Alli Heads OTC Brand Cull at Glaxosmithkline

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COMPANY NEWS 3 Valeant sets Cephalon 3 Alli heads OTC brand a May deadline J&J’s OTC sales drop 4 by a quarter in US cull at GlaxoSmithKline Atrium strikes deal 5 in Canada Omega encouraged by 6 laxoSmithKline Consumer Healthcare’s Brand Category opening quarter Gflagship weight-loss medicine Alli is one Novartis OTC sprints 7 of a number of OTC brands put up for sale Abtei VMS* ahead of market by the company because it has not got the Alli Weight management Bart Becht to leave 8 marketing clout to make them successful. Beano Gastrointestinal Reckitt Benckiser In a shock move,the firm has admitted that BC Analgesic North American sales rise 9 Alli – the first medicine to be switched cen- Beconase Respiratory tract boosts turnover at Boiron trally to non-prescription status in Europe and Debrox Excess ear wax Blackmores believes Asia 10 with launch sales of £110 million (C124 mil- Dequadin Cough/cold holds key to future growth lion) in 15 weeks in the US – could do better Ecotrin Analgesic Caffetin coaxes Alkaloid forward 10 in different hands. FiberChoice Dietary supplement GlaxoSmithKline has now turned its back GENERAL NEWS 11 on the orlistat-based weight-loss medicine in Goody’sAnalgesic a move to refocus its Consumer Healthcare op- Granufink Urological Consumer group demands 11 eration. Yet as recently as June 2007, the com- Lactacyd Feminine hygiene ban on Alli pany invested enormous sums to launch the Libenar Respiratory tract US FDA targets global supply chain 12 brand in the US – after paying Roche US$100 Nytol Sleep aid FDA takes action over 13 million (C68 million) plus royalty and mile- Phillips MOM Gastrointestinal MRSA claims in the US stone payments for the US OTC rights alone Solpadeine Analgesic MARKETING NEWS 14 in 2004 (OTC bulletin,30 July 2004, page 1). Tagamet/Stomedine Gastrointestinal Moreover, a few years later the company paid Valda Cough/cold supplement Dr Reddy’s and Perrigo gain 14 an undisclosed amount to Roche for the Euro- Zantac OTCGastrointestinal store-brand Allegra pean OTC rights (OTC bulletin,27 February Sanofi and Meda launch 15 2007, page 1), wrestled with the European auth- * Vitamins, minerals and supplements allergy brands in France orities for Alli to become the first successful Figure 1: Some of the brands to be divested by ASA raps Vitabiotics 15 pan-European switch, and then backed an im- GlaxoSmithKline with annual sales of over £5 million. GSK follows Piri revamp 16 mediate launch across 24 member states. The firm intends to divest the brands in all markets in with fresh commercials Alli is one of a basket of over 100 non-core which they are sold (Source – GlaxoSmithKline) McNeil reduces Reactine packs 16 OTC brands that GlaxoSmithKline is looking panies were “better placed to maximise the to divest, even though they have combined an- brands’ potential”, the company insisted. FEATURES 18 nual turnover of £0.5 billion (C0.6 billion), or The process of communicating with inter- about a tenth of the Consumer Healthcare divi- ested parties would begin over the next few Boehringer will fight 18 for OTC growth sion’s sales. weeks, GlaxoSmithKline said, with the aim of Boehringer Ingelheim’s strategy Other well-known brands for sale include divesting the products by late 2011, subject to for its Consumer Health Care Abtei food supplements, Beconase respiratory interest and realising the appropriate value for business is shifting under the products, Beano gastrointestinal remedies, Fib- shareholders. leadership of David Wright. erChoice dietary supplements, Goody’s pain The prospect of brand divestments was first Deborah Wilkes asks the new relievers, the Lactacyd feminine hygiene range, raised by the company in February,when chief global head of the world’s Nytol sleep aids, Solpadeine analgesics, and executive officer Andrew Witty said the firm sixth-largest OTC player about his plans. Zantac OTC heartburn drugs (see Figure 1). wanted to focus more effectively on its “prior- GlaxoSmithKline said the brands – primar- ity or global” brands as well as its operations REGULARS ily sold in Europe and the US – had “strong in emerging markets (OTC bulletin,11 Febru- heritage and good prospects”,but the firm lack- ary 2011, page 1). Events – Our regular listing 17 ed critical mass in some product categories, No mention was made at that stage, how- People – Commission puts AESGP 23 while certain brands had lacked focus due to ever,that a flagship OTC brand like Alli, which onto food advisory group other global priorities. As a result, other com- ■ Continued on page 22 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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COMPANY NEWS OTC

Mergers & Acquisitions Valeant sets Cephalon a May deadline

aleant has set a date of 12 May for Ceph- support a higher offer,” it added. revocation statement’ with the SEC, the US Valon’sshareholders to give their verdict Comparing its US$73.00 (C49.90) per share firm noted that its shareholders had “no obli- on removing Cephalon’s directors and electing “all-cash offer” – that values the US firm at gation to respond to [Valeant’s] deadline”. Valeant’s seven nominees in their place. US$5.7 billion (OTC bulletin,15 April 2011, Describing Valeant’s offer as “inadequate” “This vote is a referendum on whether Ceph- page 5) – with the “uncertainty of Cephalon’s and not in shareholders’ best interests, Cephalon alon’s shareholders want to pursue Valeant’s standalone plan, which relies on the successful noted that Valeant was acting in the best inter- offer,” the Canadian firm said as it filed a pre- commercialisation of a risky pipeline portfolio”, ests of its own shareholders, not Cephalon’s. sentation with the US Securities and Exchange Valeant warned that a transaction might only “Valeant is now attempting to replace all of Commission (SEC) in connection with its ‘writ- be possible with a new Cephalon board in place your current board with a slate of Valeant’s ten consent solicitation’. “given Cephalon’s rejection of Valeant’soffer hand-picked nominees, three of whom are re- “Valeant would be willing to increase its and refusal to engage in discussions”. cent Valeant directors,”Cephalon said. offer price modestly if Cephalon’s board of The Provigil prescription brand accounted Underlining a 0.5% compound annual de- directors would allow Valeant to conduct due for 41% of Cephalon’s net sales last year and cline in Cephalon’s share price over the past diligence and the results of such due diligence would face generic competition in 2012, Valeant five years, including a 19% decline in the 12 pointed out. This would cut Provigil’s earnings months before its offer,Valeant said its all-cash by more than 40%. “Cephalon’s value to Val- proposal was a 29% premium to Cephalon’s 30- OTC bulletin eant erodes each day Valeant is delayed in im- day trading average at the time of its bid. plementing its business strategy,” it said. Cephalon bought Mepha – the leading Swiss 29 April 2011 Number 361 Cephalon, however, urged its shareholders generics company with a portfolio of prescrip- to reject Valeant’s proposals. In filing a ‘consent tion and OTC drugs – from Merckle last year. Editor & Publisher: Deborah Wilkes OTC Associate Editors: Aidan Fry Mike Rice Licensing Agreements Business Editor: Matt Stewart Assistant Editors: Jenna Lawrence Oxford Nutrascience agrees Brazil deal David Wallace Advertising Controller: Debi Minal he UK’s Oxford Nutrascience has signed an target this sector by working closely with Aché.” Texclusive licensing and distribution agree- The deal with Aché also demonstrated that Marketing Manager: Val Davis ment with Aché Laboratórios Farmacêuticos the firm was capable of partnering with major Editorial, Subscription and Advertising to help the Brazilian firm expand its Inellare pharmaceutical companies that were “seeking enquiries should be addressed to: OTC bulletin, OTC Publications Ltd, 54 Creynolds Lane, Solihull, women’s health brand. product innovation”, Theobald claimed. West Midlands B90 4ER, UK. Under the terms of the seven-year deal, Ox- He added that “big pharma companies” were Tel: +44 1564 777550. Fax: +44 1564 777524. ford Nutrascience, using its own intellectual attracted to Oxford Nutrascience’s “ability to E-mail: [email protected]. property,would develop and supply a number apply novel pharmaceutic technology to extend Subscriptions of consumer healthcare products to Aché. These the lifecycle of existing branded generic medi- Annual subscriptions to OTC bulletin in Europe are £625.00 for single copies and £355.00 for additional copies to the same ad- would then be sold in Brazil under the Inellare cines” in which they had often invested heavily. dress, including delivery. Subscriptions to addresses outside Eur- brand name, the company said. Earlier this month, Oxford Nutrascience an- ope are subject to an additional charge of £30.00 to cover postage. Subscription enquiries in Korea should be directed to Pharma Oxford Nutrascience claimed the agreement nounced that it had shifted its strategy to focus Koreana Ltd, 14th Floor,KTB Network Building, 826-14 Yeoksam- represented a “significant progression” for the primarily on the pharmaceutical sector,where dong, Kangnam-gu, Seoul 135-080, Korea (Tel: +82 2 554 9591; Fax: +82 2 563 8289; E-mail: [email protected]). business, and would give it access to the “higher it had attracted significant attention (OTC bul- Advertising value pharmaceutical industry in Brazil”. letin,15 April 2011, page 8). Advertising rates and data are available on request from the ad- Brazil had one of the “largest and most dyn- Oxford Nutrascience provided solutions that dress above or at www.otc-bulletin.com. About OTC bulletin amic pharmaceutical markets in the emerging enabled companies to innovate and add value, OTC bulletin is published 20 times a year by OTC Publications economies”, the company stated, adding that Theobald said, noting that its “technology plat- Limited: twice monthly in February,March, April, May,June, Sep- tember,October and November; and monthly in December,Jan- IMS data said the market generated sales of forms in delivery formats and drug delivery” uary,July and August. A subscription to OTC bulletin includes US$22.9 billion (C16.0 billion) in 2010. were attracting “significant attention” from maj- the weekly electronic newsflash, news@OTCbulletin,which is published around 45 times a year. OTC bulletin is printed by the The Brazilian OTC market, Oxford Nutra- or pharmaceutical companies. Warwick Printing Company Limited, Caswell Road, Leamington science said, had been forecasted by the Brazil- In particular,the company’s “no burn” ibu- Spa CV31 1QD, UK. ian Life Science UK Trade and Investment Team profen product had been very well received, No part of this publication may be copied, reproduced, stored in a retrieval system or transmitted in any form without prior to be worth US$6.5 billion by 2012. Theobald pointed out. Launching the product permission from OTCPublications Ltd. Nigel Theobald, Oxford Nutrascience’s chief in February,the company said it allowed ibu- ©OTC Publications Ltd. All rights reserved. Company registered in England No 2765878. Registered Office: executive officer,said Aché had a “significant profen to be incorporated into “next generation” 54 Creynolds Lane, Solihull, West Midlands B90 4ER, UK. commercial infrastructure in Brazil”, which he chewable tablets and liquid suspensions with OTC bulletin® is registered as a trademark in the European described as one of the “most important global “no taste or burn irritation issues” (OTC bul- Community. markets for pharmaceutical companies”. letin,28 February 2011, page 9). ISSN 1350–1097 www.OTC-bulletin.com “Our objective,” Theobald pointed out, “is to OTC

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OTC COMPANY NEWS

First-Quarter Results J&J’s OTC sales drop by a quarter in US

ohnson & Johnson reported a 26.8% drop als sales improved by 10.1% to US$732 million, transfers,Mehrotra said, which meant that while Jin US sales at its OTC & Nutritionals busi- as a 6.9% operational advance was boosted by some of the “key”OTC brands would return to ness in the first quarter of 2011, and warned a 3.2% positive currency impact. the US market in late 2011, the majority would that the bulk of its OTC brands manufactured The slump at OTC & Nutritionals led to not be back on shelves until 2012. at McNeil Consumer Healthcare’s shuttered Fort worldwide sales at Johnson & Johnson’s Con- Plans to reopen the Fort Washington facil- Washington facility would not now return to the sumer division falling by 2.2% to US$3.68 bil- ity by the end of this year were scuppered in US market until early 2012. lion (see Figure 2). The slide would have been March, when the US Department of Justice and OTC & Nutritionals’ US turnover dropped greater but for a 1.9% positive currency effect. the Food and Drug Administration (FDA) de- to US$397 million (C278 million), as a series of Commenting on the OTC business in the US, cided to charge McNeil-PPC with violating fed- product recalls and the suspension of production Louise Mehrotra, Johnson & Johnson’s vice- eral law (OTC bulletin,17 March 2011, page at Fort Washington cost the business US$145 president of investor relations, noted that the 1). The facility can now only reopen when the million in sales. company had started to transfer production of FDA gives the go-ahead. This decline pushed down worldwide sales the McNeil OTC brands previously made at Fort The charges against McNeil followed a string at the OTC & Nutritionals unit by 6.5% to Washington to other facilities. of product recalls over the past 19 months. These US$1.13 billion (see Figure 1). The fall would Johnson & Johnson had hoped to have these included a recall of over 40 OTC medicines for have been worse but for a 1.7% positive cur- products back on the US market in 2011, but the infants and children, which prompted a US gov- rency effect. company had decided to “upgrade and reformu- ernment investigation and led to the closure of Meanwhile, international OTC & Nutrition- late quality methods” during the course of the the Fort Washington facility (OTC bulletin,14 May 2010, page 1). Business First-quarter Change Operational Currency The Department of Justice and the FDA sales (US$ millions) (%) change (%) effect (%) have filed a consent decree of permanent injunction against McNeil for failing to comply with Medical Devices & Diagnostics 6,432 +3.3 +1.3 +2.0 current Good Manufacturing Practice require- Pharmaceutical 6,059 +7.5 +6.4 +1.1 ments at the Fort Washington plant, its facility Consumer 3,682 -2.2 -4.1 +1.9 in Las Piedras, Puerto Rico, and its Lancaster, Pennsylvania site. Total Johnson & Johnson 16,173 +3.5 +1.8 +1.7 Under the terms of the consent decree, John- Figure 2: Johnson & Johnson’s sales in the first quarter of 2011 (Source – Johnson & Johnson) son & Johnson has to destroy all drugs under

Business First-quarter sales Change Operational Currency (US$ millions) 2010/2011 (%) change (%) effect (%) OTC & Nutritionals – US 397 -26.8 -26.8 – OTC & Nutritionals – International 732 +10.1 +6.9 +3.2 Total OTC & Nutritionals 1,129 -6.5 -8.2 +1.7 Skin Care – US 426 -5.8 -5.8 – Skin Care – International 473 +1.1 -1.7 +2.8 Total Skin Care 899 -2.3 -3.7 +1.4 Baby Care – US 105 +1.9 +1.9 – Baby Care – International 456 +7.0 +3.3 +3.7 Total Baby Care 561 +6.0 +3.1 +2.9 Women’s Health – US 125 -14.4 -14.4 – Women’s Health – International 334 +3.4 +0.7 +2.7 Total Women’s Health 459 -2.1 -4.0 +1.9 Oral Care – US 163 -6.3 -6.3 – Oral Care – International 228 +10.1 +5.6 +4.5 Total Oral Care 391 +2.6 +0.2 +2.4 Woundcare/Other – US 129 -9.8 -9.8 – Woundcare/Other – International 114 -2.6 -6.9 +4.3 Total Woundcare/Other 243 -6.5 -8.4 +1.9 Total Consumer 3,682 -2.2 -4.1 +1.9 Consumer – US 1,345 -13.8 -13.8 – Consumer – International 2,337 +5.9 +2.6 +3.3

Figure 1: Breakdown of sales by Johnson & Johnson’s Consumer division in the first quarter of 2011 (Source – Johnson & Johnson)

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COMPANY NEWS OTC

McNeil’s control that had been recalled from brand (OTC bulletin,17 March 2011, page 3). Mergers & Acquisitions the three sites since December 2009. Woundcare/Other reported worldwide sales McNeil must also retain an independent ex- down by 6.5% to US$243 million, with both Atrium strikes pert to inspect the three facilities to determine US and international turnover falling. US sales whether the violations have been corrected, and dropped sharpest, declining by 9.8% to US$129 to ensure that adequate processes are in place. million, while international sales decreased by deal in Canada Following expert certification, the FDA will det- 2.6% to US$114 million. ermine whether the facilities are in compliance. By contrast, Baby Care’s worldwide turnover trium Innovations has expanded its pres- Johnson & Johnson noted that it would con- grew by 6.0% to US$561 million. US sales rose Aence in its home market of Canada by ac- tinue to operate the manufacturing facilities in by 1.9% to US$105 million, while international quiring Montreal-based natural products distrib- Lancaster and Las Piedras. Based on the find- sales jumped up by 7.0% to US$456 million. utor Robert & Fils for an undisclosed sum. ings of the independent expert, the firm will Oral Care also performed better,with glo- Pierre Fitzgibbon, Atrium’s president and develop remediation plans for the two plants that bal turnover growing by 2.6% to US$391 mil- chief executive officer,said the deal gave the will then be submitted to the FDA for approval. lion. A 10.1% increase in international sales to company a “strong platform” in the province US$228 million offset a 6.3% decline in the US of Quebec and provided it with “market exper- Expert to review product quality to US$163 million. tise and additional knowledge” of the natural Johnson & Johnson added that the indepen- Following the close of the quarter,Johnson products industry in the region. dent expert would review certain manufactur- & Johnson announced a shake-up of the Con- Atrium and Robert & Fils had been “long- ing records at the two sites during remediation sumer division that would isolate the McNeil time partners”, having worked together since to ensure that products released from the sites business in the US (OTC bulletin,15 April Atrium was formed in 2000, Fitzgibbon said, continued to meet quality standards. 2011, page 3). adding that close to 50% of Robert & Fils’ sales Mehrotra warned that production volumes Under the new structure, the Consumer div- were generated by distributing Atrium prod- shipped from the two sites would be impacted ision will consist of a global franchise organi- ucts, including the Wobenzym enzyme brand by the consent decree, although “shipments of sation composed of four consumer categories and Douglas Laboratories supplement range. key products are expected to ramp up in the – Skin Care for Baby and Adult; OTC; Oral Care latter half of 2011”. and Topical Health; and Women’s and Intimate Benefit from expertise of firm’s president Meanwhile, sales declines in three of the Health – and four regional business units that The company would also benefit from hav- other five categories in Johnson & Johnson’s will market the various consumer product lines. ing Denise Poirier,president of Robert & Fils, Consumer division compounded the slump in Three of the four regional units – Asia-Pac- as a consultant for the rest of 2011, he added, OTC & Nutritionals turnover. ific, Europe/Middle East/Africa and Latin Am- providing Atrium with the “deep industry know- The Skin Care business posted worldwide erica – will market all the consumer product ledge” she had built up over the past 26 years first-quarter sales down by 2.3% to US$899 mil- lines. The North America unit will market all as owner and operator of the business. lion. Mehrotra pointed out that sales had been product lines except OTC medicines in the US. Founded in 1937, Robert & Fils distributes hit by a temporary reduction in shipments of several lines of “premium quality,natural thera- certain products caused by equipment upgrades. Consumer accounted for nearly a quarter peutic products” to healthcare practitioners and US Skin Care sales fell by 5.8% to US$426 The Consumer division accounted for 23% health food and speciality stores across Quebec. million, wiping out the 1.1% rise in interna- of the company’s total sales in the first quarter, The company also formulates its own sup- tional turnover to US$473 million that had been which increased by 3.5% to US$16.2 million. plements and therapeutic foods under the Bio driven by a 2.8% positive currency effect. The dominant Medical Devices & Diagnos- Vita, TF and Vitarôm brand names. The Women’s Health business posted sales tics division reported turnover up by 3.3% to Robert & Fils is the third Canadian company down by 2.1% to US$459 million, as a 14.4% US$6.43 billion, while sales at the Pharmaceu- Atrium has acquired in a little over a year as it drop in US turnover to US$125 million, offset tical unit grew by 7.5% to US$6.06 billion. attempts to build scale in its home market. a 3.4% international gain to US$334 million. Pre-tax profits fell by 28.2% to US$4.51 bil- In March last year,the company snapped US sales had been hit by lower sales of KY lion, due to a rise in cost of products sold, and up the assets of vitamin, mineral and herbal products and divesting the e.p.t pregnancy-test selling, marketing and administrative expenses. supplements manufacturer Trophic Canada for OTC around US$11.0 million (C7.68 million) (OTC bulletin,31 March 2010, page 8). At the time, Fitzgibbon admitted that Atrium IN BRIEF was a relatively small domestic player,but that ■ ORION said that following the good de- ■ ALLIANCE PHARMA has completed its acquiring Trophic clearly signalled the com- velopment of its sales in the early part of the £2.55 million (C2.90 million) acquisition of the pany’s “accelerated emphasis” on growing in year,it now expected its operating profit in Anbesol and Ashton & Parsons mouth-pain multiple distribution channels, and its aim of 2011 to be higher than in 2010. The Finnish brands in the UK and Ireland from Reckitt assuming a “major role” in its home market. company – which markets the Burana ibuprofen Benckiser after gaining European Union ap- Less than a year later,Atrium made another brand – had previously forecast that its 2011 proval. The deal was announced on 23 March addition in Canada – and what it described as operating profit would only be “slightly” better (OTC bulletin,31 March 2011, page 10). Rec- “one of the largest acquisitions” in its history – than in the prior year. Despite the bright start, kitt Benckiser agreed to sell the two brands to when it paid US$110 million in cash for fel- sales were still expected to be only “slightly gain approval from the European Commission low Canadian-firm Seroyal International and higher” than the approximately C850 million for its acquisition of SSL International last year its portfolio of dietary supplements (OTC bul- achieved in 2010, Orion noted, adding that both (OTC bulletin,15 October 2010, page 3). letin,21 January 2011, page 1). marketing and research spending would rise. OTC OTC

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OTC COMPANY NEWS

Trading Update Omega encouraged by opening quarter

mega Pharma said it had made an “encour- First-quarter sales Change Proportion Oaging” start to 2011, with sales in the first (C millions) 2010/2011 (%) of total (%) quarter of the year up by 7.8% to C218 million. Organic growth of 3.5% had been boosted by Western Europe 88.9 +2.8 41 acquisitions, the Belgian firm noted, especially Belgium 64.7 +12.7 30 the Duo LP Pro head-lice treatment it had gain- France 42.0 +14.1 19 ed when it bought Terre Santé at the start of the Emerging Markets 22.1 +3.9 10 year (OTC bulletin,21 January 2011, page 5) Total Omega Pharma 217.8 +7.8 100 and the Physiomer nasal-care brand that had come with Laboratoire de la Mer (OTC bul- Figure 2: Breakdown of Omega Pharma’s sales in the first quarter of 2011 (Source – Omega Pharma) letin,29 October 2010, page 1). These two brands had accounted for approx- Multi-Locals business reported sales down by which advanced by 2.8% to C88.9 million. imately half of the 11% growth recorded across 12% to C8.0 million. A spokesperson for Omega The company’s performance in Emerging Omega’s five core business categories – Clas- told OTC bulletin that the category would be Markets had been defined by a weak quarter in sics, Cough & Cold, Derma, Multi-Locals and boosted later in the year by innovations and Russia, Omega said. All other key markets in Parasites – Omega noted, which had generated marketing campaigns. this segment had performed well, the company sales of C118 million in the three months. Geographically,Omega performed best in insisted, but in Russia, the low incidence of in- The Cough & Cold category had performed France, where sales increased by 14.1% to fluenza over the winter period had hit sales of best over the quarter,the company said, with C42.0 million (see Figure 2). Organic growth the Aflubin and Septivon brands. sales jumping up by 77% to C17.8 million (see was 5.9%, the company noted, with acquisitions Acquisitions were the driver of growth in Figure 1), driven by the Phytosun medicinal aro- accounting for the other 8.2%. Emerging Markets, offsetting a 5.2% decline matherapy brand and Physiomer. The result demonstrated that the French busi- in organic turnover and thereby ensuring a 3.9% Successful marketing campaigns for the ness was ready for further structural improve- rise in total sales to C22.1 million. Davitamon vitamin line, XLS weight-manage- ments, Omega claimed, and for building both Looking ahead, Omega said that taking into ment brand and Predictor pregnancy test kits local and international brands. account improved results in emerging markets had lifted sales in the Classics segment by 18% In Omega’s home market, sales improved and southern Europe in the second half of 2011, to C27.0 million. by 12.7% to C64.7 million, continuing a run of the company was confident of reporting sales Davitamon, Omega noted, had consolidated consecutive quarterly double-digit gains. of C927 million for the year. its leading position in the Netherlands and had Both OTC and generics products had deliv- OTC also posted “great results” in Belgium. ered good results in Belgium, the company said, The Predictor brand, meanwhile, had been noting that “impressive”turnover growth over IN BRIEF boosted by the roll-out of the Predictor Early the three months had confirmed that a recent products in a number of markets, Omega point- change in country manager (OTC bulletin,28 ■ NYCOMED will market Bionorica’s Klim- ed out, noting that Predictor Early could be used February 2011, page 23) had not had a detri- adynon menopause product in Turkey,after four days sooner than a standard pregnancy test. mental impact on the unit’s performance. the Swiss firm acquired the distribution rights Additional Predictor line extensions would Sales growth in the firm’s largest business to a portfolio of over 10 products in the country. be launched in the second half of the year,the region – Western Europe – was held back by The company said it had struck deals with Al- company said. the difficult economic environment in Greece, mirall, Anika Therapeutics, CSL Behring and Acquiring the Duo LP Pro head-lice treat- Portugal and Spain. Strong performances in the Helsinn Healthcare, as well as Bionorica, to ac- ment, coupled with a good performance from other markets only partially offset the problems quire the Turkish rights to the products, which the Paranix brand, helped drive up sales in the elsewhere, as organic sales dropped by 1.6%. were previously owned by speciality pharma- Parasites category by 5% to C18.5 million. Only acquisitions put a positive spin on the ceutical firm Biomeks Ilaç. In contrast to the other four categories, the region’s results, helping to improve total sales, ■ PRECISION MARKETING GROUP has Product category First-quarter salesChange Proportion consolidated its five core businesses – Guard- (C millions) 2010/2011 (%) of sales (%) ian Direct Marketing, Guardian Products, John Derma 47.2 ±0 22 Turner Direct Marketing, Open Door Telemar- keting and Precision Direct Marketing – under Classics 27.0 +18 12 one name. The UK firm, which specialises in Parasites 18.5 +5 8 communication delivery in the pharmaceutical Cough & Cold 17.8 +77 8 sector,said customers would notice little dif- Multi-locals 8.0 -12 4 ference, except for an obvious freshening in Other OTC/Generics 99.3 –46the group’s logo “and the opportunity to make the most of the full range of marketing services Total Omega Pharma 217.8 +7.8 100 we offer as a group”. Figure 1: Omega Pharma’s sales in the first quarter of 2011 by product category (Source – Omega Pharma) OTC

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COMPANY NEWS OTC

First-Quarter Results Novartis OTC sprints ahead of market

orldwide OTC sales by Novartis Con- Region First-quarter sales Change 2010/2011 (%) W sumer Health grew “significantly faster” (US$ millions) US$ Local currencies than the market in the first quarter of 2011, according to the Swiss firm, thanks to good per- Europe 689 +3 +2 formances in the US and emerging markets. US 545 +16 +16 The OTC unit had delivered double-digit Asia/Africa/Australasia 262 +20 +11 sales growth over the three months, Novartis Canada and Latin America146 +19 +16 said, as prior-year investments in advertising Total Novartis Consumer Health* 1,642 +11 +9 and promotional support, as well as a continued focus on key brands and markets, paid off. * Continuing operations In the US, the lansoprazole-based Prevacid Figure 2: Breakdown of Novartis Consumer Health’s sales in the first quarter of 2011 (Source – Novartis) 24HR had benefited from “normalised quarterly stock movement” compared to the prior-year Kelman’s appointment coincided with key Consumer Health’s biggest region in terms quarter,Novartis said,and had maintained a changes to Novartis’ Consumer Health division of sales – Europe – was also the division’s worst “solid market share” in what the company des- – which consists of the Animal Health and performer,with turnover edging up by just 3% cribed as a “large and growing”US OTC pro- CIBA Vision businesses, as well as OTC – fol- – 2% in local currencies – to US$689 million. ton-pump inhibitor heartburn market. lowing the company’s acquisition of the US- US sales moved forward by 16% to US$545 Launched in November 2009 (OTC bullet- based eyecare specialist Alcon (OTC bulletin, million, while in Canada and Latin America in,16 November 2009, page 1), Prevacid 24HR 15 April 2011, page 13). turnover advanced by 19% – 16% in local cur- competes with Procter & Gamble’s omepraz- Following the close of the first quarter,the rencies – to US$146 million. ole-based Prilosec OTC and Merck & Co’s Zeg- OTC and Animal Health businesses have be- Consumer Health’s operating income more erid OTC, which combines 20mg omeprazole come standalone divisions alongside the exist- than doubled over the three months to US$562 with 1,100mg sodium bicarbonate. ing Pharmaceuticals, Sandoz, and Vaccines and million. This was thanks to a US$183 million OTC sales had also been lifted by a “strong Diagnostics divisions, while the CIBA Vision litigation settlement related to the Ciba Vision cough and cold season” in key markets, Novar- business has been integrated into the new Al- business, the sale of non-core OTC brands for tis noted. This factor,when combined with a con eyecare division. US$43 million and the divestment of a Ciba “focused investment strategy”, had driven a Vision business related to the Alcon acquisition double-digit rise in turnover of the Otrivin, Consumer Health sales rise by 11% for US$21 million. Theraflu and Triaminic brands. Sales at Novartis Consumer Health rose by Excluding these one-off gains, the company Joseph Jimenez, Novartis’ chief executive 11% – 9% in local currencies – to US$1.64 noted, Consumer Health’s core operating in- officer,noted that the strong cough and cold billion (C1.15 billion), as turnover grew at Ani- come had increased by 24% – 30% in local season in the US had lifted Theraflu’s turnover mal Health and Ciba Vision, as well as at the currencies – to US$358 million. Core operat- by 50% in local currencies. division’s OTC unit (see Figure 1). ing margin had risen by 2.3 percentage points, The Excedrin pain relief brand had also per- Novartis pointed out that all three of it Con- to 21.8% of net sales. formed well, Jimenez noted, with sales grow- sumer Health business units had grown faster The Consumer Health division made up 12% ing by 19% in local currencies. than their respective markets over the opening of Novartis’ total group sales, ahead by 16% During the quarter,Novartis named Naomi three months of 2010. – 14% in local currencies – to US$14.0 billion. Kelman – the former president of the Lifes- Asia/Africa/Australasia was the best per- Novartis’ operating income slipped back by can North America business within Johnson forming region for Consumer Health, with sales 3% to US$3.41 billion, due to negative currency & Johnson’s Diabetes Care division – as head rising by a fifth to US$262 million. In local cur- effects. In local currencies, operating income of its global OTC business (OTC bulletin,28 rencies, the rise was a slightly less impressive had been flat,the company noted. February 2011, page 1). 11% (see Figure 2). OTC

Division First-quarter salesChange 2010/2011 (%) Operating income Change Operating (US$ millions) US$ Local currencies (US$ millions) 2010/2011 (%) margin (%) Pharmaceuticals 7,765 +7 +5 2,499 +10 32.2 Sandoz 2,318 +16 +15 390 +26 16.8 Consumer Health* 1,642 +11 +9 562 +113 34.2 Vaccines and Diagnostics 371 -73 -73 -101 –-27.2 Alcon 1,931 –– 207 –10.7 Corporate –––-149 –– Total Novartis 14,027 +16 +14 3,408 -3 24.3

* Continuing operations

Figure 1: Breakdown of the financial performance of Novartis in the first quarter of 2011 (Source – Novartis)

29 April 2011 OTC bulletin 7 OTC29-04-11p8-9FIN.qxd 27/4/11 13:08 Page 2

OTC COMPANY NEWS

People/First-Quarter Results Bart Becht to leave Reckitt Benckiser

eckitt Benckiser has announced that Bart ledge and understanding of consumers and retail- RBecht will retire as chief executive officer ers in both developing and developed countries. Developing Markets Pharmaceuticals in September after 16 years in the role. Furthermore, having led the pan-European £546 million £156 million +23% +23% The unexpected news took investors by sur- and largest healthcare business in Reckitt Benc- prise, leading to an immediate 7% drop in Rec- kiser when also head of Northern Europe, Ka- kitt Benckiser’s share price. poor had been one of the architects of the com- Becht will be replaced on 1 September by pany’s acquisition of Boots Healthcare Inter- Rakesh Kapoor,the company’s executive vice- national in 2006 (OTC bulletin,17 October president of global category development and 2005, page 1), which had transformed the com- an executive committee member. To “ensure a pany into a global consumer healthcare player. smooth transition”, Becht will stay on as a part- Kapoor had been equally involved in the North America Europe time adviser until September 2012. recent acquisitions of SSL International (OTC & Australia £1,028 million £553 million Explaining his decision to step down, Becht bulletin,30 July 2010, page 1) and Paras India +17% said he felt that after 16 years at the head of Rec- (OTC bulletin,16 December 2010, page 1). +5% kitt Benckiser “now was the right time to retire”. Chairman Adrian Bellamy said the board Figure 2: Breakdown of Reckitt Benckiser’s sales Under Becht’s leadership, Reckitt Benck- had been unanimous in its choice of Kapoor as in the first quarter of 2011 – £2,283 million – by operating segment. Changes in sales are at constant iser’s sales have doubled since 2000. In 2010, he had the “necessary drive,strategic thinking exchange rates (Source – Reckitt Benckiser) the company reported sales up by 9% – 7% at and operational experience”. He also under- constant exchange rates – to £8.45 billion (C9.58 stood Reckitt Benckiser’s financial performance reported – and by 46% at constant exchange billion). Operating profit jumped up by 13% and earnings model. rates – to £758 million (see Figure 1). On a to £2.13 billion. like-for-like basis, the company said, sales had Becht will retire less than a year after Reck- SSL integrated by September grown by 13%. Durex and Scholl had contri- itt Benckiser’s chief financial officer Colin Day “We have the strongest senior management buted £172 million out of SSL’s total sales of announced that he was leaving the company cadre we have ever had,”Becht claimed, “our £203 million. The remaining £31 million from (OTC bulletin,29 October 2010, page 23). new chief financial officer has bedded in excel- SSL brands was classified as “Other revenue”. Day’s successor,Liz Doherty,joined Reckitt lently and our SSL integration is on track and Like-for-like Health & Personal Care growth Benckiser in January 2011 (OTC bulletin,30 by September will be all but completed”. – excluding the impact of acquisitions, dis- November 2010, page 27). SSL added just over £200 million to Reckitt posals, discontinued operations and foreign ex- Kapoor joined Reckitt Benckiser’s Indian Benckiser’s turnover in the first quarter of the change – had derived in large measure from unit in 1987, and was appointed to the com- year. Consolidated from 1 November 2010, the a “strong performance” by Mucinex, Nurofen pany’s executive committee in 2006 to lead in- Durex and Scholl brand-owner grew by only and Strepsils, Reckitt Benckiser observed, high- novation and the global powerbrands strategy. 3%, the firm said, “owing to the impact of align- lighting the launch of Strepsils Warm. In the intervening years, Kapoor had led ing SSL’s trading practices with those of Reckitt A “more normal” incidence of cold and flu Reckitt Benckiser’s UK and Northern Europe Benckiser”. It was “not practicable”, it added, – compared to the first quarter last year – had units to the best financial performance these to identify SSL’s operating profit “due to its also contributed to growth, the firm added. Det- businesses had ever delivered, the company said. integration into the commercial infrastructure tol products had performed well in both the He had wide experience of the household, of Reckitt Benckiser”. firm’s Developing Markets and Europe regions. health and personal care categories, Reckitt Adding SSL boosted Reckitt Benckiser’s Reckitt Benckiser singled out Nuromol in the Benckiser continued, and an intimate know- Health & Personal Care segment by 45% as UK as well as Strepsils Warm for Health & Per- sonal Care’s “strong growth” in Europe, where Business First-quarter salesChange 2010/2011 (%) group sales rose by 13% as reported, or by 17% (£ millions) £CER* at constant exchange rates (see Figure 2). Other segments, however, pegged back Europe’s like- Health & Personal Care758 +45 +46 for-like sales improvement. All of the region’s Fabric Care375 -8 -6 reported turnover rise at constant exchange rates Surface Care363 +6 +3 came from acquisitions and disposals. Home Care283 -4 +1 Launched exclusively in Boots at the start of Dishwashing 235 -1 +1 this year (OTC bulletin,21 January 2011, page Other 44 –– 16), Nuromol is claimed by the company to be Household and Health & Personal Care 2,058 +14 +15 “the first pharmacy-only (P) fixed-dose com- Pharmaceuticals 156 +19 +23 bination of ibuprofen and paracetamol”. Food 69 +5 +6 Both ingredients – 200mg ibuprofen and Total Reckitt Benckiser 2,283 +14 +15 500mg paracetamol – are said to be released simultaneously,ensuring the active ingredients * CER is constant exchange rates deliver a combination effect. Figure 1: Reckitt Benckiser’s sales in the first quarter of 2011 by business (Source – Reckitt Benckiser) Strepsils Warm was launched in Germany

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COMPANY NEWS OTC

on 1 August last year (OTC bulletin,30 July First-Quarter Results 2010, page 17). The lozenges – which contain extracts of ginger and wasabi (Eutrema japon- North American sales rise ica) as non-active ingredients alongside 1.2mg of 2,4-dichlorobenzyl alcohol and 0.6mg of amylmetacresol as active ingredients – were rolled out under the Dobendan umbrella brand boosts turnover at Boiron as Dobendan Strepsils Warm. MCM Kloster- frau collaborates with the UK firm in market- ales rising by almost a fifth in North Amer- Most of the firm’s turnover came from non- ing the brand in Germany. Sica was the highlight of Boiron’s first-quar- proprietary homoeopathic medicines, despite a Meanwhile, Tesco was the exclusive outlet ter results and the reason the French homoeo- double-digit sales rise in OTC Specialties. in the UK until a full launch into grocery and pathy specialist reported an overall 6.3% turn- pharmacy channels took place last autumn. over rise to C129 million. Business First-quarter Change Mucinex had benefitted from a “good per- As Figure 1 shows, Boiron’s domestic sales sales (C millions) (%) formance” by Mucinex DM in the firm’s North remained at about 55% of the total and growth France 70.5 +6.3 America & Australia region, Reckitt comment- exactly matched that of the group. But sales in Europe* 47.0 +4.8 ed, resulting in a reported regional sales rise the rest of Europe lagged behind with an im- North America 9.6 +19.9 of 5%. Three percentage-points of the sales provement of only 4.8% – 4.1% at constant ex- growth had come from acquisitions and dis- change rates – and sales outside Europe and Other countries 1.9 -14.8 posals, the company said, while the other two North America slipped back by 14.8% as re- Total Boiron 128.9 +6.3 points had been a like-for-like improvement. ported to C1.89 million. Non-proprietary 69.4 +2.8 Reckitt also remarked on the “normal inci- North American sales jumped by 19.9% to OTC specialties 59.4 +10.7 dence” of cold and flu in the quarter compared C9.57 million, or by 16.7% at constant exchange with the same period a year earlier. rates. Boiron pointed out that both France and Other 0.2 -25.7 Dettol personal-care products had put in a Italy in Europe,as well as the US and Canada in * Excluding France

“continued excellent performance” in Devel- North America, had been successful in growing Figure 1: Breakdown of Boiron’s sales in the first oping Markets, backed by the Veet depilatory their sales, but turnover declines had been reg- quarter of 2011 (Source – Boiron) brand and Strepsils. istered in Hungary,Romania and Russia. OTC Bart Becht commented that overall like-for- like turnover growth of 5% had been “driven by the success of innovations, such as Dettol No Touch, and continued excellent performance in Developing Markets”. “The SSL business is well on track to deliver the targeted cost synergies and net revenue growth in 2011.”

Meet full-year targets Noting net turnover growth of 15% and adjusted net income growth of 12%, Becht said: “These results position us well to achieve our full-year financial targets of 12% net turnover growth and 10% adjusted net income growth – both at constant exchange rates.” Operating profit as reported was £492 million, which was only a 7% increase as reported, or 9% at constant exchange rates. Reckitt Benckiser said, however, that the figure included an exceptional pre-tax charge of £38 million associated with its acquisition of SSL. Without the exceptional item, operating profit would have been £530 million, the firm said, which would have been a rise of 15%, or 17% at constant exchange rates. The adjusted increase would have pushed the operating margin up by 20 basis points to reach 23.2%. Cost synergies from the SSL acquisition had amounted to £11 million in the quarter,it added, noting an exceptional charge of £1 million had also been incurred for financing the deal. OTC

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OTC COMPANY NEWS

Business Strategy/Annual Results Third-Quarter Results Caffetin coaxes Blackmores believes Asia Alkaloid forward holds key to future growth heavyweight OTC advertising campaign Afor Alkaloid’s paracetamol-based combi- lackmores, Australia’s leading natural- Region Third-quarter Change nation analgesic Caffetin in Russia should help Bhealth brand, has reported Asian sales up sales (A$ millions) (%) to raise sales in the country,the Macedonian by 61% in its third quarter ended 31 March company believes. “As a leading brand, Caffetin 2011. “Asian sales are up by 37% for the year Australia 41.5 -7 can pull our entire portfolio of products,”the to date,”commented chief executive officer Asia* 12.2 +61 firm’s managing director Zhivko Mukaetov in- Christine Holgate. “The result vindicates our Other 1.4 +72 sisted, adding that Russia was one of the firm’s strategy to grow our footprint across differ- Total Blackmores 55.1 +4 “priority markets”. ent markets to protect our business from the Alkaloid has also introduced Caffetin in impact of any individual market challenges.” * Growth is 30% excluding Korea, 35% in constant currency Romania as it looks to build up a portfolio of Asian turnover made up nearly a quarter Figure 1: Breakdown of Blackmores’ sales in its third registered drugs in central European markets of Blackmores’ sales total of A$55.1 million quarter to 31 March 2011 (Source – Blackmores) including the Czech Republic, Hungary,Poland (C40.5 million) during the three months, an of stock levels by major retailers”. “We remain and Slovakia. A subsidiary in Ljubljana, Slove- improvement of 4% (see Figure 1). cautious about the retail environment,”she said. nia, acts as a hub for the company’s activities The company claims to be the number one Noting consumer research had shown that throughout the European Union. brand in its category in Thailand, and number Blackmores continued to be “the preferred Noting that “in some markets the Caffetin two in Malaysia. It entered the A$1.1 billion brand by our customers in Australia”, Holgate brand is better known than the Alkaloid brand”, South Korean market last December and has added the firm had invested in a “significant Mukaetov said the firm had taken advantage a strategic partnership with CJO Shopping, brand-marketing campaign across all key mar- of the brand’s market position through line ex- Korea’s number one online retailer. kets”, and had rolled out 13 new products. tensions. These included Caffetin Cold, Caffetin The Asian third-quarter gains, however, had The company’s profitability suffered from Menstrual, and Caffetin Cold Plus, which also to compensate for declining sales in the firm’s launching its “Today’s the Day” advertising includes vitamin C. home market. Holgate noted that in the year to campaign (OTC bulletin,11 February 2011, OTC sales increasing by 3.1% to C17.7 mil- date, domestic ex-factory sales had been “in line page 19), with earnings before interest, taxes, lion helped to push up the company’s total phar- with the previous period, reflecting the chal- depreciation and amortisation (EBITDA) de- maceutical sales by 8.0% to C80.9 million in lenges in the retail market and the cutting back clining by 2% to A$10.2 million. 2010. Along with Caffetin, Alkaloid’s OTC OTC portfolio also includes the Bil-ol, Diprol and Primulin brands as well as herbal drops. Preliminary Results Domestic sales rising by 11.5% to C32.5 million made up a third of the company’s total, in- Veropharm posts double-digit OTC gain cluding non-pharma segments, which rose by 8.1% to C96.5 million. Alkaloid’s operating profit eropharm’s OTC drugs enjoyed strong Xilen (xylometazoline) accounting for half. was unchanged at C10.9 million. Vdouble-digit sales growth in 2010, as the Ginecotex made up the remaining 2%. OTC Russian group reported a 23% uplift in total Prescription drugs dominated Veropharm’s sales to RUB5.40 billion (C134 million). sales, accounting for 70% of the total, while Ad- OTC turnover increased by 34% to RUB705 hesive Bandages contributed 16% and Tradi- IN BRIEF million in the year (see Figure 1), accounting tional drugs the other 1%. ■ EUROMEDIN – European Medical Instru- for 13% of the company’s total sales. Russia remained Veropharm’s biggest mar- ments – has acquired two brands from the The company’s top five best-selling OTC ket, providing 96.3% of the firm’s sales, but ex- Finnish pharmaceutical company, Verman, for drugs – Motilak,Slabilen, Vitasharm, Vitatress ports increased over the period, and now rep- an undisclosed sum. Lactocaps, aimed at lac- and Xilen – generated 98%, or RUB688 mil- resent 3.7% of turnover, up from 2.5% in 2009. tose-intolerance sufferers, and Nogasin, a cap- lion, of its OTC sales, with the respiratory brand OTC sule to prevent both flatulence and bloating, will be launched in the UK later this year. Euro- Product typeAnnual sales Change Proportion medin also plans to introduce the products in (RUB millions) (%) of total (%) France and Ireland. The acquisitions follow Prescription 3,762 +25 70 the launch of Euromedin’s first product, Aso- nor,said to be a clinically-proven anti-snoring Adhesive bandages 879 +15 16 nasal spray that alleviates the main cause of OTC705 +34 13 snoring and associated sleep disturbance. It has Traditional drugs 49 -46 1 been available in the UK through the website Total Veropharm 5,395 +23 100 www.asonor.co.uk since March 2011. OTC Figure 1: Breakdown of Veropharm’s sales in 2010 by product type (Source – Veropharm)

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GENERAL NEWS OTC

ConsumerRegulatory Affairs group demands ban on Alli

he weight-loss medicines Alli and Xenical pancreatitis associated with use of Xenical or worldwide who had used Xenical or Alli. Fur- Tshould be withdrawn in the US because Alli. Thirty-nine of these patients had required thermore, some patients in the reported cases they “can cause severe injury to the liver, pan- hospitalisation and one had died, it noted. had used other drugs or had other conditions creas and kidneys”, according to Public Citizen. Furthermore, Public Citizen said its analysis that may have contributed to the development The consumer-advocacy organisation is call- had identified 73 cases of kidney stones asso- of severe liver injury,the FDA said, adding that ing for an immediate ban on both GlaxoSmith- ciated with use of Xenical or Alli, of which 23 severe liver injury could occur in people not tak- Kline Consumer Healthcare’s OTC medicine had required hospitalisation. ing drugs and without a distinct cause. Alli and Roche’s prescription drug Xenical – Last year,awarning about rare reports of Although there was no confirmed link, the both of which contain the active ingredient orli- severe liver injury was added to Alli packs aft- FDA said it had added the information about stat – after studying the adverse-reaction files of er the FDA completed a safety review of orli- reported cases of severe liver injury to the lab- the US Food and Drug Administration (FDA). stat. Labelling on Xenical was also changed els of Alli and Xenical to educate the general Its demands are set out in a petition sent to the (OTC bulletin,11 June 2010, page 10). public about the signs and symptoms of liver FDA on 14 April. The FDA said that one US report concern- injury and the need to see a physician promptly Not only can orlistat cause “severe liver dam- ing severe liver injury with Alli and 12 foreign should they occur. age”, says Public Citizen, but it has also been reports with Xenical had been identified by The petition is Public Citizen’s second at- associated with “47 cases of acute pancreatitis the safety review. tempt to have Xenical removed from pharmacy and 73 cases of kidney stones”. However, the agency acknowledged that it shelves. In April 2006, the organisation urged “Any one of these serious risks alone would had been unable to establish a cause and effect the FDA to ban Xenical because research in rats be a sufficient basis for banning Xenical and relationship between severe liver injury and orli- had demonstrated that orlistat caused the for- Alli,”insisted Dr Sidney Wolfe, director of Pub- stat for a number of reasons. Only 13 cases had mation of pre-cancerous lesions in the colon. lic Citizen’s Health Research Group. “These been reported between April 1999 and Aug- That petition was rejected by the FDA. drugs have the potential to cause significant ust 2009 out of an estimated 40 million people OTC damage to multiple critical organs, yet they provide meagre benefits in reducing weight loss in obese and overweight patients.” Reacting to Public Citizen’s petition, Glaxo- SmithKline Consumer Healthcare said Alli was “safe and effective when used as directed”. “Orli- stat’s safety has been established through 100 clinical studies involving more than 30,000 patients,”the company pointed out. Public Citizen said its analysis of the FDA’s adverse reaction reports had found 47 cases of

Regulatory Affairs Perrigo passes FDA re-inspection in US

xport licences and Abbreviated New Drug EApplications (ANDAs) linked to Perrigo’s manufacturing facility in Allegan, Michigan, will once again be eligible for US review and approval after the Food and Drug Administra- tion (FDA) granted the plant an “acceptable” regulatory status. The FDA conducted a re-inspection of the Allegan facility following a Warning Letter issued to Perrigo last year (OTC bulletin,11 June 2010, page 1). The plant makes some of the company’s store-brand ibuprofen and Milk of Magnesia products. OTC

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OTC GENERAL NEWS USRegulatory Affairs FDA targets global supply chain

trengthening the safety and integrity of the “These changes are essential,”insists the ■ National security threats Sglobal supply chain is one of five strategic FDA, “if we are to protect product safety in a ■ Enforcement tools that do not reflect today’s priorities for the US Food and Drug Adminis- way that Americans expect and deserve.” commercial practices tration (FDA) over the next five years. The FDA says it has been forced to reeval- ■ Corporations lacking accountability The regulatory agency acknowledges in a uate its approach to safety by “complex global ■ Current import regulatory system, that is an document setting out its strategic priorities for supply chains, international trade, the foreign honour system 2011-2015 that the growing challenges of glob- sourcing and manufacture of regulated products, Strengthening the safety and integrity of the alisation have “far outstripped the FDA’s re- and the increase in the volume and complexity global supply chain is one of the FDA’s five sources for inspection and quality monitoring”. of imported products”. It points to a number of “cross-cutting” strategic priorities. The other “The inability to maintain adequate oversight warning signs, including contaminated heparin, four are: means potential risk to consumers grows every melamine-tainted pet food, and counterfeit glu- ■ Advancing regulatory science and innovation year,” insists the FDA. cose test strips. ■ Strengthening compliance and enforcement According to the FDA, a “paradigm shift” “Globalisation presents a host of internal activities to support public health will be required to address these challenges. and external challenges to the design, develop- ■ Expanding efforts to meet the needs of spe- The focus will need to shift to prevention – on ment, manufacturing, and distribution of reg- cial populations stopping threats before they ever become real- ulated food and medical products,”says the ■ Advancing medical countermeasures ity – and the border will have to be viewed as agency, “challenges that make critical the pre- Dr Margaret Hamburg, the FDA’s commis- a final checkpoint for preventive controls, rath- vention, detection, intervention, and response to sioner,highlighted the importance of advanc- er than the primary line of defence against un- product safety.” ing regulatory science and innovation. “Science safe imports, the FDA argues. “More than 20 million import lines of food, underlies everything we do at this agency. To “The FDA must require more, and better, devices, drugs, and cosmetics arrived at US serve the public health we must have the cap- information about product supply chains, and ports of entry in fiscal year 2010 – more than acity to effectively oversee the translation of monitor this information throughout the prod- three times the number of imports 10 years breakthrough discoveries in science into inno- uct lifecycle,”maintains the agency, adding that ago,”the FDA adds. “Today,there are more vative,safe, and effective products and life-sav- “regulatory standards must foster corporate re- than 130,000 importers of record and about 300 ing therapies for the people who need them sponsibility to identify,protect, and control risks.” ports of entry in the US. The array of regulated most,”she stressed. Such an effort will “entail more strategic and products comes from 300,000-plus facilities in Hamburg added that it was clear the FDA’s consistent coordination among foreign, federal, more than 150 different countries.” job was “fundamentally different and far more and state counterparts”, says the FDA, “The Challenges presented by globalisation, the complex than it was even a few years ago”. FDA needs novel and updated compliance and FDA notes, include: “We will address these challenges and aim enforcement tools; a greater global safety net ■ Increasing volume of imported products to fulfil our mission by embracing innovation that includes a global alliance of regulators; ■ Greater complexity in imported products and actively pursuing partnerships with federal, coordination of activities with international cap- ■ More foreign facilities supplying the US state, and local agencies, international authori- acity-building and standards-setting organisa- ■ Incomplete regulatory information about sup- ties, academia, non-government organisations, tions; adequate funding to allow for inspections, ply chains and the private sector,” she promised. examinations and sample collections and an- ■ Patchwork of foreign, federal,and state over- The FDA’s strategic priorities are set out in alysis; and updated systems, including infor- sight of product safety a 50-page document entitled ‘Strategic prior- mation technology support, to assist with the ■ Greater opportunities for economic adulter- ities 2011-2015: Responding to the public health increased workload.” ation and intentional fraud challenges of the 21st century’. OTC

Regulatory Affairs ent proposals if they are to be adopted, whilst the translation requirements must be unani- Europe pursues single patent system mously approved. In March, the ECJ ruled that proposals to roposals outlining a single European patent tries developed the proposals through the mech- create a single European patent court were not Psystem have been published by the Euro- anism of ‘enhanced cooperation’ after reach- compatible with the provisions of core Euro- pean Commission, despite a recent ruling by ing unanimous agreement on the system’s lan- pean Union treaties (OTC bulletin,17 March the European Court of Justice (ECJ) that de- guage regime amongst all 27 member states 2011, page 10). cided plans to create a single European pat- proved impossible. However, the Commission said it was “in ent court to enforce the system were not com- Two regulations – one covering the creation the process of analysing the opinion and con- patible with European Union law. of a unitary European patent and the other out- sidering ways to address the court’s concerns”. The proposals outline a framework for a lining its translation requirements – will be con- The Commission said the unitary patent sys- single patent that will be valid in 25 European sidered by the European Council and Parlia- temwould reduce “red tape” and would “rad- Union member states, comprising every mem- ment. A qualified majority of the 25 member ically reduce the cost of patents in Europe”. ber state except Italy and Spain. The 25 coun- states must vote in favour of the unitary pat- OTC

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GENERAL NEWS OTC

Regulatory Affairs tizer,CleanWell All-Natural Hand Sanitizing Wipes, and CleanWell All-Natural Antibacte- rial Foaming Handsoap. FDA takes action over The FDA pointed out that the labelling and marketing materials for affected products also claimed they could prevent infection from oth- MRSA claims in the US er disease-causing agents. In addition, the FDA said the labelling for some of the firms’ hand- sanitising drug products made claims related to he Food and Drug Administration (FDA) ed Deborah Autor,who is compliance director preventing E.coli and/or the H1N1 flu virus. Tin the US has told four firms to stop mak- at the FDA’s Center for Drug Evaluation and In a Consumer Update on the issue, the FDA ingunproven claims that their OTC drug pro- Research (CDER). said unproven claims found on product labels ducts can prevent infection from methicillin-re- Autor pointed out that the FDA had “not ap- included: “kills over 99.9% of MRSA”; “helps sistant Staphylococcus aureus (MRSA) bacteria. proved any products claiming to prevent infec- prevent skin infections caused by MRSA and Warning Letters sent to the companies point tion from MRSA, E. coli, Salmonella, or the other germs”, and “is effective against a broad out that the FDAdoes not have sufficient evi- H1N1 flu virus, which a consumer can just walk spectrum of pathogens, including MRSA”. dence that the OTC products, including hand into a store and buy”. “These products give con- The FDA pointed out that one firm claimed sanitisers and antiseptic products, are safe and sumers a false sense of protection,”she stressed. that its hand-sanitising lotion prevented infec- effective for this purpose. Warning Letters were sent to Tec Laborato- tion from the bacterium E. coli and the H1N1 The FDA said it was cracking down on com- ries for its Staphaseptic First Aid Antiseptic/ flu virus, while another maintained its “patent- panies that had broken federal law by promot- Pain Relieving Gel; JD Nelson and Associates ed formulation of essential plant oils” killed ing their products as preventing MRSA infec- for its Safe4Hours Hand Sanitizing Lotion and the bacterium Salmonella. tions and other diseases without agency review Safe4Hours First Aid Antiseptic Skin Protec- The four companies have 15 days to correct and approval. “Consumers are being misled if tant; Dr GH Tichenor Antiseptic Co for its Dr. the violations cited in the Warning Letters. they think these products you can buy in a drug- Tichenor’s Antiseptic Gel; and Oh So Clean Failure to do so might result in legal action store or from other places will protect them for its CleanWell All-Natural Foaming Hand including seizure and injunction, pointed out from a potentially-deadly infection,” comment- Sanitizer,CleanWell All-Natural Hand Sani- the FDA. OTC

29 April 2011 OTC bulletin 13 OTC29-04-11p14-15FIN.qxd 28/4/11 07:20 Page 2

OTC MARKETING NEWS

Line Extensions Launches Magnetrans gets Dr Reddy’s and Perrigo granular additions wo unlicensed, once-a-day granular for- gain store-brand Allegra Tmulations are the latest additions to Stada Arzneimittel’s Magnetrans magnesium brand in Germany. anofi-Aventis’ Allegra Allergy portfolio of FDA in January of this year (OTC bulletin, The first newcomer – Magnetrans 375mg SOTCmedicines based on fexofenadine hy- 11 February 2011, page 16). Direkt-Granulat is supplied as sachets of cit- drochloride now has store-brand competition Sanofi-Aventis is backing the launch with rus-flavoured granules that melt in the mouth in the US. a “massive”investment in advertising and pro- without water. Dr Reddy’s Laboratories said on 13 April motion. The company intends to make Allegra Stada is supporting the launch with a free- that it had launched OTCfexofenadine tablets into one of the top three brands in the US$1.5 standing floor display for pharmacies. This after gaining approval for 60mg and 120mg billion (C1.1 billion) OTC allergy market in the holds 42 packs, the same number of bicycle strength products the previous day. US (OTC bulletin,28 February 2011, page 6). bells as free gifts, and 60 free samples. In addi- Perrigo, meanwhile, said its partner Teva The television commercial, which aired for tion, there is a counter display that holds 12 Pharmaceutical Industries had received final the first time on 4 March, alerts viewers to “big packs, 12 bells and 30 samples. OTCapproval for 60mg and 120mg fexofen- news for allergy sufferers” (OTC bulletin,17 Eack pack of 20 orodispersible sachets has adine tablets. Perrigo acquired the exclusive March 2011, page 1). a recommended retail selling price of C8.95. rights to sell and market store-brand OTC Al- “Prescription strength Allegra is now avail- The second addition – Magnetrans 375mg legra from Teva last July (OTC bulletin,30 able without a prescription,”states a voiceover, Trink-Granulat, which also provides 375mg July 2010, page 19). adding that the OTC medicine “delivers fast, magnesium each day – dissolves in water to Both Dr Reddy’s and Perrigo will supply non-sedating, 24-hour relief for your toughest form an orange and grapefruit-flavoured drink. their generic OTC versions of Allegra Allergy allergy symptoms”. “Same Exact Medicine. Packs of 20 and 50 sachets retail at C9.25 and under store-brand labels. Same Full Prescription Strength,”is Sanofi- C17.95 respectively. The Allegra Allergy portfolio of products Aventis’ promise to Americans. Stada is promoting the drinkable granules – Allegra 12 Hour,Allegra 24 Hour,Allegra-D The launch of Allegra Allergy is being han- with a 12-pack counter display,which offers 12 Hour,Allegra-D 24 Hour and Children’s dled by Chattem, which was acquired by San- aluminium drink bottles as a free gift and pro- Allegra – was approved for OTC sale by the ofi-Aventis just over a year ago. vides 30 sample sachets. OTC The Magnetrans range also includes licens- ed 300mg granules and 240mg effervescent British Medical Journal tablets, as well as 150mg and 243mg capsules. OTC Calcium supplements may affect heart

alcium supplements may increase the risk Women who were taking personal calcium C of cardiovascular events – particularly heart supplements at the start of the trial, however, attacks – in older women, according to research were not at a greater cardiovascular risk from published in the British Medical Journal (BMJ). combined calcium and vitamin D supplements. However, an editorial in the journal by Pro- Suspecting that the abrupt change in blood- fessors Bo Abrahamsen and Opinder Sahota calcium levels after taking a supplement causes argues that there is insufficient evidence avail- the adverse effect – rather than the total amount able to support or refute the association. of calcium consumed – the authors note that The authors of the new study – led by Pro- high blood-calcium levels are linked to hard- A diver swimming with a dolphin is the image that Normon has chosen to symbolise the link between fessor Ian Reid at the University of Auckland ening of the arteries, which may also help to the sea and nasal hygiene in launch advertising for its – re-analysed the results of a Women’s Health explain the results. Normomar range in Spain. Initiative (WHI) study – of 36,000 women over Further analyses of 13 different trials involv- Under the slogan “hay parejas inseparables” or “inseparable partners”, Normon’s advertisement seven years – which had found no cardiovas- ing 29,000 people also found consistent in- points to the connection between “the riches of the cular effect of taking combined calcium and creases in the risk of heart attack and stroke sea and good nasal hygiene”. vitamin D supplements. The majority of par- associated with taking calcium supplements, Billing Normomar as “a complete range of nasal hygiene products”, Normon offers three products ticipants were already taking personal calcium with and without vitamin D. under the brand: decongestant seawater supplied as supplements, and it was suspected that this may Abrahamsen and Sahota argue, however, either a spray or single-dose vials; moisturising saline have obscured any adverse effects. that the new study’s limitations mean “it is spray and gel; and a roll-on treatment containing natural oils to soothe irritation. Reid analysed the data from 16,718 women not possible to provide reassurance that cal- Normon said the advantages of the Normomar who were not taking personal calcium supple- cium supplements given with vitamin D do range were that it was natural, it was suitable for all ments at the start of the (WHI) trial. not cause adverse cardiovascular events, or to ages, and it contained no preservatives. The moisturising spray helped counteract dryness caused Those given combined calcium and vitamin link them with certainty to increased cardio- by using antihistamines, the company added. D supplements were at an increased risk of vascular risk”. OTC cardiovascular events, especially heart attacks. OTC

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MARKETING NEWS OTC

SanofiLaunches and Meda launch allergy brands in France

llergy remedies have been introduced in tis said it was positioning DoliAllergie as a AFrance by Sanofi-Aventis and Meda Pharma “new alternative”for patients suffering from in time for the hayfever season. allergic rhinitis. Sanofi-Aventis has expanded its Doli range Pharmacy-press advertising for DoliAllergie of non-prescription medicines in France with a points out that the medicine prevents sneezing, loratadine-based allergy remedy. DoliAllergie clears nasal passages, and reduces itching around tablets join the French firm’s Doliprane pain the eyes and nose. reliever and Dolirhume cold remedy. The non-reimbursable, non-prescription med- Meda, meanwhile, has introduced ProAller- icine is suitable for adults and children over 12 godil containing the active ingredient azelas- years of age and should be taken once a day. tine, which is a non-reimbursable, non-prescrip- DoliAllergie has a recommended retail selling tion version of its prescription drug Allergodil. price of C5.10 for a pack of seven, 10mg lora- Packs of DoliAllergie feature the yellow liv- tadine tablets. Keen cyclists are the main target audience for the eryused for Doliprane and Dolirhume, but have Meanwhile, Meda has launched what it claims latest addition to Cesra Arzneimittel’s Ilon skincare a central purple stripe in place of the blue one is France’s only non-prescription H1-antihis- range in Germany. Cesra said the petroleum jelly in Ilon Protect-Salbe on packs of Doliprane and the green one on tamine in spray form. ProAllergodil nasal spray formed a protective film that helped to prevent chafing packs of Dolirhume. comes in a 10ml bottle that dispenses 0.127mg and pressure sores. Olive oil cared for the skin, while Non-prescription medicines containing lora- of azelastine per 0.14ml dose. herbal extracts including larch turpentine and eucalyptus oil had antibacterial effects. tadine are already available in France from a Meda said the fast-acting medicine should According to Cesra, the line extension was also number of companies, including Arrow, Ratio- be taken no more than twice a day. It is suit- ideal for people who spent long periods sitting, such pharm and Teva. Nevertheless, Sanofi-Aven- able for adults and children over 12. as office workers or taxi drivers. The company is distributing more than half a million free samples through leading cycling magazines in Germany. Visitors to a brand website at www.ilonprotect.de can also order samples. Launch trade-press advertising (pictured above) urges pharmacists to stock up to meet demand created by the sampling initiatives. A 100ml tube of the pharmacy-exclusive, unlicensed ointment has a recommended retail selling price of C16.70. OTC

Advertising Complaints ASA raps Vitabiotics wo poster advertisements for Vitabiotics’ T Neurozan and Neurozan Plus food supplements have been rejected by the UK’s Adver- tising Standards Authority (ASA). A complaint sent to the ASA had insisted DoliAllergie (pictured above) from Sanofi-Aventis that claims made in the posters – which carried contains the active ingredient loratadine, while the headlines “Advanced nutrients for the brain” ProAllergodil (right) from Meda Pharma is and “Advanced micronutrients for the brain” based on azelastine OTC – were misleading. The posters said recent research had shown B vitamins could help maintain brain function and mental performance. IN BRIEF Vitabiotics told the ASA that it had not made ■ RECKITT BENCKISER is supporting its advertising, said the company, and would high- any claims about the effect of B vitamins on Strepsils sore-throat remedies in the UK with light non-traditional causes of sore-throats dur- brain function and mental performance. an “out-of-season” campaign encouraging con- ing the spring and summer months, such as However, the ASA ruled the posters includ- sumers to treat “season affected throat”. The hayfever, air conditioning, air pollutants and ed “implied claims”, and research provided by “heavyweight” marketing spend would encom- lifestyle excess. Vitabiotics had not substantiated them. pass public relations, social media and radio OTC OTC

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OTC MARKETING NEWS GSKMarketing Campaigns follows Piri revamp with fresh commercials

ct before you react” is GlaxoSmith- “A Kline Consumer Healthcare’s message to Britons in the latest marketing campaign for its Piri umbrella brand. The company is backing Piri allergy remedies with a £3.3 million (C3.7 million) market- ingcampaign in the UK this hayfever season. The nationwide campaign from the agency Grey, which breaks at the end of April and runs for three months, includes two television com- An image of a stressed businessman pulling his hair GlaxoSmithKline and its agency Grey have come out is Spanish firm Bama Geve’s way of mercials. One promotes the entire Piri range, up with two new television commercials for the demonstrating that its Kamirel hair-loss treatment while the other focuses on Pirinase Hayfever Piri allergy remedies in the UK has been “subjected to the most demanding tests”. Nasal Spray. The latter highlights that the nasal New pharmacy-press advertising (pictured above) for Kamirel claims that the product slows the loss of spray can prevent hayfever symptoms and is GlaxoSmithKline recently changed the name hair whilst promoting its growth and repairing its more effective than one-a-day antihistamine tab- of its Flixonase Allergy Nasal Spray to Pirinase structure and integrity. lets at relieving them. Hayfever Nasal Spray in the UK (OTC bulletin, Launched in Spain in November, the product is based on Procapil which contains apigenin, biotinoyl GlaxoSmithKline said that focusing on Piri- 28 February 2011, page 16). The fluticasone pro- tripeptide and oleanolic acid. nase Hayfever Nasal Spray would “encourage pionate spray joined the Piriton and Piriteze al- Bama Geve said the product was a “new adults to trade up to nasal sprays and tap into lergy products under the Piri umbrella brand. generation” treatment that was formulated to minimise the causes of hair loss such as atrophy of this largely unexploited market”. At the same time, the Piri offering – com- hair follicles and poor microcirculation in the scalp. prising Piriteze Allergy Syrup, Piriteze Allergy Kamirel is available in a pack of 16 single-dose Viewers are directed to new website Tablets, Pirinase Hayfever Nasal Spray,Piri- 5ml vials or a 100ml bottle with a spray applicator. Both have a recommended retail price of C43.00. The Both 30-second commercials direct consum- ton Allergy Tablets and Piriton Syrup – was re- product should be used once daily for two months, ers to the new brand website at www.PiriAl- packaged in designs with a “stronger” Piri logo. followed by application on alternate days for a further lergy.com,which includes a product selector, The new look provided a “distinct Piri iden- two months. OTC national and regional pollen forecasts, advice tity across the range”,commented GlaxoSmith- for parents, and information on the products in Kline, “whilst clearly differentiating between the Piri range. the different ingredients”. The pack design in- Line Extensions Television advertising will be supported by corporates blue for Pirinase, green for Piriteze sponsorship of the pollen count on Daybreak products based on cetirizine hydrochloride and Taurus adds two TV,as well as point-of-sale material and out- orange for Piriton products containing chlor- door initiatives. phenamine maleate. to Ciclopoli line OTC

aurus Pharma has expanded its Ciclopoli Relaunches Tanti-infective brand in Germany with cream and liquid formulations. McNeil reduces Reactine packs Like the existing Ciclopoli 8% nail lacquer, the newcomers contain ciclopirox olamine as cNeil Consumer Healthcare has received from that date as prescription-only medicines. their active ingredient. Mclearance in Germany to launch a six- Acting on the advice of Germany’s Expert The 1% Ciclopoli Creme is indicated for tablet pack of Reactine Duo, its combination Committee for Prescription (OTC bulletin, 30 treating all fungal skin infections, but is posi- medicine containing cetirizine hydrochloride July 2010, page 10), the country’s upper house tioned as a remedy for athlete’s foot. The twice- and pseudoephedrine hydrochloride. of parliament, the Bundesrat,said that reduc- a-day pharmacy-only medicine for adults and The non-prescription medicine for allergic ing pack sizes would lessen the risk of mis- children aged six years and older comes in 20g rhinitis is currently available in packs of 14 and use of pseudoephedrine to manufacture ille- and 40g tubes with recommended retail prices 28 extended-release tablets, each containing gally the drug methamphetamine,also known of C7.97 and C13.97 respectively. 5mg cetirizine and 120mg pseudoephedrine. as ‘crystal meth’. Meanwhile, the alcohol-free Ciclopoli Lö- However, Germany is restricting non-pre- The six-tablet pack of Reactine Duo – the sung 1% solution, which has the same indica- scription medicines to a maximum of 720mg largest non-prescription pack allowed under tion and positioning as the cream, retails at pseudoephedrine per pack from 1 May of this the new restrictions – has a recommended re- C9.97 for a 30ml pack. year (OTC bulletin,28 February 2011, page tail price of C5.90. OTC 10). Any larger pack sizes will be classified OTC

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EVENTS OTC

cines, nutraceuticals, branded pre- MAY 8-10 June scription drugs and generics. 47th AESGP Annual Meeting 10 May Contact:RauCon. ■ Rome, Italy Molecule Lifecycle Tel: +49 6222 9807 0. ■ ‘A new treaty for self-care’ will be the theme of the 47th Annual Meeting Fax: +49 6222 9807 77. Management of the Association of the European Self-Medication Industry,the AESGP. E-mail: [email protected]. London, UK The three-day meeting will include a session entitled ‘Self-medication Website: www.europlx.com. Representatives of the UK’s Med- industry quo vadis?’, featuring a presentation by Cavan Redmond, pre- icines and Healthcare products Reg- JUNE sident of Pfizer Diversified Businesses. ulatory Agency (MHRA) will speak Speakers at the meeting will also include: John Dalli, European com- at this one-day meeting. 6-7 June missioner for health and consumer policy; Ferruccio Fazio, Italian min- Contact: Zain Philbey, SMi Group. ■ DIA European Regulatory ister of health; Dagmar Roth-Behrendt, vice-president of the European Tel: +44 20 7827 6722. Affairs Forum 2011 Parliament; Andreas Pott of the European Medicines Agency (EMA); Fax: +44 20 7827 6001. London, UK Vittorio Silano of the European Food Safety Authority (EFSA); Basil E-mail: [email protected]. Mathioudakis of the European Commission; June Raine from the UK’s Website: www.smi-online.co.uk. Pharmacovigilance, the centralised authorisation procedure, and Medicines and Healthcare products Regulatory Agency (MHRA); Andy 10-12 May transparency will be discussed at Tisman, senior principal, Consumer Health at IMS Management Con- sulting; Stefano Maruzzi, country manager at Google Italy; and War- ■ Vitafoods this two-day event. Geneva, Switzerland Contact:DIA Europe. ren Teichner of McKinsey. A three-day exhibition and confer- Tel: +41 61 225 5151. Contact:Association of the European Self-Medication Industry,the AESGP. ence focusing on nutraceuticals, Fax: +41 61 225 5152. Tel: +32 2 735 51 30. Fax: +32 2 735 52 22. cosmeceuticals, functional foods E-mail: [email protected]. E-mail: [email protected]. Website: www.aesgp.be. and functional drinks. Website: www.diahome.org. Contact: Chris Lee,IIR Exhibitions. 27-28 June 5-6 July 9 June Tel: +44 20 7017 7036. ■ Regulatory Affairs ■ Marketing Authorisation The Nutrition and Health Fax: +44 20 7017 7818. ■ in Africa – including in the Middle East E-mail: [email protected]. Claims Regulation South Africa Frankfurt, Germany Brussels, Belgium Website: www.vitafoods.eu.com. London, UK Day one of this two-day meeting A one-day conference subtitled Countries that will be covered at will focus on the regulatory en- 17-19 May ‘Dealing with the present – plan- this two-day meeting include Al- vironment within the Middle East, ning for the future’. ■ Russian Pharmaceutical geria, Ghana, Morocco, Nigeria, while day two will cover different Contact:EAS. Forum Tanzania and Uganda. products including OTC drugs. Tel: +32 2 218 1470. St. Petersburg, Russia Contact: Management Forum. Contact:Dr Henriette Wolf-Klein, E-mail: [email protected]. Speakers from the Association of Tel: +44 1483 730071. Forum Institut für Management. Website: www.eas.eu. the European Self-Medication In- Fax: +44 1483 730008. Tel: +49 6221 500 680. dustry,the AESGP,Merck Ser- 19-23 June E-mail: registrations@management- Fax: +49 6221 500 555. ono, Novartis Group Russia, Pfi- 47th DIA Annual forum.co.uk. E-mail: [email protected]. zer and Sanofi-Aventis will take ■ Meeting Website: www.management- Website: www.forum-institut.com. part in this three-day event. forum.co.uk. Contact: Adam Smith Conferences. Chicago, Illinois, US 11 July Tel: +44 20 7017 7444. ‘Convergence of science, medi- 27-29 June ■ Critical Success Factors Fax: +44 20 7017 7447. cine and health’ is the theme of ■ Stepping It Up for Switch Success E-mail: events@adamsmith this five-day event, which is the Basel, Switzerland London, UK conferences.com. annual meeting of the Drug In- A three-day pharmaceutical mar- A one-day seminar – hosted by Website: www.russianpharma.com. formation Association (DIA). ket research conference. Mediapharm – analysing factors Contact: Vicki Adkinson, DIA. Contact: EphMRA. affecting switches of medicines 25-27 May Tel: +1 215 442 6162. Tel: +41 22 33 99 596. from prescription-only to pharm- ■ Pharmaceutical Fax: +1 215 442 6199. Fax: +41 22 33 99 631. acy (POM-to-P) status. Regulatory Affairs E-mail: [email protected]. E-mail: [email protected]. Contact: Zain Philbey, SMi Group. in Asia – including India Website: www.diahome.org. Website: www.ephmra.org. Tel: +44 20 7827 6722. London, UK 21 June Fax: +44 20 7827 6001. Day one of this three-day seminar JULY E-mail: [email protected]. ■ Marketing Authorisation Website: www.smi-online.co.uk. will discuss regulatory affairs in in South Africa, 4 July China, while day two will focus Australia and ■ Pharmaceutical on India and day three will cover AUGUST Regulatory Affairs Korea and Taiwan. New Zealand 11 August Contact: Management Forum. Frankfurt, Germany in Turkey Tel: +44 1483 730071. This one-day conference will look London, UK ■ Basics of Fax: +44 1483 730008. at the pharmaceutical markets and Turkey’s regulatory environment Regulatory Affairs E-mail: registrations@management- marketing authorisation proced- and application process will be dis- London, UK forum.co.uk. ures in Australia, New Zealand and cussed at this one-day event. A one-day course from The Org- Website: www.management-forum.co.uk. South Africa. Contact: Management Forum. anisation for Professionals in Reg- Contact:Dr Henriette Wolf-Klein, Tel: +44 1483 730071. ulatory Affairs (TOPRA). 30-31 May Forum Institut für Management. Fax: +44 1483 730008. Contact:TOPRA. ■ EuroPLX 46 Tel: +49 6221 500 680. E-mail: registrations@management- Tel: +44 20 7510 2560. Vienna, Austria Fax: +49 6221 500 555. forum.co.uk. Fax: +44 20 7537 2003. A two-day partnering and licens- E-mail: [email protected]. Website: www.management- E-mail: [email protected]. ing forum focusing on OTC medi- Website: www.forum-institut.com. forum.co.uk. Website: www.topra.org.

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OTC COMPANIES Boehringer will fight for OTC growth

Boehringer Ingelheim’s strategy for its Consumer Health Care business to switching medicines from prescription-to- OTC status around the world. “The complexity is shifting under the leadership of David Wright. Deborah Wilkes asks of switches, particularly those involving medi- the new global head of the world’s sixth-largest OTC player about his plans. cines for chronic and symptom-less conditions, requires pioneering regulatory and marketing ore fighting talk can be expect- with regard to investment globally,” he explains, approaches,”maintains Wright. ed from Boehringer Ingelheim’s stressing the initiative is “about driving effi- The eight-strong switch team, which oper- Consumer Health Care business ciency rather than cutting costs”. ates as a standalone unit within the Consumer Mnow that David Wright has taken Meanwhile, Wright is continuing to stream- Health Care business, brings together commer- over as permanent global head. “Our approach line Consumer Health Care’s marketing efforts; cial, marketing and regulatory expertise. Wright to marketing, sales and trade marketing will be a process that he started after becoming global highlights that the team includes people with more visible,”says Wright, promising: “We will marketing director in 2004. some hands-on experience of groundbreaking fight to get visibility.” switches, such as GlaxoSmithKline Consumer Wright points out that he has been the driv- Global agency for advertising Healthcare’s Alli weight-loss medicine. ing force behind some important changes at the Boehringer Ingelheim recently awarded the The new unit will focus firstly on switch- Consumer Health Care business since he was global advertising accounts for three of its in- ing mature Boehringer Ingelheim medicines, made acting global head in early 2010 follow- ternational core brands – the cough remedies explains Wright, and secondly on becoming the ingthe departure of Hans Regenauer to Sanofi- Bisolvon and Mucosolvan as well as the gas- “partner of choice” for external switch candi- Aventis. “The senior management team is com- trointestinal product Buscopan – to the Young dates. Consumer Health Care’s strengths in Eur- pletely fresh,”he says, “and Consumer Health & Rubicam agency. “We will unleash the full ope, Japan and Latin America make it an attrac- Care is now more of a standalone business.” power of our network to expand these impor- tive partner for companies with switch candi- Furthermore, continues Wright, Consumer tant brands around the world,”promised David dates, comments Wright, 46, who was made Health Care is currently rolling out programmes Sable, global chief executive officer of Young senior vice-president and global head of Boeh- to promote sales efficiency and sales excellence & Rubicam, adding that work in Asia, Europe ringer Ingelheim’s Consumer Health Care busi- around the world. “We are trying to bring more and Latin America would get underway soon ness earlier this year (OTC bulletin,28 Febru- transparency into the organisation at the local (OTC bulletin,31 March 2011, page 8). ary 2011, page 23). level, so that we can make the right decisions The Consumer Health Care business has gradually centralised its agencies, Wright ex- Worldwide sales up by 4.5% plains, noting that two other international core At the German company, Wright leads a Business Sales Change brands – the laxative Dulcolax and the vitamin business which reported worldwide sales up by (C millions) (%) and mineral product Pharmaton – are handled 4.5% to C1.32 billion in 2010. He joined the Prescription Medicines 9,702 -3.5 by Grey Healthcare. privately-owned company in 1997 as divisional Consumer Health Care 1,318 +4.5 Wright is quick to point out, however, that director for the UK and Ireland, and was nam- Animal Health 921 +51.0 input from local markets is still extremely im- ed global marketing director in 2004. Industrial Customer 638 -18.7 portant. “Brands evolve at different speeds in Starting at Boots Healthcare International, Other 7–different markets, so there has to be an align- where he held a variety of sales and marketing ment between centralised and local execution positions, Wright moved in 1992 to Novartis, Boehringer Ingelheim 12,586 -1.1 of policy,”he says. where he was UK sales director and general

Figure 2: Breakdown of Boehringer Ingelheim’s sales Probably the most high-profile change is the sales manager. in 2010 (Source – Boehringer Ingelheim) arrival of a global switch unit that is dedicated Wright’s propensity for fighting talk reflects his rugby union career,which at its height saw him play at scrum half at national level and for Cardiff and Leicester Tigers at top club level. 1.501.5 C1.32 bn C1.26 bn C1.19 bn +4.5% “Consumer Health Care aims to win,”he as- C1.14 bn +5.9% +4.3% C1.06 bn +7.2% serts, insisting that “even a draw will not be +1.1% good enough in future”. 1.001 Speaking at the annual-results press conference in early April, Hubertus von Baum- billions)

C bach – the member of Boehringer Ingelheim’s board of managing directors responsible for 0.500.5 Sales ( finance and animal health – remarked that the Consumer Health Care business had continued to grow in a “difficult market environ- 0.000 ment”. In Japan, however, sales had declined 2006 2007 2008 2009 2010 12 345by 5.8% in “a contracting market”, von Baum-

Figure 1: Annual sales and sales growth at Boehringer Ingelheim’s Consumer Health Care business over the bach stated. But on a more positive note, he past five years. Changes in sales are as reported (Source – Boehringer Ingelheim/OTC bulletin) pointed out that sales in emerging markets had

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COMPANIES OTC

moved ahead by 19.4% to C413 million. in the US and Canada since the end of 2010 for Over the past five years, Consumer Health stroke prevention in patients with atrial fibril- Care’s sales have grown by a quarter from C1.06 lation. During 2011, Pradaxa has also gained billion in 2006 to C1.32 billion last year (see approval for this indication in Japan, New Zea- Figure 1). land, South Korea and a number of other coun- Consumer Health Care accounted for 10.5% tries. Furthermore, the European Medicines of Boehringer Ingelheim’s total group sales in Agency’s (EMA’s) Committee for Medicinal 2010, which slipped back by 1.1% to C12.6 bil- Products for Human Use (CHMP) has just giv- lion (see Figure 2). In local currencies, the de- en a positive opinion for this use. crease was a more severe 6.0%. Barner singled out Pradaxa as “the highlight The fall was underscored by the performance of 2010 for Boehringer Ingelheim”. It heralded of the dominant Prescription Medicines busi- “a new growth phase for the company”, he said. ness, which saw sales drop by 3.5% to C9.70 Boehringer Ingelheim has also recently un- billion. Boehringer Ingelheim said the decline veiled a worldwide strategic alliance with Eli was primarily due to a loss of exclusivity on a Lilly and Company to develop and commer- number of its key brands in the US, which cut cialise jointly a portfolio of diabetes treatments. C1.40 billion from sales. The alliance should see the German company’s linagliptin launched this year. Hit by generic competition With merger and acquisition activity in the Group operating income had decreased by pharmaceutical industry at a high, von Baum- Boehringer Ingelheim is prepared to make a large 15.3% to C1.90 billion, Boehringer Ingelheim bach stressed that the family-owned company, acquisition should the right opportunity arise, says pointed out, as it maintained a high level of in- which ranked number 15 in the global pharma- David Wright, senior vice-president and global head of Boehringer Ingelheim’s Consumer Health vestment in research and development, despite ceutical market, wanted to retain its indepen- Care business the loss of sales to generic competition. Return dence. “The shareholders have the long-term on net sales had declined from 17.6% to 15.1%, independence of our group of companies as the Boehringer Ingelheim’s independence. Boeh- the company noted. supreme goal,”he said. ringer Ingelheim makes sustained investment Professor Andreas Barner,chairman of Boeh- This had implications for refinancing oppor- in research and development and thereby pos- ringer Ingelheim’s board of managing directors, tunities, von Baumbach continued, as private sesses the growth potential for the future.” described 2010 as “a year of transition”. “Due ownership of the company meant access to the According to Wright, the family is keen to to patent expiries and the associated competi- capital markets was restricted. “But it is this retain a presence in the consumer healthcare tionfrom generics, launch preparations for new very fact that allows us to take a very long- market and, consequently,Boehringer Ingel- products and regulatory changes in the mar- term approach,”he said. heim is willing to invest in its Consumer Health kets, we had already anticipated in 2009 that we Von Baumbach pointed out that over many Care business. Enhancing the geographic pres- could not achieve the high growth rates of the decades the shareholders had retained substan- ence of the business, switching medicines from previous years,”said Barner. “So we made use tial profits in the company to provide it with the prescription-to-OTC status and extending the of the time and laid foundations for new growth.” necessary financial scope. “This creates the fin- existing brands with innovative products, are Boehringer Ingelheim has high expectations ancial strength and unique quality of Boeh- all high on the investment agenda, he says, for its new prescription-only medicine Pradaxa ringer Ingelheim,”he said. “High liquidity and as is developing global sales and marketing (dabigatran etexilate), which has been approved sustained positive cash flow are the basis of communications. Boehringer Ingelheim claimed that the Con- sumer Health Care business ranked sixth out Johnson & Johnson10 -10.7% of the top-10 global consumer healthcare companies (see Figure 3). It also believed the unit Nova9rtis +6.0% outperformed the 4.1% rise in global OTC sales Bayer8 +3.2% over the year. Von Baumbach said the company held a “very strong competitive position”. Sanofi-Aventis7 +8.1% Wright maintains that Boehringer Ingel- GlaxoSmithKline6 -1.8% heim’s Consumer Health Care business has a “unique” geographic presence. “We are strong Boehringer Ingelheim5 +3.7% in Japan, Latin America and Western Europe,” Pfizer4 +3.3% he says, “but relatively weak in the US and Eastern Europe.” Taisho3 -1.7% In terms of geographic regions, Europe was Reckitt Benckiser2 +2.3% the most important market for Consumer Health

Merck &1 Co +2.8% Care in 2010, with sales up by 5.5% to C502 million (see Figure 4 on page 20). The region 01.0 2.0 3.0 01000 2000 3000 accounted for 38% of turnover at the business Sales (C billions) (see Figure 5 on page 20). Sales in Germany – Consumer Health Care’s Figure 3: Top 10 consumer healthcare companies ranked by worldwide sales of non-prescription products in 2010, accompanied by sales growth compared to 2009. Figures are based on value sales at manufacturers’ biggest European market – were flat at C131 selling prices (Source – Boehringer Ingelheim/IMS Consumer Health’s OTC ReViewPlus) million due to the weak cold and flu season,

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Boehringer Ingelheim noted. This was despite Region Sales Change According to Wright, the money is avail- sales of the Thomapyrin range of pain reliev- (C millions) (%) able to boost Boehringer Ingelheim’s Consum- ers growing by almost 4% to C29 million, fol- er Health Care business with a big acquisition. lowing a relaunch of the brand. Europe 502 +5.5 “If the right target comes along and fulfils our Consumer Health Care’s strongest growth Asia, Australia, Africa 441 +1.3 strategic criteria, then Boehringer Ingelheim was recorded in the Americas region, where Americas 374 +7.2 will make an active move,” he says. turnover advanced by 7.2% to C374 million. Consumer Health Care1,318 +4.5 However, Wright is a pragmatist. “If you are In the Asia, Australasia, Africa region, sales always looking for the ideal acquisition target, edged up by 1.3% to C441 million. This was Figure 4: Breakdown of sales by Boehringer then you may be disappointed,”he remarks. despite the 5.8% slump in Japanese turnover, Ingelheim’s Consumer Health Care business in 2010 In the past, Boehringer Ingelheim has focus- (Source – Boehringer Ingelheim) which accounted for 67% of Consumer Health ed on supporting Consumer Health Care’s org- Care’s sales in the region. anic growth with fill-in acquisitions. The com- Boehringer Ingelheim strengthened its pres- Americas Europe pany wanted to “close gaps in specific coun- 38% ence in Japan’s consumer healthcare market in 28% tries and accelerate its presence in core cate- 2010 by acquiring the 40% stake in its Japan- gories, such as gastrointestinal products and ese OTC subsidiary,SSP,that it did not already cough/cold remedies”. The aim was to “achieve own (OTC bulletin,26 February 2010, page category leadership and obtain a sustainable 3). The company had held a majority stake in business in the given country” (OTC bulletin, SSP since 2001 (OTC bulletin,16 November 15 May 2009, page 18). 2001, page 1). But Wright says Consumer Health Care now Taking full control of SSP had transformed has a more flexible approach to acquisitions, Consumer Health Care into the largest OTC particularly when it comes to categories and cough business in the world, Boehringer Ingel- brands. “If you restrict yourself to the cate- Asia, heim said at the time. Australasia,Africa gories you know best and look at the strong 33% brands within those categories,”he observes, Plant evacuated in Japan “then you may find they are not up for sale or Commenting on the recent earthquake, tsu- Figure 5: Sales by Boehringer Ingelheim’s Consumer you may have to pick them up along with brands Health Care business in 2010 broken down by region nami and consequent nuclear catastrophe in (Source – Boehringer Ingelheim) that are not part of your core business.” Japan, Boehringer Ingelheim said it had almost “We have looked at our core categories and 3,000 employees at five locations in the coun- tion in a weak market environment during the the strong brands within those categories, but try. Stressing that all of its employees were safe, 2009/2010 season. unfortunately we cannot prise them open,”he the firm said its OTCmanufacturing plant in Four of Consumer Health Care’s most im- adds. “So we have broadened our sights to cov- Fukushima, which makes products almost ex- portant brands – the laxative Dulcolax, the er other categories. The only way to get some- clusively for the Japanese market, would not cough medicine Mucosolvan, the vitamin and thing sizeable is not to restrict yourself com- be accessible for the foreseeable future. How- mineral product Pharmaton, and the anti-spas- pletely to what you know best.” ever,production at another OTC manufactur- modic Buscopan – each generated sales of over When it comes to enhancing the Consumer ing plant near Tokyo had restarted, as had work C100 million in 2010 (see Figure 6). Health Care business’ geographic presence via at its Yamagata facility for making prescription Dulcolax, which is claimed by Boehringer acquisitions, however, the top priority remains medicines. Ingelheim to be the world’s best-selling laxative unchanged. “Finding the right deal in the US The crisis at Japan’s Fukushima nuclear pow- for constipation relief, was Consumer Health is particularly important,”comments Wright. er plant meant the nearby OTCmanufacturing Care’s biggest seller. Turnover improved by “If we want to be a billion-dollar player in the facility had been evacuated as a precautionary 8.9% – or by 3.7% on a currency-adjusted basis US, then clearly we are not going to achieve measure, the company explained, noting that – to C159 million. that through organic growth and/or switches.” the 40 employees who worked at the site were However, Buscopan performed strongest, Just over four years ago, Boehringer Ingel- safe and had been deployed at two other pro- reporting sales up by a fifth to C134 million, heim boosted its Consumer Health Care busi- duction sites. although the currency-adjusted growth was ness by buying the US OTCrights to Zantac Boehringer Ingelheim said it was not pos- lower at 13.9%. Boehringer Ingelheim noted for US$510 million (C356 million) from John- sible at this point in time to say anything about that Buscopan was the number one anti-spas- son & Johnson and Pfizer Consumer Health- the extent of the damage to the buildings. “The modic brand worldwide. care (OTC bulletin,31 October 2006, page 1). site is located in an evacuation zone around the The ranitidine-based heartburn medicine com- neighbouring nuclear plant and is not acces- Will invest in right acquisitions plemented Boehringer Ingelheim’s Dulcolax sible,”the company noted. Discussing the firm’s annual results, Barner range of laxatives in the US. Wright says Boehringer Ingelheim is seek- said Boehringer Ingelheim was prepared to in- Wright says China is second on the list of ingthird-party manufacturers for the products vest in the right acquisitions for the company. acquisition priorities, with Russia close behind. made at its Fukushima facility. “Where we see specific opportunities to make In Europe, he adds, France and the UK are im- Looking at brands, Wright maintains that sensible additions to our product portfolio – portant targets. However, he notes that Con- Consumer Health Care’s core brands each oc- whether quite early in the research phases or,as sumer Health Care is “not restricting its tar- cupy one of the top three positions in most of was possible in Animal Health in 2010, with gets” to these countries. their respective categories, and all recorded products already on the market – individual Wright stresses the importance of flexibil- growth during 2010. Furthermore,he adds, the business areas will be supplemented by target- ity in the current business environment, where company’s cold portfolio maintained its posi- ed acquisitions,”explained Barner. many firms have similar acquisition strategies

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COMPANIES OTC

and where buyers can sometimes become sell- ersovernight. Outright acquisitions are the fav- oured option for Consumer Health Care, he says, but Boehringer Ingelheim may be prepared to consider other ways of enhancing the geographic presence of the business. As well as making acquisitions, Boehringer Ingelheim is keen to invest in innovation. In- deed, the company noted that achieving “excel- lencein innovation and technology” had been a guiding principle since it was founded by Albert Boehringer in 1885. This is reflected in A series of line extensions has transformed Boehringer Ingelheim’s Dulcolax into an umbrella brand the company slogan: “Value through innovation”. for gastrointestinal remedies comprising Dulcolax (bisacodyl or sodium picosulfate) and Dulcolax Balance Wright stresses that innovation is key to cre- (macrogol 4000) for constipation; Dulcofibre (glucomannan) for intestinal irregularity; and Dulcoease ating and maintaining sustainable growth in the (docusate sodium) for softening hard stools OTC market. Switches, innovative line exten- such as benign prostatic hyperplasia, hyperten- Medicines and Healthcare products Regulatory sions and new approaches to marketing will all sion, restless legs syndrome, generalised anx- Agency (MHRA) approved the switch of 0.4mg be important drivers of growth at Consumer iety disorder,and peripheral neuropathic pain tamsulosin hydrochloride capsules from pre- Health Care, he believes. associated with diabetes. scription-only to pharmacy (POM-to-P) status for In its latest annual report, Boehringer Ingel- Two medicines – Micardis (telmisartan) for treating lower urinary-tract symptoms in men heim noted that the market for OTC healthcare high blood pressure and Spiriva (tiotropium bro- aged between 45 and 75 years. was undergoing constant change. “Ageing pop- mide) for chronic obstructive pulmonary dis- Available under the Flomax Relief banner ulations and cost pressures on healthcare sys- ease – accounted for 47% of sales by Boeh- since the first quarter of 2010, the switch marks tems are changing the landscape of markets in ringer Ingelheim’s Prescription Medicines busi- the creation of a whole new self-medication cat- which the Consumer Health Care business com- ness in 2010. Micardis is one of Boehringer Ing- egory in the UK, comments Wright, and will petes,”the company stated. “Cost pressure leads elheim’s most promising switch candidates. serve as a reference case for further switches in to governments no longer supporting reimburse- Secondly,the new unit will use Consumer the UK and other countries around the world. ment of all medications, which has led to an in- Health Care’s reputation as a leading self-med- Sales of Flomax Relief have been relatively crease in preventive medicines and an increas- ication firm to become the “partner of choice” low to date, but Wright says the company has ing willingness of regulators to consider switch- for external switch candidates, Wright adds. gained valuable regulatory and marketing ex- ing medicines from prescription-to-OTC status.” He maintains that Consumer Health Care’s perience with the product in the UK. He adds strength in Europe, Japan and Latin America that OTC availability in the UK will provide Dedicated global switch unit makes it an attractive partner for companies a good platform for switches in other countries Boehringer Ingelheim pointed out that the with switch candidates. such as the US. dedicated switch unit had been set up by the To highlight the strength of Boehringer Ing- Boehringer Ingelheim also draws attention Consumer Health Care business, as it sought to elheim’s switch capabilities, Wright points to to the fact that switches of Buscopan – based “assess and exploit this promising opportunity”. the company’s “first-in-class” UK switch of Flo- on the active ingredient hyoscine butylbromide Wright says the new unit will focus firstly max for treating an enlarged prostate (OTC bul- – have been implemented step-by-step in many on switching mature Boehringer Ingelheim med- letin,18 December 2009, page 1). regions over decades. Buscopan comprises both icines, thus extending their lifecycle well be- The UK became the first country in the world prescription and OTC products, as some com- yond patent expiry and offering consumers new to make Flomax a non-prescription medicine binations sold under the Buscopan brand have self-care solutions. for treating benign prostatic hyperplasia, or an not yet been switched. Boehringer Ingelheim has a broad range of enlarged prostate, in December 2009 (OTC Meanwhile, in Japan, the company has re- prescription medicines for treating conditions bulletin,18 December 2009, page 1). The UK’s cently switched Alesion (epinastine) to non- prescription status for allergic rhinitis. In addition to switches, Boehringer Ingel- 200 200 heim is working on more innovative line exten- 159 (+8.9%) 148 sions for its existing international brands. “The (+11.3%) 134 130 regulatory situation for umbrella branding is 150150 (+20.7%) (+7.4%) not straightforward,”says Wright, “but we do see some opportunities for growth.” millions)

C 100100 Dulcolax brand extended The Dulcolax brand, for example, has been

Net sales ( 5050 built into a portfolio of gastrointestinal remedies including: Dulcolax (bisacodyl or sodium picosulfate) and Dulcolax Balance (macrogol 00 4000) for constipation; Dulcofibre (glucoman- Dulcolax Mucosolvan Buscopan Pharmaton 1234nan) for intestinal irregularity; and Dulcoease

Figure 6: Net sales achieved by Boehringer Ingelheim’s most important international Consumer Health Care (docusate sodium) for softening hard stools. brands in 2010. Changes in sales are as reported (Source – Boehringer Ingelheim) ■ Continued on page 22

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Divestments Alli heads OTC brand cull at GlaxoSmithKline

■ Continued from front page Nutrition – in which the company has “fast- loss medicine that offered a US Food and Drug had been so recently launched on both sides of growing leading brands such as Sensodyne, Administration (FDA)-approved alternative to the Atlantic, would be a victim of the cull. Panadol and Horlicks” (see Figure 2). “fad diets, unproven miracle pills, and poten- Underlining that Consumer Healthcare was On a proforma basis, the retained business tially unsafe weight-loss supplements that may a “key growth driver” for the company, Witty would have delivered sales of approximately not work”. emphasised that the business had to be focus- £4.5 billion in 2010, GlaxoSmithKline pointed Alli generated US sales of over £320 million ed around “product categories, brands and mar- out, with a compound average growth rate of in the period from its launch until the end of the kets” where it had the most depth and compet- 6% over the period 2007-2010. first quarter of 2010, but the brand’s financial itive advantage, and with the best prospects for As reported, Consumer Healthcare’s 2010 performance in the US has been erratic. strong growth. sales rose by 7% – 5% at constant exchange Sales started off high over the initial launch He noted that 90% of the division’s sales rates – to £5.01 billion (OTC bulletin,11 Feb- period, before falling away in 2008 and pick- came from its top global brands and its emerg- ruary 2011, page 7). ing up again in the first half of 2009. ing markets operations. Alli is the biggest name included in the list However, Alli’s turnover stalled in the sec- “The other 10% is essentially a selection of of over 100 non-core OTC brands. Its poten- ond half of 2009 following an FDA “early com- about 100 or so fragmented brands, often OTC tial sale comes just two years after the OTC munication about an ongoing safety review” brands sold in pharmacy, and often only sold weight-loss medicine was launched in Europe into the brand’s active ingredient orlistat (OTC in one or two countries,”he said. “Frankly,they (OTC bulletin,30 April 2009, page 22) and bulletin,31 August 2009, page 1). are a drag on the growth of this business.” just under four years after it hit the market in In 2010, GlaxoSmithKline noted that Alli’s Following the divestments, the Consumer the US (OTC bulletin,31 May 2007, page 16). US sales had dropped below the £96 million Healthcare division will focus on three prior- When Alli was launched in the US in mid- achieved in 2009. ity segments – Oral Health, Wellness/OTC and June 2007, it was positioned as the first weight- In Europe, meanwhile, Alli was described as one of only a few truly pan-European OTC BrandCategory brands, after GlaxoSmithKline gained a non- Wellness/OTC prescription licence using the European Union’s centralised procedure (OTC bulletin,29 Jan- Fenbid, Grandpa, Panadol, Synthol Pain uary 2009, page 1). Beechams, Breathe Right, Coldrex, Flonase/Flixonase, Respiratory tract Alli achieved sales of £105 million in the Nurses, Piriton nine months after its launch across the Euro- Nicabate, Nicorette (US), NiQuitin Smoking control pean Union, making it the third best-selling Andrews, Eno, Scotts, Tums Gastrointestinal OTCbrand in Europe (OTC bulletin,10 Feb- Oral care ruary 2010, page 1). By the end of March 2010, Aquafresh, Biotene, Corsodyl/Paradontax, Macleans, Sensodyne Oral care Alli had notched up total sales of £139 mil- Corega,Polident, Poligrip Denture care lion throughout the region (OTC bulletin,14 Nutritionals May 2010, page 6). In 2010, however, Alli was unable to match Horlicks, Lucozade, Maxinutrition, Ribena – its 2009 turnover, with GlaxoSmithKline dis- Figure 2: Key Consumer Healthcare brands that GlaxoSmithKline intends to retain (Source – GlaxoSmithKline) closing an unspecified decline in sales. OTC

by booster phases on television, which doubled Boehringer will fight for OTC growth the market share to 8%. Boehringer Ingelheim pointed out that its ■ Continued from page 21 television, are no longer the only and most effec- Consumer Health Care business had reached Similarly,the Pharmaton brand containing tive methods of communication,”he notes. more than 300 million consumers through digi- vitamins, minerals, trace elements and stand- Television and print campaigns will remain tal media campaigns in 2010. It runs more than ardised Ginseng G115 extract offers a full range an important part of Consumer Health Care’s 250 websites around the world with over 15 mil- of products adapted to the needs of different marketing mix, he insists, but new media will lion visitors per year in over 40 countries. target audiences. These include: Pharmaton also be used to reach targets more efficiently. The messages communicated to consumers Kiddi for children; Pharmaton Matruelle for will be backed by ongoing technical research pregnant and lactating women as well as those Digital campaign in Poland into Consumer Health Care’s brands, explains planning a pregnancy; and Pharmaton Cardio- In Poland, for example, Buscopan had been Wright, which will provide scientific support active for people aged over 40 years. backed by a successful digital campaign dur- for their claims. Existing brands will be aided by embracing ing 2009 without any television support, said Wright believes the changes at Consumer new communications channels, Wright main- the company, which had resulted in a market Health Care will give the business a fighting tains, especially the internet. “Classical adver- share increase from 2% to 4%. The campaign chance to achieve its potential. tising patterns using only mass media, such as had been continued throughout 2010, supported OTC

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PEOPLE OTC

Manufacturers Industry Associations Novartis names Commission puts AESGP chief in China onto food advisory group ovartis believes that recruiting Dong Yin Nfrom AstraZeneca to run its operations in China will benefit all of the Swiss firm’s local he European Commission has appointed of the group, which already had 36 members. businesses, including its Chinese OTC unit. Tthe Association of the European Self-Medi- Other new members include the European Fed- “We believe that Yin’s experience in terms cation Industry,the AESGP,as a member of its eration of Associations of Health Product Man- of being able to build salesforce excellence as Advisory Group on the Food Chain and Ani- ufacturers (EHPM) and Friends of the Earth well as build a commercial operation in China mal and Plant Health. Europe (FoEE). is directly relevant to our business,”said Novar- Created in 2004, the group advises the Euro- Issues discussed by the group in recent years tis’ chief executive officer Joseph Jimenez. pean Commission on policy initiatives planned had included the feasibility and advisability of “We’ve also hired him because we believe in the areas of food safety,animal and plant establishing fees for the European Food Safety that there is substantial opportunity for the oth- health. It brings together key stakeholders, in- Authority (EFSA), and the framework legisla- er divisions to gain scale and to leverage the cluding the food industry,retailers and con- tion on additives, pointed out the AESGP,not- [prescription] Pharma unit’s strength,”Jimenez sumer organisations. ing that more technical issues were examined stated, highlighting the potential to expand the The AESGP is one of nine new members in working groups. size of not only the OTC operation, but also OTC Novartis’Animal Health and Sandoz generics businesses in China. Regulatory Agencies “We expect to see accelerating growth in China,”Jimenez asserted. Having recently re- Pittner retires from Austrian regulator viewed plans with Yin, he said Novartis would be “doing something very different in China than r Heribert Pittner has retired as direc- Austrian Ministry of Health in 1997. we have done in the past”. D tor of the department of herbal medicines Pittner was a member of Europe’s Herbal Meanwhile, the Swiss group has announced and homoeopathy at Austria’s AGES Pharmed. Medicinal Products Working Party from 1999- that Felix Ehrat will become its general coun- After starting his career with Austrian com- 2004, and then a member of the Committee on sel from 1 October this year,reporting directly pany Chemie Linz in 1972, Pittner moved to Herbal Medicinal Products (HMPC). He was to Jimenez. the Austrian Control Institute of Pharmacology also on Europe’s Committee for Medicinal Pro- Ehrat joins Novartis from Swiss law firm in 1986. He became a medical assessor at the ducts for Human Use (CHMP). Baer & Karrer,where he was most recently ex- OTC ecutive chairman and senior partner. He succeeds Thomas Werlen,who is leaving after five years in the post to “pursue opportunities including entrepreneurial and commercial interests”. OTC

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29 April 2011 OTC bulletin 23