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16 December 2010

COMPANY NEWS 3 Reckitt Benckiser set to buy Sinclair signs Decapinol 3 partner in US 36.6 resurrects its 4 India’s Paras for INR32.6bn expansion strategy Navamedic secures rights 5 to NYDA in three markets eckitt Benckiser is set to boost its con- GNC quiet on takeover 5 Rsumer healthcare business by acquiring speculation India’s Paras Pharmaceuticals for INR32.6 Mag-Ox buy fails to offset 6 billion (C546 million). OTC sales drop at Hi-Tech The premium price tag represents more than Beiersdorf to cut offering 7 eight-times Paras’ sales of INR4.0 billion in the as it focuses on skincare year to March 2010, and nearly 30-times the company’s operating earnings before interest, GENERAL NEWS 8 tax, depreciation and amortisation (EBITDA) of INR1.1 billion. McNeil recalls Rolaids 8 in Canada and the US The deal comes soon after Reckitt Benck- iser expanded its consumer healthcare business Buying Paras will give Reckitt Benckiser a portfolio of Three pharmacy bodies 9 OTC brands in India including Moov topical analgesics speak with single voice with the purchase of SSL International and its Durex and Scholl brands for £2.54 billion (C3.02 Paras’ personal-care business, meanwhile, ASA gives Lyclear 11 the all-clear in UK billion) (OTC bulletin,30 July 2010, page 1). was led by the Set Wet brand of hair gels and Commenting on the Paras deal, Bart Becht, deodorants for men, the company said. MARKETING NEWS 12 Reckitt Benckiser’s chief executive officer,said The deal will also give Reckitt Benckiser a the growth potential of the business, the cre- new state-of-the-art and Good Manufacturing Clarityn’s fast acting claim 12 ation of a material healthcare business in India’s Practice compliant manufacturing plant in Nor- is stopped in UK by MHRA large and growing healthcare market, and the thern India, which employs around 700 people. Happy and healthy kids 13 global synergies available made Paras an “ex- Becht said the Paras deal was another step star in PediaCare spots citing addition” to the company’s portfolio. forward in Reckitt Benckiser’s consumer health- Flucalyptol offers France 15 Reckitt Benckiser pointed out that acquir- care growth strategy. “We believe the Paras ‘free access’ pholcodine ing privately-held Paras would give it a port- business has extremely good growth potential Anadin gets a boost in UK 17 folio of Indian OTC brands with leading mar- when supported by Reckitt Benckiser’s invest- with effervescent ibuprofen ket positions, including India’s number two ment and innovation strength,”he added. Coughing animals promote 18 topical analgesic pain ointment Moov and the Reckitt Benckiser’s Health & Personal Care Buttercup’s benefits in UK number two cold and flu remedy D’Cold. division is the company’s largest, with sales of FEATURES 20 Paras also marketed Krack, India’s leading £1.67 billion in the first nine months of 2010 medicated skin treatment for cracked heels, (OTC bulletin,16 November 2010, page 4). 2010 turns out to 20 Reckitt Benckiser pointed out, along with the It represented 27% of Reckitt Benckiser’s total be an eventful year Itch Guard and Ring Guard antifungal creams. sales for the period of £6.18 billion. Recalls, acquisitions, people on the move, traditional herbal medicines and food claims were hot topics in 2010 Kindler makes abrupt GSK adds muscle REGULARS departure from Pfizer with Maxinutrition Consumer viewpoint 10 – Erectile dysfunction is effrey Kindler has stepped down as chair- laxoSmithKline Consumer Healthcare is the topic of this month’s Jman and chief executive officer of Pfizer, Gpoised to expand its Nutritional Health- European consumer survey and retired from the company with immedi- care business by acquiring Maxinutrition from Events – Our regular listing 19 ate effect. Darwin Private Equity for approximately £162 People – NBTY names Nagel 22 In the wake of Kindler’s abrupt departure, million (C192 million) including the repay- as its new chief executive the US-based pharmaceutical firm has nam- ment of outstanding debt. People – Merck raises Frazier 23 ed Ian Read, 57, head of its global biopharm- Described as “Europe’s number one sports to chief executive officer ■ Continued on page 8 ■ Continued on page 7 Gen 4-COL Ad FOR OTC Promo Flash -Oct 2010.qxd 19/10/10 07:09 Page 1

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COMPANY NEWS OTC

Distribution Agreements Sinclair signs Decapinol partner in US

inclair Pharma has signed up Sunstar Amer- in the Asia-Pacific region, and had acquired Sicas to relaunch its Decapinol mouthwash the rights to the Kelo-cote wound care brand in the US. Sunstar will market Decapinol as an in the UK and Germany. OTC product under its GUM brand name. Sunstar – which already markets Sinclair’s Under the terms of the agreement, said Sin- Aloclair mouth-ulcer gel and mouth rinse in the clair,Sunstar had also taken an option to lic- Americas region under the GUM Canker-X and ense Decapinol in Japan once the product had GUM Rincinol brand names – would return De- been registered, as well as further options cov- capinol to the US market during 2011,Sinclair ering several other countries where the prod- pointed out, and would market the product uct was not currently marketed. through pharmacies and other US retailers to The deal was struck shortly after Sinclair appeal to the “health-conscious consumer”. announced that it had teamed up with biophar- Previously,Decapinol had been available maceutical firm Invida to launch its dermatol- in the US under the Impede brand name. How- ogy and wound care products across 11 markets ever,in November of last year Sinclair said it had mutually agreed to terminate its US distri- bution deal with the Johnson & Johnson sub- OTC bulletin sidiary Orapharma, so that the product could be repositioned for the OTC market (OTC bul- Sinclair’s Decapinol mouthwash will be sold by 16 December 2010 Number 354 letin,30 November 2009, page 2). Sunstar under its GUM brand name in the US Sinclair claimed its “ecological” approach Editor & Publisher: Deborah Wilkes to oral hygiene was in marked contrast to the Invida would market the brands to general Associate Editors: Aidan Fry standard antiseptic mouthwashes that current- practitioners, dermatologists and paediatricians, Mike Rice ly dominated the US$750 million (C566 mil- Sinclair noted, as well as through pharmacies, Business Editor: Matt Stewart lion) mouthwash market in the US. drugstores and other retail outlets. Assistant Editors: Joanne Grew, Jenna Lawrence, In light of this, the company was aiming to The “early emphasis on marketing invest- David Wallace use consumer education to help grow the brand, ment” demonstrated Sinclair’s focus on “sus- Advertising Controller: Debi Minal in much the same way that food manufacturers tainable value creation”, Spooner noted, adding had grown the market for yoghurts that the deal structure would serve as a blue- Marketing Manager: Val Davis by educating consumers about gastro micro flora print for future partnerships in the region. Editorial, Subscription and Advertising maintenance, according to Sinclair’s commer- Sinclair’s dermatology portfolio covers acne, enquiries should be addressed to: OTC bulletin, OTC Publications Ltd, 54 Creynolds Lane, Solihull, cial chief scientific officer Simon Youlton. atopic dermatitis, fungal infections and family West Midlands B90 4ER, UK. Adding Sinclair’s delmopinol-based alter- dermatology,and includes the company’s flag- Tel: +44 1564 777550. Fax: +44 1564 777524. native to antiseptic mouthwashes to Sunstar’s ship Atopiclair dermatitis brand. The company’s E-mail: [email protected]. existing PerioBalance probiotic lozenge, Youl- wound care offering includes the Flammazine Subscriptions ton pointed out, gave Sunstar the platform to and XClair brands. Annual subscriptions to OTC bulletin in Europe are £595.00 for single copies and £345.00 for additional copies to the same ad- move consumers towards a “healthier,natu- Regulatory approvals permitting, launches dress, including delivery. Subscriptions to addresses outside Eur- ral approach to daily oral care”. would begin in the summer of 2011, the com- ope are subject to an additional charge of £30.00 to cover postage. Subscription enquiries in Korea should be directed to Pharma A “slow initial build-up in sales” was an- pany said, noting that it could take up to two Koreana Ltd, 14th Floor,KTB Network Building, 826-14 Yeoksam- ticipated, Sinclair noted, as the marketing mes- years for the products to be introduced across dong, Kangnam-gu, Seoul 135-080, Korea (Tel: +82 2 554 9591; Fax: +82 2 563 8289; E-mail: [email protected]). sage was developed and rolled out. all 11 markets. Advertising Meanwhile, Sinclair has named Invida as On top of the deals in the US and Asia- Advertising rates and data are available on request from the ad- its exclusive distribution partner for its derma- Pacific, Sinclair has also expanded its wound dress above or at www.otc-bulletin.com. About OTC bulletin tology and wound care portfolios in Australia, care portfolio and direct sales presence by ac- OTC bulletin is published 20 times a year by OTC Publications China, Hong Kong, Indonesia, Malaysia, Philip- quiring Cranage Healthcare in the UK for an Limited: twice monthly in February,March, April, May,June, Sep- tember,October and November; and monthly in December,Jan- pines, Singapore, South Korea, Taiwan, Thai- initial payment of £0.40 million (C0.47 million). uary,July and August. A subscription to OTC bulletin includes land and Vietnam. The deal includes the distribution rights to the weekly electronic newsflash, news@OTCbulletin,which is published around 45 times a year. OTC bulletin is printed by the Chris Spooner,Sinclair’s chief executive the Kelo-cote wound care brand in the UK, Warwick Printing Company Limited, Caswell Road, Leamington officer,said the deal was a “landmark” for the which, although sold mainly on prescription, Spa CV31 1QD, UK. company. It validated the company’s “strong is also available via Cranage’s online store. No part of this publication may be copied, reproduced, stored in a retrieval system or transmitted in any form without prior conviction”, he added, that there was a “terrific In addition, the company has acquired the permission from OTCPublications Ltd. opportunity” to take Sinclair’s product portfo- distribution rights to Kelo-cote in Germany ©OTC Publications Ltd. All rights reserved. Company registered in England No 2765878. Registered Office: lio into “leading emerging markets”. from Advanced Bio-Technologies for an initial 54 Creynolds Lane, Solihull, West Midlands B90 4ER, UK. In the medium term, the two companies sum of C0.84 million. Sinclair already holds OTC bulletin® is registered as a trademark in the European were targeting “high volumes and strong prof- the distribution rights to Kelo-cote in France, Community. itability”,Sinclair said, “requiring substantial Italy and Spain. ISSN 1350–1097 www.OTC-bulletin.com marketing investment to build the brands”. OTC

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OTC COMPANY NEWS

Third-Quarter Results 36.6 resurrects its expansion strategy

harmacy Chain 36.6 will resurrect its ex- billion (C83.2 million) (see Figure 2). Region Number of Share of Ppansion plans in 2011, following a period of He added that the Retail business had been pharmacies sales (%) store closures and restructuring, according to lifted by a “gradual recovery” in the consumer chief executive officer Artyom Bektemirov. sector,as well as the expansion of its private- Moscow Central 344 49.7 The Russian retailer had completed its pro- label range and its decision to cut the prices of South Urals 179 13.0 gramme of shutting under-performing stores, its most popular products by an average of 20% South 168 12.0 restructuring its finances and rebuilding rela- in its Moscow stores (OTC bulletin,16 April Volga147 11.7 tions with suppliers, Bektemirov said, and now 2010, page 2). North Urals 83 6.3 had the requisite resources to resume the grad- Siberia 52 4.3 ual expansion of its pharmacy chain. Average spend in stores increased North West 24 3.0 As of 30 September 2010, Pharmacy Chain The size of the average spend in its stores 36.6 was operating 997 stores across Russia had increased by 8.3% to RUB248 in the third Total 997 100.0 (see Figure 1). This was down from 1,026 stores quarter,Pharmacy Chain 36.6 noted, adding a year earlier. that in the Moscow region the average spend Figure 1: Number of pharmacies operated by Pharmacy Chain 36.6 as of 30 September 2010, broken down Three stores had been opened organically had risen by 6.7% to RUB350. by region of Russia (Source – Pharmacy Chain 36.6) during the third quarter,the company stated, Sales of private-label products had grown five stores had been closed, 14 had been re- by 10.5% to RUB300 million during the quar- drugs, and vitamins, minerals and supplements branded, and one had been reformatted. ter,Pharmacy Chain 36.6 said, accounting for making up the remainder. The reduction in store numbers, Bektemirov around a tenth of the company’s Retail sales. Retail sales accounted for 70% of Pharm- pointed out, had been the primary reason be- Parapharmaceuticals made up the bulk of acy Chain 36.6’s total group sales in the third hind the 3.3% decrease in Pharmacy Chain the company’s 932-strong private-label range, quarter,which ended up by 6.3% to RUB4.87 36.6’s third-quarter Retail sales to RUB3.41 Pharmacy Chain 36.6 pointed out, with OTC billion. The company’s Veropharm manufac- turing business generated a further 26% of the Business Third-quarter sales Change Proportion sales total, with the remainder coming from (RUB millions) 2009/2010 (%)of sales (%) other businesses. Veropharm’s sales jumped by 37.8% to RUB1.26 billion in the period. Retail 3,413 -3.3 70 Meanwhile, Pharmacy Chain 36.6 also con- Veropharm 1,261 +37.8 26 firmed its sales and earnings for the opening six Other 204 +18.7 4 months of 2010. Total group sales had slipped Elimination -10 ––back by 14.9% to RUB9.75 billion, the com- pany noted, while earnings before interest, tax, Pharmacy Chain 36.6 4,868 +6.3 100.0 depreciation and amortisation (EBITDA) edged Figure 2: Breakdown of Pharmacy Chain 36.6’s sales in the third quarter of 2010 (Source –Pharmacy Chain 36.6) forward by 3.6% to RUB854 million. OTC

IN BRIEF Annual Results ■ JOHNSON & JOHNSON has launched a Tough market curbs sales at Merz C24.75 per share offer for the 82% stake it does not own in Dutch vaccines company Crucell. erz Pharma Group said that an “aggres- of Merz’ turnover in the 12 months, which The deal, which values Crucell at around C1.8 M sive marketplace” had led to a decline improved by 14.2% to C674 million. The bulk billion, has received the backing of Crucell’s in turnover at its Consumer Care business – in- of Merz’ group sales came from its Pharma- management and supervisory boards. Share- cluding the Tetesept portfolio of OTC products ceuticals business, which posted sales up by holders will vote on the offer at an extraordi- – in the year ended 30 June 2010. 19.4% to C552 million from its portfolio of pre- nary general meeting on 8 February 2011. The privately-held German firm reported scription products and non-prescription derma- Consumer Care sales down by 6.0% to C103 tology brands. ■ GEDEON RICHTER has agreed to invest million in the 12 months. The result marks the RMB18 million (C2.0 million) in setting up a second successive decline in Consumer Care’s Acquired BioForm Medical joint venture in China with its local marketing annual sales, following the 4.0% decrease dur- Earlier in the year,Merz advanced its strat- partner Rxmidas Pharmaceuticals. The com- ing the previous year (OTC bulletin,30 Nov- egy of becoming a “leading player in aesthetic panies will each hold a 50% share in Gedeon ember 2009, page 8). medicine – a fast-growing, multibillion dollar Richter Rxmidas Joint Venture Co,which Merz’ Consumer Care business includes global market” – by acquiring the medical aes- the Hungarian company said would initially the Merz Spezial health and beauty brand, as thetics company BioForm Medical for US$253 be used to register and launch its range of fe- well as the core Tetesept range of licensed and million (C191 million) (OTC bulletin,26 Feb- male healthcare products in the Chinese market. unlicensed healthcare products. ruary 2010, page 3). OTC Consumer Care’s sales accounted for 15% OTC

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COMPANY NEWS OTC

Business Strategy Distribution Agreements Beiersdorf sets Navamedic secures rights Vietnam targets to NYDA in three markets eiersdorf – owner of the Nivea and Euc- Berin skincare brands – has established an avamedic’s Vitaflo Scandinavia sales and independent affiliate business in Vietnam, as the N marketing business has gained the exclu- company seeks to more than double its turn- sive rights to distribute Pohl-Boskamp’s NYDA over in the country by 2015. non-prescription head-lice remedy in Denmark, Beiersdorf Vietnam – which is based in Ho Norway and Sweden. Chi Minh City – would not only enable the firm Olof Milveden, Navamedic’s chief executive to meet the “strong and consistently rising de- officer,said the company was seeing a growth mand” for skincare products in Vietnam, the in demand for head-lice remedies. Milveden not- German firm said, but would also act as a plat- ed that the market for such products across all form for expansion in South-East Asia. three countries was worth SEK18 million (C2.0 million) annually. Growing faster than the market Described by the Norwegian company as a James Wei, the member of Beiersdorf’s ex- “unique” head-lice remedy,NYDA works by ecutive board in charge of Asian operations, suffocating both the lice and eggs. If the pro- insisted that the company’s goal in Vietnam of duct was used correctly,Navamedic pointed out, “continuing to grow significantly faster than then it would get rid of all of the lice with just Pohl-Boskamp’s NYDA head-lice remedy works by the market” would now be easier to reach. one treatment. suffocating both the lice and the eggs “We can now adapt Nivea products even NYDA was a mild product suitable for chil- more closely to the specific needs of Vietnam- dren aged two years and older,added Nava- products in the Benelux countries and Norway. ese consumers,”he added, “and react faster to medic, noting the product was a medical device. Navamedic’s Vitaflo Scandinavia business local market trends.” Navamedic said the deal represented anoth- reported sales down by 1.7% to NKr13.7 mil- “Nivea already holds leading positions in er step in the company’s growth strategy,which lion (C1.7 million) in the third quarter of 2010 numerous product categories, and is the un- had already seen it sign exclusive distribution (OTC bulletin,30 November 2010, page 9). disputed market leader for body care, deodor- agreements to sell the Norwegian firm Smart- The business has a portfolio of over 40 brands ants and men’s care products,”Wei claimed, fish’s medical nutrition products in Denmark, in 10 product categories, including the Gluco- adding: “These market positions are a solid Finland and Sweden, and market the South med glucosamine brand, which it distributes in basis for future growth.” African company Aspen Healthcare’s generic Denmark, Finland, Norway and Sweden. OTC OTC

Mergers & Acquisitions Business Strategy GNC quiet on takeover speculation PepTcell changes eneral Nutrition Centers (GNC) is refusing China – would be formed and would launch its name to SEEK Gto comment on speculation that China’s products by mid 2010. Bright Food is poised to acquire the US-based The tie-up with GNC marked Bright Food’s EEK is the new name of UK-based drug- nutritional supplements retailer. formal entry into the nutritional products arena, S discovery firm PepTcell, which has a port- Rumours are circulating as GNC prepares adding a new sector to its established operations folio of prescription and consumer health pro- for an initial public offering (IPO), which could in fresh and processed foodstuffs. ducts in development. raise up to US$350 million (C265 million) (OTC GNC was acquired by private-equity firm Explaining the change, SEEK’s chief exec- bulletin,15 October 2010, page 2). Apollo management for US$750 million seven utive officer Gregory Stoloff said the company’s Various media outlets have reported that years ago (OTC bulletin,31 October 2003, new identity better reflected its efforts “to seek Bright Food is set to bid between US$2.0 bil- page 3). GNC postponed a planned IPO in 2006 a cure” in a number of major disease areas. lion and US$3.0 billion for GNC, and that the (OTC bulletin,17 November 2006, page 1). SEEK recently appointed Manfred Scheske deal could be agreed before the end of 2010. A The company generated group turnover of – the former European president of Glaxo- number of reports have also claimed that pri- US$1.71 billion in 2009, with an operating pro- SmithKline Consumer Healthcare – as chief vate-equity firm Blackstone could join forces fit of US$181 million. executive officer of its Consumer Health unit with Bright Food for the bid. At the end of the year,the company had (OTC bulletin,15 October 2010, page 1). Earlier in the year,GNC signed a memo- more than 6,900 outlets – over 5,400 of which Scheske has full responsibility for SEEK’s randum of understanding to form a strategic were in the US – and had franchise operations consumer health product portfolio, which in- partnership with Bright Food in China (OTC across a further 47 countries (OTC bulletin, cludes what the company describes as a “first- bulletin,26 February 2010, page 9). At the 31 March 2010, page 7). in-class” cough suppressant. time, GNC said the joint venture – called GNC OTC OTC

16 December 2010 OTC bulletin 5 OTC16-12-10p6-7FIN.qxd 14/12/10 06:38 Page 2

OTC COMPANY NEWS

Nine-Month Results Second-Quarter Results Grindeks sees Mag-Ox buy fails to offset jump in sales OTC sales drop at Hi-Tech

atvia’s Grindeks has reported a 21.7% in- cquiring the Mag-Ox brand of magnesium Mag-Ox joined Hi-Tech’s existing OTC Lcrease in sales to LVL46.9 million (C66.1 Asupplements earlier this year did not pre- brands for diabetics including Diabetic Tussin million) in the opening nine months of 2010. vent turnover at Hi-Tech Pharmacal’s Health for coughs and colds, Diabeti Derm skincare The majority of the firm’s sales – LVL44.5 Care Products division slipping back in the com- creams, Diabeti Sweet sugar substitutes, the million – had been generated through exports pany’s second quarter ended 31 October 2010. Multi-betic multimineral/multivitamin supple- to 51 countries worldwide, Grindeks said. The US-based firm said turnover at its Health ment for diabetics, and Zostrix cream for relief The company offers a portfolio of prescrip- Care Products division had dropped by 7% to of diabetic foot pain. tion medicines, generics, active pharmaceuti- US$3.4 million (C2.6 million) during the three cal ingredients and OTC brands. months, as lower sales of its existing diabetic Still seeking acquisitions Looking ahead, Janis Romanovskis, Grin- product portfolio offset the addition of Mag- Despite the recent acquisition of Mag-Ox, deks’ chairman, said the company would con- Ox, which the company acquired from Blaine Seltzer said the company was still looking to tinue to introduce new products, enter into new Company in March (OTC bulletin,17 March expand its OTC portfolio with “near and long- markets, increase production capacity,and in- 2010, page 3). term acquisition and licensing opportunities”. vest in future development. The acquisition gave Hi-Tech the rights to The Health Care Products division account- Meanwhile, Grindeks said that East Capi- the Mag-Ox, Maginex, Uro-Mag and Corban ed for 7.6% of Hi-Tech’s total sales, which grew tal Asset Management had acquired a 10.18% brands, which generated net sales of US$3.4 by 10% to US$44.9 million for the quarter. stake in the company. million during 2009. Sales by the dominant Generics division, East Capital Asset Management has bought At the time of the deal, David Seltzer,Hi- which increased by 13% to US$36.8 million, into Grindeks just over a month after the Rus- Tech’s president and chief executive officer, accounted for 82.0% of the firm’s turnover. ECR sian pharmaceutical company Pharmstandard said Mag-Ox was a good strategic fit with the Pharmaceuticals generated a further 10.5%. disposed of the 11.38% stake it had acquired existing line of OTC brands for diabetics offer- Hi-Tech’s total pre-tax profits jumped up by controversially earlier this year (OTC bulletin, ed by the Health Care Products division. 34.6% to US$15.2 million. 30 April 2010, page 7). OTC Explaining the reasons why Pharmstandard had sold its stake in Grindeks, a spokesperson Nine-Month Results Annual Results told OTC bulletin that the company had not received any offers to increase its stake, and Self-medication up Amerifit pushes up had decided to accept a good offer. Pharmstandard – which markets Grindeks’ at Slovenia’s Krka Martek’s turnover prescription-only cardiovascular medicine Mil- dronate in Russia – acquired the stake from lovenia’s Krka said sales of its self-medi- cquiring Amerifit Brands in February of the president of Latvia’s employers’confed- S cation products had grown by 31% to C75.4 Athis year helped lift Martek Biosciences’ eration, the LEC, prompting Grindeks to re- million in the opening nine months of 2010. sales by 32% to US$435 million (C329 million) sign from the organisation. During the period, the company had expand- in the year ended 31 October 2010. Grindeks accused the confederation’s pre- ed a number of its brands in various markets, The US-based nutritional ingredients firm sident Vitalijs Gavrilovs of “essentially breach- Krka noted. In Estonia, Latvia and Slovenia, said Amerifit – which it bought from private- ing business ethics” by selling the stake to a pastille and spray had been added to its Sep- equity firm Charterhouse Group for US$200 Pharmstandard. tolete Plus sore-throat remedies, the company million (OTC bulletin,10 February 2010, page OTC pointed out, while in Russia, the Pikovit vita- 3) – had contributed sales of US$61.4 million min line had been expanded with the Pikovit from the acquisition date of 12 February until IN BRIEF Omega 3 and Pikovit Prebiotik products. the end of the period. Meanwhile, chewable tablet versions of Duo- Martek gained a number of natural-wellness ■ PERRIGO has launched a generic version vit Elegance and Duovit Sila had been added brands in the US by acquiring Amerifit, includ- of UCB Pharma’s prescription-only medicine to the Duovit vitamin and supplement brand in ing the probiotic supplement Culturelle and the Xyzal in the US. The US-based store-brand Russia and Ukraine, Krka pointed out, while -relief supplement Estroven. specialist’s generic levocetirizine tablets are Orsoslim weight-management capsules had The majority of Martek’s sales came from protected by 180 days of generic market exclu- been approved in Kazakhstan and Ukraine. its nutritional ingredient’s business, which re- sivity,after its partner Synthon successfully Self-medication products generated 10.4% ported turnover up by 14% to US$372 million. challenged a Xyzal patent. Perrigo acquired ex- of Krka’s total sales in the nine months, which Non-nutritional products generated a further clusive US sales and distribution rights to the grew by 5% to C727 million. Sales outside of US$1.45 million. generic version of the switch candidate in 2008 Slovenia were responsible for 89% of the com- Martek’s operating profit dropped by a fifth (OTC bulletin,29 September 2008, page 2). pany’s total turnover. to US$50.8 million in the 12-month period. OTC OTC OTC

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COMPANY NEWS OTC

Business Strategy Mergers & Acquisitions Beiersdorf to cut offering GSK adds muscle with Maxinutrition

as it focuses on skincare ■ Continued from front page nutrition company by market share”, Maxin- eiersdorf – owner of the Nivea and Euc- Implementing these changes would lead to utrition generated sales of around £36 million B erin skincare brands – is streamlining its additional costs of approximately C270 million in the year ended April 2010, and achieved a product portfolio and realigning its regional up to 2012, Beiersdorf said, noting that roughly compound annual growth rate (CAGR) of ap- structures. C120 million of this amount would probably proximately 21% over the past three years. A “comprehensive package of measures and be booked in 2010. The costs also include write- Acquiring the UK-based company adds the investments” had been drawn up, the German downs of intangible assets relating to the firm’s Maximuscle, Maxifuel and Maxitone sports company pointed out, to help implement its new Chinese business. nutrition brands to GlaxoSmithKline’s exist- “Focus on Skin Care. Closer to Markets” con- As a result of these additional costs, the ing Nutritional Healthcare business, which is sumer business strategy. company’s earnings before interest and tax dominated by the Horlicks, Lucozade and Rib- The entire skin and body care range had (EBIT) margin was expected to be approxi- ena drinks lines. been analysed, Beiersdorf said, and the deci- mately 9% in 2010, Beiersdorf stated, while John Clarke, worldwide president of Glaxo- sion had been made to streamline the comp- sales growth should be 2% to 3%. SmithKline Consumer Healthcare, said the deal any’s product offering and to exit the decora- Meanwhile, Beiersdorf has appointed Ümit would give the company a “strong presence in tive cosmetics market in Germany. All other Subasi as its new executive board member for the fast-developing protein-based sports nutri- local affiliates would decide the future of their emerging markets. tion market” with brands that appealed across own decorative cosmetics businesses indepen- As of 1 March 2011, Subasi would be re- a “broad spectrum of consumers from elite ath- dently,the company noted. sponsible for Africa, India, Latin America, the letes to sports participants and those seeking Although the product portfolio would be Middle East and Turkey,as well as Russia and additional nutritional supplementation”. trimmed, substantial investments in the com- the Commonwealth of Independent States. The acquisition demonstrated GlaxoSmith- pany’s skin and body care brands were plan- Subasi will join Beiersdorf from SC John- Kline’s strategy of expanding its Consumer ned, Beiersdorf stressed, with a large number son,where he was responsible for the central, Healthcare business through appropriate bolt- of new products scheduled. northern and eastern European regions. on purchases which met the company’s strict OTC financial criteria, he added. “GlaxoSmithKline will invest behind Maxi- People nutrition’s science-proven products to extend the growth of Maxinutrition within its UK and Merck KGaA gets new pharma chief European footprint,” Clarke pointed out, “and expand it to the global marketplace where erck KGaA said Stefan Oschmann would control of the Merck Serono business, while GlaxoSmithKline has existing infrastructure Mbecome the new head of its Pharmaceu- Peter Shotter would remain in charge of the and capabilities.” ticals business sector on 1 January 2011, after Consumer Health Care business and would re- Peter Boddy,chief executive officer of Maxi- Elmar Schnee had decided to leave the Ger- port to Oschmann. nutrition, said that as a “fast-growing, focused man company for “personal reasons” at the end Oschmann joins Merck KGaA from US-bas- sports nutrition business with excellent growth of this year. ed Merck & Co, where he has served as pres- prospects and a strong management team”, the Oschmann, 53, will join the German firm’s ident of emerging markets since 2009. company was a “perfect fit” for GlaxoSmith- executive board and become a general partner In a separate move,Merck said Kai Beck- Kline and its ambition to grow its Nutrition- in the company with overall responsibility for mann had been appointed to the new position al Healthcare business. both the Merck Serono and Consumer Health of head of human resources. He would join the GlaxoSmithKline’s strong commercial and Care divisions. executive board and become a general partner research and development capability,Boddy Merck noted that Oschmann would take full on 1 April 2011, the company noted. added, coupled with its investment in expand- OTC ing its global nutrition healthcare franchise in new markets and territories, offered “tremen- People dous new opportunities” to develop the Maxi- nutrition brands and deliver impressive growth Avicenna appoints Coles to board going forward. GlaxoSmithKline’s Nutritional Healthcare vicenna has announced the appointment former chairman of the British Association of business generated turnover of £851 million A of David Coles to its board as a non-exec- Pharmaceutical Wholesalers (BAPW). in 2009, of which £791 million came from the utive director with effect from 1 January 2011. In a separate development, Avicenna has Horlicks, Lucozade and Ribena brands. The The UK-based virtual pharmacy chain said promoted Dipesh Vaja from pharmacy busi- business represented 18% of Consumer Health- Coles brought “immense knowledge” of the ness manager to national sales manager. He care’s total turnover of £4.65 billion (OTC pharmaceutical sector to the position. He is a joined the company in 2008. bulletin,26 February 2010, page 6). former managing director of Unichem and a OTC OTC

16 December 2010 OTC bulletin 7 OTC16-12-10p8-9FIN.qxd 14/12/10 06:40 Page 2

OTC GENERAL NEWS

Product Recalls started until the required corrective actions had been implemented. This latest recall comes less than a month McNeil recalls Rolaids after McNeil recalled a number of OTC medi- cines in the US, including products sold under the Benadryl, Motrin, Rolaids and Tylenol brands in Canada and the US (OTC bulletin,30 November 2010, page 12). Meanwhile, Johnson & Johnson-Merck Con- sumer Pharmaceuticals – the OTC joint venture cNeil Consumer Healthcare has recalled US. It also applies to all lots of Rolaids Ultra between Johnson & Johnson and Merck & Co Ma number of its Rolaids products in Can- Strength SoftChews and Rolaids Ultra Strength – has issued a wholesale and retail level recall ada and the US, and has halted production fol- SoftChews plus Gas Relief sold in Canada. of 12 Mylanta gastrointestinal liquid remedies lowing consumer reports of foreign materials McNeil said it had initiated the recall fol- and one AlternaGEL antacid liquid product. in the gastrointestinal remedies. lowing some consumer reports of foreign mate- The recall affecting the US and Puerto Rico is The news follows a series of product recalls rials in the product, including metal and wood due to a labelling problem. and suspension of production at the Johnson & particles. The company stressed that while the The recall had been initiated, the company Johnson subsidiary’s Fort Washington manu- risk of “serious adverse health consequences” said, after an internal review had revealed that facturing facility in the US. As a result, US sales was remote, consumers were advised to stop information about the presence of alcohol from by Johnson & Johnson’s OTC & Nutritionals using the recalled products. flavouring agents had not been noted on the business are expected to decline by US$600 An investigation had determined that the packaging. million (C454 million) in 2010 (OTC bulletin, materials had been potentially introduced into It was unlikely that the use of these prod- 29 October 2010, page 4). the product during the manufacturing process ucts would cause either alcohol absorption or The latest recall includes all lots of Rolaids at a third-party manufacturer,McNeil said. alcohol sensitivity-related adverse events, John- Extra Strength Softchews, Rolaids Extra Strength While the investigation was ongoing, the son & Johnson-Merck Consumer Pharmaceu- plus Gas Softchews and Rolaids Multi-Symp- company noted, production of all three prod- ticals stressed, adding the recall had not been tom plus Anti-Gas Softchews distributed in the ucts had been suspended and would not be re- undertaken on the basis of adverse events. OTC

Manufacturers Kindler makes abrupt departure from Pfizer

■ Continued from front page time to “recharge my batteries, spend some rare -aceutical operations, as president, chief execu- time with my family,and prepare for the next tive officer and director. A new non-executive challenge in my career”. chairman would be appointed before the end “Our team can proudly boast of some trans- of December,Pfizer said. formational accomplishments,”Kindler added. Kindler’s departure comes a little over a year “However, the combination of meeting the re- after Pfizer completed the US$68 billion (C52 quirements of our many stakeholders around billion) acquisition of its smaller rival Wyeth the world and the 24/7 nature of my responsi- Stiefel Laboratories has announced the winner of its (OTC bulletin,30 October 2009, page 3). The bilities, has made this period extremely de- MaxClarity Fresh Face Challenge in the US. buy broadened Pfizer’s portfolio, and returned manding on me personally.” She is Cindy Reed (pictured above), whose story the company to the consumer healthcare mar- Commenting on Read’s appointment, Pfiz- about her new-found confidence since tackling acne with MaxClarity was “a clear favourite”. Reed has ketjust under three years after selling its own er’s lead independent director Constance Hor- won a shopping and pampering trip for two to Los global OTC business to Johnson & Johnson ner said that over the past four years Read had Angeles or New York. (OTC bulletin,25 January 2007, page 6). “redefined”the company’s go-to-market ap- To take part in the challenge, acne sufferers had to use MaxClarity for up to 30 days and submit their Explaining his departure after nine years at proach with the creation of global business units self-defined “moment of clarity” – together with Pfizer,including four and a half as chief exec- and had brought to product development a foc- before and after photographs of their skin – to the utive officer,Kindler said that he felt it was us and commitment to advance only medicines company’s website www.freshfacechallenge.com. A panel of judges selected the finalists, then visitors to that have clear value to our customers. Ian Read the website voted for their favourite. Read joined Pfizer in 1978, and was appoint- Launched earlier this year, MaxClarity is claimed ed president of the company’s international to be “the first non-prescription foam-based acne treatment system with VersaFoam technology”. pharmaceuticals group with responsibility for The MaxClarity Foam Acne Medication Latin America and Canada in 1996. In 2001, range comprises a deep cleanser, an advanced Pfizer made Read its corporate vice-president acne treatment and a rejuvenating toner. The products contain either benzoyl peroxide or with responsibility for Europe and Canada, and salicylic acid, which Stiefel said “penetrate the skin subsequently added the Africa/Middle East and quickly and fight acne at the source before it Latin America regions to his leadership respon- becomes a pimple”. Stiefel said the range provided consumers with sibilities. He was promoted to head of Pfizer’s “an acne solution that is easy-to-use, effective and global biopharmaceutical operations in 2006. backed by science from dermatology experts”. OTC OTC

8 OTC bulletin 16 December 2010 OTC16-12-10p8-9FIN.qxd 14/12/10 06:40 Page 3

GENERAL NEWS OTC

Regulatory Affairs Retailers UK’s MHRA offers Three pharmacy bodies OTC ‘slots’ in 2011 he UK’s Medicines and Healthcare prod- speak with single voice T ucts Regulatory Agency (MHRA) says it has slots available in 2011 in all therapeutic areas, including biologicals and OTC medi- hree pharmacy associations in the UK have This would be achieved by “offering un- cines, to act as reference member state (RMS) Tteamed up to establish a community phar- rivalled accessibility,value and quality for pat- for decentralised licensing applications in the macy organisation with “a stronger,unified ients and driving forward both the medicines European Union. voice” for its members. optimisation and public health agendas”, the Companies which have completed dossiers Set up by the Association of Independent trio added. ready for submission, or can submit earlier than Multiple Pharmacies (AIMp), the Company Pharmacy Voice will be led by chairman Ian originally anticipated, are invited to contact Chemists’Association (CCA) and the National Facer and chief executive Rob Darracott. Facer [email protected]. Pharmacy Association (NPA), Pharmacy Voice is also chairman of the NPA, while Darracott OTC will begin operating in the New Year. serves as chief executive of the CCA. The group had been established, said the Facer and Darracott were unanimously ap- Switches three bodies, to simplify and strengthen the pointed by the Pharmacy Voice board, which way they represented their members. consists of two nominees each from the AIMp, MHRA consults on Noting the National Health Service (NHS) the CCA and the NPA. was entering “a period of rapid change”, they The three organisations highlighted that they a Nicorette change said “community pharmacy must fulfil its pot- would continue to provide their members with ential and play an expanded role as a health- a full range of other support services, such as icorette 15mg Inhalator could soon go on care provider of choice in the new NHS”. insurance, training, and information. Ngeneral sale in the UK, if the latest switch OTC proposal from the Medicines and Healthcare products Regulatory Agency (MHRA) is given the go-ahead. Consultation document ARM 69 states that McNeil Products is seeking to switch the Nic- orette 15mg Inhalator from pharmacy to gen- eral-sales list (P-to-GSL) status. GSL status al- ready applies to the Nicorette 10mg Inhalator. ARM 69 argues that the GSL version of Nicorette 15mg Inhalator will provide “no add- itional safety risk or issues” because it deliv- ers the same dose of nicotine per puff as the 10mg cartridge. The benefit of a cartridge containing 15mg of nicotine is that it can be used for twice as long as the 10mg version, notes ARM 69, add- ing that this would “reduce the number of car- tridges needed during a quit attempt and there- by aid patient compliance”. The Nicorette 15mg Inhalator will be indi- cated for “smokers wishing to quit or reduce prior to quitting”, says ARM 69, adding it will “assist smokers who are unwilling or unable to smoke”, and provide “a safer alternative to smoking for smokers and those around them”. If the switch is approved, Nicorette 15mg Inhalator will be available in packs of four, 20 and 36 cartridges.

■ Comments on ARM 69 should be sent by 11 January 2011 to Clare Hedges, Reclassification Unit, Room 3-O, 151 Buckingham Palace Road, London SW1W 9SZ, UK (E-mail: [email protected]). OTC

16 December 2010 OTC bulletin 9 OTC16-12-10p10-11FIN.qxd 14/12/10 06:41 Page 2

OTC GENERAL NEWS

CONSUMER viewpoint ...... er

Erectile dysfunction is the subject

of this month’s Consumer viewpoint France5 1.6% survey of ailments suffered by Europe’s consumers. The survey Germany4 0.7%

appears exclusively in OTC bulletin Italy3 0.8% courtesy of Ipsos MORI. Spain2 0.4% rench men are more likely to say they have

Fsuffered from erectile dysfunction during 1 0.8% UK the past year than their counterparts in Germany, Italy,Spain or the UK, according to our Con- 0.0000.5.5 1.0111.5.5 2.02 sumer viewpoint European survey. Proportion of men who say they have suffered from erectile dysfunction (%) Of the five countries covered by the Ipsos Figure 1: Proportion of men in France, Germany, Italy, Spain and the UK who say they have suffered from MORI survey,France has the highest proportion erectile dysfunction within the past year (Source – OTC bulletin 2010/Ipsos MORI) of men who say they have suffered from erec- tile dysfunction during the past year at 1.6%, Proportion of sufferers (%) Index followed by Italy and the UK at 0.8%, Ger- Fra Ger Ita Spa UK Fra Ger Ita Spa UK many at 0.7% and Spain at 0.4% (see Figure 1). Male 100.0 100.0 100.0 100.0 100.0 ––––– Sufferers are more likely to be aged over 65 years in all five countries (see Figure 2). Female ––––– ––––– The low incidence of erectile dysfunction in 18-24 ––––5.4 ––––43 the survey countries means the following results 25-34 11.0 –––– 58 –––– should be treated with caution. As can be seen from Figure 3, prescription 35-44 8.6 17.6 25.7 –– 45 88 130 –– products are the most popular treatment option 45-54 21.1 13.2 ––20.5 137 73 ––121 in the survey countries. 55-64 15.1 6.8 18.3 21.4 –8947124 170 – The UK has the highest proportion of men 65+ 44.2 62.4 56.0 78.6 74.1 247 250 301 403 382 who have treated the condition with an OTC remedy or a prescription product (see Figures Figure 2: Consumers in France, Germany, Italy, Spain and the UK who say they have suffered from erectile 4 and 5). Germany has the highest proportion dysfunction in the past year, analysed by sex and age. The index indicates the likelihood that a consumer in a specific population group will have suffered from erectile dysfunction, and is the ratio of the of herbal treaters (see Figure 6). proportion of total sufferers in a population group to the proportion of that group in the population as a OTC whole (Source – OTC bulletin 2010/Ipsos MORI)

Product type

OTC Prescription Herbal

6060.0

5050.0

4040.0

3030.0

2020.0

1010.0 Proportion of sufferers treating with..... (%)

0.00 France12345GermanyItaly Spain UK

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

10 OTC bulletin 16 December 2010 OTC16-12-10p10-11FIN.qxd 14/12/10 06:41 Page 3

GENERAL NEWS OTC

Advertising Complaints ...... erectile dysfunction ASA gives Lyclear the all-clear in UK France5 9.5% laims made in Omega Pharma’s television Cadvertising for its Lyclear head-lice treat- Germany4 9.6% ment have been given the okay by the UK’s

Italy3 0.0% Advertising Standards Authority (ASA). Rival Thornton & Ross lodged three com- Spain2 0.0% plaints with the ASA about the commercial for Omega Pharma’s Lyclear Spray. UK1 14.1% Firstly,Thornton & Ross maintained that 0.0033.0 6.0699.0 12.012 15.015 Omega Pharma’s claim that Lyclear was “an Proportion of men suffering from erectile dysfunction who have treated the condition with an OTC remedy (%) unbeatable treatment for head lice” was mis- leading and could not be substantiated. Figure 4: Proportion of men in France, Germany, Italy, Spain and the UK who say they have suffered from erectile dysfunction who have treated the condition with an OTC remedy (Source – OTC bulletin 2010/Ipsos MORI) Noting that “unbeatable” was a top parity rather than a superiority claim, the ASA said it referred to the 100% effectiveness rate of the

France5 36.5% treatment only,and not the time or ease of use. As no treatment could exceed 100%, ruled the Germany4 15.0% ASA, the advertisement was not misleading. Secondly,Thornton & Ross challenged the Italy3 18.3% claim that “Lyclear is guaranteed to remove

Spain20.0% 100% of head lice and eggs”. Pointing out that egg removal was only possible with the use of UK1 55.8% acomb, Thornton & Ross said the commercial

0.00110.00220.00330.00440.00550.00660.00implied that a comb was not necessary. However, the ASA rejected this challenge. Proportion of men suffering from erectile dysfunction who have treated the condition with a prescription remedy (%) The focus of the advertisement was the prop- Figure 5: Proportion of men in France, Germany, Italy, Spain and the UK who say they have suffered from erectile erties of the treatment,commented the ASA, dysfunction who have treated the condition with a prescription remedy (Source – OTC bulletin 2010/Ipsos MORI) adding that it understood that most viewers would be aware that a comb was needed. The final complaint lodged by Thornton & France50.0% Ross was that the commercial was misleading because it did not distinguish between the ad- Germany4 9.6% vertised spray and other less effective products

Italy30.0% in the Lyclear range. Rejecting this complaint, the ASA noted that Spain20.0% the advertisement focused on the spray only and not the portfolio of products. UK10.0% OTC

0.0022.0 4.0 466.0 8.08110.00 Proportion of men suffering from erectile dysfunction who have treated the condition with a herbal remedy (%) IN BRIEF Figure 6: Proportion of men in France, Germany, Italy, Spain and the UK who say they have suffered from erectile ■ ASA – the UK Advertising Standards Auth- dysfunction who have treated the condition with a herbal remedy (Source – OTC bulletin 2010/Ipsos MORI) ority – has upheld three complaints about a press insert for Revitalise’s joint pain tablets Ipsos MORI and the ailments survey and cream. The ASA pointed out the company had made “breakthrough” claims – including ur Consumer viewpoint ailments survey appears exclusively in OTC bulletin courtesy that the products could reverse the effects of Oof Ipsos MORI. The survey is based on research conducted in February 2009 using Capi- arthritis, eliminate pain and had no known side- bus, the market researcher’s weekly European omnibus service. Ipsos MORI carried out face- effects – that could not be substantiated and to-face interviews with 1,000 plus adults in each of the survey countries – France, Germany, were therefore misleading. Describing the in- Italy,Spain and the UK. An OTCremedy was defined as a product purchased over-the-counter sert as “irresponsible”, the ASA added that it from a pharmacy or off a shop shelf. could discourage people from seeking essen- tial treatment for a serious medical condition. ■ For more information on the research supplied by Ipsos MORI, please contact Susan Purcell (Tel: +44 208 The ASA ruled that the insert must not appear 861 8000; Fax: +44 208 861 5515; E-mail: [email protected]). OTC again in its current form. OTC

16 December 2010 OTC bulletin 11 OTC16-12-10p12-13FIN.qxd 14/12/10 06:42 Page 2

OTC MARKETING NEWS

Regulatory Affairs Clarityn’s fast acting claim is stopped in UK by MHRA

SD Consumer Care has agreed to stop from their symptoms within a period of around Musing the “fast acting” claim for its Clar- 30 minutes after taking the product”. “A new and delicious way to help Americans reach ityn Allergy Tablets in the UK, after a complaint The MHRA noted that it had taken action to their recommended daily and vitamin D was made to the Medicines and Healthcare pro- ensure the claims were removed from the pack- intake,” is how Pfizer Consumer Healthcare describes Caltrate Soft Chews. ducts Regulatory Agency (MHRA). aging and advertising of other medicines con- Pfizer highlighted that new US health guidelines The company recently used the claim on its taining loratadine. recommended that consumers increased their daily packaging and other marketing materials for McNeil’s competing products Benadryl Al- intake of vitamin D. The company said Caltrate Soft Chews, which come in a choice of chocolate truffle or Clarityn Allergy Tablets. lergy Relief and Benadryl Plus, which both con- vanilla crème flavours, were “a great-tasting and Rival firm McNeil Products complained to tain the active ingredient acrivastine, are claim- convenient way” to help them reach these goals. the MHRA because it believed the claim “Fast ed to start working in 15 minutes. Furthermore, pointed out Pfizer, each chew provided “20% more essential calcium than acting hay fever relief” used in point-of-sale Meanwhile, the MHRA has upheld a com- McNeil Nutritional’s Viactiv” chews, and contained material for the 10mg loratadine tablets was not plaint against the consumer goods company just 15 calories. supported by adequate evidence. Multibrands. Pfizer is backing Caltrate Soft Chews with a television commercial featuring the sign-off message The MHRA upheld the complaint, pointing The firm had stated on a website that its Pan- “We put the yum in calcium”, as well as print and out that there was inadequate evidence to show odyne products, which are claimed to relieve online activity aimed at women. that symptomatic relief could be achieved within pain, were “tested and certified by MHRA”. Two of the soft chews provide 1,200mg calcium and 800 IU vitamin D. around 30 minutes after taking the tablets. However, the products were not authorised, A pack of 60 chews has a recommended retail According to the MHRA, claims for fast act- said the MHRA, adding it did not test or cer- selling price of US$8.00-US$9.00 (C6.00-C7.00). ion for a hayfever product need to be support- tify individual products. Pfizer acquired the Caltrate range of calcium supplements when it bought Wyeth for US$68 billion ed by “evidence demonstrating that the average Multibrands has agreed to withdraw the web- last year (OTC bulletin, 30 October 2009, page 3). consumer would experience meaningful relief site until the products have been authorised. OTC OTC

Marketing Campaigns Durex plays with bewitching chemistry

eckitt Benckiser is backing the Durex Play states a sexy female voiceover. Rlubricants and massage products it has just Meanwhile, television advertising for Durex acquired with a European advertising camp- Play Massage 2 in 1 products features a pas- aign that “explores the bewitching chemistry sionate couple undressing and massaging each

between lovers”. other with gel, leaving trails of “magic” over A tiger is one of the images that appear on a Created by the agency McCann Manchester, each other’s bodies. man’s skin in Reckitt Benckiser’s new television the campaign includes two television commer- A female voiceover advises consumers to commercial for Durex Play lubricants cials, which made their debut in the UK at the “get in the mood with the new Durex 2 in 1 end of November and will be rolled out to oth- Massage range”. er countries in Europe over the next six months. Both commercials carry the sign-off mes- The UK campaign, which is running for four sage “Love sex. Durex”. The company has weeks, also includes in-store, online and social just introduced this as the first-ever brand sig- media activity. nature for Durex, marking a “strategic shift The commercials, which focus on Durex away from safe sex to more magical sex” (OTC Play lubricants and Durex Play Massage 2 in 1 bulletin,30 November 2010, page 15). gels, are running terrestrially on Channel 4 and Commenting on the campaign for Durex A passionate couple are the stars of television Five,as well as on satellite channels. Play,brand manager Katy Oliver, said “the advertising for Durex Play Massage 2 in 1 gels The commercial for Durex Play lubricants magic of sexual connection is what makes this highlights the sexual chemistry between two Durex campaign so special”. “It is all too easy lovers. A scantily clad woman is seen stroking to get into the same routine, but sex should different parts of a man’s body with the lubri- be magical,”she explained. cant. Her touch produces a tingling sensation Reckitt Benckiser gained the Durex ‘power- on his skin, followed by drawings of flames brand’ after purchasing SSL International in a and tigers. deal worth £2.54 billion (C2.97 billion) (OTC

“Discover new and exciting sensations with bulletin,30 July 2010, page 1). “Love sex. Durex” is the sign-off message for both a magical range of Play lubes from Durex,” OTC television commercials

12 OTC bulletin 16 December 2010 OTC16-12-10p12-13FIN.qxd 14/12/10 06:42 Page 3

MARKETING NEWS OTC

HappyMarketing Campaigns and healthy kids star in PediaCare spots

restige Brands Holdings is backing its re- fants Fever Reducer Pain Reliever, which was Pcently-acquired PediaCare children’s cough launched in September and contains the active and cold remedies in the US with a new national ingredient acetaminophen. A giggling baby and a dancing girl are the stars of Prestige’s first television campaign in the US for its television advertising campaign. Based around a giggling baby who has just recently-acquired PediaCare brand Tim Connors, chief marketing officer of Pres- recovered from a fever, the commercial features tige, pointed out that the commercials were on the on-screen text “Goodbye: Fever” followed air just two weeks after the company had ac- by the word “Hello” accompanied by a yellow quired PediaCare. “It is our plan to reach con- smiley logo. A voiceover points out new Pedia- sumers now, at the beginning of the cough/cold Care infant drops with acetaminophen is “rec- season, when parents are most in need of reme- ommended by paediatricians to reduce fever”. dies for their children’s ailments,”he said, adding Meanwhile, the second commercial focuses that Prestige was “fully committed to support on PediaCare Children’s Fever Reducer Pain and invest in PediaCare as a key brand”. Reliever Plus Multi Symptom Cold. Prestige explained that the two new com- Images of a young girl dancing to music are mercials – created by the agency VIA Group – accompanied by the on-screen message “Yes- “repositioned the brand for continued long-term terday: Scratchy throat, fever...... Today: Danc- growth” by “celebrating the joys of healthy and ing queen”. A voiceover states that PediaCare Elixir “brings the benefits of natural honey” to happy children”. is “relied on by moms and paediatricians to children aged one to four years – the group The campaign had a “cinéma vérité style”, help kids feel better”. most often advised against taking medicated continued Prestige, adding that it captured “par- Prestige acquired PediaCare when it purch- products for a cough or sore throat. ent-child moments in a way that is reminiscent ased Blacksmith Brands Holdings for US$190 The newcomer offered a “pleasant, sweet of a home movie shot by a mom or dad”. million (C122 million) (OTC bulletin,29 Sept- taste that makes taking the elixir easier for kids The first commercial supports PediaCare In- ember 2010, page 1). who don’t like the taste of most medications”, The launch of PediaCare Infants Fever Re- Prestige commented. ducer Pain Reliever came soon after Johnson Furthermore, added the company, the prod- & Johnson’s McNeil Consumer Healthcare sub- uct did not contain any alcohol, saccharin, dyes sidiary recalled more than 40 OTC medicines and gluten. for infants and children manufactured at its Fort Washington facility in the US. The recall New addition “soothes cough naturally” included liquid Tylenol products containing A packaging strapline highlights that the acetaminophen, known as paracetamol in many newcomer is “Non-medicated”. Meanwhile, markets (OTC bulletin,14 May 2010, page 1). bullet-points state that it is “Safe for toddlers Johnson & Johnson has since resumed ship- 12 months & older”, “Soothes cough naturally” ping limited quantities of the acetaminophen- and “Calms fiery throats”. based Children’s Tylenol Grape Splash liquid Infants aged one to four years should take (OTC bulletin,15 October 2010, page 4). a teaspoon every two to four hours. The sup- In a separate development, Prestige Brands plement is also suitable for children aged over has extended its Little Remedies range in the four years, who should take two teaspoons every US with a that is claimed to two to four hours. A dietary supplement containing honey is the latest addition to Prestige’s Little Remedies range for naturally soothe infants’ coughs with honey. The recommended retail selling price for a children in the US The company said that Little Colds Honey 120ml pack is US$6.99. OTC

Homoeopathic Medicines mun, and nearly half – 47% – said there had been an improvement two or three days after Study by Sophien supports Katimun taking the product. A further third of the group of consumers erman company Sophien-Arzneimittel said sumers who had bought Sophien’s Katimun felt better more than three days after taking Git had achieved “clear success” with what homoeopathic cold remedy in 14 pharmacies the licensed medicine, which contains extracts it claims is the country’s first scientifically- spread throughout Germany. of boneset, bryony, jessamine, monkshood conducted observational study of a homoeo- Of this group of consumers, 11% reported and sorrel. pathic medicine. The study involved 64 con- feeling better on the first day after taking Kati- OTC

16 December 2010 OTC bulletin 13 Te ll the right people what you want to buy and

E KNOW the people sell who want to in-license, Wout-license, buy or sell your OTOTCC products, brands or technologies. We know them because they are registering with us at the SourceOTC website. Reach the SourceOTC community

by posting your own message. in association with

New cost-effective rates apply for 2010, so there has never been a better time to use the SourceOTC website to tell the right people what OTC assets you want to buy and sell. The new entry-level service means you can post up to five business opportunities on the SourceOTC website for three months for just £495 (plus VAT where applicable). And there is no success fee to pay. New cost-effective This gives companies of all shapes and sizes a cost-effective rates apply for 2010 way of getting their message across to the right people.

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2010SourceOTC A4 ad5.indd 1 2/2/10 16:28:27 OTC16-12-10p15FIN.qxd 14/12/10 06:43 Page 3

MARKETING NEWS OTC

Launches Flucalyptol offers France ‘free access’ pholcodine

‘free-access’ version of Zambon’s Bio- Acalyptol cough syrup has been launched in France under the brand name Flucalyptol. The eucalyptus-flavoured medicine for dry and irritating coughs contains 1.31mg/ml of the cough suppressant pholcodine. The non-reim- bursable, non-prescription medicine comes in a200ml bottle. Long-lasting relief from dry, burning and painful eyes France’s ‘free-access’ initiative,allowing is the on-pack claim for Bausch & Lomb’s Artelac self-selection displays of certain non-prescrip- Rebalance eye drops in Germany. tion medicines in pharmacies, was launched in The company explained that the artificial tears used “an innovative two-polymer combination” of 2008 (OTC bulletin,31 July 2008, page 17). hyaluronic acid and PEG 8000 to rebalance moisture Flucalyptol Toux Sèche is suitable for adults levels in the eye. While 0.15% hyaluronic acid is said and children above six years of age. The medi- to offer rapid distribution across the eye’s surface with hydrophilic properties, PEG 8000 increases how cine comes with a measuring cup that allows the acid remains on the cornea. cough sufferers to prepare the correct dose. Bausch & Lomb noted that Artelac Rebalance’s The adult dose is 15ml up to four times a day. moisturising effect was boosted by electrolytes including calcium, magnesium and potassium Children between 12 and 15 years of age can Zambon’s Flucalyptol is a non-reimbursable medicine – as well as vitamins such as – that take 5ml up to six times a day,while children were naturally found in tears. younger than 12 years of age can take 2.5ml Laboratoires Genévrier’s Codotussyl Toux Sèche, According to the company, the artificial tears used the “innovative preservative” Oxyd, which broke up to six times a day. The maximum treatment Laboratoires Urgo’s Toux Sèche Humex and down into the constituents of tears – water, oxygen period is five days. Sanofi-Aventis’ Rhinathiol Toux Sèche. and salts – upon coming into contact with the eye. Other ‘free access’ cough syrups contain- Zambon’s Biocalyptol is a reimbursable, non- Bausch & Lomb said the 10ml bottle of eye drops was portable and easy to use. It has a recommended ing pholcodine include Cooper’s Clarix Sirop, prescription medicine. retail price of C13.99. OTC The company is promoting the medical device through advertising in the trade press and inserting laminated information cards in Relaunches pharmacists’ magazines. Furthermore, Bausch & Lomb is running promotions with certain online pharmacies, whereby GlaxoSmithKline rethinks Contac in UK customers who order Artelac Rebalance receive a free branded lip balm. laxoSmithKline Consumer Healthcare has continued because of “export restrictions in the OTC Greplaced its Contac 12 Hour Relief de- country of manufacture”. congestant medicine with Contac Dual Relief GlaxoSmithKline said the new non-drowsy IN BRIEF in the UK. formulation would provide “additional benefits According to the company, Contac 12 Hour to consumers due to its dual-action formula”. ■ ASA – the UK’s Advertising Standards Auth- Relief – a pharmacy-only (P) medicine con- Contac Dual Relief comprises tablets con- ority – has upheld a complaint about a press taining 120mg pseudoephedrine hydrochloride taining 30mg pseudoephedrine hydrochloride advertisement for NeoCell’s beauty supple- per prolonged-release capsule – had been dis- and 500mg paracetamol. Packaging highlights ment containing collagen. Rival company Vita- that the P medicine is a “New formula with biotics challenged whether the headline “The paracetamol” that “Clears nasal and sinus con- world’s best selling natural beauty supplement” gestion” and “Relieves headache and pain”. was misleading. The ASA noted that consum- The newcomer is suitable for adults and ers might not realise the claim referred to col- children aged over 12 years, who should take lagen supplements only. Vitabiotics also ques- two tablets up to three times a day. tioned whether claims that the product led to A pack of 18 tablets has a recommended re- “the reduction of fine lines and wrinkles” and tail selling price of £3.89 (C4.59). “repaired nails” could be substantiated. The Restrictions have been imposed on medi- authority concluded that NeoCell could not sup- cines containing pseudoephedrine in a number port these claims, which were therefore mis- of countries because of the potential for mis- leading. The ASA ruled the advertisement must use in the illegal manufacture of methylamph-

not appear again in its current form. New Contac Dual Relief tablets contain paracetamol etamine or ‘crystal meth’. OTC as well as pseudoephedrine OTC

16 December 2010 OTC bulletin 15 In association with OTC Marketing Awards Recognising2011 the achievements of the British OTC industry Gala Dinner & Awards Presentation Park Lane Hotel, Piccadilly, London Thursday, 10th March 2011 Take Centre Stage at the Awards that Really Matter

Visit the Awards website at www.otc-bulletin.com/awards to find out more

Sponsored by

2011 Advert-1.indd 1 06/09/2010 17:37 OTC16-12-10p17FIN.qxd 14/12/10 06:45 Page 3

MARKETING NEWS OTC

Line Extensions Anadin gets a boost in UK with effervescent ibuprofen

fizer Consumer Healthcare has extended Pits Anadin pain relievers in the UK with ef- fervescent ibuprofen tablets that are claimed to work “four times faster than standard ibuprofen”. The company is positioning Anadin Liqui- Fast Effervescent tablets, which each contain 200mg ibuprofen, as “a perfect painkilling solu- tion” for people who have trouble swallowing

Nicotine gum that helps to keep teeth white capsules or tablets. The newcomer can relieve Effervescent tablets containing 200mg ibuprofen are while doubling the chances of quitting smoking back, muscle, period and dental pain. the latest addition to Pfizer Consumer Healthcare’s is the latest addition to McNeil Consumer Describing the effervescent tablets as “pow- Anadin range of pain relievers in the UK Healthcare’s Nicorette portfolio of smoking-cessation aids in Germany. erful” and “cleverly designed”, Pfizer said they or two tablets dissolved in a glass of water every Nicorette Kaugummi Whitemint comes in a “dissolve quickly and easily in water”, and “work four to six hours, and take no more than six in choice of 2mg and 4mg nicotine strengths, and fast to relieve your pain and let you get on with a 24-hour period. is said by McNeil to have an “irresistible fresh mint flavour”. your life”. Pfizer is currently backing the Anadin brand The newcomer joins the existing Mint, Freshmint “Aside from easing pain,”Pfizer continued, with television, print and radio advertising bas- and Spicemint flavours, as well as the Classic and the tablets “also help relieve inflammation by ed on the theme “Wherever your pain your ans- Freshfruit variants. Launch trade-press advertising for Whitemint blocking prostaglandin production in the tis- wer is Anadin” (OTC bulletin,16 November stresses that the flavour is “neu vom Marktführer”, or sues of the body”. 2010, page 17). “new from the market leader”. The gum is said to A general-sales list (GSL) medicine, Anadin The company has also recently repackaged “maintain the natural whiteness of teeth”. Thirty-piece packs of the pharmacy-only LiquiFast Effervescent is grapefruit flavoured. the range, revamped its website at www.anadin. medicine have recommended retail selling prices of It has a recommended retail selling price of co.uk and launched an iPhone application. C9.93 for the 2mg strength and C11.00 for the £3.49 (C4.19) for a pack of 10 tablets. Pfizer acquired Anadin when it purchased 4mg version. Larger packs containing 105 pieces are The tablets are suitable for adults and chil- Wyeth for US$68 billion last year (OTC bul- also available. dren aged over 12 years. Users should take one letin,30 October 2009, page 3). OTC OTC

Marketing Campaigns Pepto-Bismol puts a stop to American under-indulgence

rocter & Gamble is backing its Pepto-Bis- “Under-indulgent tummies are as dead as plates at a Christmas party are interrupted by Pmolstomach remedy in the US with a tele- a condemned disco club,”commented Jeong. Jeong, who bursts in between them and knocks vision and digital marketing campaign focus- “Enjoying your holiday parties includes enjoy- the plates out of their hands. “Pathetic. Call ing on “holiday party under-indulgence”. ing various meats and treats. Normal indulging this a holiday party? We need a help,”he says, The company explained that the humorous is fine and if you occasionally overdo it, Pepto pointing out “these people are under-indul- campaign “aims to increase awareness about has you covered.” gers” who are “not enjoying the holidays”. this common buzz kill at all holiday parties”. Created by the agency Publicis, the cam- The party begins to liven up as Jeong ex- It added that it had teamed up with actor Ken paign includes a 15-second television commer- plains that “together,we can end under-indul- Jeong – who recently starred in the movies cial, which will run throughout December on gence”. “And if you over-do it, Pepto-Bismol’s Knocked Up and The Hangover – to fulfil this channels including ABC, CBS, FOX and NBC. got you covered,”he adds, grabbing a bottle “very important initiative”. A man and woman holding virtually empty of Pepto-Bismol. The commercial ends with the sign-off mes- sage “Eat, drink & be covered”. The company is also backing Pepto-Bismol with a 30-second online video based around the same theme. It is available on Facebook at www.facebook.com/peptobismol and on You- Tube at http://www.youtube.com/peptobismol. In addition, Procter & Gamble is running a public relations campaign offering “search and rescue tactics to liberate under-indulgers”. Procter & Gamble’s humorous television commercial for Pepto-Bismol in the US stars Ken Jeong OTC

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OTC MARKETING NEWS

Marketing Campaigns Coughing animals promote Buttercup’s benefits in UK

oughing animals highlight that Buttercup CSyrup contains “only natural active ingre- dients” in Omega Pharma’s new television ad- vertising campaign for the medicine in the UK. Devised by the agency VCCP,the £0.25 mil- lion (C0.30 million) plus campaign is built on the sign-off message “It’s soothing, by nature”. The humorous campaign comprises a 30- second commercial together with a 10-second cut-down version, both of which are running until 23 January on channels including ITV1, ITV2, Fiver and Sky. It is voiced by comedi-

An extra strong lotion that kills 100% of head lice ans Jon Culshaw and Kevin Bishop. within just 15 minutes of a single application is the Filmed in the style of a nature programme, latest addition to Cooper’s Pouxit range of head lice the commercial features different animals – in- treatments in France. Pharmacy-press advertising for Pouxit XF – which cluding a stag and a bird – that cannot stop stands for “extra fort” or “extra strong” – calls the coughing. After a pair of grebes joke about the product the “ultimate weapon” against head lice. It animals, the stag takes action by instructing the points out Pouxit XF contains the additive Penetrol, others to “take Buttercup”. “It’s soothing, by nature” is the theme of Omega which makes the eggs of head lice absorb the product Pharma’s new television advertising for Buttercup more effectively than other Pouxit treatments. A mouse then appears and advises consum- Syrup in the UK Clinical tests indicate that just one shampoo with ers that “For an effective cough medicine with Pouxit XF kills all head lice within 15 minutes, Cooper claims, after which the product can be rinsed only natural active ingredients, choose Butter- campaign, Omega Pharma said the focus on out of the hair. Other Pouxit products must be applied cup Syrup”. “It’s soothing, by nature,”states the soothing – rather than fighting – coughs clearly for an hour, and then reapplied seven days later to kill mouse, as packs of the medicine appear in the differentiated the Buttercup brand from its com- young head lice that had not been affected by the first application. landscape shot. petitors. “The intention of this campaign is to The odourless, colourless and insecticide-free The commercial ends with the bird flying up stand out by communicating a different and uni- product – which is available in a 100ml bottle of into the air and squawking excitedly: “I’m feel- que reason to purchase, and to engage consum- 4% dimeticone lotion – can be used on children from the age of six months and is suitable for pregnant ing better now.” ers with humour and a refreshingly different women and asthmatics. Commenting on the approach taken in the tone of voice,”the company added. OTC OTC

Launches Johnson & Johnson said it had teamed up with the National Eczema Association to “edu- J&J refreshes Aveeno eczema range in US cate and empower” eczema sufferers about the condition for the winter. The campaign in- ohnson & Johnson has replaced its Aveeno over 90% of babies who had been treated with cludes online videos –entitled ‘Introducing JEczema Care products in the US with a trio the products daily. Aveeno Eczema Therapy’, ‘Revolutionary In- of “clinically shown” moisturisers aimed at Packaging for the products carries the Nat- gredient’and ‘Soothing Skin Testimonial” – adults and babies. ional Eczema Association’s Seal of Acceptance. which are available on the Facebook social- The company said the “breakthrough for- networking site. mulas”, which contained natural colloidal oat- The firm is also running consumer-press ad- meal and oat essence, supported healthy devel- vertising and public relations activity. opment of delicate skin and helped relieve ir- The cream for adults is supplied in a 7.3 oz ritation due to mild to moderate eczema. tube with a recommended retail selling price The three products – Aveeno Baby Eczema of US$8.20 (C6.19). Supplied in a 5.0 oz tube, Therapy Moisturizing Cream, Aveeno Baby the cream for babies retails at US$5.99, while Cleansing Therapy Moisturizing Wash and Ave- an 8.0 fl.oz bottle of the wash for babies has a eno Eczema Therapy Moisturizing Cream for price of US$4.99. adults – did not contain parabens, steroids or The discontinued Aveeno Eczema Care range propylglycol, added Johnson & Johnson. offered a body wash and cream suitable for both Johnson & Johnson highlighted a clinical adults and babies (OTC bulletin,25 January A trio of moisturisers for adults and babies suffering study in which the baby wash and cream had from eczema has been added to Johnson & Johnson’s 2008, page 13). improved multiple symptoms of eczema in Aveeno portfolio in the US OTC

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EVENTS OTC

JANUARY FEBRUARY 1-2 February 20 January 3 February ■ What Regulation for Food Supplements and Herbal ■ Herbal Products After ■ Basics of Medicinal Products in Europe? April 2011 Regulatory Affairs Brussels, Belgium London, UK London, UK This two-day meeting is organised by the Association of the European A one-day seminar organised by A one-day course from The Org- Self-Medication Industry,the AESGP. the British Herbal Medicine Asso- anisation for Professionals in Reg- There will be sessions entitled: ‘Implementation/enforcement of the ciation (BHMA) and the Royal ulatory Affairs (TOPRA). nutrition and health claims regulation’; and ‘A single market for herbal Pharmaceutical Society (RPS). It Contact:TOPRA. medicines in Europe?’. will focus on the end of the tran- Tel: +44 20 7510 2560. Speakers will include: Dagmar Roth-Behrendt of the European Par- sitional period for the European Fax: +44 20 7537 2003. liament; Basil Mathioudakis and Paola Testori-Coggi of the European Union’s traditional herbal medic- E-mail: [email protected]. Commission; Vittorio Silano of the European Food Safety Authority inal products directive,and will ex- Website: www.topra.org. (EFSA); and Ioanna Chinou of the European Medicines Agency’s Com- plore the borderline between med- mittee on Herbal Medicinal Products (HMPC). icines, foods, cosmetics and med- 8 February Contact:AESGP. ical devices. ■ Introduction to Tel: +32 2 735 51 30. Fax: +32 2 735 52 22. E-mail: [email protected]. Contact:Royal Pharmaceutical Medicines Law Website: www.aesgp.be. Society (RPS). Bonn, Germany Tel: +44 20 7572 2737. A one-day meeting organised by Fax: +44 20 7735 7629. Germany’s medicines manufact- be booked separately. 22-23 March E-mail: [email protected]. urers’ association, the BAH, and Contact:Henriette Wolf-Klein, ■ Regulatory Affairs in Website: www.rpharms.com. conducted in German. Forum Institut für Management. India and China Contact:BAH. Tel: +49 6221 500 680. Frankfurt, Germany 26 January Tel: +49 228 957 45 0. Fax: +49 6221 500 555. Day one of this two-day seminar ■ Homoeopathic Fax: +49 228 957 45 90. E-mail: [email protected]. will discuss regulatory affairs, clin- Medicines E-mail: [email protected]. Website: www.forum-institut.com. ical trial regulation and variations Bonn, Germany Website: www.bah-bonn.de. in India, while day two will focus 24 February Speakers from Germany’s federal on China. Each day can be book- 10 February institute for drugs and medical de- ■ Hot Topics in ed separately. vices, BfArM, will be at this one- ■ The Pharma Advertising Contact:Henriette Wolf-Klein, day conference run by Germany’s Summit 2011 A one-day event run by the UK’s Forum Institut für Management. medicines manufacturers’ associ- London, UK Medicines and Healthcare prod- Tel: +49 6221 500 680. ation, the BAH. It will be conduct- This event will look at ‘Reinvent- ucts Regulatory Agency (MHRA). Fax: +49 6221 500 555. ed in German. ing pharma for a new generation’. Contact:MHRA. E-mail: [email protected]. Contact: BAH. Contact:Economist Conferences. Tel: +44 20 3080 6903. Website: www.forum-institut.com. Tel: +49 228 957 45 0. Tel: +44 20 7576 8116. E-mail: mhraconferences@mhra. Fax: +49 228 957 45 90. Fax: +44 20 7576 8472. gsi.gov.uk. 28-30 March E-mail: [email protected]. E-mail: weurope_customerservice@ Website: www.mhra.gov.uk. ■ DIA Annual Website: www.bah-bonn.de. economist.com. EuroMeeting Website: www.economistconferences. 28 February-1 March Geneva, Switzerland 26 January com. ■ EuroPLX 45 A three-day conference organis- ■ Marketing Authorisation Lisbon, Portugal ed by the Drug Information As- in Turkey 17-18 February A two-day partnering and licens- sociation (DIA). Wider access in- Frankfurt, Germany ■ Pharmaceutical ing forum focusing on OTC medi- cluding generics and self-care med- Classification and pharmacovig- Regulatory Affairs cines, nutraceuticals, branded pre- icines will be one of the 15 paral- ilance in Turkey are on the agenda in the Middle East scription drugs and generics. lel sessions at the conference. for this one-day conference. London, UK Contact:RauCon. Contact: DIA European Office. Contact:Henriette Wolf-Klein, Countries to be discussed at this Tel: +49 6222 9807 0. Tel: +41 61 225 51 51. Forum Institut für Management. two-day conference include Bah- Fax: +49 6222 9807 77. Fax: +41 61 225 51 52. Tel: +49 6221 500 680. rain, Iran, Israel, Saudi Arabia, Sy- E-mail: [email protected]. E-mail: [email protected]. Fax: +49 6221 500 555. ria and Yemen. Website: www.raucon.com. Website: www.diahome.org. E-mail: [email protected]. Contact: Management Forum. Website: www.forum-institut.com. Tel: +44 1483 730071. MARCH JUNE Fax: +44 1483 730008. 27-28 January 10-12 March 8-10 June E-mail: registrations@management- ■ Latest Developments forum.co.uk. ■ CHPA Annual ■ 47th AESGP in Pharmacovigilance Website: www.management- Executive Conference Annual Meeting London, UK forum.co.uk. Aventura, Florida, US Rome, Italy A two-day event focusing on dev- The Annual Meeting of the US The Annual Meeting of the Asso- elopments in Europe and the US. 22-23 February Consumer Healthcare Products ciation of the European Self-Med- Contact: Management Forum. ■ Variations Regulation Association (CHPA) is only open ication Industry,the AESGP. More Tel: +44 1483 730071. Bonn, Germany to members. details will be available soon. Fax: +44 1483 730008. Peter Bachmann and Cornelia Nop- Contact: Phyllis Taylor,CHPA. Contact: AESGP. E-mail: registrations@management- itsch-Mai from Germany’s federal Tel: +1 202 429 9260. Tel: +32 2 735 51 30. forum.co.uk. institute for drugs and medical de- Fax: +1 202 223 6835. Fax: +32 2 735 52 22. Website: www.management- vices, BfArM will speak at this E-mail: [email protected]. E-mail: [email protected]. forum.co.uk. two-day conference. Each day can Website: www.chpa-info.org. Website: www.aesgp.be.

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OTC REVIEW OF THE YEAR 2010 turns out to be an eventful year

Product recalls,mergers and acquisitions, people on the move, OTC business unit (OTC bulletin,30 April traditional herbal medicinal products and food claims have all been hot 2010, page 23). Although companies and people grabbed the topics in 2010. Deborah Wilkes reports. lion’s share of the headlines in 2010, regulatory issues also had their fair share of coverage. ompanies dominated the headlines Johnson had just announced more product re- Herbal medicines were recently back in the in 2010, with both good and bad sto- calls affecting its Rolaids brand in Canada and news when Members of the European Parlia- ries unfolding during the year. John- the US (see page 8). ment (MEPs) probed John Dalli, European Com- Cson & Johnson’s McNeil Consumer As a result of its troubles, Johnson & John- missioner for health and consumer policy, about Healthcare subsidiary had a truly terrible time, son expects that US sales at its OTC & Nutri- the European Union’s simplified procedure for following a series of product recalls and sus- tionals business will decline by US$600 mil- registering traditional herbal medicinal products pension of production at its Fort Washington lion (C457 million) during 2010 . (OTC bulletin,30 November 2010, page 12). manufacturing facility in the US. By contrast, Meanwhile, at the beginning of 2010, San- Two MEPs pointed out that no Chinese or Reckitt Benckiser finally acquired SSL Inter- ofi-Aventis recruited Hans Regenauer – pre- Indian Ayurvedic medicinal products had so far national after years of speculation, and has just viously worldwide head of Boehringer Ingel- been registered using the simplified procedure. agreed to buy India’s Paras Pharmaceuticals heim’s Consumer Health Care division – to de- They wanted to know whether the Commission (see front cover). Meanwhile, Sanofi-Aventis velop its OTC business. Regenauer took on the planned to amend Directive 2004/24/EC to make continued to grow its OTC business with acqui- newly-created post of vice-president, Consumer it more applicable to non-European herbal cul- sitions in Canada, China, Poland and the US. Health Care, Europe, and global development tures before the transition period ended in Ap- (OTC bulletin,20 January 2010, page 22). ril of next year. People on the move News of Regenauer’s appointment followed Products that were already on the market People on the move in the OTC industry also hard on the heels of the announcement that San- when the directive entered into force have to hit the headlines on a regular basis. One of the ofi-Aventis intended to enter the US OTCmar- comply with its requirements by 30 April 2011. biggest stories came in September,when John- ket by acquiring Chattem for around US$1.9 Noting the simplified procedure was han- son & Johnson announced that Colleen Gog- billion (OTC bulletin,20 January 2010, page dled by member states, Dalli said the Commis- gins would step down as worldwide chairman 1). Since then, Sanofi-Aventis has boosted its sion did not have information on the products of its troubled Consumer division at the begin- OTC business by acquiring Poland’s Nepentes licensed by the member states. As a result, he ning of March 2011 (OTC bulletin,29 Sept- for PLN420 million (C105 million) and Canada’s added, it did not know whether there had been ember 2010, page 25). Canderm for an undisclosed sum. Last month, applications and registrations for Chinese or Goggins will leave Johnson & Johnson just it unveiled plans to strengthen its presence in Indian products. over a year after the company received a Warn- the Chinese OTC market by acquiring BMP ing Letter from the US Food and Drug Admin- Sunstone and its portfolio of cough/cold and Does not reduce access istration (FDA) about McNeil Consumer Health- women’s health brands for around US$520 mil- However, Dalli insisted that the European care’s plant in Las Piedras, Puerto Rico (OTC lion (OTC bulletin,16 November 2010, page 1). Union’s simplified procedure for registering bulletin,10 February 2010, page 22). A few Merck & Co signalled its ambitions for its traditional herbal medicinal products did not months after receiving the Warning Letter,Mc- recently-acquired Consumer Care business in reduce access to Chinese or Indian products. Neil also announced that it had suspended pro- February by recruiting Bridgette Heller to lead Neither did it reduce access to products of com- the operation. Previously pres- panies with reduced financial capacity,he said. By 13 December 2010, 194 traditional ident of Johnson & Johnson’s Dalli stressed that the simplified procedure herbal medicines had been registered using global Baby business unit, Hel- facilitated the possibility to place specific tra- ler has a brief to grow the Con- ditional medicinal products on the European Europe’s simplified procedure sumer Care business in non- market, and did not introduce new requirements US markets (OTC bulletin,26 more burdensome than the ones following from duction at its Fort Washington facility after vol- February 2010, page 1). the marketing authorisation procedures. untarily recalling over 40 OTCmedicines for The following month, GlaxoSmithKline an- “On the contrary,” Dalli maintained, “the infants and children made at the plant (OTC nounced that it had recruited the next world- aim of these rules is to safeguard public health bulletin,14 May 2010, page 1). wide head of its Consumer Healthcare division and at the same time facilitate the free circu- The recalls sparked an investigation by the from cosmetics company L’Oreal. Emma Walm- lation of traditional herbal medicinal products Committee on Oversight and Government Re- sley – formerly leader of L’Oreal’s Consumer within the European market.” form within the US House of Representatives. Products business in China – joined Glaxo- Dalli was adamant that if a traditional herbal Goggins told the committee hearing that the re- SmithKline on 1 May as European president medicinal product was not registered or autho- call was a “disappointment” and that McNeil’s and worldwide president designate of the world- rised as such by 1 May 2011, then the product quality and process issues had been “unaccept- wide Consumer Healthcare division (OTC bul- could not be placed on the European market. able” (OTC bulletin,11 June 2010, page 11). letin,31 March 2010, page 1). According to figures compiled by the Asso- She also apologised to parents for the “concern And in April, it emerged that Dirk Van de ciation of the European Self-Medication Indus- and inconvenience caused”. Put was leaving Novartis just eight months after try,the AESGP,the number of registrations in As OTC bulletin went to press, Johnson & becoming worldwide head of the company’s Europe is growing relatively fast but is still low.

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REVIEW OF THE YEAR OTC

The AESGP told OTC bulletin that 194 pro- tional and well-established herbal medicinal to finalise opinions on all claims other than ducts had been registered using the simplified products are not legally binding on member botanicals by the end of June 2011. The Com- procedure by 13 December 2010. This is up states of the European Union, but they should mission would then “immediately” follow up from 162 at the end of April 2010 (OTC bul- be taken into account. By contrast, entries on with the necessary legislative measures. letin, 30 June 2010, page 23), and 66 a year ear- the Community list of herbal substances, prepa- The community list of permitted general lier (OTC bulletin, 19 June 2009, page 19). rations and combinations for use in traditional health claims for foods – covered by Article The UK leads the way in terms of the num- herbal medicinal products are legally binding. 13.1 of regulation 1924/2006 – should have ber of traditional herbal medicinal products reg- Since directive 2004/24/EC came into force been completed by 31 January 2010. However, istered by 13 December 2010. The UK had reg- six years ago, only seven entries have been add- it became clear some time ago that the dead- istered 73 products, almost double the number ed to the Community list (OTC bulletin, 31 May line would not be met (OTC bulletin, 30 Oct- achieved by second-placed Austria with 40. 2010, page 15). The HMPC proposes entries ober 2009, page 18). Of the 194 traditional herbal medicinal prod- to the Commission, which then adds them to The first batch of permitted general health ucts registered, 129 contain only one plant and the Community list. claims was finally put forward for adoption 65 contain combinations of plants. Meanwhile, only around 70 monographs recently. But the European Union’s Standing Some companies are taking their products have been finalised (OTC bulletin, 15 Octo- Committee on the Food Chain and Animal to market via alternative routes, such as autho- ber 2010, page 9). Health (SCFCAH) did not adopt the claims risation as a well-established herbal medicine Full application of the directive would re- (OTC bulletin, 30 July 2010, page 13). or a food supplement. Dalli noted that herbal quire between 200 and 300 herbal monographs, Adoption was necessary for these general products may be placed on the market as foods, the HMPC has said in the past. health claims to be included in a community provided that they do not fulfil the definition The low number of herbal monographs – to- register, as described by Article 20 of the reg- of medicinal products. gether with the unwillingness of some coun- ulation. Claims rejected by EFSA would have Companies are also tapping into the exist- featured in a negative list in the ing pool of registrations. Schwabe Pharma UK, The OTC industry will have a chance to air community register and would for example, said in October that it could sup- its views on both food claims and traditional have had to have been with- ply other firms with a ‘piggy-back’ variation drawn from the market. to its registrations for Thisilyn Milk Thistle and herbal medicinal products in February The first batch was based Thisilyn Maximum Strength Milk Thistle in the on the scientific opinions pub- UK. “Some companies have already contacted tries to act upon them – is causing problems lished by EFSA last October. EFSA only gave us and are in a position to launch their own ver- for industry. OTC bulletin understands that the go-ahead to a third of the first group of 500- sions of our milk thistle traditional herbal medi- gaining access to market for new herbal medi- plus general health claims assessed (OTC bul- cines before the April 2011 deadline,” com- cines, including traditional herbal medicinal letin, 16 October 2009, page 11). mented the company (OTC bulletin, 15 Octo- products, is a key concern for industry. EFSA published a second group of opinions ber 2010, page 15). Another hot topic during 2010 was food earlier this year (OTC bulletin, 17 March 2010, Schwabe Pharma UK highlighted that it al- claims. The European Commission recently de- page 11). Only a handful of the 416 submissions ready had 18 registrations for traditional herbal cided to change the process for adopting gen- in the second group were given the okay. medicines, and planned to obtain more. eral health claims for foods (OTC bulletin, 15 When the third group of opinions was pub- A portfolio of registrations for traditional October 2010, page 1). lished in October, most of the 808 submissions herbal medicines is also available from Dia- The move came after industry and some had been rejected (OTC bulletin, 29 October pharm. The German pharmaceutical services member states complained about the Commis- 2010, page 9). provider recently announced that it had reg- sion’s progressive approach whereby claims EFSA has now said no to 80% of the 1,745 istered Europe’s first traditional herbal medi- were set to be adopted in a number of batches. general-function health claims assessed to date. cinal product to be combined with minerals They pointed out that this approach could lead So far, the authority has assessed just over a (OTC bulletin, 15 October 2010, page 8). to market distortions between companies whose third of the 4,637 health claims compiled by The traditional herbal medicine containing claims had been rejected and companies whose European Union member states and the Euro- 40mg hawthorn extract together with potas- claims had not yet been assessed. pean Commission. sium and magnesium salts has just been reg- The OTC industry will have a chance to air istered by Germany’s federal institute for drugs Botanicals were treated differently its views on both food claims and traditional and medical devices, BfArM. It is indicated for Furthermore, concerns had been expressed herbal medicinal products at a meeting organ- supporting cardiovascular function and protect- that botanical ingredients were treated differ- ised by the AESGP in Brussels on 1-2 Febru- ing against climatic stress. ently under the food claims regulation than ary. Speakers will include Basil Mathioudakis Diapharm said it planned to register the tra- they were under the legislation for traditional and Paola Testori-Coggi of the European Com- ditional herbal medicine in other European coun- herbal medicinal products. mission, and EFSA’s Albert Flynn (see page 19). tries, including Austria and the UK. The Commission announced in October that Ending on a positive note, 2010 saw the Slow progress with herbal products was be- the community list of permitted general health arrival of Boehringer Ingelheim’s Flomax Re- hind the European Medicines Agency’s (EMA’s) claims for foods would now be established in lief in the self-medication arena. The UK was announcement in June of an action plan to in- two steps. The list for all substances other than the first country in the world to make 0.4mg crease significantly the “quality and number” botanicals would be adopted in a single step, it tamsulosin hydrochloride a non-prescription of Community herbal monographs and list entries explained, with claims for botanicals consid- medicine for treating benign prostatic hyper- produced by its Committee on Herbal Medi- ered once the first step had been completed. plasia (BPH), or an enlarged prostate (OTC cinal Products (HMPC). The Commission noted that the European bulletin, 31 March 2010, page 13). Community herbal monographs for tradi- Food Safety Authority (EFSA) was expected OTC

16 December 2010 OTC bulletin 21 OTC16-12-10p22-23FIN.qxd 14/12/10 06:48 Page 2

OTC PEOPLE

Manufacturers Manufacturers/Retailers Wines moving NBTY names Nagel as to Seven Seas its new chief executive mega Pharma’s Andy Wines is moving Oto Seven Seas as marketing director at the BTY has appointed Jeffrey Nagel as its Jeffrey Nagel beginning of 2011. Nnew chief executive officer. Nagel succeeds Wines has been Omega’s marketing direc- Scott Rudolph,who will continue as chair- tor for the UK and Ireland since November man of the US-based nutritional supplements 2009. Together with the team at Omega,he manufacturer and retailer. has revamped the consumer marketing camp- The news of Nagel’s appointment comes aigns for a number of brands including Jungle shortly after NBTY was acquired by the private- Formula and Wartner (OTC bulletin,11 June equity company The Carlyle Group in a deal 2010, page 8). worth US$3.8 billion (C2.8 billion) (OTC bul- He pointed out that his eight years at Roche letin,15 October 2010, page 2). Consumer Health would be valuable when deal- Commenting on the appointment, Rudolph ingwith the Seven Seas portfolio of food sup- said that Nagel would be able to “take NBTY plements. Wines held the positions of market- to the next level of growth and performance ing director,global head of category marketing and further establish its position as a global and group brand manager at Roche Consumer market leader”. nologies, general manager of business devel- Health, which is now part of Bayer Health- opment at GE Aircraft Engines, and president Care, and worked on the company’s Berocca Joins from General Electric of GE Home Electric Products. Nagel joined and Sanatogen food supplements. Nagel joins NBTY from General Electric GE in 1997 as a manager in business develop- Wines has also had global marketing posts Company (GE), where he most recently served ment at GE Lighting. at Johnson & Johnson and Reckitt Benckiser. as vice-president and general manager of GE Prior to joining GE, Nagel worked at Energy Oil & Gas Global Services. His previous posi- Biosystems, Cannon Associates, Reid & Host- Andy Wines tions at the company included president and age, and Strategic Planning Associates (now chief executive officer of GE Inspection Tech- Mercer Management). OTC

Manufacturers Prestige recruits new finance chief

restige Brands Holdings has recruited Ron extensive background in business development, PLombardi as the replacement for its retir- acquisitions and divestitures, and debt and equity ing chief financial officer Pete Anderson. structuring will serve Prestige well as we move The US-based company said that Lombardi into our next phase of growth following our re- brought extensive financial management expe- cent acquisition of Blacksmith Brands,”he said. OTC rience to his new role. Most recently,he served Prestige acquired Blacksmith Brands Hold- as chief financial officer for Waterbury Inter- ings and its portfolio of OTC brands for US$190 national Holdings, a private equity-owned firm. million (C122 million) (OTC bulletin,29 Sept- IN BRIEF Commenting on the appointment, Matthew ember 2010, page 1). ■ TBWA\PALING WALTERS said its chair- Mannelly,president and chief executive offi- Mannelly noted that Anderson had made man and chief executive officer, Mike Paling, cer of Prestige, described Lombardi as a “re- “many significant contributions to Prestige” had received the Judge’s Award for Outstand- sults-orientated financial professional”. “His during his 10 years with the company. ing Contribution to Pharmaceutical Marketing OTC at the UK’s Pharmaceutical Marketing Excel- lence Awards (PMEAs). At the end of this year, Retailers Paling will hand over the running of the health communications agency – which he founded 30 China Nepstar changes finance head years ago and is now part of the TBWA\Lon- don Group – to managing director Andy Hay- hina Nepstar said its chief financial offi- to chief financial officer. He joined in 2003. ley. Paling will continue to advise and support Ccer, William Weili Dai,had left the drug- Previously,Shao worked as a director,vice the UK-based agency in a non-executive chair- store chain due to “personal reasons”. general manager and chief financial officer in man’s role. Zixin Shao – vice-president and financial China Resources Supermarket (Suzhou) Co. OTC controller of the company – has been promoted OTC

22 OTC bulletin 16 December 2010 OTC16-12-10p22-23FIN.qxd 14/12/10 06:48 Page 3

PEOPLE OTC

Manufacturers Retailers D’Arcy heads Numark Merck raises Frazier to after Mottram departs chief executive officer ony Mottram has stepped down as the Tmanaging director of Numark less than 18 months after taking up the post. The UK- erck & Co has promoted Kenneth Fra- Kenneth Frazier based virtual pharmacy chain said Mottram had Mzier to chief executive officer with effect left to “pursue other business interests”. from 1 January 2011. He will also remain pres- He has been replaced by John D’Arcy,com- ident of the US-based pharmaceutical company. mercial director of sister company Rowlands Frazier will replace Richard Clark,who Pharmacy. D’Arcy had been managing direc- will continue in his role as chairman. Clark has tor of Numark on an interim basis prior to Mot- been chief executive officer since 2005. tram’s promotion from the post of commercial Merck said Frazier’s appointment was the director in June 2009 (OTC bulletin,15 May result of a “long-term thoughtful succession- 2009, page 22). planning process”. D’Arcy was interim managing director for Frazier has spent 18 years with Merck in a more than a year following the death of Simon number of senior posts, including general coun- Colebeck in 2007 (OTC bulletin,25 January sel from 1999-2007. He was appointed execu- 2008, page 21). tive vice-president and president of Global Hum- Commenting on his appointment, D’Arcy an Health in 2007, before becoming president ceutical and vaccine sales and marketing, re- said he had rejoined Numark at a “challeng- of Merck earlier this year (OTC bulletin,14 search and development, and manufacturing ing time for community pharmacy, particu- May 2010, page 27). and supply. larly the independent sector”. “Numark has Merck pointed out that he had played a key Merck said that in his new position Frazier a key role in equipping its members with the role in the firm’s US$41 billion (C32 billion) ac- would “take the helm and guide the continued tools needed not just to rise to the challenges quisition of Schering-Plough (OTC bulletin, implementation of our long-term strategy”. ahead,”he added, “but also to maximise the 17 March 2009, page 1). The company’s strategy includes expanding opportunities.” The company also noted that Frazier had the reach of its Consumer Care business in Eur- Paul Smith, chairman of Numark, said that improved the effectiveness of its three largest ope and emerging markets (OTC bulletin,18 D’Arcy would provide “clarity and leadership worldwide divisions responsible for pharma- August 2010, page 1). for Numark, its membership and staff”. OTC John D’Arcy

Retailers Walmart sues CVS over Mullany

almart has taken legal action against CVS ground in operations, finance and strategic W Caremark over its appointment of Hank planning”, CVS pointed out that he had been Mullany as president of the CVS/pharmacy re- responsible for the operation of 1,300 stores tail operations in the US. across 19 states in his role at Walmart. Mullany, 52 – former executive vice-pres- Earlier in his career,Mullany held a num- ident and president of Walmart North – has ber of senior management roles, including as been temporarily suspended from joining CVS president of Genuardi’s Family Markets.

after Walmart filed a lawsuit in the Court of Larry Merlo,president and chief operat- Tony Mottram Chancery in Delaware claiming that he is in ing officer of CVS Caremark, said Mullany und- breach of a contract forbidding him from work- erstood the many demands and challenges of ing for a competitor for two years. Mullany the retail business. “His expertise, along with worked at Walmart until 5 November. his demonstrated ability to execute strategies and produce outstanding results, make him the Allegations are “without merit” right candidate to drive continued growth in our CVS insisted that the allegations in the law- retail business and further our industry lead- suit were “without merit”. ership for many years to come,”he added. If Mullany is granted permission to join CVS Mullany is set to succeed Merlo, who will following a preliminary hearing on 15 Decem- replace Tom Ryan as chief executive officer ber,he will bring nearly 30 years of retail ex- at CVS’ meeting of shareholders in May 2011 perience to the US pharmacy chain. (OTC bulletin,31 May 2010, page 31). Noting that Mullany had “a strong back- OTC OTC

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

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