J&J Accused of Covering up a “Phantom” Product Recall

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11 June 2010

COMPANY NEWS 3 J&J accused of covering up Bayer enters talks with 3 US haircare firm Price rises lift OTC sales at Adcock 4 a “phantom” product recall Sigma opens its accounts for Aspen 5 Weak cold season hits 6 sales at ProPhase Labs ohnson & Johnson initially tried to cover consumer protection,”said representative Ed Jup the potential US recall of its Motrin Towns in a letter to the firm’s chief executive Oxford Nutrascience offers 7 two new chews to industry analgesic two years ago, it has been reveal- officer William Weldon. ed. The US company’s McNeil OTC sub- Addressing a hearing of the House of Rep- Omega aims to double UK business 8 sidiary claimed at the time that its contrac- resentatives’ Committee on Oversight and Gov- GENERAL NEWS 9 tor had been asked to perform “statistical ernment Reform, Towns said the FDA had giv- sampling”. en his committee a document that showed John- ECJ at odds with Commission 9 This news came as the Food and Drug Ad- son & Johnson’s McNeil OTC subsidiary had on pharmacy ministration (FDA) announced yet another Mc- known there was a potential problem with one Alli labelling to include 10 Neil-related recall, this time of a McNeil-made of its Motrin products in 2008. Rather than liver injury warning in US children’s OTC brand – Blacksmith Brands’ issue a public recall, however, Johnson & John- Bill seeks full enforcement 11 PediaCare – and said it was considering fur- son allegedly sent contractors out to stores to of DSHEA supplements law ther action, including criminal charges, against buy the product back and told the stores “not Three more herbal 13 McNeil in the light of recent recalls. to mention” a recall. monographs done Referring to the “phantom recall” of Mot- “It was not until the FDA caught Johnson MARKETING NEWS 14 rin, the chairman of the Congressional com- & Johnson in the midst of the phantom recall mittee investigating Johnson & Johnson’s re- that the company announced a proper recall Nicabate shows Australians 14 cent recall of more than 40 children’s medi- of the flawed Motrin,”Towns observed, add- how smoking can age skin cines (OTC bulletin,14 May 2010, page 1), ing that the incident “raises serious questions FDA gives final approval to 15 said that it warranted further investigation. “It about the integrity of this company”. Perrigo’s generic Monistat raises the question of whether Johnson & John- According to a document provided to the Power Health acquires rights 18 son placed a higher priority on preserving the committee by the FDA, the CSCS Motrin Pur- to Sanatogen protein powder reputation of its Motrin brand than it did on ■ Continued on page 11 FEATURES 20 German firms expect 20 consolidation FDA sends Warning Letter to Perrigo REGULARS he Food and Drug Administration (FDA) for finished pharmaceuticals, said the regula- Tin the US has sent Perrigo a Warning Let- tory agency. These had rendered the drug pro- Consumer viewpoint 12 ter about its manufacturing plant in Allegan, ducts adulterated within the meaning of the – Period pain is this month’s topic Michigan, which makes some of the comp- Federal Food, Drug and Cosmetic Act, it said. Pharmacy viewpoint 16 any’s store-brand ibuprofen. The Warning Letter was issued after the – Flomax stays put at top An inspection of the plant between 17 Nov- agency said that Perrigo’s 1 February 2010 re- of the rankings ember 2009 and 14 January 2010 had uncov- sponse to the inspection findings lacked “suf- Events – Our regular listing 19 ered “significant violations” of current Good ficient corrective actions”. People – Latest moves 22 Manufacturing Practice (cGMP) regulations ■ Continued on page 10 OTC Ad 2010:OTC Ad 1_07 5/1/10 14:16 Page 1

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COMPANY NEWS OTC

Business Strategy Bayer enters talks with US haircare firm

ayer’s German subsidiary Bayer Vital is in for over 40 years and was picked up by Bayer Bearly discussions with US-based company when the company acquired Roche Consumer Divine Skin over possible collaborations in the Health at the end of 2004 (OTC bulletin,28 hair-regrowth and haircare categories. January 2005, page 27). The brand is available However, Divine Skin – which markets a in Austria, Belgium, Germany, Greece, the Neth- range of OTC hair-regrowth products and dan- erlands, Switzerland and Turkey. druff shampoos – noted that it could offer “no Divine Skin’s flagship brand, DS Labora- assurances” that a formal relationship between tories, markets a range of topical hair-regrowth the two companies would be established. products, which competes in the US with Mc- Any possible tie-up with Divine Skin could Neil’s minoxidil-based Rogaine brand. expand Bayer Vital’s position in the hair-re- Two topical products with 5% minoxidil – growth category,where it offers Priorin sham- Spectral.DNC and Spectral.DNC-L – are part poo and oral capsules as OTC products. of Divine Skin’s range, as is the minoxidil- Priorin has been on the market in Germany free Spectral.RS topical hair-regrowth product. Spectral.DNC and Spectral.DNC-L combine minoxidil, which has been clinically proven, Divine Skin’s hair-regrowth range includes the OTC bulletin with additional compounds. Divine Skin point- minoxidil-based Spectral.DNC product ed out that these had also been proven in clin- 11 June 2010 Number 344 ical trials to extend the hairline. ed itself as a “leader in several topical thera- Divine Skin also markets shampoos under pies, especially hair regrowth”, with a busi- Editor & Publisher: Deborah Wilkes the Dandrene and Revita names and a hydrat- ness model built on “aggressive innovation”. Associate Editors: Aidan Fry ing shampoo and conditioner sold under the Divine Skin pointed out that the company’s Mike Rice Nia brand, as well as a range of skincare and products were distributed in more than 20 coun- Senior Assistant Editor: Matt Stewart personal care products. tries worldwide through wholesalers, special- Assistant Editors: Joanne Grew, Jenna Lawrence, Daniel Khesin, Divine Skin’s chief execu- ity retailers, online stores, spas, salons and med- David Wallace tive officer,said the company had establish- ical establishments. OTC Advertising Controller: Debi Minal Marketing Manager: Val Davis Editorial, Subscription and Advertising Business Strategy/First-Half Results enquiries should be addressed to: OTC bulletin, OTC Publications Ltd, 54 Creynolds Lane, Solihull, Phytopharm eyes Hoodia opportunities West Midlands B90 4ER, UK. Tel: +44 1564 777550. Fax: +44 1564 777524. hytopharm is talking to “major branded the traditional ingredient had not met its safety E-mail: [email protected]. P companies” about the development of its or efficacy standards. Subscriptions Hoodia gordonii extract, which is claimed to Unilever had spent around C20 million over Annual subscriptions to OTC bulletin in Europe are £595.00 for single copies and £345.00 for additional copies to the same ad- be a novel appetite suppressant. four years on developing Hoodia through the dress, including delivery. Subscriptions to addresses outside Eur- The UK-based firm said it had been evaluat- licensing and joint-development agreement, ope are subject to an additional charge of £30.00 to cover postage. Subscription enquiries in Korea should be directed to Pharma ing opportunities and had held talks with major which had potentially been worth £21 million Koreana Ltd, 14th Floor,KTB Network Building, 826-14 Yeoksam- companies with the aim of moving its Hoodia (C25 million) to Phytopharm. dong, Kangnam-gu, Seoul 135-080, Korea (Tel: +82 2 554 9591; Fax: +82 2 563 8289; E-mail: [email protected]). programme forward and eventually developing As part of the termination agreement, the Advertising consumer products containing the extract. two firms are evaluating data arising from one Advertising rates and data are available on request from the ad- Phytopharm added, however, that it was too of the development studies, with the final report dress above or at www.otc-bulletin.com. About OTC bulletin early to say whether any commercial opportu- expected in the third quarter of 2010. OTC bulletin is published 20 times a year by OTC Publications nities would emerge. Meanwhile, Phytopharm reported an oper- Limited: twice monthly in February,March, April, May,June, Sep- tember,October and November; and monthly in December,Jan- In 2008, Phytopharm and consumer prod- ating loss of £2.16 million for the six months uary,July and August. A subscription to OTC bulletin includes ucts giant Unilever agreed mutually to terminate ended 31 March 2010. Revenue of £0.11 mil- the weekly electronic newsflash, news@OTCbulletin,which is published around 45 times a year. OTC bulletin is printed by the a deal to develop and commercialise the Hoodia lion for the period came from Unilever reim- Warwick Printing Company Limited, Caswell Road, Leamington gordonii extract (OTC bulletin,28 November bursing Phytopharm’s expenses, the sale of cer- Spa CV31 1QD, UK. 2008, page 4), which Phytopharm has exclu- tain raw materials from inventory,and sales No part of this publication may be copied, reproduced, stored in a retrieval system or transmitted in any form without prior sively licensed from the South African Council of the company’s Phytopica animal health pro- permission from OTCPublications Ltd. for Scientific and Industrial Research (CSIR). duct to Intervet/Schering-Plough. ©OTC Publications Ltd. All rights reserved. Company registered in England No 2765878. Registered Office: At the time, Phytopharm said data from a More than £24 million was raised by Phy- 54 Creynolds Lane, Solihull, West Midlands B90 4ER, UK. clinical study using Hoodia extract in a drink- topharm last December to finance the devel- OTC bulletin® is registered as a trademark in the European based product had “led Unilever to conclude opment of its product pipeline, including its Community. that [the extract] was unsuitable to be taken key Parkinson’s disease treatment Cogane. ISSN 1350–1097 www.OTC-bulletin.com forward by Unilever”. However, Unilever said OTC

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OTC COMPANY NEWS

PriceFirst-Half Results rises lift OTC sales at Adcock

outh Africa’s Adcock Ingram said its OTC Business First-half sales Change Operating profit Change Ssales had increased by 7.2% during the six (R millions)(%) (R millions) (%) months ended 31 March 2010, as the company increased prices despite a shift by consumers Prescription749 +6.9 204 +0.5 towards cheaper brands and generics due to the Hospital 645 +6.7 123 +11.6 tough economic climate. OTC 635 +7.2 208 +9.8 OTC turnover had increased to R635 million Total 2,028 +6.9 535 +6.4 (C67.5 million) reflecting an 8% price increase, Adcock Ingram said (see Figure 1). However, Figure 1: Adcock Ingram’s sales and operating profit in the six months ended 31 March 2010, broken down by business (Source – Adcock Ingram) the firm claimed it had been evident in both the pharmacy and ‘fast-moving consumer goods’ Successfully integrating Tender Loving Care 8.6% overall, while the firm’s vitamins/miner- (FMCG) distribution channels that consumers and Unique Formulations would boost the OTC als/supplements/tonics portfolio had more than had continued to feel under financial pressure. business, the firm added, while further price doubled its sales, eclipsing the total category In the pharmacy channel, where Adcock gen- increases in the March-to-May period would growth of 19.8%. erated 71.8% – R456 million – of its OTC sales lift OTC margins. By contrast, analgesics recorded sales down over the six months, the company said it had Investment in the company’s OTC brands by 2.1%, compared with total category growth seen higher sales of “economy brands” as both would continue, Adcock Ingram stated, with of 0.5%, while the 1.4% sales gain made by consumers and healthcare funders opted for “major campaigns” planned for the second half the company’s digestive/stomach/urinary reme- “lower-priced products” in what it described as of the company’s year to September 2010. dies segment was slower than the total cate- a “trade-off between efficacy and price”. gory advance of 3.4%. Meanwhile, in the FMCG channel – which OTC categories produce mixed results Adcock’s OTC business accounted for 31% accounted for the remaining 28.2%, or R179 The OTC business’ key product categories of Adcock Ingram’s total turnover for the six million, of OTC sales for the period – Adcock in the FMCG channel had produced a mixed months, which increased by 6.9% to R2.02 bil- reported a decline in volume sales of its an- performance in volume terms during the six- lion. The dominant Prescription business gener- algesics, and cough drops and lozenges. month period, Adcock Ingram pointed out. ated a further 37%, while the Hospitals unit was However, on a brighter note, sales through Quoting data from market researcher AC responsible for the remaining 32%. Adcock’s the FMCG channel of the company’s vitamins, Nielsen, the company said volume sales of its operating profit grew by 6.4% to R535 million. tonics and food supplement brands had more analgesics brands as well as its cough drops OTC than doubled, Adcock Ingram pointed out, dri- and lozenges had fallen. The declines had been ven by the acquisitions last year of the Tender less severe, however, than those of their respec- IN BRIEF Loving Care and Unique Formulations busines- tive categories in the South African FMCG mar- ses (OTC bulletin,17 April 2009, page 7; OTC ket as a whole (see Figure 2). ■ DAIICHI SANKYO said sales of its OTC bulletin,30 November 2009, page 1). A move Meanwhile, volume growth of the OTC busi- products in Japan had declined by 7.4% to by consumers towards preventive products had ness’ digestive/stomach/urinary remedies and its ¥43.7 billion (C394 million) in the year ended also boosted sales in this category,the com- vitamins/minerals/supplements/tonics brands 31 March 2010. The Japanese firm blamed the pany added. had easily outstripped that of their respective drop on lower sales of ‘category 1 medicines’ Operating profit at the OTC business grew categories’ volume rises, the firm pointed out. – OTC medicines such as switch products, by 9.8% to R208 million, pushing up the oper- In value terms, only two of the OTC busi- deemed to hold the highest degree of adverse- ating margin by 0.8 percentage points to 32.8%. ness’ four key categories in the FMCG chan- event risk – including its Gaster 10 brand. Noting that it had grown its share of South nel had performed better than the market, Ad- Africa’s OTC market over the six months, Ad- cock Ingram said. ■ TAKEDA said a decline in sales of its Benza cock Ingram said the company remained pos- Cough drops and lozenges posted sales up cold remedy and Nicorette smoking-cessa- itive about its prospects in the sector. by 5.8% in a category which had declined by tion products had led to a 9.5% fall in turnover at its Consumer Healthcare business to Category Volume sales growth (%) Value sales growth (%) ¥58.2 billion (C530 million) in the year ended Total category Adcock Ingram Total category Adcock Ingram 31 March 2010. The Japanese company’s total sales fell by 4.7% to ¥1.47 trillion. Analgesics -12.3 -10.0 +0.5 -2.1 Cough drops & lozenges -14.5 -3.0 -8.6 +5.8 ■ NAVA MEDIC said sales through its Vita- Digestive/stomach/ -4.5 +3.0 +3.4 +1.4 flo Scandinavia sales and distribution business urinary remedies had increased by 7.5% to NKr13.1 million Vitamins/minerals/ +20.6 +118.0 +19.8 +129.8 (C1.61 million) in the first quarter of 2010. supplements/tonics* Vitaflo Scandinavia distributes the Glucomed * Including Tender Loving Care and Unique Formulations glucosamine brand in Denmark, Finland, Nor-

Figure 2: Adcock Ingram’s volume and value sales growth in key product categories in South Africa’s ‘fast-moving way and Sweden. consumer goods’ channel for the six months ended March 2010 (Source – AC Nielsen/Adcock Ingram) OTC

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COMPANY NEWS OTC

First-Quarter Results Mergers & Acquisitions A&D overcomes Sigma opens accounts tough conditions to South Africa’s Aspen &D Pharma reported a “very strong set Aof top-line results” in the first quarter of 2010, despite an operating environment that ustralia’s Sigma Pharmaceuticals will not The board warned that the due-diligence remained challenging, according to chief ex- Asolicit any further takeover bids for the process Aspen was undertaking “may or may ecutive officer Robert Popescu. next four weeks, as South Africa’s Aspen Phar- not result in a formal proposal or a recommen- Sales at A&D Pharma – the Dutch holding macare undertakes due diligence ahead of a dation by the board”. company which operates the Sensiblu phar- possible A$1.49 billion (C1.02 billion) acqui- Aspen’s takeover bid came after Sigma – macy chain and Mediplus wholesaling busi- sition of the company. which has interests in OTC products, generic nesses in Romania – increased by 33% to C150 Sigma said it would provide Aspen with due pharmaceuticals, pharmacy retailing and drug million over the three months. diligence information under the terms of a con- wholesaling – reported a net loss of A$389 mil- The 227-strong Sensiblu pharmacy chain fidentiality agreement. It had also agreed “not lion for the year ended 31 January 2010. reported turnover up by 32% to C57.6 million, to solicit rival bids for another whole business Sigma reported the net loss after cutting its as A&D Pharma focused on improving prof- transaction for Sigma, or to enter into contracts goodwill valuations by A$424 million. Sales itability at existing stores. in relation to asset sales” for four weeks from rose by 4.5% to A$3.22 billion (OTC bulletin, Mediplus said wholesaling revenue – in- 31 May 2010. 16 April 2010, page 2). cluding intra-company sales – had improved However, the troubled Australian firm noted In the wake of the results announcement, by 56% to C121 million in the face of what that it would continue with its previously-an- Sigma’s chief executive officer Elmo de Alwis A&D Pharma described as “difficult macro- nounced asset-sale programme. and chief financial officer Mark Smith stepped economic conditions”. Sigma’s board of directors continued to ad- down. Smith has already left the firm, while de Although turnover at the company’s sales vise the firm’s shareholders to take no action Alwis – who has spent 33 years at Sigma – will and marketing business dropped by a fifth to over Aspen’s “non-binding, indicative and con- remain in place until a replacement is found. C10.9 million – due to reclassifying some prod- ditional proposal”. Made at the end of May, Aspen’s existing Australian subsidiary gen- ucts to the wholesale business – A&D Pharma this was for all of the company’s issued share erates annual sales of around A$180 million said the business remained at the centre of its capital at a price of A$0.60 per share (OTC from an Ethicals division and an OTC/Grocery expansion plans, thanks to the sales and mar- bulletin,31 May 2010, page 1). The deal would division, which currently markets the Bio-Oil keting business’ “flexibility and ability to de- also see Aspen assume Sigma’s debts of A$785 skincare products, Murine eye drops range and velop strategic partnerships”. million, taking its value to A$1.49 billion. Tixylix cough and cold brand. Several new partnerships had already been OTC agreed this year,the firm revealed, including a deal with Bristol-Myers Squibb’s European Distribution Agreements/Trading Update OTC business, UPSA, whose products were now promoted more prominently within Sen- Decapinol gains distribution in France siblu pharmacies. inclair Pharma’s Decapinol gingivitis prod- market, after mutually terminating its deal with Focus on higher-margin portfolio Sucts will soon be available for the first time the Johnson & Johnson subsidiary Orapharma The sales and marketing unit would con- in France after the UK-based speciality phar- (OTC bulletin,30 November 2009, page 2). tinue to focus on developing a higher-margin maceutical company signed up Laboratoires Chris Spooner,chief executive officer of Sin- product portfolio, A&D Pharma stated, con- Expanscience as a distributor. clair,said further Decapinol distribution deals taining “speciality and primary-care medicines, The agreement gives Expanscience the right could be expected during the rest of 2010. OTC products, cosmetics, dermo-cosmetics to distribute the mouthwash, toothpaste, gel and Looking ahead, Spooner – who was made and medical devices”. spray based on delmopinol under a brand name chief executive officer late last year (OTC bul- At the beginning of this year,A&D Pharma to be decided. letin,30 October 2009, page 26) – said the struck a deal to acquire several pharmaceuti- Expanscience would target French dentists company anticipated reporting like-for-like cal firms across five countries in central and and pharmacists throughout the country as well underlying sales growth of 7% for the final eastern Europe for C23.2 million (OTC bul- as in overseas départments and territories, Sin- six months of its financial year ending 30 June letin,20 January 2010, page 5). clair pointed out, adding that it anticipated pro- 2010. This compared with a decline in sales of The company agreed to acquire Bulgaria’s duct launches would begin in 2011. 1% over the opening six months. Arishop Pharma AD and its local subsidiary,as Meanwhile, negotiations with a new US dis- A strong recovery in the Italian market and well as the Romanian-based Ozone Laborato- tributor for Decapinol were at an “advanced a new strategy in France had driven the improv- ries’ businesses in the Czech Republic, Hun- stage”, with the company confident of signing ed performance, Spooner said. gary,Poland and Slovakia. A&D Pharma said an agreement before the end of 2010. Annualised costs had also been reduced by the companies would add around 12% to the In November of last year,Sinclair announc- £1.5 million, Spooner noted, thanks to a re- group’s annual turnover. ed it was seeking a US distributor that could structuring programme. OTC reposition Decapinol mouth rinse for the OTC OTC

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OTC COMPANY NEWS

First-Quarter Results First-Quarter Results Hypermarcas Weak cold season hits doubles sales sales at ProPhase Labs razil’s leading OTC company, Hypermar- Bcas, said that acquiring the Neo Química OTC and generics business at the end of last ales at ProPhase Labs – formerly Quigley lion cut in sales, marketing and administration year had helped to more than double its Pharma SCorporation – halved in the first quarter of costs, ProPhase noted, and spending US$0.16 sales during the first quarter of 2010 to BRL318 2010 to US$2.0 million (C1.6 million) due to a million less on research and development. million (C134 million). lower incidence of colds and reduced confec- Looking ahead, Karkus said the end of the Neo Química had contributed BRL105 mil- tionery and contract manufacturing turnover. 2009/2010 cold season marked the “beginning lion in sales to the company’s Pharma division, However, Ted Karkus, chairman and chief of a wonderful new phase” at the company, which comprises the Dorsay Monange OTC executive officer of ProPhase, said that overall which had changed its name from Quigley to business and the company’s prescription unit. he had been pleased with the company’s per- ProPhase Labs at the end of May (OTC bul- Excluding the acquisition, Pharma’s turnover formance over the 2009/2010 cold season. letin,14 May 2010, page 9). increased by 35%. “Concerns over swine flu in the third quar- The name change came after a year during Purchased in a cash and share deal worth ter of 2009 started our cold season early,” Kar- which the company’s founder Guy Quigley was BRL1.29 billion in December of last year (OTC kus noted, adding that the incidence of swine ousted by Karkus (OTC bulletin,31 July 2009, bulletin,18 December 2009, page 3), Neo Quí- flu “then ended abruptly”. page 31). mica not only expanded Hypermarcas’ Dor- The sales weakness caused by the swift end For the upcoming season, the company had say Monange OTC business, it also took the to swine flu demand had been compounded by “dramatically” upgraded product packaging, company into the Brazilian generics market a lower incidence of respiratory illness than in Karkus pointed out, significantly improved the for the first time. the same period of 2009, Karkus added, which taste of existing Cold-EEZE flavours and had The Pharma division accounted for 48.5% of had meant sales of cold products had peaked also developed a new mint frost fresh flavour. Hypermarcas’ total first-quarter sales, which in the fourth quarter of 2010 and dropped off Kids-EEZE non-liquid medicines would also increased by 70.7% to BRL657 million. The during the first quarter of this year. be reintroduced, Karkus revealed, with improv- Despite the decline in turnover, ProPhase ed packaging, pricing and taste. Food Home Care – which owns the Cold-EEZE and Kids-EEZE Advertising campaigns and “go-to-market” 8.8% 8.4% cold remedies – managed to cut its net loss in strategies had been overhauled, Karkus added, BRL58 million BRL55 million half from US$2.2 million over the first three while senior management had met with key months of 2009 to US$1.1 million this time. retail customers with the aim of greatly improv- The reduction was thanks to a US$2.2 mil- ing distribution of the company’s products. OTC

First-Quarter Results First-Quarter Results Alkaloid drives up Grindeks reports Pharma Personal Care 48.5% 34.4% BRL318 million OTC sales by 7.9% decline in turnover BRL226 million lkaloid’s OTC sales increased by 7.9% to atvia’s Grindeks has reported sales down Figure 1: Hypermarcas’ sales in the first quarter of AC4.48 million in the first quarter of 2010. Lby 4.9% to LVL13.5 million (C19.1 mil- 2010 – BRL657 million – broken down by business (Source – Hypermarcas) The OTC business generated 23.5% of sales lion) in the first quarter of 2010. The comp- by the Macedonian company’s dominant Phar- any offers a portfolio of prescription medi- Personal Care business generated a further maceuticals division, which reported turnover cines, generics, active pharmaceutical ingred- 34.4%, Food another 8.8% and Home Care the down by 0.6% to C19.0 million. Antibiotics, ients and OTC brands. remaining 8.4% (see Figure 1). central nervous system products and cardiovas- The majority of the firm’s sales – LVL12.6 Total group earnings before interest, tax, cular ranges mainly made up the remainder of million – had been generated through exports depreciation and amortisation (EBITDA) in- the division’s sales. to 39 countries worldwide, Grindeks said. creased by 75.1% to BRL179 million. Alkaloid’s OTC portfolio includes the Bil-ol, Following the close of the quarter,Grindeks Founded in 2002, Hypermarcas’ business Caffetin, Diprol and Primulin brands, as well as resigned from Latvia’s employers’ confeder- strategy is built on an aggressive acquisitions various herbal drops. ation, the LEC, in protest at the body’s pres- policy, which has seen the company make nu- Group sales – including the Chemical, Cos- ident selling an 11.3% stake in the company merous purchases across all of its business areas metics and Botanicals divisions as well as Phar- to Russian pharmaceutical firm Pharmstandard over the past seven years. In 2009, the com- maceuticals – improved by 2.4% to C22.9 mil- (OTC bulletin,30 April 2010, page 7). pany made five acquisitions totalling around lion. Operating profit had advanced by 5.0% The company accused the LEC’s president BRL2.0 billion. to C3.18 million, the company said. of “essentially breaching business ethics”. OTC OTC OTC

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COMPANY NEWS OTC

Business Opportunities Oxford Nutrascience offers two new chews to industry

xford Nutrascience has two new chewy ingredients often tended to have too low a dose O confectionery products available for lic- to be effective. Oxford Nutrascience has developed a cranberry ensing to brand owners worldwide. One is a Traditional confectionery chews were made supplement (pictured above) and a children’s product cranberry supplement, and the other is a child- soft, it noted, by balancing the use of crystal- containing omega-3 (below) using its fortified chewy ren’s product containing prebiotic fibre, omega- lising sugars (sucrose) with reducing sugars confectionery technology 3 and vitamins A, C, D and E. (glucose syrup). Adding minerals to tradition- Nigel Theobald, chief executive officer of al confectionery chews could lead to a gritty Oxford Nutrascience, said the firm could offer texture, the company maintained. exclusive licensing deals to brand owners. The taste benefits of using traditional con- Theobald added that the formulations of the fectionery chews could also be outweighed 6g twist-wrap chews could be “tweaked” to by the high sugar content, the company said, meet the needs of brand owners. The cranberry but reducing the sugar and fat content of a supplement currently contained 250mg cran- traditional confectionery chew could compro- berry extract, he said, but this could be increas- mise both its taste and texture. ed to 500mg. Similarly,the children’s product Oxford Nutrascience said its system used incorporated 50mg omega-3, but this could be a blend of prebiotic soluble fibres to reduce It is still early days for Oxford Nutrascience, raised to 200mg. the sugars and fat traditionally used to make which through the Ellactiva brand had sales According to Theobald, the company’s pro- chews, and to provide favourable organolep- of £54,293 (C65,000) in the year ended 31 Dec- prietary fortified chewy confectionery system tic properties. There was “no loss in taste pro- ember 2009. The company’s operating loss in- was a good format for unpleasant-to-take profile” from the reduced sugar,it insisted. creased from £120,038 in 2008 to £240,518 ducts, such as large calcium tablets or child- As well as seeking brand owners to license in 2009. ren’s supplements. “The use of soluble fibres the products, Oxford Nutrascience said the two Oxford Nutrascience has just raised £1.1 enables functional ingredients, such as vita- chews would be launched under the company’s million before expenses through an initial pub- mins and minerals, to be added without com- own brand names during the second half of lic offering (IPO) on London’s Alternative In- promising taste, texture or stability,” he said, this year. The cranberry supplement will be vestment Market (AIM) (OTC bulletin,26 Feb- adding that products were “high in fibre yet part of the Ellactiva range, which is sold in ruary 2010, page 8). reduced in sugar and fat”. the UK and the Middle East. The company has also just filed two inter- Brand owners can request samples of the Oxford Nutrascience recently signed an ex- national patent applications covering more than products by contacting Theobald via e-mail clusive manufacturing agreement with confec- 130 countries. One involves the chewable oral ([email protected]). tionery specialist Lamy Lutti. “The partnership delivery system of the company’s Chewitab Oxford Nutrascience said many ingredients, with Lamy Lutti provides a scaleable produc- technology,while the other covers its gels, syr- such as omega-3, had poor taste profiles and tion facility and allows the company to expand ups and suspension systems. Oxford Nutra- food supplements containing them were often its chew development capability,” said Oxford science said both applications claimed prior- rejected by consumers. However, the company Nutrascience, noting that further chews should ity from the delivery system patent application added that functional foods fortified with these be brought to market in 2011. filed by the company in April 2009. OTC

Distribution Agreements An important consideration had been Asia United’s marketing and distribution experience BioGaia to take first step into China with pharmaceutical products requiring refrig- eration, BioGaia noted. ioGaia is set to take its first step into the ideal partner to help the company establish its The deal with Asia United is BioGaia’s sec- B Chinese market, after signing Asia United probiotic drops in the “very large and growing” ond major agreement in Asia so far this year. (China) Medical to distribute its probiotic drops. Chinese market. In February,the company expanded its pres- Under the terms of the exclusive deal, Asia Primarily a distributor of oral cholera vac- ence in Japan by signing a distribution agree- United will sell the drops – containing the Swe- cines and growth hormones, Asia United is a ment for the majority of its BioGaia-branded dish firm’s Lactobacillus reuteri probiotic – un- member of the Unilab Group, described by Bio- probiotic products with wholesaler Nippon Ac- der the BioGaia brand name in mainland China. Gaia as a “privately-held regional pharmaceu- cess (OTC bulletin,17 March 2010, page 7). BioGaia said the drops were expected to be in- tical and healthcare company with a leading BioGaia’s probiotic drops will also be avail- troduced at the end of 2011. position in south-east Asia”. Unilab had strong able in Indonesia from 2011 since the comp- Peter Rothschild, president of BioGaia, said brands in Indonesia, Malaysia, Myanmar,the any struck a distribution deal with Interbat in the deal represented an “important first step” Philippines, Singapore, Thailand and Vietnam, April (OTC bulletin,30 April 2010, page 9). into China. He added that Asia United was an the company added. OTC

11 June 2010 OTC bulletin 7 OTC11-06-10p8-9FIN.qxd 8/6/10 08:10 Page 2

OTC COMPANY NEWS

Business Strategy Omega aims to double its UK business

elgium’s Omega Pharma is seeking to dou- At the start of this year,Omega Pharma ap- Bble the size of its UK business over the next pointed VCCP – the advertising agency behind four years through a combination of organic the memorable “meerkat” campaign for com- growth, acquisitions and licensing deals. parethemarket.com – to reinvigorate its OTC UK managing director Nigel Bathurst said brands. The company is also working with the the former Chefaro operation – which owns media buyer AW Media, and the public rela- the Buttercup, Jungle Formula, Lyclear,TCP tions firm Virgo Health. and Wartner brands – had been a “sleeping The first fruits of the partnership with VCCP giant” in the UK OTC market. “But we have will be seen on 17 June, when a new televi- made a fresh start across the entire operation,” sion commercial for the Jungle Formula range “Jungle boogie” is the theme of Omega Pharma’s he pointed out, adding that the company was of insect repellants makes its debut. new television advertising for its Jungle Formula insect repellents in the UK “working to unlock the potential of its exist- Wines said the “jungle boogie” creative took ing brands through an approach rooted in con- a “fun and engaging” approach that broke away ful consumer communications, he added, and sumer insight”. from the norms of the OTC market. Featur- some would also benefit from strong pharm- Since becoming managing director a year ing a soundtrack from Kool & The Gang, the acy communications. ago, Bathurst has moved the business to Lon- commercial was based around holidaymakers According to Bathurst, Omega Pharma was don and recruited a team with OTC expertise. reacting to the instantly-recognisable sound of ranked around number 10 in the UK OTC mar- Marketing director Andy Wines has a strong an approaching mosquito, he explained. ket with a share of around 1.5%. He stressed record in the OTC industry,including global Wines said Omega Pharma was investing this was “not good enough”. marketing positions with Johnson & Johnson, £1.0 million (C1.2 million) in the Jungle For- As well as stepping up marketing activity, Reckitt Benckiser,and Roche Consumer Health. mula campaign, which was the first significant Omega Pharma intends to drive growth in the Similarly,sales director Kay Patton has worked consumer advertising for the brand in years. UK by extending its brands with product inno- on the Nicorette and Benecol brands. Wartner would be the next to benefit, said vations. Bathurst noted that these could be Bathurst said Omega Pharma had review- Wines, with a digital, outdoor and trade-press drawn from Omega Pharma’s subsidiaries in ed its roster of agencies, and taken a long hard advertising campaign commencing at the end other countries, the company’s innovation cen- look at how it did business with its retail cus- of June. The theme of the campaign would be tre in Belgium, or the local new product devel- tomers. “The coming months will see the com- “happy fingers and toes”, he said. opment facility in the UK. pany’s profile grow as star brands are relaunch- Wines stressed that Omega Pharma would Bathurst added that the company was keen ed with a dynamism rarely seen in consumer do “whatever is right to drive growth of its to make acquisitions and agree licensing deals. health,”Bathurst promised. brands”. Brands would be backed by impact- He declined to comment in detail but said the company was looking for deals that comple- The team behind the new strategy at Omega mented its existing business. Pharma in the UK In the longer term, Bathurst said that the comprises marketing UK business would be boosted by tapping into director Andy Wines (pictured left), Omega Pharma’s portfolio of established brands managing director Nigel in other countries. Bathurst (centre) and It is still early days for the new team, but sales director Kay Patton (right) releasing its first-quarter results earlier this year Omega Pharma noted that the UK business had been boosted by “strong growth” for the first time in two years (OTC bulletin,30 April 2010, page 5). OTC

IN BRIEF ■ MHRA – the UK’s Medicines and Health- vide patients with information to better man- ■ FDA – the US Food and Drug Administra- care products Regulatory Agency – said a new age their own healthcare and to assist in the tion – has warned Americans not to purchase area on its website was dedicated to the Reg- reduction of medication errors,”said the FDA, or use a product called Arrow Brand Medi- ulation of Medicines Review Panel, which dealt adding the site attracted more than 12 million cated Oil and Embrocation. The regulatory with disputes over regulation of medicines. unique visitors each month. A joint resource agency said that the product, which contained on Drugs.com will provide consumers with methyl salicylate and camphor,was potential- ■ FDA – the US Food and Drug Administra- FDA Consumer Update articles, videos, and ly toxic. Preliminary testing on samples indi- tion – is working with the website Drugs.com slideshows. Consumers will also have access cated that it contained diethylene glycol, an to expand access to the agency’s consumer to FDA health information on Drugs.com’s ingredient used in antifreeze, added the FDA. health information. “Drugs.com seeks to pro- mobile phone platform. OTC

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GENERAL NEWS OTC

Distribution ECJ at odds with Commission on pharmacy

ules for establishing pharmacies that are ment, the local court had referred the matter Nevertheless, the ECJ had reservations about Rbased on population density and location to the ECJ. whether a uniform application of the 2,800 in- constitute a restriction on the freedom of estab- The two pharmacists were objecting to a sys- habitants and 250 metres rules would be suc- lishment, the European Court of Justice (ECJ) tem in Asturias that allows only one pharmacy cessful in ensuring adequate access everywhere. has ruled. However, it also found that such mea- per 2,800 inhabitants and insists pharmacies If the inhabitants rule were to be uniformly ap- sures, which are frowned upon by the Euro- must be at least 250 metres apart. Subsequent plied in rural areas, it said, certain inhabitants pean Commission, could be justified under cer- pharmacies may be opened once the popula- would find themselves beyond reasonable reach tain circumstances and were therefore compat- tion threshold has been exceeded, but for the of a pharmacy. Conversely,in areas of high pop- ible with European Union law. fraction above 2,000 inhabitants. Selection cri- ulation density,the 250 metres rule could give The Commission has called for such phar- teria, with licences awarded to pharmacists on rise to pharmacies serving an area containing macy-establishment rules to be abolished, and the basis of their professional and teaching ex- more than 2,800 inhabitants. is still pursuing an infringement proceeding perience, are also part of the local rules. However, the Asturian decree implemented against Spain. The ECJ found firstly that the rules relating national legislation, the Court observed, and In a judgement delivered on 1 June 2010, the to population density and minimum distance this provided for adjustments to the basic for- ECJ named four conditions under which phar- between pharmacies applied without discrim- mulae. “The Court finds that it is for the refer- macy-establishment rules could be justified: the ination on grounds of nationality,thus meet- ring court to determine whether the competent measures must apply in a non-discriminatory ing the first of the Court’s four conditions. authorities make use of the power conferred manner; they must be justified by overriding National legislation was justified, the ECJ by national legislation,”the ECJ said. reasons relating to the general interest; they continued, as its objective – namely that the pro- On the matter of selection criteria, however, must be appropriate for attaining the objective vision of medicines to the public was reliable the ECJ pointed out that preferring local can- pursued; and they must not go beyond what is and of good quality – constituted an overrid- didates was discriminatory,and was therefore necessary for attaining that objective. ing reason relating to the general interest. precluded by freedom of establishment. Noting that pharmacy-establishment rules OTC contributed to an even distribution of pharmacies, John Chave,secretary-general of the pharmacy body,the Pharmaceutical Group of the European Union (PGEU), commented: “More than half European Union states have establishment rules for pharmacy, some based on rules almost exactly the same as Spain’s. If the Court had declared them illegal, it would have brought about a significant change in how these states manage their health systems.”

A matter for member states Chave noted, however, that while the ECJ had not questioned the validity of the rules, it had qualified its judgement by saying that such pharmacy-establishment rules needed to be flex- ible enough to meet local needs. He also added: “This judgement will be welcomed by those who believe that health-service planning should be a matter for member states.” In Spain, national legislation makes the set- ting up of a new pharmacy conditional upon prior administrative authorisation. That legislation is implemented by the Autonomous Com- munities, which set specific criteria for the licensing of new pharmacies. Two pharmacists in Spain – José Manuel Blanco Pérez and Maria del Pilar Chao Góm- ez – had challenged the Autonomous Commu- nity in Asturias, Spain, over the local pharmacy-licensing system. Uncertain whether the Asturian decree was compatible with the Euro- pean Union principle of freedom of establish-

11 June 2010 OTC bulletin 9 OTC11-06-10p10-11FIN.qxd 8/6/10 08:40 Page 2

OTC GENERAL NEWS

Regulatory Affairs thermore, some patients in the reported cases had used other drugs or had other conditions Alli labelling to include that may have contributed to the development of severe liver injury,the FDA said, and severe liver injury could occur in people not taking drugs and without a distinct cause. liver injury warning in US Although there was no confirmed link, the FDA said it had added the information about reported cases of severe liver injury to the lab- laxoSmithKline Consumer Healthcare’s of orlistat – covering both the 120mg prescrip- els of Alli and Xenical to educate the public GAlli weight-loss medicine in the US will tion strength used in Xenical and Alli’s 60mg about the signs and symptoms of liver injury carry a warning about rare reports of severe non-prescription strength – that had been an- and the need to see a physician promptly should liver injury,after the Food and Drug Admin- nounced in August of last year (OTC bulletin, they occur. istration (FDA) completed a safety review of 31 August 2009, page 1). Commenting on the new safety informa- the product’s active ingredient, orlistat. The agency noted that one US report con- tion, Howard Marsh, chief medical officer for The company said the updated Alli label ad- cerning severe liver injury with Alli and 12 GlaxoSmithKline Consumer Healthcare, said vised users to: “Stop use and ask a doctor if you foreign reports with Xenical had been identi- the company was committed to ensuring that develop itching, yellow eyes or skin, dark urine fied by the review. consumers and physicians understood the safe- or loss of appetite. There have been rare reports However, the FDA acknowledged that it had ty profile of orlistat and Alli. of liver injury in people taking orlistat.” been unable to establish a cause and effect re- In the wake of the FDA’s “early communi- Labelling on Xenical – Roche’s prescription lationship between severe liver injury and orli- cation about an ongoing safety review” into drug containing orlistat – has also been chang- stat for a number of reasons. Only 13 cases had orlistat last August,GlaxoSmithKline launched to reflect the new safety information. been reported between April 1999 and August ed a major communication campaign in the US The FDA said the label revisions had been 2009 out of an estimated 40 million people to stress publicly the safety and efficacy of Alli agreed after it had completed the safety review worldwide who had used Xenical or Alli. Fur- (OTC bulletin,30 September 2009, page 14). OTC

Regulatory Affairs FDA’s investigators had documented Perrigo’s failure to follow standard operating procedures FDA sends Warning Letter to Perrigo during the past three FDA inspections, as well as in other inspections since 1998. ■ Continued from front page been affected, the Warning Letter explained, Although Perrigo had acknowledged the The FDA said it expected Perrigo’s corporate the company had released and shipped a sub- procedural errors and recalls in its 1 February management to carry out a “comprehensive portion of that segregated lot, resulting in the 2010 response to the findings, the company evaluation of manufacturing operations to en- recall of the entire lot. had not provided the “corrective actions” it sure compliance with cGMP”. Furthermore, the store-brand specialist had planned to take to prevent recurrences in the Perrigo had 15 working days from receipt failed to “thoroughly investigate the failure of future, the FDA said. of the Warning Letter to notify the FDA of the a batch – or any of its components –to meet its Meanwhile, the Warning Letter pointed out, steps it had taken to correct violations or to state specifications, whether or not the batch had Perrigo had also failed “to inspect adequately the reason for delay and the time within which already been distributed”, the Warning Letter the packaging and labelling facilities immedi- it would complete the corrections. The company noted, and had failed to “extend investigations ately before use to assure that all drug products said it had now submitted a written response. to other batches of the same drug products that had been removed from previous operations”. The FDA stressed in the Warning Letter that may have been associated with the failure”. Specifically,on 10 December 2008 and 13 failure to correct the violations promptly “may One example of this had been the company’s February 2009 film-packaging employees had result in legal action without further notice in- decision not to investigate thoroughly possible observed foreign tablets, the FDA said, after cluding – without limitation – seizure and in- foreign tablet-contamination in its filling equip- Perrigo had failed to remove all ibuprofen tab- junction”. Furthermore, the FDAmay withhold ment, the FDA said. lets from a prior lot before starting the packag- approval of pending drug applications listing the After finding a brown, round ibuprofen tab- ing and labelling of ibuprofen caplets. facility,added the FDA, and other federal agen- let in a lot of brown, oval ibuprofen tablets, Per- The FDA Warning Letter pointed out that Per- cies could take the Warning Letter into account rigo did not inspect the lot of orange, round rigo had had an ongoing programme since 2005 when considering the award of contracts. ibuprofen tablets that was packaged in between to address mix-ups. However, the company had In its Warning Letter,the FDA said the in- the two lots, and therefore could not provide continued to receive complaints, the agency spection had found that Perrigo had not rejected any assurance that this lot had not also been said, and the deviations had continued, despite drug products that “failed to meet established contaminated, the agency pointed out. past assurances that previous enhancements standards or specifications and any other rele- Further violations included the failure of Per- would control these problems. vant quality control criteria”. rigo’s quality control unit to follow written stan- As a result, the FDA said it had “concerns” It cited Perrigo’s failure to reject a lot of dard operating procedures,the FDA said. This about the failure of Perrigo, including its qual- 200mg ibuprofen tablets that had been con- had led to recalls of batches of regular,cherry- ity control unit, to act “proactively” to ensure taminated with metal shavings due to an equip- flavoured and mint-flavoured Milk of Magne- compliance with standard operating procedures ment failure as an example. Although Perrigo sia due to mislabelling. and cGMP regulations. had segregated a portion of the lot that had The Warning Letter pointed out that the OTC

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GENERAL NEWS OTC

Regulatory Affairs notifications submitted to the agency, the bill wants prompt guidance from the FDA that clar- Bill seeks full enforcement ifies “when a dietary supplement ingredient is a new dietary ingredient, the evidence needed to document the safety of new dietary ingredients, and appropriate methods of establish- of DSHEA supplements law ing the identity of a new dietary ingredient”. Moreover, the bill wants the FDA to liaise ore than 15 years after the US passed that it would need between US$24 million (C20 more closely with the Drug Enforcement Ad- Mlandmark dietary supplement legislation, million) and US$65 million per year fully to ministration over anabolic steroids, or analogues abill has been introduced into the Senate that implement DSHEA, the bill also highlights the of anabolic steroids, that the agency suspects seeks to ensure the legislation is fully imple- FDA’s need for adequate resources. Additional may be in a dietary supplement as a result of mented and enforced. funds of just US$14 million were made avail- rejecting a new dietary ingredient notification. Tabled by senators Tom Harkin and Orrin able for the job in the year to September 2009, The bill authorises US$30 million to be spent Hatch, bill S3414 refers to the Dietary Sup- the senators note. in the year to September 2011 “and such sums plement Health and Education Act (DSHEA) The FDA should increase its efforts to im- as may be necessary” for the subsequent years of 1994 that covers new dietary ingredients, plement DSHEA “more fully and effectively”, to September 2014 to carry out its provisions. scientific substantiation of claims, good man- the bill says, by conducting inspections of all In the current year,it wants US$20 million to ufacturing practice (GMP) requirements and facilities where supplements are made to en- be found for its purposes. penalties for mislabelled or adulterated dietary sure compliance with GMP regulations for sup- The Office of Dietary Supplements within supplements. “While the Food and Drug Ad- plements. The agency should also ensure claims the National Institutes of Health should get ministration (FDA) has taken some important are “truthful,non-misleading and substantiated”, US$40 million this year for “expanded re- steps to implement and enforce DSHEA,”the and give the “highest regulatory priority” to search and development of consumer informa- two senators say in their bill, “the agency has “clear violations of the law” concerning inten- tion on dietary supplements”, and sums as need- not fully implemented and enforced it.” tional adulteration and spiking of products. ed until September 2014. The move has been welcomed by the Coun- All dietary supplement manufacturers, pack- One of the first jobs given to the FDA is to cil for Responsible Nutrition (CRN) and the ers and distributors should be required to par- estimate the annual costs of fully implement- Natural Products Association (NPA). “Many of ticipate in an annual registration process, and ing and enforcing DSHEA over the next five the challenges our industry continues to face,” the FDA should develop consumer education years. The agency is also tasked with produc- the CRN said, “can be attributed to the lack of initiatives. ing comprehensive annual reports from Jan- enforcement of the basic tenets of DSHEA.” Noting that the FDA had raised objections uary 2011 on how it is spending the money Noting that the FDA had estimated in 2002 to more than 70% of all new dietary ingredient and fulfilling the bill’s requirements. OTC

Regulatory Affairs J&J accused of covering up a “phantom” product recall

■ Continued from front page Towns said at the committee hearing that icine in history”. “But today we learned from -chase Project involved buying all of the Mot- he would be seeking a change in the law to the FDA that it was more than twenty-times rin IB Caplet 8 count vial products available give the FDA mandatory recall authority,as that, namely 136 million bottles.” in stores. “You should simply act like a regu- well as the power to order a halt in drug pro- Colleen Goggins, worldwide chairman of lar customer while making these purchases,” duction. “The FDA shouldn’t have to persuade Johnson & Johnson’s Consumer Group, told the contractor’s agents were told. “THERE a company to recall suspect products,”he said. the hearing the recall was a “disappointment”. MUST BE NO MENTION OF THIS BEING “I intend to introduce legislation to give FDA McNeil’s quality and process issues were “un- A RECALL OF THE PRODUCT!” it adds that authority.” acceptable”, she said, apologising to parents (emphasis as in the original). In a statement following the hearing, Towns for the “concern and inconvenience caused”. Nearly 100,000 packs of the Motrin prod- added that he had “serious questions” about The FDA’s principal deputy commissioner, uct had been distributed in August 2008, the McNeil’s Fort Washington, Pennsylvania plant Joshua Sharfstein, said the FDA had expres- FDA document says, but a dissolution prob- which had made the four PediaCare products sed its “significant concern” that McNeil had lem was identified a few months later in Nov- recalled at the end of May. shown “a pattern of conduct”, including failure ember. The contractor had been asked to per- These had been recalled as a precautionary to report material information to the agency. form “statistical sampling” of retailers, accord- step, Blacksmith Brands said, “because they It was also concerned about whether McNeil’s ing to the company, to determine if a recall was were made at the McNeil plant that has been corporate culture “was appropriately focused necessary,but the FDA learned of its actions. temporarily shut down”. on product quality”. In July 2009, McNeil initiated a recall after “FDA is considering additional enforcement having been contacted by the FDA about the Misrepresented size of recall actions against the company for its pattern of third-party contractor’s activities. Although the Towns noted that Johnson & Johnson had non-compliance which may include seizure, dissolution problem had been identified in Nov- misrepresented the size of the most recent Mc- injunction or criminal penalties,”commented ember 2008, the agency emphasises, the recall Neil recall, putting it at six million bottles, Sharfstein. was not started until the following July. making it the “largest recall of children’s med- OTC

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OTC GENERAL NEWS

CONSUMER viewpoint ...... per

Period pain is the subject of this month’s Consumer viewpoint survey France5 15.4%

of ailments suffered by Europe’s Germany4 10.5%

consumers. The survey appears Italy3 27.9%

exclusively in OTC bulletin courtesy Spain2 20.2%

of Ipsos MORI. UK1 6.5%

0.0055.0 10.010 15.015 20.020 25.025 30.030 talian women are more likely to say that they Proportion of women who say they have suffered from period pain (%) Ihave suffered from period pain in the past year than their counterparts in France, Germ- Figure 1: Proportion of women in France, Germany, Italy, Spain and the UK who say they have suffered from any, Spain or the UK, according to our Con- period pain within the past year (Source – OTC bulletin 2010/Ipsos MORI) sumer viewpoint European survey. Proportion of sufferers (%) Index Of the five countries covered by the Ipsos Fra Ger Ita Spa UK Fra Ger Ita Spa UK MORI survey,Italy has the highest proportion of women who say that they have suffered from Male ––––– ––––– period pain during the past year at 27.9%, fol- Female 100.0 100.0 100.0 100.0 100.0 ––––– lowed by Spain at 20.2%, France at 15.4%, 18-24 31.3 21.0 23.9 18.4 23.0 272 236 263 153 184 Germany at 10.5% and the UK at 6.5% (see 25-34 25.9 34.9 26.4 38.1 34.1 136 257 150 184 204 Figure 1). 35-44 42.7 25.5 32.0 29.9 30.5 221 127 162 157 155 The vast majority of period-pain sufferers 45-54 –16.2 16.2 13.5 11.3 –90998366 in all five survey countries are women under 55-64 –1.1 1.6 –0.9 –811 –6 45 years of age (see Figure 2). 65+ –1.3 ––0.3 –5––2 As can be seen from Figure 3, OTC remedies are the most popular treatment option for Figure 2: Consumers in France, Germany, Italy, Spain and the UK who say they have suffered from period pain in the past year, analysed by sex and age. The index indicates the likelihood that a consumer in a specific population the condition in all five countries. group will have suffered from period pain, and is the ratio of the proportion of total sufferers in a population Germany has the highest proportion of suf- group to the proportion of that group in the population as a whole (Source – OTC bulletin 2010/Ipsos MORI) ferers who have treated their period pain with an OTC product at 75.9% (see Figure 4). OTC Ipsos MORI and the ailments survey treaters are most likely to be women under 45 years of age (see Figure 5). ur Consumer viewpoint ailments survey appears exclusively in OTC bulletin courtesy Spain has the highest proportion of women Oof Ipsos MORI. The survey is based on research conducted in February 2009 using Capi- who have treated the condition with a prescrip- bus, the market researcher’s weekly European omnibus service. Ipsos MORI carried out face- tion remedy at 31.7% (see Figure 6), but only to-face interviews with 1,000 plus adults in each of the survey countries – France, Germany, one in 10 sufferers in the UK say that they have Italy,Spain and the UK. An OTCremedy was defined as a product purchased over-the-counter used a prescription remedy. from a pharmacy or off a shop shelf. Spain also has the highest proportion of herbal treaters at 11.1%, closely followed by Italy ■ For more information on the research supplied by Ipsos MORI, please contact Susan Purcell (Tel: +44 208 at 10.6% and the UK at 9.1% (see Figure 7). 861 8000; Fax: +44 208 861 5515; E-mail: [email protected]). OTC OTC

80.080

Product type 60.060 Series1OTC 40.040 Series2Prescription Series3Herbal

20.020

0.00

Proportion of sufferers treating with..... (%) France12GermanyItaly345Spain UK

Figure 3: Proportion of women in France, Germany, Italy, Spain and the UK who say they have suffered from period pain who have treated the condition with an OTC, prescription or herbal remedy (Source – OTC bulletin 2010/Ipsos MORI)

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GENERAL NEWS OTC

Regulatory Affairs ...... period pain Three more herbal monographs done

France5 46.2%

Germany4 75.9% hree more Community herbal monographs Thave been finalised by Europe’s Commit- Italy3 61.3% tee on Herbal Medicinal Products (HMPC). Spain2 70.0% Monographs for Mate folium (mate leaf),

UK1 56.7% Ribis nigri folium (blackcurrant leaf), and the combination of Valerianae radix and Lupuli 0.00115.05330.00445.05660.00775.05990.00 flos (valerian root and hop strobiles) were fin- Proportion of women suffering from period pain who have treated the condition with an OTC remedy (%) alised at the HMPC’s May 2010 meeting. They Figure 4: Proportion of women in France, Germany, Italy, Spain and the UK who say they have suffered from bring the total number of final Community her- period pain who have treated the condition with an OTC remedy (Source – OTC bulletin 2010/Ipsos MORI) bal monographs to 63. Proportion of sufferers treating with OTC(%) Index At its May meeting, the HMPC also adopt- Fra Ger Ita Spa UK Fra Ger Ita Spa UK ed three draft Community herbal monographs, which were released for consultation until 15 Male ––––– –––––August 2010. They are for Leonuri cardiacae Female 100.0 100.0 100.0 100.0 100.0 –––––herba (motherwort), Tanaceti parthenii herba 18-24 22.7 27.0 15.0 26.3 28.1 197 303 165 219 225 (feverfew), and Trigonellae foenugraeci semen 25-34 33.1 20.5 47.5 37.2 22.9 174 151 270 180 137 (fenugreek seed). 35-44 28.0 33.6 31.3 31.7 49.0 145 167 158 167 249 The HMPC also endorsed a recommenda- 45-54 16.3 19.0 6.3 4.8 – 106 106 38 30 – tion by the Working Party on Community Mon- 55-64 ––––– –––––ographs and Community List (MLWP) to stop 65+ ––––– –––––the assessment work for Terebinthinae laric- ina (larix). Only one combination product and Figure 5: Consumers in France, Germany, Italy, Spain and the UK who have used an OTC remedy to treat period no single-ingredient products could be found pain, analysed by sex and age. The index provides a measure of the likelihood that a consumer suffering from period pain in a specific population group will have treated the condition with an OTC remedy, and is the ratio of on the European market, noted the commit- the proportion of total OTC treaters in a population group to the proportion of that group in the population as a tee, and no interested parties had reported a whole (Source – OTC bulletin 2010/Ipsos MORI) high priority level for the work. Furthermore, the HMPC is calling for the submission of scientific data for Arnicae flos France5 28.8% (arnica flower), Hippocastani cortex (horse

Germany4 15.8% chestnut bark), and Visci albi herba (mistletoe). Data should be submitted by 30 July 2010. Italy3 16.9% The HMPC is also keen to hear from interested parties about the priorities for estab- Spain2 31.7% lishing Community herbal monographs and UK1 10.8% Community list entries. The deadline is the end of July. 0.005 5.0 10.010 15.015 20.020 25.025 30.030 35.035 Seven entries have so far been added to the Proportion of women suffering from period pain who have treated the condition with a prescription remedy (%) Community list of herbal substances, prepara- Figure 6: Proportion of women in France, Germany, Italy, Spain and the UK who say they have suffered from tions and combinations for use in traditional period pain who have treated the condition with a prescription remedy (Source – OTC bulletin 2010/Ipsos MORI) herbal medicinal products (OTC bulletin,31 May 2010, page 15). Meanwhile,the Association of the Euro- France5 1.0% pean Self-Medication Industry (AESGP) recently had a chance to discuss industry’s experi- Germany4 2.0% ence of national implementation of European Italy3 10.6% Union directive 2004/24/EC with the MLWP. The AESGP highlighted its concerns about fee Spain2 11.1% levels for traditional-use registration in some

UK1 9.1% countries, deviation from herbal monographs, and the substantial delays in some assessment 0.0022.0 4.04686.0 8.0 10.010 12.012 procedures. Proportion of women suffering from period pain who have treated the condition with a herbal remedy (%) The MLWP asked for further information

Figure 7: Proportion of women in France, Germany, Italy, Spain and the UK who say they have suffered from on industry’s experience. period pain who have treated the condition with a herbal remedy (Source – OTC bulletin 2010/Ipsos MORI) OTC

11 June 2010 OTC bulletin 13 OTC11-06-10p14-15FIN.qxd 8/6/10 08:42 Page 2

OTC MARKETING NEWS

Marketing Campaigns Nicabate shows Australians how smoking can age skin

laxoSmithKline Consumer Healthcare is ers did not believe cigarettes had damaged their Gbacking its Nicabate nicotine-replacement skin. The company pointed out, however, that Inova Pharmaceuticals has added a eucalyptus and therapies in Australia with digitally-enhanced its research suggested “smokers of more than menthol-flavoured lozenge to its Duro-Tuss range of images showing how smoking cigarettes can 20 cigarettes a day are three-times more likely cough medicines in Australia. Noting that the newcomer was free of sugar, damage women’s skin. to wrinkle prematurely than non-smokers, and alcohol, lactose and gluten, Inova pointed out that it The public relations campaign was launch- the effect is more pronounced in women than was a “full-strength cough medicine in a convenient, ed ahead of World No Tobacco Day 2010 on in men”. portable dose form for those on the go”. Each Duro-Tuss Chesty Cough lozenge contains 31 May,which had a theme of gender and tob- The research also found that women were 8mg of the mucolytic bromhexine hydrochloride to acco with an emphasis on marketing to women. less likely to have tried to quit than men. Only “clear chest congestion” and 1.33mg of the Former smoker and Australian model Chloe 13% of smokers had not tried to quit, 17% of antibacterial cetylpyridinium chloride to “relieve a sore throat”. A strapline on the packaging highlights Maxwell is fronting the campaign, which fea- whom were women and 9% men. that Duro-Tuss Chesty Cough “Clears congestion and tures eight images of her at the ages of 34, 47, Also to coincide with World No Tobacco relieves a sore throat associated with chesty cough”. 61 and 72 years as a smoker and a non-smoker. Day 2010, GlaxoSmithKline has launched an Last year, Inova launched a lemon-flavoured Duro-Tuss Chesty Cough lozenge, which contains the GlaxoSmithKline said that recent research online behavioural support programme called same active ingredients as the latest addition. The had discovered that 80% of Australian smok- QuitPartner in Australia. company said it was backing the two products with a The company said the programme, which “campaign to help pharmacy staff make appropriate recommendations to consumers”. was available at www.quitpartner.com.au, was Both products are suitable for adults and children “designed to work hand-in-hand with Nicabate aged six years of age and older, and come in packs of products to help smokers deal with not only 24 lozenges. their physical attachment but also their emo- OTC tional and habitual attachment to cigarettes”. Once smokers have registered online, they Marketing Campaigns can track their daily quit progress, receive a per- sonalised quit programme, record where they Herbalife has deal were tempted to smoke and receive tips. In addition, online games are available if smok- with FC Barcelona ers need an immediate distraction to take their mind of cravings. erbalife is sponsoring Spanish football club The Nicabate brand in Australia includes HBarcelona in a “multimillion dollar” deal. GlaxoSmithKline Consumer Healthcare is supporting its Nicabate nicotine-replacement therapies in gum, lozenges and patches. The US-based direct-selling specialist has Australia with an online programme called QuitPartner OTC also agreed a three-year personal sponsorship deal with team player Lionel Messi, who will be involved in its global promotional activities. The agreement with Barcelona to be its Of- ficial Nutrition Sponsor covers global association rights, publicity assets, and a presence at the team’s pre-season friendly games and international tours over the next three years. In addition, Herbalife will provide nutrition program- mes to the club’s first team. Michael Johnson, chairman and chief executive officer of Herbalife, said Barcelona was one of the greatest clubs in the world with ex- traordinary athletes who “illustrate our phil- osophy of living a healthy, active life”. Herbalife recently announced that it had become the official nutrition adviser to Brazilian football team Santos, which lists Pele amongst its former players. The company already spon- sors Inter Milan in Italy,Valencia in Spain, Schalke 04 in Germany, LA Galaxy in the US,

The impact of smoking cigarettes on a woman’s skin is illustrated by digitally-enhanced images in and Pumas in Mexico. GlaxoSmithKline Consumer Healthcare’s public relations campaign for Nicabate in Australia OTC

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MARKETING NEWS OTC

Launches FDA gives final approval to Perrigo’s generic Monistat

he Food and Drug Administration (FDA) Thas given final approval in the US to Per-

“Sudocrem’s small babies become big babies, but we rigo’s generic version of Johnson & Johnson’s will always need soothing,” is the opening line of Monistat-1 Combination Pack for treating vag- Forest Laboratories latest television commercial for inal thrush. Sudocrem Skin Care Cream in the UK. The company said babies had been “relegated to Perrigo said that it expected to begin ship- a subsidiary role” for the first time in the history of ping store-brand versions of the OTC medicine the nappy-rash brand, because the product was “immediately”. aimed at a “new audience of beauty-conscious but cash-strapped women aged 16-34 years”. The store-brand specialist pointed out that The commercial builds on Sudocrem’s heritage as the FDA approval included 180 days of gen- a nappy-rash brand by using a brief shot of a baby at eric exclusivity,as the company had been the the beginning, but then quickly shifts to a young woman looking in a mirror. first to file an Abbreviated New Drug Appli- She sees a blemish on her face, and starts cation (ANDA) containing a Paragraph IV cer- applying the cream. Next, she is seen rubbing the tification. The resulting patent-infringement lit- cream into other parts of her body, including her elbows and knees, and a sunburnt shoulder. igation filed by Johnson & Johnson was dis- “There, sorted,” states the voiceover, as the missed in 2008 (OTC bulletin,29 September young woman grins. “Try new Sudocrem Skin Care 2008, page 11). Cream, I am never without it,” adds the voiceover, as the woman grabs her jacket and leaves her house. According to Perrigo, Monistat-1 had an- The commercial draws attention to the fact nual retail sales of around US$90 million (C75 that Sudocrem Skin Care Cream comes in a million. The vaginal cream and suppository bas- Perrigo said it would start shipping store-brand “handbag-friendly” 30g tube. versions of Johnson & Johnson’s Monistat-1 It ends with a shot of a tube of Sudocrem Skin ed on the active ingredient miconazole nitrate Combination Pack immediately in the US Care Cream accompanied by the website address are indicated for treating vaginal yeast infec- sudocremtube.com and the message “available at tions and relieving associated external itch- new products to market”. “These innovations most Boots and Boots.com”. The 20-second commercial and two 10-second ing and irritation. help save OTC healthcare consumers more than spots have just been aired on Channel 4, Five and Perrigo’s chairman and chief executive of- an estimated US$1 billion annually,” he added. satellite channels. Forest Laboratories said they were ficer Joseph Papa said the launch was “another A spokesperson for Perrigo said the com- likely to be repeated later this year. The company launched Sudocrem Skin Care example of Perrigo’s commitment to innova- pany would support the product with market- Cream last year. tion by challenging brand patents and bringing ing and promotional activity. OTC OTC

Marketing Campaigns “delivers education and tests their knowledge of the category”, noted GlaxoSmithKline. Zantac 75 offers “Beat the Burn” game Devised by the agencies Spink and Tamba, the games are available on the brand website eat the Burn” is the name of an online at www.zantac.co.uk. GlaxoSmithKline said “Bgame that GlaxoSmithKline Consumer players would be recruited through a “massive” Healthcare is using to promote its Zantac 75 e-mail campaign, as well as press advertising heartburn and indigestion remedy in the UK. and public relations activity. The company claimed the “viral” game – Meanwhile, the consumer-press campaign which is part of a £1.0 million plus (C1.2 mil- for Zantac 75 – created by the agency t7F – is lion plus) press, online and public relations targeting both men and women with advertise- campaign – was “a breakthrough in health- ments in women’s titles and urban commuter care promotion”. It would put a “completely magazines until the end of June. A series of new spin” on the “De-fuse your food” theme of four advertisements includes a new barbeque- the established consumer advertising for Zan- based execution in which a lighted fuse is at- tac 75 insisted GlaxoSmithKline (OTC bul- tached to a dish of food that “may cause heart- letin,16 October 2009, page 17). burn and indigestion”. All feature the estab- “Players are asked to undertake a choice of A “viral” game is a key element of GlaxoSmithKline lished strapline “De-fuse your food”. Consumer Healthcare’s latest support for its tasks, and as they select various foods to keep Zantac 75 brand in the UK GlaxoSmithKline, which is working in part- their energy levels up a time bomb shows the nership with Ceuta Healthcare, is also support- effect on their digestion,”explained Glaxo- In addition, the company is targeting phar- ing Zantac 75 with a Pharmasite poster cam- SmithKline, adding that “Zantac 75 can then macy assistants with a similar game, giving paign and point-of-sale material. be used to put out the fuse”. them the chance to win a coffee maker. This OTC

11 June 2010 OTC bulletin 15 OTC11-06-10p16-17FIN.qxd 8/6/10 08:43 Page 2

OTC MARKETING NEWS Flomax stays put at top of the rankings

Boehringer Ingelheim’s Flomax Relief remains top of the rankings in Pharmacy viewpoint – our monthly survey of UK pharmacists’ attitudes to OTC sales and marketing, which is published exclusively in OTC bulletin courtesy of the Intr@PharmQ service from IMS.

oehringer Ingelheim’s humorous launch Boehringer Ingelheim is backing the launch B campaign for Flomax Relief is once again of Flomax Relief with a package including the best performer in our Pharmacy viewpoint pharmacy training, pharmacy-press advertis- survey by a clear margin. ing, public relations activity and consumer ad- For the second month running, the pharm- vertising. The company is investing more than acy-only medicine fought off tough competi- £5.0 million (C6.0 million) in the consumer cam- tion to maintain its place at the top of the rank- paign, which uses an animated blue letter ‘P’ ings in all four sections of the May survey (see to represent annoying pee problems (OTC bul- Figures 1, 2, 3 and 4). letin,31 March 2010, page 13). In December,the UK became the first coun- When IMS Consumer Health questioned try in the world to make Flomax a non-pre- UK pharmacists between 26 April and 19 May Boehringer Ingelheim’s Flomax Relief sits at the top scription medicine for treating benign prostatic 2010 using its Intr@PharmQ service, one in of the rankings in all four sections of our Pharmacy hyperplasia, or an enlarged prostate (OTC bul- five of them said Flomax Relief was backed viewpoint survey for the second month in a row letin,18 December 2009, page 1). The UK’s by the best current trade-press advertising for Medicines and Healthcare products Regula- an OTC medicine or dietary supplement (see relievers followed in second place, attracting tory Agency (MHRA) approved the switch of Figure 1). Trade-press advertising for Flomax 7.8% of the best trade-press advertising vote. 0.4mg tamsulosin hydrochloride capsules from Relief urges pharmacy staff to “Help men take “A painkiller feared by headaches” is the prescription-only to pharmacy (POM-to-P) sta- control of their annoying pee problems”, and message to pharmacists in trade-press adver- tus for treating lower urinary-tract symptoms shows a product pack flattening the letter ‘P’. tising for Nurofen, which features the “Nuro” in men aged between 45 and 75 years. Reckitt Benckiser’s Nurofen range of pain superhero from the new consumer campaign for the brand (OTC bulletin,10 February 2010, BEST CURRENT REPRESENTATIVE DETAILING page 18). Advertising also includes the claim “Nurofen 200mg tablets (ibuprofen) provide Rank Brand Company Product type Pharmacists (%) faster and longer relief from headaches than 1Flomax Boehringer Ingelheim Benign prostatic hyperplasia 17.8 standard paracetamol tablets”. Meanwhile, Boehringer Ingelheim’s launch 2NiQuitin GlaxoSmithKline Smoking-cessation aid 6.7 trade-press advertising for Buscopan Cramps 3= Nurofen Reckitt Benckiser Oral/topical analgesic 4.4 entered the rankings in third place with 5.6% Gaviscon Reckitt Benckiser Indigestion remedy 4.4 of the vote. Piriton/Piriteze GlaxoSmithKline Allergy remedy 4.4 Boehringer Ingelheim recently extended its Solpadeine GlaxoSmithKline Oral analgesic 4.4 Buscopan brand with Buscopan Cramps, which it claimed was the UK’s “first specialist treat- 7= Alli GlaxoSmithKline Weight-loss medicine 3.3 ment for abdominal pain and cramps”. It con- Lemsip Reckitt Benckiser Cough/cold remedy 3.3 tains the same active ingredient – 10mg hyo- Base: 90 pharmacists who named a brand of OTCmedicine or food supplement scine butylbromide – as Buscopan IBS Relief for irritable bowel syndrome (OTC bulletin, Figure 4: Unprompted response of UK pharmacists between 26 April and 19 May 2010 when they were asked the question: “In your opinion, which OTC medicine/dietary supplement is currently backed by the best 31 March 2010, page 15). representative detailing?” (Source – OTC bulletin/IMS’ Intr@PharmQ service) In the television section of Pharmacy view- Intr@PharmQ and Pharmacy viewpoint

harmacy viewpoint is a monthly survey reflecting their general feelings about partic- The service can be used to ask pharmacists Pof pharmacy attitudes to OTC marketing ular OTC brands. about a range of subjects including products, in the UK, which appears exclusively in OTC Intr@PharmQ is a rapid information-gath- company image and representatives. OTC bulletin courtesy of the Intr@PharmQ service ering service consisting of web-based interac- from IMS. tive questionnaires on the Intr@Pharm com- ■ For further information contact Tai Azeez, IMS, 7 The survey highlights pharmacists’ attitudes munity pharmacy portal. Questionnaires can Harewood Avenue, London NW1 6JB, UK (Tel: +44 to OTC marketing campaigns – both as health- be set up on the site quickly,and responses col- 20 3075 4142; Fax: +44 20 7393 5900; E-mail: TAzeez care professionals and consumers – as well as lated within days. @uk.imshealth.com).

16 OTC bulletin 11 June 2010 OTC11-06-10p16-17FIN.qxd 8/6/10 08:43 Page 3

MARKETING NEWS OTC PHARMACY viewpoint

BEST CURRENT TRADE-PRESS ADVERTISING Rank Brand Company Product type Pharmacists (%)

1Flomax Boehringer Ingelheim Benign prostatic hyperplasia 20.0

2Nurofen Reckitt Benckiser Oral/topical analgesic 7.8

3Buscopan Boehringer Ingelheim Irritable bowel syndrome 5.6

4= Alli GlaxoSmithKline Weight-loss medicine 4.4 Nicorette McNeil Products Smoking-cessation aid 4.4 Second place in the trade-press section was taken by NiQuitin GlaxoSmithKline Smoking-cessation aid 4.4 Reckitt Benckiser’s Nurofen Vitabiotics Vitabiotics Food supplement 4.4

8Lanacane Combe International Skincare 3.3

Base: 90 pharmacists who named a brand of OTCmedicine or food supplement

Figure 1: Unprompted response of UK pharmacists between 26 April and 19 May 2010 when they were asked the question: “In your opinion, what is the best current trade-press advertisement for an OTC medicine/dietary supplement?” (Source – OTC bulletin/IMS’ Intr@PharmQ service) BEST CURRENT TELEVISION ADVERTISING Rank Brand Company Product type Pharmacists (%) Trade-press advertising for Boehringer Ingelheim’s Buscopan Cramps entered the rankings in third place 1Flomax Boehringer Ingelheim Benign prostatic hyperplasia 27.8 point,Flomax Relief led the way with 27.8% 2Gaviscon Reckitt Benckiser Indigestion remedy 6.7 of the best-advertising vote (see Figure 2). The 3Nurofen Reckitt Benckiser Oral/topical analgesic 5.6 commercial is aimed at older men through the straightforward message “Take control of your 4= Alli GlaxoSmithKline Weight-loss medicine 4.4 annoying pee problems”. The letter ‘P’ is seen Piriton/Piriteze GlaxoSmithKline Allergy remedy 4.4 distracting one man from his game of golf, irri- 6= Adios Dendron Slimming aid 3.3 tating a second trapped in a traffic jam, and keeping a third awake at night. Berocca Bayer Vitamin supplement 3.3 Reckitt Benckiser’s Gaviscon indigestion Nicorette McNeil Products Smoking-cessation aid 3.3

remedy was in second place with 6.7% of the Base: 90 pharmacists who named a brand of OTCmedicine or food supplement best television advertising vote, just ahead of the same company’s Nurofen brand with 5.6%. Figure 2: Unprompted response of UK pharmacists between 26 April and 19 May 2010 when they were For the best pharmacy-support package, asked the question: “In your opinion, what is the best current television consumer advertisement for an OTC medicine/dietary supplement?” (Source – OTC bulletin/IMS’ Intr@PharmQ service) one in four pharmacists voted for Boehring- er Ingelheim’s Flomax Relief. GlaxoSmith- BEST CURRENT PHARMACY-SUPPORT PACKAGE Kline Consumer Healthcare’s Alli weight-loss medicine was in second spot with 6.7% of the Rank Brand Company Product type Pharmacists (%) vote (see Figure 3). 1Flomax Boehringer Ingelheim Benign prostatic hyperplasia 24.4 And in the best current representative detailing section, Flomax Relief led the way with 2Alli GlaxoSmithKlineWeight-loss medicine 6.7 17.8% of the vote (see Figure 4). 3= Gaviscon Reckitt Benckiser Indigestion remedy 5.6 Of the hayfever remedies, GlaxoSmithKline Piriton/Piriteze GlaxoSmithKline Allergy remedy 5.6 Consumer Healthcare’s Piri Team – compris- ing the Piriton and Piriteze brands – was the 5Nurofen Reckitt Benckiser Oral/topical analgesic 4.4 best performer,putting in an appearance in the 6= Benadryl McNeil Products Allergy remedy 3.3 television, pharmacy-support package and rep- NiQuitin GlaxoSmithKline Smoking-cessation aid 3.3 resentative detailing rankings. The company is backing the Piri Team this hayfever season Solpadeine GlaxoSmithKline Oral analgesic 3.3 with a £2.4 million television-advertising cam- Base: 90 pharmacists who named a brand of OTCmedicine or food supplement paign, as well as point-of-sale material and category-management initiatives in stores (OTC Figure 3: Unprompted response of UK pharmacists between 26 April and 19 May 2010 when they were asked the question: “In your opinion, which OTC medicine/dietary supplement is currently backed by the bulletin,31 March 2010, page 18). best pharmacy-support package (consumer/trade advertising, bonus deals, profit margin, training, etc)?” OTC (Source – OTC bulletin/IMS’ Intr@PharmQ service)

11 June 2010 OTC bulletin 17 OTC11-06-10p18FIN.qxd 8/6/10 08:44 Page 2

OTC MARKETING NEWS

Distribution Agreements Power Health acquires rights to Sanatogen protein powder

ower Health has acquired the worldwide Pdistribution rights to Sanatogen High Pro- tein Powder from Bayer Consumer Care. The food supplement would initially be sold in Canada, Malta, Mauritius, Sierra Leone, the UK, and the US, said Power Health. The company noted that Bayer – which acquired the Sanatogen brand when it purchased Roche Consumer Health in 2005 (OTC bulletin, 28 January 2005, page 27) – would continue to hold the trademark for Sanatogen High Blackmores has extended its natural health portfolio Protein Powder. in Australia with a trio of products that relieve the Commenting on the position in the UK, a symptoms of colds and flu and/or support the body’s immune system. spokesperson for Power Health told OTC bul- Blackmores Cold & Flu Day/Night comprises letin that Sanatogen High Protein Powder had Power Health is offering Sanatogen High Protein two separate herbal combinations that are claimed been discontinued briefly because it was unpro- Powder in a number of countries including Canada, to relieve symptoms and help the body fight colds the UK and the US and flu. The day capsules contain echinacea, fitable. However, the product was now avail- eucalyptus, holy basil and willow bark, while the able from www.powerhealth.co.uk and Boots prepare”, and could be “easily absorbed by the night capsules have a similar formulation but with stores, she added, after Power Health had tak- body”. “It can be added to hot or cold drinks, hops instead of echinacea. A pack of 24 capsules – sufficient for six days en a fresh approach to the product including or simply sprinkled onto meals such as soups, – has a recommended retail selling price of sourcing new suppliers. stews, breakfast cereals or desserts,”comment- A$16.95 (C11.75). The spokesperson said the food supplement ed the company. The company said the second new addition – Blackmores Immunodefence – contained lactoferrin, should soon be available from more retailers. Suitable for all ages, Sanatogen High Pro- which “helps to boost the activity of certain immune “Our salesforce is pursuing more retail outlets tein Powder is supplied in a 275g pack with a cells”, and vitamin D and zinc, which “may help to and talking to pharmaceutical wholesalers – recommended retail price of £8.99 (C10.50) support healthy immune resistance”. A one-month supply of 60 capsules retails at A$39.95. it’s just early days,”she remarked. in the UK. Meanwhile, Blackmores Kids Immunities is Describing Sanatogen High Protein Pow- Bayer’s Sanatogen range also includes Sana- claimed to “support growing children’s immune der as an “excellent source of high-quality pro- togen Gold, Sanatogen Kids, Sanatogen New systems”. Free of artificial sweeteners, colours and flavours, the product is suitable for children aged tein”, Power Health said that it was “easy to Mother,and Sanatogen Vital 50+. 2-12 years and contains vitamins A, C, D and E, OTC together with zinc. A one-month pack of 60 tablets costs A$14.95. Blackmores is backing the launches with a Kobayashi Healthcare has relaunched its Fever “high impact” consumer campaign throughout the Kool ‘n’ Soothe cooling gel sheets in the UK with Australian winter. new packaging featuring Disney characters. Current trade-press advertising (pictured above) The company said the actual cooling gel sheets advises retailers “When winter strikes, be ready with – which are for use by children aged one year and over Blackmores”. with fever and a high temperature – would also carry OTC images of Mickey Mouse, Donald Duck and Goofy. Kobayashi said the move would “help younger children feel more comfortable about wearing the cooling gel sheets”. “Parents too will be attracted to IN BRIEF use the cooling gel sheets for their children, since ■ COMBE INTERNATIONAL is support- Disney is one of the world’s most universally loved and recognised brands,” added the company. ing its Vagisil brand with television advertis- The revamp followed “strong sales growth” for the ing “in all areas” of the UK from 31 May. The Kool ‘n’ Soothe brand – which also includes Migraine four-week burst is part of a £1.0 million (C1.2 Kool ‘n’ Soothe for adults – in 2009, said Kobayashi, noting it had doubled its marketing spend on the million) spend on television advertising for the brand in 2010 compared to last year. brand this year. Meanwhile, current pharmacy- Kobayashi added that it was backing the press advertising highlights that “Nobody un- Kool ‘n’ Soothe brand with a burst of television advertising in July. The campaign will feature a derstands intimate feminine care better than testimonial-style commercial for Migraine Kool ‘n’ Vagisil”. The Vagisil range comprises Medi- Soothe, with Fever Kool ‘n’ Soothe highlighted in a cated Feminine Wipes, Feminine Wash, Com- tag at the end of the commercial. Fever Kool ‘n’ Soothe comes in packs of four or pact Deodorant Mist, Feminine Powder and eight sheets with recommended retail selling prices Medicated Crème. of £2.59 (C3.05) and £4.59 respectively. OTC OTC

18 OTC bulletin 11 June 2010 OTC11-06-10p19FIN.qxd 8/6/10 08:44 Page 3

EVENTS OTC

JULY 26-28 August Natural Products 5-8 November ■ 8th WSMI Asia-Pacific Regional Conference 7-8 July Expo Asia 2010 ■ Chinese Taipei ■ Marketing Authorisation Wan Chai, Hong Kong ‘The changing landscape of Self-Medication’ is the theme of the 8th A three-day exhibition and confer- in the Middle East World Self-Medication Industry (WSMI) Asia-Pacific Regional Con- ence focusing on natural health Frankfurt, Germany ference to be held in Chinese Taipei. ingredients and finished products, Countries to be discussed at this The four-day meeting will review the global and regional regulatory including dietary supplements. two-day meeting include Jordan, trends and developments in self-medication, with a focus on switching, Contact:Angel Ng, Lebanon and Saudi Arabia. new indications and market opportunities. Marketing and Conference, Contact:Henriette Wolf-Klein, Contact:2010 WSMI Secretariat. Penton Media Asia. Department Manager, Tel: +886 2 8226 1010. E-mail: [email protected]. Tel: +852 3104 0660. Forum Institut für Management. Website: www.2010wsmi-taiwan.org. Tel: +49 6221 500 680. Fax: +852 2857 6144. Fax: +49 6221 500 555. E-mail: [email protected]. E-mail: h.wolf-klein@forum- Website: www.naturalproducts 29 September-2 October fair and conference. institut.de. asia.com. ■ CRN’s Annual Contact:Gabriele Stadler, Website: www.forum-institut.com. Symposium for the Project Manager, 30-31 August Dietary Supplements Werbe- und Vertriebsgesellschaft 8-9 July All About Regulatory ■ Industry Deutscher Apotheker. ■ Pharmaceutical Affairs in Europe Austin, Texas, US Tel: +49 6196 928 411. Regulatory Affairs in Heidelberg, Germany This four-day event is organised Fax: +49 6196 928 404. Russia, Belarus, Ukraine Speakers at this two-day confer- by the US Council for Responsi- E-mail: [email protected]. ence conducted in German will and the Former Soviet ble Nutrition (CRN). Website: www.expopharm.de. include Peter Bachmann of Ger- States Contact:Jill Ferguson, PlanNet. 25-26 October many’s federal institute for drugs London, UK Tel: +1 703 778 9000. Nutraceuticals and and medical devices, BfArM. ■ This two-day meeting will cover Fax: +1 703 778 9001. Functional Foods recent and expected regulatory de- Contact:Henriette Wolf-Klein, E-mail: [email protected]. London, UK velopments and pharmacovigilance Department Manager, Website: www.crnusa.org. Topics for discussion at this two- requirements. Forum Institut für Management. day meeting include global per- Contact: Management Forum. Tel: +49 6221 500 680. OCTOBER spectives and evolution of func- Tel: +44 1483 730071. Fax: +49 6221 500 555. tional foods, marketing opportun- Fax: +44 1483 730008. E-mail: h.wolf-klein@forum- 4-5 October ities, nutrition and health claims, E-mail: registrations@management- institut.de. ■ Herbal Medicines: nanotechnology,and probiotics. forum.co.uk. Website: www.forum-institut.com. Quality Data for Approval Contact:Samantha Graves, SMi Group. Website: www.management- and Registration Tel: +44 20 7827 6052. forum.co.uk. SEPTEMBER Bonn, Germany Fax: +44 20 7827 6001. 14 July 8 September Speakers at this two-day meeting E-mail: [email protected]. conducted in German will include ■ Marketing Authorisation ■ OTC Approval and Website: www.smi-online.co.uk. in Japan Marketing Strategies Friederike Stolte from Germany’s federal institute for drugs and med- 26-27 October Bonn, Germany Frankfurt, Germany ical devices, BfArM. ■ AESGP Conference This one-day conference in Ger- Speakers at this one-day confer- Contact:Elsa Eckert, Antwerp, Belgium man will look at OTCproducts in ence on Japan will include Bet- Conference Manager, ‘How can non-prescription medi- Europe including food supple- tina Fiedler from Bayer Schering Forum Institut für Management. cines best contribute towards pub- ments, devices and cosmetics. Pharma. Tel: +49 6221 500 650. lic health?’ is the theme of this Contact:Henriette Wolf-Klein, Contact:Henriette Wolf-Klein, Fax: +49 6221 500 555. two-day event organised by the Department Manager, Department Manager, E-mail: [email protected]. Association of the European Self- Forum Institut für Management. Forum Institut für Management. Website: www.forum-institut.com. Medication Industry,the AESGP. Tel: +49 6221 500 680. Tel: +49 6221 500 680. Contact:AESGP. Fax: +49 6221 500 555. Fax: +49 6221 500 555. 4-6 October Tel: +32 2 735 51 30. E-mail: h.wolf-klein@forum- E-mail: h.wolf-klein@forum- ■ The 7th TOPRA Fax: +32 2 735 52 22. institut.de. institut.de. Annual Symposium E-mail: [email protected]. Website: www.forum-institut.com. Website: www.forum-institut.com. London, UK Website: www.aesgp.be. 27 September A three-day meeting run by The AUGUST Organisation for Professionals in NOVEMBER ■ The Borderline Between Regulatory Affairs (TOPRA) with 4 August Medicines and Foods 8-9 November the UK Medicines and Healthcare ■ Basics of London, UK products Regulatory Agency. ■ EuroPLX 44 Regulatory Affairs This one-day seminar will focus Barcelona, Spain Contact:TOPRA. London, UK on the borderline between medi- A two-day partnering and licens- Tel: +44 20 7510 2560. A one-day course from The Org- cines and foods. ing forum focusing on OTC medi- Fax: +44 20 7537 2003. anisation for Professionals in Reg- Contact: Management Forum. cines, nutraceuticals, branded pre- E-mail: [email protected]. ulatory Affairs (TOPRA). Tel: +44 1483 730071. scription drugs and generics. Website: www.topra.org. Contact:TOPRA. Fax: +44 1483 730008. Contact:RauCon. Tel: +44 20 7510 2560. E-mail: registrations@management- 7-10 October Tel: +49 6222 9807 0. Fax: +44 20 7537 2003. forum.co.uk. ■ Expopharm 2010 Fax: +49 6222 9807 77. E-mail: [email protected]. Website: www.management- Munich, Germany E-mail: [email protected]. Website: www.topra.org. forum.co.uk. International pharmaceutical trade Website: www.raucon.com.

11 June 2010 OTC bulletin 19 OTC11-06-10p20-21FIN.qxd 8/6/10 08:45 Page 2

OTC MARKET RESEARCH German firms expect consolidation

More mergers and acquisitions are expected in Germany’s OTC industry Stay the same as pharmacy groupings increase their influence, according to a new study 8% from Sempora Consulting. Aidan Fry reports. Fall 13% erman pharma companies are unan- their company had reduced the size of its sales- imous in believing that the growing force in favour of key-account management. influence of pharmacy franchises To compile its German pharmacy market Gand mail-order pharmacies will lead study – the seventh such survey that the man-

to more OTC mergers and takeovers, according agement consultancy has carried out – Sempora Rise to a major new study conducted by management also questioned 133 pharmacists and 298 con- 79% consultancy Sempora Consulting. sumers. The research was conducted in March When Sempora asked 48 executives from the and April this year. Figure 3: Proportion of a panel of 48 executives from OTC, prescription and diagnostic industries how Revealing their expectations for OTC prices pharmaceutical manufacturers in Germany who think likely it was that there would be “further marin community pharmacies, the 48 industry exec- the importance of own-label healthcare products will rise, stay the same, or fall (Source – Sempora) ket consolidation among OTC producers due to utives were divided in their forecasts. Almost the growing market influence of pharmacy co- two-fifths felt prices would fall, while nearly just over three-quarters of pharmacists who operatives and mail-order pharmacies”, 54% or half foresaw stable prices. A minority – 13% responded to Sempora’s survey in 2009 were 26 thought it was probable, while 46% or 22 – expected OTC prices to rise (see Figure 1). preparing for OTC discounting, this year just believed such a development was very proba- A third of the executives thought OTC prices a quarter said price cuts were in their plans. ble. None of the executives felt that industry offered by mail-order pharmacies would fall, but Another reason for pharmacists’ reticence to consolidation was unlikely. a quarter believed prices would rise. As Figure cut OTC prices could be that their customers are Germany’s current ban on third-party owner- 2 shows, 42% expected no major change. showing little interest in seeking the best deals. ship of pharmacies – which effectively prohibits The 133 pharmacists surveyed were less Only 37% of the 298 German consumers major pharmacy chains – was the leading issue optimistic. Nearly three-fifths of them antici- questioned by Sempora said they were increas- identified by the executives when Sempora ask- pated OTC price declines for community phar- ingly asking about offers on non-prescription ed them to identify the key topics that would macies, with just 7% predicting higher retail medicines, while 27% did research about prices face industry in future. prices. One out of 10 believed prices offered by online before buying from their local pharmacy. Mail-order pharmacies, falling prices for mail-order pharmacies would increase, but this Only one in every 20 consumers said they tried OTC products, key-account management and was far fewer than the 38% that believed mail- to negotiate a discount with their pharmacist. the borderline between pharmacy-only and gen- order OTC retailers would cut their prices. Just Sempora noted that consumers tended to eral-sale status were also high up the list of the over half of pharmacists expected mail-order overestimate retail prices for OTC medicines, issues industry expected to be tackling in future. retailers to keep their OTC prices constant. often to a considerable degree. For example, the Industry professionals said they were at Four-fifths of the pharmacists surveyed said German public on average thought that a 30- present occupied primarily with OTC pricing they regularly ran special OTC offers, while one tablet pack of 500mg paracetamol from Ratio- issues, pharmacy exclusivity,mail-order trade out of three claimed to have permanently re- pharm cost C6.53, three-times the actual rec- and pharmacy franchises. duced their prices for non-prescription products. ommended retail price of C2.20. Furthermore, just over half of the executives This relatively high level of discounting per- This over-inflated impression of OTC prices identified prescription-to-OTC switches as haps explains a steep reduction in the number must have been a key factor behind 81% of among the strategic issues with which their of pharmacists who said their plans for the German consumers maintaining that medicines firm was grappling. A similar proportion said future included cutting OTC prices. Whereas prices were too high. Nearly half of those surveyed believed that pharmacists were to a large part responsible for preventing a lasting reduc- Rise Stay the same Rise Stay the same tion in the cost of self-medication. 42% 13% 48% 25% German consumers, the study suggests, are open to the idea of buying healthcare products from retailers other than pharmacies. Fewer than half of them believe general-sale medicines from pharmacies are of ‘higher value’ than those available from drugstores or supermarkets. The vast majority of the industry executives Fall Fall felt it was likely that supermarkets and drug- 39% 33% stores would increasingly sell pharmacy-exclusive products. But any move in that direction Figure 1: Proportion of a panel of 48 executives from Figure 2: Proportion of a panel of 48 executives from would be a major gamble for suppliers. pharmaceutical manufacturers in Germany who think pharmaceutical manufacturers in Germany who think prices for OTC products in community pharmacies will prices for OTC products sold by mail-order pharmacies Sempora’s research found that many com- rise, stay the same, or fall (Source – Sempora) will rise, stay the same, or fall (Source – Sempora) munity pharmacists in Germany were ready

20 OTC bulletin 11 June 2010 OTC11-06-10p20-21FIN.qxd 8/6/10 08:45 Page 3

MARKET RESEARCH OTC

to replicate the infamous example of the boycott executives believed the variety of non-prescrip- chise operated by the German pharmacists’ mar- of Lichtwer’s whole portfolio after the herbals tion medicines available would rise in future. keting association, the MVDA, on 53%. No specialist decided in 1998 to sell its Kwai garlic This belief does not seem to tally with the other group scored over 20%. medicine through general-sale outlets. Within widespread expectation among both pharma- DocMorris largely made its name as a mail- a year,Lichtwer was forced to backtrack with ceutical executives and pharmacists that phar- order pharmacy supplying medicines to German its reputation and balance sheet in tatters (OTC macy franchises or co-operatives will become customers from a base in the Netherlands. When bulletin,14 October 1999, page 1). more prevalent over the next few years. prompted,69% of German consumers identi- Asked how they would react if a manufac- More than three-quarters of the independent fied DocMorris as a mail-order pharmacy. Its turer supplied a formerly pharmacy-exclusive pharmacists surveyed already belonged to a closest rival on 19% was Sanicare, which the product to drugstores and supermarkets, a third franchise or similar grouping. More than half industry executives named as the most effective of pharmacists said they would stop stocking of the group members said they got support mail-order player in Germany. the product. Three-fifths of pharmacists said with OTC pricing strategies, while 74% receiv- The executives were unanimous in forecast- they would remove the product from display, ed own-label support. ing that mail-order retailers would form an in- but would continue to stock it. Meanwhile, two-thirds of the industry exec- creasingly important channel for OTC firms. Sempora noted that 17% of pharmacists ap- utives questioned said their firm already worked Noting that mail-order pharmacies had a peared to have no problem with such a general- closely with such groups. Half of the executives market share of around 9% to 10% of Ger- sale move,as they would keep recommend- believed working with these groups could help many’s non-prescription market in 2009, Sem- ing the product in question. In last year’s survey, their company influence which products indi- pora asked the industry representatives what not one pharmacist had been prepared to ad- vidual pharmacies recommended. share they would have in 2013. Nearly two out vise customers to use such a brand (OTC bul- Last year’s ruling by the European Court of of five executives thought it would be between letin,30 November 2009, page 12). Justice (ECJ) that European Union member 10% and 12%, while half of them pointed to Nearly a third of German pharmacists said states could ban third parties from owning and the 12% to 15% band. Another 13% thought they would refuse to recommend products from operating pharmacies (OTC bulletin,29 May mail-order pharmacies would account for more any company that produced own-label ranges 2009, page 1) means there is no immediate than 15% of the OTC market within the next for pharmacy franchise groups. And two-fifths prospect of fully-fledged pharmacy chains tak- three years (see Figure 4). would not recommend brands from firms that ing hold in Germany. Indeed, Germany’s re- By contrast, a quarter of pharmacists did not were clearly supporting such franchise groups. cently-elected coalition government has shown expect mail-order retailers to capture any addi- Nevertheless, three-quarters of industry exec- no signs of wanting to liberalise the country’s tional share of the OTC medicines market. utives believed it was probable or very prob- pharmacy market. However, nearly one in five thought mail-order able that manufacturers would increasingly pro- Nevertheless, almost three out of five indus- pharmacies would hold more than 15% of the duce own-label products for retailers. Similarly, try executives – and two out of five pharmacists market by 2013. four-fifths of the executives expected the overall – expected Germany to drop its ban on third- The vast majority – 88% – of the execu- importance of own labels to increase (see Figure party ownership of pharmacies within the next tives questioned said their firms were already 3), although only 55% of pharmacists agreed. five years. collaborating with mail-order pharmacies. Their Accordingly,four-fifths of industry represen- Should the ban on chains fall, then Celesio partnerships comprised mainly of advertising tatives thought the number of brands per cate- appears well-placed to capitalise. The DocMor- in the retailers’ catalogues or on their websites, gory or indication would decrease, and a similar ris brand that the German pharmacy and whole- as well as including flyers in mail-order pack- proportion anticipated pharmacy franchises in sale group acquired three years ago (OTC bul- ages sent to customers. time stocking only the top two brands in a cate- letin,30 April 2007, page 1) was adjudged by gory or indication, plus an own-label version. the industry representatives to have the strongest ■ Contact Tobias Brodtkorb, Managing Partner,Sem- What was less clear was whether the industry brand identity of any pharmacy franchise. pora Consulting,Siemensstrasse 27, 61352 Bad Hom- executives had clearly thought through what the And when Sempora prompted consumers burg,Germany (Tel: +49 6172 45349 30; Fax: +49 6172 consequences could be of such stocking deci- with a list of pharmacy groups or brands, 73% 45349 49; E-mail: t.brodtkorb @sempora.com). sions by pharmacy franchises. Nearly half of the recognised DocMorris, ahead of the Linda fran- OTC

60.060 50% 50.050

40.040 38% 32% Series1Manufacturers 30.030 23% Series2Community pharmacists 19% 19% 20.020 13%

10.010 6%

Proportion of panel members (%) 0% 0% 0.00 Below 9% 9%-10% 10%-12% 12%-15% More than 15% 12345 Share of the German non-prescription medicines market that will be held by mail-order pharmacies in 2013 (%)

Figure 4: Estimates by a panel of 48 executives from pharmaceutical manufacturers and 133 community pharmacists in Germany of the share of the country’s non-prescription medicines market that will be held by mail-order pharmacies in 2013 (Source – Sempora)

11 June 2010 OTC bulletin 21 OTC11-06-10p22-23FIN.qxd 8/6/10 08:46 Page 2

OTC PEOPLE

Obituary Manufacturers Tylenol launch man Beiersdorf recruits Feld Robert McNeil dies obert Lincoln McNeil Jnr,the man who to lead European region Rlaunched Tylenol in 1955 before selling his family’s business to Johnson & Johnson a few years later,has died at the age of 94. eiersdorf has named Peter Feld as exec- Peter Feld The third generation of his family to work Butive board member with responsibility at the firm founded by his grandfather in 1879, for Europe. McNeil introduced the first version of one of He takes over from Thomas Quaas,chair- the world’s biggest-selling OTC products as a man of the executive board, who had been per- liquid children’s analgesic called Tylenol Elixir. forming the role on an interim basis since a Its marketing campaign included a cartoon fire new board structure was unveiled earlier this engine and the slogan “For little hotheads”. year (OTC bulletin,16 April 2010, page 22). A qualified pharmacist, McNeil is credited Most recently at Johnson & Johnson as man- with coming up with the active ingredient’s US agement board chairman of the US firm’s Ger- generic name of acetaminophen, that is known man subsidiary,Feld’s areas of responsibility as paracetamol in other parts of the world. were the consumer and OTC business segments. Although it had been known for more than He had also been an area managing director 50 years, little work had been done to evalu- covering Austria, the Benelux countries, Ger- sibilities for the supply chain, currently dis- ate the drug’s efficacy and develop it for com- many and Switzerland. This had followed sim- charged by existing executive board member mercial use. Moreover, aspirin was already est- ilar responsibilities for Procter & Gamble. Markus Pinger. Pinger will take over the new- ablished as a relatively low-cost painkiller. Meanwhile, Pieter Nota – chief marketing ly-created brands and supply chain function McNeil launched Tylenol as a prescription and innovation officer,and the executive board on 1 July in a role that would, for the first time, drug in 1955 and became chairman of the com- member responsible for marketing, sales and bring together all product-related areas and dir- pany a year later. research and development – is leaving Beiers- ect them from a single source, the company It was not until a year after Johnson & John- dorf at the end of the month to take up a “top commented. son bought the company in 1959 that Tylenol management position at a large brand-name Pinger’s successor as executive board mem- became an OTC product. company” in his native Netherlands. ber with responsibility for the Americas, a role McNeil continued as chairman after the take- As a result, Nota’s functions on Beiersdorf's he had recently assumed, would be named at over until 1964. executive board will be combined with respon- a later date, the company noted. OTC OTC We also publish Generics bulletin www.generics-bulletin.com

22 OTC bulletin 11 June 2010 OTC11-06-10p22-23FIN.qxd 8/6/10 08:46 Page 3

PEOPLE OTC

IN BRIEF Retailers

■ PRESTIGE BRANDS HOLDINGS has appointed Charles Hinkaty to its board of dir- China Nepstar appoints ectors. In almost four decades working in consumer products, Hinkaty was most recently president and chief executive officer of Del acting chief executive Laboratories,where he spent 23 years. He has also worked for Bristol-Myers Squibb in marketing, acquisitions, licensing, strategic plan- hina Nepstar has promoted its chief oper- Same store-sales – covering stores opened ning and business development, and is a past Cating officer Jason Xinghua Wu as its act- before 31 December 2008 – increased by 6.9%. chairman of the US Consumer Healthcare Pro- ing chief executive officer with immediate ef- The company was operating 2,559 stores on ducts Association (CHPA). fect. He succeeds Ian Wade,whose resigna- 31 March 2010, having added 104 new outlets tion from the drugstore chain was effective from and closed 24 during the quarter. ■ PODRAVKA re-elected Miroslav Vitko- 2 June, the day it was announced. Sales of OTC drugs had represented 36.7% vic as president of its management board at a Wade had spent just 18 months with China of China Nepstar’s turnover during the quar- meeting held on 31 May. Krunoslav Besvir, Nepstar,having been appointed co-chief exec- ter,the company noted, with prescription drugs Lidija Kljajic, Marin Pucar and Miroslav utive officer in January 2009. He only took full contributing another 24.8%. Nutritional sup- Repic form the rest of the Croatian company’s control of the business in August of last year, plements generated a further 17.9%, tradition- management board. Meanwhile, Branko Vul- following the resignation of co-chief execu- al Chinese herbal products 3.7% and other pro- jak is stepping down as deputy board member tive officer Jiannong Qian. ducts the remaining 16.9%. to return to the firm’s supervisory board. Commenting on Wu’s appointment, Simin The retailer noted that its private-label port- Zhang, chairman of China Nepstar,said Wu folio included 1,559 products as of 31 March ■ BAUSCH & LOMB has appointed Hide- had been an important member of the comp- 2010. Sales of private-label products represent- yuki Ashikaga as president, Japan. He joins any’s operational team for two years. He had ed approximately 26.6% of sales in the first the US-based eyecare specialist from Nippon a deep knowledge of the Chinese retail mar- quarter,it added. Becton Dickinson, where he was president of ket and of the China Nepstar business, point- the Japanese subsidiary. ed out Zhang. Working on new type of store Wu joined China Nepstar in July 2008. He During the quarter,China Nepstar said, it ■ RELIV INTERNATIONAL has elected served as vice general manager of the drug- had entered into strategic collaborations with John Klimek from the US-based hedge-fund store chain’s Guangzhou branch and regional “certain world-leading fast-moving consumer management company HFR Asset Manage- general manager of the company’s North China goods companies” to design a new type of health ment to its board of directors. region before being appointed vice-president and beauty concept store. of operations in March 2009. Three months lat- Aimed at attracting a broader customer base, ■ TGA – Australia’s Therapeutic Goods Ad- er,he was made chief operating officer. the concept stores would use half of their dis- ministration – is recruiting members for its new Meanwhile, China Nepstar said its sales had play space for health and beauty products, China Advisory Committee on Non-prescription Med- grown by 12.1% to CNY567 million (C69.0 mil- Nepstar said, while the remainder would be de- icines (ACNM) that will provide advice and lion) in the first quarter of 2010. Higher op- voted to the core-product offering of an exist- make recommendations to the TGA and the erating costs, however, meant China Nepstar ing China Nepstar outlet. No information was Minister for Health and Ageing. Formed in reported an operating loss of CNY4.16 million given about when or where the new concept January 2010, the ACNM effectively replaces for the period. stores would open. the Medicines Evaluation Committee. Experts OTC on consumer issues as well as community pharmacy, microbiology,pharmacology,pharma- DIARY DATE...... DIARY DATE...... DIARY DATE...... DIARY DATE ceutical chemistry and other related areas are sought by the TGA for a three-year term of DIARY DATE...... DIARY DATE...... DIARY DATE...... DIARY DATE office from 1 January 2011 until 31 December DIARY DATE...... DIARY DATE...... DIARY DATE...... DIARY DATE 2013. Successful candidates will attend five, one-day meetings per year in Canberra. Inter- DIARY DATE...... DIARY DATE...... DIARY DATE...... DIARY DATE ested parties should send an e-mail to otc.med- DIARY DATE...... DIARY DATE...... DIARY DATE...... DIARY DATE [email protected].

■ MHRA – the UK’s Medicines and Health- The OTCMarketing Awards 2011 care products Regulatory Agency – has announced the appointment of two new mem- will be held in London on Thursday 10th March 2011 bers to the Committee on the Safety of De- vices (CSD). Adrian Harris has been named DIARY DATE...... DIARY DATE...... DIARY DATE...... DIARY DATE an expert member for accident and emergency medicine, while Timothy Wilton has been ap- DIARY DATE...... DIARY DATE...... DIARY DATE...... DIARY DATE pointed as an expert member of orthopaedics. DIARY DATE...... DIARY DATE...... DIARY DATE...... DIARY DATE OTC

11 June 2010 OTC bulletin 23 Te ll the right people what you want to buy and

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