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6November 2015

COMPANY NEWS 2 Alliance India’s Strides adds J&Jlines 2 Uriach grabs Laborestto 3 boostsupplementsrange SFIset to buy UK’sPotter’s 3 expands with Rite Aid buy GSKfocused on realising 4 Consumer value algreens Boots Alliance (WBA) is across all 50 US states, the District of Col- Wpoised to grow significantly its pres- umbia, Puerto Rico and the US Virgin Islands. Bayerpursuingfurther 5 OTCacquisitions ence in the US, after agreeing to acquire Rite Aid’s4,600 stores are located across drugstorerivalRite Aid in atransaction 31 US states and the District of Columbia and Perrigoseekingbolt-on dealsfor Omega 6 valued at around US$17.2 billion (C15.7 bil- generated sales of US$26.5 billion in the 12 Reckitt sees potential 7 in Latin America lion), including acquired debt. months ended 28 February 2015. , WBA’schief executive offi- Rite Aid would become awholly-owned Keybrands driveup 8 turnover at Sanofi cer and executive vice chairman, said the ac- subsidiary of WBA, the firm noted, and was“ex- quisition of Rite Aid would “accelerate” the pected to initiallyoperate” under its existing BioGaiasigns up Axero 9 as distributor in SriLanka wholesale and giant’slong-term objec- brand name. tive to strengthen its “presence and coverage Synergies “in excess of US$1 billion” were Pfizer and Allergan 11 enter mergertalks nationally across the US”. expected from the transaction, WBApointed “The addition of Rite Aid,”Pessina insisted, out, adding that the firm would makedecisions Elder committedtopayingoff debts 12 “will accelerate our strategy by completing our “overtime” about integrating the twocompa- GENERAL NEWS 13 network; providing alarger and more compre- nies, with the aim of “creating afully harmon- hensive portfolio; and by creating amore com- ised portfolio of stores and infrastructure”. US adults tr ying 13 prehensive and stronger platform for the dev- Expanding on the rationale behind the deal, new supplement types elopment of our brand presence and the future Pessina said the “complementary retail foot- EFSA givesgreen light to 16 growth of the business.” prints” of Rite Aid and WBAinthe US would lactitoldefecationclaim Upon completion of the deal –scheduled create “an even better network, with more Ansell sues RB over RealFeel 16 for the second half of 2016 –WBA will own health and wellness solutions available in stores FTCseekspublic comment 17 the biggest pharmacychain in the US, with over and online”. on e-cigarette marketstudy 12,600 locations. “This combination will generate astronger Isoflavones safe in supplements 17 WBAcurrently operates over8,000 outlets ■ Continued on page 12 MARKETING NEWS 19 Pfizer buildsonRobitussin 19 for RobiCold launchinUK Nicotinelltackles weight-gainworries 19 Perrigo to sell US VMS business Bayerloses NARB appeal 20 for itsUSClaritin-D claims errigo is to sell its US vitamins, minerals “While our US VMS business delivers ex- Pand supplements (VMS) business as part cellent products to our long-standing customers, UPSA adds four products 21 to itsFrenchFervexrange of aprogramme of portfolio and organisation- we think that it will thrive more fully under new al changes the companyclaims will “maximise ownership,”Papa explained. Taisho adds X5 Plus option 22 to itsRiUP rangeinJapan profit growth”. Claiming that the firm had “recently im- Offloading the US VMS business is just one proved” its performance in the US VMS cat- UK’sASA bans New Nordicad 22 of anumber of initiatives announced by the egory,Papa insisted the sale would “enhance FEATURES 24 firm that are aimed at fending offMylan’s [Perrigo’s] revenue, operating margins, earnings recently-launched hostile takeoveroffer,which and return on invested capital”. Industrybacks 24 expires on 13 November (OTC bulletin,25 “Efficiencyand productivity” would be max- medical device potential September 2015, page 3). imised by selling the US VMS business and a Joseph Papa, the US store-brand specialist’s range of other initiatives, the companysaid, and REGULARS chairman and chief executive officer,said Per- would further leverage the “strength of Perrigo’s Events – Our regularlisting 23 rigohad decided to sell its US VMS portfolio global platform”. This would “delivershare- People – Chaudhuriheads 27 as the business wasnot providing areturn that holder value farsuperior” to Mylan’sproposal. Mylan’s global OTCunit was“above Perrigo’sweighted average cost Noting that these initiativesincluded oper- of capital”. ■ Continued on page 26 OTC06-11-15p2-12_Layout 1 03/11/2015 16:38 Page 2

OTC COMPANY NEWS

Mergers&Acquisitions India’s Strides adds J&J lines

ndia’sStrides Arcolab has strengthened its Idomestic non-prescription brands business by agreeing to buyseven brands from Johnson & Johnson for an undisclosed sum. Spread across the antiemetic, dermatology and pain-management categories, the seven brands include the Ethnorub pain-relieving oint- ment, Otogesic analgesic and decongestant ear drops and Stugil anti-vomiting tablets. In aseparate deal, the firm is also set to take amajority stakeinMedispan’sIndian branded- products business. Strides said the transaction would give it access to the country’sprobiotics market, which it described as “niche”. Medispan’sIndian portfolio included the Lactogut and Lactovit brands, Strides pointed out, adding that the portfolio would be trans- ferred to anew subsidiary called Strides Bio- logix, in which it would hold a51% stake. The twoproduct portfolioscombined were forecast to generate sales of INR320 million (C4.5 million) in 2015-2016, the firm claimed. Both deals are subject to regulatory clearance and other closing conditions. For more than 25 years, we OTC

have acted on behalf of our BusinessStrategy clients as advisors, doers and Amway opens unit a source of ideas for medicinal and health products: to research TCMs mway has opened aUS$13 million (C12 Regulatory Affairs Amillion) research and development facil- Medical Affairs ity in Wuxi, China, to help it “study plants associated with traditional Chinese medicine Clinical Affairs (TCM)” for future use in its products. The newly-opened Amway Botanical Re- Business Development search Center (ABRC) had been built to “sup- Quality Management port the examination of crops harvested from the land” in China, the US direct-selling com- panysaid, and would allowAmway to research “soil nutrients, plant physiology,extract qual- ity standards and processes”. Commenting on the move,George Calvert, We rock Amway’svice-president of supply chain and research and development, said ABRC would helpthe firm to “research and understand Chi- nese botanicals to agreater extent and integrate these findings into our products”. Calvert noted that the firm intended to use the traditional botanicals studied at ABRC to develop both health and beauty products. Diapharm GmbH & Co. KG · Muenster · London · Vienna · Shanghai · +44 203 178 2790 · www.diapharm.com OTC

2 OTC bulletin 6November 2015 OTC06-11-15p2-12_Layout 1 03/11/2015 16:38 Page 3

COMPANY NEWS OTC

Mergers&Acquisitions Mergers&Acquisitions SFI set to buy Uriach grabsLaborest to UK’s Potter’s boost supplements range ustraliannatural medicines firm Soho Flor- Adis International(SFI) is set to snap up rupo Uriach has expanded its product port- ach said it intended to introduce the Italian UK traditional herbal medicines specialist Pot- Gfolio by acquiring Italian dietary supple- firm’sproducts to the Spanish market. Uriach ter’sfrom ’sVifor Pharma business mentsfirm Laborest for an undisclosed sum. would also takeadvantage of Laborest’sexist- for an undisclosed sum. Describing Laborest as a“leading” player ingdistribution network, the companyadded, Commenting on the deal –which is set to in the Italian supplements market, the Spanish to roll out its ownproducts in Italy. be completed before the end of the year by firm said the deal would add anumber of “inno- Uriach pointed out that the acquisition of SFI’sSwiss subsidiary Ginsana –Nigel Pollard, vative”supplements to its product range. Laborest wasinline with the firm’s“2013- the company’schief executive officer,said that Laborest’sportfolio comprises avariety of 2017 strategic plan” of “growth through acqui- Potter’swas a“strong iconic brand in the nat- dietary supplements, including the Ferromas sitions and international expansion”. ural medicines sector” and would give SFI “an iron and vitamin Cproduct, Grisù probiotic, As part of this strategy,Uriach earlier this extensive portfolio of trusted products”. Kistinox Forte women’shealth supplement and yearsnapped up the rights in Italy,Latin Amer- Potter’sportfolio of brands is led by the the Pineal Notte sleep-aid. ica, Portugal and Spain to FC Resources’ Fisio- Equazen fish-oil line and also includes Calcia Noting that the Laborest product range gen- crem line of topical natural products for treat- calcium supplements, Red Koogaginseng prod- erated annual sales of around C25 million, Uri- ing muscle problems (OTC bulletin,12June uctsand the Seatone mussel-extract range. ach claimed the acquisition would be a“major” 2015, page 4). SFI currently offers arange of natural med- boost to its turnover, which stood at approxi- The firm said at the time that the deal rep- icinal products primarilymarketed through mately C120 million in 2014. resented the next step towards its ambition of be- healthcare professionals. Commenting on its plans for Laborest, Uri- coming a“leading natural products player”. Explaining its decision to sell Potter’s, Gal- OTC enica said that it wanted to focus its resources and efforts on “maximising and expanding its portfolio of speciality pharmaceuticals”. IN BRIEF Earlier this year,Galenica announced its ■ BLACKMORES –the Australian natural growth strategy”. As one of the “largest health- Consumer Health business would be transferred health firm –has announced it will establish care companiesinSouth-East Asia”, Kalbe was from the Vifor Pharma pharmaceuticals unit into ajoint venture with Kalbe Farma to “facili- “uniquely positioned” to help Blackmores enter its Galenica Santé business. This would allow tate” its entry into the Indonesian market. Com- the Indonesian market, the firm said. The joint Vifor Pharma to concentrate on its prescription menting on the rationale behind the move, venture –tobeknown as Kalbe Blackmores brands (OTC bulletin,24July 2015, page 23). Blackmores said that establishing apresence in Nutrition –will be operational by 2016. OTC Indonesia wasanimportant part of its “Asia OTC

6November 2015 Number 452 Individual subscriptions Te rms &Conditions: An annual subscription comprises: These can be viewedinfull at Editor: Matt Stewart www.OTC-bulletin.com/subscribe. Editor-in-Chief: Aidan Fry ■ 20 OTC bulletin newsletters; ■ AND at least 45 weekly news@OTCbulletin No partofthis publication maybecopied, reproduced, Production Editor: Jenna Meredith stored in aretrieval system, distributed or transmitted by electronic newsflashes containing the week’s Assistant Editors: To mGallen, Marie McEvoy anymeans, including electronic,mechanical, photocopying top news stories (currentlydelivered by email). Contributing Editor: David Wallace or recording, without the prior written permission of the publisher,orunder the terms and conditions of Advertising Controller: Debi Minal Choice of formats aGlobal Site Licence or of alicence issued by the Director of Subscriptions:ValDavis The 20 OTC bulletin newsletters areavailable: Copyright Licensing Agency (CLA) in London, UK, or Group Sales Manager: Rob Coulson ■ EITHER as the digital OTC bulletin-i for rights bodies in other countries that have reciprocal Awards Manager: Natalie Cornwell online access by desktop,and tablet and agreements with the CLA. Managing Director: MikeRice smartphone.Mobile devices can have Apple or Neither maythis publication be exported, distributed Android operating systems. or circulated by anymeans without the prior written Editorial enquiries: OTC bulletin, ■ OR in traditional hard-copyprint format, permission of the publisher. 4Poplar Road, Dorridge,Solihull, delivered by airmail. While due carehas been taken to ensurethe accuracy West Midlands B93 8DB, UK. of information contained in this publication, the Website: www.OTC-bulletin.com Corporate and multiple subscriptions publisher makes no claim that it is free of errorand Te l: +44 (0)1564 777550 Global Site Licences areavailable to companies. disclaims anyliability whatsoeverfor anydecisions or Fax: +44 (0)1564 777524 These provide in-house electronic access for actions taken as aresult of its contents. Email: [email protected] staff to OTC bulletin and news@OTCbulletin. ©OTC Publications Ltd. All rights reserved. ® Please ask foraquotation. OTC bulletin is registered as atrademark in Advertising enquiries: the European Community. Discounted multiple subscriptions areavailable to As above,[email protected] ISSN 1350-1097. OTC bulletin-i at the same location. SUBSCRIPTIONS Companyregistered in England No 2765878. Subscription rates arepublished at Subscription enquiries: Printed by Warwick Printing CompanyLimited, www.OTC-bulletin.com/subscribe. Contact [email protected] Leamington Spa CV31 1QD,UK.

6November 2015 OTC bulletin 3 OTC06-11-15p2-12_Layout 1 04/11/2015 08:57 Page 4

OTC COMPANY NEWS

BusinessStrategy/Third-QuarterResults GSK focused on realising Consumer value

laxoSmithKline (GSK) is not seeking a Business Third-quarter sales Change Proportion Gtransformational acquisition and will in- (£ millions) 2014/2015 (%)* of total (%) stead focus on the “significant opportunity” it has to create value in its recently-expanded Con- Wellness 813 >100 52 sumer Healthcare and Vaccines businesses, ac- Oral health 460 +9 29 cording to chief executive officer AndrewWitty. Nutrition 172 +7 11 Speaking as the UK-based pharmaceutical Skin health 131 +92 8 giant reported its third-quarter results, Witty Consumer Healthcare1,576 +55 100 said GSK’sattention was“devoted” to growing *Change is at constant exchange rates Consumer Healthcare and Vaccines –following the three-part deal with , involving Figure1:GlaxoSmithKline Consumer Healthcare’s sales in the thirdquarter of 2015 broken down by individual business unit (Source –GlaxoSmithKline) GSK’sConsumer,Oncology and Vaccines busi- nesses (OTC bulletin,25April 2014, page 1) – in Consumer and Vaccines, the delivery of the Driving this increase had been a“signifi- insisting that the companywas “not looking at” sales growth of those businesses, and the bring- cant improvement” in gross margin in the third any“high-levelmergers and acquisitions”. ing through of the pharmaceutical pipelines into quarter,Witty explained, reflecting benefits from “Weare very happywith the strategy that all three of our businesses,”Witty explained. both improvedsupply and pricing, as well as we laid out as we went through and executed Expanding on GSK’sstrategy to growits synergies from the Novartis transaction. the transaction with Novartis,”Witty claimed, consumer healthcare joint venture with Nov- Turning to Consumer Healthcare’ssales per- adding that the firm wasnot “looking around artis, Witty said the firm remained “very focus- formance in the third quarter (see Figure 1), randomly for other alternatives”. ed”ondriving an improvement in the business’ GSK reported turnoveratthe business up by “Wethink it is the right strategy for the operating profit margin. 55% to £1.58 billion (C2.20 billion), primarily environment in which we are operating today “I’m pleased to report that we are starting drivenbysales of the newly-acquired brands. and are highly likely to operate in the future,” to makeprogress on this front,”henoted, “with Proforma constant-currencygrowth was7%, he argued. the margin increasing to 13.3% this quarter.” GSK noted, reflecting the strong performance “Wesee avery significant opportunity to cre- This was3.0 percentage points higher on acon- of Flonase Allergy Relief in the US, which was ate value through the expansion of the margins stant-currencybasis than in the prior-year period. launched in February (OTC bulletin,13Feb- ruary 2015, page 1). Region Third-quarter sales Change 2014/2015 (%)* Proportion Reported turnoveratConsumer Healthcare’s (£ millions) £Proforma of total (%) Wellness category –which contains the bulk International 735 +37 +6 47 of the division’sOTC medicines –more than Europe 481 +87 +1 31 doubled at constant exchange rates to £813 mil- US 360 +61 +18 23 lion with the addition of the Novartis brands. Sales had also been boosted by the growth Total Consumer Healthcare1,576 +55 +7 100 of Flonase and Therafluinthe US, GSK said. *Change is at constant exchange rates Oral health turnover–which wasnot im- Figure2:GlaxoSmithKline Consumer Healthcare’s turnover in the thirdquarter of 2015 by region. Proforma pacted by the joint venture –improvedby9% sales include Novartis Consumer Health in the prior-year and 2015 period (Source –GlaxoSmithKline) in constant currencies to £460 million, with Sensodyne enjoying “globally strong growth”. Third quarter Change 2014/2015 (%)* Proportion (£ millions) £Proforma of total (%) Horlicks had continued its momentum in India in the third quarter,GSK revealed, help- Sales ing to drive up turnoverinthe Nutrition category Pharmaceuticals 3,340 -7 +1 55 by 7% to £172 million. Consumer Healthcare 1,576 +55 +7 26 Skin health sales had jumped by 92% to Vaccines 1,181 +32 +13 19 £131 million, the firm said, thanks to the Novar- Total** 6,097 +11 +5 100 tis brands and growth of Bactroban in China. Flonase lifted proforma sales in the US by Coreoperating profit 18% –61% as reported –to£360 million, while Pharmaceuticals 1,079 -5 +7 62 turnoverinEurope edged up by 1% on apro- Vaccines 464 +30 +44 26 formabasis, and 87% as reported, to £481 mil- Consumer Healthcare 210 +92 +22 12 lion (see Figure 2). Total*** 1,753 +10 +16 100 International proforma sales advanced by 6% to £735 million, arise of 37% as reported. *Change is at constant exchange rates ** Excluding corporate and other unallocated turnoverof£30 million Consumer Healthcare contributed 26% to *** Excluding corporate and other unallocated costs of £35 million GSK’sthird-quarter group sales of £6.10 billion

Figure3:GlaxoSmithKline’s ‘core’ sales and operating profit in the thirdquarter of 2015. Coreresults exclude (see Figure 3). amortisation, goodwill, restructuring costs, legal charges and other items (Source –GlaxoSmithKline) OTC

4 OTC bulletin 6November 2015 OTC06-11-15p2-12_Layout 1 04/11/2015 08:57 Page 5

COMPANY NEWS OTC

BusinessStrategy/Third-QuarterResults Bayer pursuing further OTC acquisitions

espite significantly expanding its Consum- Business Third-quarter sales Change EBIT Change Der Care operation last year through its deal ( C millions) 2014/2015 (%) (C millions) 2014/2015 (%) with Merck &Co, Bayer remains “particularly interested” in OTCacquisitions to growthe busi- Pharmaceuticals 3,428 +14.6 859 +22.9 ness further,according to chairman of the firm’s Consumer Care1,424 +41.6 –– management board Marijn Dekkers. Medical Care388 +6.3 –– While Bayer’s“flexibility” to go after alarge Animal Health 357 +8.2 –– acquisition was“not as high” as twoyears ago Consumer Health 2,169 +27.5 360 -0.8 –with the company’sdebt standing at C19 bil- Total Bayer HealthCare5,651 +19.2 1,219 +14.8 lion following anumber of sizeable deals across itsbusinesses –the German firm would “con- Figure1:Breakdown of Bayer HealthCare’s sales and earnings beforeinterest and tax (EBIT) in the third tinue to look at opportunities”toadd to Con- quarter of 2015 (Source –Bayer) sumer Care’sportfolio, Dekkers promised. Care business to C1.42 billion in the third quar- Care’sthird-quarter sales (see Figure 2). Consumer Care wasapriority for Bayer terof2015 (see Figure 1), as the German firm In terms of Bayer’sestablished OTCbrands, when it came to reviewing opportunities, Dek- continued to feel the impact of acquiring Merck the Canesten thrush treatment had been Con- kers revealed, along with the company’sCrop- &Co’sConsumer Care business late last year sumer Care’sbest performer in the period, with Science and Pharmaceuticals businesses. (OTC bulletin,10October 2014, page 1). salesrising by 7.5% –19.5% adjusted for cur- Noting that the group had been “quite act- Brands gained through the Merck buy–in- rencyeffects –toC72 million, the firm said, ive” on the acquisitions front overthe past num- cluding Claritin, Coppertone, Dr Scholl’sand drivenbygains in emerging markets. ber of years, Dekkers insisted that Bayer’s“focus MiraLAX –had contributed C366 million to The Bepanthen/Bepanthol skin-care line had on opportunities” to strengthen the portfolio the result, the companynoted. also developed well in the three months, Bayer had “not really changed”. Loratadine-based Claritin is nowBayer’s pointed out, with asolid showing in emerging Dekkers made his comments as Bayer an- joint biggest-selling OTCbrand –along with markets lifting up sales by 4.8% to C88 million. nounced a41.6% rise in sales at its Consumer Aspirin –accounting for 9% of Consumer The Consumer Care business accounted for 66% of turnoveratBayer’sConsumer Health Brand (business unit) Third-quarter sales Change 2014/2015 (%) division in the third quarter,which advanced ( C millions) C CER* by 27.5% to C2.17 billion. Sales movedforward Advantage (Animal Health) 130 +8.3 -1.7 at the slower rate of 2.2% when adjusted for portfolio and currencyeffects. Claritin 124 –– Bayer’stop-10 Consumer Health brands Aspirin** 124 +1.6 -3.2 formed 40% of divisional sales, up by four per- Aleve/naproxen 91 -1.1 -12.9 centage points from the prior-year period. Bepanthen/Bepanthol 88 +4.8 +15.2 North America overtook Europe in the three Ultravist (Medical Care) 78 +6.8 +5.6 months to become Consumer Health’sbiggest Gadovist (Medical Care) 71 +22.4 +18.8 region in terms of sales, reflecting the addition Coppertone 28 ––of the Merck brands. Turnoverinthe region ad- Canesten 72 +7.5 +19.5 vanced by 67.1% –49.4% adjusted for currency Dr Scholl’s55––effects –toC862 million (see Figure 3). Currencyfluctuations left sales in Europe Top-10 total 861 +39.8 +33.8 down by 1.3% to C605 million for the three Consumer Health total 2,169 +27.5 – months. When adjusted for currencyeffects, *CER is constant exchange rates sales in the region edged up by 0.8%. ** Total Aspirin sales –including Aspirin Cardio, which is part of the Pharmaceuticals division –were C 254 million The Merck brands had also contributed to Figure2:Sales of the top-10 best-selling brands in Bayer’s Consumer Health division in the thirdquarter of strong growth in the division’semerging mar- 2015. Brands arepartofthe Consumer Carebusiness unit unless stated (Source –Bayer) kets, the companypointed out, with turnover in the Asia-Pacific region up by 25.7% to C362 Region Third-quarter sales Change 2014/2015 (%) million, and sales in the Latin America/Africa/ ( E millions) C CER* Middle East region moving ahead by 19.7% North America 862 +67.1 +49.4 to C340 million. Europe 605 -1.3 +0.8 After the close of the period, Bayer announc- Asia-Pacific 362 +25.7 +20.8 ed plans to transfer Consumer Care into anewly- Latin America/Africa/Middle East 340 +19.7 +31.7 created Consumer Health division on 1January, Consumer Health total 2,169 +27.5 – as part of amajor reorganisation at the firm following the spin-offofits MaterialScience *CER is constant exchange rates unit (OTC bulletin,9October 2015, page 5). Figure3:Breakdown of Bayer Consumer Health’s sales in the thirdquarter of 2015 by region (Source –Bayer) OTC

6November 2015 OTC bulletin 5 OTC06-11-15p2-12_Layout 1 03/11/2015 16:38 Page 6

OTC COMPANY NEWS

BusinessStrategy/Third-QuarterResults Perrigoseeking bolt-on deals for Omega

errigo is on the look out for “bolt-on” ac- Business Third-quarter Change Operating income Change Pquisitions to expand the reach of its Omega sales (US$ millions) (%) (US$ millions) (%) Pharma business in Europe, according to the US store-brand specialist’schairman and chief ex- Consumer Healthcare 675 +5 139 +48 ecutive officer Joseph Papa. Branded Consumer Healthcare 302 –44– Speaking as Perrigo announced the results Prescription Pharmaceuticals 260 +34 110 +34 of its third quarter ended 26 September 2015, Specialty Sciences/Other 107 –66– Papa said the firm wasworking to identify Total Perrigo 1,345 +41 359 +45 “additional products, in additional categories” that it could bolt on to the Omega business. Figure1:Perrigo’s sales and operating income in the three months ended 26 September 2015 (Source –Perrigo) “Wedobelieve that there are opportunities “continue to look at” potential deals. turnoverby5%, Brown reported. to bolt on additional products and [to identify] “Since April we have looked at anumber of Sales at Consumer Healthcare had improv- additional geographies to sell our products,” transactions,”Papa revealed, “and we are inter- ed to US$675 million, she noted, with existing Papa insisted. ested in ophthalmics, adult nutrition, the dia- products adding US$49 million to the quarter- Acquiring brands and expanding into new betic area and pet care.” ly total and newproducts contributing afurther markets would help Perrigo to “drive signifi- Turning to Perrigo’sthird-quarter results, US$65 million. cantly” the growth of Omega,heargued. chief financial officer Judy Brown said that Growth of Consumer Healthcare had been sales at the newly-formed Branded Consumer held back by the loss of US$52 million in sales Tremendous bottom-line growth Healthcare division –which consists of the from discontinued products,Brown pointed “Couple that with our ability to reduce the Omega business and the basket of brands the out, while sales of certain existing products – cost of goods sold for Omega by bringing more firm recently acquired from GlaxoSmithKline mainly analgesics, animal health and diabetes products into our manufacturing plants”, con- (GSK) (OTC bulletin,12June 2015, page 1) – lines –had dropped by US$27 million. tinued Papa, “we think that we can drive tre- hadreached US$302 million (C274 million) in Negative currencyeffects had wiped another mendous bottom line [growth] for Omega.” the period (see Figure 1). US$14 million offthe total. Commenting on Perrigo’sapproach to acqui- This had been driven, Brown said, by a6% Perrigo’sBranded Consumer Healthcare sitions generally,Papa said the firm waslooking increase in sales of Omega’s top-20 brands and and Consumer Healthcare divisions accounted for deals that were “strategic, accretive to earn- an additional US$30 million in turnoverfrom for 73% of the company’stotal third-quarter ings” and delivered agood return on investment. the ex-GSK brands. sales, which advanced by 41% to US$1.35 bil- Despite Perrigo’sdecision to sell its US vita- Better sales of cough and cold products, gas- lion. The remainderwas generated by the firm’s mins, minerals and supplements (VMS) business trointestinal treatments and infant formula had Prescription Pharmaceuticals and Specialty (see front cover), Papa said the companywould helped to lift store-brand Consumer Healthcare Sciences divisions, plus ‘other’ sales. OTC

Nine-MonthResults ing deal with Seoul Milk (OTC bulletin,23 October 2015, page 8). US deliveries boost turnover at Probi Under the terms of the agreement, Probi said its Lactobacillus plantarum 299v probiotic xtensive”deliveries of probiotics to its that the product wasnow available to US con- strain would be included in Seoul Milk’sprod- “Epartners in the US helped to more than sumers under NBTY’sNature’sBounty brand. uct range by the end of the year. double Probi’sConsumer Healthcaresales in Consumer Healthcare’ssales had also been Noting that Seoul Milk wasthe largest sup- the opening nine months of 2015, according boosted by consignments shipped to Pharma- plier of milk products in Korea, Probi pointed to chief executive officer Peter Nählstedt. vite,Nählstedt noted, for use in the company’s outthat the firm’sportfolio also included fruit Turnoveratthe Swedish firm’sConsumer newrange of “probiotic plus vitamins and min- juices and “other types of beverages”. Healthcare operation had reached SEK152 mil- erals” products. lion(C 16.3 million) in the nine months, up from Pharmavite has distributed Probi’sprobi- Looking forwardtolaunch SEK67.6 million in the prior-year period, Nähl- otics in the US under its Nature Made brand Commenting on the deal at the time, Nähl- stedt reported, thanks to large orders of probi- since 2012 (OTC bulletin,14September 2011, stedt said the firm was“looking forward to oticsfrom natural products retailer NBTY and page 11). the first launch of afood product containing dietary supplementsmanufacturer Pharmavite. The rise in Consumer Healthcare sales help- Probi’sprobiotics in the important and grow- NBTY had been stocking up with Probi’s ed to lift Probi’stotal group turnoverby89% ing Asia region”. probiotics during the period, he explained, for to SEK180 million. The Functional Foods divi- “Weare increasing our business develop- useinarecently-launched newformulation of sion reported sales down by 1% to SEK27.5 ment activities in functional food,”Nählstedt its Probiotic 10 product. million in the three months. explained, “and Asia-Pacific, with its high con- Noting that Probiotic 10 nowincluded for Following the close of the period, Probi re- sumer acceptance for probiotics, is avery in- thefirst time Probi’sprobiotic strains for diges- vealed that it wasset to growthe reach of its teresting area for expansion.” tive and immune health, Nählstedt pointed out probiotics in South Korea, after signing alicens- OTC

6 OTC bulletin 6November 2015 OTC06-11-15p2-12_Layout 1 03/11/2015 16:38 Page 7

COMPANY NEWS OTC

BusinessStrategy/Third-QuarterResults Reckitt sees potentialinLatin America

eckitt Benckiser’s(RB’s) consumer health- Business Third-quarter sales Change 2014/2015 (%) Proportion Rcare business in Latin America will be (£ millions) £CER* of total (%) much more “fruitful” for the companyfrom next year,according to chief executive officer Hygiene 865 -3 +4 39 Rakesh Kapoor. Health 739 +6 +14 34 Noting that the firm had recently exercised Home 444 -5 +5 20 its option to buyoutright abasket of Bristol- Portfolio Brands/Food 147 -6 +5 7 Myers Squibb’sOTC brands in the region – Total Reckitt Benckiser 2,195 -1 +7 100 to which the companygained the marketing rights in 2013 (OTC bulletin,22February *CER is constant exchange rates 2013, page 1) –Kapoor said RB wasanticipat- Figure1:Reckitt Benckiser’s sales in the thirdquarter of 2015 by business (Source –Reckitt Benckiser) ingtaking full control of the portfolio in May 2016, subject to antitrust approvals. Activinsoles, and the successful launch of the On aregional basis, overall group sales in Kapoor revealed that RB had also exercised Velvet Smooth Electronic Nail Care System in Europe and North America (ENA) –which also aseparate option to acquire from Bristol-Myers the US and anumber of European countries. includes Australia/NewZealand, along with Squibb the Mexican plant that currentlymanu- Noting that the Velvet Smooth Electronic Russia and the Commonwealth of Independent factured the brands. Nail Care System had enjoyed “encouraging States (CIS) –fell back by 1% to £1.47 billion The combination of OTCbrands and manu- early results”, Kapoor revealed that RB had due to negative currencyeffects (see Figure 2). facturing site would “prove to be amuch more “only just recently cracked the code of howto Commenting on the regional performance, fruitful combination” when RB took “full own- innovate and expand the Scholl brand”. RB said ENAhad been boosted by innovations ership”, Kapoor insisted. “We’ve made material progress overthe last behind certain healthcarebrands, including RB paid US$438 million (C397 million) to fewyears with Scholl,”Kapoor insisted, adding Scholl/Amopé and Strepsils. license the brands, which generated combined that RB had “only just started” to exploit the Furthermore, the firm had benefitted from an sales of US$102 million in 2012. The portfolio brand’spotential, despite the companyhaving “improveddistribution model” for its healthcare includes the Graneodin cough and cold medi- owned the rights to Scholl since acquiring SSL brands in Russia, RB noted, which had helped cine, Micostatinantifungal, Picot antacid line International in 2010 (OTC bulletin,30July to lift sales in the country.However,despite the and Tempra analgesics range. 2010, page 1). better performance in Russia, RB warned that Kapoor made his comments on Latin Amer- “This is avery different looking brand in the outlook for the country remained “uncer- ica as RB posted sales down by 1% to £2.12 RB’shands compared to what it wasbefore,” tain” due to the “current market conditions”. billion (C2.95 billion) in the third quarter.Ex- Kapoor claimed. RB’sDeveloping Markets, or DvM, report- cluding negative currencyeffects, turnoverwas Meanwhile, RB said Nurofen and Strepsils ing region –consisting of the Middle East, said to have improvedby7%. hadbeen stand-out performers during the three North Africa and Turkey,Sub-Saharan Africa, Sales in the firm’sHealth category advanced months. Nurofen had been boosted by an “im- and Latin America, as well as North Asia and by 6% –14% at constant exchange rates –to provedgo-to-marketmodel in Russia”, the South and South-East Asia –also posted sales £739 million (see Figure 1). firm explained, while Strepsilshad benefitted down by 1% to £645 million due to negative “Broad-based growth” across its Health from the launch of the Strefen Direct Spray. currencyeffects. ‘power brands’ –including Nurofen, Scholl/ RB’sHealth business accounted for 34% of RB pointed out that while the company’s Amopé and Strepsils –had driventhe increase the company’stotal third-quarter sales, while sales in China had continued to improve,the in sales at the unit, RB said. the firm’sHygiene operation generated 39% competitive environment in Brazil, and in a Scholl/Amopé had produced a“good per- and its Home category 20%. The remainder number of markets across Africa and South- formance”, RB pointed out, with better sales of came from the company’sPortfolio Brands and East Asia, remained challenging. both the Velvet Smooth Express Pedi and Gel- Food products. OTC

Region Third-quarter sales Change 2014/2015 (%) Proportion IN BRIEF (£ millions) £CER* of total (%) Europe and North America** 1,474 -1 +6 67 ■ WEIFA reported Consumer Health sales flat at NOK77 million ( C 8.2 million) in the Developing Markets*** 645 -1 +10 29 third quarter of 2015, with growth held back by Food**** 76 +10 +3 4 a“slight decline” in turnoverfrom its “major” Total Reckitt Benckiser 2,195 -1 +7 100 analgesic brands Ibux and Paracet. Lower sales *CER is constant exchange rates of analgesics had been compounded by adouble- ** Europe and North America region also includes Australia/NewZealand, along with Russia and the Commonwealth of digit drop in turnoverfrom nutraceuticals, the Independent States (CIS) *** Developing Markets region consists of the Middle East, North Africa and Turkey,Sub-Saharan Africa, and Latin Norwegian firm noted. On amore positive note, America, as well as North Asia and South and South-East Asia Weifasaid that its cough and cold brands had **** Food is not reported as part of anyregion shown “good progress” in the three months. Figure2:Reckitt Benckiser’s sales in the thirdquarter of 2015 by region (Source –Reckitt Benckiser) OTC

6November 2015 OTC bulletin 7 OTC06-11-15p2-12_Layout 1 03/11/2015 16:38 Page 8

OTC COMPANY NEWS

Third-QuarterResults Key brandsdrive up turnover at Sanofi

anofireported third-quarter sales at its Con- Region Third-quarter Change (%) Proportion Ssumer Healthcare unit up by 3.2% at con- sales (C millions) CER* of sales (%) stant exchange rates to C814 million, thanks to Emerging Markets 393 +2.0 48 the growth of keybrands. The fexofenadine-based brand Allegra re- US 209 +10.8 26 mained the best-selling of Sanofi’sConsumer Western Europe 146 -7.6 18 Healthcare brands in the three months (see Fig- Rest of World 66 +20.7 8 ure 1), with Dorflexand Lactacyd also singled Total Consumer Healthcare814 +3.2 100

out by the French firm as important contributors *CER is constant exchange rates to the unit’sgrowth. Sales of Allegra advanced at adouble-digit Figure2:Sanofi’s Consumer Healthcaresales in the thirdquarter of 2015 broken down by region (Source –Sanofi) rate in the third quarter,moving forward by bursable range of self-medicationtreatments Sanofiexplained. Growth in Emerging Mar- 11.5% to C91 million. (OTC bulletin,23October 2015, page 18). kets had been held back, the firm added, by a While Allegra remained Consumer Health- The non-reimbursable line would “comple- weaker performance in China. care’sbiggest product, the painkiller Dorflex ment the existing reimbursable range”, Sanofi Sales in Western Europe had slipped back posted the biggest gains, with turnoverjumping noted, adding that the reimbursable Doliprane by 7.6% to C146 million, Sanofipointed out, by 55.6% to C21 million. line wasmore geared towards sufferers of chron- due to the drop in turnoverfrom Doliprane. Lactacyd also enjoyed double-digit growth ic pain requiring long-term treatment. Turnoverinthe US had advanced by 10.8% in the third quarter,with sales of the feminine Meanwhile, Sanofi’s10top-selling Consum- to C209 million, while sales in the Rest of World hygiene line climbing by 37.5% to C26 million. er Healthcare brands had total sales of C373 region had risen by 20.7% to C66 million in the Despite better performances from anumber million in the third quarter,just under half of three months, Sanofinoted, reflecting a“good of keybrands, growth of Consumer Healthcare the division’stotal. performance” in Australia. in the third quarter had been held back by Doli- On aregional basis, 48% of Consumer Consumer Healthcareaccounted for 8% of prane, Sanofinoted. Healthcare’ssales were generated in Emerging the French firm’stotal third-quarter sales, which Sales of the analgesic had slipped back by Markets, where turnovermovedforward by improvedby3.4% at constant exchange rates 12.2% to C65 million, the firm pointed out, after 2.0% in constant currencies to C393 million to C9.60 billion. aprice decrease in France in January. (see Figure 2). During the period, Sanofiannounced that Following the close of the period, Sanofi “A lowbasis for comparison in Brazil” had it wasset to transfer Consumer Healthcare into launched Doliprane in France as anon-reim- been behind the rise in turnoverinthe region, anewly-created global business unit on 1Jan- uary,aspart of ashake-up instigated by the Business Third-quarter sales Change (%) Proportion firm’schief executive officer Olivier Brandi- (C millions) CER* of sales (%) court (OTC bulletin,24July 2015, page 2). Allegra91+11.5 1 The General Medicines and Emerging Mar- Doliprane 65 -12.2 >1 kets global business unit will house Consumer Essentiale 46 -1.9 >1 Healthcare, alongside the firm’sEstablished Enterogermina 33 -25.0 >1 Products and Generics operations. “All pharma- Nasacort 27 +4.3 >1 ceutical businesses in Emerging Markets” will Lactacyd 26 +37.5 >1 also be in the newunit. No Spa 22 -12.9 >1 General Medicines and Emerging Markets Maalox 21 +8.7 >1 is to be led by executive committee member Dorflex21+55.6 >1 Peter Guenter,who has for the past twoyears Magne B6 21 ±0.0 >1 served as Sanofi’svice-president of global com- Other Consumer Healthcarebrands 441 +5.0 5 mercial operations. Consumer Healthcare 814 +3.2 8 Four other global business units will also Generics 452 +6.7 5 be created: SanofiGenzyme, headed by David Meeker,which will cover‘speciality care’; Genzyme 923 +32.7 10 SanofiPasteur for vaccines, which will continue Diabetes 1,852 -6.6 19 to be led by Olivier Charmeil; Merial animal Oncology/Other Pharmaceutical 3,222 –34health, which will retain its current chief Carsten Pharmaceuticals 7,267 +2.6 76 Hellmann; and aDiabetes and Cardiovascular Vaccines 1,717 +5.5 18 unit led by Pascale Witz. Animal Health 607 +9.3 6 “Thenew organisation simplifies and focuses Total Sanofi9,591 +3.4 100 Sanofitooptimise growth,”said Brandicourt, who took on the role of chief executive in April *CER is constant exchange rates (OTC bulletin,6March 2015, page 23). Figure1:Sanofi’s sales in the thirdquarter of 2015 broken down by business (Source –Sanofi) OTC

8 OTC bulletin 6November 2015 OTC06-11-15p2-12_Layout 1 03/11/2015 16:38 Page 9

COMPANY NEWS OTC

BusinessStrategy DistributionAgreements/Nine-MonthResults Phynova secures BioGaia signs up Axero £5mn of capital as distributor in Sri Lanka atural healthcare products firm Phynova Nhas secured £5.0 million (C7.0 million) ioGaia’sprobiotics will soon be available in Brazil and Italy,had helped to drive up turn- of investment from China’sXiangxue Pharma- Bin Sri Lanka, after the Swedish firm signed overatthe Paediatrics unit by 51% to SEK313 ceuticals to help it launch further traditional adistribution agreement with Axero Associates. million, the companysaid. Chinese medicines (TCMs) onto the European Under the terms of the deal, BioGaia said However, growth had been held back some- OTCmarket. Axero would launch its ProTectis drops and tab- what by falling sales in Ukraine, BioGaia point- Describing Xiangxue as a“leader in the lets –containing the probiotic Lactobacillus ed out, due to “current instability in the country”. modernisation of TCM”, Phynova pointed out reuteri –inSri Lanka during “early 2016”. Ax- Turning to its Adult Health business, BioGaia that it had previously collaborated with the ero would then introduce at alater date Bio- reported sales up by 18% to SEK54.6million. Chinese companyonanumber of projects. Gaia’sProDentis oral-health lozenges and Gas- Better sales of digestive-health tablets in TheUK-based firm said the investment from trus stomach-health tablets, the firm added. Europe –mainly in Italy and Finland –had Xiangxue would provide it with “further cap- Describing Axero as a“reputable local part- been behind the rise, the companyrevealed. ital to introduce awider variety of TCM-deriv- ner”, Peter Rothschild, BioGaia’spresident, said Sales of oral-health tablets had also moved ed healthcare products into European markets”. the firm washopeful for the “successful launch” forward, BioGaia noted, attributing the improve- Together,Phynova and Xiangxue planned of its probiotics on the Sri Lankan market. ment to better performances in both Asia and to “makemore TCMs available” on the global The agreement wasannounced shortly after Western Europe. OTCmarket, which wasestimated to be worth BioGaia reported sales up by 43% to SEK379 Following the close of the period, BioGaia around US$106 billion (C95.8 billion) by 2017, million (C40.4 million) in the opening nine announced that it had appointed Axel Sjöblad the companyclaimed. months of 2015, as turnoveratboth its Pae- as its managing director.Hehas replaced Roths- In addition,the financial support from Xiang- diatrics and Adult Health businesses advanced child, who has been promoted to group pres- xue would allowPhynova to “extend” its re- at adouble-digit rate. ident (OTC bulletin,23October 2015, page 23). search and development activities, the firm said, Higher sales of probiotic drops, primarily OTC “in the use of active compounds found in plants”. Commenting on the investment, Phynova’s chairman, Robert Miller,said he was“delight- ed” to have secured Xiangxue’sbacking. Claiming that there wasa“significant mar- ketacross the globe for natural, plant-derived healthcareproducts”,Miller noted that the in- vestment would “provide Phynova with the cap- ital it needs to accelerate its growth plans”. Wang Yonghui, Xiangxue’schairman, said the Chinese firm’sinvestment in Phynova would have “considerable strategic merit”. “The investment will strengthen our rela- tionship with Phynova,” Yonghui insisted, “and we see them as imperative to fast tracking the roll-out of TCMs as OTCproducts across West- ern markets, with aparticular focus on Europe.” Working with Xiangxue,Phynova achieved in March the first-everTCM approvalfrom the UK’sMedicines and Healthcare products Reg- ulatory Agency(MHRA), for its Joint and Mus- cle Relief Tablets under the agency’sTradi- tional Herbal Registration scheme. After successfully navigating the MHRA registration process, Miller told OTC bulletin in June that the firm wasplanning further appli- cations and targeting European expansion (OTC bulletin,26June 2015, page 10). Miller said at the time that Phynova had recentlysubmit- ted its second application to the UK regulator for its Isatis Cold and Flu TCM product. OTC

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COMPANY NEWS OTC

BusinessStrategy/Third-QuarterResults Pfizer and Allergan enter merger talks

fizer and Allerganare “in preliminary friend- Business Third-quarter sales Change Proportion Ply discussions”about amerger,although (US$ millions) 2014/2015(%) of sales (%) both sides stressed that no deal had been struck as yet. Ireland-domiciled Allergan–which, like Global Established Pharmaceutical 5,219 -16 43 Pfizer,has aroster of OTCbrands –said it had Global Innovative Pharmaceutical 3,521 +1 29 been “approached by Pfizer”. Global Vaccines 1,629 +43 13 There could be “no certainty” that these dis- Consumer Healthcare817 -1 7 cussions would “lead to atransaction”, Pfizer Global Oncology 786 +43 7 noted, adding that it would not comment on the Global Vaccines, Oncology and 3,231 +29 27 potential terms of such adeal. Consumer Healthcare “Any further announcement will be made Other 116 -4 1 if and when appropriate,”the US-based com- panyexplained. Total Pfizer 12,087-2100 Allergan’sOTC portfolio features the Biso- Figure1:Pfizer’s sales in the thirdquarter of 2015 broken down by business (Source –Pfizer) dolindigestion brand, Decubal dermatology line, Ear-Calm minor ear-infection product and Pin- care’sturnoverhad been “primarily driven” by in the country by 7% to US$442 million. ex analgesic. “increased demand” for Nexium 24HR in the Sales in the US had also been boosted by The firm gained asizeable European OTC US,combined with lower sales in the prior-year Caltrate calcium supplements, Centrum multi- and consumer healthcare business –including period, Pfizer said, when retailers had “reduced vitamins and the Chapstick lip-balm range, the Imigran Recovery migraine treatment, Infa- initial stocking levels” following the product’s Pfizer noted, with all three brands “performing col colic range, Sudocrem dermatology line launch in May 2014 (OTC bulletin,30May well” in the three months. and Veno’scough and cold brand –when it 2014, page 1). In contrast to the growth recorded in the snapped up US-based Forest Laboratoriesfor Indicated for the treatment of frequent heart- US, International Consumer Healthcare turnover US$28billion (C25 billion) last year (OTC bul- burn, Nexium 24HR (20mgesomeprazole) had slipped back by 8% to US$375 million due to letin,25July 2014, page 3). been approvedfor OTCuse by the FDAin negative currencyeffects. Operationally,sales Pfizer revealed it had entered into talks with March. The companypaid AstraZeneca an ini- had improvedby6%, Pfizer pointed out, due Allerganshortly after it reported third-quarter tial US$250 million for the global rights to to growth in both Asia and Latin America. sales at its Consumer Healthcare unit down by non-prescription versions of Nexium in 2012 Consumer Healthcareaccounted for aquar- 1% to US$817 million due to negative currency (OTC bulletin,14September 2012, page 1). terofPfizer’sGlobal Vaccines, Oncology and effects. Operationally,sales advanced by 7%. Higher sales of Nexium 24HR in the US Consumer Healthcaredivision’ssales, which The operational rise in Consumer Health- helped to lift Consumer Healthcare’sturnover movedforward by 29% to US$3.23 billion (see Figure 1). With Pfizer’sdominant Global Established Pharmaceutical unit losing ground, First-QuarterResults Pfizer’stotal group sales slipped back by 2% to US$12.1 billion. P&G posts drop at Personal Health Care During the period, Pfizer announced it had abandoned its attempt to switch Lipitor from rocter &Gamble (P&G) reported sales at letin,24July 2015, page 3). prescription-to-OTC status in the US (OTC P itsPersonal Health Care business –which Having announced last year that it wasto bulletin,14August 2015, page 1). includes its OTCoperations –downby“low “harvest, partner out, discontinue or divest” An “actual use” trial intended to simulate single digits” for the three months ended 30 90 to 100 brands to focus on just 70 to 80 core the OTCuse of Lipitor (atorvastatin calcium) September 2015. brands (OTC bulletin,15August 2014, page 9), 10mg –completed in December 2014 –had The US consumer goods giant noted that P&G said in July that the sell-offwas “essen- failed to meet its primary objectives, Pfizer the fall in turnover–including sales from PGT tially complete” after the companyagreed to said, of “demonstrating patient compliance with Healthcare, the OTCjoint venture it established offload 43 of its beauty brands to US firm Coty. the direction to check their low-density lipo- with Teva Pharmaceutical Industries in 2011 Meanwhile, sales at P&G’sHealth Care unit protein cholesterol (LDL-C) leveland, after ( OTC bulletin,16November 2011, page 1) – –including Oral Care, Pet Care and Personal checking their LDL-C level, takeappropriate had been due to increased “competitiveactivity”. Health Care –slipped back by 11% to US$1.80 action based on their test results”. Growth had also been hit by atough com- billion (C 1.63 billion) in the first-quarter. “Based on dialogue with the US Food and parison with the prior-year quarter,P&G noted, Organically,turnoveratthe Health Care Drug Administration (FDA) and analysis of when sales had been boosted by a“strong” unit had dropped at the slower rate of 1%, this data, the programme wasterminated,”the period of innovation. the companypointed out, as lower volume sales companyexplained. The future of P&G’sconsumer healthcare had been partially offset by “favourable geo- Despite the setback, the firm insisted that brands is nowlooking slightly more secure, graphic mix” and increased pricing in both Per- it “continued to evaluate” anumber of other after the firm indicated during the quarter that sonal Health Care and Oral Care. products as potential switch opportunities. its brand cull was“essentially” over(OTC bul- OTC OTC

6November 2015 OTC bulletin 11 OTC06-11-15p2-12_Layout 1 03/11/2015 16:38 Page 12

OTC COMPANY NEWS

Mergers&Acquisitions/Annual Results ing WBA’sfinancial year,Pessina revealed, with 75 of those outlets shut down in the fourth quarter alone. Meanwhile, WBAreported sales of US$8.8 billion at its Retail PharmacyInternational division –consisting of health and beauty chains expandswith Rite Aid buy in eight countries, the largest of which is Boots UK –after eight months of operation. ■ Continued from front page page 5), Pessina said he was“pleased” with the Sales at the unit had been drivenbya“good base for sustainable growth and investment progress already made. performance” from Boots UK in both the into Rite Aid stores, while realising synergies Turnoveratthe company’sRetail beauty category and the boots.com online busi- overtime,”heclaimed. USA division –which comprises Walgreens ness, WBAnoted. “WBAwill provide to Rite Aid its global and drugstores as well as US on- The No7 beauty brand in particular had expertise and resources to accelerate the de- linesales –advanced by 6.0% to US$81.0 bil- performed well, WBAsaid, enjoying “strong” livery of integrated frontline care,”Pessina lion in the 12 months. growth in the period. noted, “and to offer innovative solutions for Prescription sales, which accounted for The increase reported by Boots UK had providers, payers and other entities in the US 66.1% of the total, had increased by 8.2%, beencomplementedbyhigher sales at WBA’s healthcare system.” WBAnoted, while prescription sales in com- Mexican pharmacychain, , John Standley, Rite Aid’schairman and parable stores had improvedby9.3%. the companyadded. chief executive officer,said “joining” with WBA The division’soperating income movedfor- Alliance Boots snapped up Farmacias Bena- would “enhance” the firm’sability to “meet the ward by 4.8% to US$5.1 billion in the period. vides, along with Chilean pharmacychain Far- health and wellness needs” of its customers. As of 31 August 2015, Retail Pharmacy macias Ahumada, from Mexican wholesaler “This transaction is atestament to the hard USA wasoperating 8,173 drugstores across all andretailer Grupo Casa Saba for MXN8.3 bil- work of all our associates to deliverahigher 50 US states, the District of Columbia, Puerto lion (C488 million) last year (OTC bulletin, levelofcare to the patients and communities Rico and the US Virgin Islands. 12 September 2014, page 8). we serve,”Standleyinsisted. At the time of the deal, Alliance Boots noted “Together with WBA,”continued Standley, Cost-cutting to save US$500 million that as the third-largest retail pharmacychain “the Rite Aid team can continue to build upon Pessina pointed out that the companywas in Mexico, Farmacias Benavides operated about this great work through access to increased progressing with its cost-reduction initiative 1,000 stores across 21 of the country’s31states. capital that will enhance our store base and forthe Retail PharmacyUSA division that was Farmacias Ahumada wasone of the three expand opportunitiesaspart of the first global expected to save US$500 million by the end of biggest pharmacychains in Chile, the com- pharmacy-led, health and wellbeing enterprise.” WBA’s2017 financial year. panysaid, with approximately 400 stores. WBAannounced its acquisition of Rite Aid As part of this cost-cutting plan, WBAan- Boosted by better sales in Mexico and the as it reported sales up by 35.4% to US$103 nounced in April that the firm planned to close UK, Retail PharmacyInternationalposted an billion in its financial year ended 31 August 200 drugstores in the US (OTC bulletin,17 operating income of US$616 million for the 2015, after eliminations of US$1.64 billion. April 2015, page 4). eight-month period. While the firm still had “much work to do” These would be replaced by “around 200” As of 31 August 2015, the division wasop- in integrating the Alliance Boots and Walgreens newstores in locations where there were more erating 4,582 health and beauty stores across businesses, following the completion of their opportunities for growth, WBAnoted. Chile, Ireland, Lithuania, Mexico, the Nether- merger deal (OTC bulletin,17April 2015, Atotal of 84 stores had been closed dur- lands, Norway,Thailand and the UK. Meanwhile, WBA’sPharmaceutical Whole- sale unit –which mainly operates under the Al- BusinessStrategy liance Healthcare brand –generated sales of US$15.3 billion after eight months of operation. Elder committed to paying offdebts The division reported an operating income of US$450 million in the period. ndia’sElder Pharmaceuticals has insisted claimed it wasnow “on the path to recovery”, WBApointed out that the Pharmaceutical Iit remains “committed” to repaying all of its adding that it had a“substantial asset base to Wholesale division supplied medicines, other creditors by raising funds through a“combi- coverall of its liabilities”. healthcare products and services to more than nation of debt, equity and asset sales”. “Raising funds is atime-consuming process 200,000 , doctors, health centres Elder admitted at the start of September and cannot be done overnight,”Elder noted, andhospitals from over350 distribution cen- that it wasfacing a“severe financial crunch”, “as the due diligence required by lenders/in- tres located in 19 countries. which had led to manyofits senior staffresign- vestors takes up to manymonths at times.” Turning to group-wide synergies, Pessina ing and adelay in filing its end of year accounts. “The companyhas not been able to sell off said combined synergies from the merger had Last month, the firm said it wasconsidering itsnon-core assets quickly or at the price want- totalled US$799 million in the 12 months end- selling its overseas subsidiaries –which in- ed,”the firm pointed out, “but efforts continue ed 31 August 2015. He pointed out that the clude anumber of consumer healthcare assets – to realise the best value for these assets.” companywas targeting synergies of “at least” to help it secure newfinancing (OTC bulletin, “The firm remains committed to doing its US$1.0 billion by 31 August 2016. 9October 2015, page 4). best to repay all the liabilities and to turn WBA’stotal operating income for the period Noting that the companyhad been “going around the business,”Elder insisted. amounted to US$6.16 billion after eliminations. through atough cash flowsituation”, Elder OTC OTC

12 OTC bulletin 6November 2015 OTC06-11-15p13-17_Layout 1 03/11/2015 17:26 Page 2

GENERAL NEWS OTC

Market Research US adults trying new supplementtypes

he popularity of herbal and botanical-based 2015 2014 Tsupplements, and those used to manage sporting performance and weight, has increas- Vitamins and 98% minerals 97% ed by 5% or more in the past 12 months, ac- cording to asurvey of 2,016 US adults by the Speciality 45% supplements 43% US Council for Responsible Nutrition (CRN). While consumption of speciality supplements Herbals and 31% botanicals 26% and vitamins and minerals by US supplement users had remained steady between August Sports nutrition and 25% weight management 19% 2014 and August 2015, the CRN survey found, consumption of herbals and botanicals had risen 020406080100 Response (%) from 26% to 31% and consumption of sports- nutrition and weight-management products had Figure1:Changes in consumption of different supplement categories by US adult users (Source –CRN) grown from 19% to 25% (see Figure 1). Green tea wasnamed as the most popular Green tea 12% Protein 14% herbal and botanical supplement, with 12% of those that took such supplements using it. Cran- Cranberry 8% Energy drinks/gels 8% berry –often used for treating and managing urinary tract infections –was second most pop- Garlic, ginseng 6% Hydration drinks/gels 5% Garcinia cambogia, ular on 8% (see Figure 2). Echinacea, green coffee, amino ginkgo biloba, 5% 4% In the sports-nutrition and weight-manage- acids, recovery turmeric ment category,protein wasbyfar the most pop- drinks/powders ular option, with 14% of such consumers using Milk thistle 4% Creatine 3% protein-basedproducts such bars, powders and 02468101214 0481216 ready-made drinks (see Figure 3). Response (%) Response (%) Atotal of 68% of all respondents to the sur- vey said theyused supplements. The vast major- Figure2:Top-five herbal and botanical supplements Figure3:Top-five sports-nutrition and weight-manage- ity took some form of vitamin and mineral among US adult users (Source –CRN) ment supplements among US adult users (Source –CRN) supplement, the CRN noted, making it by far the most popular category. Multivitamin 78% Omega 3/fatty acids 19% Mutivitamins remained the most widely-used product in the vitamins and mineralscategory Vitamin D 32% Fibre 13% (see Figure 4), the associationsaid, with 79% of male consumers of the category and 77% of Vitamin C 27% Probiotics 12%

females taking amultivitamin. Melatonin, glucosamine/ Calcium 24% 8% Three nutrients that US government reports chondroitin, CoQ10 hadidentified as “shortfall nutrients” –vitamin Vitamin B/ 18% Digestive enzymes 5% C, vitamin Dand calcium –along with vitamin Bcomplex B/B complexmade up the rest of the top five. 020406080100 01020 Among supplement users that takespecial- Response (%) Response (%) ity supplements, omega 3/fatty acids are the most popular,with fibre and probiotics second Figure4:Top-five vitamin and mineral supplements Figure5:Top-five speciality supplements among US among US adult users (Source –CRN) adult users (Source –CRN) and third respectively (see Figure 5). Turning to the public perception of supple- Female Male ments, the CRN said that its survey showed that Vitamins and 87% consumer confidence in the products remained minerals 82%

high, with “84% of US adults expressing over- Speciality 63% all confidence in the safety,quality and effect- supplements 62% iveness of dietary supplements”. Herbals and 61% Broken down by sex, women had slightly botanicals 58% more confidence in all categories except for Sports nutrition and 44% sports nutrition and weight management (see weight management 52% Figure 6). Less than half –44% –offemales said theytrusted the safety,quality and effective- 020406080100 ness of such products, compared to 52% of men. Response (%) OTC Figure6:Confidence of US adults in four supplement categories by gender (Source –CRN)

6November 2015 OTC bulletin 13 ENTRY DEADLINE The Presented by In association with The deadline for Awards entries is s… 11th December 2015 Makesureyou enter the Awards Get all of your great ideas, hard work and commercial success that Really Matter recognised by entering the OTC Marketing Awards 2016. The OTC Marketing Awards 2016: Gala Dinner & Awards Presentation Park Lane Hotel, Piccadilly, London, Th ursday, 10th March 2016 Companies of all sizes – from ◆ OTC Company of the Year Sponsored by IRI the smallest to the very largest – ◆ OTC Brand of the Year have the opportunity to win one ◆ OTC Launch of the Year ◆ OTC Brand Revitalisation of the Year of OTC bulletin’s prestigious OTC Supported by PAGB Marketing Awards 2016, recognising ◆ Most Innovative New OTC Product ◆ Best OTC Marketing Campaign on a Big Budget the best of the British OTC industry. Sponsored by Skills in Healthcare It’s now time to start preparing your entries. ◆ Best OTC Marketing Campaign on a Small Budget ◆ Best OTC Consumer Advertising on Television The entry deadline of 11th December 2015 ◆ Best OTC Consumer Advertising in the Press or Out-of-Home may seem a long way ahead, but you Sponsored by NetDoctor ◆ Best OTC Campaign in Digital & Social Media need to start turning your latest campaign Sponsored by CIG Healthcare Partnership into a prestigious Award winner. ◆ Best OTC Public Relations Campaign for a Medicine ◆ Best OTC Public Relations Campaign for a Non-Medicine The winners will be announced at a Gala ◆ Best New OTC Packaging Design Dinner & Awards Presentation on Thursday, ◆ Best OTC Trade Advertising & Support Package Sponsored by Pharmacy Magazine 10th March 2016 at London’s Park Lane Hotel. ◆ Best OTC Pharmacy Training Sponsorship packages are available that offer Sponsored by Powermed Plus ◆ Best OTC Pharmacy Salesforce companies a unique opportunity to highlight ◆ Best OTC Performer Outside Pharmacy their commitment to OTC excellence. Sponsored by IRI ◆ Best OTC Multiple Retailer of the Year Sponsored by Bristol Laboratories

Sponsored by Supported by Visit OTC-bulletin.com/Awards Or call Natalie Cornwell on 01564 777550 ENTRY DEADLINE The Presented by In association with The deadline for Awards entries is s… 11th December 2015 Makesureyou enter the Awards Get all of your great ideas, hard work and commercial success that Really Matter recognised by entering the OTC Marketing Awards 2016. The OTC Marketing Awards 2016: Gala Dinner & Awards Presentation Park Lane Hotel, Piccadilly, London, Th ursday, 10th March 2016 Companies of all sizes – from ◆ OTC Company of the Year Sponsored by IRI the smallest to the very largest – ◆ OTC Brand of the Year have the opportunity to win one ◆ OTC Launch of the Year ◆ OTC Brand Revitalisation of the Year of OTC bulletin’s prestigious OTC Supported by PAGB Marketing Awards 2016, recognising ◆ Most Innovative New OTC Product ◆ Best OTC Marketing Campaign on a Big Budget the best of the British OTC industry. Sponsored by Skills in Healthcare It’s now time to start preparing your entries. ◆ Best OTC Marketing Campaign on a Small Budget ◆ Best OTC Consumer Advertising on Television The entry deadline of 11th December 2015 ◆ Best OTC Consumer Advertising in the Press or Out-of-Home may seem a long way ahead, but you Sponsored by NetDoctor ◆ Best OTC Campaign in Digital & Social Media need to start turning your latest campaign Sponsored by CIG Healthcare Partnership into a prestigious Award winner. ◆ Best OTC Public Relations Campaign for a Medicine ◆ Best OTC Public Relations Campaign for a Non-Medicine The winners will be announced at a Gala ◆ Best New OTC Packaging Design Dinner & Awards Presentation on Thursday, ◆ Best OTC Trade Advertising & Support Package Sponsored by Pharmacy Magazine 10th March 2016 at London’s Park Lane Hotel. ◆ Best OTC Pharmacy Training Sponsorship packages are available that offer Sponsored by Powermed Plus ◆ Best OTC Pharmacy Salesforce companies a unique opportunity to highlight ◆ Best OTC Performer Outside Pharmacy their commitment to OTC excellence. Sponsored by IRI ◆ Best OTC Multiple Retailer of the Year Sponsored by Bristol Laboratories

Sponsored by Supported by Visit OTC-bulletin.com/Awards Or call Natalie Cornwell on 01564 777550 OTC06-11-15p13-17_Layout 1 03/11/2015 17:26 Page 3

OTC COMPANY NEWS

Legal Cases Regulatory Af fairs Ansell sues RB EFSAgives green light to over RealFeel lactitol defecation claim nsell HealthcareProducts wants to bar A Reckitt Benckiser’s(RB’s) DurexReal- hen taken at daily doses of 10g, the bulk uct and an improvement in reading ability in Feel condom from the US market overapatent- Wsweetener lactitol can help maintain nor- healthychildren aged three to 13 years. infringement dispute. maldefecation, the European Food Safety Auth- Acause-and-effect relationship could not be US-based Ansell said that it had filed a ority (EFSA) has ruled in its latest opinions. established between Equazen Eye Q–acom- lawsuit in the US against RB for infringing a Responding to an application made by Du- bination of eicosapentaenoic acid (EPA), doc- number of its patents related to its non-latex Pont Nutrition BioSciences through the UK osahexaenoic acid (DHA) and gamma-linolenic Skyn condom line. competent authority,the EFSA panel on Dietetic acid (GLA) at aweight ratio of 9:3:1 –and As part of the lawsuit, Ansell has requested Products, Nutrition and Allergies (NDA) said the claimed effect in the target population. apermanent injunction to stop RB from import- acause-and-effect relationship had been estab- ing, selling and supplying the non-latexReal- lished between lactitol –adisaccharide polyol DRVs for iron and copper Feel condom in the US or offering to sell and consisting of galactose and sorbitol –and the EFSA’s NDApanel has also set Dietary Ref- supply the product in the country.The firm is claimed health benefit in the adult population. erence Values (DRVs) for iron and copper. also seeking “enhanced damages” from RB. The application wasmade under Article 13(5) Formen, Average Requirements (ARs) for Ansell has accused RB of violating three of of EC Regulation 1924/2006and wasbased on ironhavebeen set at 6mg/day,while the Pop- its patents all entitled “Dip-formed Synthetic newly-developed scientific evidence. ulation ReferenceIntake(PRI) is 11mg/day. Polyisoprene LatexArticles with ImprovedIn- Out of 15 human intervention studies identi- These are the same DRVs as for post-meno- traparticle and Interparticle Crosslinks” and all fied as pertinent to the health claim, the NDA pausal women, whereas the AR and PRI for pre- related to its Skyn condom range. panel noted, 12 studies with “various method- menopausal women –aswell as pregnant and Thelawsuit waspart of a“global strategy”, ological limitations” had consistentlyshowed lactating women –is7mg/day and 16mg/day. Ansell said, “to protect its valuable intellectual that consumption of at least 10g aday of lactitol In girls aged 12 to 17, the AR is 7mg and property protecting the non-latexSkyncon- increased stool frequency. the PRI is 13mg. dom product line”. Meanwhile, five studies showed the food soft- In infants aged sevento11months, child- Ayear ago, Ansell filed apatent-infringe- ened stool consistency, and twostudies showed ren aged sevento11years and boys aged 12 to ment lawsuit against RB in Australia for vio- that lactitol increased stool bulk. 17, the AR is 8mg/day,while the PRI is 11mg lating the Australian counterpart patents to the The claimed effect could be achievedatthis daily.Inchildren aged one to six years, the AR US patents protecting the Skyn brand. dosage without inducing diarrhoea,the panel said. is 5mg, and the PRI is 7mg. The Australian litigation, the firm said, was However, the NDArejected DuPont Nutri- Noting that it wasunable to set ARs or PRIs ongoing and had entered the discovery phase. tion’sproposed wording, which stated that the for copper,the NDApanel has proposed Ade- OTC claimed effect was“normal bowel function by quate Intakes (AIs). increasing stool frequency, increasing stool bulk These are 1.6mg/day for men and 1.3mg/day Market Research and moisture, softening stool consistencyand for women. In infants between sevenand 11 reducing transit time”. Instead, the NDAsaid months, the AI is 0.4mg/day,and 0.7mg daily for Dermocosmetics “lactitol can contribute to normal defecation” children aged between one and three years. This reflected the scientific evidence. is upped to 1.0mg aday for those from three to Meanwhile, the panel rejected an application 10 years, and to 1.1mg and 1.3mg/day for girls set for rebound through the UK competent authority by Galeni- and boys aged 10 to 18 years, respectively. trong demographic trends and an increase ca’sVifor Pharma for an Article 14 children’s Forpregnant and lactating women, the AI Sin consumer purchasing power will see sales health claim relating to its Equazen Eye Qprod- for copper has been set at 1.5mg. of dermocosmetics in Poland rebound in 2016, OTC says areport from market researcher PMR. The companypoints out that there has IN BRIEF been a“considerable slowdown” in the market growth rate for dermocosmetics by value in ■ EMA –the European Medicines Agency– more, the arrangement wasexpected to accel- 2015, as growing competition in the space forces and the European Commission have agreed erate access to newand innovative medicines down prices. with the World Health Organization (WHO) in the EU, the agencyclaimed, avoid dupli- However, this growth rate will recoverin to sharecertain non-public information on cation of assessments and improve the auth- 2016 as the macroeconomicsituation in Po- the safety,quality and efficacyofmedicines al- orisation and safety of medicines.Under the land improves, PMR claims, noting that the ready authorised or under reviewinthe Euro- confidentiality arrangements, the organisations category still showed “very good growth pros- pean Union (EU), or pre-qualified or under mayshare information, including post-authori- pects” thanks to agrowing trend towards such reviewbythe WHO. This would strengthen sation pharmacovigilance data and data related products in established western markets and communication between the organisations, the to inspections, manufacturing facilities and the relatively young age of users. EMA said, and makeiteasier and quicker to clinical research activities. OTC takeaction to protect public health. Further- OTC

16 OTC bulletin 6November 2015 OTC06-11-15p13-17_Layout 1 03/11/2015 17:26 Page 4

GENERAL NEWS OTC

Regulatory Af fairs Regulatory Af fairs Isoflavones safe FTCseeks public comment in supplements on e-cigarette market study here is “no indication” that isoflavones at T levels typically found in food supplements he US Federal Trade Commission (FTC) resent the entire industry,the responses given are harmful to post-menopausal women, ac- T is seeking public comment on its proposed should provide “valuable information about a cording to the European Food Safety Auth- study of the electronic cigarette –e-cigarette – reasonable percentageofthe e-cigarette market, ority (EFSA). market in the country. including its major players”, the agencyadded. Following arequest from the German Fed- In a Federal Register notice published on The public has until 28 December to com- eral Institute for Risk Assessment (BfR), the 27 October,the commission said it wanted pub- ment on anumber of topics, including whether EFSA panel on Food Additivesand Nutrient lic input on the proposed study,which would the FTC should seek to collect data according to: Sources added to Food (ANS) investigated a see the watchdog collect information from ap- ■ the various types of productssold and possible association between the intakeofiso- proximately “fivelarge and 10 smaller e-cig- givenawaybyindustry members; flavones from food supplements and harmful arette marketers”. ■ the various flavours and nicotine strengths effects on the mammary gland, uterus and thy- Explaining the rationale behind the study, of those sales and giveaways; roid in peri- and post-menopausal women. the FTC notice said that “giventhe increasing ■ the various sizes and liquid capacities of The assessment included asystematicre- prevalence of e-cigarettes alongside conven- disposable e-cigarettes,cartridges, and e-liquids, viewof43human studies –using doses of iso- tional cigarettes and smokeless tobacco”, the sold and givenaway; and flavones ranging from 30-900mg aday –and agencybelieveditwas “necessary to begin ■ whether the companysells directly to con- 62 animal studies. collecting information from e-cigarette market- sumers or to wholesalers and distributors. EFSA’s ANS panel said the human data did ers about their sales and marketing activities”. Analysts have forecasted that the US e- not showanincreased risk of breast cancer. “The commission intends to publish are- cigarette market will growtoUS$3.5 billion There wasalso no effect on endometrial thick- port with the data it obtains,”the notice add- ( C 3.2 billion) by the end of this year,upfrom ness or histopathological changes in the uterus ed, “and to issue annual information requests US$2.5 billion in 2014. for up to 30 months of supplementation with to the major marketers, in order to track trends More than half of that figure would come 150mg/day of soyisoflavones, it pointed out. overtime.” from sales of ‘vapour tanks’ and custom-built Furthermore, thyroid hormone levels were Information requests would be sent to the e-cigarettes called vapourisers, analysts claimed. not seen to have changed following an intake “ultimate US parent of e-cigarette marketers”, Arecent online survey of 5,679 Americans of isoflavones from food supplements. the FTC pointed out, to ensure that “no rele- by Reuters/Ipsos found that around 10% of the While the ANS panel pointed out that food vant data from affiliated or subsidiary com- US population nowuses aform of e-cigarette, supplements targeted at peri- and post-meno- panies” went unreported. nearly four-times higher than aUSgovernment pausal women typically provided adaily dose While the five large and 10 small industry estimate that 2.6% of adults used such prod- of isoflavones in the range of 35-150mg aday, members the FTC would contact did not rep- ucts in 2013. it said it was“not possible to derive asingle OTC health-based guidance value for the different preparations in post-menopausalwomen”. The doses used in the intervention studies Regulatory Af fairs and their duration could serveasguidance for the intakeoffood supplements, the panel con- UAE registers complementarymedicines cluded, adding that more data should be gener- ated on the doses and duration of consumption. onsumers in the United Arab Emirates formulations,useage, source and targeted patient OTC C(UAE) will soon have access to awhole groups, Al Amiri said. It consolidatedvarious host of newcomplementary medicinesafter quality-control factors into asingle platform IN BRIEF the country’sMinistry of Health granted 90 new efficiently to determine the risk factor of aprod- product registrations. uct and what its classification should be, from ■ MEDLINE INDUSTRIES –aUS-based Dr Amin Hussein Al Amiri, assistant under- low- to high-risk categories. manufacturer and distributor –has issued a secretary for the Ministry of Health’sPublic consumer level recall of one lot of its 500mg Health Policyand Licensing Sector,said the Points-based assessment acetaminophen –paracetamol –tablets in the medicines and nutritional supplements cover- Each risk category washandled differently, US. The affected lot had been mislabelled, ed arange of conditions including diabetes and he added, and apoints-based risk-assessment the companysaid, as acetaminophen 325mg liverconditions. tool wasused to speed up registration. instead of acetaminophen 500mg. If the mis- Commenting on the move,AlAmiri insisted The UAEwas now–incollaboration with labelled product wastaken at the maximum that complementary medicines were an “essen- other Gulf states –looking at aprice-regulation daily dose, or with other medications that con- tial part” of the UAE’shealthcare system and mechanism for complementary medicines, Al tained acetaminophen, there wasadanger of that the regulator had developed an “innovative Amiri noted, buthewarned that finding a“fair livertoxicity or failure, Medline warned. system to measure the risks” of such products. and effective”system would be achallenge. OTC The newsystem took into account product OTC

6November 2015 OTC bulletin 17 Where ideas meet results

Healthcare Communications

spinkhealth.com [email protected] OTC06-11-15p19-22_Layout 1 03/11/2015 17:51 Page 2

MARKETING NEWS OTC

PfizerProductLaunches builds on Robitussin for RobiColdlaunch in UK

fizer Consumer Healthcare is leveraging Pits established Robitussin cough brand to offer UK consumers cold and flu relief with RobiCold Sinus Relief tablets. Pointing out that Robitussin had a“strong heritage in pharmacy” and wasthe “most rec- ommended cough brand among pharmacists”, the firm said its aim wastobuild on the brand’s Amulti-tasking mum is the star of promotional activities “great reputation” and broaden its “care plat- supportingDrKade Pharma’s latest addition to its form” into the cold and flu market. Sanostol multivitamin lineinGermany. Launch trade-press advertising for Sanostol Spezial Apharmacy-only (P) medicine, RobiCold Energie Sticks depicts amother who is seeking to Sinus Relief –which is already available in balance activities such as shopping, jogging and doing markets such as Ireland and the US under the the laundrywith caring for her daughter and her dog. The headline reads “Ich bin, ich kann, ich mache. Advil name –contains 200mg ibuprofen and Und meistens alles gleichzeitig!”, which translatesas 30mg pseudoephedrine hydrochloride per tablet. “I am, Ican, Ido. And usually all at the same time!”. It is indicated for the symptomatic relief of nasal/ Classified as afood supplement and targeted at adults,Sanostol Spezial Energie Sticks aresachets of sinus congestion with headache, feverand pain orodispersible granules that, whentaken without associated with the common cold and flu. water,each provide at least the recommended daily One or twoRobiCold Sinus Relief tablets intake of severalBvitamins, as well as minerals such as calcium, iron and magnesium. should be taken every four-to-six hours by those Dr Kade said mothers who bought Sanostol vitamin agedover12years, Pfizer recommended, up to Trade-press advertising for RobiCold Sinus Relief highlights that the product is “from the experts products for their children and knewthe brand from amaximum dose of six tablets in 24 hours. their own childhood could now turntothe brand to behind Robitussin” helpthem cope with their many duties. RobiCold Sinus Relief complemented the Apack of 20 peach and passion fruit-flavoured Robitussin range of syrups, the firm pointed vertisements for Robitussin and RobiCold Sinus one-a-day sachets, available exclusively from out, which comprises an option for chesty cough Relief. These showthe newproduct in front pharmacies, has arecommended retail price of C12.95. with guaifenesin, avariant for mucus cough of the Robitussin syrups, and highlight that it OTC and congestion relief containing guaifenesin is “from the experts behind Robitussin”. and pseudoephedrine, and adextromethorphan- Meanwhile, pharmacypoint-of-sale mate- based product for dry cough. rials for RobiCold Sinus Relief featured the The product’slaunch wasbeing supported product-specific tagline “Powerful, effective with a“dedicated marketing programme aim- cold and flu relief”, Pfizer pointed out. ed at pharmacists and pharmacystaff”, Pfizer RobiCold Sinus Relief has arecommended noted, which included combined trade-press ad- retail price of £4.99 (C6.90) for 20 tablets. OTC

Cinfa has added arange of products for oily,acne-prone skintothe Be+ ‘dermopharmacy’ brand in Spain. Line Extensions Comprisingcleansing gels, scrubs and masks –along with toning lotions, moisturisers, and skin- Nicotinell tacklesweight-gain worries regulating cosmetics –the Be+ Piel Grasa Tendencia Acneica line grows the Be+ brand, which was launched by the Spanishfirmfive years ago (OTC bulletin,26 omenwho fear that quitting smoking weight? Ileave that concern behind me!”. February2010, page 15). Wwill lead to them putting on weight are Around half of female smokers who wanted The linealso includes sunscreens, paediatric skin- careproducts, hair supplements and dryskin offerings. the target group for the spearmint-flavoured to quit were worried about their weight, the Cinfa pointedout that the Be+ Piel Grasa Nicotinell nicotine chewinggum that Glaxo- companynoted. Tendencia Acneica range contained the exclusive Skin SmithKline (GSK)Consumer Healthcare has “The newlight and fresh pack design, the Barrier Protection ingredient. Each of the nine variants wereformulated with different “specific cosmetic justintroduced in Germany. fresh spearmint flavour and accompanying com- ingredients”, the company added, to improve skin Launch trade-press advertising depicts that munications appeal mainly to women,”GSK health in cases of mild, moderate and severeacne, weight-gain can be reduced by smoking-cessa- pointed out. reducing the condition by 60% and “promoting up to three-times-faster skinrecovery”. tion. It shows aslim young woman in ablue Nicotinell Spearmint 2mg gum in The other cosmetic ingredients include zinc dress standing in front of afatter shadowofa German pharmacies at C10.05 for 24 pieces sulphate, retinyl palmitate, aloe vera and bisabolol, woman eating chocolate and potato crisps. and C31.39 for apack of 96. The line extension as wellasthe Sebaryl complex –owned by Cognis France –toprovide “comfort, hydration and to Aheadline reads “Rauchen aufhören und joins cool mint and tropical fruit-flavoured decrease the production of sebum”. viel zunehmen? Diese Sorge lass ich hinter gums, as well as nicotine lozenges and patches. OTC mir!”, or “Stop smoking and put on alot of OTC

6November 2015 OTC bulletin 19 OTC06-11-15p19-22_Layout 1 04/11/2015 09:36 Page 3

OTC MARKETING NEWS

BayeAdvertisingComplaintsrloses NARB appeal for its US Claritin-D claims

he US National Advertising ReviewBoard for Claritin-D, the panel concluded, and the T(NARB) has rejected Bayer’sappeal against NAD’soriginal ruling wasvalid. “Applies like adrop, but relieves like agel” is the aruling that it must discontinue claims that Meanwhile, the board also upheld an appeal claim made to US consumers by Allergan for its Refresh Optive Gel Drops for dryeyes. no other allergy product “works faster” than by Chattem overadecision in favour of Bayer Formulated with glycerin and a“unique blend of its Claritin-D brand. made by the NADinthe same case. the active ingredient CMC (carboxymethylcellulose)”, Bayer wasunhappywith an earlier decision Thewatchdog had originally ruled that Bayer the Gel Drops aresaid to provide a“moreviscous artificial tear option” for consumers to relieve their by the National Advertising Division (NAD) had provided areasonable basis for its claim dryeye symptoms “day or night”. that the firm had not provided areasonable that Claritin-D “starts to work on allergies in The aqueous Gel Drops had a“shear-thinning basis to support the claim for the loratadine-and 30 minutes”. effect” that spread “quickly and evenly over the eye surface”, Allergan explained, as well as creating a pseudoephedrine-based Claritin-D (OTC bul- However, after reviewing asupporting study “soothing shield to protect the eye surface from letin,1May 2015, page 16). provided by Bayer,the NARB said that al- hypertonic stress”. An investigation into the claim wasinitially though the study was“reliable and well-con- Adding the Gel Drops to its Refresh Optive line – which includes the original lubricating eye drops, as launched following acomplaint from Chattem, ducted”, there was“variability” in the findings well as Advanced and Tears variants –meant that Sanofi’sUSsubsidiary,which owns the fexo- “with respect to the effectiveness of Claritin- consumers now had an “even morecomprehensive fenadine-based Allegra brand and Nasacort Al- Datstudy sites with higher levels of pollen”. line of artificial tear types”, the firmpointed out. Allergan also offers under the Refresh Optive lergy 24HR (triamcinolone) nasal spray. As this evidence wasthe “sole support re- brand aLiquigel product, which is only formulated Refusing the appeal, the NARB panel noted lied on by Bayer” for the 30-minute onset of with CMC, as well as aLacri-Lube option specifically that although Bayer had submitted multiple tests action claim, the NARB panel concluded that designed for night-time use. The firmpointed out that with everypurchase of to support the “nothing works faster” claim –in- the“unqualified” statement had not been “rea- Refresh Optive Gel Drops until 31 July 2016, it would cluding tests that examined the onset of action sonably supported”. make adonation to its Refresh America timefor competing products –such claims were To “avoid conveying the unsupported mes- charitable programme, which aims to supply US emergency services with free eye drops. “best supported by head-to-head testing against sage” that Claritin-D would “start to work for OTC at least 85% of the relevant marketplace”. all consumers within the first 30 minutes”, the Therefore, the companyhad not provided a panel recommendedthat Bayer qualify anyon- reasonable basis, through competent and reli- set of action claim, such as by stating that the able scientific evidence, to support the claim product could work in “as little as” half an hour. OTC

ProductLaunches Trommsdorff offers UtiproPlus capsules

Indian mothers areencouraged to give their children omen who suffer from cystitis are the Utipro Plus capsules contain acombination two mugs aday of Horlicks in the latest multimedia W target for Utipro Plus, amedical device of gelatine, xyloglucan, propolis and Roselle campaign for GlaxoSmithKline (GSK) Consumer launched in GermanybyTrommsdorffunder ( hibiscus sabdariffa)extract. Healthcare’s health-food drink. Comprising print, television and digital activity, licence from Swiss firm Novintethical Pharma. Launch trade-press advertising stresses that the campaign was intended to highlight that Horlicks theproduct “containsnatural ingredients”, re- –which is GSK’s biggest-selling consumer brand in lievesthe symptoms of urinary infections and India –was “designed with food science”, the company pointed out, and that it was clinically proven to make helps to prevent infections recurring. children “taller,stronger and sharper”. It shows ayoung woman holding her hand up As partofthe campaign, atelevision spot, created with the slogan in English “Stop &Go! Ultipro”. by advertising agency J. Walter Thompson, features a mother cutting up fruit for her child, who is about to Trommsdorffsaid 20% to 30% of women leave the house for his evening tuition. suffered from recurring bladder infections, and Acamera focuses on aplate with apple slices next manyofthem felt let down by currentlyavail- to another with cake and biscuits, beforeanutritionist enters the kitchen to point out that while a“mother ableoptions for self-medication. As amedical tries and does everything for her child’s nutrition”, she device, Utipro Plus offered “an innovative thera- cannot be surethat “an evening snack will suffice”. peutic option” with adual effect, whereby the The nutritionist goes on to encourage both morning and evening consumption of Horlicks, gelatine and xyloglucan formed aprotective pointing out that it is formulated with ingredients film in the intestines that hindered e-coli bacte- such as wheat, barley,milk and “23 vital nutrients”. ria spreadingtogenitourinary tracts. Meanwhile, “Do bar Horlicks do. Nutrition ko aur surekaro!’ is the propolis and hibiscus fostered an acidic en- the sign-offmessage, which translates as “Give two Launch trade-press advertising shows ayoung woman glasses of Horlicks to be sureoffurther nutrition”. with her hands up next to the slogan in English ‘Stop vironment that reduced bacterialgrowth. OTC &Go! Utipro’ OTC

20 OTC bulletin 6November 2015 OTC06-11-15p19-22_Layout 1 03/11/2015 17:51 Page 4

MARKETING NEWS OTC

ProductLaunches ProductLaunches Stratpharma to UPSA addsfour products spendA$5mn to its French Fervex range wiss firm Stratpharma plans to spend “in Sexcess of” A$5 million (C3.2 million) until rance’sUPSA says it is aiming to “best theend of 2016 to promote the recent Australian Frespond to consumer needs” by adding a launch of its Stratamark stretch-mark gel. day and night presentation to its Fervex range Containing acombination of polydimethyl- of cold treatments under the name Fervex siloxanes, siloxanes and alkyldimethyl sili- Rhume Jour &Nuit. cones, Stratamark is claimed by the firm to be At the same time, the companyhas intro- the first clinically-provenOTC medical device duced three sprays –two of which are oral for the prevention and treatment of stretch sprays aimed at soothing sore throats in both marks that is registered with the Australian adults and children, while the third is ade- Aday and night option is one of four new additions to the Fervex line in France Therapeutic Goods Administration (TGA). congestant nasal spray suitable for adults and Consumer marketing activity for Stratamark older children. amine maleate, each pack of Fervex Rhume Jour would include pharmacypoint-of-sale mate- Day and night treatment Fervex Rhume &Nuit has arecommended retail price of C5.50. rials, advertising in “mainstream magazines” Jour &Nuit is suitable for adults and children Meanwhile, the twoFervex oral sprays for and public-relations initiatives, the firm noted, older than 15 years of age, and is aimed at sore throat are available in a30ml adult pre- as well as social-media activity and promotion treating blocked nose, headaches and fever. sentation, suitable for those over12years of age, through stands at baby and toddler shows. Sufferers should take‘day’ tablets in the morn- anda20ml version for children more than three The marketing spend also included apro- ing, and if necessary at midday and in the early years old. Both are honey-flavoured. Packaging motional campaign geared towards “healthcare evening –ensuring these are taken at least for the adult version boasts that the product professionals associatedwith stretch marks”, four hours apart –with asingle ‘night’ tablet “soothes intense sore throat in twohours”. the companypointed out, such as midwives, to be taken before sleeping. UPSA’s decongestant nasal spray –based plastic surgeons and dermatologists. Comprising 12 light-coloured ‘day’ tablets on essential oils including peppermint,euca- Designed for the treatment and prevention –containing 500mg paracetamol, 200mg vita- lyptus, rosemary and thyme –comes in a15ml of all types of stretch marks “both old and new” minCand 60mg pseudoephedrine hydrochlo- bottle. The decongestant spray and adult throat resulting from pregnancy, adolescent growth ride –and four dark-coloured ‘night’ tablets spray each have arecommended retail price of spurts, weight gain or bodybuilding, the odour- of 500mg paracetamol and 4mg chlorphen- C7.90, while the children’sthroat spray is C6.50. less, transparent gel dried to form athin, flexi- OTC bleand protective gel sheet that was“gasperm- eable and waterproof”, Stratpharma explained. ProductLaunches The unique formulation meant that it re- quired “substantially less product per applica- PGT introduces Swisse range to the UK tion than typical moisturising creams or cos- metic preparations”, the firm added. GT Healthcare has expanded the reach of navigation issues within the VMS category”. Available through pharmacies, Stratamark PtheSwisse vitamins, minerals and supple- Consumers are also offered the opportunity hasrecommended retail prices of A$49.95 for ments (VMS) brand into the UK. to discoverwhich products are “tailored” to their a20g tube and A$89.95 for a50g tube. Available exclusively through Boots, the needs through aseries of questions on the Swisse Claiming that the OTCmarket for stretch range of 29 products includes options for en- homepage of the Boots website, based on fac- marks wasestimated to be worth between A$30 ergy,beauty and women’shealth, as well as eye, tors such as age, gender,and the area of nutri- million and A$50 million at retail, Stratpharma heart and omega-3 offerings, and variants for tion theyconsider most important. said it was“seeking market leadership” within joints, bones and muscles. PGT –created in 2011 as an OTCjoint the first two-to-three years of launch. Alaunch marketing campaign for the brand venture between Teva and Procter &Gamble Stratamark wasregistered in all of the Euro- would include television advertising, the firm (P&G) (OTC bulletin,16November 2011, page pean Union (EU), Stratpharma noted, butonly explained, as well as digital and in-store activ- 1) –pointed out that the Swisse brand had also currently commercially available in the Czech ity,toensure consumers receivedthe “right partneredwith the Team GB Olympic team. Republic, Greece,Italy,Romania, Slovakia, information for them in regard to Swisse”. The PGT signed an exclusive licensing agreement and . activity would also “break down anycurrent in 2013 with Australian firm Swisse (OTC bul- Other markets in which the gel wasavailable letin,29November 2013, page 1) to “enable included Canada, NewZealand, South Africa, the rapid expansion of Swisse-branded VMS and South Korea, the firm pointed out. products into newcountries” and to create “a Launches in the “remaining major EU mar- newglobal ‘megabrand’”. kets” were expected in early 2016, Stratpharma In September,Swisse wassnapped up by added, along with Argentina, Brazil, China, China-based baby-care specialist Biostime Swisse’s partnership with Team GB is an “extension” Colombia, Mexico, and the US. of P&G’s relationship with the International Olympics (OTC bulletin,25September 2015, page 1). OTC Committee as asponsor of the Olympic Games OTC

6November 2015 OTC bulletin 21 OTC06-11-15p19-22_Layout 1 04/11/2015 08:54 Page 5

OTC MARKETING NEWS

AdvertisingComplaints Line Extensions UK’s ASA bans Taisho adds X5 Plus option New Nordic ad to its RiUP range in Japan ew Nordic’sprint advertisement for its NBlue Berry Eyebright Plus supplement has apanese firm Taisho has refreshed its core been banned by the UK’sAdvertising Standards JRiUP X5 minoxidil-based hair-regrowth Authority (ASA) for making unauthorised and product in its domestic market with aPlus vari- unsubstantiated eye-related health claims. ant containing three added ingredients. The advertisement –which had featured Acategory Idrug –amedicine whose side in amagazine targeted at older people –show- effects may possibly cause health hazards to ed awoman wearing glasses, with claims in- the extent of disrupting daily life –the RiUP cluding “nowIcan see and read my maga- X5 Plus lotion combined 5g minoxidil per zines”, as well as statements claiming that many 100ml with 0.05g pyridoxinehydrochloride RiUPX5Plus contains 5% minoxidil as well as three other ingredients to further supporthair growth people started taking Blue Berry Eyebright Plus (vitamin B6), 0.08g tocopheryl acetate ester to “preservehealthyeyes” and “normal eye- (vitamin E), and 0.3g menthol per 100ml to iveingredient per 100ml, while the latter three sight” or when theyfelt that their eyesight was support hair growth further,the firm claimed. options also contain 1g pantothenyl ethyl ether beginning to change. RiUP X5 Plus should be used twice aday (provitamin B5), 0.08g tocopheryl acetate ester, These were health claims that implied that by men aged over20years with thinning hair, and 0.3g menthol. theproduct –containing vitamin A, euphrasia Taisho recommended, to prevent hair loss and Taisho also offers shampoos, conditioners and officinalis (eyebright), lutein and vaccinium to stimulate hair growth. hair tonics under the RiUP umbrella in Japan. myrtillus (bilberry) –improvedvision, the ASA The original X5 product –which also con- A60ml bottle of RiUP X5 Plus has arecom- said, particularly in older people. tains 5% minoxidil –was launched in 2009 and mended retail price of ¥7,048 (C51.00) with- Furthermore, anumber of the statements leads the RiUP range in Japan, which includes out tax. could be interpreted as implying that Blue Berry the original, Jet and Plus products, as well as a The firm said it wasaiming for ¥12 mil- Eyebright Plus could prevent or treat age-related Regenne variant aimed at women. lion worth of shipmentswithin the first year macular degeneration, the watchdog added. These are all formulated with 1g of the act- of the product’s launch. In its responsetothe ASA, NewNordic OTC pointed out that aclaim in the advertisement for vitamin Awas authorised on the European ProductLaunches Union (EU) Register,while claims for eyebright and bilberry were currently on hold. Schwabe launchesNature’s WaySoftJells While the ASA permitted the claim for vita- min A, it said other claims in the advertise- chwabe has grown its Nature’sWay Alive! vegetarians.This wasa“keyfeature” that it ment exaggerated those submitted to the Euro- Smultivitaminsbrand in the UK with five washighlighting to consumers. pean Food Safety Authority (EFSA) and im- ‘Soft Jell’ gummy variants. The firm added that it was“liaising with plied that the product could improve vision. Comprising Women’sEnergy,Men’sEn- vegetarian groups” on howfurther to commu- The watchdog added that although New ergy,Women’s50+, and Children’svariants, nicate this aspect going forward. Nordic had provided evidence to support the ‘on as well as an Immune Support offering, the Schwabe –which also offers arange of hold’ claims, this had not been sufficiently robust Nature’sWay Alive!Soft Jell multivitamin line gummy vitamins under its Alive!brand in the to substantiate those made in the advertising. joins the current range of tablets launched at US –said the launch of the Soft Jells in the As aresult, the advertisement must not the start of the year. UK would be supported initiallywith an on- appear again in its current form. NewNordic Available in either berry or orange and line campaign. wastold not to state or imply that Blue Berry berry flavours, the Soft Jell products had been There would also be press and public-rela- Eyebright Plus could improve vision or to make developed to suit UK consumers’ tastes, the tions activity,the companyexplained, while a anyeye-related health claims for the product, companyclaimed, and contained “only natural television advertisementwas expected to air apart from those authorised on the EU Register. fruit flavours”. in late 2016. OTC Nature’sWay Alive!Soft Jell multivitamins Pointing out that it had “strong growth plans” were also made with pectin for “superior mouth forAlive!and “the Soft Jells range in particu- IN BRIEF texture”, Schwabe noted, and were suitable for lar”, Schwabe said it would invest a“signifi- cant” amount in marketing activity next year. ■ BIOELECTRONICS has made its Acti- Further product launches were planned for Patch pain-relief medical devices available in 2016,the companyadded. 1,077 UK LloydsPharmacystores. The line of Available in “health and beauty outlets products for back, knee, and muscle and joint across the UK”, including Holland &Barrett, pain is nowalso stocked in 60 Gordons Chemist each Nature’sWay Alive!Soft Jell variant has

locations in Scotland and Northern Ireland. The five Nature’s WayAlive! Soft Jell multivitamins arecommended retail price of £14.99 (C20.88). OTC aremade with pectin and suitable for vegetarians OTC

22 OTC bulletin 6November 2015 OTC06-11-15p23Events_Layout 1 03/11/2015 17:55 Page 2

EVENTS OTC

NOVEMBER Email: info@management- 15-16 February forum.co.uk. 19-20 November ■ AESGP Conference Website: management-forum.co.uk. Amsterdam, theNetherlands ■ EMA Review of the Year This two-day conference is being organised by the Association of the London, UK MARCH This two-day reviewofthe activ- European Self-MedicationIndustry,the AESGP with the EU Heads of 1-4March ities of the European Medicines Medicines Agencies (HMA) during the Dutch Presidency. Agency(EMA) and national agen- Contact:AESGP. ■ OTC Pharma Asia cies that work within the European Tel: +32 2735 51 30. Fax: +32 2735 52 22. Singapore regulatory system is being run by Email: [email protected]. Website: aesgp.eu/events/Amsterdam2016/. Speakers from Boehringer Ingel- The Organisation for Professionals heim, GlaxoSmithKline, Johnson in Regulatory Affairs (TOPRA). lookatregulatory considerations tory Agency(MHRA) –will cover &Johnson, Merck Consumer Contact:TOPRA. and support for innovative medi- good distribution practice (GDP), Health, Novartis and Teva will at- Tel: +44 20 7510 2560. cines and technologies. while day twowill look at good tend this four-day event, which will Fax: +44 20 7537 2003. Contact:Glasgows. manufacturing practice (GMP). The look at countries suchasChina, Email: [email protected]. Tel: +44 1772 767 778. twodays will then be repeated. India, and the Philippines. Website: topra.org. Email: mhrainnovativemedicines@ Contact:Glasgows. Contact:IBC Life Sciences. glasgows.co.uk. Tel: +44 1772 767 715. Tel: +65 6508 2401. 23-24 November Website: mhrainnovativemedicines. Email: [email protected]. Email: [email protected]. ■ EuroPLX 59 glasgows.co.uk. Website: mhragmdp.co.uk. Website: otcpharmaasia.com Athens,Greece This two-day meeting will pro- DECEMBER JANUARY2016 3-4March vide aforum for business devel- ■ Business Development opment decision makers for dis- 1December 19 January and Innovation cussing and negotiating collabor- ■ Advertising ■ Basics of Pharmaceutical Opportunities in ative agreements in licensing, mar- Medicinal Products RegulatoryAffairs Consumer keting, and distribution of patented Bonn, Germany London, UK Healthcare/OTC medicines, generics, biosimilars, Aone-day seminar focusing on ad- Aone-day seminar run by The London, UK OTCproducts, medical devices vertising medicinal products, run Organisation for Professionals in Organised jointly by the Phar- and food supplements. by Germany’smedicines manu- Regulatory Affairs (TOPRA). maceuticalLicensing Group and Contact:RauCon. facturers’ association, the BAH. Contact:TOPRA. OTCToolbox, this conference and Tel: +49 6221 426 2960. Contact:BAH. Tel: +44 20 7510 2560. networking event will focus ex- Email: [email protected]. Tel: +49 228 95745 0. Fax: +44 20 7537 2003. clusively on business development Website: europlx.com. Fax: +49 228 95745 90. Email: [email protected]. and innovation in the consumer Email: [email protected]. Website: topra.org. healthcare/OTC market. There will 24-25 November Website: bah-bonn.de. be industry speakers from firms – Ukrainian ■ 20-21 January including Boehringer Ingelheim, Pharmaceutical Forum 1-2December ■ Social Media in the IMSHealth, RB, Thornton &Ross Kiev, Ukraine ■ RegulatoryAffairs andUnilever–and anetworking Speakers from GlaxoSmithKline, in Latin America London, UK drinks reception and dinner. Pfizer,SanofiAventis and Takeda London, UK Pharmacovigilance, digital market- Contact:OTCToolbox. will attend this two-day event. Atwo-day workshop that can be ing and social-media trends will be Tel: +44 (0)121 314 8757. Contact:Adam Smith Conferences. tailored for your companyand de- examined at this two-day seminar. Email: [email protected]. Tel: +44 20 3377 3182. livered in-house. Contact:SMi Group. Website: plg-group.com/events/ Fax: +44 20 7017 7447. Contact:Pharmaceutical Training Tel: +44 20 7827 6000. bdconsumerhealthcareotc/. Email: nataliapr@adamsmith International. Fax: +44 20 7827 6001. conferences.com. Tel: +44 20 7017 7481. Email: [email protected]. 16-17 March Website: ukrainianpharma.com. Fax: +44 20 7017 7823. Website: smi-online.co.uk. ■ RegulatoryAffairs India and China 26-27 November Email: [email protected]. Website: pti-global.co.uk/latin. FEBRUARY Mannheim, Germany ■ Pharmaceutical Day one of this two-day seminar RegulatoryAffairs 7-9December 11-12 February will coverIndia, while day-two in China ■ Pharmacovigilance ■ EU Pharmaceutical will discuss China. Each day can Basel, Switzerland London, UK Regulations &Strategy be booked separately. Regulatory requirements in coun- Athree-day course discussing drug London, UK Contact:Forum Institut tries such as China, Hong Kong, safety monitoring in the European This two-day course will give an für Management. Macau and Taiwan will be covered Union (EU), Japan and the US. overviewofthe European pharma- Tel: +49 6221 500 680. at this two-day conference. Contact:Management Forum. ceutical regulatory environment. Fax: +49 6221 500 555. Contact:Management Forum. Tel: +44 1483 730071. Contact:Management Forum. Email: [email protected]. Tel: +44 1483 730071. Email: [email protected]. Tel: +44 20 7749 4730. Website: forum-institut.com. Email: [email protected]. Website: management-forum.co.uk. Website: management-forum.co.uk. 10 March 8-11 December OTC Marketing Awards 30 November GDP and GMP Symposium ■ ■ London, UK ■ MHRA Innovative London, UK Formore information on Medicines Symposium Day one of this two-day meeting – sponsoring, entering or attending London, UK organised by the UK Medicines visit OTC-bulletin.com/Awards or email [email protected]. This one-day conference will and Healthcare products Regula-

6November 2015 OTC bulletin 23 OTC06-11-15p24-27_Layout 1 03/11/2015 17:46 Page 2

OTC AESGP MEETING Industrybacks medical device potential

As European Union (EU) legislators work to finalise the long-delayed medical device regulation, Matt Stewart reports on why industry is keen to protect the rapidly-expanding market forself-care devices in the region.

lthough it might not always be ob- to engage in an “intense political campaign”, vious, substance-based medical de- Scarlett-Smithpointed out, to “increasethe un- vicesare featuring more and more derstanding of the products at stakeand of the Ain the portfolios of consumer health- devastating impact such legislation could have care companies across Europe, according to if adopted without change”. Roger Scarlett-Smith, president of the Asso- This campaign had led to the European ciation of the European Self-Medication Indus- Parliament deleting the proposed medical de- try,the AESGP. vice legislation’scontroversial Rule 21, which Speaking at meeting organised by the AESGP would have seen araft of self-care medical on the future of medical devices, Scarlett-Smith devices removedfrom the market, he added. –who is also GlaxoSmithKline (GSK) Con- Butwith the file nowinthe hands of the Coun- sumer Healthcare’shead of global categories – cil of Health Ministers, the rule had returned Roger Scarlett-Smith, president of the AESGP,said that a“reasonable and proportionate legal said that while the number of substance-based in only aslightly less restrictive form (OTC framework” was needed for medical devices medical devices available to consumers wasin- bulletin,24July 2015, page 1). creasing, alack of understanding of this grow- As the process to finalise the legislation be- Echoing Scarlett-Smith’scall to protect in- ing market sector wasputting it at risk. gantodrawtoaclose, it wasimperative that a novation within the medical devices space, Mai- With the European Commission (EC) ini- solution wasfound which delivered a“reason- kelHendriks, chief executive officer of Dutch tially proposing to “ban the category,oratleast able and proportionate legalframework”, guar- medical devices specialistMedical Brands, said to no longer classify the products on the mar- anteeing consumer protection, butalso allow- that the newlegislation wasanopportunity to ketasmedical devices”, the AESGP had had ing for innovation, Scarlett-Smith insisted. define the market and secure asignificant tool to help build astronger self-care environment

Medical devices Medical Devices in Europe. 56 million units C675 million “There is areal desire for people to take their healthcare into their ownhands,”Hendriks pointed out, “yet consumers still rely heavily on the advice of their doctors when it comes to treating minor ailments.” These visits to doctors significantly increas- ed member states’ healthcare costs, Hendriks argued, noting that an AESGP study of seven European countries had found that if only 5% of the medicines prescribedfor certain self- OTCproducts OTCproducts C2,408 million 301 million units limiting conditions were made available OTC, it would save those countries C16 billion ayear. Figure2:Value sales of OTC medicines –excluding Figure3:Volume sales of OTC medicines –excluding cosmetics, food supplements and other categories – cosmetics, food supplements and other categories – Responding to the challenge of greater con- and medical devices in Italy in the year ended June and medical devices in Italy in the year ended June sumerdemand for more control overtheir own 2015 (Source –Aboca/IMS Health) 2015 (Source –Aboca/IMS Health) health and the desire of governments to cut healthcarebudgets, industry had adjusted its Oral forms Oral forms C123 million 8million units thinking to get closer to the consumer,hesaid. “Consumer healthcare firms are no longer thinking just about treatment,”Hendriks con- tinued. “Weare also thinkingabout diagnosis and prevention.” Within this environment, the boundaries be- tween product categories had started to blur, Hendriks admitted, with newcategories –such as nutraceuticals and cosmeceuticals –stretch-

Local use Local use ingthe definitions of products used to maintain, C552 million 48 million units treat or improve health. Industry might be blurring boundaries and Figure4:Value sales of local-use and ingested Figure5:Volume sales of local-use and ingested med- medical devices in Italy in the year ended June 2015 ical devices in Italy in the year ended June 2015 legislators might be strugglingtoreact to the (Source –Aboca/IMS Health) (Source –Aboca/IMS Health) changing market dynamics, butconsumers were

24 OTC bulletin 6November 2015 OTC06-11-15p24-27_Layout 1 03/11/2015 17:46 Page 3

AESGP MEETING OTC

only looking at the health claim on the pack, he argued. It wasimperative for industry and regulators to ensure that the products theydelivered were “safe, effective,available on demand, easy to use and featuredclear claims”. There already existed clear legalframeworks for cosmetics, food supplements and medicines, Hendriks pointed out, so it wasnow about doing Dry mouth Haemorrhoids Acid reflux the same for medical devices. Head lice Acne Stomach cramps What needed to be taken into account when Nasal allergy Cough Diarrhoea Nasal decongestion Sore throat Sensitive teeth looking at self-care medical devices wasthat Eye drops Cold sores Vaginal infection themarket had already been established, Hen- Saline spray Corns Wound treatment Urinary-tract infection driks argued, pointing out that as of January Nail fungus Vaginal gel 2014 there were around 240 self-care medical Athlete’sfoot devices on the market in the Netherlands alone, Warts an increase of 100 in less than twoyears. Quoting figures from the Dutch industry Figure1:Breakdown of common conditions by the class of medical device available to treat them in the association Neprofarm, Hendriks said that 8.8 Netherlands (Source –Neprofarm) million units covering arange of minor ailments Highlighting arecent study by Neprofarm Aboca had entered the medical devices arena hadbeen sold in the Netherlands in 2014, with in 2014, Hendriks said that that there had been in 2005, Giovagnoni said, having discovered the majority classified as Class IIa or Class “only twomedical complaints against self-care that the complexnatural substances the firm IIb (see Figure 1). medical devices per 100,000 units sold”. had developed could be used to offer therapies “These medical devices have had asignifi- “If you look into these complaints, it is things that hadnopharmacological, immunologicalor cant impact on self-care in the Netherlands by re- likethe product doesn’twork,”heexplained. metabolic mechanisms of action. sponding to consumers’ preferences to help them- “There have been no big adverse events with This different mechanism of action opened selves,”Hendriks said, “and they, crucially,have these types of products, so what you have here up an “extraordinary possibility for innovation been shown to have astrong safety profile.” is avery safe product group.” in the healthcare sector”, he claimed, as while “This strong safety profile is important, as Anynew regulationshad to takethis safety the intended use of the product might be the people argue that medical devices enjoyasofter profile into account, Hendriks said, and recog- same as amedicine, the method of action made legalframework and it is easier to comply it amedical device. with their safety profiles,”Hendriks said. Medical devices nowplay- “But if you look closely at the safety re- “Therehave been no big adverse events ed akey role in Italy’sOTC quirements,theyare very detailed,”headded. with these types of products, so what you market, Giovagnoni pointed “Weare talking about biocompatibility and tox- have hereisaverysafe product group.” out, with more than 500 com- icology.Wehavepost-marketsurveillance sys- panies producing products that tems in place, we have complaint systems in generated C675 million in value place, and we have to do clinical studies that are nise that innovation in the sector wasbeing sales and 56 million units in volume sales in at the same levelasthose for medicines.” done in asafe and responsible way. the year ended June 2015 (see Figures 2and 3). “Basically,the safety requirements laid out Providing an example of areas where the Of these medical devices, ingested substance- for medical devices are already quite strict in my medical devices sector could play acrucial role based products accounted for C123 million in opinion,”Hendriks stated. when it came to self-care innovation, Hendriks value sales and eight million units in volume said that diagnostic testing kits could provide sales (see Figure 4and 5), he said, with the mar- real growth opportunities for industry. ketfor these products growing by 37%. Urinary tract infections were agood example, With these products nowplaying an im- Hendriks claimed, noting that while his com- panyhad developed amedical device to treat theproblem –Cranberry Active –there wasstill no wayfor women to diagnose themselves, so theystill ended up visiting adoctor. “If you had adiagnosis kit available which identified the bacteria responsible with asimple urine test, patients could treat the condition early and avoid avisit to the doctor,” he maintained. While safety would play akey role in in- novation, ensuring that substance-based medi- cal devices were correctly classified would also Maikel Hendriks, chief executive officer of Medical be crucial in developing and protecting the mar- Brands, said the new medical devices legislation was ket, commented Emiliano Giovagnoni, director an opportunity to define the market and securea Medical Brands’ Cranberry Active medical device is significant tool to help build astronger self-care of regulatory affairs at the Italian natural prod- helping women treat UTIs and playing arole in boosting environment in Europe ucts firm Aboca. self-care, according to the firm’s head Maikel Hendriks

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OTC AESGP MEETING

medical devices that are on the market in ac- Committee on Medical Devices, arguing that cordance with the current directive.” there was“no rationale” for Rule 21. “Absorption as such cannot be acriterion “The proposed rule is difficult to interpret, for the classification of all medical devices in- which will no doubt lead to differences across tended to be introduced to the gastrointestinal member states and differences in opinion,”Wil- tract,”Giovagnoni insisted. son said. “Webelieve it will end up stifling “Absorption per se cannot indicate anyrisk innovation and restricting access to self-care, anditdoes not relate exclusively to substance- as this rule could block products from becom- based medical devices,”heclaimed. ing devices.” “Onthe other hand, absorption can be used “If there is areal concern about acertain to classify the product when absorption is nec- substance-based device, we believe it should be essary to achieve the intended action,”hesaid. called out clearly on acase-by-case basis,”he “In this case, the complexity of the product added, “with an assessment performedthrough can justify the higher classification as we have atransparentand scientific process.” to be sure howthe substance is absorbed, dis- tributed and metabolised.” No data to supportconcerns “All other medical devices that are intro- “Wehaveheard it said that member states Emiliano Giovagnoni, director of regulatoryaffairs at duced to the gastrointestinal tract should be are concerned about ingested medical devices, the Italian natural products firmAboca, insisted that absorption should not be acriteria for classification classified in the lower class regardless of ab- yet we’ve not seen anydata to support this con- sorption,”Giovagnoni stated. cern,”Wilson claimed. “But if there is, let’sreach portant role in the market, it wascrucial the reg- “Wecannot use the same criterion that is used aconclusion on it.” ulations fairly recognised the difference between formedicinal products for these products,”he “Then if action is needed, let’smakepro- substance-based medical devices and medicines. reiterated, “as it has been proventhat theywork vision in adelegated act,”heurged. “Let’swrite “These products are an opportunity for the through adifferent mechanism of action.” atechnical specification for ingested medical self-medication sector,” he argued, “and the new It wasclear that what wasneeded, Gio- devices and the standards theyshould meet.” legislation could be an opportunity to growin vagnoni concluded, were common technical “It will be clear,understandable, actionable the right direction.” specifications that were specific for substance- and easier to reach alignment on than agen- “But unnecessary legalrequirements must based devices, as there were already for other eral rule,”Wilson added. be avoided,”Giovagnoni insisted. “Rule 21 is categories of medical devices. “The regulation has the tools to do this al- acritical issue, especially as the data we have Giovagnoni’scalls were supported by the ready,and because of this we would urge the frompost-marketsurveillance at the European AESGP,with GSK’sAndrewWilson, speaking trialogue discussions to come out in line with levelbacks the safety of the substance-based in his capacity as amember of the AESGP’s the Parliament’sposition and delete Rule 21.” OTC

BusinessStrategy lion in annual savings, Papa pointed out. Highlighting the proposed organisational Perrigo to sell US VMS business changes, Papa said Perrigo planned to stream- line its structure to increase efficiencyand “el- ■ Continued from front page Perrigo also intended to divest other parts iminate redundant administrative functions”, -ational and organisational changes, as well as of its business that did not meet the company’s which would lead to about 250 job losses. divestments, Papa said Perrigo expected the “return on invested capital threshold”, Papa Claiming that these actions would not “com- programme to generate “operational and tax said, noting that details of these plans would promise the firm’sfocus on innovation”, Papa benefits of US$175 million (C159 million) on be revealed at alater date. said the restructure wasexpected to deliver an annualised run-rate basis”. “These actions will improve the firm’sop- US$35 million annually in operational savings. To oversee this programme, Perrigo has pro- erating margins and return on invested capi- Explaining the rationale behind the full moted to companypresident its global oper- tal,” he explained, “and are expected to deliver programme of organisational, operational and ations and supply chain head John Hendrick- US$35 million in annual operating benefits.” portfolio changes, Papa claimed that these ini- son. He takes the title from Papa, who has held tiativeswould allowPerrigo to “drive continued it since joining the firm in 2006 (OTC bulletin, Taking immediate steps strong profit growth and build substantial share- 15 September 2006, page 1). Turning to the planned operational changes, holder value”. “Hendrickson is the ideal leader to oversee Papa said Perrigo wastaking “immediate steps” “The actions we are announcing today,” con- the transformational initiativesannounced to- to consolidate its operations, supply chain and tinued Papa, “makethe gross inadequacyof day,” commented Papa. “He has adeep under- procurement activities into one “global centre Mylan’soffer clearer than ever.” standing of our business, provenmanagement of excellence” in Ireland. “Westrongly believe that Mylan’sclaims skills and astrong, competitive drive to ensure In addition,Papa noted that the firm’sglobal about synergies, the benefits of its expected Perrigo continues to deliveratthe highest lev- research and development leadership would vertical integration and its ability to manage els in our industry in terms of quality,efficiency join the firm’sglobal portfolio management our business are simply wrong,”Papa insist- and innovation.” team in Ireland to “drive acompany-wide prod- ed, “particularly giventhe significant differ- Papa noted that the planned sale of the US uct selection and development process”. ences in our businesses and the markets in VMSbusiness wasone of anumber of actions These initiatives, when taken together,were which we operate.” the firm wasundertaking to “refine” its portfolio. expected to generate afurther US$105 mil- OTC

26 OTC bulletin 6November 2015 OTC06-11-15p24-27_Layout 1 03/11/2015 17:46 Page 5

PEOPLE OTC

Manufacturers Chaudhuri heads Mylan’s global OTC unit

ylan has appointed GlaxoSmithKline in brand, the companyadded. to the firm’s“ongoing evolution”. M(GSK) Consumer Healthcare’s Ranjan Commenting on the appointment, Mylan’s Mylan’schief executive officer,Heather Ray Chaudhuri as global commercial lead president, RajivMalik, said Chaudhuri wasjoin- Bresch, pointed out that the firm was“com- for its OTCbusiness. ing the firm at an “opportune time” and would mitted to significantly expanding” its OTCbusi- The move comes as the generics giant seeks bring to his newrole “deep knowledge of the ness. Consumer healthcare wasan“important to secure the acquisition of Perrigo, with its OTCspace”. channel”, she said, that would complement My- hostile takeoverbid for the US store-brand spe- lan’sexisting strengths in prescription and gen- cialist set to expire on 13 November (OTC bul- Work on aglobal level eric medicines. letin,25September 2015, page 3). “He will work closely with me and my col- “This is whywebelieve our combination Chaudhuri brought almost 30 years of ex- leagues at the global levelwithin both Mylan with the Perrigo and Omega platformspresents perience at GSK to his newrole, Mylan noted, and Perrigo’scommercial structures,”Malik such acompelling opportunity to accelerate our having most recently led the sale of the firm’s revealed, “to further realise the combination’s efforts,”Bresch insisted. NiQuitin nicotine-replacement therapy(NRT) commercial value should we complete the Per- Following Mylan’shostile bid, Perrigo’s brand in the European Economic Area (EEA) to rigo transaction.” board of directorsrecommended that its share- Perrigo (OTC bulletin,12June 2015,page 1). Describing his newrole as “tremendously holders “should not tender anyoftheir shares Previously,Chaudhuri had been responsible exciting”, Chaudhuri said he waslooking for- to Mylan”. The companyhas since launched a for GSK’sglobal smoking reduction and ces- ward to the opportunity to “build upon Mylan’s number of initiativestofend offthe takeover sation business. This had included the NiQuit- one-of-a-kind global platform”and to contribute (see front page). OTC

Industr yAssociations BAH raids Bayer for spokesperson ermany’smedicines manufacturers’ asso- Gciation, the BAH, has recruited Yvonne Möller from Bayer to head its press and public Make sure your colleagues are relations department from 1January next year. Möller will takeoverfrom Heinz-Gert as well informed as you Schmickler who will retire after 23 years with theassociation. She will also assume the BAH’s Make sure your fellow directors and executives get the latest spokesperson role from Wolfgang Reinert, consumer healthcare news and exclusive insights from OTC bulletin. who will focus on healthcare policy. Empower them to make informed decisions and take decisive actions Highlighting Möller’sextensive communi- to keep your business ahead of its competitors. Make sure your cations experience in Germanyand abroad, theBAH said she would oversee the transfer of company has a Corporate Subscription. the association’scommunications function from Bonntothe Berlin office headed by deputy Business benefits director-general Dr Hermann Kortland. OTC bulletin is available During her career with Bayer,Möller has ❖ electronically worldwide to all Executives in the held several communications roles covering company executives world’sleading OTC dermatology,Bayer Schering and the Asia- companies are already ❖ Keeps your business up-to-date benefitting from a Pacific region. with industry news and corporate subscription Yvonne Möller exclusive insights to OTC bulletin. ❖ A fully-searchable archive offers in-house research facilities ❖ Flexible formats –desktop, mobile and print options available ❖ Flexible access –online or via ContactValDavis, company intranet Subscriptions Director, ❖ Modest cost –available for a at subs@otc -bulletin.com fraction of the price of multiple, or tele phone+44 (0) 1564 777 550 individual subscriptions OTC

6November 2015 OTC bulletin 27 2016_Ad_Consumer-LiquiGel_R7_OTC.

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