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15 April 2011

COMPANY NEWS 3 Taisho expands in Asia by J&J isolates McNeil in 3 Consumer shake-up Boehringer looks to 4 switches for growth acquiring Malaysia’s Hoe Private-equity group KKR 5 to gain Pfizer’s Capsugel Adcock is set to acquire 6 aisho Pharmaceutical is set to grow its Noting that Hoe was the “leading local phar- NutriLida in South Africa Tpresence outside of Japan by acquiring maceutical company in Malaysia”, Taisho said Stadais ready to make 7 Malaysia’s Hoe Pharmaceuticals for approx- its products were available in more than 40 big acquisitions imately MYR370 million (C85.5 million). countries, the majority of which were in Asia. Oxford Nutrascience sees 8 Japan’s leading OTC company said the deal Acquiring Hoe is in line with Taisho’s strat- growth in pharmaceuticals enabled it to enter the Malaysian pharmaceu- egyof expanding its Asian operations, which US Supreme Court rules 9 tical market “in earnest”, and also to grow its saw the company buy Bristol-Myers Squibb’s against Matrixx business across Asia by using Hoe’s distribu- OTC assets in the Asia-Pacific region, exclud- tion channels to sell its existing products. ing China and Japan, in 2009 (OTC bulletin, GENERAL NEWS 10 Taisho said the transaction was expected to 30 September 2009, page 1). The US$310 mil- close in August of this year. lion (C217 million) deal included the rights to EMA consults on 10 OTC pack design Under the terms of the deal, Taisho is paying the Tempra antipyretic analgesic, Counterpain almost five-times Hoe’s annual sales of MYR76 topical analgesic, Theragran-M and Engran Diclofenac and ibuprofen 11 on draft list of pollutants million, which are generated by a portfolio of multivitamin products, Ceetrus paediatric drops consumer and medical dermatology products. and the Keri brand, as well as Bristol-Myers Australia’s TGA settles 12 Pan case for A$67.5m Hoe’s portfolio of consumer dermatology Squibb’s Indonesian subsidiary. products includes the Baby Shield brand, as Prior to the Bristol-Myers Squibb deal, the German pharmacy customers 13 have specific product in mind well as the Neucare T3, Neucare Men, and T3 bulk of Taisho’s overseas operation was built FDA rule on supplement GMP 14 Acne face-care lines. The company also offers around its Lipovitan health drink brand, which is not arbitrary and capricious the Daily Repair and Ellgy hand- and body-care the company sells through local subsidiaries in EFSA’s fourth batch 15 brands, Ellgy cracked-heel repair products, Hair- China, Hong Kong, Indonesia, Malaysia, the sparks call for change monius haircare line, and Orregel teething gel. Philippines, Taiwan, Thailand and Vietnam. MARKETING NEWS 16 Seven Seas shakes up 16 Germany may ban JointCare range in UK US FDA warns PL gains exclusive rights 17 OTC paracetamol to store-brand Zegerid OTC on benzocaine FEATURES 20 everse-switching all paracetamol medi- onsumers in the US have been warned by Rcines to prescription-only status in Ger- Steady growth for most in 2010 20 Cthe Food and Drug Administration (FDA) manyis on the agenda for discussion when the A round up of the annual results that applying OTCbenzocaine gels and liquids country’s Expert Committee for Prescription to the gums or mouth is associated with a rare, next meets on 5 July this year. REGULARS but potentially-fatal, adverse effect. Similar reverse-switches for dextromethor- Events – Our regular listing 19 The regulatory agency said it was particu- phan and topical ketoprofen are also on the People – Latest moves 22 larly concerned about the use of OTC benzo- agenda for the meeting. caine gels and liquids in children for relief of A spokesperson for Germany’s medicines Becht to leave Reckitt teething pain, because of the serious outcomes, manufacturers’ association, the BAH, told OTC Bart Becht will retire as chief executive officer including death, that may be associated with bulletin that he was not aware “of any new of Reckitt Benckiser on 1 September 2011. Ra- methemoglobinemia. Consumers might have evidence” that would support removing parac- kesh Kapoor,the company’s executive vice-pres- difficulty recognising the signs and symptoms etamol medicines from non-prescription use. ident of category development, has been named when using such products at home, added the Earlier this year,the BAH spokesperson chief executive officer designate. Reckitt Ben- ckiser noted that Becht would act as a part-time agency, noting the symptoms might not always pointed out, the Pharmacovigilance Working adviser to Kapoor until September 2012. be evident or attributed to the condition. Party within the European Medicines Agency ■ Continued on page 22 ■ Continued on page 22

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COMPANY NEWS OTC

Business Strategy J&J isolates McNeil in Consumer shake-up

ohnson & Johnson is to isolate its McNeil lion (C768 million) in 2010, after McNeil issu- has also made a number of appointments, all of JConsumer Healthcare business in the US, as ed a series of products recalls (OTC bulletin, whom will report to Jesse Wu,worldwide chair- it attempts to repair the damage caused by a 11 February 2011, page 4). These included a man of the Consumer division. series of products recalls and the closure of its recall of over 40 OTC medicines for infants Pat Mutchler has been named as company Fort Washington manufacturing facility. and children, which prompted a US government group chairman of US OTC, McNeil Nutrition- McNeil Consumer Healthcare in the US investigation and the closure of the company’s als and Wellness & Prevention, as well as the would operate from April as a separate business Fort Washington facility (OTC bulletin,14 Johnson & Johnson/Merck Consumer Pharma- under the Consumer umbrella, Johnson & John- May 2010, page 1). ceuticals joint venture. son said. This would enable the firm to give the Mutchler will be supported by Denice Tor- “focused attention to quality and compliance” Wider restructuring of Consumer division res, who has been appointed president of Mc- that was needed to complete the “critical task” The latest move forms part of wider changes Neil Consumer Healthcare. Torres will take up of restoring McNeil’s reputation. to the firm’s global Consumer division. the role on 25 April 2011. US sales at Johnson & Johnson’s OTC& Under the new structure, the Consumer div- Torres joined Johnson & Johnson in 2005 Nutritionals business dropped by US$1.09 bil- ision will consist of a global franchise organ- as vice-president, marketing, at the Ortho-Mc- isation composed of four consumer categories Neil Neurologics business. In 2007, she was – Skin Care for Baby and Adult; OTC; Oral named vice-president of US sales and market- OTC bulletin Care and Topical Health; and Women’s and ing at Ethicon and was promoted to her current Intimate Health – and four regional business position of president, central nervous system 15 April 2011 Number 360 units that will market the various consumer business at Ortho-McNeil-Janssen Pharmaceut- product lines. icals in 2009. Editor & Publisher: Deborah Wilkes Three of the four regional units – Asia-Pac- Prior to joining Johnson & Johnson, Torres Associate Editors: Aidan Fry ific, Europe/Middle East/Africa and Latin Am- spent 15 years at Eli Lilly and Company. Mike Rice erica – will market all the consumer product Grace Castano has been made company Business Editor: Matt Stewart lines. The North America unit will market all group chairman for the Asia-Pacific region, Assistant Editors: Jenna Lawrence product lines except OTC medicines in the US. while Jose Justino has taken the same role in David Wallace Johnson & Johnson said the new structure the Europe/Middle East/Africa region. Advertising Controller: Debi Minal would enable the company to react more rapid- The North America unit’s company group ly to changing market conditions and execute chairman will be Roberto Marques, and Susan Marketing Manager: Val Davis region-wide initiatives more efficiently. Further- Rivetti has been named international vice-pres- Editorial, Subscription and Advertising more, it would accelerate growth in emerging ident for Latin America. enquiries should be addressed to: OTC bulletin, OTC Publications Ltd, 54 Creynolds Lane, Solihull, markets, added the company. Pericles Stamatiades will take charge of West Midlands B90 4ER, UK. In light of the changes, Johnson & Johnson Consumer’s global franchise organisation. Tel: +44 1564 777550. Fax: +44 1564 777524. OTC E-mail: [email protected]. Subscriptions Annual subscriptions to OTC bulletin in Europe are £625.00 for Mergers & Acquisitions single copies and £355.00 for additional copies to the same ad- dress, including delivery. Subscriptions to addresses outside Eur- ope are subject to an additional charge of £30.00 to cover postage. Lloydspharmacy takes over DrThom Subscription enquiries in Korea should be directed to Pharma Koreana Ltd, 14th Floor,KTB Network Building, 826-14 Yeoksam- loydspharmacy has expanded its online the Lloydspharmacy partnership had begun, the dong, Kangnam-gu, Seoul 135-080, Korea (Tel: +82 2 554 9591; L presence in the UK by acquiring for an un- company said, noting that DrThom offered con- Fax: +82 2 563 8289; E-mail: [email protected]). Advertising disclosed sum the 67% share in online doctor sultations on premature ejaculation, erectile dys- Advertising rates and data are available on request from the ad- service DrThom it did not already own. function, contraception and sexually-transmit- dress above or at www.otc-bulletin.com. About OTC bulletin The Celesio-owned pharmacy chain acquired ted infections, as well as a travel clinic and ser- OTC bulletin is published 20 times a year by OTC Publications in August 2009 a 33% stake in DrThom, which vices for hair loss and quitting smoking . Limited: twice monthly in February,March, April, May,June, Sep- tember,October and November; and monthly in December,Jan- had been helping to run Lloydspharmacy’s own Founding director of DrThom, Dr Thom Van uary,July and August. A subscription to OTC bulletin includes online doctor service since 2008. Every,would remain with Lloydspharmacy as the weekly electronic newsflash, news@OTCbulletin,which is published around 45 times a year. OTC bulletin is printed by the Tony Page, Lloydspharmacy’s managing di- director of medical services, the company noted. Warwick Printing Company Limited, Caswell Road, Leamington rector,said the company’s online doctor service The wider team of DrThom doctors would also Spa CV31 1QD, UK. was a “rapidly growing area” of its business. remain with the company, Lloydspharmacy said, No part of this publication may be copied, reproduced, stored in a retrieval system or transmitted in any form without prior “We know there is an increasing demand to provide the online doctor service and help permission from OTCPublications Ltd. from customers for online healthcare,”com- develop new services. ©OTC Publications Ltd. All rights reserved. Company registered in England No 2765878. Registered Office: mented Page, because they “feel more com- Under the terms of the deal, DrThom would 54 Creynolds Lane, Solihull, West Midlands B90 4ER, UK. fortable in an online environment or prefer the continue to trade from its existing website at OTC bulletin® is registered as a trademark in the European convenience over a face-to-face appointment”. DrThom.com, which would retain its exist- Community. DrThom had seen a “significant increase” in ing branding, Lloydspharmacy said. ISSN 1350–1097 www.OTC-bulletin.com the number of patients using the service since OTC

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OTC COMPANY NEWS

Annual Results Boehringer looks to switches for growth

oehringer Ingelheim said that developing switch candidates, Boehringer Ingelheim said. mote sales had started in early 2011 and would B“pioneering” prescription-to-OTC switches, To highlight the strength of its switch cap- be rolled out during the year. utilising new communications media, and ex- abilities, Boehringer Ingelheim pointed to its The Consumer Health Care business now panding the medical and scientific support for “first-in-class” UK switch of Flomax (tamsu- ranked sixth among the top-10 global consumer its brands, would all be important drivers of losin) for treating enlarged prostate (OTC bul- healthcare companies, Boehringer Ingelheim growth at its Consumer Health Care business. letin,18 December 2009, page 1). claimed, and had outperformed the 4.1% rise Reporting a 4.5% rise in Consumer Health Available OTC under the Flomax Relief in global OTC sales over the year. Care sales to C1.32 billion in 2010 (see Figure banner since the first quarter of 2010, the switch Consumer Health Care’s 4.5% sales growth 1), the privately-owned German firm said inno- marked the creation of a whole new self-med- in 2010 had been achieved despite a declining vation was “key”to creating and maintaining ication category in the UK, Boehringer Ingel- market in Japan and a weak cold and flu season sustainable growth in the OTC market. heim claimed, and would serve as a reference at the start of the year,the company noted. A unit dedicated to switching medicines from case for further switches in the UK and other Europe remained Consumer Health Care’s prescription-to-OTC status had been set up by countries around the world. most important market, with sales up by 5.5% the Consumer Health Care business, Boehring- Ageing populations and cost pressures on to C502 million (see Figure 2). The region ac- er Ingelheim said, as it sought to “assess and healthcare systems were changing the land- counted for 38% of the business’ turnover (see exploit this promising opportunity”. scape of markets in which the Consumer Health Figure 3). The new unit would focus firstly on switch- Care business competed, Boehringer Ingelheim Sales in Germany – the company’s biggest ing mature Boehringer Ingelheim products, the noted, and had made regulators willing to con- European market – were flat at C131 million, company stated, thus extending their lifecycle sider switching more medicines from prescrip- due to the weak cold and flu season, Boehringer well beyond patent expiry and offering con- tion-to-OTC status. Ingelheim noted, despite relaunching the Thom- sumers new self-care solutions. apyrin pain-relief brand. Secondly,it would use Consumer Health New communications channels The strongest growth was recorded in the Care’s reputation as a leading self-medication While switches would play a role in devel- Americas region, where turnover advanced by company – with high-level marketing and sales oping new brands for the Consumer Health 7.2% to C374 million. capabilities and a “unique” global reach – to Care business, growth of its existing brands In the Asia, Australasia, Africa region, sales become the “partner of choice”for external would be aided by embracing new communi- edged up by 1.3% to C441 million. This was de- cation channels, especially the internet, Boeh- spite a 6% slump in Japanese turnover, which ringer Ingelheim said. accounted for 67% of Consumer Health Care’s Business Sales Change Television and print campaigns would re- sales in the region. (C millions) (%) main an important part of Consumer Health Boehringer Ingelheim strengthened its pres- Prescription Medicines 9,702 -3.5 Care’s marketing mix, it commented, but new ence in Japan’s consumer healthcare market in Consumer Health Care 1,318 +4.5 media would also be used to reach target groups 2010 by acquiring the 40% stake in its Japan- Animal Health 921 +51.0 more efficiently. ese OTC subsidiary,SSP,that it did not already Industrial Customer 638 -18.7 The messages communicated to consumers own (OTC bulletin,26 February 2010, page 3). Other 7–would be backed by ongoing technical research The company had held a majority stake in SSP into Consumer Health Care’s brands, the com- since 2001 (OTC bulletin,16 November 2001, Boehringer Ingelheim 12,586 -1.1 pany added, which would provide scientific page 1).

Figure 1: Breakdown of Boehringer Ingelheim’s sales support for their claims. Taking full control of SSP had made Con- in 2010 (Source – Boehringer Ingelheim) Furthermore, specific programmes to pro- sumer Health Care the largest OTC cough busi- ness in the world, Boehringer Ingelheim said. Commenting on the recent earthquake and 200 200 tsunami in Japan, Boehringer Ingelheim said 159 (+8.9%) 148 that its OTC manufacturing facility in the Jap- (+11.3%) 134 130 anese city of Fukushima would not be oper- 150150 (+20.7%) (+7.4%) ational for the “foreseeable future”. millions)

C 100100 Evacuated as a precautionary measure Problems at the nuclear power plant in the area after the earthquake and tsunami meant Net sales ( 5050 the facility had been evacuated as a precaution- ary measure, the company said,noting that the 40 employees that worked at the site were safe 00 and had been deployed at two other produc- Dulcolax Mucosolvan Buscopan Pharmaton 1234tion sites.

Figure 4: Net sales achieved by Boehringer Ingelheim’s most important international Consumer Health Care Boehringer Ingelheim noted that all of its brands in 2010. Changes in sales are as reported (Source – Boehringer Ingelheim) 3,000 employees in Japan were safe and that

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COMPANY NEWS OTC

Region Sales Change Mergers & Acquisitions (C millions) (%) Europe 502 +5.5 Private-equity group KKR Asia, Australia, Africa 441 +1.3 Americas 374 +7.2 to gain Pfizer’s Capsugel Consumer Health Care1,318 +4.5

Figure 2: Breakdown of sales by Boehringer fizer has agreed to sell its Capsugel drug- The company said it would use the proceeds Ingelheim’s Consumer Health Care business in 2010 P delivery business to private-equity company from the sale to expand its share repurchase pro- (Source – Boehringer Ingelheim) Kohlberg Kravis Roberts (KKR) for US$2.38 gramme, but would also “continue to look to billion (C1.66 billion) in cash. identify and invest in other opportunities to max- Americas Europe The price represents over three-times Cap- imise its value, including business development”. 38% 28% sugel’s sales of approximately US$750 million The deal, which is expected to close in the in 2010, which were generated by its range of third quarter of 2011, will see Capsugel join hard capsules and other drug-delivery systems KKR’s portfolio of more than 60 companies for the pharmaceutical, OTC, and health and with combined annual turnover in excess of nutrition sectors. US$210 billion. In October of last year,Pfizer announced Capsugel will keep a corporate presence in that it was exploring strategic options, including the US, and its global headquarters will be based divestment, for the Capsugel business, which it in New Jersey. The company will remain under had gained through its US$68 billion acqui- the leadership of Guido Driesen, president and sition of Wyeth in 2009. At the time, Pfizer general manager of Capsugel, once the trans- Asia, stressed that the strategic review did not involve action is completed. Australasia,Africa 33% the other units in its Diversified Businesses In 2007, KKR teamed up with Stefano Pes- division, including Animal Health, Consum- sina to acquire Alliance Boots in a deal worth Figure 3: Sales by Boehringer Ingelheim’s Consumer er Healthcare and Nutrition (OTC bulletin, £11.1 billion (C12.6 billion) (OTC bulletin,30 Health Care business in 2010 broken down by region (Source – Boehringer Ingelheim) 15 October 2010, page 1). April 2007, page 1). OTC production at its other sites had resumed. Meanwhile, four of Consumer Health Care’s Mergers & Acquisitions most important brands – the laxative Dulcolax, the cough medicine Mucosolvan, the vitamin Cephalon rejects hostile Valeant and mineral product Pharmaton, and the anti- spasmodic Buscopan – had each generated sales ephalon has rejected Valeant Pharmaceu- leant shareholders and away from its own. of over C100 million, the firm pointed out. C ticals International’s unsolicited cash bid Furthermore, the current board of directors Dulcolax – which was boosted by “excel- of US$5.7 billion (C4.0 billion) for the firm. were “best positioned to maximise value” for lent” clinical trial results – remained Consumer Following the rejection, Valeant announced shareholders, Cephalon argued, warning that Health Care’s biggest seller,with turnover im- that it would go directly to Cephalon’s share- Valeant had “no duty to act in Cephalon share- proving by 8.9% or by 3.7% on a currency-ad- holders to obtain approval to remove the cur- holders’ best interests”. justed basis to C159 million. However, Busco- rent board of the US-based biopharmaceutical Valeant’s bid for Cephalon comes less than pan performed strongest, reporting sales up by company and replace it with its own nominees. a month after the Canadian firm completed the a fifth to C134 million, although the currency- However, Cephalon has replied by urging C350 million acquisition of branded generics adjusted growth was 13.9% (see Figure 4). its shareholders to reject Valeant’s proposals to and OTC company PharmaSwiss (OTC bul- Consumer Health Care accounted for 10.5% remove and replace its current directors. letin,11 February 2011, page 3). of Boehringer Ingelheim’s group net sales in Canada’s Valeant said that it believed a new Meanwhile, Valeant said its sales had in- 2010, which slipped back by 1.1% to C12.6 bil- board would “act in the best interests of Ceph- creased by 6% on a proforma basis in 2010, lion. In local currencies, the decline was a more alon stockholders and remove impediments to following its merger with Biovail in November severe 6.0%. a tender offer”. last year (OTC bulletin,15 October 2010, page The dominant Prescription medicines busi- Cephalon reported sales of US$2.76 billion 3). However, merger costs, Valeant said, had ness reported sales down by 3.5% to C9.70 bil- in 2009, from a portfolio of products focused left the firm with an operating loss of US$110 lion, primarily due to a loss of exclusivity on on cancer,central nervous system disorders and million for the 12 months. a number of its key brands in the US. pain. The firm also owns Switzerland’s leading The company also revealed that Michael Group operating income had dropped by generics firm Mepha, which offers a range of Pearson had replaced Robert Ingram as chair- 15.3% to C1.90 billion, Boehringer Ingelheim branded OTC and prescription drugs, as well as man of Valeant’s board of directors. pointed out, as the company maintained a high generic and value-added generic products. Valeant said Pearson would retain his posi- level of investment in research and development Commenting on Valeant’s bid, Cephalon said tion of chief executive officer,and had agreed to despite the loss of sales to generic competition. the US$73.00 per share offer undervalued the extend his contract until February 2017. Return on net sales had declined from 17.6% company, ascribed little to no value to Ceph- Ingram will remain on the board as an in- to 15.1%, the company noted. alon’s pipeline and was an “opportunistic at- dependent member and lead director. OTC tempt” to shift the value of the company to Va- OTC

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OTC COMPANY NEWS

Mergers & Acquisitions Mergers & Acquisitions Sinclair agrees Adcock is set to acquire merger with IS NutriLida in South Africa inclair Pharma and IS Pharma have agreed Sterms on a merger the two firms claim will dcock Ingram is set to boost its presence create “a substantial, fully-integrated, pan-Euro- Ain the vitamins, minerals and supplements pean specialty pharmaceutical company” under (VMS) market by acquiring fellow South Afri- the Sinclair IS Pharma banner. can company NutriLida Healthcare for an un- Both companies have recommended the disclosed sum. deal. They claim that combining the two prod- Dr Jonathan Louw,Adcock Ingram’s chief uct portfolios would create “enhanced market- executive officer,said the deal – which is sub- ing and cross-selling opportunities”, while the ject to approval from the Competition Com- enlarged group would also have an “in-house mission of South Africa – gave the company development capability” that would focus on a portfolio of brands across several niche seg- Acquiring NutriLida gives Adcock Ingram a portfolio of products, including the ProbiFlora brand leveraging existing products, as well as new de- ments of the domestic VMS space. velopment opportunities. Acquiring NutriLida was in line with Adcock few years, primarily by acquiring supplements Under the terms of the proposed merger,IS Ingram’s strategy of gaining market share in the firms Tender Loving Care and Unique Formu- Pharma shareholders would receive 2.6868 Sin- fast-moving consumer goods (FMCG) channel, lations (OTC bulletin,17 April 2009, page 7; clair shares for each of their shares, the com- Louw continued, expanding into adjacent prod- OTC bulletin,30 November 2009, page 1). panies noted, valuing IS Pharma at approxi- uct categories and developing a stronger posi- The South African VMS market had shown mately £55 million (C62 million). tion in self-medication products. “substantial growth” over the past few years, If the proposed merger goes ahead, Sinclair Adcock Ingram would grow NutraLida’s Adcock Ingram pointed out, due mainly to shareholders will own 63.3% of the enlarged brands – such as ProbiFlora, GynaGuard, Viral- “consumer awareness, education and access, company, with IS Pharma stock holders pos- Guard and ArthroGuard – by leveraging its ex- the emerging middle class, the increase in pro- sessing the remaining 36.7%. isting brand-building expertise. In this way, it active health management and self management Subject to shareholder approval, the merg- would become a leading player in the South by consumers”. er is expected to come into effect on 20 May African VMS market, Louw insisted. With this in mind, acquiring NutriLida would 2011, while the admission of Sinclair IS Phar- After establishing itself in the tonics cate- enable the company to move further into cate- ma to London’s Alternative Investment Market gory with its Bioplus, Vita-thion and Liviton gories adjacent to its current business, Adcock (AIM) is expected in early June. brands, Adcock Ingram has sought to broaden Ingram said, and increase its “visibility in the The merger will bring together Sinclair’s its offering in the FMCG channel over the past growing self-medication segment”. portfolio of speciality skincare, woundcare and OTC oral-care products – including the Atopiclair dermatitis brand, Decapinol oral-care range and XClair wound-care line – with IS Phar- ma’s range of late-stage pharmaceuticals and medical devices focused on the oncology,crit- ical care and neurology sectors. Sinclair IS Pharma would be headquarter- ed in the UK, the companies noted, with direct commercial operations in France, Germany, Ireland,Italy,Spain and the UK. OTC

IN BRIEF ■ ACTAVIS said around 100 of its employees had moved into the group’s corporate head- quarters in Steinhausen near Zug, Switzer- land, by early April. The company – which has dubbed its new offices the ‘Orange Power Tower’ – will officially open the headquarters next month. A manufacturing and development centre will remain in Iceland, which will also remain the home of Actavis’ Medis third-party sales division. OTC

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COMPANY NEWS OTC

Business Strategy/Annual Results Stada is ready to make big acquisitions

tada Arzneimittel is ready to step up its Business Annual sales Change Operating profit Change Sspending on acquisitions this year,as it (C millions) (%) (C millions) (%) looks to expand the group’s footprint in eastern Europe and its portfolio of branded products. Generics 1,124 +1 146 -7 “The cautious acquisitions policy that we Branded Products 425 +8 84 +12 have pursued over the past two years will be re- Commercial 67 +30 -19 – placed by an accelerated acquisitions approach,” Group/other 11 +22 -49 – promised chairman of the executive board, Hart- Total Stada 1,627 +4 162 -16 mut Retzlaff. Retzlaff revealed that the German group was Figure 1: Stada’s sales and operating profit in 2010 broken down by business (Source – Stada) currently pursuing three takeover targets, none of which would require Stada to raise addition- Non-prescription products accounted for lion, the company noted, as a strong perform- al capital. Among these targets were “an East- 60% of sales at Stada’s Branded Products di- ance from the Ladival sunscreen range offset ern Europe package” and “an interesting gener- vision in 2010, which increased by 8% to C425 the fall in Grippostad sales. The German Hemo- ics target not far from Germany”. Stada had million (see Figure 1). Adjusted for portfolio pharm label had more than doubled its sales “absolutely no interest” in a rumoured merger changes and currency effects, the rise was a less to C9.5 million, Stada said, primarily due to the with Actavis, he added. impressive 3%. Eunova acquisition, which had added C5.9 mil- Retzlaff said the company was looking for Operating profit grew quicker than sales, lion over the year. brands with “high growth and high margins”. rising by 12% to C83.7 million,and the operat- Turnover by Branded Products in Russia Acquiring GlaxoSmithKline’s Eunova vita- ing margin increased from 19.1% to 19.7%. – Stada’s second-biggest market in terms of min brand for C12 million was a good example Sales of the Grippostad cold medicines had sales – increased by 13% to C118 million, rep- of the type of deal Stada was seeking, Retzlaff slipped back by 16% to C28.7 million, Stada resenting over half of Stada’s sales in the coun- pointed out. Since acquiring the brand in Nov- noted, due to the weak cold season in Germany. try,which grew by 15% to C221 million. At con- ember 2009, Stada had been able to increase stant exchange rates, sales advanced by 9%. its sales from around C6.0 million to slightly Double-digit growth from Mobilat A restructuring exercise was underway in over C8.0 million, he said. By contrast, sales of the Mobilat brand for Italy,Stada said, following a 10% fall in Brand- Asked whether Stada would be interested in blunt injuries had risen by 15% to C17.5 million, ed Products’ sales to C44.7 million in 2010. The acquiring Merck KGaA’s Consumer Health the company said, pushing it ahead of its Hiru- division contributed only 33% to Stada’s group Care business, Retzlaff said the company would doid brand for the same type of injuries, which sales in Italy,which increased by 17% to C137 be interested, but as far as he was aware the posted turnover up by 4% to C16.8 million. million. This was down from 42% in 2009. business was not for sale. Branded Products’ sales in Stada’s home Stada’s Branded Products business in Bel- When pushed on whether the company was market of Germany advanced by 9% to C112 gium posted sales up by 14% to C6.3 million, actively pursuing Merck’s OTC operation, Retz- million. They represented 22% of the group’s lifting its contribution to Stada’s group sales in laff said the acquisition would mean having to sales in the country,which decreased by 3% the country to 5%. The firm’s group sales in Bel- raise additional capital. As the company did not to C516 million (see Figure 2). gium moved forward by 7% to C135 million. need to do this for the three deals it was current- Turnover from Branded Products carrying Nearly three-quarters of Stada’s sales in the ly pursuing, the answer was obvious. the Stada label edged up by 0.2% to C97.6 mil- UK – 74% – was generated by the Branded Products division, with generics in niche cate- CountryStada’s sales Change Branded Products’ Branded Products’ gories accounting for the remainder. UK Brand- (C millions) (%) sales (C millions) sales in Stada (%) ed Products’ sales increased by 17% to C39.7 Germany516 -3 112 22 million, while total sales grew by 6% – 2% at constant exchange rates – to C54.4 million. Russia 221 +15 118 53 Branded Products’ sales in the Netherlands Italy 137 +17 45 33 improved by 12% over the year to C16.0 mil- Belgium 135 +7 65 lion, accounting for 34% of Stada’s Dutch sales. Serbia 99 -16 88Overall, the company’s turnover grew by 24% Spain 83 +12 67to C47.2 million. France 81 -2 56The Branded Products division accounted UK 54 +6 40 73 for 26% of Stada’s group sales, which increased The Netherlands 47 +24 16 34 by 4% to C1.63 billion. Adjusted for portfolio Denmark 34 +33 38changes and currency effects, the rise was 2%. Others 220 –6630Group operating profit fell back by 16% to C162 million. Earnings before interest, tax, de- Total Stada 1,627 +4 425 26 preciation and amortisation (EBITDA) were 4%

Figure 2: Breakdown of sales by Stada and its Branded Products division in 2010, together with the proportion lower at C269 million. of group sales accounted for by Branded Products (Source – Stada) OTC

15 April 2011 OTC bulletin 7 OTC15-04-11p8-9FIN.qxd 15/4/11 10:41 Page 2

OTC COMPANY NEWS

Annual Results Business Strategy/Annual Results Kneipp expands Oxford Nutrascience sees its market share growth in pharmaceuticals he Hartmann Group said its Kneipp natur- Tal remedies division had expanded its mar- xford Nutrascience’s strategy will now be 128% to £0.12 million (C0.14 million), driven ketshare in Germany and Japan last year. The Oprimarily focused on the pharmaceutical by increased sales of its own branded calcium German company attributed this progress to sector,where the firm’s drug-delivery technolo- supplement, particularly in the Middle East. “a broad palette of product innovations and a gies are attracting significant attention, accord- A loss of £0.81 million had been in line with promotional campaign that focused on the ef- ing to chief executive officer Nigel Theobald. forecasts, the company noted, and reflected the fectiveness of the products”. To reflect this shift, the company is planning technology development and scale up of com- Kneipp’s “solid growth” in 2010 contributed to change its name to Oxford Pharmascience. mercial activities over the 12 months. to the turnover of Hartmann’s non-core Other The pharmaceutical sector offered “many A successful initial public offering (IPO) had Activities unit rising by 5.6% to C254 million. exciting opportunities”, Theobald noted, as drug- raised £1.1 million before expenses, Oxford That total comprised sales in Germany ahead development companies sought ways to differ- Nutracience said, enabling it to accelerate the by 8.5% to C132 million and turnover in other entiate their products. development and commercialisation of its tech- markets 2.6% higher at C123 million. Oxford Nutrascience provided solutions that nology base and also raise its profile amongst The Other Activities division made up 15.6% enabled companies to innovate and add value, pharmaceutical companies worldwide. of Hartmann’s group turnover, which increased he continued, noting that its “technology plat- by 4.6% to C1.63 billion. forms in delivery formats and drug delivery” In talks with major firms An improved performance by the non-core were attracting “significant attention” from ma- As a result, the company was now in talks cosmetic cotton wool and homecare operations jor pharmaceutical companies. with a number of major OTC and prescription returned the Other Activities division to profit, In particular,the company’s “no burn” ibu- pharmaceutical firms over the possible licens- as it recorded earnings before interest and tax profen product had been very well received, ing of it intellectual property,Oxford Nutra- (EBIT) of C1.4 million. Theobald pointed out. Launching the product science claimed. Hartmann’s EBIT exceeded C100 million for in February,the company said it allowed ibu- Looking ahead, the company said now that the first time. A 7.4% improvement took the profen to be incorporated into “next generation” it had an ability to provide genuine product in- group profit to C103 million. chewable tablets and liquid suspensions with novation to the market, it would focus on secur- OTC “no taste or burn irritation issues” (OTC bul- ing commercial agreements with both pharma- letin,28 February 2011, page 9). ceutical companies and academic institutions Mergers & Acquisitions The shift in strategy was announced as Ox- where the company could source “complemen- ford Nutrascience reported turnover up by tary novel technologies”. Laboratoires Thea OTC

buys Novartis lines Mergers & Acquisitions aboratoires Thea has acquired from Novar- First China heads south with Ming He Tang Ltis a range of ophthalmology products in 30 countries across Europe as well as Canada, harmaceutical wholesaler First China Phar- ed, and offered immediate access to a “very Mexico and Turkey for an undisclosed sum. Pmaceutical is set to take a step into south- firm business foundation” and an “existing The French ophthalmic specialist said the ern China after it signed a letter of intent to ac- large distribution network throughout Guang- deal would “significantly strengthen” the com- quire Shenzhen Ming He Tang Pharmaceutical dong Province”. pany’s geographical reach and enable it to open for an undisclosed sum. Although based in Hong Kong, First China new affiliates in countries where it currently Acquiring Ming He Tang presented a signif- was formed to acquire the Yunnan-based phar- only had a presence through distributors or icant opportunity for First China to expand into maceutical wholesaler Kun Ming XinYuan Tang where it had no presence at all. Southern China, the company said, and was a Pharmacies and turn it into a ‘wholly foreign- Acquiring the portfolio also marked Labora- “huge leap forward” for the business. owned enterprise’. Companies in China with toires Thea’s entrance into the contact-lens sol- Ming He Tang reported sales of CNY110 this status enjoy regulatory,revenue, currency, ution market, the company pointed out, with the million (C11.6 million) in 2010 from a port- and intellectual property protection and finan- Ciba Vision Solocare brand. The acquired port- folio of over 2,500 drugs delivered to over 880 cial advantages over domestic joint ventures. folio also includes the Zaditen Ophtha, Volt- primary clients, First China pointed out. First China claimed it also had a “significant aren Ophtha and Oculotect prescription prod- Prior to the onset of negotiations with Ming strategic advantage” over most of its competi- ucts and the Fluoresceine diagnostics range. He Tang, the company’s strategic planning had tors as it had acquired a licence to provide prod- Laboratoires Thea reported sales of C192 not targeted southern China, First China said, ucts directly to its customers via the internet. million in 2010, two-thirds of which were gen- mainly due to the highly mature state of the The Chinese government had now suspend- erated outside of France. The company has a marketplace in China’s southern provinces. ed applications for this licence due to several direct presence in over 65 countries worldwide. However, Ming He Tang was well known cases of fraud, the company noted. OTC and respected in this region, First China add- OTC

8 OTC bulletin 15 April 2011 OTC15-04-11p8-9FIN.qxd 14/4/11 13:15 Page 3

COMPANY NEWS OTC

Legal Cases US Supreme Court rules against Matrixx

he US Supreme Court has upheld a deci- the reports provide statistically-significant evi- reports that the intranasal products could cause Tsion to re-open a lawsuit against Matrixx dence that the adverse events may be caused by a loss of sense of smell (OTC bulletin,19 June Initiatives that accuses the firm of not telling – and are not simply randomly associated with – 2009, page 15). investors that its Zicam nasal sprays could cause a drug’s use. Matrixx disputed that the product could a loss of sense of smell, or anosmia. In its filing to the Supreme Court, Matrixx cause loss of sense of smell, but was told by A district court had dismissed the lawsuit said that under the ninth-circuit court’s ruling, the FDA in November 2009 (OTC bulletin,16 in 2005, after ruling that the adverse events re- a pharmaceutical company that failed to dis- November 2009, page 12) and in March 2010 ported were not statistically significant enough close a small number of adverse-event reports (OTC bulletin,17 March 2010, page 8) that the to link the Zicam products to anosmia. However, could be sued even if the reports were not statis- letter would not be withdrawn and the company the ninth circuit appeals court disagreed and re- tically significant enough to link a drug to the should file New Drug Applications (NDAs) for opened the case in 2009. adverse event. the two products. In June last year,Matrixx filed an appeal In turn, this would mean all pharmaceutical Although the company denied the products against the ninth-circuit court’s decision with the companies would have to inform investors and were harmful, Matrixx announced in January US Supreme Court, arguing that reviving the consumers of every adverse event reported. that it had agreed to pay US$15.5 million (C10.7 case had “immense consequences” for pharma- Meanwhile, Matrixx is facing numerous con- million) to settle a nationwide personal-injury ceutical companies, investors and consumers sumer and investor lawsuits after it voluntarily lawsuit suit involving the two products (OTC (OTC bulletin,30 June 2010, page 4). withdrew its Zicam Cold Remedy Nasal Gel bulletin,21 January 2011, page 9). However, the Supreme Court has now dis- and Zicam Cold Remedy Gel Swabs products Despite its legal problems, Matrixx was ac- missed Matrixx’ appeal and upheld the ninth- from the US market. quired by the private investment firm HIG Cap- circuit court’s ruling, paving the way for the The withdrawals came after the US Food and ital at the start of the year,in a deal which val- lawsuit to be re-opened. Drug Administration (FDA) issued the company ued the company at US$75.2 million. In its ruling, the Supreme Court said that the with a Warning Letter in 2009 citing consumer OTC allegations against Matrixx “taken collectively” gave rise to a “cogent and compelling” infer- ence that Matrixx had elected not to disclose the reports of adverse events, not because the firm believed they were meaningless but because it understood their likely effect on the market. However, the court noted that whether the allegations in the lawsuit could ultimately be proven was an “altogether different question”. The Supreme Court’s ruling validates the ninth-circuit court’s decision to disagree with the US first-, second- and third-circuit courts. These had all held that drug companies have no duty to disclose adverse-event reports until

IN BRIEF ■ SCOLR said it was attempting to address its immediate liquidity problems, as the troubled company reported a net loss of US$3.2 million (C2.2 million) in 2010. Sales had fallen by 34% to US$0.62 million, the US company noted, as royalties from a deal with Perrigo declined.

■ PROPHASE LABS – owner of the Cold- EEZE brand – reported sales down by 27% to US$14.5 million (C10.0 million) in 2010. The company blamed a tough comparison with the prior year,when sales had been boosted by the swine-flu outbreak. ProPhase recorded a net loss of US$3.5 million, which was better than the US$3.8 million loss a year earlier. OTC

15 April 2011 OTC bulletin 9 OTC15-04-11p10-11FIN.qxd 14/4/11 13:21 Page 2

OTC GENERAL NEWS EMARegulatory Affairs consults on OTC pack design

he European Medicines Agency (EMA) is the correct identification of the medicine name”. However, the phrase “sugar-free” can be includ- Tconsulting on draft recommendations on Discussing the use of symbols or pictograms, ed, as it “can be considered useful information pack design and labelling for non-prescription the draft recommendations state that images of for the patient”. medicines authorised through Europe’s central- children should not be included, as they “may According to the draft recommendations, ised procedure. lead to confusion as to the exact age group they clear identification and selection of the appro- The regulatory agency pointed out that the are representing”. Neither should images of toys priate product is very important for non-pre- draft recommendations had been developed aft- and balloons be placed on the packaging, ac- scription medicines, especially in cases where er consulting European Union member states on cording to the draft recommendations, as “these there is no intervention by a pharmacist. “Pack national practices for pack design and labelling can cause confusion with other types of prod- design and labelling are considered key ele- for non-prescription medicines. It noted there uct like, for example, confectionery”. ments to ensure the safe use of this type of med- were differences in national practices, partic- The draft recommendations also prohibit the icine,”they add. ularly “regarding the acceptability of symbols/ use of images of leaves or fruit to illustrate the In terms of the general design and layout of pictograms, and any additional information com- taste of the medicine. packs, the draft recommendations include views patible with the Summary of Product Charac- However, images of the pharmaceutical form, on graphic elements, body text, multilingual teristics (SmPC)”. special administration aids, such as spoons or packs, the use of capital letters and italics, the The Association of the European Self-Med- oral syringes, and parts of the body,are allowed. use of colour,and the use of contrast. The sec- ication Industry,the AESGP,described the draft Commenting on additional information com- tion on contrast, for example, states that “high- recommendations as “disappointing”. “They patible with the SmPC, the draft recommenda- ly glossy,metallic reflective packaging may take a very restrictive approach to some aspects tions discourage the use of statements about a affect the legibility of the information”,and the of packaging, and the importance of creative lack of side-effects. They also maintain that choice of packaging material should ensure that pack design for consumer recognition has not statements like “can be used in pregnancy” or information is clear and legible. been fully taken into account,”commented the “suitable for diabetics” should not be allowed, Interested parties have until 30 June 2011 to industry association. as pregnant women and diabetics should be comment on the draft recommendations, which advised not to take medicines without profes- are aimed at companies preparing mock-ups and Use of colours in brand name sional advice. specimens of the packaging for non-prescription Existing non-prescription medicines author- In addition, statements about the speed and medicines authorised through the centralised pro- ised through the centralised procedure are out duration of action of the medicine are not allow- cedure. The draft recommendations were pro- of line with the draft recommendations. ed, according to the draft recommendations, un- duced by the Working Group on Quality Re- Packaging for GlaxoSmithKline Consumer less they are “deemed to be helpful for the safe view of Documents. Healthcare’s Alli weight-loss medicine, for ex- use of the medicine”. The AESGP said it would release a detailed ample, uses four different colours in the brand Furthermore, statements related to excipients response after studying the document in depth. name. However, the draft states that “different that are not part of the medicine formulation The draft recommendations will also be discuss- colours in the name of the medicine are dis- and, therefore, do not have any known action or ed at the industry association’s Annual Meeting couraged since they may negatively impact on effect, should not be allowed on the packaging. in Rome in June. OTC

Which? of Which?,said self-test kits “could be useful tools, but the lack of clear information about Self-test kits come under scrutiny how to use them could do more harm than good”. “As your general practitioner may well elf-test health kits for complaints such as “Some tests failed to mention factors that have to carry out his or her own tests to con- S diabetes, prostate cancer and stomach ulc- could affect the results and cause unnecessary firm a positive diagnosis anyway,” Vicary-Smith ers could produce “false alarms or false reas- worry,” continued Which?,noting that the Boots advised consumers, “you may be better off sav- surance”, the UK-based consumer watchdog blood-glucose test failed to explain that blood- ing your money and going straight to your gen- Which? has warned. glucose levels could be raised after a meal. eral practitioner.” Baffling language,gaps in the information Meanwhile, continued Which?,the Boots Which? said it would pass the findings of provided and misleading names were just some bowel-test kit provided no guidance on col- the survey on to manufacturers of self-test kits of the problems encountered when Which? lecting a sample. and the UK’s Medicines and Healthcare prod- bought six widely-available self-test kits and Which? also pointed out that its experts felt ucts Regulatory Agency (MHRA). had them assessed by health experts and mem- the Simplicity Stomach Ulcer Screening Test Furthermore, Which? noted that it planned bers of the public. was “misleadingly named” and the company’s to contribute to the European Union’s review “Experts and consumers alike were left puz- website was “unduly alarming”. “The product of medical devices. zled over an instruction to draw blood from the tests for a particular bacteria,”noted the con- Two health experts, the Plain English Cam- ‘hillside’ of the finger,” said Which?,adding sumer watchdog, “but only a minority of peo- paign and 64 members of the public contrib- that other terms likely to cause confusion were ple with the bacteria develop a stomach ulcer.” uted to the Which? survey. “desiccant” and “in-vitro diagnostic device”. Peter Vicary-Smith,who is chief executive OTC

10 OTC bulletin 15 April 2011 OTC15-04-11p10-11FIN.qxd 14/4/11 13:21 Page 3

GENERAL NEWS OTC

Regulatory Affairs be given to the consequences for patient access to medicines and more generally to health pol- Diclofenac and ibuprofen icy in the European Union. Pointing out that it had raised its concerns with the Commission’s Directorate-General En- vironment, the AESGP maintained that a com- on draft list of pollutants prehensive evaluation – such as that required under the new pharmacovigilance legislation – “would have been more appropriate to deal iclofenac and ibuprofen are two of four ides and dioxins – believed to present a signif- with the issue”. D pharmaceutical ingredients that could be icant environmental risk. The four pharmaceuticals are included in a labelled as chemical pollutants in the European Noting that pharmaceutical substances had shortlist of 17 possible new priority substances Union’s official list of substances considered been “introduced very late into the process” for which draft environmental quality standards to be of significant risk to the environment. that had begun during 2006, the Association have been derived. Dossiers on the pharma- Along with 17 beta-estradiol and 17 alpha- of the European Self-Medication Industry,the ceutical substances have recently been referred ethinylestradiol, diclofenac and ibuprofen have AESGP,commented that from its perspective for an opinion to a committee – the Scientific been included in a draft list of ‘priority sub- diclofenac and ibuprofen “have not been dealt Committee on Health and Environmental Risks stances’ to be included in an annex to the Euro- with fairly”. (SCHER) – attached to the Commission’s Dir- pean Union’s Water Framework Directive. “Due regard should be given to the speci- ectorate-General for Health and Consumers. Member states have to monitor environmen- ficities of pharmaceuticals and their well-de- Separately,an impact assessment is being tal concentrations of these substances and en- fined objectives,”the AESGP said. “In addition, drafted by the Commission, based on a techni- sure they do not exceed certain thresholds. the association doubts that the Water Framework cal report developed by a consultant. This is The proposed listing is part of a regular re- Directive is the appropriate vehicle to address expected to determine which priority substances view of the Water Framework Directive 2000/ these four substances, and pharmaceutical sub- should be listed in the annex. 60/EC. Every four years, the European Com- stances in general.” The AESGP said it understood that if phar- mission is expected to update the directive’s The European Generic medicines Associ- maceutical substances were added to the list annex with new substances – typically cyan- ation (EGA) said thorough consideration should it would be by cluster. OTC

15 April 2011 OTC bulletin 11 OTC15-04-11p12-13FIN.qxd 14/4/11 13:25 Page 2

OTC GENERAL NEWS

Regulatory Affairs Legal Cases EMA wants more Australia’s TGA settles data on Canazole Pan case for A$67.5m reland should suspend a marketing authori- Isation for Pinewood Laboratories’ Canazole 1% clotrimazole cream pending further stud- he Federal Court of Australia has approv- ilyharm and manufacturing counterfeit medi- ies into the antifungal medicine, according to Ted an A$67.5 million (C49.3 million) set- cines, and was fined A$3 million. The company Europe’s Committee for Medicinal Products for tlement of a class-action lawsuit brought against subsequently went into liquidation. Human Use (CHMP). the country’s Therapeutic Goods Administra- The settlement by the TGA comes after a “The benefits of Canazole do not outweigh tion (TGA) by suppliers and distributors of pro- class-action suit was filed in 2008 against the the risks, and the marketing authorisation grant- ducts made by Pan Pharmaceuticals. Australian government and five current and ed in Ireland cannot be recognised in other Pan hit the headlines in 2003 when the TGA former TGA officers by Pharm-a-care Labora- member states,”the CHMP stated following suspended the firm’s manufacturing licence and tories and 161 other sponsors,suppliers and an arbitration procedure. recalled medicines it had manufactured. At the distributors of Pan products, over the TGA’s Having secured Irish approval for the anti- time, the company was one of Australia’s top handling of the suspension of Pan’s licence and fungal in December 2000, Wockhardt’s Pine- contract manufacturers of complementary med- the product recalls. wood applied for an authorisation in the UK icines (OTC bulletin,30 May 2003, page 9). The TGA stressed that the settlement had through the European Union’s mutual-recog- The TGA had taken action after investigat- been made “without any admission of liabil- nition procedure. ing a series of adverse event reports related to ity”, and that Pharm-a-care would obtain the When the UK disagreed on Canazole’s ther- the Travacalm medicine made by Pan. appropriate orders to dismiss a second class- apeutic similarity to Bayer’s Canesten original, According to the TGA, deficiencies in Pan’s action suit that had been filed with the Supreme the Irish Medicines Board (IMB) referred the manufacturing of Travacalm were associated Court of New South Wales. dispute to the CHMP,which found that “the with 19 cases where people had been hospital- In August 2008, the TGA agreed to pay currently available data were not sufficient to ised following serious side-effects and more A$50 million plus legal costs to Pan Pharma- show therapeutic equivalence with the reference than 100 reports of additional adverse reactions. ceuticals and its former chief executive officer medicine and that further data would need to Pan later pleaded guilty to a number of crim- Jim Selim over its handling of the Pan case be generated”. inal charges, including inflicting grievous bod- (OTC bulletin,29 August 2008, page 16). OTC OTC

Regulatory Affairs Regulatory Affairs IN BRIEF

HMPC pushes on US FDA proposes ■ FDA – the US Food and Drug Adminis- tration – said it had launched a “consumer- with herbals work benzocaine move friendly” search engine on its website,which enabled consumers to search for recalls involv- ne more Community herbal monograph enzocaine looks set to lose monograph ing food, drugs, medical devices and other Ohas been finalised by Europe’s Commit- B status as an OTCmedicine for weight con- products more easily. The search results pro- tee on Herbal Medicinal Products (HMPC). trol in the US. vide data from news releases and other recall At its meeting in January,the HMPC fin- The Food and Drug Administration (FDA) announcements in the form of a table, which alised the monograph for Trigonella foenum- issued a proposed rule in the 9 March 2011 includes the date, brand name, product descrip- graecum L,semen (fenugreek seed). The total Federal Register to reclassify benzocaine from tion, reason for the recall, and the recalling number of final monographs is now 76. its previously-proposed monograph status to firm. The table also provides a link to the news At its previous meeting in November,the non-monograph status. release on each recall for more information. HMPC had finalised seven monographs. “Based on our evaluation of the available In January,the HMPC also adopted eight data and information, we have tentatively con- ■ FDA – the US Food and Drug Administra- draft Community herbal monographs, which cluded that the data are not sufficient to sup- tion – has warned Americans to stop using Sol- are out for public consultation until 15 June. port the safety and effectiveness of benzocaine adek vitamin solution, as it “may contain dan- Furthermore, the HMPC adopted a draft for this use,”stated the FDA. gerously high levels of vitamins A and D”. The ‘Public statement on the use of herbal medic- If the proposed rule is finalised, then com- FDA said it had received seven reports of seri- inal products containing thujone’. It is out for panies would have to obtain an approved new ous health problems experienced by consum- public consultation until 15 May. drug application (NDA) or abbreviated new ers who had used the product, which is mar- Meanwhile, the HMPC has published on drug application (ANDA) before they could keted by Indo Pharma of the Dominican Re- the website of the European Medicines Agency market OTC weight-control products contain- public for a range of conditions including rick- (EMA) a document providing answers to com- ing benzocaine. ets. The agency said that the reports of adverse mon regulatory questions about herbal medic- Comments should be sent to the FDA by events and other information indicated Sola- inal products. 7 June 2011. dek was available illegally in the country. OTC OTC OTC

12 OTC bulletin 15 April 2011 OTC15-04-11p12-13FIN.qxd 14/4/11 13:25 Page 3

GENERAL NEWS OTC

Market Research Ears, nose, Food supplement teeth required German pharmacy customers 6.3% 5.9% Joint and Others movement pain 21.4% have specific product in mind 9.9% Headache 10.1% ell over half of customers visiting Ger- knowledged that this proportion would prob- Wman pharmacies are looking to self-med- ably have been higher if the study had not been Skin and icate, according to an observational study con- conducted in the summer. wound care 17.6% ducted by the pharmacy chamber of Baden- Another 12.2% of customers sought solu- Gastrointestinal 12.2% Württemberg and the Cologne-based market re- tions to gastrointestinal complaints,including Cough, cold, fever 16.6% searcher Institut für Handelsforschung (IfH). nausea, while a further one in ten people want- Furthermore, seven out of ten of the 56.8% ed to relieve their headache (see Figure 1). A Figure 1: Breakdown by indication of the conditions suffered by over 46,000 self-medication customers of German pharmacy customers who are look- similar proportion of them were looking to al- in pharmacies in the German state of ing to self-medicate ask for a specific product. leviate joint and movement pain. Baden-Württemberg during the summer of 2010 Completed in the summer of 2010, the study According to the study,slightly more than (Source – Landesapothekerkammer involved 564 pharmacies in the federal state of a quarter of self-medication customers had con- Baden-Württemberg/IfH) Baden-Württemberg, which completed reports sulted a doctor in advance, but had still decid- lion enquiries about self-medication. Of that on over 46,000 individual customer interactions. ed to treat their condition themselves by vis- total, just over two-thirds, or 1.57 million, of Just under two-thirds – 64.4% – of the cus- iting a pharmacy. pharmacy customers had not consulted a doc- tomers were female. The customers were split In return, the pharmacy chamber remarked, tor beforehand. almost equally between those aged up to 39 Baden-Württemberg pharmacies sent 15,000 Citing a recent study by the Barmer GEK years, between 40 and 59 years, and aged 60 patients every day to the “competition”repre- health insurance fund, Preißner said each doc- years and older. sented by doctors. tor consultation cost German statutory insurance Of those customers who requested a specific This number,the chamber’s managing direc- funds C56.01 on average. Therefore, he calcu- product, 91.1% were deemed suitable to self- tor Dr Karsten Diers insisted, proved that phar- lated, multiplying C56.01 by the 1.57 million medicate. When those who did not name a par- macists were more healthcare professionals than doctor consultations avoided through self-med- ticular product were included in the total, that business people, because they chose not to sell ication in pharmacies gave a saving of C88 mil- proportion fell slightly to 89.8%. medicines they did not feel were suitable. Lift- lion per day. Commenting on this finding, the pharmacy ing a ban on third-party pharmacy ownership Referring to a recent study that had suggest- chamber claimed that “Baden-Württemberg’s – thereby permitting pharmacy chains – would ed that one in five potential visits to a general pharmacists prevent 29,000 cases of dangerous threaten this situation,he alleged. practitioner in Germany were avoided through self-medication each day”. On 13.0% of the occasions when customers self-medication, Preißner said this still equated In just 3.0% of cases did the participating sought self-medication, they also presented a to around 313,000 patients per day who visited pharmacist consider that the specific product prescription. And in 6.4% of cases, the customer a pharmacy rather than a doctor. This worked requested by the customer was not suitable. handed the pharmacist a so-called ‘green pre- out at C17.5 million saved per day. Looking at the type of products requested scription’, which is a recommendation from a Once weighted for the proportion of the Ger- by pharmacy customers, or the symptoms re- doctor for a non-prescription medicine written man public covered by statutory health insur- ported, the most common indication was skin on a sheet designed to resemble a prescribing ance funds, this gave an annual saving of around and wound care, cited by 17.6% of people vis- pad (OTC bulletin,30 June 2010, page 7). C4.2 billion. That figure was almost identical iting pharmacies. The IfH’s Dr Markus Preißner stated that to the C4.18 billion that statutory funds paid to Coughs, colds and fevers ranked second on around four million visits to German pharma- pharmacies as dispensing fees in 2009, observ- 16.6%, although the pharmacy chamber ac- cies nationwide each day equated to 2.27 mil- ed Preißner. OTC

Mergers & Acquisitions tive officer of Alcon, will lead the new Alcon division within Novartis, which will also in- Novartis closes Alcon takeover clude the Ciba Vision business. The combin- ed eyecare division had a proforma turnover last year of US$8.7 billion. ovartis has completed its acquisition of any (OTC bulletin,21 January 2011, page 4). The new division will also include Alcon’s N Alcon after the company’s shareholders Three months earlier,Novartis had lifted US$1.0 billion consumer business, deriving pri- approved the deal. its holding in Alcon to 77% by paying Nestlé marily from contact-lens disinfectants under The Swiss firm announced in January that US$28.3 billion for another 52% of Alcon’s the Opti-Free brand as well as artificial tears it would take full control of Alcon after agree- shares in a deal the two companies had agreed and products for dry eyes under the Systane ing to pay US$12.9 billion (C8.90 billion) in around three years ago (OTC bulletin,15 Ap- label. Alcon also offers ICaps vitamin and min- cash and shares for the 23% stake it did not ril 2008, page 4). eral supplements. already own in the US-based eyecare comp- Kevin Buehler,president and chief execu- OTC

15 April 2011 OTC bulletin 13 OTC15-04-11p14-15FIN.qxd 14/4/11 13:28 Page 2

OTC GENERAL NEWS

Regulatory Affairs Regulatory Affairs FDA to discuss FDA rule on supplement GMP acetaminophen is not arbitrary and capricious aediatric medicines containing acetamino- Pphen will be discussed next month by two hallengers to the US rules governing good to regulate dietary supplement production; and advisory committees to the US Food and Drug Cmanufacturing practice (GMP) for dietary secondly,that the language used was uncon- Administration (FDA). supplements have failed to convince a Wash- stitutionally vague as it used terms like “ade- The FDAsaid its Nonprescription Drugs ington district court. quate”, “suitable” and “qualified”. Advisory Committee and its Pediatric Advi- Describing some of the challengers’ argu- Their first reason hinged on the meaning of sory Committee would review “pertinent phar- ments as “defying common sense”, Judge Beryl the law when it said the FDA should not im- macokinetic, safety and efficacy data, and dis- Howell ruled that the Food and Drug Admin- pose “standards for which there is no current cuss whether new dosing information for oral istration (FDA) had not exceeded its author- and generally available analytical methodology”. OTC drug products containing acetaminophen ity in drawing up its GMP Final Rule. More- However, the judge said to interpret this to should be added to the label for children less over, the rule was not “impermissibly vague” mean that the FDA was only permitted to issue than two years of age”. and should not be considered “arbitrary and GMP regulations that were based on analyti- The committees would also consider “add- capricious”. cal methodologies and that these methodolo- ing a weight-based dosing regimen to the exist- Two supplement-formulation scientists – gies had to be current and generally available ing age-based dosing regimen for children 2- Duke Pearson and Sandy Shaw – together with was “flawed”. She could find no objection to 12 years of age”, continued the FDA, noting the Alliance for Natural Health USA and the the FDA’s various procedural, recordkeeping that dosing for children 12 years of age and Coalition to End FDA and FTC Censorship and quality-control requirements that were not older would not be discussed. had sought to have parts of the FDA’s GMP based on ‘analytical methodology’. Furthermore, added the FDA, the commit- Final Rule declared invalid. “The FDA has not violated [the law] because tees would discuss “ways that administration But, as the judge pointed out, to do so would it has not imposed any standards for which there by caregivers can be improved so that medica- have invalidated “more than 40 sections of the is no current and generally available analyti- tion errors can be minimised” for acetamino- [rule] which was the outcome of a lengthy agency cal methodology,” she said. phen, which is known as paracetamol in many rulemaking process that spanned a decade from Howell dismissed the plaintiff’s second argu- other countries. the Advanced Notice of Proposed Rulemaking ment by observing that the regulations were not The joint meeting of the advisory commit- in 1997 to adoption of the Final Rule in 2007”. unconstitutionally vague because the rule “flesh- tees will take place on 17-18 May 2011. Pearson and Shaw had joined in the “extensive ed out the meaning” of terms like ‘adequate’. OTC public participation”, she observed, along with Moreover, a “reasonably prudent person”, fam- other industry representatives. iliar with the conditions addressed and objec- IN BRIEF Company size determined the rule’scom- tives sought would have “fair warning of what pliance date, which was staggered from June the regulations require”. ■ A STUDY of food supplements sold via the 2008 until June 2010. The plaintiffs’ assertions of FDA inspectors internet in Sweden has found that a signifi- Two reasons for objecting to the rule were abusing their power by exploiting the regula- cant proportion contain substances that could extended by the plaintiffs, who started their tions’ “flexibility” was also dismissed by the harm consumers. When Sweden’s National Food action in August 2009. Firstly,they said that judge, who said the court “must presume the Administration (NFA) purchased 43 food sup- the FDA had exceeded its statutory authority agency will act in good faith”. plements backed by analgesic, performance- OTC enhancing, potency-enhancing or weight-loss claims from eight Swedish-language websites, Regulatory Affairs Switches two-thirds of the products contained substances that could cause adverse effects. Only two of Denmark opens up Switch list updated the 43 products came in packaging that met the audited labelling requirements, said the NFA, time slots in 2012 list showing the legal status of 230 active and 19 products did not have a label in Swed- Aingredients widely used in non-prescrip- ish. Of the 24 products that did have a label in he Danish Medicines Agency is fully book- tion medicines has just been updated by the Swedish, continued the NFA, 18 were backed Ted this year for new decentralised autho- Association of the European Self-Medication by health claims, many of which lacked a sci- risation procedures, including line extensions, Industry,the AESGP. entific basis. using Denmark as reference member state. The industry association said the table cov- However, the agency is currently accepting ering 36 key countries around the world now ■ FDA – the US Food and Drug Administra- requests for time slots during the first half of included the changes since the last update in tion – has asked consumers to contact the reg- 2012, but these must be lodged with the agency December 2008. ulatory agency if they have had a “negative by the end of April. The updated list is available through the reaction to a beauty,make-up or personal hy- Time slots after the first half of 2012 have AESGP’s website at www.aesgp.be/publica- giene product”. not yet been made available. tions/otcIngredientTables.asp. OTC OTC OTC

14 OTC bulletin 15 April 2011 OTC15-04-11p14-15FIN.qxd 14/4/11 13:28 Page 3

GENERAL NEWS OTC

Regulatory Affairs EFSA’s fourth batch sparks call for change

ost of the 442 submissions in the fourth function, and maintenance of normal blood joint and oral health; oxidative damage and Mbatch of general-function health claims cholesterol levels. cardiovascular health; and satiety,weight man- assessed by the European Food Safety Author- EFSA said positive opinions had been given agement and blood glucose concentrations. ity (EFSA) have been rejected. to claims involving the relationship between EFSA said it would finalise assessments for EFSA has now said no to around 80% of walnuts and improved function of blood ves- the remaining 600 submissions by June 2011. the 2,187 general-function health claims asses- sels, the antioxidant effects of polyphenols “Experts on the panel have completed the eval- sed to date. found in olive oil on LDL cholesterol, caffeine uation of about 80% of general-function health The majority of the 808 submissions in the and alertness, and caffeine and increased phys- claims, excluding so-called botanical claims, third batch were turned down (OTC bulletin, ical endurance. and are committed to finalising the remaining 29 October 2010, page 9); only a handful of Furthermore, continued EFSA, a number of claims by the agreed deadline,”said Dr Juliane the 416 submissions in the second batch were claims based on replacement of certain nutri- Kleiner,head of EFSA’s panel on Dietetic Pro- given the okay (OTC bulletin,17 March 2010, ents had been given the okay. Examples cited ducts, Nutrition and Allergies (NDA). page 11); and just a third of the 521 claims in by EFSA include the replacement of digestible The June 2011 deadline is in line with the the first batch received a positive opinion (OTC starch by resistant starch to lower the increase European Commission’s modified process for bulletin,16 October 2009, page 11). of blood glucose levels after meals, and the re- adopting general-function health claims (OTC The high proportion of negative opinions has placement of saturated fatty acids with mono- bulletin,15 October 2010, page 1). prompted three industry associations to demand and polyunsaturated fatty acids to maintain nor- The Commission announced in October of a “fundamental reappraisal” of the process. mal blood cholesterol levels. The authority also last year that the community list of permitted “Continued reliance in the assessment pro- recognised the role of a range of sugar replac- general-function health claims for foods would cess on criteria which are unfeasible and inap- ers, such as xylitol or sorbitol, in maintaining be established in two steps. The list for all sub- propriate for the majority of claims is contribut- tooth mineralisation or lowering the increase stances other than botanicals would be adopt- ing to the high number of negative EFSA opin- of blood glucose levels after meals. ed in a single step, it explained, with claims ions,”maintained the European Federation of As with the first three batches, many of the for botanicals considered once the first step Associations of Health Product Manufacturers negative opinions were said by EFSA to be had been completed. The Commission noted (EHPM), the European Responsible Nutrition “linked to the poor quality of the information that it would “immediately” follow up with the Alliance (ERNA), and the European Botani- provided”. EFSA pointed out that information necessary legislative measures. cal Forum (EBF). “The European Commission gaps included: the inability to identify the spe- The move came after industry and some should undertake a discussion of the specifici- cific substance on which the claim was based; member states complained about the Commis- ties and limitations of nutritional research, and the lack of evidence that the claimed effect was sion’s progressive approach whereby claims reappraise the claims evaluation process before indeed beneficial to the maintenance or im- were set to be adopted in a number of series. rejecting claims based on EFSA opinions.” provement of body functions; and lack of pre- The community list of permitted general- The three industry associations said their de- cision regarding the health claim being made. function health claims for foods – covered by mands had been highlighted last month in a let- In addition, noted EFSA, some of the claims Article 13.1 of the European Union’s Regula- ter to Basil Mathioudakis, head of the Com- were outside the scope of the current legal tion 1924/2006 on nutrition and health claims mission’s food law unit. framework. for food – should have been completed by 31 The 442 claims in the fourth batch include To provide guidance to applicants, EFSA is January 2010. However, it became clear some protection against oxidative damage to body arranging three additional online consultations time ago that the deadline would not be met cells, contribution to either cognitive or bowel this month on health claims related to bone, (OTC bulletin,30 October 2009, page 18). OTC

Regulatory Affairs ical signal” to the European Commission on authorisation of health claims. Bid to block DHA health claim fails Commenting on the action, Monika Kosin- ska,secretary general of the EPHA, said: “If he European Parliament’s Environment, Mead Johnson Nutritionals, which states that marketing were not effective,companies would TPublic Health and Food Safety Committee intake of the substance contributes to the visual not invest in it. Therefore, we need to proceed has failed in a bid to block authorisation of a development of infants up to 12 months of age, very cautiously when authorising claims aimed health claim for docosahexaenoic acid (DHA). was the main concern for the committee. at vulnerable groups.” The committee had adopted a ‘Motion for a Insisting that the claim was not backed by The Commission’s draft regulation received resolution’ objecting to the European Commis- scientific evidence, the European Public Health a favourable opinion from the Standing Com- sion’s draft regulation covering a number of Alliance (EPHA) said the World Health Orga- mittee on the Food Chain and Animal Health health claims. During a vote in the European nization (WHO) and UNICEF had recommend- (SCFCAH) in December. The draft regulation Parliament plenary session earlier this month, ed that the claim be rejected. The EPHA point- covers seven Article 14 health claims on the ef- however, the motion failed to attract an abso- ed out 328 Members of the European Parlia- fects of DHA and alpha-linolenic acid on the lute majority. ment (MEPs) had supported the motion against visual, brain and eye development of children. An Article 14 health claim for DHA from the DHA health claim, sending a “strong polit- OTC

15 April 2011 OTC bulletin 15 OTC15-04-11p16-17FIN.qxd 14/4/11 13:32 Page 2

OTC MARKETING NEWS SevenRelaunches Seas shakes up JointCare range in UK

even Seas has revamped its JointCare range “Bodies work better” is the slogan Sigma-Tau Sof food supplements in the UK to “enhance HealthScience is using to launch a range of six nutraceutical products in France, the Netherlands customer understanding of the role of supple- and Spain. ments and help them to choose the right prod- Colour-coded packaging indicates the therapeutic uct for their needs”. category of each product. The energy-enhancer B Record Plus, containing To help consumers select the most appro- amino acids and vitamin B12, comes in an orange priate JointCare product, Seven Seas has intro- box, while the immune-defence booster Resvis duced a “clearer hierarchy of increasing pot- XR – which contains lactoferrin, resveratrol, vitamins, and zinc and is available in both adult and children’s ency” by dividing the range of six products versions – is supplied in green packs. into three categories. Two JointCare ‘be’ for- Men’s health products – including the mulations are for lifestyle management; three Seven Seas has relaunched its JointCare supplements erectile-dysfunction treatment Ezerex, the with a “clearer hierarchy of increasing potency” antioxidant Proxana and the fertility booster Proxeed JointCare ‘PRO’ products are for therapy; and – have blue packaging. JointCare ‘XCEL’is for treatment. age joint health and provide all round support” UK-based marketing agency MBA said the Commenting on the relaunch, Seven Seas – by JointCare PROSustain, the new name for advertisements and website supporting the launch of Sigma-Tau HealthScience’s range emphasised the said consumer insights had highlighted a need the existing JointCare Opti-release product. brand’s unique selling point as the most effective for more signposting within the range, which Finally,the company said it had reformu- range of nutraceutical products on the market. had previously consisted simply of six products lated the JointCare Max product and renamed Italy’s Sigma-Tau, which has subsidiaries throughout Europe, claims to be the market leader for with different formulations. it JointCare XCELMax, reflecting its position food supplements in Italy. The company also says its Packaging had also been updated with a new as the variant with the highest potency. nutraceutical products – which are available in both “contemporary” brand logo, the company said, All the JointCare ‘be’ products, along with pharmacies and parapharmacies – have been clinically and scientifically tested. while five out of the six JointCare products had JointCare PROSustain and JointCare XCEL- OTC been reformulated and four were now supplied Max, would benefit from the new smaller cap- in smaller,easier-to-swallow capsules. Depend- sules, Seven Seas noted. ing on the product, ingredients could include In addition to a targeted public relations calcium, chondroitin, glucosamine, hyaluronic campaign, the new JointCare range would be acid, omega-3, vitamin C and/or vitamin D. supported by an “entirely new” heavyweight Seven Seas JointCare ‘be’ products helped marketing and advertising campaign, Seven support everyday maintenance of joints, the Seas pointed out, built on the brand’s “Take company said,noting the JointCare besupple JointCare of Yourself” message. and JointCare beactive products had replaced National and consumer press, as well as on- the JointCare Original and JointCare Advanced line and digital outlets, would be targeted, the products respectively. company noted, adding that television adver- JointCare Complete and JointCare Sport had tising would run on selected channels from both been reformulated, Seven Seas noted, and June until September. would now be known as JointCare PROCom- A spokesperson for Seven Seas said that the plete and JointCare PROSportFlex. These would campaign formed part of the company’s annual be joined in the ‘PRO’ range – which had been £2.7 million (C3.0 million) advertising and pub- scientifically developed to “pro-actively man- lic relations spend on the JointCare range. OTC

GlaxoSmithKline Consumer Healthcare is backing its new Sensodyne Repair & Protect toothpaste in the UK with a £3 million (C3.4 million) marketing The alternative to antihistamines is how Novartis campaign including television, consumer press, Consumer Health is positioning Otriven Allergie Aktiv outdoor and digital advertising, as well as public in German trade-press advertising for the new relations activity. beclometasone dipropionate nasal spray. The company said national television advertising The advertising features a young woman whose – running on terrestrial and satellite stations from mouth forms an ‘O’ shape as she blows the top off a 4 April until mid-May – featured a dentist dandelion. “O … wie Otriven Allergie Aktiv” or “O … accompanied by a mode-of-action visualisation. like Otriven Allergie Aktiv” is the headline. Launched last month, Sensodyne Repair & Protect Novartis says its beclometasone spray, which has is claimed by GlaxoSmithKline to be the “world’s first just been launched in Germany (OTC bulletin, 31 everyday fluoride toothpaste with NovaMin March 2011, page 16), acts against acute hayfever technology that can repair sensitive teeth” symptoms and reduces nasal inflammation. (OTC bulletin, 17 March 2011, page 15). OTC OTC

16 OTC bulletin 15 April 2011 OTC15-04-11p16-17FIN.qxd 14/4/11 13:32 Page 3

MARKETING NEWS OTC

Licensing Agreements PL gains exclusive rights to store-brand Zegerid OTC

L Developments has acquired from Par Phar- of the store-brand firm’s “dedication to bring- Pmaceutical the exclusive sales and distribu- ing valuable products and technologies” to its tion rights to store-brand versions of Merck & retail partners. Co’s Zegerid OTC heartburn medicine in the US. PL noted that IRI data for the 52 weeks end- Par already had approval from the US Food ed January 2011 showed store-brand sales in and Drug Administration (FDA) for the prescrip- the gastrointestinal category had risen by 11.9%, tion version of Zegerid, said PL, and had filed outpacing national brand growth by 8.7 per- an Abbreviated New Drug Application (ANDA) centage points. for the OTC version. Once FDAapproval had been obtained and Defending against patent challenges patent litigation had been settled, PL said that Merck & Co is currently defending Zegerid it would market the OTCversion – containing OTC in the US from patent challenges by Par Capsules containing plant sterols and a multivitamin product for expectant or breastfeeding mothers are 20mg omeprazole and 1,100mg sodium bicar- and store-brand specialist Perrigo (OTC bul- two of the latest additions to the Das gesunde Plus bonate – as a store-brand option to its custom- letin, 29 September 2010, page 3). own-label healthcare range offered by German ers. The company noted Par had been the first Both Par and Perrigo have filed ANDAs for drugstore chain dm-drogeriemarkt. Cholesterin Control is a dietary supplement to file an ANDA, so PL’s store-brand version generic 20mg omeprazole and 1,100mg sodium that is claimed to be “proven to reduce cholesterol would enjoy 180 days of generic exclusivity. bicarbonate capsules with the FDA, effectively levels”. A pack of 45 of the three-a-day capsules has Zegerid OTC – which is an immediate-re- challenging Zegerid OTC’s patents. a recommended retail price of C4.95. Das gesunde Plus A-Z Mama provides 400µg folic lease, oral proton pump inhibitor – was launch- In the lawsuit, Merck & Co and its develop- acid as well as a range of other vitamins and minerals ed by Schering-Plough, now part of Merck & ment partner Santarus allege infringement of that are important during or after pregnancy. A pack Co,in April of last year (OTC bulletin,16 Ap- all four patents listed against the OTC brand in of 60 of the one-a-day tablets retails at C3.95. Other recent additions to the own-label range ril 2010, page 14). the Orange Book maintained by the FDA. The include two dietetic foods: ginger lozenges to PL pointed out that market researcher IMS four patents expire on 15 July 2016. combat nausea; and lactase capsules to help digest had forecasted that Zegerid OTC would gen- The two brand companies are also appeal- dairy products. At the end of April, dm-drogeriemarkt plans to erate turnover of US$100 million (C69.3 mil- ing against a Delaware district court’s finding introduce Das gesunde Plus Sodbrennen akut lion) by 2012. in April last year – in a case concerning the pre- Suspension, a medical device that combats Mitch Singer,PL’s president and chief ex- scription version of Zegerid – that the same pat- heartburn “in a purely physical way” by creating a barrier in the stomach. A pack of 20 individual ecutive officer,said the deal with Par for gen- ents were invalid due to obviousness (OTC sachets will cost C5.95. eric Zegerid OTC was an “exciting example” bulletin,30 April 2010, page 1). OTC OTC

Line Extensions Prestige adds cetirizine to PediaCare

n allergy medicine based on cetirizine hyd- million) to private-equity group Charlesbank Arochloride is the latest addition to Pres- Capital Partners for Blacksmith Brands Hold- tige Brands Holdings’ PediaCare range of child- ings and its portfolio of OTC brands (OTC ren’s remedies in the US. bulletin,29 September 2010, page 1). The company said Children’s PediaCare 24 At the time, the US-based firm said that ac- Hr Allergy was a one-dose-per-day treatment quiring Blacksmith’s OTC brands – which in- for children aged two years and older. Bullet- cluded Efferdent, Effergrip, Luden’s and Nasal- points on the packaging point out that the pro- Crom – would be “transformative”. duct provides “all day relief” from sneezing, Prestige pointed out that it had recently ex- watery eyes, runny nose and itchy throat or nose, tended the PediaCare brand with new formu- while straplines highlight the product is “dye lations for colds, coughs, fever, gastrointesti- free” and comes in “grape” flavour. nal complaints and sore throats. The newcomer joins two existing PediaCare Furthermore, noted the firm, a new brand New Children’s PediaCare 24Hr Allergy comes in allergy remedies: one containing diphenhydra- website at www.pediacare.com featured a symp- grape flavour mine, and the other combining diphenhydra- tom checker and product selector to help par- dren entertained, added Prestige, and a Pedia- mine with phenylephrine hydrochloride. ents find the right products for their children. Care Shopper’s Guide iPhone application could Prestige obtained the PediaCare brand last Printable games, puzzles and colouring pages be downloaded for free. year,after agreeing to pay US$190 million (C142 were available from the website to keep ill chil- OTC

15 April 2011 OTC bulletin 17 Te ll the right people what youwant to in-license and out-license EKNOW the people who want to in-license, Wout-license, buy or sell your OTOTCCp products,roducts, brands or technologies. We knowthem because theyare registering with us at the SourceOTC website. Reach the SourceOTC community by posting your ownmessage. in association with

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EVENTS OTC

Tel: +44 20 7017 7036. MAY 8-10 June Fax: +44 20 7017 7818. 47th AESGP Annual Meeting 5 May E-mail: [email protected]. ■ Rome, Italy ■ Basics of Website: www.vitafoods.eu.com. ‘A new treaty for self-care’ will be the theme of the 47th Annual Meeting Regulatory Affairs 17-19 May of the Association of the European Self-Medication Industry,the AESGP. London, UK ■ Russian Pharmaceutical The three-day meeting will include a session entitled ‘Self-medication A one-day course from The Org- industry quo vadis?’, featuring presentations from Cavan Redmond, pre- anisation for Professionals in Reg- Forum St. Petersburg, Russia sident of Pfizer Diversified Businesses, and Emma Walmsley, world- ulatory Affairs (TOPRA). wide president designate of GlaxoSmithKline Consumer Healthcare. Contact:TOPRA. Speakers from the Association of the European Self-Medication In- Speakers at the meeting will also include: John Dalli, European com- Tel: +44 20 7510 2560. missioner for health and consumer policy; Ferruccio Fazio, Italian min- Fax: +44 20 7537 2003. dustry,the AESGP,Merck Ser- ono, Novartis Group Russia, Pfi- ister of health; Dagmar Roth-Behrendt, vice-president of the European E-mail: [email protected]. Parliament; Andreas Pott of the European Medicines Agency (EMA); Website: www.topra.org. zer and Sanofi-Aventis will take part in this three-day event. Vittorio Silano of the European Food Safety Authority (EFSA); Basil 5-6 May Contact: Adam Smith Conferences. Mathioudakis of the European Commission; June Raine from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA); Andy ■ 2011 Regulatory & Tel: +44 20 7017 7444. Scientific Conference Fax: +44 20 7017 7447. Tisman, senior principal, Consumer Health at IMS Management Con- sulting; and Stefano Maruzzi, country manager at Google Italy. Bethesda, Maryland, US E-mail: events@adamsmith Contact:Association of the European Self-Medication Industry,the AESGP. A two-day regulatory and scien- conferences.com. Tel: +32 2 735 51 30. Fax: +32 2 735 52 22. tific conference organised by the Website: www.russianpharma.com. E-mail: [email protected]. Website: www.aesgp.be. US Consumer Healthcare Prod- 25-27 May ucts Association (CHPA). ■ Pharmaceutical Contact:Maria Sarabia, CHPA. 9 June 27-28 June Regulatory Affairs Tel: +1 202 429 3545. The Nutrition and Health ■ Regulatory Affairs in Asia – including India ■ Fax: +1 202 223 6835. Claims Regulation in Africa – including London, UK E-mail: [email protected]. Brussels, Belgium South Africa Day one of this three-day seminar Website: www.chpa-info.org. A one-day conference subtitled will discuss regulatory affairs in London, UK ‘Dealing with the present – plan- 6 May China, while day two will focus Countries that will be covered at ning for the future’. this two-day meeting include Al- ■ Marketing Authorisation on India and day three will cover Contact:EAS. in the CIS Countries Korea and Taiwan. geria, Ghana, Morocco, Nigeria, Tel: +32 2 218 1470. Tanzania and Uganda. Frankfurt, Germany Contact: Management Forum. E-mail: [email protected]. Contact: Management Forum. Belarus, Kazakhstan, Russia and Tel: +44 1483 730071. Website: www.eas.eu. Tel: +44 1483 730071. Ukraine will be the main focus of Fax: +44 1483 730008. Fax: +44 1483 730008. this one-day seminar,but other E-mail: registrations@management- 19-23 June E-mail: registrations@management- countries such as Armenia, Azer- forum.co.uk. ■ 47th DIA Annual forum.co.uk. baijan, Mongolia and Uzbekistan Website: www.management- Meeting Website: www.management-forum.co.uk. will also be covered. forum.co.uk. Chicago, Illinois, US Contact:Dr Henriette Wolf-Klein, ‘Convergence of science, medi- 27-29 June Forum Institut für Management. 30-31 May cine and health’ is the theme of ■ Stepping It Up Tel: +49 6221 500 680. ■ EuroPLX 46 this five-day event, which is the Basel, Switzerland Fax: +49 6221 500 555. Vienna, Austria annual meeting of the Drug In- A three-day pharmaceutical mar- E-mail: [email protected]. A two-day partnering and licens- formation Association (DIA). ket research conference. Website: www.forum-institut.com. ing forum focusing on OTC medi- cines, nutraceuticals, branded pre- Contact: Vicki Adkinson, DIA. Contact: EphMRA. 10 May scription drugs and generics. Tel: +1 215 442 6162. Tel: +41 22 33 99 596. ■ Molecule Life Cycle Contact:RauCon. Fax: +1 215 442 6199. Fax: +41 22 33 99 631. Management Tel: +49 6222 9807 0. E-mail: [email protected]. E-mail: [email protected]. Website: www.diahome.org. London, UK Fax: +49 6222 9807 77. Website: www.ephmra.org. E-mail: [email protected]. Representatives of the UK’s Med- 21 June icines and Healthcare products Website: www.europlx.com. JULY ■ Marketing Authorisation Regulatory Agency (MHRA) will in South Africa, 4 July speak at this one-day meeting. JUNE Pharmaceutical Contact: Zain Philbey, SMi Group. Australia and ■ 6-7 June Tel: +44 20 7827 6722. New Zealand Regulatory Affairs Fax: +44 20 7827 6001. ■ DIA European Regulatory Frankfurt, Germany in Turkey E-mail: [email protected]. Affairs Forum 2011 This one-day conference will look London, UK Website: www.smi-online.co.uk. London, UK at the pharmaceutical markets and Turkey’s regulatory environment Pharmacovigilance, the centralis- marketing authorisation proced- and application process will be 10-12 May ed authorisation procedure, and ures in Australia, New Zealand and discussed at this one-day event. ■ Vitafoods transparency will be discussed at South Africa. Contact: Management Forum. Geneva, Switzerland this two-day event. Contact:Dr Henriette Wolf-Klein, Tel: +44 1483 730071. A three-day exhibition and confer- Contact:DIA Europe. Forum Institut für Management. Fax: +44 1483 730008. ence focusing on nutraceuticals, Tel: +41 61 225 5151. Tel: +49 6221 500 680. E-mail: registrations@management- cosmeceuticals, functional foods Fax: +41 61 225 5152. Fax: +49 6221 500 555. forum.co.uk. and functional drinks. E-mail: [email protected]. E-mail: [email protected]. Website: www.management- Contact: Chris Lee,IIR Exhibitions. Website: www.diahome.org. Website: www.forum-institut.com. forum.co.uk.

15 April 2011 OTC bulletin 19 OTC15-04-11p20-21FIN.qxd 15/4/11 10:38 Page 2

OTC COMPANIES Moderate growth for most in 2010

Acquisitions helped Sanofi-Aventis achieve strong sales growth at its & Personal Care division in 2009. Consumer Health Care business in 2010, while most of its OTCpeers put in The 2010 result excluded £90 million gen- erated by SSL International in the short period moderate performances and Johnson & Johnson was hit hard by product from when it was consolidated on 1 November recalls. Deborah Wilkes looks at the financial results of the leading players. 2010 to the end of the year. Reckitt Benckiser paid £2.54 billion for SSL International and its Durex and Scholl powerbrands (OTC bul- oderate sales growth was report- During 2010, Sanofi-Aventis also added to letin,30 July 2010, page 1). ed by most of the big OTCplay- its Consumer Health Care business in Canada Bayer’s Consumer Care business matched ers in 2010. The only two firms by acquiring skincare specialist Canderm (OTC the performance of Reckitt Benckiser’s Health Mto stand out from the crowd were bulletin,30 June 2010, page 1) and in Eastern & Personal Care division. It recorded a 9.4% Sanofi-Aventis and Johnson &Johnson, albeit Europe, where the company bought the Pol- rise in turnover to C3.37 billion in 2010. Ad- for very different reasons. ish OTC company Nepentes (OTC bulletin, justed for currency and portfolio effects, sales Sanofi-Aventis led the pack, as global sales 31 May 2010, page 1). moved forward by 4.2% (OTC bulletin,17 at its Consumer Health Care business shot up “Sanofi-Aventis is not a business with big March 2011, page 5). by 55.0% to C2.22 billion (see Figure 1). At global brands,”commented Viehbacher,“but The German company said it had restored constant exchange rates, the rise was still an Consumer Health Care is a local business, so expenditure on marketing and distribution to impressive 45.7% (OTC bulletin,28 February we’ve got very strong positions in Europe, very “normal levels”. It explained that it had reduc- 2011, page 6). strong positions in Latin America and now ed spend by the Consumer Care business dur- Acquisitions made a big contribution to this we are building good positions in the US and ing 2009 in the wake of the global economic growth. Chris Viehbacher,chief executive offi- Asia as well.” crisis. Last year,however,Consumer Care’s in- cer of Sanofi-Aventis, pointed out the French Sanofi-Aventis’ Consumer Health Care busi- vestment in marketing and distribution activ- pharmaceutical company’s Consumer Health ness also benefited from a 44.4% rise in turn- ities had returned to normal levels, leading to Care business had started 2010 with no pres- over in emerging markets to C1.05 billion in double-digit growth by four out of the com- ence in the US or Chinese consumer markets, 2010. The performances in Latin America and pany’s six leading OTC brands. but had finished the year having made signif- Eastern Europe were highlighted. Elsewhere in the OTC industry,the OTC icant progress in both. Acquisitions also played a significant role at businesses of Boehringer Ingelheim, Glaxo- In the US, Sanofi-Aventis acquired Chattem Perrigo’s Consumer Healthcare division, which SmithKline, Merck & Co, Nycomed, Novartis in February 2010 for approximately US$1.9 bil- recorded a double-digit rise in sales in the year and Omega Pharma, achieved moderate sales lion (C1.3 billion). The price represented 4.8- ended 26 June 2010. The store-brand special- rises of 4% or 5% in 2010. times Chattem’s sales in 2009 and 13.3-times ist, which generates most of its turnover in the Japan’s Taisho Pharmaceutical did not fare its earnings before interest, tax, depreciation and so well in its most recent finan- amortisation (EBITDA) (OTC bulletin,20 Jan- We’ve got very strong positions in Europe, cial year ended 31 March 2010, uary 2010, page 1). very strong positions in Latin America, and as sales by the Self-Medication Announcing the annual results earlier this division dropped back by 1.1% year,Viehbacher said Chattem provided Sanofi- we are now building good positions in the to ¥159 billion (C1.33 billion). Aventis with a “very strong consumer base”, US and Asia as well The company blamed the weak which had now been complemented by the ap- Japanese OTCmarket. proval of OTC Allegra (fexofenadine hydro- US, said the 12% rise to US$1.83 billion had However, Taisho pushed up its Self-Medica- chloride) in the US. Allegra was a “very excit- been driven by US$89 million in additional sales tion sales by 5.2% to ¥131 billion in the nine ing opportunity” for the company, he added, from a series of acquisitions (OTC bulletin,10 months ended 31 December 2010 (OTC bul- noting that a head of one of the major US phar- September 2010, page 8). letin,11 February 2011, page 8). macychains had described it as the “most excit- In March of last year,Perrigo acquired the The big loser in 2010 was Johnson & John- ing OTC switch” the market would see during store-brand infant formula manufacturer PBM son, as a series of product recalls and suspend- the next five years. Holdings for US$808 million and Australia’s ing production at McNeil Consumer Health- Orion Laboratories for US$48 million (OTC care’s Fort Washington facility took their toll. Striking deals in China bulletin,31 March 2010, page 1; OTC bulletin, US sales at Johnson & Johnson’s OTC& In China, meanwhile, Sanofi-Aventis estab- 17 March 2010, page 3). Nutritionals business fell by 37.1% to US$1.85 lished a majority-owned vitamin and minerals Reckitt Benckiser’s Health & Personal Care billion, pushing worldwide sales down by 19.2% joint venture with Minsheng Pharmaceutical division reported sales up by 9% – 6% at con- to US$4.55 billion. This fall would have been (OTC bulletin,10 February 2010, page 2) stant exchange rates – to £2.27 billion (C2.57 worse but for a 0.6% positive currency effect and acquired BMP Sunstone and its portfolio billion) in 2010. The UK-based company said (OTC bulletin,11 February 2011, page 4). of OTC cough/cold and women’s health brands the increase had been driven by “excellent” The slump at OTC & Nutritionals led to a (OTC bulletin,16 November 2010, page 1). growth of its powerbrands (OTC bulletin,28 7.7% drop in worldwide sales at Johnson & These buys had propelled Sanofi-Aventis into February 2011, page 5). Johnson’s Consumer division to US$14.6 bil- fifth place in the Chinese OTC market, claim- However, 9% was well below the 24% sales lion, which in turn was the major factor behind ed Viehbacher. increase achieved by Reckitt Benckiser’s Health the 0.5% decline in Johnson & Johnson’s world-

20 OTC bulletin 15 April 2011 OTC15-04-11p20-21FIN.qxd 15/4/11 10:38 Page 3

COMPANIES OTC

Parent group OTC business Annual sales of OTC business Change as % of Comments reported (%) group

Bayer HealthCare Consumer Care C3.37 billion +9 19.9 – Boehringer Ingelheim Consumer Health Care C1.31 billion +5 10.5 – GlaxoSmithKline OTC Medicines £2.46 billion (C2.79 billion) +5 8.7 Launched Alli throughout Europe in early 2009 Johnson & Johnson OTC & Nutritionals US$4.55 billion (C3.17 billion) -19 7.4 Series of product recalls Merck & Co Consumer Care US$1.34 billion (C0.93 billion)+52.9 Sales in the US and Canada only. Merck & Co bought Schering-Plough for US$41 billion on 3 November 2009 Merck KGaA Consumer Health Care C472million +1 5.1 – Nycomed Total OTC C433 million +4 1.4 – Novartis OTC– +5 –Sales growth in local currencies rather than as reported Omega Pharma Omega Pharma C857 million +5 100.0 Majority of sales are generated in Europe Perrigo Consumer Healthcare US$1.83 billion (C1.27 billion) +12 80.6 Figures are for the year ended 26 June 2010. Made a number of acquisitions in the financial year. Majority of sales come from store-brands in the US Pfizer Consumer Healthcare US$2.77 billion (C1.93 billion) –4.1 Pfizer acquired Wyeth, including its Consumer Healthcare business, for US$68 billion in 2009 Procter & Gamble Health Care US$11.5 billion (C7.99 billion) +2 14.6 Figures for the year ended 30 June 2010. Health Care sales included Feminine Care and Oral Care as well as Personal Health Care Reckitt Benckiser Health & Personal Care £2.27 billion (C2.57 billion) +9 26.8 Acquired SSL International towards the end of 2010, but figures do not include SSL sales. Sanofi-Aventis Consumer Health Care C2.22 billion +55 7.3 Made a series of local OTC acquisitions in 2010 Taisho Self-Medication ¥159 billion (C1.33 billion) -1 61.5 Figures for the year ended 31 March 2010. Acquired Bristol-Myers Squibb’s OTC assets in the Asia-Pacific region, excluding China and Japan. Majority of sales come from Japan

Figure 1: Performance of selected OTC businesses in 2010 (unless otherwise stated) as reported by the parent groups. Changes in sales are as reported in the parent group’s chosen currency and include the effect of acquisitions/divestments and currency translations, and they are compared to the same period a year earlier. Currency conversions to euros are at rates on 14 April 2011. The range of products covered by OTC business units in this table varies from one company to another and may include personal-care products (Source – OTC bulletin)

wide sales to US$61.6 billion. not restart manufacturing at its Fort Washing- Furthermore, the move means that McNeil The billion-dollar drop in US sales at the tonfacility until the FDA gives the go-ahead. has a “strict timetable” to bring its facilities at OTC & Nutritionals business included US$900 Production was suspended in April of last Las Piedras in Puerto Rico and Lancaster in million due to the recalls. This was US$300 mil- year in the wake of the product recalls, but Pennsylvania into compliance. lion more than the US$600 million forecasted Johnson & Johnson had hoped to reopen the Within the past few weeks, Johnson & John- by Johnson & Johnson last October (OTC bul- facility in the second half of 2011 (OTC bul- son has announced plans to isolate its McNeil letin,29 October 2010, page 4). letin,11 February 2011, page 4). Consumer Healthcare business in the US, as it Johnson & Johnson is struggling to move A spokesperson for Johnson & Johnson told attempts to repair the damage caused by the on from the product recalls. In March, the US OTC bulletin that the plant would not now re- product recalls and closure of the Fort Wash- Department of Justice and the FDA officially open this year. It would remain closed until a ington facility (see page 3). charged Johnson & Johnson’s McNeil-PPC busi- remediation plan had been completed, certi- Set against this background,Johnson & John- ness with violating federal law following the re- fication of compliance from an independent ex- son faces a tough challenge to get the OTC& calls (OTC bulletin,17 March 2011, page 1). pert had been received, and approval from the Nutritionals business back on track. The move means Johnson & Johnson can- FDA had been given, added the company. OTC

15 April 2011 OTC bulletin 21 OTC15-04-11p22-23FIN.qxd 14/4/11 13:43 Page 2

OTC PEOPLE

Switches Drug-Delivery Companies Germany may ban Oxford Nutrascience names OTC paracetamol Norwood as new chairman ■ Continued from front page (EMA) had found that the available evidence did not support a causal link between parac- xford Nutrascience said shareholder David and his belief that the company was “now at etamol and asthma in children after exposure ONorwood had been appointed non-exec- a point of inflection and poised for signifi- during pregnancy or use in early infancy. utive chairman with immediate effect. cant growth”. In a move aimed at reducing liver damage, Norwood, 42, replaces Marcelo Bravo,who Norwood – a former chief executive of the the US Food and Drug Administration (FDA) will remain with the UK-based pharmaceuti- stockbroker Beeson Gregory and a former dir- recently reduced the maximum prescription cals and drug-delivery technology firm as its ector of brokerage company Evolution – is the dose of paracetamol – or acetominophen as it chief technology officer. founder of IP Group, which specialises in de- is known locally – to 325mg. However, it left An early investor in Oxford Nutrascience, veloping intellectual property-based businesses. unaffected non-prescription medicines con- Norwood currently holds a 17.5% stake in the He is currently chairman of Retroscreen Virol- taining the active ingredient (OTC bulletin, company. Norwood’s appointment, Oxford Nut- ogy, a specialist virology contract research firm. 22 January 2011, page 1). rascience explained, demonstrated his commit- Oxford Nutrascience has just announced a Fears of misuse triggered the proposed dex- ment to building science-based UK businesses name change to Oxford Pharmascience. tromethorphan reverse-switch. However, the OTC BAH spokesperson said, incidences of misuse did not appear to be increasing. Regulatory Affairs The Netherlands last year moved to reverse- switch the cough medicine (OTC bulletin,14 US FDA warns on benzocaine May 2010, page 19). Following a safety review of topical keto- ■ Continued from front page under the advice and supervision of a health- profen due to serious photosensitivity reactions, There had been 21 reported cases of methe- care professional. If benzocaine products were the EMA recommended last year that the non- moglobinemia after the use of OTC benzocaine used, the agency added, they should be used steroidal anti-inflammatory drug (NSAID) only gels and liquids, pointed out the FDA, of which sparingly and only when needed, and not more be used in topical formulations when prescrib- 11 had occurred in children two years of age or than four times a day. ed by a doctor (OTC bulletin,30 July 2010, younger who had been treated with benzocaine The FDA highlighted several OTCbrands, page 1). gel for teething. Ten of the 21 cases had been including Pfizer Consumer Healthcare’s Anbe- The Expert Committee will also consider categorised as life threatening,added the FDA, sol and Church & Dwight’s Orajel. It also sug- a comparative analysis of triptans (OTC bul- and there had been one reported death, but it gested alternative methods for reducing teeth- letin,31 March 2011, page 11). This will ac- was unclear whether the use of benzocaine had ing pain, including giving the child a teething company its considerations of applications to contributed to this outcome. ring that had been chilled in a refrigerator or switch from prescription-only to non-prescrip- In a Drug Safety Communication issued gently rubbing the child’s gums. tion status 10mg rizatriptan forms and 20mg earlier this month, the FDA pointed out that Given the seriousness of the cases of methe- sumatriptan nasal sprays. benzocaine use could cause methemoglobine- moglobinemia, the FDA said it would continue The committee has already recommended mia, a condition where the amount of oxygen to evaluate the safety of benzocaine products switching sumatriptan oral forms, but German that could be carried through the bloodstream and take regulatory actions as warranted. legislators have yet to act on that advice. McNeil was greatly reduced. In the most severe cases, The Consumer Healthcare Products Asso- is currently launching 12.5mg almotriptan tab- the communication noted, methemoglobinemia ciation (CHPA) stressed that the products were lets as an OTC migraine remedy under the could result in death. safe when used as directed for the large major- Dolortriptan brand name. According to the communication, methemo- ity of consumers. Other points for the committee to consider globinemia could occur the first time a person In a separate Drug Safety Communication, in July will be raising the maximum OTC nico- used benzocaine or after a person had used ben- the FDAhas alerted healthcare professionals tine dose from 10mg to 15mg; and harmonis- zocaine several times. Furthermore, the condi- to reports of methemoglobinemia associated ing the duration of OTC treatment for diclo- tion had been reported with all strengths of with benzocaine sprays used during medical fenac, ibuprofen and naproxen. benzocaine gels and liquids, including concen- procedures to numb the mucous membranes OTC trations as low as 7.5%. of the mouth and throat. The FDAdrew attention to the fact that la- Since it had issued a Public Health Advi- IN BRIEF belling for OTCbenzocaine products did not sory warning in 2006 about methemoglobine- ■ MHRA – the UK’s Medicines and Health- contain warnings about methemoglobinemia. mia with the use of benzocaine sprays during care products Regulatory Agency – has pro- As a result, consumers might not be aware of medical procedures, the FDAsaid, it had re- moted Mark Birse to group manager inspec- this condition and monitor for it when using ceived reports of 72 new cases, including three tions for Good Manufacturing Practice (GMP) OTCbenzocaine products. resulting in deaths. This brought the total num- and Good Distribution Practice (GDP). He suc- Parents and caregivers should not use OTC ber of cases to 319, including seven resulting ceeds Bryan Wright who has retired. benzocaine products on children under two in deaths, it said. OTC years of age, recommended the FDA, except OTC

22 OTC bulletin 15 April 2011 OTC15-04-11p22-23FIN.qxd 14/4/11 13:43 Page 3

PEOPLE OTC

IN BRIEF Manufacturers

■ EFPIA – the European Federation of the Pharmaceutical Industries and Associations – Regenauer to leave post has recruited Richard Bergström as director- general. Bergström moves to EFPIA from LIF, the Swedish research-based pharmaceutical in- at Sanofi-Aventis in May dustry association, where he held a similar posi- tion. He succeeds Brian Ager,who is joining the European Round Table of Industrialists as ans Regenauer will leave Sanofi-Aven- Hans Regenauer secretary-general. Htis on 16 May. The French pharmaceuti- cal company said that it had recruited Vincent ■ ABPI – the Association of the British Phar- Warnery from global cosmetics giant, L’Oréal, maceutical Industry – has appointed Stephen to replace Regenauer as vice-president Consum- Whitehead as chief executive. He succeeds er Healthcare Europe and global development. Richard Barker,who will step down as direc- A spokesperson for Sanofi-Aventis told tor-general on 25 May 2011. Whitehead will OTC bulletin that Regenauer was leaving to join the ABPI on 1 June from Prudential, where “pursue other career opportunities outside of he was the group communications director. He the group”. has also worked for Glaxo and Eli Lilly. The news of Regenauer’s departure comes just 15 months after he was appointed to de- ■ PERRIGO has appointed Tony Schott as velop Sanofi-Aventis’ OTC business. vice-president diabetes care at its Consumer Regenauer had previously been the world- Healthcare division. The US-based company wide head of Boehringer Ingelheim’s Consum- recently entered into an exclusive agreement er Health Care division (OTC bulletin,20 Jan- Sanofi-Aventis pointed out that prior to join- to sell and distribute blood-glucose monitors uary 2010, page 22). Before joining Boehring- ing L’Oréal, which owns a 9.02% stakehold- and test strips from AgaMatrix via the store- er Ingelheim in 1997, Regenauer held various ing in Sanofi-Aventis, Warnery had worked brand channel in the US (OTC bulletin,28 marketing, sales and general management posi- for Procter & Gamble and the rum manufac- February 2011, page 9). tions at Bayer. turer Bacardi & Company. OTC OTC

15 April 2011 OTC bulletin 23