COMPANYNEWS 3 PerrigograbsGSKbrands toexpandacrossEurope

Perrigo is set to broaden its branded OTCproduct portfolio in Europe by acquir-

ing a basket of brands with 2014 sales ofUS$110 million (C98.7 million) from the con-sumer healthcare joint venture between Glaxo-SmithKline (GSK) and Novartis.

The deal – which is expected to close, sub-ject to regulatory clearances, in the third quar-ter of 2015 – will see Perrigo gain GSK’s Ni-Quitin nicotine-replacement therapy (NRT)brand and the UK firm’s Coldrex cold and fluline in the European Economic Area (EEA).

Furthermore, the US-based store-brand spe-cialist will acquire Novartis’ cold-sore productsprimarily in the EEA, which are marketed un-der the brand names Fenivir, Fenlips, Pencivir,Vectatone and Vectavir.

The rights to NiQuitin in Brazil and Nov-artis’ NRT business in Australia – includingthe Nicotinell brand – are also included in theagreement, along with the Panodil pain-reliefline, and the Nasin and Nezeril nasal deconges-tant brands in Sweden.

Perrigo pointed out that by selling off thebrands, GSK and Novartis had satisfied a num-ber of competition concerns raised by the Euro-pean Commission and other regulatory agenciesahead of the consumer healthcare joint venturebetween the two companies, which was estab-lished in February (OTC bulletin, 6 March2015, page 1).

Acquiring the selection of brands will sign-ificantly bolster Perrigo’s presence in Europe’sbranded OTC market, which the company enter-ed earlier this year when it snapped up BelgianOTC specialist Omega Pharma (OTC bulletin,17 April 2015, page 3).

Joseph Papa, Perrigo’s chief executive offi-cer, said the deal fitted with the firm’s strategy ofmaking “selective, accretive transactions” whichexpanded its “durable base business”.

“We are building on the global platform weestablished with the Omega deal to capture an

even greater share of the US$30 billion Euro-pean OTC market opportunity,” Papa explained.

Further acquisitions were also likely, Papahinted, noting that now Perrigo had its “globalplatform” in place and a “robust balance sheet”,it was “ideally positioned to execute immedi-ately accretive deals”, such as this one, thatwould enhance the firm’s growth.

Pointing out that the deal gave Perrigo “sev-eral well-established, complementary brands”,Papa insisted the firm would invest behind thebrands to “grow their market positions in keygeographies, by following Omega’s proven ap-proach to brand building”.

“Perrigo is uniquely positioned to maximisethe potential of these brands by leveragingOmega’s leading European commercial infra-structure, pan-European distribution network,strong brand building capabilities and except-ional management team,” Papa added.

Announcing in April that Perrigo had com-pleted its deal for Omega, Papa said that thefirm was well placed to “accelerate” its inter-national expansion, claiming that the buy hadcreated an “industry-leading global healthcarecompany” with the structure and cash flow toexpand its international presence “even further”.

Omega had immediately increased Perrigo’sscale and footprint in Europe, Papa noted, givingthe business access to an “established commer-cial network connected to 211,000 pharmacists,105,000 retail stores and 3,900 parapharmacies”.

12 June 2015

Strides returns to Australia 3with OTC line from AspenPharmstandard gets deal advice 3Merck grows OTC portfolio 4with Serono brand transferUK worried by RB’s K-Y deal 4Taisho reveals plans 5for domestic blissStrong cough/cold season 6boosts sales at OTCPharmWalmark grabs Pneumolan line 6Prestige throws weight 7behind Little RemediesFDA inspectors clear J&J plants 7

GENERAL NEWS 8

Strong wave of flu boosts 8German OTC sales by 16%ACMS rejects 9oral-contraceptive switchThe time is now for 10digital healthcareHMPC admits to TCM worry 11GSK’s Scarlett-Smith 12sees bright futureBotanicals still stuck in limbo 13Compromise needed 14on medical devices

MARKETING NEWS 15

Abbott targets US adults 15for Pedialyte promotionStada to change sunscreen views 15Pfizer adds sleep aids to 16Emergen-C line in the USSanofi helps Australians 17fight sore-throat battleFerndale offers RectiCare Wipes 17Stada launches its first UK 18television push for Flexitol

FEATURES 20

Industry calls for 20better switch benefits

REGULARS

Events – Our regular listing 19People – GSK expands board 23with consumer-goods specialist

COMPANY NEWS 3

Our in-depth coverage of the51st AESGP Annual Meeting starts on page 10.

Perrigo grabs GSK brandsto expand across Europe

Perrigo is set to expand its European business witha raft of brands from GSK and Novartis, including theNiQuitin nicotine-replacement therapy line

OTC12-06-15p1_OTC15/11/2005 p1&24 09/06/2015 16:05 Page 1

■ GLAXOSMITHKLINE (GSK) ConsumerHealthcare in the US has cut 350 jobs at twoof its locations in Parsippany, New Jersey, fol-lowing the start of its joint venture with Nov-artis (OTC bulletin, 6 March 2015, page 1). Ac-cording to a Worker Adjustment and Retrain-

ing Notification (WARN) issued by the NewJersey Department of Labor and WorkforceDevelopment, the move was made to help“meet established financial and synergy targetsand eliminate duplication”.

Pharmstandard’s board has engaged Renais-sance Capital to advise the company on a

tender offer launched by Augment Investmentsthat could see the investment firm take full con-trol of the Russian company.

Having agreed to acquire from Bristley Enter-prises 2.42 million shares representing 6.40%of Pharmstandard’s equity at US$22.00 (C19.78)per share, Augment is set to raise its stake inthe Russian company further to 60.72%.

Sale of 10% shareThe investment firm has launched a tender

offer to buy global depository receipts (GDRs)that can be converted to shares at US$5.50 each.Bristley has provided to Augment an irrevo-cable undertaking to sell almost 15.2 millionGDRs representing just over 10.0% of Pharm-standard’s issued ordinary shares.

If the deal was successfully completed, Pharm-standard noted, Augment planned to acquire theremaining outstanding shares it did not own.

Pharmstandard spun off its branded OTCbusiness into OTCPharm at the end of 2013(OTC bulletin, 17 January 2014, page 6), butretained a number of non-prescription brandswhich generated sales of RUB5.55 billion (C99.7million) in 2014 (OTC bulletin, 22 May 2015,page 5).

312 June 2015 OTC bulletin

COMPANY NEWS OTC

12 June 2015 Number 444Editor: Matt StewartEditor-in-Chief:Aidan FryProduction Editor: Jenna MeredithAssistant Editors:Tom Gallen, Marie McEvoyContributing Editor:DavidWallaceAdvertising Controller:Debi MinalDirector of Subscriptions:Val DavisGroup Sales Manager: Rob CoulsonAwards Manager:Natalie CornwellManaging Director: Mike Rice

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Mergers & Acquisitions

Pharmstandardgets deal advice

OTC

Indian generics specialist Strides Arcolab isset to enter Australia’s OTC market after

agreeing to buy Aspen Pharmacare’s Australiangenerics business and certain branded assetsfor A$380 million (C270 million).

Acquiring South Africa-based Aspen’s gen-erics business would give the Indian firm notonly 140 generic prescription drugs, Stridespointed out, but also an “extensive range ofnon-prescription pharmacy products”, and makeit one of the top-10 players in Australia’s phar-maceutical market.

The deal, Strides said, was expected to becompleted by late 2015.

Strides revealed that it would also revivethe Arrow Pharmaceuticals brand name, underwhich the business operated when it was partof Sigma Pharmaceuticals.

The Arrow operation, Strides said, would be

led by Dennis Bastas, former chief executiveofficer of Ascent PharmaHealth. Ascent servedas Stride’s previous generics business in Aus-tralia before it was sold to Actavis in 2012.

Commenting on the agreement, Arun Ku-mar, founder and group chief executive officerof Strides, said the assets would serve as a“valuable and unique platform” for the com-pany to rebuild its presence in the country.

“Strong local management and a market-leading product portfolio supported by our in-house cost-effective manufacturing,” Kumarclaimed, “will be the key ingredients of ourstrategy in Australia.”

Aspen acquired the generics business andthe range of non-prescription brands when itpaid A$900 million for Sigma’s Pharmaceuti-cal division in 2011 (OTC bulletin, 30 Nov-ember 2010, page 3).


Strides returns to Australiawith OTC line from Aspen

OTC

IN BRIEF

OTC

OTC12-06-15p2-9_Layout 1 09/06/2015 16:33 Page 3

Merck KGaA has expanded its ConsumerHealth portfolio with the transfer of the

Vigantol vitamin D brand to the business fromits Merck Serono prescription unit.

Vigantol would add around C28 million inannual turnover to the Consumer Health busi-ness, Merck noted, with over two-thirds of thesesales coming from Germany. The remainderwere generated across “several” European mar-kets, the firm pointed out, including the CzechRepublic, Poland and Romania.

Explaining the rationale behind the transfer,Merck said it wanted to “utilise the potential ofthe consumer-oriented business model of Con-sumer Health, in order to position and marketVigantol even more successfully”.

A spokesperson for the German firm toldOTC bulletin that Consumer Health was “bet-ter positioned” than Serono to “generate aware-ness and interest in the brand among consum-ers” and to “drive recommendations by health-care professionals”.

The Consumer Health division had an op-portunity to grow Vigantol, the spokespersonnoted, by educating consumers on the “signals”of vitamin D deficiency.

Merck claimed that Vigantol had “similar”growth potential to the firm’s Floratil probioticantidiarrhoea brand and Neurobion vitamin Bline, which were transferred to Consumer Healthfrom Serono last year (OTC bulletin, 17 March2014, page 1).

Transferring Floratil and Neurobion had beena “success”, the firm insisted, adding that it hopedto replicate this achievement with Vigantol.

Merck announced the transfer of Vigantol asit reported first-quarter sales at its ConsumerHealth division up by 20% – 13% adjusted

for currency effects – to C217 million.Investments in marketing and innovation

behind Consumer Health’s six strategic brandshad helped to drive up sales at a double-digitrate, the firm explained.

Collectively, the strategic brands – Bion,Dolo-Neurobion, Femibion, Nasivin, Neuro-bion and Seven Seas – had grown by “around10%”, Merck said.

Dolo-Neurobion and Neurobion had beenthe stand-out performers among the strategicbrands, the company pointed out, while SevenSeas had also enjoyed a solid quarter, thanks tothe launch late last year of the Perfect7 rangeof omega-3 and multivitamin products (OTCbulletin, 24 October 2014, page 20).

Growth in all five regionsOn a geographical basis, Consumer Health

had experienced growth across all five of itsregions, the firm said.

Latin America and Asia-Pacific had been the“main drivers” of sales growth in the period,Merck noted, generating 86% of ConsumerHealth’s turnover.

Consumer Health accounted for 7% of thefirm’s total first-quarter sales, which advancedby 15.7% to C3.04 billion.

Beginning on 1 January 2015, Merck restruc-tured its operations into three sectors: Healthcare,Life Science and Performance Materials.

Consumer Health is now reported as part ofthe Healthcare sector, along with Allergophar-ma, Biosimilars and Merck Serono.

Merck’s regional reporting structure alsochanged and now comprises five regions:Europe, North America, Asia-Pacific, Latin Am-erica, and Middle East and Africa.

4 OTC bulletin 12 June 2015

OTC COMPANY NEWS

Business Strategy/First-Quarter Results

Merck grows OTC portfoliowith Serono brand transfer

Reckitt Benckiser’s (RB’s) acquisition ofpersonal-lubricant brand K-Y from John-

son & Johnson could be blocked in the UK,after the country’s Competition and MarketsAuthority (CMA) said the deal could lead tohigher prices and less competition.

Following its investigation into the acquisi-tion, the CMA said it had “provisionally found”that the deal “could lead to a substantial reduc-tion in competition, possibly through higherprices, making consumers buying these prod-ucts worse off”.

RB grabbed the global rights to K-Y for anundisclosed sum in March last year, in a movethe company claimed would “create a uniqueportfolio of brands in the sexual-wellbeing cate-gory” (OTC bulletin, 17 March 2014, page 4).

Approving the deal would add the K-Y prod-ucts to RB’s existing portfolio of Durex-brand-ed lubricants, the watchdog pointed out, givingthe firm an “almost three-quarters” share of theUK’s personal-lubricant market.

Phil Evans, chair of the investigation, saidconsumers and retailers did differentiate be-tween the two brands “to some extent”.

“However, on balance, there seems to beenough of an overlap in the market for personallubricants for there to be a realistic prospect ofconsumers facing less competition and possiblyhigher prices if the two biggest brands comeunder single ownership,” Evans insisted.

In addition to its findings, the CMA hasalso published a list of “possible remedies”.

These include: RB not buying K-Y in theUK; Johnson & Johnson selling the UK K-Ybusiness to a party other than RB; or Johnson& Johnson licensing the rights to K-Y in theUK to a party other than RB.

The CMA said it was inviting responses toits provisional findings and would “continueto assess all the evidence” before making itsfinal decision in August.


UK worried byRB’s K-Y deal

OTC

■ URIACH – the Spanish pharmaceutical com-pany – has snapped up the rights in Italy, LatinAmerica, Portugal and Spain to FC Resources’Fisiocrem line of topical natural products fortreating muscle problems. The firm said thedeal was in line with its strategic aim of becom-ing a leading natural products player.

IN BRIEF

OTC

OTC

Boots – the retail arm of Walgreen BootsAlliance covering the UK and Ireland,

and including Boots Opticians – is set to cut 700non-store jobs as part of a new plan to secureits status as a “true omni-channel retailer”.

Noting that the business had to address the“rapidly changing needs of its customers”,Boots said it planned to “evolve” its existingbusiness models across key areas by reinvent-

ing its customer offer, focusing on customerengagement, investing in technology and simpli-fying its support operations.

Reorganising the company’s support func-tions would lead to the loss of around 700 non-store roles, Boots admitted. However, it did planon recruiting in some areas, such as digital anddelivery of the new customer offer.

Business Strategy

Boots to cut around 700 jobs in the UK

OTC

OTC12-06-15p2-9_Layout 1 09/06/2015 16:33 Page 4

Investing in new brands, enhancing consumercommunications and introducing innovative

line extensions to key ranges will all play a partin turning around domestic sales of OTC self-medication products, according to Japan’s Tai-sho Pharmaceutical.

Reporting its annual results for the year end-ed 31 March 2015, the country’s largest OTCplayer said that it was crucial for the firm towork to increase demand in its home market bybolstering its existing brands.

Furthermore, the company had to “pave theway for future growth” by nurturing new brandsand improving how it communicated to con-sumers, Taisho explained.

Domestic turnover at the firm’s Self-Medi-cation division slipped back by 5.4% to ¥146billion (C1.05 billion), as sales from all but twoof its leading OTC brands dropped, along withturnover from its energy drinks business.

To help drive demand, the Self-Medicationdivision was “increasing coordination betweenmarketing and sales activities”, Taisho pointedout, and “working to enhance direct communi-cation with consumers by expanding into newdistribution channels, such as mail-order”.

In addition, the company would continue torespond to the “heightened health conscious-ness” of consumers by developing new productsthat met their needs.

In October last year, Taisho said that thegroup would develop products in areas to whichconsumers were paying more and more attention

– such metabolic syndrome – and step up prod-uct development in line with consumer needs(OTC bulletin, 24 October 2014, page 6).

Taisho has previously said it would explorethe feasibility of a range of prescription-to-OTCswitches to bolster the Japanese market.

Furthermore, the company noted, Taishowould strive further to grow the brand value ithad built over many years with its key brands– including the Lipovitan tonics and nutrientsdrinks range, Pabron cold remedies brand andRiUP hair-regrowth line – while focusing onnurturing newer brands such as Livita, whichis centred on the Foods for Specified HealthUse category.

Overall turnover at Taisho’s Self-Medicationdivision fell back by 3.0% to ¥176 billion, de-

spite a 10.1% advance in international sales to¥27.9 billion, or nearly 16% of the total (seeFigure 1). Other sales added ¥2.7 billion.

Last year, Taisho expanded its internationaloffering by acquiring from Roche the rights tothe Flanax OTC naproxen-based analgesic inthe Philippines for an undisclosed sum (OTCbulletin, 17 March 2014, page 4).

International sales of the division’s OTCproducts grew by 13.5% to ¥17.6 billion, whileinternational turnover from energy drinks im-proved by 5.2% to ¥9.4 billion.

Taisho’s president and chief executive offi-cer, Akira Uehara, said in 2014 that the firmplanned to “vigorously develop” its internationalbusiness and wanted it to account for a signifi-cant proportion of the Self-Medication divi-sion’s turnover in the near future.

Meanwhile, domestic sales of Taisho’s coreLipovitan brand of tonics and nutrient drinksslipped back by 8.0% to ¥62.1 billion duringthe year (see Figure 2).

Turnover from Lipovitan D fell by 9.8% to¥40.0 billion, while sales of other Lipovitanproducts dropped by 4.5% to ¥22.1 billion.

The decline in sales of other Lipovitan prod-ucts had been due to lower sales of both the50ml and 100ml variants, Taisho noted.

Sales of Pabron cold remedies slid by 3.2%to ¥25.2 billion, as a poor performance frommainstay general cold remedies offset a goodshowing from nasal decongestants. By contrast,turnover from the Vicks brand of cold reme-dies improved by 7.3% to ¥3.5 billion.

Meanwhile, sales of the Livita brand inJapan’s Foods for Specified Health Use cate-gory declined by 13.6% to ¥4.0 billion, whileturnover from gastrointestinal treatments fellby 5.1% to ¥4.1 billion.


COMPANY NEWS OTC

Annual Results

Taisho reveals plans for domestic bliss

Business Annual sales Change Forecast sales Change(¥ billions) (%) (¥ billions) (%)

Lipovitan D 40.0 -9.8 38.9 -2.7Other Lipovitan 22.1 -4.5 22.5 +1.8Total Lipovitan brand 62.1 -8.0 61.4 -1.1

Cold remedies (Pabron brand) 25.2 -3.2 25.0 -0.7

Hair treatments (RiUP brand) 14.9 -4.1 15.0 +0.4

Biofermin 6.7 +0.9 7.0 +4.2

Gastrointestinal treatments 4.1 -5.1 4.1 -0.5

Livita series 4.0 -13.6 4.2 +4.5

Analgesics (Naron brand) 3.7 -9.6 3.7 -0.8

Cold remedies (Vicks brand) 3.5 +7.3 3.5 +0.4

Laxatives (Colac brand) 3.3 -7.3 3.3 +0.3

Zena brand 3.0 -8.8 2.9 -1.2

Tokuhon 1.1 -19.0 1.1 +6.4

Other Self-Medication products 14.0 – 16.9 –

Total Domestic Self-Medication 145.6 -5.4 148.1 +1.7

Figure 2: Breakdown of Taisho Pharmaceutical’s Self-Medication sales in Japan in the year ended 31 March2015. Forecasted sales are for the year ending 31 March 2016 compared with actual sales in the financial yearended 31 March 2015 (Source – Taisho Pharmaceutical)

Business Annual sales Change Forecast sales Change(¥ billions) (%) (¥ billions) (%)

Japan 145.6 -5.4 148.1 +1.7

International OTC drugs 17.6 +13.5 19.3 +9.9International energy drinks 9.4 +5.2 9.7 +2.9International other 0.9 – 0.9 –International 27.9 +10.1 29.9 +7.1

Others 2.7 +8.0 2.5 -7.4

Total Self-Medication 176.3 -3.0 180.5 +2.4

Prescription operations 114.2 ±0.0 114.5 +0.3

Total for Taisho 290.5 -1.8 295.0 +1.5

Figure 1: Taisho Pharmaceutical’s sales in the year ended 31 March 2015. Forecasted sales are for the yearending 31 March 2016 compared with actual sales in the previous year (Source – Taisho Pharmaceutical)

OTC

OTC12-06-15p2-9_Layout 1 09/06/2015 16:33 Page 5

Czech dietary supplements and natural prod-ucts firm Walmark has expanded its reach

in Poland by snapping up the Pneumolan rangeof children’s natural respiratory-health prod-ucts from Novascon Pharmaceuticals for an un-disclosed sum.

Walmark said Pneumolan complementedthe company’s existing portfolio of natural res-piratory-health products and strengthened fur-ther the firm’s position in the key Polish market.

Describing Pneumolan as the “leading child-ren’s natural respiratory-health brand in Po-land”, Walmark claimed that acquiring theproduct line had made it the top player in Po-land’s natural respiratory-health category.

Established in 1990, Walmark has operationsacross Central and Eastern Europe (CEE). In2012, the company’s founders, the Walach fam-ily, sold a 50% stake in the firm to private-equity group Mid Europa Partners.

Mylan has accused Teva of violating USantitrust laws by acquiring shares in its

generics rival. In a letter sent to Teva’s chiefexecutive officer, Erez Vigodman, Mylan’s ex-ecutive chairman Robert Coury says the 1.35%Mylan stake that Teva has acquired exceedsthe US$76.3 million (C67.2 million) thresholdfor transactions that have to be notified to fed-eral antitrust authorities.

Noting that Mylan will hold a meetingearly in the third quarter of this year to obtainshareholder approval for its offer to buy Perrigo –Mylan made its first offer for Perrigo in April(OTC bulletin, 17 April 2015, page 1) – Couryclaims Teva’s stake in Mylan is “a further in-dication of its intention to meddle with our busi-ness, strategy and mission while remaining un-clear as to its actual intentions”.

“It is time for Teva and its board to stopplaying games,” insists Coury, who calls on theIsraeli firm’s board to provide “clarity on wheth-er or not Teva will make an actual offer”.

Teva had previously seen Mylan knock backits non-binding US$82-per-share takeover bid(OTC bulletin, 22 May 2015, page 3).


OTC COMPANY NEWS


Global adhesives specialist Bostik has takena step into the medical adhesives market

by licensing out a “breakthrough” adhesive foruse in a new single-layer patch developed byUK-based drug-delivery start-up Medherant.

The deal covered a “patented, heat and mois-ture curable pressure-sensitive adhesive”, whichMedherant said would help it further developa single-layer patch that was “more comfort-able, durable and easier to remove than currentmedicinal patches”.

The patch’s construction allowed for the“development of patches for drugs previouslyunsuited for this type of delivery”, Medherantsaid, and offered faster-release and higher doses.

Furthermore, Medherant had also securedseed funding from Mercia Fund Management,the firm noted, adding that it wanted to workwith the pharmaceutical industry to develop“novel patch-based therapeutics” for a wide rangeof medical conditions, initially in pain relief.

Licensing Agreements/Product Development

Bostik gets stuck into the medical arena

Russia’s OTCPharm said it had maintainedits position as the country’s third-largest

OTC player, with sales advancing by 24% toRUB3.66 billion (C65.9 million) in the openingthree months of 2015.

A significant rise in sales of the company’scold and flu brands – including Amixin, Arbi-dol, Codelac, Maxicold and Rhinostop – hadboosted turnover in the period, the firm noted,pointing out that sales of wholly-owned brandshad improved by 30% to RUB3.20 billion.

Sales of Codelac cold and flu products hadmore than doubled in the three months toRUB199 million (see Figure 1), the companysaid, making it one of the firm’s top-six brands.

There had also been solid growth from thecompany’s Complivit multivitamin brand, OTC-

Pharm pointed out, adding that it believed thatthis rise had been as a result of consumerslooking to take preventive action during a strongcold and flu season.

The firm’s leading brand, Pentalgin, had notperformed as hoped, it added, falling back by0.1% to RUB489 million.

The gains achieved by the firm’s wholly-owned brands had been offset, OTCPharm ex-plained, by lower sales of products the companymarkets in Russia on behalf of other manufac-turers. Turnover from these products had de-clined by a tenth to RUB460 million.

OTCPharm was established via a spin-off ofPharmstandard’s branded OTC business at theend of 2013 (OTC bulletin, 17 January 2014,page 6).

First-Quarter Results

Strong cough/cold seasonboosts sales at OTCPharm

Business First-quarter sales Change 2014/2015 Proportion(RUB millions) (%) of sales (%)

Pentalgin 489.2 -0.1 13.4Arbidol 474.0 +11 13.0Complivit 457.2 +36 12.5Amixin 412.3 +52 11.3Aphobasolum 239.2 +29 6.5Codelac 198.9 +126 5.4Acipol 184.7 +28 5.0Flukostat 176.0 +10 4.8Rinostop 135.3 +137 3.7Magnelis 104.8 +133 2.9Other 327.3 – 8.9Wholly-owned brands 3,198.9 +30 87.4

Third-party products 459.8 -10 12.6

Total OTCPharm 3,658.7 +24 100.0

Figure 1: OTCPharm’s sales in the first quarter of 2015 broken down by business (Source – OTCPharm)

OTC OTC


Walmark grabsPneumolan line

OTC

Mylan slams Teva’stakeover tactics

OTC

OTC12-06-15p2-9_Layout 1 09/06/2015 16:33 Page 6


COMPANY NEWS OTC

Business Strategy/Annual Results

Johnson & Johnson has announced that twoof its three OTC manufacturing plants oper-

ating under a consent decree have passed re-cent inspections by the US Food and Drug Ad-ministration (FDA).

In a statement, the company said that FDAinspections of its Lancaster, Pennsylvania facil-ity in the US and its Las Piedras site in PuertoRico had found both locations to be “in confor-mity with applicable laws and regulations”.

The results of the FDA inspections, Johnson& Johnson pointed out, were consistent with thefindings of a third-party good manufacturingpractice (GMP) expert made earlier this year(OTC bulletin, 2 February 2015, page 4).

Johnson & Johnson added that it was await-ing the results of a more recent FDA inspectionof its plant in Fort Washington, Pennsylvania.

In April, the company said that it had made“great progress” in tackling the changes at itsOTC business required by the consent decree(OTC bulletin, 1 May 2015, page 4), whichhad been filed by the Department of Justice(DoJ) and the FDA in 2011 (OTC bulletin, 17March 2011, page 1).

Johnson & Johnson was issued with theconsent decree for failing to comply with GMPrequirements at its Fort Washington plant andthe Las Piedras facility.

A string of product recalls by Johnson &Johnson’s OTC business during 2010 and 2011prompted a government investigation and theclosure of the Fort Washington facility. Manu-facturing problems at Fort Washington led tothe withdrawal of the bulk of Johnson & John-son’s OTC portfolio in the US.

Regulatory Affairs

FDA inspectorsclear J&J plants

OTC

Prestige Brands is to make Little Remediesits “lead paediatric brand” in the US as it

seeks to stand out in an “increasingly compet-itive” market, according to the firm’s outgoingchief executive officer Matthew Mannelly.

Speaking as the US company announced theresults of its financial year ended 31 March2015, Mannelly – who retired on 1 June (OTCbulletin, 1 May 2015, page 23) – said thatLittle Remedies would replace PediaCare asits best supported paediatric brand in the USmarket as it had “more potential to grow andgain distribution”.

Little Remedies also offered a better “pointof difference to the competition” than Pedia-Care, Mannelly insisted.

Commenting on these differences, Mannellysaid that the Little Remedies range – includingHoney Cough Syrup, Multi Symptom Cold &Fever and Gas Relief Drops – offered US con-sumers “effective solutions” that were “morenatural” than traditional OTC products as theycontained “no artificial flavours or unneces-sary ingredients”.

Clearly resonating with consumersThis differentiation from the more tradition-

al OTC brands – including PediaCare – was“clearly resonating strongly with consumers”,he noted, as Little Remedies had enjoyed a“terrific year” in terms of sales.

Quoting IRI data, Mannelly said consump-tion of Little Remedies in the US was up by8.5% in the 12 weeks ended 22 March 2015.

By contrast, PediaCare had experienced a“rough year”, he noted, thanks to the return ofcompetitive brands to the market, such as John-son & Johnson’s children’s Motrin and Tylenol.

While Mannelly did not disclose PediaCare’ssales for the 12 months, he did reveal that thebrand had suffered “distribution losses”.

Despite lower sales of PediaCare, Prestigereported North American OTC turnover up by17.5% to US$564 million (C507 million).

Strong performances from ‘core’ brandsand the firm’s acquisition of Insight Pharma-ceuticals had been behind the increase in turn-over, Mannelly noted.

Prestige claimed it would create a “leadingplatform in feminine care” in North Americaafter agreeing to pay US$750 million for US-based Insight last year (OTC bulletin, 9 May2014, page 9).

Describing Insight as Prestige’s “largesttransaction yet”, Mannelly said at the time thatbuying Insight would give the company its firstUS$100 million brand. It would be gaining theMonistat yeast-infection treatment, he noted, aspart of a feminine-care portfolio with annualsales of around US$130 million.

Prestige was now “well underway” with itsstrategy to boost sales of Monistat, Mannellyexplained, which involved encouraging health-care professionals to recommend the productto their patients.

“We are investing in educating the healthcareprofessional about Monistat and, at the sametime, creating new, more effective advertisingto reach consumers,” he revealed.

Meanwhile, Mannelly reported InternationalOTC sales of US$61.2 million for the 12 months,up from US$29.9 million in the prior year.

Acquiring last year oral-rehydration brandHydralyte in Australia and New Zealand (OTCbulletin, 25 April 2014, page 3) had helpedto more than double International OTC sales,Mannelly noted.

Care buy lifts salesTurnover had also been boosted by Aus-

tralia’s Care, Mannelly added, which Prestigesnapped up in 2013 to expand its reach in theAsia-Pacific region (OTC bulletin, 26 July2013, page 3).

OTC sales accounted for 87% of Prestige’stotal turnover in 2015, which rose by 19.6% toUS$715 million. The remainder was generatedby its Household Cleaning unit, which postedturnover up by 2.5% to US$89.9 million.

The double-digit rise in sales helped Pres-tige to post operating income up by a tenth toUS$208 million.

Prestige throws weightbehind Little Remedies

OTC

Prestige claims Little Remedies’ natural ingredientswill help the range to stand out in a crowded market

■ OXFORD PHARMASCIENCE – the UK-based development firm – has raised £20 mil-lion (C27 million) through a placing of newshares. The proceeds of the placing would beused to further develop its OXPzero aspirinproduct for cardiovascular use and advance dev-elopment of a “selected OXPzero non-steroidalanti-inflammatory drug”, the company noted,as well as to accelerate work on other products.Meanwhile, Oxford Pharmascience said it hadcompleted development of an immediate-re-lease, taste-masked, chewable form of its OXP-zero ibuprofen product.

IN BRIEF

OTC

OTC12-06-15p2-9_Layout 1 09/06/2015 16:33 Page 7

Increasing US women’s access to oral contra-ceptives by encouraging the manufacturers

to apply for prescription-to-OTC switches isthe aim of a bill recently introduced to the coun-try’s Senate.

The ‘Allowing Greater Access to Safe andEffective Contraception Act’ would, accordingto its authors – Republican senators Kelly Ayotteand Cory Gardner – incentivise oral-contracep-tive manufacturers to file switch applicationswith the Food and Drug Administration (FDA)“by allowing for priority review of the appli-cation and waiving the filing fee”.

“These incentives would be available for anyoral contraceptive accessible to adults aged 18years and above and which was found by theFDA to be safe and effective for routine OTCuse,” the senators explained.

In addition to offering incentives to manu-facturers, the bill would also “repeal the Afford-able Care Act’s restriction on the use of health,medical, and flexible savings accounts to pur-chase OTC drugs without a prescription”, thesenators noted.

Commenting on the bill, Gardner said thatit was time to give women “the ability to maketheir own decisions about safe, effective andlong-established methods of contraception”.

“Making this medication available OTC,”Gardner claimed, “will increase access in ruraland underserved areas, save consumers moneyby increasing competition and availability, andsave women time by making it easier to ob-tain safe contraception.”

Cautiously welcoming the bill, the US Con-sumer Healthcare Products Association (CHPA)said its members were generally in favour of anylegislation that had the potential to increase con-sumers’ access to OTC medicines.

“The concept of providing manufacturerswith substantive incentives to submit switchapplications, such as priority review, has prom-ise,” the association insisted.

Noting that it was also in favour of theproposal to waive the switch application filingfee, the CHPA said such a move would givesmaller firms the opportunity to submit appli-cations to the FDA.

“We are also pleased that this legislation re-peals a provision in the Affordable Care Actthat requires consumers to get a prescription topurchase OTC medicines with their health sav-ings accounts,” the association noted.


OTC GENERAL NEWS

Regulatory Affairs

Senators tablepill-switch bill

Strong demand for cough and cold remediesin the early part of this year drove up sales

of OTC healthcare products through Germany’scommunity and mail-order pharmacies by 15.7%to C2.21 billion at retail prices in the first quar-ter of 2015. Volume sales also moved forwardby approximately 16%.

Data released by market researcher IMSHealth shows that the double-digit OTC marketgrowth was led by cough, cold and respiratoryproducts with a 35.8% advance to C645 million.

Noting that a “strong wave of flu grippedGermany from the start of January until themiddle of March”, IMS said volume sales ofcold remedies had increased by 31%.

“The market for general analgesics also prof-ited from the flu wave with a sales increase of14% and a similar volume uptick,” the marketresearcher observed.

In the adult analgesics sub-segment, ibupro-fen-based medicines led the way. This was achange since the 2013 strong cough and coldseason, when more paracetamol-based productswere purchased by sufferers.

The paediatric analgesics sub-segment sawparticularly strong growth during the first quar-ter of this year, with value sales ahead by 33%and a 31% volume rise. “Around 70% of these

products were prescribed, and 30% boughtdirectly in pharmacies,” IMS commented, add-ing that mail-order pharmacies’ market sharefor paediatric painkillers was just 2%.

As can be seen from Figure 1, mail-orderpharmacies captured 14.0% of Germany’s totaloral and topical non-prescription analgesics mar-ket that expanded by 11.3% to C329 million inthe first quarter of this year.

Germans also evidently did what they couldto avoid contracting colds and flu. Immuno-stimulant sales increased by 37% in value termsand 35% by volume, while vitamin C supple-ments saw sales rise by 35% at retail value ona 31% advance in packs sold.

Total sales of non-prescription immunostim-ulants, geriatric products and tonics, includingMelissengeist, grew by nearly a fifth in the firstquarter to C53.6 million. Mail-order pharmaciesaccounted for 18.5% of that total, well ahead oftheir average 12.6% of the overall OTC health-care products market.

Mail-order retailers’ share of the market re-mained constant. Their 15.8% sales growth toC278 million was all but matched by commu-nity pharmacies’ 15.7% OTC turnover increaseto C1.94 billion.

Market Research

Strong wave of flu boostsGerman OTC sales by 16%

Product category First-quarter sales Change Proportion of sales(Cmillions) (%) through mail order (%)

Cough, cold respiratory 644.6 +35.8 8.0Oral and topical analgesics 329.4 +11.3 14.0Gastrointestinal remedies 281.6 +10.9 12.2Vitamins, minerals, supplements 219.2 +9.5 14.9Skin care 176.0 +5.1 11.2Cardiovascular 122.4 +2.6 19.9Eye care 84.2 +3.5 14.4Genitourinary 72.9 +5.7 17.5Miscellaneous 72.4 +29.5 15.6Calming, sleeping, mood-enhancing 65.7 +1.2 15.8Tonics, geriatrics, immunostimulants 53.6 +19.6 18.5Oral care 24.1 +2.6 7.6Nausea remedies 18.7 +16.7 7.2Cessation aids 15.0 +1.3 21.4Weight-loss aids 14.8 +4.9 36.4Ear care 8.0 +15.2 5.5Other products 10.5 +12.2 5.8

Total OTC Market 2,213.1 +15.7 12.6

Figure 1: Breakdown by product category of OTC healthcare sales through German community andmail-order pharmacies in the first quarter of 2015 at retail prices, with the proportion of sales throughmail-order pharmacies (Source – IMS Health)

OTC

OTC

OTC12-06-15p2-9_Layout 1 09/06/2015 16:33 Page 8

Australia’s Advisory Committee on Med-icines Scheduling (ACMS) has advised

that oral contraceptives should remain schedule4 – prescription-only – medicines over fears forpatient safety and a lack of pharmacist training.

Under a proposal referred to the committee,schedule 3 – pharmacist-only – status wouldhave been granted on the condition that a phar-macist conducted a questionnaire about the con-sumer, covering family history of heart prob-lems, hypertension and stroke, and that eitheran in-house blood-pressure test was conducted,or that results from a recent blood-pressuretest were provided to ensure suitability.

Supply would have also have been limitedto three to six months.

However, the ACMS noted that use of oralcontraceptives might mask serious health issues,and that misuse of such products might leadto fertility problems.

Furthermore, the ACMS felt that pharmacistswere not currently trained to conduct physicalexaminations of consumers, and that “othersafer, more effective and more appropriate” con-traceptive methods were available.

The medicines scheduling delegate to thesecretary of the Department of Health (DoH)– who has the final call on rescheduling deci-sions – backed the ACMS recommendation.

Meanwhile, the proposed pharmacist-onlystatus of a hydrocortisone and aciclovir com-bination product for cold sores was viewed

more favourably by the ACMS and delegate.An amendment should be made to the

schedule 3 entry for hydrocortisone to allowadditionally for “1% or less of hydrocortisonewhen compounded with aciclovir 5% w/w orless in primary packs of not more than 2g”,the delegate noted, for dermal use in adults andadolescents over the age of 12 years.

The delegate agreed with the ACMS’ viewthat the combination product would be used forthe same indication and route of administration,dose, frequency and duration as aciclovir 5%cream, and that early access through a pharma-cist was likely to be safe and “beneficial inreducing progression of symptoms”.

Risks were minimised by the small packsize and dermal application, the delegate point-ed out, adding that no change to Appendix H ofthe Poisons Standard – which lists substancespermitted to be advertised to the public – wasrequired for the combination product.

Meanwhile, the proton-pump inhibitor (PPI)esomeprazole – which is already a schedule 3medicine – could soon be advertised to consum-

ers, after the delegate agreed with the ACMS’recommendation that a new Appendix H entrybe created for the ingredient.

This entry would cover esomeprazole inoral preparations containing 20mg or less perdosage unit for the relief of heartburn and othersymptoms of gastro-oesophageal reflux disease(GORD), in packs containing no more than 14days’ supply.

Esomeprazole was a “safe and effectivefirst-line treatment for consumers with frequentsymptoms of GORD”, the delegate pointed out.Noting that “other less-effective treatments”were advertised to consumers, the delegate main-tained that increasing public awareness of theavailability of a schedule 3 PPI in pharmaciesmight have public-health benefits through “mak-ing consumers aware of more effective treat-ment options”.

An implementation date of 1 October 2015has been proposed for the amendments for bothesomeprazole and combined hydrocortisone-aciclovir products.


GENERAL NEWS OTC

Regulatory Affairs

ACMS rejects oral-contraceptive switch

OTC

■ G-BA – a German federal committeecharged with advising on reimbursement deci-sions – acted within its remit by delisting Al-mirall Hermal’s Jacutin Pedicul Fluid med-ical device, the country’s federal social courthas ruled. Almirall Hermal had challenged adecision by the G-BA in 2010 to remove theJacutin Pedicul Fluid hair-lice treatment froma positive list of reimbursable medical devices.The committee justified its decision on thegrounds that more appropriate hair-lice treat-ments with better scientific proof of effective-ness had become available. Ruling in favour ofthe federal committee’s appeal against a Berlin-Brandenburg court’s earlier ruling, the Bundes-sozialgericht federal court said the G-BA hadbeen justified in differentiating between levelsof evidence from studies to determine whetherbetter alternative treatments were available.

IN BRIEF

OTC

OTC12-06-15p2-9_Layout 1 09/06/2015 16:33 Page 9

Digital healthcare is the OTC industry’s bestopportunity to innovate “better, faster and

more often”, according to Brian McNamara,head of Americas and Europe at GlaxoSmith-Kline (GSK) Consumer Healthcare.

Speaking at the 51st Annual Meeting of theAssociation of the European Self-MedicationIndustry, the AESGP, in Barcelona, Spain, Mc-Namara said it was “imperative” for firms bet-ter to harness healthcare technologies. Thiswould drive innovation in the sector and em-power consumers to self-care.

The pace of innovation in the industry hadstagnated in recent years, McNamara admitted,pointing out that in a list of the most innovativeglobal companies, no consumer healthcare firmcame close to the top-10.

“You have to go down to number 45 on thatlist to find a company in our industry,” Mc-Namara pointed out.

Echoing McNamara’s comments, AshleyVan Heteren, associate partner at McKinsey &Company, warned delegates: “We are in a veryinnovative industry, but we are not innovating.”

Sluggish response to digitalThis was highlighted best by the sector’s

sluggish response to the global “digital trans-formation”, she noted, which had left consumerhealthcare firms playing catch-up.

If industry continued to play a “wait and seegame” when it came to digital healthcare, it was indanger of being left behind,Van Heteren stressed.

Outside the industry, activity in digital health-care was already “heating up”, she noted, withtechnology firms such as Apple, Google andSamsung entering the fray, along with a “hugeincrease” in competitive start-up companies.

Global venture-capital funding for digital

healthcare had reached US$6.5 billion (C4.3 bil-lion) in 2014, Van Heteren pointed out, jumpingup from US$2.9 billion in 2013.

Google had increased its investment in lifesciences over the past two years to US$720million, while Samsung had created a ‘digitalhealth innovation laboratory’ to trial new mobilehealth (mHealth) technologies, she explained.

These firms were responding to the growingtrend “across all age groups” of consumers tak-ing an active interest in their health, Heteren said.

McKinsey’s research had found that 70%of 18-65 year olds surveyed had monitoredtheir health digitally, she claimed, while 68%had used an mHealth app.

The extent to which consumers were usingthe internet to give them greater control overtheir health was highlighted to delegates byRyan Olohan, industry director of healthcareat technology giant Google.

Olohan revealed that one in 20 searchesmade through Google per day were healthcarerelated, with “headache and pain”, “skin care”and “allergies” among the leading search terms.

“People are searching more and more forhealth information,” Olohan explained, notingthat the number of searches was rising “muchfaster than for any other industry”.

When consumers looked for health inform-ation on the internet they didn’t just rely onsearch engines, Olohan pointed out.

Consumers were increasingly turning tovideo-sharing sites, he noted, with over onebillion health-related searches per month re-corded on YouTube.

Social media was also an important toolfor consumers, Olohan said, noting that parentswere regularly using Facebook to ask for ad-vice when their child fell ill.

The way consumers accessed online healthinformation was changing, Olohan pointed out,with 52% of searches in the US in 2014 happen-ing on mobile devices (see Figure 1). This hadgrown from less than 30% over the past twoyears, he added.

In Asia, the figure was an even greater 60%,he noted, while in Europe the proportion was45% “and growing”.

In light of the rising number of consumersturning to the internet for health advice, Olohancalled on industry to adopt a “moonshot” ap-proach towards innovation in the digital-health-care space.

Google had already seized the initiative inhealth advice and was working to “fix” the in-formation consumers found online when they

performed a health-related search, he revealed.The firm wanted to make sure consumers re-

ceived the correct advice for their health queries,Olohan explained, by directing searches to infor-mation provided by healthcare professionals.

Olohan stressed that industry had an impor-tant role to play in making sure consumers re-ceived reliable advice on minor ailments.

If a consumer searched for information abouta certain ailment then they wanted “to be edu-cated, not sold a drug”, he insisted.

“As an industry, we can stop trying to sell apill and first try to answer some of those ques-tions the consumer has,” Olohan argued.

One way to do this, he explained, was toreach consumers through YouTube, by upload-ing videos featuring healthcare professionalstalking about health conditions and explainingthe symptoms and possible treatments.

“Ultimately you’ll sell more products, butyou have to start with education,” Olohan stress-ed to delegates.

In agreement with Olohan, Van Heteren tolddelegates that industry needed to establish a “dia-logue” with consumers about their health viasocial media and video-sharing sites.

Consumer healthcare firms could no longerget away with simply updating their websites“once a year” with new information, she warned.

Industry had an opportunity to harness digitalhealthcare not only though internet tools such


OTC AESGP MEETING

Business Strategy

The time is now for digital healthcare

Brian McNamara, head of Americas and Europe atGlaxoSmithKline Consumer Healthcare, said newtechnologies offered industry a “huge opportunity”for growth

Ashley Van Heteren, associate partner at McKinsey &Company, warned delegates that if industry continuedto play a “wait and see game” with digital healthcareit was in danger of being left behind

OTC12-06-15p10-14_Layout 1 09/06/2015 18:24 Page 2

The rise in popularity of traditional Chinesemedicines (TCMs) and Indian Ayurvedic

medicines could pose problems, especiallyaround definitions of traditional use and howthese products were distributed, according toWerner Knöss, chair of the Herbal MedicinalProducts Committee (HMPC) of the EuropeanMedicines Agency (EMA).

Knöss told delegates at the 51st AnnualMeeting of the Association of the EuropeanSelf-Medication Industry, the AESGP, in Bar-celona, Spain, that applying European Union(EU) standards to herbal products from outsidethe EU, and especially TCMs and Ayurvedicproducts, was a challenge for the HMPC.

To tackle the problem, the HMPC had issu-ed a ‘question-and-answer’ document on tradi-

tional herbal medicinal products of non-Euro-pean origin, Knöss pointed out, and had alsoestablished a pilot project to look at mono-graphs for TCMs and Ayurvedic medicines.

However, the process was not easy, he warn-ed, noting that there were many areas to discuss,including the transfer of product indicationsand access to supporting data.

Furthermore, the HMPC had to considerhow much these traditional methods of treat-ment were designed to support self-medication,Knöss explained.

“The starting point for using a TCM or anAyurvedic product is normally a very carefuldiagnosis by a specialist,” he noted, and thena “very individual prescription”.

Despite these questions, the HMPC’s basicposition was clear, Knöss pointed out, and thatwas that these products had to meet the samestandards as any herbal medicinal productvalid in the EU.


AESGP MEETING OTC

as search and social media, Van Heteren pointedout, but also through physical devices.

“Technological innovations for better self-care are exploding in number,” Van Heterenstated, “from sensors that record medicationcompliance, to remote care monitoring, to appsthat connect you to your doctor.”

However, it was the move towards apps thatmanaged chronic conditions which was “mostinteresting”, she claimed, highlighting the Foodand Drug Administration (FDA) approved appsWellDoc and Glooko for diabetes management.

Echoing Van Heteren’s comments, DidierDeltort, general manager of GE Healthcare’sGlobal Monitoring Solutions division, told del-egates that technologies such as these gaveconsumer healthcare an opportunity to widenits remit to include disease management.

Deltort noted that GE was working on tech-nology to allow those with chronic conditions– such as asthma, diabetes and heart disease –remotely to monitor their health. This involvedthe “miniaturisation” of patient-monitoring de-vices so they could be used by patients in theirown home, he explained.

Ageing populations and increasing cost pres-sures would require chronic diseases in thefuture to be managed away from the hospital,Deltort noted.

Expanding self-care into “new areas” suchas chronic-disease management by utilising tech-nology offered industry a “huge opportunity”for growth, McNamara insisted.

However, it would be important for the sectorto recognise when self-care was appropriatefor managing chronic conditions and when anintervention by a healthcare professional wasrequired, McNamara stressed.

Before exploring these new areas, McNa-mara said consumer healthcare firms needed to“do better” at leveraging already widely-usedtechnology such as the internet.

It was extremely important for industry to“build its capabilities in the basics: digital,

mobile and social”, he claimed.“We’ve made progress as an industry in these

three areas, but we still have a long way to go,”McNamara admitted.

GSK’s recent social-media marketing cam-paign for its Flonase allergy relief nasal spraywas a “great example” of a firm using the in-ternet to engage consumers, he said.

Following the launch of Flonase onto theUS OTC allergy-relief market in February, GSKtold OTC bulletin that it had decided to moveaway from traditional media to promote theproduct and to concentrate instead on educat-ing consumers through frequent posts on Flo-nase’s Facebook, Twitter and YouTube profiles(OTC bulletin, 13 February 2015, page 1).

Isolated example of innovationHowever, McNamara stressed that examples

of consumer healthcare firms utilising digitalcampaigns “remained isolated”.

Harnessing the power of technology in theself-care space required “strong collaborationbetween industry, technology partners and reg-ulators”, McNamara said.

“As a group, we need to create the right stan-dards, focused on quality, efficacy and con-sumer privacy, while at the same time allowingcompanies the freedom to pursue innovation.”

Regulatory Affairs

HMPC admitsto TCM worry

Google’s industry director of healthcare, Ryan Olohan,revealed that one in 20 searches through Googlewere health-related and the figure was growing

Didier Deltort, general manager of GE Healthcare’sGlobal Monitoring Solutions division, told delegatesthere was a need to move the treatment of chronicconditions from the hospital to the home

Figure 1: Healthcare-related searches through Googleby device – mobile and desktop – across Asia, Europeand the US in 2014 (Source – Google)

Mobile

Asia US Europe

Desktop

52%45%

60%

40% 48% 55%

OTC

Werner Knöss, chair of the Herbal Medicinal ProductsCommittee (HMPC) of the European Medicines Agency(EMA), said traditional Chinese medicines and IndianAyurvedic medicines could pose problems for regulators

OTC

100

80

60

40

20

0

Sear

ches

(%)

OTC12-06-15p10-14_Layout 1 09/06/2015 18:24 Page 3

The consumer healthcare industry needs to“join together, move faster and seize the

opportunities” the positive feeling surroundingthe industry is delivering, according to RogerScarlett-Smith, head of global categories atGlaxoSmithKline (GSK) Consumer Healthcare.

Speaking at the 51st Annual Meeting ofthe Association of the European Self-Medica-tion Industry, the AESGP, in Barcelona, Spain,as president of the AESGP, Scarlett-Smith saidthat optimism towards the consumer healthcaremarket stemmed from not just the consistentgrowth in the sector, but that self-care was “tak-ing on a broader role in healthcare systems”and becoming “a part of government solutionsto balance healthcare budgets without compro-mising quality or access”.

“It is my hope that my enthusiasm be-comes contagious and is turned into rapidaction to create a more positive business cli-mate for self-care,” Scarlett-Smith said, “andleads to more longer-term solutions for con-sumer empowerment.”

While the climate for the consumer health-care industry was good, it was vital that the sec-tor did not forget that it was the consumer thatwould ultimately decide its fate, he warned,adding that if the industry did not keep up withthe ever-changing consumer base, it would fail.

“Citizens are indeed consumers, they votewith their wallets and they must be at the heartof everything we do,” Scarlett-Smith insisted.

Noting that there were “seven billion peoplein the world, and therefore seven billion poten-tial consumers”, Scarlett-Smith suggested to del-egates how industry should best reach out and

empower consumers to manage their own health.The key, Scarlett-Smith said, was for industry

to engage with the “four pillars of empower-ment”, starting with information and knowledge.

“Consumers are using the internet more andmore to search for healthcare information,”Scarlett-Smith pointed out. “In 2011, four outof five internet users had searched for health-care information – I’m sure that number is high-er now – most often searching for specific dis-eases and treatments.”

Furthermore, around 44% of those usershad looked for information about doctors andother healthcare professionals, he said. “Thereis a new era of scrutiny by consumers.”

“Amongst consumers in Latin and NorthAmerica, more than 50% of those asked agreedthat in their moment of need, healthcare infor-mation was easy to find on the internet on anyof their devices,” Scarlett-Smith revealed.

It was incumbent on the industry to ensurethat information received online by consumerswas accurate, he said, as a properly informedconsumer was a knowledgeable consumer andthis drove their ability to diagnose, to engagewith healthcare professionals and to properlychoose and use self-care products.

These products, however, had to meet thequality standards expected and be innovativeenough to keep up with consumer demands, heinsisted, noting these were the second pillar.

“Consumers want products that are safe andof high quality,” he added, “while consistentlydelivering the expected health benefits.”

The third pillar of empowerment was credi-ble and reliable advice from healthcare profes-

sionals, Scarlett-Smith said.“No matter how informed and knowledge-

able a consumer may be, when it comes to theirhealth and the health of their family, they wantadditional advice from their doctors or phar-macists,” he claimed.

“More than 40% of consumers,” Scarlett-Smith pointed out, “start or continue to useself-care products based on recommendationsfrom doctors or pharmacists.”

These professionals had started to recog-nise self-care and consumer healthcare productsfor the good they could do, Scarlett-Smith noted,pointing out that nine out of 10 general practi-tioners (GPs) and primary-care physicians inthe UK and US agreed that OTC medicineswere “effective as a first-line treatment for avariety of common minor conditions”.

Furthermore, self-care, he added, was “in-creasingly reflected in clinical practice guide-lines from global, regional and nation organ-isations, such as the World Health Organization(WHO), European Medicines Agency (EMA)and countries ministries of health”.

The final pillar, and possibly the most cru-cial, was access, Scarlett-Smith stated.

“Consumers want convenient and easy ac-cess to self-care, especially when seeking relieffrom minor ailments like headache, cough orallergies,” he explained. “A recent survey show-ed that nine out of 10 consumers in Europeview self-care as a vital and important part ofthe management of minor ailments and chronicconditions and diseases.”

Paramount to building on these pillars was apositive business climate, Scarlett-Smith argued,and as healthcare systems changed, regulatorsand industry needed to work to keep pace.

“It is an interesting time in healthcare, withincreasing demands met with a very clear real-isation that governments simply can’t just carry


OTC AESGP MEETING

Business Strategy

GSK’s Scarlett-Smith sees bright future

Roger Scarlett-Smith, head of global categories atGlaxoSmithKline Consumer Healthcare, called forindustry to work to build a self-care ecosystem

The four pillars to drive consumer empowerment outlined by Roger Scarlett-Smith, head of global categories atGlaxoSmithKline Consumer Healthcare (Source – GlaxoSmithKline)

OTC12-06-15p10-14_Layout 1 09/06/2015 18:24 Page 4


AESGP MEETING OTC

There is no news on when work on the 2,078pendingArticle 13(1) general-function health

claims for botanicals will restart, according toValeriu Curtui, head of the nutrition unit at theEuropean Food Safety Authority (EFSA).

Speaking to delegates at the 51st AnnualMeeting of the European Self-Medication In-dustry, the AESGP, in Barcelona, Spain, Curtuipointed out that EFSA had actually evaluatedand rejected around 500 Article 13(1) healthclaims for botanicals, which was what had ledto the European Commission putting the workon hold back in 2010.

While the European Commission announceda further “reflection” on the issue in the sum-

mer of 2012 (OTC bulletin, 10 August 2012,page 1), since then there had been “no news”on whether or not EFSA would ever proceedwith the list of general-function claims for bot-anicals, he said.

The problem with botanicals was that botan-ical ingredients were being treated differentlyunder the food claims regulation than they wereunder legislation covering traditional herbalmedicines (OTC bulletin, 15 October 2010,page 1).

In response to the concerns, the EuropeanCommission announced in 2010 that the com-munity list of permitted general health claimsfor foods would be established in two steps.The list for all substances other than botanicalswould be adopted in a single step, it explained,with claims for botanicals considered once thefirst step had been completed.

This means that while a list of 222 permittedhealth claims was agreed in 2012, evaluating2,078 Article 13(1) general-function claimsfor botanicals has remained on hold.

Regulatory Affairs

Botanicals stillstuck in limbo

on with business as usual,” he pointed out.Governments needed people to take more

responsibility for their own health. In this way,limited resources could be focused where theywere needed, Scarlett-Smith said. Collabora-tion was needed between industry and policy-makers to empower consumers and prove thebenefits attributed to self-care.

This collaboration could only begin if a two-way dialogue was established, Scarlett-Smithargued. This exercise should seek to “under-stand the business challenges and opportunitieswe experience in empowering consumers andidentify the issues that policy makers careabout”, he added.

“Then we need to turn this intelligence intobalanced policy, which targets solutions to partsof the self-care paradigm that need improve-ments, fixing things that are not working andkeeping things that work well.”

While recognising that consumer healthcarewas understandably one of the most highly-reg-ulated industries in the world, Scarlett-Smithcalled for a framework that was a “blend offlexible, mandatory and voluntary measures”.

Levelling the playing fieldThis would expand consumer access, pre-

serve information to consumers, protect privacyand maintain consumer safety, while “levellingthe playing field” and allowing “headroom forinnovation” but also ensuring that everyone meta “common standard”.

Industry practices worldwide were improv-ing, Scarlett-Smith insisted, noting that effortsby companies towards complying with currentgood practices and common standards were al-ready underway in Russia and many of the Eur-asian markets. However, this framework neededto be transparent, consistently applied and prop-erly enforced, he cautioned.

Achieving this more flexible framework – inEurope at least – was very much in the graspof all stakeholders, Scarlett-Smith noted, par-ticularly if action was taken on the excellentrecommendations contained in the EuropeanCommission’s “not-quite-yet-published” report

on better regulation for better results.“The report,” he claimed, “basically encap-

sulates the key tenets I’ve just described fora more favourable self-care paradigm.”

Turning to how the industry could “bringself-care to life” for consumers, Scarlett-Smithsaid that communication through technologyand social-media platforms would be crucial.

“As consumers become more tech-savvyand socially connected, we have to evolve ourcommunications channels to keep pace withthat,” he warned.

But for industry to do this successfully, pub-lic policy and regulation must also keep pacewith technological innovation, Scarlett-Smithadded, noting that last year the AESGP launch-ed its set of voluntary guidelines on using socialmedia (OTC bulletin, 16 June 2014, page 13).

These guidelines had ensured a “consistentstandard among companies”, he noted, and hadgiven industry the “means to sustain safety andadverse-reporting requirements”.

Furthermore, the AESGP was hopeful, Scar-lett-Smith said, of securing similar codes ofpractice for the more than 97,000 mobile healthapps that already existed and were used byconsumers and healthcare professionals.

Another opportunity to create a more agileself-care system was around safety reporting,he pointed out.

“Pharmacovigilance and the rules that de-fine how manufacturers collect, detect, assess,monitor and prevent adverse events from ourproducts are necessary, of course,” Scarlett-Smith conceded, “but then there may be an op-portunity to reduce the red tape and to improvecompliance through more simple targeted pro-cesses that are proportional to the benefits andthe risks of the product and the situation.”

All this progress and opportunity was evi-dence of an “optimistic future” for the self-careindustry, he insisted.

“We are showing positive signs of fosteringthe right ecosystem for consumers,” Scarlett-Smith said, “by driving simplicity of choice,greater engagement with healthcare profession-als, more access and better quality products.”

The 52nd AESGP Annual MeetingHotel Divani Apollon Place, Athens | 31 May-2 June 2016

For further details email [email protected]

OTC

Valeriu Curtui, head of the nutrition unit at theEuropean Food Safety Authority (EFSA), said therehad been no news on when work to validate general-function health claims for botanicals would restart

OTC

OTC12-06-15p10-14_Layout 1 10/06/2015 09:24 Page 5

The proposed medical devices legislation is“one of the saddest pieces of legislation I

have done”, according to former member of theEuropean Parliament, Dagmar Roth-Behrendt.

Speaking to delegates at the 51st AnnualMeeting of the Association of the EuropeanSelf-Medication Industry, the AESGP, in Bar-celona, Spain, Roth-Behrendt – who acted asrapporteur for the legislation before steppingdown from the European Parliament last year –said that the agreement voted on a year agowas “a very weak compromise”.

There was a danger, she added, that theEuropean Council – which has been discussingthe legislation since the parliament’s plenaryvote last April (OTC bulletin, 25 April 2014,page 13) – would upset the compromise and“turn everything upside down”.

In its draft proposal filed in 2012, the Com-mission had noted that the line between medicinesand medical devices was “difficult to draw”.

It then suggested – under Rule 21 in An-nex VII – that substance-based medical devicesshould be classified in the highest-risk class

as this was appropriate to ensure a high levelof safety, regardless of their use.

The AESGP warned that Rule 21 wouldplace many self-care medical devices in thehighest-risk category and argued that this pro-posal was “neither appropriate nor justified bythe risk profile” of these products (OTC bul-letin, 18 December 2012, page 10).

Six months later, the parliament’s environ-ment, public health and food safety (ENVI)committee proposed a massive 762 amend-ments to the legislation, on top of the 145 thathad been proposed by Roth-Behrendt (OTCbulletin, 31 May 2013, page 14).

Vote removes Rule 21In an attempt to move forward, the Parlia-

ment backed a number of the suggested changeswith its plenary vote, including the deletion ofRule 21 and of the need to comply with medi-cines legislation, Directive 2001/83/EC.

The Council, however, remained split on sub-stance-based device regulation, according toGwenole Cozigou, director of the directorate-

general for Internal Market, Industry, Entre-preneurship and Small and Medium Enterprises– DG GROW – at the European Commission.

Some member states wanted to regulate theproducts as medical devices, some as pharma-ceuticals and some wanted the products regu-lated as anything but medical devices or phar-maceuticals, he told delegates.

Discussions in the Council had taken muchlonger than the Commission would have liked,he admitted, but since January the process had“considerably accelerated”.

“We at the Commission are quite open withour objectives,” Cozigou pointed out. “We seethis as a high priority and we are doing ourupmost to help the Council and Parliament tofind compromises as soon as possible, as weconsider the legislation essential for the sectorand to restore confidence in medical devices.”

“For this sector of the market to flourish,we must have trust in the sector,” Cozigou in-sisted, “so we have to have legislation that en-sures that these products are safe but that isalso transparent.”


OTC AESGP MEETING

Regulatory Affairs

Compromise needed on medical devices

OTC

OTC12-06-15p10-14_Layout 1 09/06/2015 18:24 Page 6

Abbott Nutrition is running sampling drivesfor its Pedialyte oral-rehydration brand at

festivals and events around the US as part of awider “See the lyte” campaign targeting adults.

Noting that the brand had previously beenmarketed as solely for children, a spokespersonfor the brand told OTC bulletin that new packsdesigned for adults would be handed out byPedialyte “street team” ambassadors at 144sports, music and street events, including theElectric Daisy Carnival and Summerfest.

The overall aim of the “See the lyte” cam-paign was to highlight that Pedialyte could beused to prevent mild-to-moderate dehydration“due to a variety of reasons”, the spokespersonpointed out, including occasional alcohol con-sumption, illness, exercise and travel.

Explaining the rationale behind this newfocus, the spokesperson said Abbott was tappinginto a long-established “underground movementof adults” who knew that Pedialyte was “an ef-fective hydration solution”.

Noting that the “movement” had “gained mo-mentum with the popularity of social media”, thespokesperson explained that Abbott had respond-ed by launching the campaign, which uses thehashtag #seethelyte, on its newly-created Pedi-alyte Facebook page and Twitter profile.

Other digital activity as part of the campaign– which would run into 2016 – included part-nerships with news and entertainment websiteBuzzfeed and targetted banner advertisementson websites, the spokesperson noted, bolsteredby public-relations and couponing activity.

One-third of sales from adult useClaiming that adult use of Pedialyte had in-

creased by 57% since 2012, Abbott said thatone-third of the brand’s sales now came fromadult usage.

To widen further Pedialyte’s appeal to adultconsumers, the firm recently introduced largerpacks to the product range, which also includesthe original and AdvancedCare ready-to-drinksolutions and ‘Freezer Pops’.

Available in strawberry-lemonade and orangeflavours, the 0.6oz (17g) adult packs were twicethe size of the existing Pedialyte sachets, thefirm noted, and were “more convenient” foradults, as the soluble powders could be “easilymixed in a traditional 16oz bottle of water”.

The company has also tweaked the pack-aging for the new powders to get across the

advertising message to adult consumers.Although the usage instructions on existing

Pedialyte labelling referenced both adults andchildren, the firm pointed out, the statement thatthe brand was “great for kids and adults” wasdisplayed prominently on the front of the boxof the new larger powders. The packaging alsohighlights that Pedialyte has been “trusted bydoctors and hospitals since 1966”.

Meanwhile, a seethelyte.com website hasalso been created as part of the marketing cam-paign in addition to the existing brand website,pedialyte.com, which contains information forparents and healthcare professionals.

The “See the lyte” website notes that “adultscan use Pedialyte too” and claims the brandis “the secret to hydration for kids and adults”.Images used in the campaign include that of awoman wearing her pyjamas slumped againsta refrigerator, drinking Pedialyte from the bottle.

While the overall message to consumerswas that “Pedialyte helps you feel better”, thespokesperson stressed, the brand was not beingmarketed as “a cure for anything”.

According to Nielsen figures, the US oral-electrolyte category was estimated to be worthUS$167 million (C148 million), the spokesper-son pointed out, which consisted primarily ofPedialyte – which held nearly three-fifths of themarket – and private-label products.

Noting that it had doubled its marketingspend to reach adult consumers, the spokes-person added that Abbott expected the new posi-tioning to “drive double-digit growth” for thePedialyte brand.

While Pedialyte was also available in Can-ada, Latin America and Mexico – with “smallerdistribution” in Korea, SaudiArabia and Taiwan –the spokesperson said the “See the lyte” cam-paign would be implemented only in the US.


MARKETING NEWS OTC

Stada aims to “mark a change” in how UKconsumers think about sun protection with

a £2.0 million (C2.8 million) “Think Infra-red defence” multimedia campaign to supportthe launch of its Ladival sunscreen range.

The German firm is looking to differentiateLadival from tival sunscreens by educating UKconsumers on the dangers of Infrared-A rays– said to make up a third of the sun’s rays –and highlighting that the brand is the first“mainstream” sun-care brand to protect againstboth these and UV rays.

Currently available in 18 markets, includingGermany – where it is said to be the number-one selling sunscreen brand – and Spain, Ladi-val is also claimed by Stada to protect against

“four-times more of the sun’s rays than stan-dard UV-only sunscreens”.

To drive home the impact of Infrared-Arays on skin, the launch campaign includes anational television spot – created by advertisingagency Bray Leino – which uses a “stark visualmetaphor” of a “cracked and weathered face”sculpted in sand.

A voiceover asks: “Do you know what In-frared-A is doing to your skin?” before encour-aging consumers to compare their sunscreenwith Ladival. The spot then ends with the tag-line: “Sunscreen in a new light.”

Consumer-press and online activity wouldalso support the launch “across the key sum-mer months”, Stada added, along with public-relations and social-media activity, as well asin-store education materials.

The firm told OTC bulletin that it wantedLadival to become a “leading player” in the UKsun-protection market – worth approximately£160 million annually – over the next five years.

The Ladival range in the UK includes lotionsand sprays offering protection of up to Factor50+, along with a Kids line.

Product Launches

Stada to changesunscreen views

OTC

Television advertising for Lavidal shows a “crackedand weathered” face made from sand

Abbott’s “See the lyte” campaign aims to highlightto adults that Pedialyte can be used to preventdehydration caused by a variety of reasons, includingexercise and occasional alcohol consumption

Marketing Campaigns

Abbott targets US adultsfor Pedialyte promotion

OTC

OTC12-06-15p15-18_Layout 1 09/06/2015 18:43 Page 2


OTC MARKETING NEWS

Pfizer Consumer Healthcare has grown itsEmergen-C food-supplement line in the US

with melatonin-based sleep aids.Containing 3mg melatonin – as well as vit-

amins C and D, calcium, manganese and zinc –the Emergen-Zzzz soluble effervescent pow-ders are available in three flavours: Berry PM,Mellow Berry, and Peach PM.

Although all three variants contained thesame ingredients, Pfizer explained, the Berryand Peach PM products would be positioned inthe sleep-aid aisles of retailers, while the Mel-low Berry option would be placed alongsidethe other current Emergen-C supplements.

One packet should be taken 30 minutes be-fore bedtime, the firm recommends, to relieveoccasional sleeplessness.

Targeted at those aged between 25 and 44years who were “looking for natural sleep aids”,Emergen-Zzzz was being supported by activityon Emergen-C’s Facebook, Instagram and Twit-ter profiles, Pfizer noted, along with public-relations activity and in-store promotion.

The overall message to consumers would bethat “Emergen-Zzzz has a unique formula withmelatonin to help you fall asleep naturally, plusvitamin C and other key antioxidants to fortifyyour body while you sleep”, the firm said.

This advertising message would be “tailor-

ed” to suit each media platform, Pfizer added.Two free-trial sachets were also being in-

cluded in 30-count boxes of standard Emergen-C powders, Pfizer added, while product sam-pling would be on-going throughout the year.

Pfizer expanded the reach of Emergen-Coutside of its domestic market last year withlaunches in the UK and Korea (OTC bulletin,12 September 2014, page 19); (OTC bulletin,6 March 2015, page 17). However, the firmtold OTC bulletin that it did not have any“immediate plans” to launch Emergen-Zzzzoutside of the US.

The Emergen-C line has also recently beenextended further with chewable vitamin C tablets.A recommended intake of two orange-flavouredtablets is said to provide 1,000mg vitamin C.

Product Launches

Pfizer adds sleep aids toEmergen-C line in the US

OTC

Scrubs UK is supporting Asonor anti-snoringnasal spray in the UK with its first television

sponsorship campaign.The healthcare supplier’s sponsorship of

Indian celebrity dance competition Nach Bali-ye, which is shown daily on television channelStar Plus, includes a 30-second advertisement

showing “the life journey of a long-sufferinghusband and his snoring wife”.

A voiceover states in Hindi that Asonormay help to reduce or stop snoring for up toeight hours.

As part of the £100,000 (C137,000) cam-paign – which will run until the end of July –Scrubs UK said it was also “speaking to” wo-men’s national weekly and monthly magazines,including Pick Me Up and Woman’s Own, aswell as Good Housekeeping and Prima. Web-sites and newspapers were also being targeted,the company noted.

Asonor is said by Scrubs UK to be a clear,odourless and tasteless solution that lubricatesand softens mucous membranes in the throat,whilst also tightening the throat muscles.

Sponsorship Campaigns

Asonor sponsors television dance contest

Asonor's sponsorship of television show Nach Baliyefeatures a snoring wife and “long-suffering husband”

The Emergen-Zzzz ‘PM’ flavours would be positionedin the sleep-aid aisles of retailers, Pfizer noted

OTC

Reckitt Benckiser (RB) aims to raise awareness amongUK consumers of the symptoms and causes of ‘dry-eye’with a £1.6 million (C2.2 million) campaign for its OptrexActimist 2in1 Eye Spray for dry and irritated eyes.

Set to air until the beginning of August ontelevision and digital platforms, the 30-second creativeused the “eye’s perspective” to “show the damagecaused by everyday modern life on the eye’s protectivelayer”, RB pointed out, and positioned Optrex Actimist2in1 Eye Spray as “a convenient and easy-to-usesolution” for dry-eye problems.

It did this, the firm explained, by focusing on areflection of a computer screen in a close-up of an eye,accompanied by the sound of typing on a keyboard.

As dryness was shown spreading across the eye,the advertisement highlighted how Optrex Actimist2in1 Eye Spray could be sprayed over closed eyelids tohelp repair the protective lipid layer, RB maintained.

The Optrex Actimist 2in1 range also includes eyesprays for itchy and watery eyes, as well as for tiredand uncomfortable eyes.

OTC

Flexéa, the glucosamine-based brand marketed byLaboratoires Expanscience in France, is now availablewithout prescription, the company has confirmed.

The brand – which is available in a 60-count packof 625mg tablets – was among a range ofglucosamine-based medicines that were delisted fromreimbursement in France from the start of March thisyear due to their “insufficient” therapeutic value.

Also among these medicines was Biocodex’ Dolenio– which was also recently made available on anon-prescription basis in France (OTC bulletin, 22May 2015, page 18) – and Novartis’ Voltaflex,which is also available without prescription.

OTC

■ NORMON has extended its OTC portfolioin Spain with simethicone tablets. Indicatedfor the symptomatic relief of gas in adults andadolescents aged 12 years and over, Simethi-cona Normon contains 40mg of the activeingredient in each tablet. The Spanish firmrecommends that two tablets should be takenthree times daily after each main meal, with amaximum dose of 12 tablets.

OTC

IN BRIEF

OTC12-06-15p15-18_Layout 1 09/06/2015 18:43 Page 3

Boots UK has partnered with parenting siteNetmums to host an online branded hub

and position itself as “the go-to parenting ex-pert on the high street”.

The six-figure annual deal – which also ex-tends to social-media networks such as Face-book and Twitter, as well as within Boots stores –

brought together “the two most trusted namesin parenting”, the UK’s largest pharmacy chainsaid, with the aim of raising awareness of its“baby expertise” among Netmums’ audienceof over eight million visitors.

Targetting at mothers of children aged up totwo years, the partnership included a Boots-branded tab on Netmums’ navigation bar, thefirm noted, which would lead users to “exclu-sive” editorial that was in line with its seasonalproduct promotions.

Users can also register to become part of theBoots Parenting Club initiative through the site.

Rachel Burrows, Netmums’ editor-at-large,told OTC bulletin that Boots’ website wasalso likely to feature endorsement of productsthat had been reviewed and recommendedby Netmums’ users, although this had yet tobe confirmed.

Adding lozenges to its Betadine antisepticbrand inAustralia, Sanofi Consumer Health-

care claims, provides consumers with “anotheroption in their battle against sore throats”.

Containing 1.2mg and 600µg of the anti-bacterial ingredients dichlorobenzyl alcohol andamylmetacresol respectively, Betadine SoreThroat Lozenges were a “great companion prod-uct” to the povidone-iodine-based Betadine SoreThroat Gargle, Sanofi noted.

The two products could be used together tocreate a “treat and relieve” combination for sorethroats, the firm pointed out.

While the gargle should be used morningand night potentially to treat the cause of sorethroats, Sanofi explained, the lozenges could betaken throughout the day as “an antibacterial,on-the-go solution for fast, soothing and effec-tive relief from the discomfort of a sore throat”.

Betadine Sore Throat Lozenges are the onlyproduct within the Betadine range in Australia– which also includes first-aid and cold-soreproducts – not to contain the povidone-iodineactive ingredient.

The launch of the lozenges was being sup-ported until the end of August by an overarch-ing promotional campaign for the Betadine

Sore Throat line, the firm pointed out.Featuring an animated bacterium called

‘Brutus’, the campaign included television com-mercials, Sanofi explained, as well as trade-media and digital advertising.

The company is also providing training forhealthcare professionals and in-store displaymaterials for retailers.

Available in three flavours: Fresh Menthol& Eucalyptus, Orange, and Soothing Honey &Lemon, Betadine Sore Throat Lozenges haverespective recommended retail prices of A$6.29(C4.30) and A$9.99 for 16 and 36-count packs.

Sanofi holds the Australian distribution rightsto the Betadine brand from Mundipharma.


MARKETING NEWS OTC

Line Extensions

Sanofi helps Australiansfight sore-throat battle

Betadine Sore Throat Lozenges are the only productwithin the brand not to contain povidone-iodine

OTC

OTC

Ferndale Health has extended the reach of itsRectiCare brand into the US haemorrhoid-

wipe market – worth about US$30 million (C26million) at retail – with what it claims is theonly wipe in the category to contain lidocaine.

Claiming that current wipe offerings typi-cally contained various strengths of the astrin-gent witch hazel – and no anaesthetic ingredi-ents – the US-based firm said its “dual action”Recticare Medicated Anorectal Wipes were for-mulated with 5% lidocaine and 20% glycerine,to provide both relief from symptoms and pro-tection from further irritation.

The “discreet”, individually-packaged wipescomplement the RectiCare Anorectal Cream,which also contains 5% lidocaine.

Noting that the total haemorrhoid-relief mar-ket was currently worth US$110 million, thefirm said it had forecasted combined RectiCarebrand sales of US$10 million in 2015.

A national launch campaign for the wipeswas underway, Ferndale noted, which positionedthe product as being suitable for the relief ofpain, itching and burning caused by “other anor-ectal disorders”, in addition to haemorrhoids.

Males and females aged over 30 years werethe target of the marketing drive, Ferndale main-tained, which included television and radio ad-vertising, as well as print promotion in Preg-nancy & Newborn magazine. Trade-press titleswere also being targeted, the firm added.

Currently available at Rite Aid and Wal-greens stores, RectiCare Medicated AnorectalWipes would roll out in supermarket chainPublix “later this summer”, Ferndale said.

Product Launches

Ferndale offersRectiCare Wipes

■ ARISTO PHARMA IBERIA – the Span-ish subsidiary of India’s Aristo – has grown itsOTC portfolio with the ibuprofen-based Diltixtopical spray. Containing 47mg ibuprofenper ml, the product is indicated for the reliefof occasional mild pain and inflammation –caused by ailments such as bruises, sprains,stiff neck and spasms – in Spanish consumersaged 12 years and above. To support the launch,the company has created a special website,combateeldolor.com, which provides consum-ers with advice and information on pain. Thefirm also offers in Spain eye drops and cold andflu options as part of its self-medication range.

OTC

IN BRIEF

OTC

Digital Marketing

Boots UK creates Netmums partnership

A Boots-branded tab on the Netmums website leadsusers to exclusive editorial content

OTC12-06-15p15-18_Layout 1 09/06/2015 18:43 Page 4

Stada is backing its Flexitol dermatologyrange in the UK with the first national tele-

vision campaign since it acquired the brandnearly a year ago.

Airing on “mainstream” channels through-out June and July, the advertisements used com-puter-animated visuals to highlight the “stressesand strains” that feet underwent on a daily basis,the German firm explained, as well as to pointout how Flexitol could help with dry skin.

The campaign would “champion” the Flex-itol Heel Balm, the company pointed out, andinclude the key message “your hard-workingfeet deserve Flexitol”.

A new brand website would be unveiled inconjunction with the television campaign, Stadapointed out, offering consumers “lots of prac-tical and expert advice on foot health”.

The firm added that a new pack design forFlexitol Heel Balm would be rolled out “laterthis year”, supported by an “integrated media-communication campaign”.

Stada gained the production and distributionrights to the Flexitol range of hand- and foot-care products – including a Skin Balm and Anti-Itch Soothing Cream – from the LaCoriumGroup for £10 million (C14.6 million) last year(OTC bulletin, 25 July 2014, page 7).

The deal was completed though Stada’sBritish affiliate Thornton & Ross, which it ac-quired in 2013 (OTC bulletin, 23 August 2013,page 1).


OTC MARKETING NEWS

Marketing Campaigns

Stada launches its first UKtelevision push for Flexitol

OTC

Refreshed packaging for Flexitol Heel balm would beintroduced in the UK later in the year, Stada said

Dr August Wolff has started a major promotionalcampaign for the Linoseptic topical disinfectant thatit has just introduced in Germany.

A 15-second television commercial devised byHamburg’s Brandmeyer agency features the animatedblue ‘Lino’ mascot that also promotes the company’sLinola linoleic acid range.

Lino also features in trade-press advertisingfor Linoseptic Gel and Spray, which contain 1%phenoxyethanol and 0.1% octenidine. The trade-presscampaign said the colourless gel was “the onlyantiseptic hydrogel licensed as a medicine”, and could beused to treat scratches and minor wounds for patientsof any age, including under plasters and bandages.

A 30g tube of the gel has a recommended retailprice of C8.46, while a 30ml bottle of spray costs C6.38.

OTC

OTC12-06-15p15-18_Layout 1 09/06/2015 18:43 Page 5

20 August■ Basics of

PharmaceuticalRegulatory AffairsLondon, UKThis one-day course is run by TheOrganisation for Professionals inRegulatory Affairs (TOPRA).Contact: TOPRA.Tel: +44 20 7510 2560.Email: [email protected]: topra.org.

20-21 August■ Marketing Authorisation

in Russia/CISBerlin, GermanyCountries to be discussed at thistwo-day seminar include Belarus,Kazakhstan, Russia and Ukraine.Contact: Forum Institut für Management.Tel: +49 6221 500 680.Fax: +49 6221 500 555.Email: [email protected]: forum-institut.com.

2-3 September■ Vitafoods Asia

Hong KongA two-day exhibition and confer-ence focusing on nutraceuticals,as well as functional foods anddrinks and dietary supplements.Contact: Informa UK.Tel: +44 20 7551 9785.Email: [email protected]: vitafoodsasia.com.

4 September■ Marketing Authorisation

in North & South AfricaFrankfurt, GermanyThe regulatory environment inMaghreb and South Africa will bethe subject of this one-day course.Contact: Forum Institut für Management.Tel: +49 6221 500 696.Fax: +49 6221 500 555.Email: [email protected]: forum-institut.com.

10 September■ Mutual Recognition &

Decentralised ProcedureBonn, GermanyThis one-day seminar will look atregulatory strategy and submis-sion management.Contact: Forum Institut für Management.Tel: +49 6221 500 680.Fax: +49 6221 500 555.Email: [email protected]: forum-institut.com.

16 September■ CHPA Meet the

Manufacturer with BayerNew Jersey, USThis one-day meeting with BayerConsumer HealthCare is only opento associate members of the Con-sumer Healthcare Products Asso-ciation (CHPA).Contact: CHPA.Tel: +1 202 429 9260.Fax: +1 202 223 6835.Email: [email protected]: chpa.org/MTM/.

17-18 September■ Marketing Authorisation

for Human Medicinesin Latin AmericaBerlin, GermanyTopics to be discussed at this two-day meeting will include legalframework and national authori-ties; national marketing authorisa-tion procedures; dossier require-ments; and harmonisation trends.Contact: Forum Institut für Management.Tel: +49 6221 500 696.Fax: +49 6221 500 555.Email: [email protected]: forum-institut.com.

21-23 September■ Advanced

PharmacovigilanceLondon, UKA three-day course covering drugsafety regulations.Contact: Management Forum.Tel: +44 1483 730071.Fax: +44 1483 730008.Email: [email protected]: management-forum.co.uk.

22-23 September■ Good Manufacturing

Practices and RecentInspection Findings forHuman OTC DrugsWashington DC, USThis two-day workshop – organ-ised by the Consumer HealthcareProducts Association (CHPA) –will look at regulations set out bythe US Food and Drug Adminis-

tration (FDA).Contact: CHPA.Tel: +1 202 429 9260.Fax: +1 202 223 6835.Email: [email protected]: chpa.org.

5-6 October■ AFAMELA/WSMI

ConferenceMexico City, Mexico‘Advancing self-care and respon-sible self-medication for a health-ier future’ is the theme of this two-day conference, run by the Mexi-can non-prescription association,AFAMELA and the World Self-Medication Industry (WSMI).Contact: AFAMELA.Tel: +52 55 5286 5297.Email: [email protected]: afamela.org/index.php/afamela-wsmi-conference.

12-14 October■ 12th TOPRA

Annual SymposiumBerlin, GermanyA three-day event run by The Org-anisation for Professionals in Reg-ulatory Affairs (TOPRA).Contact: TOPRA.Tel: +44 20 7510 2560.Email: [email protected]: topra.org.

13 October■ Global Generics &

Biosimilars Awards 2015Madrid, SpainThese Awards will recognise theachievements of the global gen-erics and biosimilars industries.Organised by Generics bulletin,they will reward business develop-ment initiatives, clever licensingdeals and smart legal manoeuvres.Contact: Generics bulletin.Tel: +44 1564 777 550.Fax: +44 1564 777 524.Email: [email protected]: generics-bulletin.com/generics-biosimilars-awards.

21-24 October■ CRN’s Annual

Symposium for theDietary SupplementIndustryCalifornia, USA four-day conference organisedby the US Council for Responsi-ble Nutrition (CRN).Contact: CRN.Tel: +1 202 204 7700.Fax: +1 202 204 7701.Email: [email protected]: crnusa.org/2015events.

26-28 October■ Vitafoods Russia & CIS

Moscow, RussiaA three-day event covering diet-ary supplements, food supplementsand functional food and drinks.Contact: Adam Smith Conferences.Tel: +44 20 7017 7444.Fax: +44 20 7017 7447.Email: [email protected]: vitafoodsrussia.com.

3-5 November■ 10th Ceuta International

Alliance conferenceIstanbul, TurkeyDelivering a solution to your inter-national market management sup-port or expansion plans. This uni-que event brings together leadinghealth and beauty, OTC and diag-nostic manufacturers, key industryopinion leaders, retailers and out-source solution distributors fromover 100 global markets givingdelegates an opportunity to meetlike-minded people.Contact: Ceuta Healthcare.Tel: +44 1202 449 709.Email: [email protected]: ceutahealthcare.com.

23-24 November■ EuroPLX 59

Athens, GreeceThis two-day meeting will pro-vide a forum for business devel-opment decision makers for dis-cussing and negotiating collabor-ative agreements in licensing, mar-keting, and distribution of patentedmedicines, generics, biosimilars,OTC products, medical devicesand food supplements.Contact: RauCon.Tel: +49 6221 426 2960.Fax: +49 6222 9807 77.Email: [email protected]: europlx.com.


EVENTS OTC

OCTOBER

NOVEMBER

AUGUST

SEPTEMBER

14-15 October■ AESGP Conference

Brussels, BelgiumThis two-day conference, subtitled ‘Substance-based medical devices: Animportant part of self-care’, is being organised by the Association ofthe European Self-Medication Industry, the AESGP.Contact: AESGP.Tel: +32 2 735 51 30. Fax: +32 2 735 52 22.Email: [email protected]. Website: aesgp.eu/events/Brussels2015/.

OTC12-06-15p19Events_Layout 1 09/06/2015 16:02 Page 2


OTC AESGP MEETING

Offering more incentives to manufacturers,such as longer exclusivity periods, will

foster a more fertile ground for prescription-to-OTC switches, according to senior figuresin the global consumer healthcare industry.

Addressing delegates at the 51st AnnualMeeting of the Association of the EuropeanSelf-Medication Industry, the AESGP, in Bar-celona, Spain, industry leaders from Glaxo-SmithKline (GSK), Pfizer and Sanofi called foran incentive-driven switch procedure to encour-age firms to invest both their time and money.

Roger Scarlett-Smith, head of global cate-gories at GSK Consumer Healthcare, and presi-dent of the AESGP, described the current switchprocess as a “long run for a short jump” andsaid companies could only justify investing inswitching if it was commercially viable.

A more “friendly environment” for switch-ing was needed, Vincent Warnery, head of San-ofi’s global consumer healthcare business, tolddelegates, a call that was supported by SuneetVarma, president of Pfizer Consumer Healthcare.

Varma said it was time for all industry stake-holders to come together to find a “favourable”solution to the problem.

Commenting on ways better to incentiviseswitches, switch consultant Dr Natalie Gauldargued that all successful applications shouldbe accompanied by “at least a few years” ofexclusivity for the product.

Gauld said regulators around the world need-ed to “take a very close look” at how exclusiv-ity could be used to encourage more manufac-turers to invest in switching medicines.

Noting that in her own country of New Zea-land the issue of market exclusivity had been“talked about for 15 years” with no progress,Gauld explained that the national medicinesregulator, Medsafe, was “currently reconsider-ing” the legislation. “Hopefully we’ll get some-where with it this time,” she said optimistically.

Echoing Gauld’s comments on New Zealand,Alison Van Wyk, head of professional servicesat pharmacy retail group Green Cross Health,claimed that a lack of market exclusivity inthe country had “made it difficult for manufac-turers to pursue OTC switches”.

Without exclusivity, the returns manufactur-ers received on their investments in switcheswere not worth their time, Van Wyk explained.

Frederique Welgryn, head of Women’s Healthat HRA Pharma, made delegates aware that theproblem of exclusivity was not confined to NewZealand, noting that her company’s recent cen-tralised switch of EllaOne (ulipristal acetate)in Europe had been rewarded with only oneyear of data exclusivity.

In January, the centralised switch of Ella-One was granted final approval by the Euro-pean Commission (OTC bulletin, 16 January2015, page 8).

Previously, by 21 to eight votes, the Com-mittee for Medicinal Products for Human Use(CHMP) within the European Medicines Agency(EMA) had recommended switching EllaOneto non-prescription status (OTC bulletin, 28November 2014, page 11).

By the same majority, the CHMP said HRAPharma was entitled to one year of data exclu-sivity as a reward for conducting “significantpre-clinical tests or clinical trials” in supportof a change in legal status.

Such a short period of exclusivity was “notvery helpful”, Welgryn claimed, especially asthe period kicked in when the product wasswitched, but not launched.

“We produced new data which was signifi-cant in securing the switch but we will not bene-fit from extended exclusivity,” she protested.

“The question is: Is one year enough to stim-ulate such a high level of investment?” Welgrynasked delegates.

“We really need to solve this exclusivityissue,” Welgryn insisted, “because if we don’tit will prevent companies from going aheadwith other switches in the future.”

Welgryn called for the introduction of aEuropean framework for switches which would“incentivise” firms to invest in the process.

GSK’s Scarlett-Smith also bemoaned the lackof incentives offered to manufacturers, often aftersignificant investments in the switch application.

“The current switch process is a very longrun for a very short jump, which adds up to alot of effort for a not very good result,” Scarlett-Smith argued.

Nevertheless, he insisted: “None of us inthe industry have given up on switching. It isstill a massive driver of growth.”

Must make commercial sense“But the honest truth is, we are commer-

cial operations and things have to make com-mercial sense for us to pursue them,” he added.

There was a “strong case to make”, Scar-lett-Smith said, for “truly adaptive approaches”to the switch process, “rather than ones thatassume companies will be making a whole lotof money and therefore will do anything tojump over the switch hurdles”.

Supporting Scarlett-Smith’s and Welgryn’scomments, Sanofi’s Warnery issued a “call toaction” to industry to find ways, in collabora-tion with regulators, to create a “more friendly,yet responsible switch environment in Europe”.

Such an environment would not only leadto a “more robust OTC sector”, Warnery argued,but would also benefit hard-pressed health ser-vices across the region and improve consumers’access to medicines.

If the switch process could be improved, henoted, there were clear opportunities for indus-try to take advantage.

“We are fortunate enough to have the chanceto leverage the huge amount of real-life safetydata which has been collected over the years

Industry calls for better switch benefits

Vincent Warnery, head of Sanofi’s global consumerhealthcare business, issued a “call to action” toindustry to find ways to create a “more friendly, yetresponsible” switch environment

Suneet Varma, president of Pfizer ConsumerHealthcare, told delegates that switching treatmentsfor chronic conditions from prescription to OTC statuswas a “tremendous opportunity”

Switching remains one of the best ways to drive growth. However, seniorOTC executives told a recent industry gathering that a lack of incentives wasmaking it harder to justify the effort involved. Tom Gallen reports.

OTC12-06-15p20-23_Layout 1 09/06/2015 18:45 Page 2


AESGP MEETING OTC

by dozens of prescription-only medicines, treat-ing ailments that are fully eligible for OTCstatus,” Warnery pointed out.

“Through switches,” he insisted, “we can in-crease people’s ability to access these treatmentsand have more command over their health.”

Taking Sanofi’s own quest to switch erectile-dysfunction treatment Cialis – which the com-pany holds the rights to switch in Australia,Canada, Europe and the US (OTC bulletin, 30May 2014, page 1) – Warnery claimed the prod-uct had a “well-established safety profile”, andhad been used by “millions” of consumers.

Switching Cialis (tadalafil) would not onlyallow consumers to access an erectile-dysfunc-tion treatment OTC but would also help to cutexposure to counterfeit versions, he said.

Noting that treatments for erectile dysfunc-tion accounted for over 30% of counterfeit med-icine sales in the US, Warnery promised that anOTC version of Cialis would carry “fully-fledgedpack protection, including mass serialisationfeatures” to combat the illegal market.

The need to ensure the safe supply of med-icines was also a key consideration for Pfizer,as it moved forward with plans to switch choles-terol-lowering drug Lipitor (atorvastatin), ac-cording to Suneet Varma.

Pfizer said in May that it expected to an-nounce by the end of June 2015 the results ofits Lipitor actual-use trial, which had been com-pleted in November (OTC bulletin, 22 May2015, page 5).

Tremendous switch opportunitySwitching treatments for chronic conditions

like high cholesterol was a “tremendous oppor-tunity” for Pfizer, Varma insisted, as long as con-sumers could safely self-select such products.

Commenting in November on how Pfizercould achieve a successful Lipitor switch, Al-berta Bourla, president of the firm’s GlobalVaccines, Oncology and Consumer Healthcarebusiness, said it was key for the company todemonstrate to the US Food and Drug Admini-stration (FDA) that consumers could “accuratelyself-select” the cholesterol-lowering drug “with-out the intervention of a physician” (OTCbulletin, 28 November 2014, page 3).

Bourla pointed out that previous attemptsto switch a statin had failed as the FDA hadnot believed consumers would be able to ac-curately self-select.

If the FDA approved the switch of Lipitor,Varma argued that there would be an “incre-mental societal benefit” by giving a “large, un-

treated population” access to a statin.Around two-thirds of US adults had been

screened for high cholesterol, Varma explained,but “less than half” of those who needed tolower their cholesterol were using a statin.

Studies had shown that giving consumersaccess to an OTC statin would increase the useof such products and thereby reduce cardio-vascular events, he noted.

While Pfizer was pursuing its own effortswith Lipitor, Varma agreed with Warnery andWelgryn that creating a more favourable environ-ment for switch required a “group effort”.

“It’s not just about one company, or oneregulatory body,” Varma insisted, “it’s aboutbringing all stakeholders together so we canachieve the health, cost and societal benefitsthat switching medicines brings.”

The need for industry to continue to workwith regulators to foster a better switch envi-ronment was addressed by director general ofthe AESGP, Dr Hubertus Cranz.

“Switching has been one of the most im-portant topics in our industry for a number ofyears and continues to be so,” Cranz insisted.

“The AESGP will work to facilitate switchin Europe, by keeping the topic high on theagenda,” he promised.

“Identifying and alleviating the concernsof regulators” is vital to achieve a suc-

cessful switch through Europe’s centralisedprocedure, according to Frederique Welgryn,head of Women’s Health at HRA Pharma.

Welgryn told delegates at the 51st AnnualMeeting of the Association of the EuropeanSelf-Medication Industry, the AESGP, in Bar-celona, Spain, that ongoing dialogue with theEuropean Medicines Agency (EMA) had been“key” to securing the recent centralised switchof its EllaOne (ulipristal acetate) emergencycontraceptive (OTC bulletin, 16 January 2015,page 8).

Noting that EllaOne was only the fourthmedicine to be switched through the central-ised procedure, Welgryn said HRA Pharmahad been able to alleviate regulators’ concernsby adopting a three-pronged approach focusedon product safety, consumer education andpharmacist collaboration.

To address concerns over the safety of non-prescription EllaOne, Welgryn explained thatthe firm had collected primary clinical trial dataand collaborated with medical professionals.

“Good regulatory experts” had also helped

the company to understand the kind of data theEMA was looking for, she noted.

Turning to HRA Pharma’s work on con-sumer education, Welgryn pointed out that thefirm had developed a website – ellaone.com –which contained information in 25 languagesabout how emergency contraception workedand when it could be used. The website alsoinformed women about using regular contra-ception, she noted.

In addition to the website, Welgryn explain-ed that the company had also created a quickresponse (QR) code for the packaging of Ella-One, which when scanned by a mobile phoneallowed consumers to view the product’s patientinformation leaflet.

“Through the website and the QR code weshowed the regulators that we wanted the con-sumer to be involved and have access to allthe necessary information about emergencycontraception,” Welgryn insisted.

On HRA Pharma’s work with the pharmacyprofession, Welgryn revealed that the firm hadconducted a survey of pharmacists in 11 coun-tries “to show how emergency contraceptionwas perceived and to understand training needs”.

This information had helped the firm todesign training material for pharmacists, sheexplained, which it then presented to the Phar-maceutical Group of the European Union(PGEU) for feedback.

Using this feedback, a website just forpharmacists was created, Welgryn pointed out,which included training materials for EllaOne,as well as important information that pharma-cists could use to educate consumers.

Welgryn admitted that there were not a lotof precedents for centralised switches in Europeand therefore the application process required“creativity and perseverance” as well as theinvestment of “extensive resources”.

“There are ups and downs in this proce-dure,” Welgryn warned. “Sometimes you’revery optimistic, other times less so.”

Despite these bumps in the road, Welgrynsaid the switch of EllaOne was a “testament”to the centralised route as a pathway for in-novation and improved consumer choice.

Switching EllaOne centrally had given 48million women in Europe access for the firsttime to an emergency contraceptive withoutthe need for a prescription, she noted. OTC

HRA Pharma offers switch tipsOTC

OTC12-06-15p20-23_Layout 1 09/06/2015 18:45 Page 3

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Chinese drugstore chain China Nepstar hasnamed Rebecca Yingnan Zhang as its

chief executive officer, following the suddendeparture of Fuxiang Zhang.

Commenting on the move, the company saidthat Zhang had stepped down as chief execu-tive officer for personal reasons.

Yingnan Zhang – who has also been ap-pointed to the firm’s board – has served as Nep-star’s chief operating officer since November2014, having previously led the company’s pro-curement, merchandising, logistics and qual-ity departments.

Indispensible assetNepstar said Yingnan Zhang was an “indis-

pensible asset” and the firm was confident shewould help the company to achieve its potential.

As of 31 March 2015, Nepstar was operat-ing 1,969 stores across 74 cities in China, alongwith one national distribution centre and 15regional distribution hubs.


PEOPLE OTC

Retailers

China Nepstarappoints CEO

GlaxoSmithKline (GSK) has announcedthat Manvinder Singh Banga – a former

senior executive at Unilever – will join its boardas a non-executive director on 1 September.

Prior to his current role as partner at private-equity fund Clayton, Dubilier & Rice, Bangawas president of global foods, home and per-sonal-care businesses at Unilever, GSK noted,adding that he had held a “number of seniorpositions” during his 33-year tenure at the con-sumer-goods giant.

Banga would also take over the role of sen-ior independent director on 5 May 2016, GSKnoted. He will succeed Sir Deryck Maughan,who is set to retire from the board at the com-pany’s 2016 annual general meeting.

Commenting on the appointment, Sir Phil-

ip Hampton, GSK’s chairman designate, saidBanga would bring with him “many years ofexperience” and a “track record of deliveringoutstanding performance in a highly-compet-itive global consumer-focused industry”, whichwould be “invaluable” to the firm.

Manufacturers

GSK expands board withconsumer-goods specialist

OTC

ManvinderSingh Banga

OTC

Sanofi has appointed Suresh Kumar to thenewly-created role of executive vice pres-

ident of external affairs.As part of this position, Kumar – who has

joined from management-consulting firm OliverWyman – would be responsible for “definingSanofi’s vision for meeting global health chal-lenges”, the French firm noted.

This would include “setting the strategy and

priorities” for the firm’s public-affairs activitiesand its interactions with governments and in-ternational organisations, Sanofi added, as wellas “aligning internal and external communica-tions around these priorities”.

Kumar had more than 30 years’ experiencein the healthcare industry, the firm pointed out,including at Johnson & Johnson, where he hadserved as international vice president of thefirm’s global Consumer business.

He had also held “increasingly senior roles”in consumer healthcare in Asia, Canada, andLatin and North America at Warner Lambert,Sanofi added, where he spent nearly a decade.

Olivier Brandicourt, Sanofi’s chief executiveofficer, said Kumar would be a valuable addi-tion to the company and its executive commit-tee, as he brought with him a “genuinely uniqueprofile” that included a “diversified, interna-tional career within the healthcare industry”.

Manufacturers

Sanofi adds external affairs role

Suresh Kumar

OTC

■ WALGREENS BOOTS ALLIANCE’s ex-ecutive vice president, global chief informationofficer (CIO), Tim Theriault, has stepped downfrom the position for “personal reasons”. Hewill continue to serve as a consultant to thefirm and as a senior advisor to its executive vice

chairman and acting chief executive officer,Stefano Pessina. Theriault is succeeded byAnthony Roberts – previously senior vicepresident, international CIO – who has assumedthe role of senior vice president, global CIO.

IN BRIEF

OTC

Shantanu Khosla will step down from hisrole as managing director and chief exec-

utive officer of Procter & Gamble’s Indianoperations on 30 June 2015.

Khosla has spent three decades at the firm,including 13 at the helm of Procter & GambleIndia. The US-based consumer-goods giant’sIndian business comprises Hygiene and HealthCare, Home Products and Gillette India units.

He will be replaced by Al Rajwani, who iscurrently vice-president of Procter & Gamble’sArabian Peninsula and Pakistan operation.

Over 30 years’ experienceRajwani, who will assume the role on 1 July,

has over 30 years’ experience at the companyacross various markets, including Canada,China, Korea and the US.

While Procter & Gamble did not specifythe reasons behind Khosla’s exit, media reportsclaim he is set to take up a “senior leadershipposition” at the consumer products businessof engineering firm Crompton Greaves.

Manufacturers

Rajwani to replaceKhosla at P&G India

OTC

OTC12-06-15p20-23_Layout 1 09/06/2015 18:45 Page 5

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