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COMPANY NEWS 3 Johnson & Johnson recall Ransom has no plans to 3 sell more brands Recall not only reason for 4 J&J’s slump cuts OTC sales by quarter Omega Pharma sees sales rise 5 by 4% to over C200 million oluntarily recalling Tylenol and other Neil Consumer Healthcare business a warn- Boehringer OTC goes up 6 VOTC products in response to regula- ing letter about the unit’s Las Piedras plant in despite economic crisis tory concerns slashed US sales by Johnson Puerto Rico. Pharmstandard snaps up stake 7 & Johnson’s OTC & Nutritionals business The firm immediately initiated a voluntary Novartis OTC grows ahead of market 8 unit by a quarter in the first three months recall of certain lots of its Benadryl, Motrin, Economic crisis hits turnover at Krka 9 of this year. Rolaids, Simply Sleep, St Joseph Aspirin and Sales by the business in the US had slump- Tylenol products made at the facility (OTC 36.6 restructures as 10 turnover declines ed by 25.3% to US$542 million (C404 million) bulletin,10 February 2010, page 22). The re- in the period, revealed Dominic Caruso, John- call applied to the Americas, the United Arab GENERAL NEWS 11 son & Johnson’s chief financial officer,who ad- Emirates (UAE) and Fiji. mitted that second-quarter sales would also be Consumer reports of “an unusual mouldy, EMA recommends bufexamac 11 hit by the recall. He claimed, however, that the musty or mildew-like odour that, in a small withdrawal action had “not really impacted physician rec- number of cases, was associated with tempo- Germany’s BAH fears the rise of 12 ommendation or consumer preferences” for the rary and non-serious gastrointestinal events” mail-order pharmacy company’s OTC products. had already prompted McNeil to carry out two German committee to 13 In February,the US Food and Drug Admin- recalls of Tylenol Arthritis Pain caplets in Jan- consider orlistat switch istration (FDA) sent Johnson & Johnson’s Mc- uary of this year and in November 2009. MARKETING NEWS 14 Reckitt revamps E45 14 Endless Moisture Zegerid OTC could face store brands Mentholatum invests in Regenovex 15 egerid OTC could face generic competi- ing a store-brand version of Zegerid OTC but FEATURES 19 Ztion in the US, after a Delaware district has not yet stated publicly whether it has fil- court found that five patents protecting San- ed an ANDA. Centralised route requires 19 passion and perseverance tarus’ Zegerid (omeprazole/sodium bicarbon- Schering-Plough Healthcare Products, which – Manfred Scheske talks about key ate) capsules and powder for oral suspension is Santarus’ partner in the OTC market, has just issues facing the OTC industry until 2016 were invalid due to obviousness. started a major consumer advertising campaign Par Pharmaceutical currently holds tenta- for Zegerid OTC, which is available as capsules REGULARS tive approval for 20mg/1,100mg and 40mg/ for treating frequent heartburn containing 20mg 1,100mg capsules. omeprazole and 1,100mg sodium bicarbonate Pharmacy viewpoint 16 Santarus, which plans to appeal, said it was (OTC bulletin,16 April 2010, page 14). A spo- – Flomax flows to top of rankings not aware of any companies other than Par that kesperson for Schering-Plough’s parent com- Events – Our regular listing 18 had filed an Abbreviated New Drug Applica- pany Merck & Co told OTC bulletin that the People – Bayer recruits Reinhardt 21 tion (ANDA) for omeprazole/sodium bicarb- “court decision does not change Merck Con- People – Connors joins Prestige 22 onate products. sumer Care’s commitment to the launch and People – Sigma chief resigns 23 Perrigo has expressed an interest in produc- ■ Continued on page 12 OTC30-04-10p2-3.qxd 27/4/10 13:03 Page 2 OTC30-04-10p2-3.qxd 27/4/10 13:03 Page 3

COMPANY NEWS OTC

Business Strategy Ransom has no plans to sell more brands

illiam Ransom & Son said it did not plan brands (OTC bulletin,31 March 2010, page 8). Wto sell any more brands after securing a It has also terminated its supply and licensing new long-term financing agreement. agreement for the Medibee honey brand (OTC The UK-based natural products specialist bulletin,26 February 2010, page 11). has made a series of divestments to help re- Ransom pointed out that selling these brands duce its bank debt and provide working capi- had helped reduce its bank debt to £2.6 million tal, as part of the turnaround plan introduced (C3.0 million) as of 31 March 2010. This com- in September 2008 (OTC bulletin,29 Septem- pared with £3.8 million a year earlier. ber 2008, page 6). The company also sold the Pavacol-D and This year alone, Ransom has sold its Meta- Radian B brands in 2008 for £3.1 million (OTC nium nappy-rash brand (OTC bulletin,20 Jan- bulletin,18 December 2008, page 3). uary 2010, page 3), its honey-based Manuka A spokesperson for Ransom told OTC bul- Gold brand (OTC bulletin,10 February 2010, letin that although the company did not plan page 13) and its Snufflebabe and Easy Breathe to divest more brands it was still pursuing the sale of its Pharmaceuticals contract manufac- turing division. The first products in the Ransom Naturals range are now available in selected Tesco outlets in the UK OTC bulletin Under the new financing agreement with KBC Business Capital, Ransom said its exist- ufacturing divisions and cost-reduction initia- 30 April 2010 Number 341 ing debt facilities had been replaced by asset- tives had helped cut the underlying loss, but based facilities comprising an accounts receiv- progress had been hindered by “challenging Editor & Publisher: Deborah Wilkes able finance facility,stock facility and a plant market conditions and brand disposals”. Associate Editors: Aidan Fry and machinery long-term loan. The new facil- Exceptional costs – excluding goodwill im- Mike Rice ities would provide the company with the addi- pairment, financing costs and gains on asset Senior Assistant Editor: Matt Stewart tional working capital required to build on the disposals – were expected to be around £1.1 Assistant Editors: Joanne Grew, Jenna Lawrence, progress it had made since launching its turn- million for the year,said Ransom, adding that Dave Wallace around plan, Ransom noted. this reflected the cost of refinancing the com- Advertising Controller: Debi Minal The new financing agreement was announc- pany’s debt and restructuring costs associated ed as Ransom revealed that it expected to re- with the turnaround plan. Marketing Manager: Val Davis port a reduced underlying operating loss – be- Ivor Harrison, Ransom’s chief executive, Editorial, Subscription and Advertising fore exceptional costs, non-recurring items and noted that the company had just introduced the enquiries should be addressed to: OTC bulletin, OTC Publications Ltd, 54 Creynolds Lane, Solihull, goodwill impairment – of approximately £0.5 first products in its Ransom Naturals range. Two West Midlands B90 4ER, UK. million for the year ended 31 March 2010. This digestive juice products are now available in Tel: +44 1564 777550. Fax: +44 1564 777524. compared with £1.9 million in the same period selected outlets of supermarket chain Tesco in E-mail: [email protected]. a year earlier. the UK, and more products will be launched Subscriptions Ransom said better performances by its man- in the near future. Annual subscriptions to OTC bulletin in Europe are £595.00 for OTC single copies and £345.00 for additional copies to the same ad- dress, including delivery. Subscriptions to addresses outside Eur- ope are subject to an additional charge of £30.00 to cover postage. Subscription enquiries in Korea should be directed to Pharma Mergers & Acquisitions Koreana Ltd, 14th Floor,KTB Network Building, 826-14 Yeoksam- dong, Kangnam-gu, Seoul 135-080, Korea (Tel: +82 2 554 9591; Fax: +82 2 563 8289; E-mail: [email protected]). Valeant expands with Brazil deal Advertising Advertising rates and data are available on request from the ad- aleant Pharmaceuticals International is set The deal was expected to close in the second dress above or at www.otc-bulletin.com. Vto expand its presence in Brazil still fur- quarter of 2010, Valeant said. About OTC bulletin OTC bulletin is published 20 times a year by OTC Publications ther by acquiring another unnamed branded This latest acquisition came after Valeant Limited: twice monthly in February,March, April, May,June, Sep- tember,October and November; and monthly in December,Jan- generics and OTC company for BRL97.0 mil- said in March that it had agreed to acquire for uary,July and August. A subscription to OTC bulletin includes lion (C41.4 million). US$28 million (C21.0 million) another unnam- the weekly electronic newsflash, news@OTCbulletin,which is published around 45 times a year. OTC bulletin is printed by the The US-based company said the Brazilian ed Brazilian firm, which has now been named Warwick Printing Company Limited, Caswell Road, Leamington firm had generated annual sales of approxi- as branded generics and OTC company Insti- Spa CV31 1QD, UK. mately BRL49.0 million in 2009 from a pro- tuto Terapeutico Delta. It also acquired a man- No part of this publication may be copied, reproduced, stored in a retrieval system or transmitted in any form without prior duct portfolio that largely comprised branded ufacturing plant in Brazil for the same price permission from OTCPublications Ltd. generics, but also included topical OTC lines. (OTC bulletin,31 March 2010, page 3). ©OTC Publications Ltd. All rights reserved. Company registered in England No 2765878. Registered Office: Michael Pearson, Valeant’s chairman and Pearson pointed out that the deals provided 54 Creynolds Lane, Solihull, West Midlands B90 4ER, UK. chief executive officer,said the unnamed com- Valeant with expanded opportunities for growth OTC bulletin® is registered as a trademark in the European pany’s product sales had grown in excess of in Brazil and enhanced the company’s Latin Community. 30% over the past year and it had achieved op- American franchise. ISSN 1350–1097 www.OTC-bulletin.com erating margins greater than 20%. OTC

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OTC COMPANY NEWS

First-Quarter Results Recall not only reason for J&J’s slump

cNeil Consumer Healthcare’s voluntary represented a decline of 15.0% on an opera- sales increased by 11.1% to US$2.21 billion. Mrecall of Tylenol and other OTC products tional basis, partially offset by a positive cur- Positive currency effects of 9.7% bolstered the made at its Puerto Rico facility (see front page) rency effect of 4.5% (see Figure 1). international operational growth of 1.4%. had not been the only reason for the 25.3% first- International OTC & Nutritional sales in- Dominic Caruso, Johnson & Johnson’s chief quarter fall in US sales of Johnson & Johnson’s creased by 6.9% to US$665 million as report- financial officer,pointed out that Consumer’s OTC & Nutritionals business unit said Louise ed, but this growth was solely down to a pos- sales would have been flat on an operational Mehrotra, the firm’s vice-president of investor itive currency effect of 9.6%. basis had the impact of the recall been excluded. relations. The impact of the product recall had The product recall responsible for the drop been compounded, she said, by a less severe Consumer sales slip back in OTC & Nutritionals’ sales was initiated in cold and flu season than had been anticipated. Some sales declines in other parts of John- January (OTC bulletin,10 February 2010, page She added that a more positive note had son & Johnson’s Consumer division meant that 22). This was when Johnson & Johnson’s Mc- been struck by the strong growth achieved by the McNeil recall translated into the total Con- Neil Consumer Healthcare operation received the cetirizine allergy medicine Zyrtec OTC, sumer result. Operationally,the division slip- a warning letter from the US Food and Drug thanks to the launch of Zyrtec Liquid Gels. ped back by 3.7%, although a positive 5.2% Administration (FDA), which said processes But with international OTC & Nutritional currency effect meant it was ahead in dollar at its Puerto Rico facility deviated from cur- sales also slipping back by 2.7% at an operating terms by 1.5% to US$3.77 billion. rent Good Manufacturing Practice (cGMP). level, worldwide turnover as reported slumped US Consumer turnover dropped back by An earlier recall of Tylenol Arthritis Pain by 10.5% to US$1.21 billion (C0.91 billion). This 9.6% to US$1.56 billion, while international caplets had occurred in December (OTC bul- letin,10 January 2010, page 15), and a recall Business First-quarter Change Operational Currency of five lots of the same product had been ini- sales (US$ millions) (%) change (%) effect (%) tiated in November 2009 (OTC bulletin,16 November 2009, page 17). Medical Devices & Diagnostics 6,227 +12.5 +8.1 +4.4 Consumers had complained of “an unusual Pharmaceutical 5,638 -2.5 -5.7 +3.2 mouldy,musty or mildew-like odour”, which Consumer 3,766 +1.5 -3.7 +5.2 McNeil said had been caused by trace amounts of a chemical called 2,4,6-tribromoanisole. This Total Johnson & Johnson 15,631 +4.0 -0.1 +4.1 can result from the breakdown of a wood-treat- Figure 2: Johnson & Johnson’s sales in the first quarter of 2010 (Source – Johnson & Johnson) ment chemical used on the wooden pallets that

Business First-quarter sales Change Operational Currency (US$ millions) 2009/2010 (%) change (%) effect (%) OTC & Nutritionals – US 542 -25.3 -25.3 – OTC & Nutritionals – International 665 +6.9 -2.7 +9.6 Total OTC & Nutritionals 1,207 -10.5 -15.0 +4.5 Skin Care – US 452 +6.9 +6.9 – Skin Care – International 468 +11.7 +2.4 +9.3 Total Skin Care 920 +9.3 +4.6 +4.7 Baby Care – US 103 +1.0 +1.0 – Baby Care – International 426 +10.1 +1.2 +8.9 Total Baby Care 529 +8.2 +1.2 +7.0 Women’s Health – US 146 -2.0 -2.0 – Women’s Health – International 323 +17.9 +7.8 +10.1 Total Women’s Health 469 +10.9 +4.4 +6.5 Oral Care – US 174 -7.4 -7.4 – Oral Care – International 207 +16.9 +5.1 +11.8 Total Oral Care 381 +4.4 -1.3 +5.7 Woundcare/Other – US 143 +3.6 +3.6 – Woundcare/Other – International 117 +10.4 ±0.0 +10.4 Total Woundcare/Other 260 +6.6 +2.1 +4.5 Total Consumer 3,766 +1.5 -3.7 +5.2 Consumer – US 1,560 -9.6 -9.6 – Consumer – International 2,206 +11.1 +1.4 +9.7

Figure 1: Breakdown of sales by Johnson & Johnson’s Consumer division in the first quarter of 2010 (Source – Johnson & Johnson)

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COMPANY NEWS OTC

transport and store products. Trading Update However, the FDA said McNeil had failed to investigate first reports of the uncharacter- Omega Pharma sees sales istic smell thoroughly,including examining other batches and alerting the authorities, de- spite numerous complaints. Responding to the warning letter a month rise by 4% to over C200mn later,McNeil said it had enhanced its quality system, made organisational changes and in- mega Pharma reported sales up by 4% to mances had been recorded in the Nordic coun- troduced greater oversight by senior managers OC202 million in the first quarter of 2010, tries,Spain and Switzerland, Omega said, but (OTC bulletin,31 March 2010, page 11). despite turnover at its French business dropping these had been partially offset by weaker show- Johnson & Johnson’s Skin Care business back by a tenth. ings in Germany and Greece. generated 24.4% of Consumer’s turnover, with The Belgian firm has now reported sales Commenting on the French business – with worldwide sales growing by 9.3% to US$920 growth for three consecutive quarters. It main- sales down by 10% to C36.8 million – Coucke million, thanks to the Aveeno, Neutrogena, John- tained that its “tighter” strategy – involving said a new management team had “performed son’s Adult and Le Petit Marseillais brands. strengthened management structures, decisive the necessary analyses” and was now “imple- The business had also been boosted by new innovation, more centralised brand manage- menting vigorous brand management” to sta- products containing new Cytomimic anti-age- ment and greater focus on emerging markets bilise quarterly revenues. ing technology,Mehrotra noted. – could “guarantee continued growth”. Looking ahead, Omega said it believed that US Skin Care sales finished ahead by 6.9% Marc Coucke, Omega’s chief executive of- its “energetic innovation projects” and presence to US$452 million. International sales grew ficer,pointed out that it was the first time the in growth markets would enable the company even faster by 11.7% to US$468 million, due company had posted first-quarter sales of over to sustain over the full year the 4% growth ach- mostly to positive currency effects. C200 million. The performance represented a ieved in the first quarter. Sales at the Baby Care business jumped by strong start to what he believed was a “promis- Commenting on Omega’s strategy going 8.2% to US$529 million, driven by a 10.1% ing year” ahead. forward, Coucke said the company had virtu- rise in international sales to US$426 million – As Figure 1 shows, sales growth was driven ally completed strengthening its management thanks to an 8.9% positive currency effect – by Omega’s Emerging Markets region, where structure – having recruited experienced coun- and aided by a 1.0% increase in the US to turnover finished up by 31% to C21.3 million. try managers and regional managers – and had US$103 million. Coucke said the result had been aided by the also finished expanding its innovation, brand The Women’s Health business posted sales “strong local structures” the company had put management and supply departments. up by 10.9% to US$469 million, thanks to a in place, which had been fuelled by innova- 17.9% improvement in international sales to tive new products and the company’s centrally- Organised to execute strategy US$323 million. The rise in international sales managed brands. He added that the company was now well offset a 2.0% drop in the US to US$146 million. Omega highlighted its good returns from organised to execute a “sustainable and viable” Australia, the Czech Republic, Hungary,Rom- strategy focused on its five new core-business Listerine grows strongly outside US ania, Russia and Turkey,adding that it had also categories – Derma, Classics, Cough & Cold, Strong growth of the Listerine mouthwash done well in other “Omega-growth countries” Multi-Locals, and Parasites. brand outside the US helped push up world- by combining successful local OTC products In March, Omega unveiled a new corporate wide Oral Care sales by 4.4% to US$381 mil- with the company’s centralised brands. strategy that focused the company on broader lion. Listerine’s performance, coupled with pos- Omega’s performance in its home market business categories rather than individual ‘star- itive currency effects, lifted international Oral had been “pleasantly surprising” once again, brands’, with the aim of becoming one of the Care sales by 16.9% to US$207 million. This Coucke said. Sales in Belgium had grown by top 10 OTC players in the world (OTC bulletin, offset a 7.4% fall to US$174 million in the US, 11% to C57.4 million in the first quarter,thanks 31 March 2010, page 2). caused by the sale of the Efferdent and Effer- to both OTC turnover and the generics busi- Omega said at the time it would switch its grip brands in the fourth quarter of 2009. ness, which had posted sales up by 9%. focus from its starbrands – which represented Woundcare/Other posted worldwide sales up Although boosted by “strong growth” in only 15% of Omega’s total sales – to brands by 6.6% to US$260 million, with both interna- the UK for the first time in two years, turnover representing 50% of its sales. tional and US sales growing. The 10.4% inter- by the Western Europe business – Omega’s These, it said, would be managed via the national growth to US$117 million came entire- biggest market in terms of sales – only edged five new business categories. ly from positive currency effects, while US sales ahead by 2% to C86.5 million. Good perfor- OTC improved by 3.6% to US$143 million. The Consumer division represented 24.1% First-quarter sales Change Proportion of Johnson & Johnson’s worldwide sales in the (C millions) 2009/2010 (%) of total (%) first quarter of 2010, which increased by 4.0% to US$15.6 billion (see Figure 2). The rise was Western Europe 86.5 +2 43 driven entirely by a 4.1% positive currency ef- Belgium 57.4 +11 28 fect, which offset a 0.1% decline on an opera- France 36.8 -10 18 tional basis. Pre-tax profits increased by 35.3% Emerging markets 21.3 +31 11 to US$6.28 billion, thanks to a US$1.59 bil- Omega Pharma 202.0 +4 100 lion gain from a legal settlement. OTC Figure 1: Breakdown of Omega Pharma’s sales in the first quarter of 2010 (Source – Omega Pharma)

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OTC COMPANY NEWS

Annual Results Four of Consumer Health Care’s most im- portant brands – the laxative Dulcolax, the Boehringer OTC goes up cough medicine Mucosolvan, the vitamin and mineral product Pharmaton, and Buscopan for abdominal cramps – had each generated sales of over C100 million in 2009 (see Figure 3), despite economic crisis Tjeenk Willink pointed out. Growth was led by Buscopan, which reported currency-adjusted oehringer Ingelheim’s Consumer Health also helped to drive up sales and would re- sales up by 14.7% to C113 million. BCare business reported sales up by 5.9% – main a focus for the company. It is the first time that Buscopan – which is 2.7% on a currency-adjusted basis – to C1.26 Boehringer Ingelheim recently strengthened sold in more than 100 countries – has record- billion in 2009. Nevertheless, the German firm its position in the Japanese consumer health- ed sales in excess of C100 million. said Consumer Health Care had been “con- care market by acquiring the 40% stake in its Boehringer Ingelheim recently extended the siderably weakened” by the impact of the glo- Japanese OTC subsidiary,SSP,that it did not brand in the UK by introducing the Buscopan bal economic crisis. already own (OTC bulletin,26 February 2010, Cramps product (OTC bulletin,31 March 2010, Engelbert Tjeenk Willink, who is responsi- page 3). The company has held a majority stake page 15). ble for pharma marketing and sales on Boeh- in SSP since 2001 (OTC bulletin,16 Novem- Described as the UK’s “first specialist treat- ringer Ingelheim’s board of managing direc- ber 2001, page 1). ment for abdominal pain and cramps”, Busco- tors, said the Consumer Health Care business European sales slipped back slightly to C476 pan Cramps contains the same active ingre- had performed well in all three of its geog- million, Tjeenk Willink said, due to the eco- dient – 10mg hyoscine butylbromide – as the raphic regions over the 12 months despite neg- nomic crisis. The impact of the difficult trading established Buscopan IBS relief product for ative market trends (see Figure 1). environment had been most evident in Spain – irritable bowel syndrome. The strongest growth was recorded in the where sales fell by 5.9% – and Eastern Europe, Asia, Australasia, Africa (AAA) region, where where turnover dropped by 11.4% as reported. Expanding the Buscopan brand turnover increased by 19.7%, or 6.6% on a cur- One bright spot in Europe had been Ger- Boehringer Ingelheim said it aimed to make rency-adjusted basis, to C436 million. As Fig- many, Boehringer Ingelheim pointed out, where Buscopan the leading OTC brand worldwide ure 2 shows, the AAA region generated 34% of sales had improved by 3.4% to C133 million. for abdominal problems. The company noted Consumer Health Care’s net sales in 2009. Sales in the Americas region had been held that it had already launched a heartburn rem- Japan generated 72.6% of Consumer Health back by a 14.9% fall in Mexico, Boehringer In- edy – Buscogast/Buscasan 24 (20mg omepra- Care’s sales in the AAA region, Tjeenk Will- gelheim said. This had led to turnover growth zole) – in Argentina, Germany and the Nether- ink said, but the business’ expansion in China, of just 0.7% – 2.0% on a currency-adjusted lands, as well as a menstrual-pain line extension Turkey and countries in the Middle East had basis – to C349 million. called Buscofem in Brazil. Rolling out the Dulcolax Balance consti- pation remedy into new markets helped the 146 160160 Dulcolax brand retain its position as Consum- (+8.6%) 133 er Health Care’s biggest seller,with turnover (+7.9%) 121 (+8.5%) 113 up by 8.6% to C146 million. 120120 (+14.7%) Launched in Germany in 2007 (OTC bul- 93 88 (-4.9%) letin,28 September 2007, page 16), Dulcolax (+10.4%)

million) Balance – which contains macrogol 4000 – had C 8080 been unveiled in South Korea and the US during 2009, the company noted, and had recently been 34

Net sales ( introduced into the UK under the Dulcobalance 4040 (-2.8%) name (OTC bulletin,31 March 2010, page 15). A “global television commercial” for Dulco- 00 lax Balance has been produced, which Boeh- Dulcolax Mucosolvan Pharmaton Buscopan Zantac Bisolvon Thomapyrin 1234567 ringer Ingelheim hopes will not only boost the product’s sales in Germany, but also act as a Figure 3: Net sales achieved by Boehringer Ingelheim’s most important international Consumer Health Care “great launch platform” in new markets as well brands in 2009. Change is on a currency-adjusted basis (Source – Boehringer Ingelheim) as underpinning the “global brand positioning” Business Annual sales Change 2008/2009 (%) Proportion of Dulcolax. (C millions) Actual Currency-adjusted of total (%) Commenting on the status of the Consum- er Health Care business within Boehringer In- Prescription Medicines 10,058 +10.4 +7.1 79 gelheim, Tjeenk Willink said that “from an en- Consumer Health Care 1,261 +5.9 +2.7 10 trepreneurial viewpoint” the business would Industrial Customer 786 -4.1 –6be of “ever-growing importance” to the com- Animal Health 610 +30.6 +29.4 5 pany. The need to control costs, he said, would Other 6–––see healthcare systems increasingly turn to switching prescription-only medicines to non- Boehringer Ingelheim 12,721 +9.7 +6.7 100 prescription status. Figure 4: Breakdown of Boehringer Ingelheim’s sales in 2009 (Source – Boehringer Ingelheim) An example of this trend, Tjeenk Willink

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COMPANY NEWS OTC

Region Annual salesChange 2008/2009 (%) Proportion Business Strategy/Annual Results (C millions) Actual Currency-adjusted of total (%) Pharmstandard Europe 476 -0.8 -0.1 38 Asia, Australasia, Africa 436 +19.7 +6.6 34 Americas 349 +0.7 +2.0 28 snaps up stake Consumer Health Care1,261 +5.9 +2.7 100 ussia’s Pharmstandard has acquired an R 11.3% stake in Latvian pharmaceutical Figure 1: Sales by Boehringer Ingelheim’s Consumer Health Care business in 2009 (Source – Boehringer Ingelheim) manufacturer Grindeks for an undisclosed sum. said, was the recent switch in the UK of its Flo- Igor Krylov, the chief executive officer of

max product for treating the symptoms of be- Americas Europe Pharmstandard, said the decision to buy into nign prostatic hyperplasia, or enlarged prostate, 28% 38% Grindeks had been based on the long-term re- from prescription-only to pharmacy status (OTC lationship between the two companies. bulletin,18 December 2009, page 1). A Pharmstandard spokesperson told OTC The UK was the first country in the world to bulletin,that the company had no plans to in- switch Flomax (0.4mg tamsulosin hydrochlo- crease its stake in Grindeks any further. How- ride), which is now available to men aged be- ever,if it were to be offered shares by other tween 45 and 75 years from UK pharmacies Grindeks shareholders, then it would consider under the Flomax Relief brand name. Asia, taking them up. Described by Boehringer Ingelheim as a Australasia, In January 2008, Pharmstandard gained the Africa “big opportunity” to obtain “significant new 34% exclusive rights to distribute Grindeks’ pre- growth” in the UK market, Flomax Relief is scription-only cardiovascular drug Mildronate backed by a £5.0 million plus (C5.5 million Figure 2: Sales by Boehringer Ingelheim’s Consumer in Russia. Since signing the agreement, Mil- Health Care business in 2009 broken down by region plus) consumer marketing campaign including (Source – Boehringer Ingelheim) dronate had generated sales of over RUB2.3 television, radio and press advertising (OTC billion (C59.2 million) in Russia, Pharmstan- bulletin,31 March 2010, page 13). ed, before pointing out that the majority of its dard pointed out. Consumer Health Care accounted for 9.9% 6.7% currency-adjusted growth had been org- Janis Romanovskis, chairman of Grindeks, of Boehringer Ingelheim’s group net sales in anic and had not come from acquisitions. said that having Pharmstandard as one of the 2009, which increased by 9.7% – 6.7% on a This performance demonstrated the success company’s largest shareholders would strength- currency-adjusted basis – to C12.7 billion. The of Boehringer Ingelheim’s policy of focusing en its position in Russia and provide new busi- dominant Prescription Medicines business – on organic growth, Barner said. He pointed out, ness opportunities. which saw sales rise by 10.4%, or 7.1% cur- however, that “targeted acquisitions” would be However, Grindeks has resigned from Lat- rency-adjusted – generated 79.1% of the group made for individual business areas where the via’s employers’ confederation, the LEC, in pro- total (see Figure 4). company saw “specific opportunities to make test at the body’s president selling the shares Andreas Barner,chairman of Boehringer sensible additions” to its product portfolio. to the Russian firm. Pointing out that the LEC Ingelheim’s board of managing directors, said Operating income increased by 13.1% to was charged with promoting Latvian industry, the company had been the fastest-growing of the C2.24 billion, while the firm’s operating mar- Grindeks accused the confederation’s presi- top 15 pharmaceutical companies worldwide, gin improved from 17.1% to 17.6%. dent Vitalijs Gavrilovs of “essentially breach- and had expanded faster than the pharmaceu- Boehringer Ingelheim pointed out that its ing business ethics” by selling his 11.3% stake tical market for the tenth year in a row. good performance in 2009 had been reflected – 1.08 million shares – to Pharmstandard. Favourable currency effects added C330 mil- in its net cash flow, which had increased by Grindeks generated sales of LVL53.6 mil- lion, or 3%, to the company’s sales, Barner not- 20.6% to C2.41 billion. lion (C75.8 million) in 2009 – a fall of 13.7% OTC compared to 2008 – from a range of prescrip- tion drugs, generics and active pharmaceutical Licensing Agreements ingredients, as well as a portfolio of OTC brands. The company’s OTC range includes analgesic, HemCon signs Japanese agreement cough and cold, and gastrointestinal brands, as well as a line of ointments, tonics and nat- oundcare specialist HemCon Medical KytoStat Bandage. The latter product, the firm ural health products. W Technologies has signed up Zeria Phar- said, was “30-times more effective than other Almost all of Grindeks’ sales – 96% – were maceuticals to market, distribute and sell its en- OTC blood-stopping technology solutions”. achieved through exports to more than 40 coun- tire range of products in Japan. Zeria already offered a range of prescrip- tries. The company’s main export markets are The US-based company said the agreement tion and consumer healthcare brands in Japan, the Baltic States, Japan, Russia and other Com- gave it the opportunity to break into the Asian HemCon noted, and would establish a new divi- monwealth of Independent States (CIS) coun- market, which had not been a focus for Hem- sion to manage the HemCon product line. tries,and the US. Con until now. The Japanese firm held a strong position Grindeks said it was aiming to lift sales to Under the terms of the deal, Japan’s Zeria in the gastroenterology field, HemCon added, LVL70 million in 2010 by building its position has the right to launch HemCon’s full range of and also marketed dermatology and cardiovas- in its existing markets, entering new territories products, including its OTC nasal plugs, which cular brands. and increasing its range of generic products. use m.doc technology to stop bleeding, and its OTC OTC

30 April 2010 OTC bulletin 7 OTC30-04-10p8-9.qxd 27/4/10 13:06 Page 2

OTC COMPANY NEWS

NovartisFirst-Quarter Results OTC grows ahead of market

orldwide OTC sales by Novartis Con- Region First-quarter sales Change 2009/2010 (%) Wsumer Health grew ahead of the market (US$ millions) US$ Local currencies in the first quarter,according to the Swiss com- pany, as it recovered from the challenges posed Europe 668 +14 +5 by the global economic crisis in 2009. US 468 +11 +11 This time last year,the company’s worldwide Asia/Africa/Australasia 219 +13 +3 OTC sales had fallen as growth in some emerg- Canada and Latin America123 +22 +4 ing markets had slowed and demand for brand- Novartis Consumer Health* 1,478 +13 +7 ed OTC products in the US had dropped (OTC bulletin, 30 April 2009, page 12). * Continuing operations

Novartis said its pain-reliever brands, partic- Figure 2: Breakdown of Novartis Consumer Health’s sales in the first quarter of 2010 (Source – Novartis) ularly Voltaren in Europe and Excedrin in the US,had been key contributors to the first-quar- Gamble’s established omeprazole-based Pri- Sales at Novartis’ Consumer Health division ter rise in its OTC sales. Their performance, losec OTC as well as Merck & Co’s recently increased by 13% – 7% in local currencies – however, had been offset by a weaker cough launched Zegerid OTC, which combines 20mg to US$1.48 billion (C1.11 billion), as turnover and cold season. omeprazole with 1,100mg sodium bicarbonate improved at the division’s Ciba Vision and Ani- Launching the OTC proton-pump inhibitor (OTC bulletin,16 April 2010, page 14). mal Health businesses as well as at its OTC Prevacid 24HR in the US last November (OTC As the first-quarter results were announced, unit (see Figure 1). bulletin,16 November 2009, page 1) had also Novartis revealed that it was seeking a new Novartis noted that all three of its Consumer boosted the OTC business, the company added. worldwide head for its OTC business. The com- Health businesses had achieved faster growth A strong advertising and promotional cam- pany said the current worldwide head, Dirk Van than their respective markets. paign had seen the lansoprazole-based Prevacid de Put – who only took up the role in Septem- Canada and Latin America was the best per- 24HR grab a 30% share of the US OTC proton- ber of last year (OTC bulletin,31 July 2009, forming region for Consumer Health, with sales pump inhibitor market – including branded and page 29) – would step down at the end of Ap- rising by 22% – 4% in local currencies – to private-label products – in the week ending 21 ril to become chief operating officer of McCain US$123 million (see Figure 2). March 2010, Novartis told OTC bulletin. Foods (see page 23). Robust growth – especially in France, Ger- In the weeks that followed, Prevacid 24HR’s George Gunn, worldwide head of Novartis’ many and Spain – led to a 14% rise in Euro- share had remained steady,standing at 29.6% Consumer Health division, would take on the pean turnover to US$668 million. In local cur- for the week ended 28 March 2010 and 29.9% responsibility for the day-to-day running of rency terms, the growth was a more modest 5%. in the week ended 4 April 2010. the OTC business until a replacement had been In the US, strong performances from the Prevacid 24HR competes with Procter & appointed, Novartis said. OTC, Ciba Vision and Animal Health businesses had helped drive up sales by 11% to US$468 First-quarter of 2010 Change million, the company noted. (US$ millions) 2009/2010 (%) Net sales in Consumer Health’s top six em- Net sales 1,478 +13 erging markets had increased by 27% – 11% Gross profit 991 +14 in local currencies – led by double-digit growth Marketing & sales -540 +15 in India, Russia and Turkey. Russian growth Research & development -86 +13 had come despite price controls. General & administration -96 +19 Operating income at the Consumer Health Other income & expenses -5 -17 division increased by 12% to US$264 million (see Figure 3). Consumer Health’s operating Operating income 264 +12 margin fell from 18.0% to 17.9% as a result. Figure 3: Novartis Consumer Health’s continuing operations in the first quarter of 2010 (Source – Novartis) OTC

Division First-quarter salesChange 2009/2010 (%) Operating income Change Operating (US$ millions) US$ Local currencies (US$ millions) 2009/2010 (%) margin (%) Pharmaceuticals 7,291 +13 +7 2,327 +13 31.9 Sandoz 2,001 +16 +9 310 +7 15.5 Consumer Health* 1,478 +13 +7 264 +12 17.9 Vaccines and Diagnostics 1,361 +451 +436 839 –61.6 Corporate –––-229 +32 – Novartis 12,131 +25 +18 3,511 +50 28.9

* Continuing operations

Figure 1: Breakdown of financial performance of Novartis in the first quarter of 2010 (Source – Novartis)

8 OTC bulletin 30 April 2010 OTC30-04-10p8-9.qxd 27/4/10 13:06 Page 3

COMPANY NEWS OTC

Annual Results Economic crisis hits turnover at Krka

rka said sales of its self-medication prod- Bilobil Aktiv, which combines ginkgo biloba Animal health K ucts had declined by a tenth in 2009, as the with ginseng. Terme Krka products 4% 3% global economic crisis hit the spending power Bilobil was the leading ginkgo biloba prod- Self-medication Cosmetics of the public in two of its biggest markets. uct in Romania and Slovenia, and also held lead- products 1% 9% Self-medication sales dropped to C89.6 mil- ing positions in Poland, Russia and the Ukraine, lion over the 12 months, with turnover in Rus- Krka claimed. sia and the Ukraine falling due to the economic Krka’s core Duovit range of vitamin/min- conditions. This had been enough to offset the eral products for adults had seen a successful gains made in the company’s other markets, 2009, the company said, with the new Duovit Krka said, most notably Albania, Bosnia and for Men and Duovit for Women variations sell- Herzegovina, the Czech Republic, Germany, ing well in key markets. Poland, Romania, Slovakia and Slovenia. Meanwhile, the children’s vitamin/mineral As can be seen from Figure 1, two product brand Pikovit had maintained leading market categories – vitamin and mineral brands, and shares in Romania, Russia, the Ukraine and Uz- Prescription pharmaceuticals herbal products – accounted for 60% or C53.8 bekistan, Krka noted. 83% million of the company’s total self-medication Cough and cold products – led by the Sep- Figure 2: Krka’s sales in 2009 – C953 million sales in 2009. tolete sore-throat brand and Herbion cough – allocated by product category (Source – Krka) Krka said that its key herbal brand Bilobil syrup – accounted for another 19% of Krka’s (ginkgo biloba) had been expanded during the self-medication sales, with products for diseas- Krka’s total sales in 2009 (see Figure 2), which year with Bilobil Intense – which has 120mg es of the alimentary tract and metabolism con- edged up by 0.3% to C953 million. Earnings of ginkgo biloba in just two capsules – and tributing 10% and analgesics 7%. before in interest and tax (EBIT) fell back by Self-medication products generated 9% of 0.8% to C235 million. Products for diseases of the OTC alimentary tract and metabolism 10% Analgesics Cough and 7% cold products 19% Others 4%

Herbal products Vitamins and minerals 30% 30%

Figure 1: Krka’s self-medication sales in 2009 – C89.6 million – by product category (Source – Krka) OTC

IN BRIEF ■ HYPERMARCAS has completed its acqui- sition of fellow Brazilian firm Luper Indús- tria Farmacêutica for BRL52.2 million (C22.0 million). Luper markets a range of OTC brands including the Ambroflux and Bequidex cough/ cold products and Cetafrin paracetamol line (OTC bulletin,17 March 2010, page 2).

■ BIOGAIA’s probiotic drops will be avail- able in Indonesia under the BioGaia brand name from 2011, after the Swedish firm reach- ed a distribution agreement with Interbat. OTC

30 April 2010 OTC bulletin 9 OTC30-04-10p10-11.qxd 27/4/10 13:09 Page 2

OTC COMPANY NEWS

Annual Results 36.6 restructures as turnover declines

ifficulties raising capital and a decline in Business Annual salesChange Proportion Dconsumer demand due to the global eco- (RUB millions) 2008/2009 (%) of sales (%) nomic crisis led to a 23.3% drop in retail sales by Russia’s Pharmacy Chain 36.6 in 2009, ac- Retail 15,989 -23.3 75.9 cording to Valeria Solok, chief executive offi- Veropharm 4,395 +2.2 20.9 cer of the management company. Other 682 -24.6 3.2 An overhaul of certain areas of the com- Pharmacy Chain 36.6 21,065 -19.1 100.0 pany had been required, she said, noting that the company had had to restructure its long- Figure 1: Breakdown of Pharmacy Chain 36.6’s sales in 2009 (Source –Pharmacy Chain 36.6) term financial obligations, completely rebuild its relations with suppliers, reduce ‘stock-out’ to RUB4.40 billion (OTC bulletin,16 April company were also cut as it closed underper- levels and become much more efficient. 2009, page 6). forming outlets. As of the 31 December 2009, By the final quarter of the year,she added, Cash-flow problems and a failure to refin- Pharmacy Chain 36.6 was operating 1,019 phar- the changes had slowed the decline in sales. ance the firm’s debt – which stood at RUB7.62 macies in 29 regions of Russia (see Figure 2). Retail sales decreased to RUB16.0 billion billion at the end of 2009 – have plagued Phar- This was down from the 1,127 a year earlier. (C412 million) in 2009 (see Figure 1), account- macy Chain 36.6 in the past year as the rapid- Pharmacy Chain 36.6 noted that the number ing for 75.9% of Pharmacy Chain 36.6’s total ly-expanding business suffered from the eco- of purchases made in its stores had dropped by sales, which fell by 19.1% to RUB21.1 billion. nomic slowdown. The company’s Retail divi- 29.9% to 70.9 million in 2009, but the average The company’s Veropharm manufacturing sion accounted for RUB6.67 billion of the debt, amount spent had risen by 12.5% to RUB236. business generated a further 20.9% of the sales with the remainder held by Veropharm. Earlier this month, the company announced total with the remainder coming from other busi- Accounts payable – particularly by the Re- that it would cut prices of the most popular pro- nesses. Veropharm’s sales increased by 2.2% tail division – grew as the company tried to ducts by an average of 20% in its Moscow stores meet its other financial obligations. This had in an attempt to increase customer traffic (OTC Region Number of Share of led to some stores suffering from “stock outs” bulletin,16 April 2010, page 2). pharmacies sales (%) (OTC bulletin,18 December 2008, page 4). Branded OTC and prescription drugs, as In January,however,Pharmacy Chain 36.6 well as cosmetics and private-label products, Moscow Central 349 47.1 raised RUB2.3 billion through a share placing had been included in the price cuts, a spokes- South Urals 217 16.8 to help pay the debt and increase working cap- person for Pharmacy Chain 36.6 told OTC bul- South 163 12.8 ital (OTC bulletin,20 January 2010, page 8). letin,noting that the scheme might be rolled Volga128 9.4 A month later,Russian pharmaceutical whole- out into other regions in the future. North Urals 86 6.6 saler SIA International acquired a 25% stake To help increase traffic further and boost Siberia 52 4.2 in the business for an undisclosed sum (OTC profitability,the company would also build its bulletin,10 February 2010, page 2). range of private-label products, Solok noted. North West 24 3.1 A spokesperson for Pharmacy Chain 36.6 In 2009, sales of private-label products had Total 1,019 100.0 declined to comment on media reports that the risen by 29.5% to RUB1.13 billion, Pharmacy deal had been struck to settle the company’s Chain 36.6 said, accounting for 7.1% of Retail Figure 2: Number of pharmacies operated by Pharmacy Chain 36.6 as of 31 December 2009, broken down by debts with SIA. sales. Its private-label range had grown from region of Russia (Source – Pharmacy Chain 36.6) The number of pharmacies operated by the 698 at the end of 2008 to 821 a year later. OTC

Development Agreements IN BRIEF Oxford Nutrascience signs Chewitab deal ■ CELESIO has raised around C500 million through its first corporate bond placement with xford Nutrascience has signed a develop- ford Nutrascience said, and Surepharm would private and institutional investors in Germany Oment deal with the contract manufacturer now be responsible for demonstrating that man- and selected other countries. The pan-European Surepharm Services to scale up and validate ufacturing processes could be scaled-up. wholesaler and retailer said the placement set manufacturing processes for its Chewitab de- Chewitabs are said to be suitable for con- the group’s finances on an “even more stable livery systems. venience-driven OTC medicines – such as an- and broader footing” and the proceeds would The UK-based company plans to license its algesics, allergy treatments and digestive aids be used primarily to reduce its bank debt. Chewitab technology to OTC healthcare com- – and medicines for the elderly. They produce panies as well as launch its own products bas- a light ‘crunch’ when bitten and then form a ■ STADA ARZNEIMITTEL said it had rais- ed on Chewitab technology including a chew- soft chew that dissolves quickly in the mouth, ed C350 million through a bond placement. able calcium supplement and a chewable multi- allowing them to be taken without water (OTC The German firm said it would use the pro- vitamin supplement. bulletin,26 February 2010, page 8). ceeds for general business purposes. Prototype tablets had performed well, Ox- OTC OTC

10 OTC bulletin 30 April 2010 OTC30-04-10p10-11.qxd 27/4/10 13:09 Page 3

GENERAL NEWS OTC

Regulatory Affairs EMA recommends bufexamac withdrawal

opical medicines containing the active in- concluded that the “benefits of these medicines allergic reaction being under-reported,”main- T gredient bufexamac should be withdrawn do not outweigh their risks for patients in any tained the EMA. in Europe, according to the European Medi- of their indications”. Bufexamac-containing medicines have been cines Agency (EMA). The EMA pointed out the CHMP’s scien- sold in European Union member states since The EMA said last week that bufexamac was tific review had identified a high risk of some- the 1970s. The non-steroidal anti-inflammatory associated with a “high risk” of contact aller- times serious contact allergic reactions with drug (NSAID) is used in topical formulations gies, and there was “very limited” data to sup- bufexamac. “The risk was even higher in pat- to treat dermatological diseases such as eczema port effectiveness of the medicine. ients with pre-disposing conditions such as cer- and dermatitis, as well as proctological condi- Earlier this year,Europe’s Committee for tain forms of eczema, for which bufexamac is tions such as haemorrhoids and anal fissure. Medicinal Products for Human Use (CHMP) frequently prescribed,” the agency said. Marketing authorisations for bufexamac-con- started a safety review of topical medicines con- taining medicines have been issued in Austria, taining bufexamac (OTC bulletin,10 February Similar to disease being treated Bulgaria, the Czech Republic, France, Hung- 2010, page 15). The EMA added that the allergic reactions ary,Italy,Latvia, Lithuania,Luxembourg, Por- The move came soon after Germany’s fed- caused by bufexamac were very similar to the tugal, Romania and Slovakia. The products are eral institute for drugs and medical devices, disease being treated, which might lead to a non-prescription medicines in some countries. BfArM, proposed withdrawing haemorrhoid potential delay in correct diagnosis and treat- It had been known for some time that buf- treatments and dermatological medicines con- ment of patients. examac may trigger contact allergic reactions. taining bufexamac (OTC bulletin,18 Decem- “It is also likely that the difficulty to dif- This has led to restrictions on the use of the ber 2009, page 13). ferentiate between a treatment failure and an medicines in some European Union countries Following its safety review, the CHMP has allergic reaction has led to the cases of contact over the years. OTC

IN BRIEF Patent Challenges ■ TGA – Australia’s Therapeutic Goods Ad- Schwabe patent ruling published ministration – has announced the membership of its new Advisory Committee on Non-pre- he European Patent Office (EPO) has pub- ceeding – herbal extracts providers Alpinamed, scription Medicines (ACNM). Formed in Jan- Tlished its reasons for revoking Dr Willmar Finzelberg and Frutarom, as well as the Afri- uary 2010, the ACNM supersedes the Medi- Schwabe’s patent, EP1,429,795, which cov- can Centre for Biosafety. Their grounds of cines Evaluation Committee, and will advise ers a method for deriving extracts from pelar- opposition included a lack of novelty,lack of and make recommendations to the TGA regard- gonium plants. inventive step and patentability,as well as in- ing the entry of non-prescription medicines on Following oral opposition hearings in Jan- sufficient disclosure. the Australian Register of Therapeutic Goods. uary of this year,the EPO announced that it The EPO decided that the patent did not would revoke the German company’s ‘795 pat- represent an inventive step, although Schwabe ■ MELDEX INTERNATIONAL has signed ent, which is entitled ‘Method for producing said it intended to appeal. In particular,the up MJT Holdings/Majeton to sell and dis- extracts of Pelargonium sidoides and/or Pelar- EPO found, a two-stage maceration process tribute its Menoflavon range of products in gonium reniforme’(OTC bulletin,10 Febru- was not inventive,because a person skilled in Singapore. The deal may be extended to other ary 2010, page 17). the art would have known how to follow this countries in South-East Asia. Four parties had brought the opposition pro- route to improve yields. OTC OTC

30 April 2010 OTC bulletin 11 OTC30-04-10p12-13.qxd 27/4/10 13:10 Page 2

OTC GENERAL NEWS

Switches Retailing Zegerid OTC may Germany’s BAH fears the face store brands rise of mail-order pharmacy ■ Continued from front page promotion of the Zegerid OTC brand”. According to the US Food and Drug Ad- he growing importance of mail-order phar- The BAH’s reservations about mail-order ministration’s (FDA’s) Orange Book, Zegerid Tmacies in Germany threatens to trivialise pharmacies appear to be supported by the find- OTC’s only protection from generics is the the status of non-prescription medicines in con- ings of a recent study conducted by German patents covered by the court case. It has no sumers’ minds, according to the country’s med- consumer watchdog Stiftung Warentest. switch marketing exclusivity. icines manufacturers’ association, the BAH. The study compared levels of service, ad- The Delaware court found that the five pat- Noting that self-medication sales of non-pre- vice and price at 50 pharmacies – 27 commu- ents at issue – all of which expire on 16 July scription medicines and unlicensed healthcare nity pharmacies and 23 mail-order pharmacies. 2016 – were obvious in light of prior art. That products through mail-order pharmacies had ris- On the whole, community pharmacies fared sig- prior art included US patent 5,840,737,which en by 32% to just over C600 million at retail sell- nificantly better than mail-order pharmacies. covered “a method for treating gastric acid dis- ing prices during 2009 (OTC bulletin,16 Ap- None of the seven pharmacies considered orders” with an aqueous solution or suspension ril 2010, page 8), the BAH said the mail-order to be “good” were mail-order operations, but of omeprazole and sodium bicarbonate. channel now accounted for around one in 10 eight of the 11 “deficient” businesses were. “The prior art at the time of the filing of the self-medication purchases. Celesio’s DocMorris pointed out that it had provisional application includes buffered, non- The BAHnoted its members in the non-pre- ranked seventh among the 23 mail-order phar- enteric-coated solutions or suspensions con- scription sector viewed this development with macies, and one of its franchise stores in Berlin taining omeprazole and sodium bicarbonate,” concern. “Selling non-prescription medicines had come third among the community outlets. the court stated, highlighting two articles pub- through mail-order tends to trivialise them and Last year,the DocMorris mail-order oper- lished in gastrointestinal journals in 1985. pushes them closer towards normal consumer ation reported double-digit turnover growth to Noting that the articles referred to aqueous goods,”the association maintained. “It is thus more than C250 million. The brand’s first tele- solutions rather than the solid formulations logical to fear that consumers will use them in vision advertising campaign had taken its cus- covered by the patents that Santarus licensed an indiscriminate manner.” tomer base above 1.3 million people and had from the University of Missouri, the court said However, the BAH welcomed the pledge achieved brand recognition in Germany of 60%, the distinction did not render the articles irrel- contained in the pharmaceuticals action plan the retailer said. evant to considering obviousness. A skilled per- recently unveiled by Germany’s ruling coali- However, parent group Celesio blamed the son would be well aware of how to convert liq- tion to ban ‘pick-up points’. These are kiosks advertising campaign for the DocMorris mail- uids into solid-dosage forms, it stated. within drugstores at which consumers can col- order operation making a C3.6 million loss in While the two articles – which taught that lect prescription and non-prescription medicines earnings before interest, tax, depreciation and a sodium bicarbonate buffer could be used as ordered through a mail-order pharmacy. amortisation (EBITDA) loss in 2009. an alternative to an enteric coating to protect OTC omeprazole from degrading in the stomach – were enough to render the five patents obvi- Market Research ous, the court said two prior-art US patents further supported that finding. Global pharma market to grow 5%-8% Furthermore, the antacid properties of so- dium bicarbonate had been well-known for lobal pharmaceutical sales will pass US$1 sion of demand in the pharmerging markets in- many years, the court added, citing Alka-Sel- Gtrillion (C0.74 trillion) at manufacturers’ cluding Egypt, Brazil and Poland.” tzer as an example. “The idea of combining an selling prices by 2014, according to a new re- “Net growth over the next five years is ex- acid-secretion inhibitor with an antacid was port from market researcher IMS Health. pected to be strong,”adds Aitken, “even as the not new at the time of invention,”it asserted, Over the next five years, forecasts the report industry faces the peak years of patent expiries highlighting a similar finding by a New York entitled IMS Market Prognosis, a compound for innovative drugs introduced 10-15 years district court in Perrigo’s 2007 victory over annual growth rate of 5%-8% will add sales ago and subsequent entry of lower-cost generic McNeil regarding Pepcid Complete. of nearly US$300 billion to a global pharma- alternatives.” OTC ceutical market worth US$837 billion in 2009. IMS Market Prognosis says the US will re- Strong overall growth in the world’s emerg- main the world’s largest pharmaceutical mar- ing markets, says the report, will be partly off- ket, with growth of 3%-6% annually pushing IN BRIEF set by the impact of leading products losing sales up to US$360-US$390 billion in 2014. ■ FDA – the US Food and Drug Administra- patent protection in developed markets. Global pharmaceutical sales in 2010 are ex- tion – has announced draft guidance that would “In developed markets with publicly-fund- pected to increase by 4%-6%, compared with expand transparency and disclosure when the ed healthcare plans, pressure by payers to curb 7% in 2009 and 5% in 2008. agency grants a conflict of interest waiver to drug spending growth will only intensify,” says The IMS Market Prognosis report includes permit an individual’s participation at an FDA Murray Aitken, senior vice-president of health- pharmaceutical sales in both audited and un- advisory committee meeting. care insight at IMS Health. “But that will be audited markets. OTC more than offset by the ongoing,rapid expan- OTC

12 OTC bulletin 30 April 2010 OTC30-04-10p12-13.qxd 27/4/10 13:10 Page 3

GENERAL NEWS OTC

IN BRIEF Switches

■ TONGJITANG CHINESE MEDICINES COMPANY said it had established a special German committee to committee to evaluate a proposal from Han- max Investment and Fosun Industrial that would see the two firms acquire all of its outstanding consider orlistat switch shares. Tongjitang produces a number of “mod- ernised traditional Chinese medicines” for the Chinese market, including an OTC product for witching all 60mg formulations of orlis- Germany recently switched all 20mg pan- osteoporosis sold under the Xianling Gubao S tat to non-prescription status is one of the toprazole medicines for short-term treatment brand. The company also owns a number of points on the agenda for the next meeting of of heartburn and acid reflux to non-prescrip- retail stores in China. Germany’s Expert Committee for Prescription tion status just months after Nycomed had in- on 6 July 2010. troduced Pantozol Control. Supplied as a 20mg ■ ORIOLA-KD has cut its operating profit GlaxoSmithKline Consumer Healthcare’s pantoprazole tablet, Pantozol Control gained forecast for 2010 because of “difficult mar- Alli weight-loss medicine, which is based on non-prescription status for heartburn through- ket conditions in Russia”. The Finnish whole- 60mg orlistat, was granted non-prescription out the European Union in June (OTC bulletin, saler and retailer said it now expected its op- status in all 27 member states of the European 20 January 2010, page 13). erating profit to be lower in 2010 than it had Union, plus Norway,on 21 January 2009 via Provided the expert committee supports the been in 2009. Group net sales were still ex- the centralised procedure (OTC bulletin,29 orlistat switch, the proposal will be forwarded pected to be higher than last year. In the first January 2009, page 1). to Germany’s upper house of parliament, the quarter of 2010, operating profits dropped by The European Commission’s Pharmaceu- Bundesrat, for approval. The switch should come 66% to C4.2 million due to the Russian busi- ticals Unit says the “same medicinal product” into effect early in 2011. ness. The Russian pharmaceutical market had should not, as a general rule, have both pre- Other items on the agenda include an ap- declined by around 10% in Ruble terms, the scription-only and non-prescription status in plication to increase the maximum single dose company noted, while pricing regulation had the same member state of the European Union of nicotine-replacement therapy (NRT) prod- led to “fierce competition”. Group sales rose (OTC bulletin,29 May 2009, page 12). The ucts from 10mg to 15mg. by 11% to C449 million in the first quarter. “same medicinal product” is defined as the same The committee will also be asked to review active substance at the same strength and in the a proposed reverse-switch to prescription-only ■ CEPHALON has completed its SFr662 mil- same pharmaceutical form. status for pancreatin in doses of at least 20,000 lion (C462 million) acquisition of Swiss gener- By switching all 60mg orlistat capsules to units per dosage form. ics player Mepha (OTC bulletin,10 Febru- non-prescription status, Germany would com- Clarifying the rules on selling pseudoeph- ary 2010, page 2). ply with the Pharmaceuticals Unit’s edict. edrine is also on the agenda. OTC OTC

Switches “The pharmacy supply protocol presents numerous opportunities to encourage the man Boehringer rejects bad press for Flomax to see his general practitioner,” noted Boeh- ringer Ingelheim, “and all men will be referred oehringer Ingelheim has rejected sugges- further investigation for conditions such as pros- to the general practitioner within six weeks of B tions by a UK newspaper that switching tate cancer,” said the newspaper,“someone suf- presenting to pharmacy for diagnosis of benign Flomax Relief to non-prescription status could fering from the symptoms of benign prostatic prostatic hyperplasia and to exclude any seri- put lives at risk. hyperplasia will be able to visit a pharmacy.” ous underlying conditions.” The UK recently became the first country A doctor quoted in the newspaper pointed Any additional supply of Flomax Relief in the world to switch the 0.4mg tamsulosin out that a minority of men visiting their phar- would be withheld if the man failed to com- hydrochloride capsules from prescription-only macist may be suffering from a more serious ply with the pharmacist’s advice to see a gen- to pharmacy (POM-P) status for treating benign problem. “There is a risk that they could not eral practitioner,the firm continued, adding prostatic hyperplasia or an enlarged prostate receive treatment as quickly as they may have that further treatment would only be supplied (OTC bulletin,18 December 2009, page 1). if they had gone directly to their general prac- by the pharmacist if a doctor had diagnosed Pharmacists can now sell Flomax Relief to men titioner,” said the doctor. the man with benign prostatic hyperplasia. aged between 45 and 75 years with lower uri- Much later on, the newspaper does briefly Boehringer Ingelheim also pointed out that nary-tract symptoms, such as urinary hesitancy mention that research shows many men suf- pharmacists would encourage men to have an and frequent urination. fering from lower urinary-tract symptoms do annual prostate health review with their gen- not visit their general practitioner anyway,so eral practitioner. Article ran in the Daily Mail pharmacists are providing some healthcare in- Describing pharmacists as “highly trained Earlier this month, however, the Daily Mail tervention for this group of patients. and educated healthcare professionals”, the newspaper claimed that switching Flomax Re- Responding to the Daily Mail article, Boeh- company said they were “well placed to be re- lief could discourage older men from visiting ringer Ingelheim stressed that the pharmacy sponsible for the first-line management of the a doctor with potentially serious consequences. model used when recommending Flomax Re- symptoms of this condition” with the support “Instead of having to visit a general practi- lief was not “instead of having to visit a gen- of a symptoms-check questionnaire. tioner,who may decide his symptoms warrant eral practitioner”. OTC

30 April 2010 OTC bulletin 13 OTC30-04-10p14-15.qxd 28/4/10 06:41 Page 2

OTC MARKETING NEWS

Line Extensions/Marketing Campaigns Reckitt Benckiser revamps E45 Endless Moisture offer

eckitt Benckiser has refreshed its E45 End- Rless Moisture skincare brand in the UK by streamlining the existing range and launching World kickboxing champion Christine Theiss has a body lotion containing gold particles. become a brand ambassador for Novartis Consumer The company is backing the relaunch with Health’s Voltaren analgesics in Germany. In return, Voltaren is now her main sponsor. a £1.5 million (C1.7 million) consumer cam- Theiss – who is also a qualified doctor paign including television and press advertis- – wears Voltaren-branded clothing in the ring and ing. New creatives use a blue ribbon to rep- includes prominent links to the brand website at www.voltaren.de on her official website. resent moisture. A blue ribbon represents moisture in Reckitt She is also supporting promotional events for the Reckitt Benckiser pointed out that the new Benckiser’s new television commercial for its diclofenac-based brand, including the recent press addition – E45 Endless Moisture Radiance – E45 Endless Moisture range launch of Voltaren Spray (40mg/g diclofenac sodium) for treating acute pain and inflammation around was enriched with “radiance boosters”. The tag was “more attractive”to customers. small- to medium-sized joints (OTC bulletin, newcomer should attract customers looking The revamped products have been renamed 10 February 2010, page 21). for a good moisturiser with a cosmetic effect E45 Endless Moisture Daily Care to “reinforce OTC on the skin, the company told OTC bulletin, their daily moisturising role”. adding that it would “broaden and re-empha- Meanwhile, the television commercial is built Line Extensions sise the beauty credentials of E45”. around the new claim:“In a clinical test, 100% E45 Endless Moisture Radiance body lotion of women should improve moisturisation from Spanish firm Cinfa is supplied in a 200ml bottle with a recommend- morning till evening.” ed retail selling price of £4.49. “Endless Moisture, only from E45,”states a offers allergy spray Reckitt Benckiser has also reduced the exist- female voiceover at the start of the commercial, ing E45 Endless Moisture range from six stock- as a woman wearing a towel applies the prod- panish OTC and generics firm Cinfa is tak- keeping units to just two 300ml body lotions in uct to her body while sitting in the bathroom. Singits market-leading Respibien nasal con- lightly fragranced and fragrance-free formula- “Endless vibrancy, as you keep that just gestant brand into the allergy market by launch- tions. The company noted that the £4.49 price moisturised feeling all day long,”continues ing a nasal spray that combines oxymetazoline the voiceover, while the blue ribbon that rep- with chlorphenamine. resents moisture wraps itself around the wo- Respibien Antialérgico is indicated for re- man’s arms and follows her to various loca- lieving allergic rhinitis and nasal congestion. tions including her flower shop. Cinfa says the oxymetazoline in the spray As she sets out for a party in the evening, unblocks the nose while the chlorphenamine the blue ribbon forms “100%” in the air and reduces excess mucus. the voiceover reads the new claim. Furthermore, the firm adds, the spray for- Near the end of the commercial, the voice- mat helps to ensure the product does not leave over states “Endless Moisture from Derma- an unpleasant taste by reaching the mouth. tological E45 – the expert touch for healthy A 15ml bottle has a retail price of C4.40. feeling skin”, and the packs of E45 Endless OTC Moisture Daily Care body lotion appear on the screen. Reckitt Benckiser’s E45 Endless Moisture The commercial ends with a woman placing IN BRIEF skincare range in the UK now comprises the new Radiance variant (pictured left) and the revamped a bottle of E45 Endless Moisture Radiance next ■ HERBALIFE has become the official nut- Daily Care products (pictured right) to the two Daily Care packs. rition adviser to the Pumas football team in OTC Mexico. The US-based direct-selling special- ist said that together with Pumas it would edu- IN BRIEF cate its distributors and consumers about the benefits of exercise and adequate nutrition to ■ BAUSCH & LOMB has launched its Renu look”. Renu Sensitive is positioned as a “gen- promote a healthy and active lifestyle. In addi- Sensitive multi-purpose contact lens solution tle formula for sensitive eyes”, while Renu Fresh tion, the Pumas club has become involved with in Australia, Hong Kong, India, Malaysia and offers “fresh lens comfort” and “removes pro- the Herbalife Family Foundation’s Casa Her- Singapore. The US-based eye health specialist tein daily”. Bausch & Lomb recently repackag- balife programme, which helps provide good said it had also revamped the packaging of Renu ed Renu Fresh in the US in a clear bottle, al- nutrition to disadvantaged children. The pro- Sensitive and Renu Fresh in selected Asian mar- lowing consumers to see how much solution is gramme will now also cover regular exercise. kets, including China, Japan and Korea, to give left (OTC bulletin,31 March 2010, page 13). OTC the brand a “fresher and more contemporary OTC

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MARKETING NEWS OTC

Launches ed retail selling price of £22.47. Users should take two capsules a day for the first 10 days, followed by one capsule a day as a mainte- Mentholatum puts £1m nance dose. One Regenovex patch is priced £2.34, while a 40ml pack of Regenovex fast-acting gel sells behind Regenovex in UK for £10.21. According to Mentholatum, the products are useful for men and women over 40 years he Mentholatum Company is putting £1.0 formula designed to do both of these,”insists of age, active sports players and those who Tmillion (C1.2 million) behind Regenovex the company. prefer a more natural approach. in the UK, as it widens distribution for the range All three Regenovex products contain hya- A double-blind, placebo-controlled clinical of joint-health products. luronic acid which is a component of synovial trial involving Regenovex is due to start in the Regenovex oral capsules, topical gel and fluid and cartilage. Mentholatum notes that as US this year. patch – which up until recently were only avail- people get older their bodies produce less hya- able in Boots’ stores – will be supported by luronic acid and it is of poorer quality. The television advertising, public relations activ- products also contain the green-lipped mus- ity and sampling initiatives over the coming sel extract Bionovex Oil, which has an anti- months. “Because movement should be a plea- inflammatory action. sure,”will be a key message to consumers. Mentholatum points out that the range in- The UK is the first market where Mentho- cludes products for both long- and short-term latum has launched Regenovex,but the prod- relief. The one-a-day capsules – described as ucts will soon be available in other countries “small” and “easy-to-swallow” – are for peo- including the US. ple requiring “daily joint health”, while the Mentholatum is positioning Regenovex in two topical products provide “targeted action Mentholatum’s Regenovex range comprises oral the UK as an “advanced formulation for joint for problem joints”. capsules for “daily joint health”, and two topical health” and higlighting the product’s dual act- The pack of 30 capsules has a recommend- products for “targeted action for problem joints” ion. “This new generation of dual-action prod- ucts contains active ingredients which work to- gether to relieve joint discomfort and help the joint restore and maintain itself,”comments the company. According to the company, existing joint- care offerings either relieve pain and inflam- mation or help restore the joint. None has a OTC

Marketing Campaigns cony, who then turns to a man sitting inside and lowers her top. SSL pushes Durex with floating condom It then floats past a woman standing in a window. She smirks, looks back at a couple floating condom that prompts people to Built around the slogan “Feeling is every- drinking champagne and closes the curtains. A “get it on” is the cheeky advertising con- thing”, the commercial begins with a couple The condom’s final stop is the windscreen cept SSL International has devised to launch kissing on a bed. A condom in its wrapper floats of a police car,leading two policemen sat in- three condoms in the UK. away from their bedside table and then hits the side to look at each other and grin. The company said the commercial – which window of another bedroom, grabbing the at- A female voiceover then states “Feel like highlighted that “it is everyone’s right to have tention of a young couple sat inside studying. never before with the enhanced range of con- a happy, healthy and fulfilling sex life” – was The man then touches the woman’s leg. doms from Durex” as packs of Durex Deluxe, the first television advertising for Durex con- The condom continues on its journey, catch- Durex RealFeel and Durex Fetherlite Ultra ap- doms in the UK for six years. ing the eye of a middle-aged woman on a bal- pear on the screen. “Feeling is everything,”is the sign-off message. SSL International said a similar commer- cial had already been aired in France. The five-week burst of advertising started on 22 April. The commercial appears on ITV1 and Channel 4 each Thursday from 9pm-10pm. SSL recently launched the three condoms in the UK, claiming they were the “thinnest” ever produced by the Durex brand (OTC bul-

“Feeling is everything” is the theme of SSL International’s launch television commercial for its Durex Deluxe, letin,16 April 2010, page 14). Durex RealFeel and Durex Fetherlite Ultra condoms in the UK OTC

30 April 2010 OTC bulletin 15 OTC30-04-10p16-17.qxd 27/4/10 13:13 Page 2

OTC MARKETING NEWS Flomax flows to the top of the rankings

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

oehringer Ingelheim’s humorous launch cies. Their solution is a humorous campaign in B campaign for Flomax Relief is proving a which an animated letter ‘P’ represents annoy- hit with pharmacists, judging by the results of ing pee problems. our Pharmacy viewpoint survey for April. The Boehringer Ingelheim’s initial activity foc- pharmacy-only medicine for benign prostatic used on pharmacy training – including a nation- hyperplasia achieved a clean sweep of wins in al roadshow, distance learning and CPD train- all four sections of the survey. ing – public relations activity,and advertising In December of last year,the UK became in the pharmacy press. The last of these urged the first country in the world to make Flomax pharmacy staff to “Help men take control of a non-prescription medicine for treating benign their annoying pee problems”, and showed a prostatic hyperplasia, or an enlarged prostate, product pack dropping onto the letter ‘P’. (OTC bulletin,18 December 2009, page 1). The Medicines and Healthcare products Reg- One in four voted for Flomax ulatory Agency (MHRA) approved the switch When IMS Consumer Health questioned of 0.4mg tamsulosin hydrochloride capsules pharmacists between 1 April and 21 April 2010 More recently,Boehringer Ingelheim start- from prescription-only to pharmacy (POM-to- using its Intr@PharmQ service, one in four of ed a £5.0 million plus (C5.5 million plus) con- P) status for treating lower urinary-tract symp- them said Flomax Relief was backed by the sumer campaign for Flomax Relief. This is bas- toms in men aged between 45 and 75 years. best current trade-press advertising for an OTC ed around a television commercial that appeals The challenge facing Boehringer Ingelheim medicine or dietary supplement (see Figure 1). to older men with the straightforward message and its advertising agency TBWA\Paling Wal- Flomax Relief attracted over twice as many “Take control of your annoying pee problems” ters is to drive men – a patient group that has votes as GlaxoSmithKline Consumer Health- (OTC bulletin,31 March 2010, page 13). historically been hard to reach – into pharma- care’s NiQuitin brand in second place. The letter ‘P’ represents the symptoms of be- nign prostatic hyperplasia, which include fre- BEST CURRENT REPRESENTATIVE DETAILING quent urination and weak flow. The annoying Rank Brand Company Product type Pharmacists (%) letter P distracts one man from his game of golf by repeatedly shouting “pee”; irritates a second 1Flomax Boehringer Ingelheim Benign prostatic hyperplasia 24 man trapped in a traffic jam by activating his 2NiQuitin GlaxoSmithKline Smoking-cessation aid 7 windscreen washer; and keeps another awake at night by pouring water into a glass. 3Nurofen Reckitt Benckiser Oral/topical analgesic 6 “One in four men over the age of 40 suffers 4Lemsip Reckitt Benckiser Cough/cold remedy 5 from pee problems – ranging from difficulty 5Alli GlaxoSmithKlineWeight-loss medicine 4 getting started to a frequent urge to go, partic- ularly at night-time,”says a voiceover. “Fortu- 6Piriton/Piriteze GlaxoSmithKline Allergy remedy 3 nately,there is now a simple and effective treat- Base: 100 pharmacists who named a brand of OTCmedicine or food supplement ment. New once-a-day Flomax Relief can ease all of these symptoms within one week.” Figure 4: Unprompted response of UK pharmacists between 1 April and 21 April 2010 when they were asked the question: “In your opinion, which OTC medicine/dietary supplement is currently backed by the best A pack of Flomax Relief drops on top of the representative detailing?” (Source – OTC bulletin/IMS’ Intr@PharmQ service) letter P, which is last seen wildly waving its Intr@PharmQ and Pharmacy viewpoint

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

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MARKETING NEWS OTC PHARMACY viewpoint

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

1Flomax Boehringer Ingelheim Benign prostatic hyperplasia 25 2NiQuitin GlaxoSmithKline Smoking-cessation aid 12 3Dulcobalance Boehringer Ingelheim Laxative 9 4Gaviscon Reckitt Benckiser Indigestion remedy 8 5Nurofen Reckitt Benckiser Oral/topical analgesic 6 6Alli GlaxoSmithKlineWeight-loss medicine 4

An animated letter ‘P’ represents annoying pee 7= Nicorette McNeil Products Smoking-cessation aid 3 problems in Boehringer Ingelheim’s launch Vitabiotics Vitabiotics Food supplement 3 marketing campaign for Flomax Relief in the UK. Wellman Vitabiotics Food supplement 3 Trade initiatives include pharmacy-press advertising (pictured above), while the consumer campaign is Base: 100 pharmacists who named a brand of OTCmedicine or food supplement based around a television commercial (pictured left) Figure 1: Unprompted response of UK pharmacists between 1 April and 21 April 2010 when they were asked arms and legs around in an attempt to escape. the question: “In your opinion, what is the best current trade-press advertisement for an OTC medicine/dietary “Ask your pharmacist for Flomax Relief and supplement?” (Source – OTC bulletin/IMS’ Intr@PharmQ service) take control of your annoying pee problems,” BEST CURRENT TELEVISION ADVERTISING is the sign-off message at the end of the 30-sec- ond commercial. Rank Brand Company Product type Pharmacists (%) Two versions of the television commercial 1Flomax Boehringer Ingelheim Benign prostatic hyperplasia 24 – the full 30-second execution and a cut-down 10-second spot – are running for three months 2Nurofen Reckitt Benckiser Oral/topical analgesic 12 now and again in September and October. 3Gaviscon Reckitt Benckiser Indigestion remedy 9 As can be seen from Figure 2, nearly one in four pharmacists surveyed thought Flomax 4Alli GlaxoSmithKlineWeight-loss medicine 7 Relief was backed by the best current televi- 5= Canesten Bayer Consumer Care Antifungal 4 sion advertising. NiQuitin GlaxoSmithKline Smoking-cessation aid 4 In addition to television advertising, Flo- OptrexReckitt Benckiser Eyecare 4 max Relief will benefit from radio spots as 8Bio-Oil Keyline Brands Skincare 3 well as press advertising in national newspa- pers and other relevant publications such as Base: 100 pharmacists who named a brand of OTCmedicine or food supplement Saga Magazine. Boehringer Ingelheim is also planning a washroom-poster campaign in mot- Figure 2: Unprompted response of UK pharmacists between 1 April and 21 April 2010 when they were asked the question: “In your opinion, what is the best current television consumer advertisement for an OTC orway service stations. medicine/dietary supplement?” (Source – OTC bulletin/IMS’ Intr@PharmQ service) The brand’s online presence includes a web- site at www.flomaxrelief.co.uk, as well as ad- BEST CURRENT PHARMACY-SUPPORT PACKAGE vertising on the NetDoctor and 50connect sites. Rank Brand Company Product type Pharmacists (%) Flomax Relief also tops the rankings for best current pharmacy-support package (see 1Flomax Boehringer Ingelheim Benign prostatic hyperplasia 27 Figure 3) and best current representative de- 2Nurofen Reckitt Benckiser Oral/topical analgesic 9 tailing (see Figure 4). Reckitt Benckiser’s new advertising for its 3Alli GlaxoSmithKlineWeight-loss medicine 8 Nurofen pain relievers – which was created by 4NiQuitin GlaxoSmithKline Smoking-cessation aid 6 the agency Mother and depicts the brand as a superhero called Nuro (OTC bulletin,10 Feb- 5= Canesten Bayer Consumer Care Antifungal 3 ruary 2010, page 18) – also did well in the Ap- Covonia Thornton & Ross Cough/cold remedy 3 ril survey. As can be seen from Figure 2, Nuro- Gaviscon Reckitt Benckiser Indigestion remedy 3 fen came second behind Flomax Relief in the Meltus SSL International Cough/cold remedy 3 television section, after attracting 12% of the Base: 100 pharmacists who named a brand of OTCmedicine or food supplement best-advertising vote. Nurofen also ranked second for best phar- Figure 3: Unprompted response of UK pharmacists between 1 April and 21 April 2010 when they were asked the question: “In your opinion, which OTC medicine/dietary supplement is currently backed by the macy-support package (see Figure 3). best pharmacy-support package (consumer/trade advertising, bonus deals, profit margin, training, etc)?” OTC (Source – OTC bulletin/IMS’ Intr@PharmQ service)

30 April 2010 OTC bulletin 17 OTC30-04-10p18.qxd 28/4/10 06:46 Page 2

OTC EVENTS

MAY rica, including South Africa. 30-31 May 53173 Bonn, Germany. Contact: Management Forum, ■ Pharmaceutical Tel: +49 228 957 45 0. 13-14 May 98-100 Maybury Road, Woking, Regulatory Affairs Fax: +49 228 957 45 90. ■ Changing Channels in Surrey GU21 5JL, UK. in the Middle East E-mail: [email protected]. the OTC Environment Tel: +44 1483 730071. Dubai, United Arab Emirates Website: www.bah-bonn.de. Fax: +44 1483 730008. Bethesda, Maryland, US Bahrain, Egypt, Iran, Iraq, Jordan, 24 June This two-day regulatory and sci- E-mail: registrations@management- Kuwait, Libya, Palestine, Qatar, forum.co.uk. ■ Pharmaceutical entific conference is organised by Saudi Arabia and other countries Quality of Herbals the US Consumer Healthcare Pro- Website: www.management- in the Middle East will be discus- Bonn, Germany ducts Association (CHPA). forum.co.uk. sed at this two-day meeting. A one-day meeting organised by Contact:CHPA, 900 19th Street, NW, Contact: Management Forum, Germany’s medicines manufac- Suite 700, Washington DC 20006, USA. 18-20 May 98-100 Maybury Road, Woking, turers’ association, the BAH, and Tel: +1 202 429 3545. ■ Vitafoods Surrey GU21 5JL, UK. conducted in German. Speakers Fax: +1 202 223 6835. Geneva, Switzerland Tel: +44 1483 730071. will include Klaus Reh from Ger- E-mail: [email protected]. This three-day global exhibition Fax: +44 1483 730008. many’s federal institute for drugs Website: www.chpa-info.org. and conference will focus on nut- E-mail: registrations@management- and medical devices, BfArM. raceutical, cosmeceutical, func- forum.co.uk. Contact:BAH, Ubierstrasse 71-73, 16 & 17-19 May tional food and functional drink Website: www.management- 53173 Bonn, Germany. ■ 2nd DIA China products. forum.co.uk. Annual Meeting Contact: Vitafoods Conference 2010, Tel: +49 228 957 45 0. Beijing, China Data House,Curriers Close,Tile Hill, JUNE Fax: +49 228 957 45 90. ‘Priming China for drug innova- Coventry CV4 8AW, UK. E-mail: [email protected]. tion and development: from strat- Tel: +44 845 218 7266. 13-17 June Website: www.bah-bonn.de. egy to execution’ is the theme of E-mail: conferencedepartment@ ■ 46th DIA Annual this three-day meeting organised melville.co.uk. Meeting JULY Website: www.vitafoods.eu.com. by the Drug Information Associ- Washington DC, US 7-8 July ation (DIA). The meeting will be With more than 350 sessions, the 19-21 May ■ Marketing Authorisation accompanied by three pre-confer- 46th Annual Meeting of the Drug in the Middle East ence workshops. ■ Russian Pharmaceutical Information Association (DIA) will Frankfurt, Germany Contact: Drug Information Association Forum cover a range of topics including Contact:Forum Institut für (DIA) China Office,11F/1177, Block A, St Petersburg, Russia outsourcing and advertising. Management, Postfach 10 50 60, Gateway Plaza, No.18, XiaGuangLi, This three-day conference focus- Contact: Drug Information 69040 Heidelberg, Germany. North Road East 3rd Ring, ing on the Russian pharmaceuti- Association (DIA), Tel: +49 6221 500 680. Chaoyang District, cal market will include sessions 800 Enterprise Road, Suite 200, Fax: +49 6221 500 555. Beijing 100027, China. on regulation; distribution; legal Horsham, PA 19044-3595, USA. E-mail: h.wolf-klein@forum- Tel: +86 10 5923 1109. issues; healthcare goods and OTC Tel: +1 215 442 6100. institut.de. Fax: +86 10 5923 1090. products; and pricing, reimburse- Fax: +1 215 442 6199. Website: www.forum-institut.com. E-mail: [email protected]. ment and market access. E-mail: [email protected]. Website: www.diahome.org. Contact:Adam Smith Conferences, Website: www.diahome.org. 8-9 July 6th Floor,29 Bressenden Place, ■ Pharmaceutical 18-19 May 14-15 June London SW1E 5DR, UK. Regulatory Affairs in: ■ Regulatory Affairs 8-9 November Tel: +44 20 7017 7444. Russia, Belarus, Ukraine in Africa Fax: +44 20 7017 7447. ■ EuroPLX 43 & 44 and the Former Soviet London, UK E-mail: pharma@adamsmithcon Berlin, Germany A two-day event covering pharm- ferences.com. Barcelona, Spain States aceutical regulatory affairs in Af- Website: www.russianpharma.com. Two-day partnering and licens- London, UK ing forums focusing on OTC med- Contact: Management Forum, 9-11 June icines, nutraceuticals, branded pre- 98-100 Maybury Road, Woking, ■ 46th AESGP Annual Meeting scription drugs and generics. Surrey GU21 5JL, UK. Dubrovnik, Croatia Contact:RauCon, Tel: +44 1483 730071. ‘Connecting with self-care. The future of self-medication in the new Eur- Kurfürstenstrasse 1A, Fax: +44 1483 730008. ope’ will be the theme of the 46th Annual Meeting of the Association of 69234 Dielheim, Germany. E-mail: registrations@management- the European Self-Medication Industry,the AESGP. Tel: +49 6222 9807 0. forum.co.uk. The three-day meeting will include a session entitled ‘How to be suc- Fax: +49 6222 9807 77. Website: www.management- cessful in self-care’, featuring presentations from Emma Walmsley, pre- E-mail: [email protected]. forum.co.uk. Website: www.raucon.com. sident of GlaxoSmithKline Consumer Healthcare for Europe; and Eti- 14 July enne de Laroullière, who is vice-president and head of global business 17 June ■ Marketing Authorisation unit OTC at Nycomed. Medicines and Medical in Japan Speakers at the meeting will also include: Martin Terberger and Basil ■ Mathioudakis of the European Commission; Thomas Lönngren of the Devices Borderline Frankfurt, Germany European Medicines Agency (EMA); Dagmar Roth-Behrendt of the Euro- Bonn, Germany Contact:Forum Institut für pean Parliament; Catherine Geslain-Lanéelle and Vittorio Silano of the A one-day meeting organised by Management, Postfach 10 50 60, European Food Safety Authority (EFSA); and Marisa Matias, who is a Germany’s medicines manufac- 69040 Heidelberg, Germany. member of the European Parliament. turers’ association, the BAH, and Tel: +49 6221 500 680. Contact:AESGP,7Avenue de Tervuren, 1040 Brussels, Belgium. conducted in German. Speakers Fax: +49 6221 500 555. Tel: +32 2 735 51 30. Fax: +32 2 735 52 22. E-mail: [email protected]. will include Guido Middeler and E-mail: h.wolf-klein@forum- Website: www.aesgp.be. Ralf Sibbing of Diapharm. institut.de. Contact:BAH, Ubierstrasse 71-73, Website: www.forum-institut.com.

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INDUSTRY VIEWPOINT OTC

hurdles”. All stakeholders must work together Centralised route requires to make it the default pathway for non-pre- scription medicines in the same way that it has become the default pathway for prescrip- passion and perseverance tion drugs, he insists. Scheske believes the centralised procedure is “absolutely critically important to the OTC Changes in the day-to-day practice of regulatory agencies industry”. “If we talk about competitiveness, – both at the European and national level – are top of the wishlist for then we have to talk about European business and we have to talk about European brands,” Manfred Scheske, former president of GlaxoSmithKline Consumer he says. “If we want more pan-European brands Healthcare Europe. Deborah Wilkes reports. in the self-medication industry,then the cen- tralised procedure is the pathway to get there.” f you want to switch a medicine to non- One problem area for the non-prescription prescription status using Europe’s central- industry,according to Scheske, is access to the ised procedure, remarks Manfred Scheske, centralised procedure. “Eligibility is still very Iyou need “a lot of passion backed up by a narrowly defined,”he remarks, noting that “only lot of hard work”. a few candidates are let through the door”. Scheske – who up until recently was pres- Non-prescription medicines have two pos- ident of GlaxoSmithKline Consumer Health- sible entry points to the centralised procedure. care Europe (OTC bulletin,16 April 2010, page The first is automatic entry for switching cen- 1) – points out that the centralised procedure is trally-authorised prescription medicines, which “no easy walk in the park” for an applicant. “It was the route taken by Alli and Viagra. The brings together the wide variations in European second – taken by pantoprazole – is non-auto- understanding of non-prescription medicines matic entry for medicines that have not been in one decision-making round,”he says, add- authorised through the centralised procedure. ing that “the result tends towards the lowest In January of this year,Patrick Le Courtois common denominator”. – head of the European Medicines Agency’s “Even when all the participants have a con- Manfred Scheske, former president of (EMA’s) human medicines development and structive approach,”he continues, “the proce- GlaxoSmithKline Consumer Healthcare Europe, evaluation unit – said that there had been 11 says self-care and self-medication will enter territory dure still demands a lot of perseverance from that was unthinkable in the past requests for eligibility through the second point, the applicant.” of which only five had been accepted (OTC Efficacy is not typically the problem when (C115 million) in Europe during the rest of 2009. bulletin,10 February 2010, page 24). switching medicines to non-prescription status, GlaxoSmithKline’s chief executive officer An- A second important issue raised by Scheske notes Scheske, but it is essential for applicants drew Witty highlighted that Alli was the third is that decision-makers have a limited under- to have a “complex understanding” of safety best-selling OTC brand in Europe during 2009 standing of issues relating specifically to non- management within the non-prescription set- (OTC bulletin,10 February 2010, page 1). prescription medicines. “Before the approval ting. “Any concerns about safety will make the Only one other medicine – Nycomed’s 20mg of Alli, the CHMP had only ever had to make switch a no-go area,”he warns. pantoprazole formulation for frequent heart- decisions about complex and sophisticated new Scheske advises applicants to ensure they burn – has managed to gain non-prescription prescription-only drugs,”says Scheske. “Com- supply Europe’s Committee for Medicinal Pro- status through the centralised procedure (OTC mittee members had little experience of OTC ducts for Human Use (CHMP) with the right bulletin,27 February 2009, page 1). labelling, pharmacy distribution and commu- quantity and quality of data. “A negative vote However, two applications involving non- nicating with consumers.” by the CHMP is very,very difficult to over- prescription medicines have been withdrawn. come,”he comments. The first was announced in late 2008, when Pfi- Agencies need more OTC expertise Scheske stresses that the CHMP is “data- zer pulled the plug on its application to switch According to Scheske, the time has come to driven”. “Applicants must generate data and the erectile dysfunction drug Viagra (sildenafil consider how the necessary non-prescription use data to make their case,”he advises. “If citrate) from prescription to non-prescription expertise could be incorporated into the EMA safety issues cannot be addressed persuasively status (OTC bulletin,28 November 2008, page and its procedures. The Food and Drug Admin- with the support of data, then the switch appli- 1). The second came at the start of this year, istration (FDA) in the US, for instance, has an cation will not succeed.” when Wyeth Consumer Healthcare – now part Office of Nonprescription Drug Products that In January of last year,GlaxoSmithKline’s of Pfizer – decided not to pursue its applica- plays an important role, he says, and some reg- Alli became the first non-prescription medi- tion to licence a new combination containing ulatory agencies in Europe have introduced cine to be licensed through the centralised pro- the existing non-prescription medicines ibupro- either OTC offices or OTC champions. cedure (OTC bulletin,29 January 2009, page fen and diphenhydramine hydrochloride (OTC A third issue raised by Scheske is the lack 1). The company rapidly introduced the weight- bulletin,10 February 2010, page 1). of a “commonly-defined role across Europe for loss medicine containing 60mg orlistat in virtu- Scheske observes that the door to Europe’s pharmacists in self-medication”. ally all 27 member states of the European Union centralised procedure is “open” to non-prescrip- Speaking in January,the EMA’s Le Cour- (OTC bulletin,30 April 2009, page 22). tion medicines, but it is “not yet wide open”. tois acknowledged that this had been “a main Following the consumer launch in April, He describes the centralised procedure as a issue for the small number of products that Alli recorded sales in excess of £100 million “high maintenance route” with some “severe have been looked at by the CHMP”. “The role

30 April 2010 OTC bulletin 19 OTC30-04-10p19-20.qxd 27/4/10 13:17 Page 4

OTC INDUSTRY VIEWPOINT

of the pharmacist has been a breaking point in er self-care and self-medication. In the UK, for dent pharmacies rather than chains, and the clas- one of the procedures,”he remarked. instance, it exists at the highest levels of both sical community pharmacies are present in al- “There is little harmonisation at the Euro- the Department of Health and the Medicines most every European country,” he says. “The pean Union level in terms of the role of the and Healthcare products Regulatory Agency pharmacy infrastructure is there to be grabbed pharmacist,”Le Courtois observed, adding that (MHRA). “A lot of effort is made in the UK to and utilised by industry and governments.” “the practice is different, the culture is differ- get things moving and challenge the status quo,” Commenting on the response of pharmacists ent, the perceptions are different, and the health- he observes. in Europe to Alli, Scheske says it has been “pos- care systems are organised differently”. Consumer healthcare will have to play an itive with very,very few exceptions”. As well as having to negotiate hurdles with- increasingly important role in all countries in Scheske points out that the future of self- in the centralised procedure, GlaxoSmithKline’s future, maintains Scheske. “The ageing popu- medication in Europe depends on the “ability Alli faced barriers at the national level. lation means the worst is still to come in terms of all stakeholders to see and accept the role The company’s launch campaign for Alli of rising healthcare costs,”he says. “Neither the that self-care can play in European healthcare”. achieved a high level of consistency in con- infrastructure nor the budgets of healthcare sys- “If self-care and self-medication is to reach its sumer advertising and pharmacy communica- tems will be able to cope with the surge in de- full potential in Europe, then pharmacists must tions throughout Europe. However, some nat- mand unless changes are made.” evolve into trusted and trustworthy first-line ionally-imposed restrictions did cause prob- According to Scheske, the OTC industry healthcare professionals,”he states. “Further- lems for the company. needs to engage at a strategic level with gov- more, consumers will need help to understand In Italy,for instance, Alli was placed in the ernments and regulatory agencies around Eur- and manage their health conditions, and prod- country’s controversial category of non-adver- ope. “It is not just about the next analgesic or uct labelling will need to enable consumers to tisable, non-prescription medicines. This stop- the next haemorrhoid treatment,”he states. “It choose the right product and to use that prod- ped GlaxoSmithKline advertising Alli to con- is about extending the boundaries of self-med- uct correctly.” sumers (OTC bulletin,19 June 2009, page 1). ication beyond the treatment of minor ailments He urges regulators to accept “unreserved- Italy’s move came despite the fact that there to encompass management of certain chronic ly”the need for self-medication products to be is no legal basis for a ban on consumer adver- conditions.” supported by consumer marketing campaigns. tising of non-prescription medicines that are To have a meaningful impact on the infras- “OTC companies cannot manage safety,sup- not reimbursable. tructure and budgets of healthcare systems, re- port correct selection of products, elevate the A European Court of Justice (ECJ) ruling in marks Scheske,self-care and self-medication role of pharmacists and drive commercial suc- 2007 clearly stated that member states could will have to enter territory that was unthinkable cess without the ability to communicate dir- not add to Europe’s advertising directive (OTC in the past. This means that both industry and ectly with consumers,”he stresses. bulletin,16 November 2007, page 1). Member regulators, he continues, will need to “redefine states could ban consumer advertising for re- how safety can be managed in the non-prescrip- Industry needs incentives imbursable medicines, said the ECJ, because tion setting”. Scheske also calls for the issue of incen- they were expressly permitted to do so by the Scheske points out that the trend towards tives for industry to be addressed. European directive. But the same was not true for non- greater self-care and self-medication will cre- legislation allows innovative switches to ob- reimbursable medicines. ate a bigger role for pharmacists in consumer tain a one-year period of data exclusivity,but In France, meanwhile, GlaxoSmithKline was healthcare. Noting that “pharmacists hold the this is proving very difficult to get in practice not allowed to run television advertising for Alli key to the success of the next big switches in and neither of the two centralised switches have for a year,but the company could use posters Europe”, he stresses that individual pharma- been successful. In any case, industry would and press advertisements to reach consumers. cists and trade associations need to pave the prefer three years rather than one. Scheske maintains there is an urgent need way for change. “Most European switches, including those for change within regulatory agencies, both at He emphasises that “European pharmacists before the centralised procedure became avail- the national and the European level. “When it must play a vital and pivotal role in driving this able, have not broken even or paid back reg- comes to day-to-day regulatory practice, some shift”. “The role of pharmacists has to a cer- ulatory and launch expenses,”he insists, ask- agencies do not reflect the important role of tain extent diminished in recent decades, and ing: “Why would anybody invest millions when self-medication within healthcare systems,”he they have turned into dispensers of high-mar- there is an almost absolute certainty that the in- says, adding that the problem is particularly ap- gin drugs,”he notes. “But this is set to change, vestment will never be recouped?” parent in southern Europe. and pharmacists will once again be first-line Set against this background, Scheske urges “Although non-prescription medicines ac- healthcare professionals, providing consumers governments and regulators to “take these com- count for half of the packs of medicines sold with advice on minor ailments and manageable mercial risks into consideration, and start dis- in most developed countries,”adds Scheske, chronic conditions like doctors do today.” cussing ways of providing incentives to bal- “some regulatory staff classify non-prescrip- According to Scheske, the Pharmaceutical ance the risks”. tion medicines somewhere between a neces- Group of the European Union (PGEU) and nat- “The centralised procedure is a long and sary and an unnecessary evil, based on the as- ional pharmacy associations generally under- winding road, and is an expensive option as sumption that the control of the doctor is the stand that the role of pharmacists has to change. well,”remarks Scheske. “It absorbs huge re- only meaningful way to protect consumers.” “Pharmacists accept that they will have to play sources and not every stakeholder – particu- “Such attitudes are based on the need to a wider role, and that they will have to become larly small- and mid-sized entities – can afford manage safety,” acknowledges Scheske,“but more involved in consultations and in services the investment.” they also include an element of protectionism beyond distribution,”he says. for doctors and their role in society.” There is more consistency in pharmacy care ■ Manfred Scheske can be contacted by e-mail on Scheske points out that the political will al- across Europe,he says, than would appear at [email protected]. ready exists in some countries to promote great- first glance. “Most countries still have indepen- OTC

20 OTC bulletin 30 April 2010 OTC30-04-10p21.qxd 27/4/10 13:19 Page 3

PEOPLE OTC BayerManufacturers places Reinhardt in charge of HealthCare

ayer has recruited Jörg Reinhardt – for- Jörg Reinhardt Bmer chief operating officer of Novartis – to lead its HealthCare division with effect from 15 August. Arthur Higgins – the current chief execu- tive officer of Bayer HealthCare – will move on from the company at the end of April. Bay- er announced in September of last year that Hig- gins had decided to “leave the company during the first half of 2010 for personal reasons”. From 1 May until 15 August, the Health- Care division will be overseen by Marijn Dek- kers,who is set to replace Werner Wenning Arthur Higgins as chief executive officer of the overall Bay- er group later this year. In January,Novartis said its chairman and chief executive officer Daniel Vasella was hand- ing over his role as chief executive officer to Joe Jimenez with effect from 1 February 2010 (OTC bulletin,10 February 2010, page 27). The Swiss group noted Reinhardt – who had been up against Jimenez for the position of chief executive officer – had left the company. Bayer has appointed Reinhardt – who is a 54 year-old German national – as chairman of the Board of Management of Bayer Health- Marijn Dekkers Care and chairman of the Bayer HealthCare Executive Committee from 15 August 2010. “Reinhardt is an acknowledged expert with many years of experience in the healthcare in- dustry,” commented Wenning. “We are convinc- ed of his ability to provide a decisive impetus to our global HealthCare business and further expand our strong competitive positions.” Reinhardt started his career with Sandoz – a predecessor company to Novartis – in 1981. After holding a series of managerial positions in research and development, he was appointed head of corporate development in 1994. Care and Pharmaceuticals businesses – report- After the formation of Novartis in 1996, ed sales up by 3.8% to C16.0 billion in 2009. Reinhardt served as head of preclinical devel- Earnings before interest and tax (EBIT) grew opment and project management before being by 21.0% to C2.64 billion (OTC bulletin,17 appointed global head of development in 1999. March 2010, page 6). At the end of 2005, he was appointed chief Dekkers, 51, will replace Wenning, 62, as executive officer of the Vaccines & Diagnos- the Bayer group’s chief executive officer on 1 tics division in the US. October. He was previously president and chief Reinhardt returned to Switzerland at the end executive officer of the laboratory equipment of 2008 to become chief operating officer of manufacturer Thermo Fisher Scientific. A chem- Novartis, and a member of the company’s Ex- ist, Dekkers has worked for a number of com- ecutive Committee. panies including General Electric, GE Plas- Bayer’s HealthCare division – which houses tics and Allied Signal. the Animal Health, Consumer Care, Diabetes OTC

30 April 2010 OTC bulletin 21 OTC30-04-10p22-23.qxd 27/4/10 13:21 Page 2

OTC PEOPLE

Manufacturers Manufacturers Herbalife appoints Connors leaves Matrixx Peru country head erbalife has appointed Jose Ramón Hern- and joins Prestige Brands Hández Gallego as its new country direc- tor for Peru. restige Brands has recruited its new chief poo brands, as well as a subsequent payment The US-based direct-selling specialist noted Pmarketing officer, Timothy Connors,from of US$1.0 million. that Hernández brought almost three decades fellowUS OTC company Matrixx Initiatives. Prestige noted that the three brands repre- of direct-selling experience to Herbalife. Connors was vice-president of marketing at sented around 2%-3% of its annual sales. He joins from the Brazilian cosmetics com- Matrixx with responsibility for increasing mar- In the firm’s third quarter ended 31 Decem- pany Natura Cosmeticos, where he had been ket share of the Zicam Cold Remedy and in- ber 2009, Prestige reported sales from contin- general manager of its Peruvian operations for troducing the firm’s new products. He joined uing operations 3% lower at US$75.4 million. two years. Before that, he spent more than 20 Matrixx in 2005 as director of national sales. The OTC Healthcare Products division saw years at Avon. Before joining Matrixx, Connors worked for sales drop by 3% to US$46.2 million. Prestige At Herbalife, Hernández reports to the com- a number of other consumer-products compa- noted that an increase in sales of the Chlora- pany’s managing director of its South and Cen- nies, including Benckiser,The Clorox Com- septic, Clear Eyes and Little Remedies brands tral America region, Patricio Cuesta. pany and Nestlé. had been offset by declines for the Allergen The company said Hernández would be re- Matthew Mannelly, Prestige’s president and Block and Murine lines. sponsible for the growth and profitability of chief executive officer,said Connors brought a Sales of Household Products were down by its business in Peru and working with its inde- “terrific combination of consumer and customer 3% to US$27.3 million, and Personal Care pendent distributors. Herbalife started doing focus” to the team. “His marketing expertise, Products experienced a 10% decline in turn- business in Peru in December 2006. strategic thinking, and entrepreneurial spirit will over to US$2.0 million. OTC serve our iconic brands as we continue to build Prestige’s operating income from continuing them in the marketplace,”he commented. operations was 22% higher at US$23.7 million Connors said he would bring “innovation, in the quarter,thanks in part to lower advertis- IN BRIEF energy and creative marketing” to the comp- ing and promotional expenditure. ■ PROCTER & GAMBLE said Charles Lee any’s brand names. Meanwhile, Matrixx Initiatives posted sales and Ralph Snyderman had left the Board of In October of last year,Prestige divested its down by more than a quarter to US$28.5 mil- Directors after reaching the company’s retire- three shampoo lines to Ultimark Products to fo- lion for its third quarter ended 31 December ment age of 70. Both men had been directors cus on its OTC Healthcare Products and House- 2009 (OTC bulletin,10 February 2010, page 8). for over 15 years. Director Patricia Woertz has hold Products divisions and pay down its debt Just under a year ago, Matrixx withdrew taken Lee’s role as chair of the firm’s Audit (OTC bulletin,16 November 2009, page 8). two of its core products, Zicam Cold Remedy Committee, while director Scott Cook now The company received an upfront payment Nasal Gel and Zicam Cold Remedy Gel Swabs, has Snyderman’s position as chair of the Inno- of US$8.0 million (C6.0 million) for the Prell, after receiving a warning letter from the US vation & Technology Committee. Denorex Dandruff and Zincon Dandruff sham- Food and Drug Administration (FDA). OTC OTC

22 OTC bulletin 30 April 2010 OTC30-04-10p22-23.qxd 27/4/10 13:21 Page 3

PEOPLE OTC

Manufacturers Manufacturers Novartis loses De Alwis resigns as chief OTC unit head of Sigma Pharmaceuticals irk Van de Put is leaving Novartis just Deight months after becoming worldwide he board of the Australian company Sigma following a poor performance in the grocery head of the company’s OTC business unit. TPharmaceuticals has accepted the resigna- channel. In addition to the Herron write-down, A company spokesperson said that Novar- tion of its chief executive officer and managing Sigma cut A$375 million off the A$819 million tis had not yet found a replacement for Van de director, Elmo De Alwis. However, De Alwis goodwill valuation placed on the Arrow busi- Put, who departs at the end of April. George will remain in the post while the board searches ness after the two companies merged in 2005. Gunn,worldwide head of Novartis’ Consum- for a successor. Excluding the goodwill impairment charges er Health division, is taking day-to-day com- De Alwis, 56, has spent 33 years with the of A$424 million, Sigma said its underlying net mand of the business. Australian group, which has interests in OTC profit had dropped by 15.5% to A$67.7 million. Van de Put becomes chief operating officer products, generic pharmaceuticals, pharmacy Sales increased by 4.5% to A$3.22 billion. of McCain Foods with effect from 17 May. retailing and wholesaling. He was appointed At the end of February,Sigma asked for trad- managing director in February 2001 and over- ing in its shares to be suspended ahead of a prof- Joined Novartis eight months ago saw the merger with generics firm Arrow Phar- its warning. He joined Novartis on 1 September 2009 maceuticals in 2005 (OTC bulletin,16 Sept- When the firm eventually revealed its annual from Groupe Danone,where he was executive ember 2005, page 5). results a week late on 31 March, its share price vice-president of Groupe Danone and president Sigma has just reported a net loss of A$389 immediately fell by more than 50%. of its Americas division, as well as a member million (C270 million) during the year ended of the company’s Executive Committee (OTC 31 January 2010, after the company cut good- Rumours of takeover bid bulletin,31 July 2009, page 29). will valuations by A$424 million (OTC bullet- There has been speculation in the financial OTC in,16 April 2010, page 2). press that the private-equity owners of iNova The company said this figure included a re- Pharmaceuticals – Archer Capital and Iron- Retailers duction of A$49.1 million in the goodwill val- bridge Capital – could make a bid for Sigma uation of its Herron range of OTC products Pharmaceuticals. Smith parts from OTC Lloydspharmacy Retail Associations CCA names Duncanson as chairman ichard Smith is stepping down as man- Raging director of Lloydspharmacy in June. urray Duncanson will become chair- Murray The UK’s second-largest pharmacy chain said M man of the UK’s Company Chemists’ Duncanson that Smith’s successor would be announced Association (CCA) in May. in due course. He will take over from Digby Emson,who Smith, who is moving to Integrated Dental is retiring after 12 years in the post (OTC bul- Holdings as chief executive officer,has been letin,26 February 2010, page 22). managing director of Lloydspharmacy for two Duncanson has extensive experience with- years (OTC bulletin,29 February 2008, page in the UK’s National Health Service (NHS), 19). He was previously chief operations and where his most recent job was interim direc- commercial director. tor of organisational development and work- force planning for NHS Medway. He has held Richard Smith a number of other senior positions within the NHS, including the chief executive of Barnet Healthcare NHS Trust, chief executive of Loth- its members in what looks like being a difficult ian Primary Care NHS Trust, and non-execu- few years for healthcare.” tive director of NHS Education Scotland. The CCA represents the interests of leading Commenting on his role at the CCA, Dun- multiple pharmacy groups in the UK. The asso- canson said 2010 was “proving a pivotal year ciation’s full members – Asda Walmart, Boots for community pharmacy and presents a real UK, The Co-operative Pharmacy, Lloydsphar- opportunity for the CCA to build upon the ex- macy, Rowlands Pharmacy, Sainsbury’s, Super- cellent work achieved throughout 2009”. drug Stores, Tesco, and Wm Morrison Super- Rob Darracott, the CCA’s chief executive, markets – between them own more than 6,000 said: “The wide-ranging experience and skills pharmacies in the UK. In addition, Day Lewis set that Duncanson brings to the CCA will be Pharmacy is an associate member. OTC of considerable benefit to the association and OTC

30 April 2010 OTC bulletin 23 OTC Ad 2010:OTC Ad 1_07 5/1/10 14:16 Page 1

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