific smells and tastes,” she says.“If I give the panel a peppermint reference tosmell, everyone will have that reference in theirhead, they won’t be thinking about their tooth-paste at home.”

“We spend a lot of time with the panel smell-ing the references and then we talk about howwe recognise peppermint, for example. Pep-permint has a strong smell and it clears thenose,” Guariglia points out, “whereas spearmintis sweet and has a herbal note.”

“When the panellists go to the booths totest the products, they can identify those similarnotes,” she says. “Through this process, every-one on the panel will judge the product in thesame way. We won’t have some people sayingit’s peppermint and others it’s spearmint.”

Loughlin explains that when the sensory pan-ellists test new products, GSK will have in mindthe score it wants to achieve for each attribute.For peppermint, it may be a score of 35, andcooling 70. These levels are based upon theinitial product testing to identify gaps in the mar-ket, and by quizzing consumer panels on whatthey want from a particular product.

Turning to the consumer testing conducted

at the CSL, Loughlin explains that GSK canquickly assemble panels of consumers from thelocal area to get their opinions on new or exist-ing products.

Each sensory booth houses recording equip-ment and a one-way mirror, allowing GSK toobserve how these consumer panels interactwith newly-developed products and the exist-ing offerings of its competitors.

“We can see everything the consumers doin the booths to help us understand what theyreally think of a product and how they use it,”Loughlin says.

“This research really helps us to give feed-back to the product development team about howwe can improve a product,” she explains.

Learn from competitors“Additionally, if a new product comes out

in the market that is really fantastic, we can get aconsumer panel to test it and help us to under-stand what we need to know,” she says. “Thisallows us to learn from what our competitorsare doing.”

In addition to the CSL booths, GSK can takeconsumers down the corridor to its SSL – openedfour years ago (OTC bulletin, 25 October 2013,page 20) – to measure further their reactions toproducts in a retail environment.

Loaded with advanced monitoring and in-teractive technology, the SSL offers “bespokeskin and facial biometric tools” to help under-stand a shopper’s “unconscious and emotionalreactions”; while a dedicated research controlroom with fixed cameras allows remote view-ing of shoppers in all the research areas.

The biometric tools, Loughlin notes, allowGSK to “dig deep to see what consumers reallythink about products”.

Loughlin says she expects that the UK facilitywill provide “substantial consumer insight, bothfor existing and developing products, whichwill allow us to refine the items we offer for manyyears to come”. OTCGSK’s Consumer Sensory Lab will help the firm spot gaps in the market for new products

GSK’s sensory booths are equipped with ‘state-of-the-art’ technology


OTC AESGP MEETING

Make reflections onscience,says AESGP

AESGP Meeting

Continued from front page

“top-10 best-selling global [consumer health-care] brands”.

The firm’s other global brands include theNexium 24HR/Nexium Control gastrointesti-nal lines, Caltrate and Emergen-C dietary sup-plements, Robitussin cough products and theChapStick lip-care range.

In addition to these global lines, Pfizer not-ed that it also offered several “local brands” thatwere “top-ranked in their respective markets”.

Pfizer’s decision to explore strategic optionsfor Consumer Healthcare follows a two-yearperiod of speculation about the future of thebusiness. This was triggered by the firm’s fail-ure to switch its blockbuster statin Lipitor fromprescription to OTC status in the US (OTC bul-letin, 14 August 2015, page 1).

Abandoning the Lipitor switch programmeafter heavy investment, Read insisted at thetime that Consumer Healthcare remained a“very valuable and growing asset”.

While Read has continued to stress the “val-ue” of Consumer Healthcare to Pfizer, he hason numerous occasions admitted that the firmregularly reviews the business to ensure it is“delivering the right return for shareholders”(OTC bulletin, 25 November 2016, page 5; OTCbulletin, 11 August 2017, page 11).

Potential suitors for Pfizer Consumer Health-care – should the firm decide to sell the unit –could include Reckitt Benckiser (RB), whichhas in the past expressed an interest in acquiringthe business.

“If the Pfizer business were to come up [forsale] for any number of reasons, would RB beinterested to look at it? Yes,” admitted RB’schief executive officer Rakesh Kapoor in 2015(OTC bulletin, 11 December 2015, page 1).

With Merck KGaA also weighing up the saleof its Consumer Healthcare operation (OTCbulletin, 8 September 2017, page 1), the globalconsumer healthcare market looks set for a shake-up in 2018. OTC

Pfizer couldsell Consumer

Business Strategy

VERU has grantedTimm MedicalTechnologiesthe US distribution rights to its Preboost pre-mature ejaculation product. “We are pleasedto be working with Timm,” commented US-basedVeru, “to significantly expand the scope ofmarketing and sales activities and patient ac-cess to Preboost.” OTC

IN BRIEF

“Provocative” ideas, such as vending mach-ines and 3D printers producing person-alised pharmaceutically-enriched foods – or“phoods” – are all very well, but the EuropeanCommission’s (EC’s) reflections should berooted in science and “very clearly defined”,according to Hubertus Cranz, director-generalof the Association of the European Self-Medi-cation Industry, the AESGP.

Speaking to the association’s meeting in Brus-sels, Belgium, last week, Cranz conceded thatpharma food was an “interesting and provoca-tive” idea and “very relevant” to the AESGP.

However, he emphasised that there were in-dustry “concerns” about companies’ ability tomake health claims for relatively simple foodsupplements. Indeed, the Commission was justabout to release the results of its long-awaitedRegulatory Fitness Evaluation (Refit) into whetherthe existing health claims regulation was “fit forpurpose” (see page 10).

“If pharma food means you give a generalblessing to health claims without scientific back-ing, then you create total market chaos,” Cranzwarned. “For industry and consumers, this wouldbe disastrous.”

“We believe that any reflection in the fieldof pharma food has to be very clearly definedand science-based,” he added.

Nathalie Chaze, deputy head of cabinet ofHealth and Food Safety Commissioner VytenisAndriukaitis, commented that “the border be-tween food and medicines is a little bit too blurredin the mind of some consumers”.

“This is clearly where the health claims regu-lation can play a very important role,” she said.“There is a demand from society to have truthabout healthy food.”

Intended to provide evidence-based scientificsupport to the European policymaking process,the EC’s report – from its Joint Research Centre –analyses four scenarios: global food; regionalfood; partnership food; and pharma food, cov-ering functional and processed foods, and foodswith added pharmaceutical substances, or phoods.

According to the report – entitled ‘Futurefood scenarios and implications’– phoods willtransform consumer healthcare over the next 30years to the point where the “pharmaceutical,and food and drink industries converge”.

People will increasingly turn to pharma foodsin a personalised diet regimen aimed at optimis-ing their health status, the report claims.

By 2050, large multinational pharma foodfirms will “control most of the food chain”, hav-ing “invested early in this field,” the reportclaims. “Hyper-retail structures” will supply arange of personalised “functional, fortified andmedical food products to the consumer”, mainlythrough online shopping channels.

Europe-based pharma food companies willdrive innovation and grab market share throughsupply-chain rationalisation and acquisitions,the report predicts, highlighting that person-alised diets will become popular and ‘nutra-ceuticals’ will enter the mainstream.

An increasing importance of self-care amongthe general public is listed as another “driver dev-elopment” by the report.

Existing regulations could be “adjusted” anda new category of phood introduced, the reportsays, but “ultimately”, a new regulatory frame-work “may need to be developed”.

“Although certain aspects may already existin the current European Union (EU) foods andpharmaceuticals legislation, it is likely that thecomplexity and the transversal nature of phoodswould necessitate the extensive adaptation ofexisting legal acts,” it argues.

“For example, the health claims regulationwould likely become obsolete or would requireconsiderable adaptation.”

An effective regulatory framework wouldalso be needed, the report maintains, to protectconsumers from other “potential drawbacks”of phoods, such as “lower quality or fraudulentproducts” entering the market, “counterfeit orinactive pharmaceutical ingredients”, and “haz-ardous components obtained from illegal sup-pliers” being added to phood products.

Similar to pharmacovigilance, “nutrivigilance”could be introduced, the report proposes. “Post-market monitoring by consumers, phood ser-vice providers, health professionals and relevantauthorities could be introduced efficiently tomonitor and detect adverse effects due to phoodconsumption, overdose and cocktail effects.”

The report is clear that any change to the legalframework will need to be EU-wide. “[This] regu-latory framework would ensure harmonisationand support the barrier-free trade of personaliseddietary components and phoods within the EU,as well as facilitate global exports,” it maintains.

“It would also ensure that no inequalities in ac-cess arise between and within the member statesdue to different implementations levels.” OTC


Europe’s long-anticipated medical devicesrules could have been an “opportunity forinnovation”, but they are turning into a “road-block for creating new products”, accordingto Maikel Hendriks, chief executive officerof Netherlands-based medical devices specialistMedical Brands.

Far from “removing technical barriers”, hesaid, the revised rules were creating new obstacles.

Speaking at last week’s meeting of the As-sociation of the European Self-MedicationIndustry, the AESGP, in Brussels, Belgium,Hendriks insisted the new legislation – pub-lished in the EU Official Journal on 5 May –was obstructive. “We create a roadblock if wesee people as patients not able to control theirown health,” he maintained.

Under the new legislation, he pointed out,medical devices were subject to much stricterdata and documentation requirements. Exist-ing medical devices were also subject to review,he added, with many OTC manufacturers facingthe prospect of reclassification of their productsinto higher risk categories.

“What is the sense of this reclassificationand all of this risk?” Hendriks asked. “Has therebeen an impact analysis?”

Hendriks said his company had carried out itsown impact analysis and found that a third of OTCmedical devices on the European Union (EU)market could be subject to such a reclassification.

Upward reclassification based on the per-

ceived risk of substance-based medical deviceslike nasal sprays has been fought against by theAESGP over the five years since the EuropeanCommission first proposed the new rules (OTCbulletin, 12 October 2012, page 7).

The Commission’s first draft suggested thatsubstance-based medical devices should be clas-sified within the highest risk category class III.

After considerable debate, however, it waseventually decided that medical devices wouldonly be considered class III if they achieved their“intended purpose” in the stomach or intestinaltract (OTC bulletin, 17 June 2016, page 1).

Medical devices were the “fastest-growingcategory” in Europe’s healthcare market, in-sisted Hendriks, with about a 100 such devicesnow on the Dutch self-care market.

Highlighting the shrinking number of noti-fied bodies, Hendriks noted growing registra-tion times and a lack of guidance documents forindustry and regulators.

“Healthcare is moving closer to the user,” heargued. “In the end there’s going to be less inter-action with the general practitioner (GP) and therewill be increased emphasis on convenience.”

“We have to be flexible and dynamic in ourguidelines,” he insisted. OTC

Botanicals issue nears endAESGP Meeting

OTC AESGP MEETING

The European Commission’s (EC’s) longdrawn out ‘reflection’ on the thorny subjectof health claims for food supplements contain-ing botanicals could soon be coming to an end.

European Union (EU) member states andstakeholders will be consulted on the reflec-tion’s results at workshops to be held at theend of this month.

Draft conclusions from a report by the EC onwhether the health claims regulation, 1924/2006,is “fit for purpose” with regard to botanicals willbe presented at workshops on 26-27 October.

The Commission’s ‘Regulatory Fitness Evalu-ation’ (Refit) report will come almost exactlyseven years after the EC decided to put on holdfor botanicals the work to establish a communitylist of permitted general health claims for foods(OTC bulletin, 15 October 2010, page 1).

Nathalie Chaze, deputy head of cabinet ofHealth and Food Safety Commissioner VytenisAndriukaitis, told delegates at a meeting of theAssociation of the European Self-MedicationIndustry, the AESGP, in Brussels, Belgium, lastweek that she was not in a position to revealany of the report’s details. She stressed, however,that “stakeholder involvement” would be wel-come when the results were presented.

“At the end of this year, we want to start get-

ting into the dynamics of decision-making atthe EU level, which is why it is really importantto have this debate now and assess which wayto go,” she explained.

The Commission has been reflecting on healthclaims for botanicals since 2012 (OTC bulletin,10 August 2012, page 1). It has been trying toextricate itself from a fundamental problem inthe legislation whereby the same botanicals arebeing treated differently under the food claimsregulation than they are under pharmaceuticallegislation covering traditional herbal medicines.

Speaking in Brussels last week, Renate Som-mer, a member of the European Parliament’sCommittee on Environment, Public Health andFood Safety, insisted that the delays had ledto “market distortion” and “legal uncertainty forall stakeholders”.

“When it comes to the question of how theseinnovative products may be advertised, the EUhas clearly failed,” she concluded.

Consumer protectionIlaria Passarani, head of food and health at

the European consumer organisation, BEUC,maintained that the extended period of reflec-tion had resulted in widely differing practicesacross European member states.

This impacted on consumer safety becausefood supplements were not subject to the sameconsumer information requirements as herbalmedicines, she argued.

“Consumers think that botanicals are safebecause they are of natural origin, when we knowin fact that some of them can have side effects,”she pointed out.

Passarani warned that a ‘refit’ of the existingregulation still needed to “to protect consum-ers against exaggerated and unsubstantiatedclaims”. “Our message in relation to food sup-plements has always been clear: no evidence,no claim,” she asserted. OTC

Nathalie Chaze

Med device rules‘obstructive’AESGP Meeting

Maikel Hendriks


A£31.8 million (C35.8 million) tender hasbeen launched by the European MedicinesAgency (EMA) to recruit temporary staff aheadof its relocation in the wake of the UK’s ‘Brexit’decision to leave the European Union (EU).

Spread across four years, the tender comprisessix separate contracting lots, with the contractfor each lot to be signed “with a maximum offive companies”. Staff requirements include gen-eral administrative and maintenance staff; confer-ence organisers; IT administrators, developersand support staff; scientific administrative staff;employees with a legal, auditing and policy back-ground; and communication specialists. Thevalues of each contracting lot range from £1.3million to £8.8 million, over the four years.

Tenders – which must be submitted by 6November, ahead of being opened on 10 Nov-ember – must be valid for a period of nine monthsfollowing the submission date.

The tender followed the publication by theEMA of a staff retention survey that raised “seri-ous concerns” over the agency’s relocation (OTCbulletin, 6 October 2017, page 10). It illustratedlikely staff retention levels for each of the 19cities bidding to host the agency of between 6%and 81%, but did not identify which candidatecities corresponded to which retention rates.

However, “in order to complete the pictureand set the record straight”, the agency has nowpublished in full the information it submittedto the European Commission (EC) in supportof its assessment of the 19 bids. The EMAsaid this decision came “following the recentpublication of isolated pieces of informationcirculating in the press”.

Two annexes published by the EMA evalu-ate the 19 bids. The first relates to the technicalassessment on the proposed building or buildingsto house the EMA. The second consists of areview of information related to other criteria,including accessibility of the location, existenceof adequate education facilities, appropriate ac-cess to the labour market, social security and med-ical care, and business continuity (see Figure 1).

In evaluating the bids, the EMA assignedeach city one of four ratings for each criterion.The highest rating was a determination thatmoving to the city would meet EMA require-ments for a given criterion, and ensure that theagency was operational on time. The next-highestrating indicated that the city would meet EMArequirements but would raise concerns that theEMA would not be operational on time.

The lower two ratings were that the city onlypartially meets EMA requirements and raises

“major concerns” regarding EMA business con-tinuity; and that the city does not meet EMArequirements and does not ensure EMA busi-ness continuity.

Four cities – Dublin, Ireland; Porto, Portugal;Vienna, Austria; and Warsaw, Poland – includedmultiple premises, leading to mixed verdicts withdifferent ratings for individual premises.

Reflecting on the EMA’s comments on themember state bids, the agency’s deputy directorNoëlWathionsaid: “Theaccessibilityof thenewpremises for delegates and experts, and staffretention, are key to ensuring the agency remainsoperational and able to deliver on its missionafter its relocation.”

Meanwhile,Yann Le Cam, patient representa-tive on the EMA board, said the decision whereto locate the EMA as of March 2019 “shouldnot be based on what the EMA would bring tothe new host country, but on whether the newhost country has what it takes to preserve thevalue the EMA brings to patients in the EU”.“The capacity of the new host city to retain cur-

rent staff and attract new people at the samelevel of quality is key for this,” he added.

The EMA’s board said that it had initiated anearly discussion on the implications for 2018’sdraft budget and 2019’s preliminary draft bud-get of “the challenges the EMA will face overthe next few years”. “While no firm predictionscan be made until the new location of the agencyis known,” the EMA said – following a vote thatis due to take place on 20 November – “theEMA is anticipating staff losses which will notonly challenge the agency’s operability, but couldalso result in a major deficit in its budget.”

“If operations are delayed or have to stopbecause of massive staff losses, the agency couldexperience a dramatic drop in fee income,” theEMA acknowledged, “which would in turn resultin reduced payment to the national competentauthorities.” Furthermore, “the financial con-sequences would be further exacerbated by thecost of replacing staff”, the EMA said, suggestingthat “such shortfall would need to be made upfrom the EU budget”. OTC

EMA seeks temporary staffRegulatory Affairs

GENERAL NEWS OTC

Amsterdam

Athens

BarcelonaBonn

Bratislava

BrusselsBucharest

Copenhagen

Dublin

Helsinki

LilleMaltaMilan

Porto

Sofia

StockholmVienna

Warsaw

Zagreb

Biddingcity

Layo

uto

fpremises

Propose

dfacilitie

sofp

remises

Relocatio

nplan

Accessibility

oflocatio

n

Adequate

educatio

nfacilitie

s

Access

tolabourm

arket,

socialsecurity

Staffretentio

n

Meets EMA requirements and ensuresthat EMA is operational on time

Meets EMA requirements but raisesconcerns that EMA is operationalon time

Only partially meets EMA requirements –raises major concerns regarding EMAbusiness continuity

Does not meet EMA requirements – doesnot ensure EMA business continuity

Mixed/multiple premises

Figure 1: Selected criteria evaluated by the EMA for the 19 bidding cities (Source – EMA)

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PAGB seeks self-care strategyRegulatory Affairs

OTC GENERAL NEWS

Reducing the rate of value-added tax (VAT)on OTC medicines, increasing the num-ber of medicine reclassifications and offeringgeneral practitioners (GPs) ‘recommendationpads’ so that they can recommend rather thanprescribe OTC medicines, should all be a partof national strategy for self-care in England, ac-cording to the Proprietary Association of GreatBritain (PAGB).

Noting that it was “vital to promote and em-power more people to self-care”, the PAGB in-sisted that a “national strategy for self-care isrequired to provide the leadership and policyco-ordination necessary to embed self-care intothe National Health Service (NHS) in Englandand people’s lives”.

The industry association outlined its plansfor a national self-care strategy for England inresponse to a consultation from NHS Englandon whether the service should stop routinelypaying for 3,200 OTC medicines for a numberof long-term conditions to help save money(OTC bulletin, 11 August 2017, page 15).

Review 3,200 OTC productsIn its consultation document ‘Items which

should not be routinely prescribed in primarycare’, the NHS outlines 18 prescription-only drugsit believes should no longer be routinely pre-scribed and says that it plans to review 3,200OTC products that could also be subject to pre-scribing restrictions.

In response, John Smith, the PAGB’s chiefexecutive, said industry recognised the “challeng-ing financial situation currently facing the NHS”and supported the aim to “ensure NHS resourcesare used in the most efficient way possible”.

However, the PAGB also felt that there need-ed to be “several supporting policies” put inplace, Smith added, before prescribing restric-tions were considered.

“The PAGB has been calling for a nationalstrategy for self-care to provide the leadershipand policy co-ordination necessary to supportwide-scale behaviour change,” he pointed out,“as this is a complex issue which cannot beaddressed without a system-wide approach.”

The PAGB proposed that a national strat-egy for self-care should:

l increase access to effective OTC medi-cines/products;

l introduce a zero-rateVAT on OTC products;l introduce a target to increase the number

of prescription-only medicine (POM) to phar-macy/general-sale list (P/GSL) reclassifications;

l introduce ‘recommendation pads’ for GPs

to recommend OTC products to patients;l empower community pharmacy to better

facilitate self-care;l launch a national campaign to promote

the expertise of pharmacists;l enable community pharmacists to have

“write” access to people’s care records;l enable community pharmacists to refer

people to other healthcare professionals, fast-tracked if necessary;

l improve NHS 111 algorithms to appropri-ately refer more people to community pharmacy;

l improve health literacy;l continue and expand national self-care

campaigns, such as ‘Stay well this winter’;l include health education in the personal,

social, health and economic (PSHE) school cur-riculum for ages five to 18 years;

l include self-care, and methods of sup-porting people to self-care, in the professionaltraining curriculum for GPs and other health-care professionals;

l support people to live healthy lifestylesand prevent ill health;

l recommend all adults take a daily multi-vitamin and fish-oil supplement; and

l pledge to continue support for NHS smok-ing-cessation services.

Expanding on some of the suggestions, thePAGB said it felt that introducing “recommen-dation pads” for GPs would be a “positive way tosupport the individual across England in access-ing the right treatment”.

In Germany, the PAGB explained, a similarscheme had been “very effective”.

“The grüne rezept – or green prescription – isa prescription pad on which GPs can recom-mend an OTC medicine to their patient,” theassociation explained.

Green prescriptions“Research conducted by Germany’s medi-

cines manufacturers’ association, the BAH, inNovember 2016 found that when people weregiven a green prescription by their GP, 87%purchased the recommended medicine from apharmacy and 4% purchased the recommendedmedicine from an online pharmacy,” the PAGBstated. “Only 6% said they did not purchase themedicine and 3% couldn’t remember.”

The BAH had also found that people re-membered the GP’s recommendation. The nexttime they experienced the same symptoms, theywent directly to the pharmacy without visitingthe GP first.

Reducing the VAT rate on OTC medicines,

self-care medical devices and food supplements,the PAGB added, would be a “positive way toimprove the affordability of medicines”.

Currently the majority of medicines attract-ed the standard VAT rate of 20%, it pointed out,although nicotine-replacement therapy (NRT)benefitted from a reduced rate of 5%.

While there would be a tax-revenue impli-cation of reducing the VAT on medicines, thePAGB admitted, the move would aid low-in-come groups which could be “disproportion-ately affected by a policy to restrict prescrib-ing practices”.

One area of the consultation that the PAGBhad strong concerns about was the criteria bywhich the 3,200 OTC medicines would be re-viewed by NHS England and the NHS Clini-cal Commissioners.

Undermine regimeUnder the proposal, the OTC medicines on

the list would be judged on safety and efficacy,among other factors, something which the PAGBsaid undermined the European Union (EU) andUK medicines licensing regime.

Calling for safety and efficacy to be removedfrom the review criteria, the PAGB pointed outthat OTC medicines on the UK market had al-ready demonstrated “clear evidence of a goodsafety profile, efficacy to treat the conditionindicated and suitability for self-care”.

“Any suggestion that medicines available tobuy in the UK are not safe or efficacious is un-helpful and potentially dangerous,” the PAGBargued. “Any concerns about the safety ofmedicines should be addressed through exist-ing Medicines and Healthcare products Regu-latory Agency (MHRA) processes and not con-flated with this policy proposal.”

Overall, Smith said that the PAGB felt NHSEngland and NHS Clinical Commissioners were“missing an opportunity to empower peopleto self-care in a sustainable way” that would leadto a reduction in GP appointments as well asvisits to accident and emergency departments forself-treatable conditions.

“The founding principles of the NHS – ‘avail-able to everyone, free at the point of delivery,based on clinical need not the ability to pay’– are important and should be protected,” Smithinsisted. “Any change in the prescribing practicefor OTC medicines needs to be implementedin a way that does not undermine this, and thisshould not be the first step towards a healthcaresystem in which only those that can afford to paycan access the treatment they need.” OTC


Homoeopathy needs controlsRegulatory Affairs

GENERAL NEWS OTC

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Homoeopathy is “undermining patient andpublic confidence in scientific evidence”and must be subject to “standardised” regulationacross the European Union (EU), according toa report from the European Academies’ ScienceAdvisory Council (EASAC).

In its ‘Homoeopathic Products and Practices’report, EASAC – which is formed by the na-tional science academies of EU member states –calls for EU-wide regulation governing the clini-cal testing, advertising and labelling of homoeo-pathic products.

Under existing EU regulations, a simplifiedregistration procedure is available for homoeo-pathic medicines administered orally or exter-nally, which have no specific therapeutic indica-tion on the labelling and which have a suffi-cient degree of dilution to guarantee safety.

Other homoeopathic medicines not fulfill-ing the above criteria need to be authorised andmost requirements concerning conventionalmedicines apply.

Drawing on previously published “science-based assessments” of homoeopathy by its mem-bers, EASAC insists in the report that tighter

regulation is needed, as homoeopathic productscan be harmful to patients “by delaying or de-terring them from seeking appropriate, evidence-based, medical attention”.

Despite insisting that there is “no robust,reproducible evidence that homoeopathic prod-ucts are effective”, EASAC says it acknowledgesthe importance of consumer choice.

“But, patient choice must be appropriatelyinformed,” EASAC insists, “and this raises is-sues for achieving a standardised, knowledge-based, regulatory framework and sound advert-ising practices that can apply equitably to allmedicinal products, whatever their origins andwhatever their mechanisms.”

Expanding on its recommendations, EASACcalls for a “consistent regulatory requirement”for claims concerning the efficacy, safety andquality of homoeopathic products to be “basedon verifiable and objective evidence, commen-surate with the claims being made”.

The advertising and marketing of homoeo-pathic products and services should “conformto established standards of accuracy and clarity,”according to EASAC’s report. “Promotional

claims for efficacy, safety and quality shouldnot be made without demonstrable and reproduc-ible evidence,” EASAC says.

Turning to labelling, the report calls for the“current exceptional labelling permitted forhomoeopathic products to be replaced by asimple description of the ingredients and theiramounts present in the formulation”.

Report receives criticismEASAC’s report has been widely criticised

by manufacturer associations and homoeopa-thy organisations.

Questioning the report’s validity, Germany’sfederal association of the pharmaceutical indus-try, the BPI, insisted that the “current EU legis-lation fully ensures the quality and safety ofhomoeopathic medicinal products based on thesame standards as for all medicinal products”.

The European Central Council for Homoeo-paths (ECCH) claimed that EASAC had “ignoredor unfairly dismissed” the available evidencewhich “supports homoeopathy’s mechanism ofaction”. “Homoeopathy is safe; few adverse effectshave been reported,” ECCH insisted. OTC


GlaxoSmithKline (GSK) Consumer Health-care is set to use a portfolio of pain brandsto drive a global push to relieve the “social andeconomic impact of pain”.

Bringing together existing initiatives runfor the firm’s global pain-relief brands – Excedrin,Fenbid, Panadol and Voltaren – the ‘Better forEveryone’ campaign aimed, GSK explained, to“reduce the impact of physical pain for a further4.3 million people by 2021”.

To achieve this goal, the firm said it wouldpartner with “retailers, advocacy groups, doctors,pharmacists, policymakers and regulators” to“drive change within communities”.

Laura Boros, senior vice president of GSK’sglobal pain business, said the campaign wouldfocus on three areas over the next four years.

“Firstly, we are committed to providing accessto the widest range of everyday pain medicationby expanding our geographic reach and achiev-ing greater flexibility around our product offer-ing, format and price to include those consumerswho may have been left behind,” Boros stated.

Furthermore, GSK would “continue to helpinform and support people, including doctors andpharmacists”, she added, “so they can better man-age their pain and the pain of those around them”.

This included education around the appro-priate use of medicines for both consumers andhealthcare experts, Boros continued, from “holis-

tic programming”, such as offering advice onhow to prevent and manage pain, to communityinitiatives, which addressed societal challengesrelated to pain.

Finally, to help people avoid and relieve pain,the company was committed, she added, to build-ing an innovative pipeline of “scientifically dif-ferentiated products” which would “acceleratethe journey back to normal life”.

The Better for Everyone campaign wouldalso use the firm’s Global Pain Index research,Boros said, to help GSK “both understand theimpact of pain and find solutions that enablepeople to live free from its negative effects”.

GSK announced the launch of the Better,for Everyone initiative as it published its ‘GlobalPain Index 2017’ report.

Covering 32 countries – up from 14 in 2016(OTC bulletin, 4 March 2016, page 16) – acrosssix continents, this year’s report found that 95%of adults aged 18 years and above had experi-enced body pain at some point in their lives and86% had suffered from head pain (see Figure 1).

Furthermore, body pain had been experiencedat least weekly by 56% of the over 19,000 peopleinterviewed, the survey revealed, with weeklyhead pain impacting 23% of those questioned.

The cost of pain to both economies and indi-viduals was “too high”, the report stated, notingthat the average worker took at least 2.6 days offsick each year due to body pain, costing anestimated US$245 million (C207 million) an-nually across the countries surveyed.

In addition, the report noted, two in 10 in-dividuals felt that their career progression hadbeen negatively impacted by pain.

As for treating pain, 39% of body pain suf-ferers said they took action – such as consult-ing a healthcare professional or taking pain relief– within hours of pain starting, with a fifth say-ing they ignored the pain until it went away.

Head pain sufferers were quicker to act, thesurvey found, with 65% saying they took actionwithin a few hours and 17% saying they ignoredthe pain until it went away.

As Figure 2 shows, over half of head painsufferers preferred taking a non-prescriptionmedicine to treat their pain, compared to 36%of body pain sufferers. Meanwhile, 40% of thosewith body pain preferred to take prescribed medi-cines compared to 29% of head pain sufferers.

Convenience was the key reason for peoplechoosing a non-prescription medicine to treattheir pain, the report said, while those who pre-ferred prescription medicines admitted it wasthe strength of the medication that swayed theirdecision (see Figure 3).

However, while self-diagnosis was the pri-mary method of identifying the cause of pain,throughout all of the 32 different markets sur-veyed there was a low level of knowledge aroundpain medications, the report noted.

Noting that medical doctors and pharmacistswere the preferred points of contact for findingout more about pain medications, the reportclaimed that providing education in an accessi-ble and comprehensible format could be keyto minimising any potential risk. OTC

OTC MARKETING NEWS

GSK to ease the world’s painMarketing Campaigns/Market Research

Figure 1: Proportion of people globally whohave suffered from body and/or head pain(Source – GlaxoSmithKline)

Laura Boros

Figure 3: Reasons why sufferers prefer either prescription or non-prescription medication to treatbody pain and head pain (Source – GlaxoSmithKline)

REASONS FOR PREFERRINGPRESCRIPTION MEDICATION

REASONS FOR PREFERRINGNON-PRESCRIPTION MEDICATION

5656

2526

1820

1517

911

Strength of themedication

It is more convenientto get this type of drug

I can get hold ofthis drug quicker

Price of themedication

Avoids making adoctor’s appointment

2019

43434547

2320

3936

Body pain Head pain

Figure 2:Treatment options preferred by body painand head pain sufferers (Source – GlaxoSmithKline)

Medicine prescribedby a doctor

Non-prescriptionpain killers

I have no preference

BODY PAINSUFFERERS

HEAD PAINSUFFERERS

40%

36%

23% 19%

52%

29%

Body pain Head pain

Strength of themedication

It is more convenientto get this type of drug

I can get hold ofthis drug quicker

Price of themedication

Avoids making adoctor’s appointment


Dermalex to makethe UK feel good

Marketing Campaigns

MARKETING NEWS OTC

“Makes you feel good inside and out”is the message to UK consumers ina new campaign from Perrigo for its Dermalexbrand of skin-care products.

Noting that it was making its biggest mar-keting investment yet behind the brand, Perrigosaid that the Dermalex campaign would be ledby a six-week television promotion which wasset to debut on 23 October. A series of follow-upadvertisements would then begin airing from 20November, the company added.

Furthermore, the firm has partnered with inde-pendent pharmacy consultant Dr Christine Clarkto provide advice to sufferers of skin conditions,along with “influential” bloggers and vloggers.

A Facebook page had also been launched– facebook.com/dermalexuk – Perrigo pointedout, to provide expert help and advice to peoplewho suffered from skin conditions.

A steroid-free eczema cream, Dermalex hadbeen scientifically proven to relieve the symptomsof a flare up, Perrigo said, by helping the skinto “repair and strengthen”.

“Dermalex is different to most skin conditiontreatments,” the company claimed, “as it relievessymptoms but contains no steroids or antibioticsand is suitable for daily, long-term use.”

Holly Turner, senior marketing director at

Perrigo, said that skin conditions such as ecze-ma, acne, psoriasis and rosacea could heighteninsecurities and impact self-confidence.

“We are therefore excited to launch this cam-paign and showcase Dermalex – which is rec-ommended by 95% of pharmacists – to consum-ers as a product that is moisturising, protectingand gentle on the skin,” she added, “and that worksto make you feel good inside and out.”

The Dermalex product portfolio includesthe core Atopic Eczema Treatment, Hand Irri-tation Treatment and Eczema Treatment forBabies & Children products, along with varia-tions designed to treat acne, rosacea and psoria-sis of the body and scalp. OTC

Dermalex is receiving its biggest UK investment

Digital health firm Carrot has gained regu-latory approval in the US for what it claimsis the first OTC carbon monoxide breath sensorfor use in smoking-cessation programmes.

Currently available to US consumers throughtheir employers, the Bluetooth-enabled device– which connects to a breath sensor applicationon a smartphone – measured carbon monoxidelevels in exhaled breath, Carrot explained, to edu-cate smokers on the health impacts of the habit.

The device recorded carbon monoxide breathlevels through a straw, Carrot added, and trans-lated the results into a traffic light system on

the smartphone app. “It enables a user to trackthe real-time effects of their smoking behaviour,”the company said.

Unlike nicotine-replacement therapies (NRT),the US-based company said its product address-ed the cognitive rather than chemical barriersto successful smoking cessation.

The breath sensor has been developed for usealongside Carrot’s Pivot programme.

A 58-week programme delivered via the smart-phone app, Pivot was designed to educate, en-courage, mentor and sustain users through suc-cessful smoking cessation, Carrot explained.

Pivot provided tailored quit strategies andcoaching, the firm noted. The programme’s appallowed users to monitor carbon monoxide re-sults from the breath sensor, and also trackedcigarette intake and other metrics, Carrot said.

The firm claimed that Pivot catered for diverseuser experiences, as it had been “designed toappeal to and help smokers no matter wherethey are in their quit journey”.

“It is a programme for all smokers, designedto give those who want to quit access to the besttools and support, and to help those who aren’tyet ready to develop confidence and motivationfor change,” Carrot said.

According to the company, its programmehad “entirely reimagined smoking cessation” forthe digital age. OTC

Product Launches

Breath sensorapproved in US

Vaccines specialist Seqirus has entered theAustralian OTC market with Nervoderm,a lidocaine-based pain-relieving patch.

Clinically proven to relieve nerve pain associ-ated with medically-diagnosed post-herpeticneuralgia (PHN) for 12 hours, Nervoderm, thecompany said, had been launched in Australiain partnership with Pharmabroker Sales.

PHN presented itself in a number of differentways, Seqirus pointed out, including burning,stabbing or shooting pains at or near the skin’s

surface, which might be accompanied by in-creased sensitivity to touch, heat or cold.

The schedule 2 – pharmacy-only – hydrogelpatch had an “instant soothing effect on the affect-ed area”, the firm said, and created a “protectivebarrier on the skin, preventing unwanted contact.”

“The active ingredient lidocaine continuouslyabsorbs into the skin,” Seqirus added, “and pre-vents damaged nerves from sending painful mes-sages to the brain without causing any numbness.”

Lorna Meldrum, vice president of commer-cial operations at Seqirus, said that as Nervo-derm was the company’s first OTC offering, itwas pleased to have partnered with Pharma-broker Sales to launch the product.

“Pharmabroker Sales’ experience in OTCpharmacy sales and well-established relation-ships within Australia’s pharmacy network,” sheadded, “has helped build our understanding ofthe market.” OTC

Product Launches

Seqirus launches first OTC brand

Nervoderm is Seqirus’ first OTC product

Carrot’s breath sensor is approved by the FDA


OTC MARKETING NEWS

RB to pay A$3.5mfor Nurofen claims

Legal Cases

Reckitt Benckiser (RB) has apologised formisleading consumers in Australia, afterthe country’s Federal Court approved the settle-ment of a class action lawsuit related to its Nuro-fen ‘Specific Pain’ range.

Judging the settlement to be “fair and rea-sonable”, the Federal Court ordered RB to payA$3.5 million (C2.3 million) plus legal costs,to settle the claim that the firm had misled con-sumers who purchased the Specific Pain prod-ucts between 2011 and 2015. RB had agreedto settle the case earlier this year (OTC bulletin,11 August 2017, page 14.)

Launched by Bannister Law, the class actioncalled for a full refund for the Specific Pain prod-ucts that consumers had purchased, claimingthat they “would not have purchased the prod-uct if they had known that it was not more ef-fective on targeted pain than any of the otherNurofen products in the range”.

The Specific Pain variants – Back Pain,Migraine Pain, Period Pain and Tension Head-ache – claimed to treat a particular type of pain,despite them all containing 342mg of ibuprofenlysine (OTC bulletin, 25 March 2016, page 12).

RB has admitted that its marketing of theline between 2011 and 2015 – both on pack-aging and on its website, nurofen.com.au – was“misleading or deceptive”. However, RB deniedthat its marketing was in breach of AustralianConsumer Law and denied it was liable to com-pensate consumers.

Commenting on the settlement, a spokes-person for RB told OTC bulletin that the com-pany apologised for “any confusion surround-ing the Specific Pain range in Australia, whereconsumers may have been misled”.

“While RB did not intend to mislead, we rec-ognise we could have done more to assist con-

sumers in navigating the Nurofen Specific Painrange,” the spokesperson added.

RB said it had “listened to the concerns ofconsumers and taken steps to ensure that futuremarketing is sensitive to the risk of misinter-pretation and likely confusion.”

The case, which began early last year(OTC bulletin, 25 March 2016, page 12), hassince engulfed almost 11,000 consumers – afigure which could increase as Australian newsoutlets circulate forms explaining eligibilityand how to apply to the settlement fund.

Consumers have until 20 January 2018 toapply, after which point the A$3.5 million settle-ment fund will be distributed amongst claim-ants by a third-party administrator, Sapere Re-search Group. Any capital which is unclaimedwill be returned to RB.

Claimants will be entitled toA$3.16 orA$5.70for purchasing 12-tablet or 24-tablet packs re-spectively, although these figures may dwindle,as more consumers join and the settlement fundbecomes segmented.

The Federal Court declined RB’s requestfor a “class closure order” which would havelimited the number of consumers lined up forrecompense in this case.

Earlier this year, RB was fined A$6 millionby Australia’s High Court for misleading con-sumers over the Specific Pain range (OTC bul-letin, 28th April 2017, page 16). OTC

RB has apologised for misleading consumers

Procter & Gamble (P&G) has agreed to payup to US$30 million (C25 million) to settlea long-running false advertising class action law-suit related to its Align probiotic brand.

The settlement comes seven years after theclass action was launched claiming that P&Gfalsely advertised Align as “clinically proven”to promote digestive health.

Under the terms of the deal, P&G will pay

up to US$15 million in cash refunds to peo-ple that bought Align, along with US$5 million-US$10 million in other benefits. The firm willalso pay US$5 million in fees and expenses.

The company has also agreed not to makethe “clinically proven” claim for the brand inany of its marketing again without new, reli-able supporting clinical data or a change inAlign’s formula. OTC

Legal Cases

P&G settles Align probiotic lawsuit“Medical care for sensitive skin” is how EduardGerlach is positioning the Gehwol Med Sensitivefoot-care cream addition to its Gehwol Medfoot-care line in Germany.Containing a“sensitive active ingredient complex

featuring MicroSilver BG”, the product worked toregenerate the skin on the feet with “natural skinflora”, the company claimed,with the“high-puritysilver ions working to stop germs forming”.Suitable for diabetics and people suffering

from neurodermatitis, foot or nail fungus,GehwolMed Sensitive helped alleviate itchiness,burningsensations and redness, the firm said.The Gerhwol product range includes the

Classic,Med, Fusskraft Soft Feet and SpecialPreparations lines. OTC

“You cough.We loosen”is the message to Germanconsumers from Hexal regarding the latestaddition to its ACC expectorant line,ACC Direkt.Described as the“first expectorant as a direct

powder”,ACC Direkt comes in packs of 10or 20 sachets. Each sachet contains 600mgacetylcysteine and can be poured directly intothe mouth,without the need for water.Thepowder dissolves to help break up mucus.Taken once daily to help ease unproductive

coughs,ACC Direkt was “practical and easy todigest”,Hexal claimed,and was ideal for whentravelling,on holiday or at work.ACC Direkt – which has a recommended retail

price of €8.97 for 10 sachets and €14.95 for 20 –joins Hexal’s existing line of ACC expectorants,led by different strength effervescent tablets. OTC


EVENTS OTC

6 NovemberBreaking New GroundFood Innovation in the EUBrussels, Belgium‘Trends in product development’and ‘the regu-latory framework’ within the European Union(EU) will be discussed at this one-day meeting.Contact: European Federation of Associationsof Health Product Manufacturers (EHPM).Tel: +32 2 721 64 95.Email: [email protected]: ehpm.org.

13-14 NovemberThe Future of PharmacyFrankfurt,Germany‘Pharmacy of the future’ and ‘When Amazonbecomes a pharmacy’will be among sessionsat this two-day conference.Contact: Inspirato.Tel: +49 151 624 179 41.Email: [email protected]: inspirato-zukunft-apotheke.de.

15-16 NovemberNatural Products ScandinaviaMalmö, SwedenAtwo-day tradeshowcoveringself-care,healthyliving, nutrition, and natural beauty.Contact: Diversified Communications.Tel: +44 1273 645 141.Email: [email protected]: naturalproductsscandinavia.com.

21 NovemberAdvertising ofMedicinal ProductsBonn,GermanyA one-day seminar run by Germany’s medi-cines manufacturers’ association, the BAH.Contact: BAH.Tel: +49 228 957 4556.Email: [email protected]: bah-bonn.de/widi-services/fachseminare.

21-22 NovemberPharmaceutical RegulatoryAffairs in ChinaBasel, SwitzerlandMarketing authorisation in China, includingHong Kong, Macau and Taiwan, will be dis-cussed at this two-day meeting.Contact: Management Forum.Tel: +44 20 7749 4730.Email: [email protected]: management-forum.co.uk.

21-22 NovemberDIA Middle-EastRegulatory ConferenceKuwait City, KuwaitThis two-day event is being organised by theDrug Information Association (DIA).Contact: DIA.Tel: +41 61 255 51 51.

Email: [email protected]: diaglobal.org.

21-24 NovemberGMDP SymposiumLondon, UKDay one of this two-day event will focus ongood distribution practice (GDP), while daytwo will cover good manufacturing practice(GMP). The two days will then be repeatedto accommodate demand.Contact: Glasgows.Tel: +44 1772 767715.Email: [email protected]: mhragmdp.co.uk.

23-24 NovemberAn Essential Overview ofthe Medical Device andthe Pharmaceutical IndustryLondon, UKDay one of this two-day workshop will focuson the regulation of medical devices and diag-nostics. Day two will cover drug development,pharmacovigilance, regulatory processes andmarketing within the pharmaceutical industry.Contact: Management Forum.Tel: +44 20 7749 4730.Email: [email protected]: management-forum.co.uk.

27-28 NovemberEuroPLX 65London, UKThis two-day meeting will provide a forumfor business development decision makersfor discussing and negotiating collaborativeagreements in licensing, marketing, and dis-tribution of patented medicines, generics, bio-similars, OTC products, medical devices andfood supplements.Contact: RauCon.Tel: +49 6221 426 2960.Email: [email protected]: europlx.com.

29-30 NovemberApplying for a MarketingAuthorisation in the UKLondon, UKA two-day seminar organised by the UK’sMedicines and Healthcare products Regula-tory Agency (MH

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