Reckitt Benckiser set to buy India's Paras for INR32.6bn

Sinclair signs Decapinol 3partner in US36.6 resurrects its 4expansion strategyNavamedic secures rights 5to NYDA in three marketsGNC quiet on takeover 5speculationMag-Ox buy fails to offset 6OTC sales drop at Hi-TechBeiersdorf to cut offering 7as it focuses on skincare

GENERAL NEWS 8

McNeil recalls Rolaids 8in Canada and the USThree pharmacy bodies 9speak with single voiceASA gives Lyclear 11the all-clear in UK

MARKETING NEWS 12

Clarityn’s fast acting claim 12is stopped in UK by MHRAHappy and healthy kids 13star in PediaCare spotsFlucalyptol offers France 15‘free access’ pholcodineAnadin gets a boost in UK 17with effervescent ibuprofenCoughing animals promote 18Buttercup’s benefits in UK

FEATURES 20

2010 turns out to 20be an eventful yearRecalls, acquisitions, people onthe move, traditional herbalmedicines and food claims werehot topics in 2010

REGULARS

Consumer viewpoint 10– Erectile dysfunction isthe topic of this month’sEuropean consumer surveyEvents – Our regular listing 19People – NBTY names Nagel 22as its new chief executivePeople – Merck raises Frazier 23to chief executive officer

COMPANY NEWS 3

16 December 2010

Reckitt Benckiser is set to boost its con-sumer healthcare business by acquiring

India’s Paras Pharmaceuticals for INR32.6billion (CC546 million).

The premium price tag represents more thaneight-times Paras’ sales of INR4.0 billion in theyear to March 2010, and nearly 30-times thecompany’s operating earnings before interest,tax, depreciation and amortisation (EBITDA)of INR1.1 billion.

The deal comes soon after Reckitt Benck-iser expanded its consumer healthcare businesswith the purchase of SSL International and itsDurex and Scholl brands for £2.54 billion (C3.02billion) (OTC bulletin, 30 July 2010, page 1).

Commenting on the Paras deal, Bart Becht,Reckitt Benckiser’s chief executive officer, saidthe growth potential of the business, the cre-ation of a material healthcare business in India’slarge and growing healthcare market, and theglobal synergies available made Paras an “ex-citing addition” to the company’s portfolio.

Reckitt Benckiser pointed out that acquir-ing privately-held Paras would give it a port-folio of Indian OTC brands with leading mar-ket positions, including India’s number twotopical analgesic pain ointment Moov and thenumber two cold and flu remedy D’Cold.

Paras also marketed Krack, India’s leadingmedicated skin treatment for cracked heels,Reckitt Benckiser pointed out, along with theItch Guard and Ring Guard antifungal creams.

Paras’ personal-care business, meanwhile,was led by the Set Wet brand of hair gels anddeodorants for men, the company said.

The deal will also give Reckitt Benckiser anew state-of-the-art and Good ManufacturingPractice compliant manufacturing plant in Nor-thern India, which employs around 700 people.

Becht said the Paras deal was another stepforward in Reckitt Benckiser’s consumer health-care growth strategy. “We believe the Parasbusiness has extremely good growth potentialwhen supported by Reckitt Benckiser’s invest-ment and innovation strength,” he added.

Reckitt Benckiser’s Health & Personal Caredivision is the company’s largest, with sales of£1.67 billion in the first nine months of 2010(OTC bulletin, 16 November 2010, page 4).It represented 27% of Reckitt Benckiser’s totalsales for the period of £6.18 billion.

Reckitt Benckiser set to buyIndia’s Paras for INR32.6bn

Jeffrey Kindler has stepped down as chair-man and chief executive officer of Pfizer,

and retired from the company with immedi-ate effect.

In the wake of Kindler’s abrupt departure,the US-based pharmaceutical firm has nam-ed Ian Read, 57, head of its global biopharm-

■ Continued on page 8

Kindler makes abruptdeparture from Pfizer

Buying Paras will give Reckitt Benckiser a portfolio ofOTC brands in India including Moov topical analgesics

GlaxoSmithKline Consumer Healthcare ispoised to expand its Nutritional Health-

care business by acquiring Maxinutrition fromDarwin Private Equity for approximately £162million (C192 million) including the repay-ment of outstanding debt.

Described as “Europe’s number one sports■ Continued on page 7

GSK adds musclewith Maxinutrition

OTC16-12-10p1.qxd 14/12/10 06:35 Page 1

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Sinclair Pharma has signed up Sunstar Amer-icas to relaunch its Decapinol mouthwash

in the US. Sunstar will market Decapinol as anOTC product under its GUM brand name.

Under the terms of the agreement, said Sin-clair, Sunstar had also taken an option to lic-ense Decapinol in Japan once the product hadbeen registered, as well as further options cov-ering several other countries where the prod-uct was not currently marketed.

The deal was struck shortly after Sinclairannounced that it had teamed up with biophar-maceutical firm Invida to launch its dermatol-ogy and wound care products across 11 markets

in the Asia-Pacific region, and had acquiredthe rights to the Kelo-cote wound care brandin the UK and Germany.

Sunstar – which already markets Sinclair’sAloclair mouth-ulcer gel and mouth rinse in theAmericas region under the GUM Canker-X andGUM Rincinol brand names – would return De-capinol to the US market during 2011, Sinclairpointed out, and would market the productthrough pharmacies and other US retailers toappeal to the “health-conscious consumer”.

Previously, Decapinol had been availablein the US under the Impede brand name. How-ever, in November of last year Sinclair said ithad mutually agreed to terminate its US distri-bution deal with the Johnson & Johnson sub-sidiary Orapharma, so that the product couldbe repositioned for the OTC market (OTC bul-letin, 30 November 2009, page 2).

Sinclair claimed its “ecological” approachto oral hygiene was in marked contrast to thestandard antiseptic mouthwashes that current-ly dominated the US$750 million (C566 mil-lion) mouthwash market in the US.

In light of this, the company was aiming touse consumer education to help grow the brand,in much the same way that food manufacturershad grown the market for probiotic yoghurtsby educating consumers about gastro micro floramaintenance, according to Sinclair’s commer-cial chief scientific officer Simon Youlton.

Adding Sinclair’s delmopinol-based alter-native to antiseptic mouthwashes to Sunstar’sexisting PerioBalance probiotic lozenge, Youl-ton pointed out, gave Sunstar the platform tomove consumers towards a “healthier, natu-ral approach to daily oral care”.

A “slow initial build-up in sales” was an-ticipated, Sinclair noted, as the marketing mes-sage was developed and rolled out.

Meanwhile, Sinclair has named Invida asits exclusive distribution partner for its derma-tology and wound care portfolios in Australia,China, Hong Kong, Indonesia, Malaysia, Philip-pines, Singapore, South Korea, Taiwan, Thai-land and Vietnam.

Chris Spooner, Sinclair’s chief executiveofficer, said the deal was a “landmark” for thecompany. It validated the company’s “strongconviction”, he added, that there was a “terrificopportunity” to take Sinclair’s product portfo-lio into “leading emerging markets”.

In the medium term, the two companieswere targeting “high volumes and strong prof-itability”, Sinclair said, “requiring substantialmarketing investment to build the brands”.

Invida would market the brands to generalpractitioners, dermatologists and paediatricians,Sinclair noted, as well as through pharmacies,drugstores and other retail outlets.

The “early emphasis on marketing invest-ment” demonstrated Sinclair’s focus on “sus-tainable value creation”, Spooner noted, addingthat the deal structure would serve as a blue-print for future partnerships in the region.

Sinclair’s dermatology portfolio covers acne,atopic dermatitis, fungal infections and familydermatology, and includes the company’s flag-ship Atopiclair dermatitis brand. The company’swound care offering includes the Flammazineand XClair brands.

Regulatory approvals permitting, launcheswould begin in the summer of 2011, the com-pany said, noting that it could take up to twoyears for the products to be introduced acrossall 11 markets.

On top of the deals in the US and Asia-Pacific, Sinclair has also expanded its woundcare portfolio and direct sales presence by ac-quiring Cranage Healthcare in the UK for aninitial payment of £0.40 million (C0.47 million).

The deal includes the distribution rights tothe Kelo-cote wound care brand in the UK,which, although sold mainly on prescription,is also available via Cranage’s online store.

In addition, the company has acquired thedistribution rights to Kelo-cote in Germanyfrom Advanced Bio-Technologies for an initialsum of C0.84 million. Sinclair already holdsthe distribution rights to Kelo-cote in France,Italy and Spain.

316 December 2010 OTC bulletin

COMPANY NEWS OTC

16 December 2010 Number 354

Editor & Publisher: Deborah Wilkes

Associate Editors: Aidan FryMike Rice

Business Editor: Matt Stewart

Assistant Editors: Joanne Grew, Jenna Lawrence,David Wallace

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Editorial, Subscription and Advertisingenquiries should be addressed to: OTC bulletin,OTC Publications Ltd, 54 Creynolds Lane, Solihull,West Midlands B90 4ER, UK.Tel: +44 1564 777550. Fax: +44 1564 777524.E-mail: [email protected].

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Distribution Agreements

Sinclair signs Decapinol partner in US

Sinclair’s Decapinol mouthwash will be sold bySunstar under its GUM brand name in the US

OTC

OTC16-12-10p2-3FIN.qxd 14/12/10 06:37 Page 3

4 OTC bulletin 16 December 2010

OTC COMPANY NEWS

Pharmacy Chain 36.6 will resurrect its ex-pansion plans in 2011, following a period of

store closures and restructuring, according tochief executive officer Artyom Bektemirov.

The Russian retailer had completed its pro-gramme of shutting under-performing stores,restructuring its finances and rebuilding rela-tions with suppliers, Bektemirov said, and nowhad the requisite resources to resume the grad-ual expansion of its pharmacy chain.

As of 30 September 2010, Pharmacy Chain36.6 was operating 997 stores across Russia(see Figure 1). This was down from 1,026 storesa year earlier.

Three stores had been opened organicallyduring the third quarter, the company stated,five stores had been closed, 14 had been re-branded, and one had been reformatted.

The reduction in store numbers, Bektemirovpointed out, had been the primary reason be-hind the 3.3% decrease in Pharmacy Chain36.6’s third-quarter Retail sales to RUB3.41

billion (C83.2 million) (see Figure 2).He added that the Retail business had been

lifted by a “gradual recovery” in the consumersector, as well as the expansion of its private-label range and its decision to cut the prices ofits most popular products by an average of 20%in its Moscow stores (OTC bulletin, 16 April2010, page 2).

Average spend in stores increasedThe size of the average spend in its stores

had increased by 8.3% to RUB248 in the thirdquarter, Pharmacy Chain 36.6 noted, addingthat in the Moscow region the average spendhad risen by 6.7% to RUB350.

Sales of private-label products had grownby 10.5% to RUB300 million during the quar-ter, Pharmacy Chain 36.6 said, accounting foraround a tenth of the company’s Retail sales.

Parapharmaceuticals made up the bulk ofthe company’s 932-strong private-label range,Pharmacy Chain 36.6 pointed out, with OTC

drugs, and vitamins, minerals and supplementsmaking up the remainder.

Retail sales accounted for 70% of Pharm-acy Chain 36.6’s total group sales in the thirdquarter, which ended up by 6.3% to RUB4.87billion. The company’s Veropharm manufac-turing business generated a further 26% of thesales total, with the remainder coming fromother businesses. Veropharm’s sales jumpedby 37.8% to RUB1.26 billion in the period.

Meanwhile, Pharmacy Chain 36.6 also con-firmed its sales and earnings for the opening sixmonths of 2010. Total group sales had slippedback by 14.9% to RUB9.75 billion, the com-pany noted, while earnings before interest, tax,depreciation and amortisation (EBITDA) edgedforward by 3.6% to RUB854 million.

Third-Quarter Results

36.6 resurrects its expansion strategy

Business Third-quarter sales Change Proportion(RUB millions) 2009/2010 (%) of sales (%)

Retail 3,413 -3.3 70

Veropharm 1,261 +37.8 26

Other 204 +18.7 4

Elimination -10 – –

Pharmacy Chain 36.6 4,868 +6.3 100.0

Figure 2: Breakdown of Pharmacy Chain 36.6’s sales in the third quarter of 2010 (Source – Pharmacy Chain 36.6)

Region Number of Share ofpharmacies sales (%)

Moscow Central 344 49.7

South Urals 179 13.0

South 168 12.0

Volga 147 11.7

North Urals 83 6.3

Siberia 52 4.3

North West 24 3.0

Total 997 100.0

Figure 1: Number of pharmacies operated by PharmacyChain 36.6 as of 30 September 2010, broken downby region of Russia (Source – Pharmacy Chain 36.6)

OTC

Merz Pharma Group said that an “aggres-sive marketplace” had led to a decline

in turnover at its Consumer Care business – in-cluding the Tetesept portfolio of OTC products– in the year ended 30 June 2010.

The privately-held German firm reportedConsumer Care sales down by 6.0% to C103million in the 12 months. The result marks thesecond successive decline in Consumer Care’sannual sales, following the 4.0% decrease dur-ing the previous year (OTC bulletin, 30 Nov-ember 2009, page 8).

Merz’ Consumer Care business includesthe Merz Spezial health and beauty brand, aswell as the core Tetesept range of licensed andunlicensed healthcare products.

Consumer Care’s sales accounted for 15%

of Merz’ turnover in the 12 months, whichimproved by 14.2% to C674 million. The bulkof Merz’ group sales came from its Pharma-ceuticals business, which posted sales up by19.4% to C552 million from its portfolio of pre-scription products and non-prescription derma-tology brands.

Acquired BioForm MedicalEarlier in the year, Merz advanced its strat-

egy of becoming a “leading player in aestheticmedicine – a fast-growing, multibillion dollarglobal market” – by acquiring the medical aes-thetics company BioForm Medical for US$253million (C191 million) (OTC bulletin, 26 Feb-ruary 2010, page 3).

Annual Results

Tough market curbs sales at Merz

OTC

■ JOHNSON & JOHNSON has launched aC24.75 per share offer for the 82% stake it doesnot own in Dutch vaccines company Crucell.The deal, which values Crucell at around C1.8billion, has received the backing of Crucell’smanagement and supervisory boards. Share-holders will vote on the offer at an extraordi-nary general meeting on 8 February 2011.

■ GEDEON RICHTER has agreed to investRMB18 million (C2.0 million) in setting up ajoint venture in China with its local marketingpartner Rxmidas Pharmaceuticals. The com-panies will each hold a 50% share in GedeonRichter Rxmidas Joint Venture Co, whichthe Hungarian company said would initiallybe used to register and launch its range of fe-male healthcare products in the Chinese market.

IN BRIEF

OTC

OTC16-12-10p4-5FIN.qxd 14/12/10 06:38 Page 2


COMPANY NEWS OTC

Navamedic’s Vitaflo Scandinavia sales andmarketing business has gained the exclu-

sive rights to distribute Pohl-Boskamp’s NYDAnon-prescription head-lice remedy in Denmark,Norway and Sweden.

Olof Milveden, Navamedic’s chief executiveofficer, said the company was seeing a growthin demand for head-lice remedies. Milveden not-ed that the market for such products across allthree countries was worth SEK18 million (C2.0million) annually.

Described by the Norwegian company as a“unique” head-lice remedy, NYDA works bysuffocating both the lice and eggs. If the pro-duct was used correctly, Navamedic pointed out,then it would get rid of all of the lice with justone treatment.

NYDA was a mild product suitable for chil-dren aged two years and older, added Nava-medic, noting the product was a medical device.

Navamedic said the deal represented anoth-er step in the company’s growth strategy, whichhad already seen it sign exclusive distributionagreements to sell the Norwegian firm Smart-fish’s medical nutrition products in Denmark,Finland and Sweden, and market the SouthAfrican company Aspen Healthcare’s generic

products in the Benelux countries and Norway.Navamedic’s Vitaflo Scandinavia business

reported sales down by 1.7% to NKr13.7 mil-lion (C1.7 million) in the third quarter of 2010(OTC bulletin, 30 November 2010, page 9).The business has a portfolio of over 40 brandsin 10 product categories, including the Gluco-med glucosamine brand, which it distributes inDenmark, Finland, Norway and Sweden.

Distribution Agreements

Navamedic secures rightsto NYDA in three markets

Pohl-Boskamp’s NYDA head-lice remedy works bysuffocating both the lice and the eggs

OTC

General Nutrition Centers (GNC) is refusingto comment on speculation that China’s

Bright Food is poised to acquire the US-basednutritional supplements retailer.

Rumours are circulating as GNC preparesfor an initial public offering (IPO), which couldraise up to US$350 million (C265 million) (OTCbulletin, 15 October 2010, page 2).

Various media outlets have reported thatBright Food is set to bid between US$2.0 bil-lion and US$3.0 billion for GNC, and that thedeal could be agreed before the end of 2010. Anumber of reports have also claimed that pri-vate-equity firm Blackstone could join forceswith Bright Food for the bid.

Earlier in the year, GNC signed a memo-randum of understanding to form a strategicpartnership with Bright Food in China (OTCbulletin, 26 February 2010, page 9). At thetime, GNC said the joint venture – called GNC

China – would be formed and would launchproducts by mid 2010.

The tie-up with GNC marked Bright Food’sformal entry into the nutritional products arena,adding a new sector to its established operationsin fresh and processed foodstuffs.

GNC was acquired by private-equity firmApollo management for US$750 million sevenyears ago (OTC bulletin, 31 October 2003,page 3). GNC postponed a planned IPO in 2006(OTC bulletin, 17 November 2006, page 1).

The company generated group turnover ofUS$1.71 billion in 2009, with an operating pro-fit of US$181 million.

At the end of the year, the company hadmore than 6,900 outlets – over 5,400 of whichwere in the US – and had franchise operationsacross a further 47 countries (OTC bulletin,31 March 2010, page 7).

Mergers & Acquisitions

GNC quiet on takeover speculation

Beiersdorf – owner of the Nivea and Euc-erin skincare brands – has established an

independent affiliate business in Vietnam, as thecompany seeks to more than double its turn-over in the country by 2015.

Beiersdorf Vietnam – which is based in HoChi Minh City – would not only enable the firmto meet the “strong and consistently rising de-mand” for skincare products in Vietnam, theGerman firm said, but would also act as a plat-form for expansion in South-East Asia.

Growing faster than the marketJames Wei, the member of Beiersdorf’s ex-

ecutive board in charge of Asian operations,insisted that the company’s goal in Vietnam of“continuing to grow significantly faster thanthe market” would now be easier to reach.

“We can now adapt Nivea products evenmore closely to the specific needs of Vietnam-ese consumers,” he added, “and react faster tolocal market trends.”

“Nivea already holds leading positions innumerous product categories, and is the un-disputed market leader for body care, deodor-ants and men’s care products,” Wei claimed,adding: “These market positions are a solidbasis for future growth.”

Business Strategy

Beiersdorf setsVietnam targets

OTC

OTC

SEEK is the new name of UK-based drug-discovery firm PepTcell, which has a port-

folio of prescription and consumer health pro-ducts in development.

Explaining the change, SEEK’s chief exec-utive officer Gregory Stoloff said the company’snew identity better reflected its efforts “to seeka cure” in a number of major disease areas.

SEEK recently appointed Manfred Scheske– the former European president of Glaxo-SmithKline Consumer Healthcare – as chiefexecutive officer of its Consumer Health unit(OTC bulletin, 15 October 2010, page 1).

Scheske has full responsibility for SEEK’sconsumer health product portfolio, which in-cludes what the company describes as a “first-in-class” cough suppressant.

Business Strategy

PepTcell changesits name to SEEK

OTC

OTC16-12-10p4-5FIN.qxd 14/12/10 06:38 Page 3

Acquiring the Mag-Ox brand of magnesiumsupplements earlier this year did not pre-

vent turnover at Hi-Tech Pharmacal’s HealthCare Products division slipping back in the com-pany’s second quarter ended 31 October 2010.

The US-based firm said turnover at its HealthCare Products division had dropped by 7% toUS$3.4 million (C2.6 million) during the threemonths, as lower sales of its existing diabeticproduct portfolio offset the addition of Mag-Ox, which the company acquired from BlaineCompany in March (OTC bulletin, 17 March2010, page 3).

The acquisition gave Hi-Tech the rights tothe Mag-Ox, Maginex, Uro-Mag and Corbanbrands, which generated net sales of US$3.4million during 2009.

At the time of the deal, David Seltzer, Hi-Tech’s president and chief executive officer,said Mag-Ox was a good strategic fit with theexisting line of OTC brands for diabetics offer-ed by the Health Care Products division.

Mag-Ox joined Hi-Tech’s existing OTCbrands for diabetics including Diabetic Tussinfor coughs and colds, Diabeti Derm skincarecreams, Diabeti Sweet sugar substitutes, theMulti-betic multimineral/multivitamin supple-ment for diabetics, and Zostrix cream for reliefof diabetic foot pain.

Still seeking acquisitionsDespite the recent acquisition of Mag-Ox,

Seltzer said the company was still looking toexpand its OTC portfolio with “near and long-term acquisition and licensing opportunities”.

The Health Care Products division account-ed for 7.6% of Hi-Tech’s total sales, which grewby 10% to US$44.9 million for the quarter.

Sales by the dominant Generics division,which increased by 13% to US$36.8 million,accounted for 82.0% of the firm’s turnover. ECRPharmaceuticals generated a further 10.5%.

Hi-Tech’s total pre-tax profits jumped up by34.6% to US$15.2 million.


OTC COMPANY NEWS

Latvia’s Grindeks has reported a 21.7% in-crease in sales to LVL46.9 million (C66.1

million) in the opening nine months of 2010.The majority of the firm’s sales – LVL44.5

million – had been generated through exportsto 51 countries worldwide, Grindeks said.

The company offers a portfolio of prescrip-tion medicines, generics, active pharmaceuti-cal ingredients and OTC brands.

Looking ahead, Janis Romanovskis, Grin-deks’ chairman, said the company would con-tinue to introduce new products, enter into newmarkets, increase production capacity, and in-vest in future development.

Meanwhile, Grindeks said that East Capi-tal Asset Management had acquired a 10.18%stake in the company.

East Capital Asset Management has boughtinto Grindeks just over a month after the Rus-sian pharmaceutical company Pharmstandarddisposed of the 11.38% stake it had acquiredcontroversially earlier this year (OTC bulletin,30 April 2010, page 7).

Explaining the reasons why Pharmstandardhad sold its stake in Grindeks, a spokespersontold OTC bulletin that the company had notreceived any offers to increase its stake, andhad decided to accept a good offer.

Pharmstandard – which markets Grindeks’prescription-only cardiovascular medicine Mil-dronate in Russia – acquired the stake fromthe president of Latvia’s employers’ confed-eration, the LEC, prompting Grindeks to re-sign from the organisation.

Grindeks accused the confederation’s pre-sident Vitalijs Gavrilovs of “essentially breach-ing business ethics” by selling the stake toPharmstandard.

Nine-Month Results

Grindeks seesjump in sales

Second-Quarter Results

Mag-Ox buy fails to offsetOTC sales drop at Hi-Tech

OTC

OTC

■ PERRIGO has launched a generic versionof UCB Pharma’s prescription-only medicineXyzal in the US. The US-based store-brandspecialist’s generic levocetirizine tablets areprotected by 180 days of generic market exclu-sivity, after its partner Synthon successfullychallenged a Xyzal patent. Perrigo acquired ex-clusive US sales and distribution rights to thegeneric version of the switch candidate in 2008(OTC bulletin, 29 September 2008, page 2).

IN BRIEF

OTC

Slovenia’s Krka said sales of its self-medi-cation products had grown by 31% to C75.4

million in the opening nine months of 2010.During the period, the company had expand-

ed a number of its brands in various markets,Krka noted. In Estonia, Latvia and Slovenia,a pastille and spray had been added to its Sep-tolete Plus sore-throat remedies, the companypointed out, while in Russia, the Pikovit vita-min line had been expanded with the PikovitOmega 3 and Pikovit Prebiotik products.

Meanwhile, chewable tablet versions of Duo-vit Elegance and Duovit Sila had been addedto the Duovit vitamin and supplement brand inRussia and Ukraine, Krka pointed out, whileOrsoslim weight-management capsules hadbeen approved in Kazakhstan and Ukraine.

Self-medication products generated 10.4%of Krka’s total sales in the nine months, whichgrew by 5% to C727 million. Sales outside ofSlovenia were responsible for 89% of the com-pany’s total turnover.

Nine-Month Results

Self-medication upat Slovenia’s Krka

Acquiring Amerifit Brands in February ofthis year helped lift Martek Biosciences’

sales by 32% to US$435 million (C329 million)in the year ended 31 October 2010.

The US-based nutritional ingredients firmsaid Amerifit – which it bought from private-equity firm Charterhouse Group for US$200million (OTC bulletin, 10 February 2010, page3) – had contributed sales of US$61.4 millionfrom the acquisition date of 12 February untilthe end of the period.

Martek gained a number of natural-wellnessbrands in the US by acquiring Amerifit, includ-ing the probiotic supplement Culturelle and themenopause-relief supplement Estroven.

The majority of Martek’s sales came fromits nutritional ingredient’s business, which re-ported turnover up by 14% to US$372 million.Non-nutritional products generated a furtherUS$1.45 million.

Martek’s operating profit dropped by a fifthto US$50.8 million in the 12-month period.

Annual Results

Amerifit pushes upMartek’s turnover

OTCOTC

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COMPANY NEWS OTC

Avicenna has announced the appointmentof David Coles to its board as a non-exec-

utive director with effect from 1 January 2011.The UK-based virtual pharmacy chain said

Coles brought “immense knowledge” of thepharmaceutical sector to the position. He is aformer managing director of Unichem and a

former chairman of the British Association ofPharmaceutical Wholesalers (BAPW).

In a separate development, Avicenna haspromoted Dipesh Vaja from pharmacy busi-ness manager to national sales manager. Hejoined the company in 2008.

People

People

Avicenna appoints Coles to board

OTC

Mergers & Acquisitions

■ Continued from front page

nutrition company by market share”, Maxin-utrition generated sales of around £36 millionin the year ended April 2010, and achieved acompound annual growth rate (CAGR) of ap-proximately 21% over the past three years.

Acquiring the UK-based company adds theMaximuscle, Maxifuel and Maxitone sportsnutrition brands to GlaxoSmithKline’s exist-ing Nutritional Healthcare business, which isdominated by the Horlicks, Lucozade and Rib-ena drinks lines.

John Clarke, worldwide president of Glaxo-SmithKline Consumer Healthcare, said the dealwould give the company a “strong presence inthe fast-developing protein-based sports nutri-tion market” with brands that appealed acrossa “broad spectrum of consumers from elite ath-letes to sports participants and those seekingadditional nutritional supplementation”.

The acquisition demonstrated GlaxoSmith-Kline’s strategy of expanding its ConsumerHealthcare business through appropriate bolt-on purchases which met the company’s strictfinancial criteria, he added.

“GlaxoSmithKline will invest behind Maxi-nutrition’s science-proven products to extendthe growth of Maxinutrition within its UK andEuropean footprint,” Clarke pointed out, “andexpand it to the global marketplace whereGlaxoSmithKline has existing infrastructureand capabilities.”

Peter Boddy, chief executive officer of Maxi-nutrition, said that as a “fast-growing, focusedsports nutrition business with excellent growthprospects and a strong management team”, thecompany was a “perfect fit” for GlaxoSmith-Kline and its ambition to grow its Nutrition-al Healthcare business.

GlaxoSmithKline’s strong commercial andresearch and development capability, Boddyadded, coupled with its investment in expand-ing its global nutrition healthcare franchise innew markets and territories, offered “tremen-dous new opportunities” to develop the Maxi-nutrition brands and deliver impressive growthgoing forward.

GlaxoSmithKline’s Nutritional Healthcarebusiness generated turnover of £851 millionin 2009, of which £791 million came from theHorlicks, Lucozade and Ribena brands. Thebusiness represented 18% of Consumer Health-care’s total turnover of £4.65 billion (OTCbulletin, 26 February 2010, page 6).

GSK adds musclewith Maxinutrition

OTC

Beiersdorf – owner of the Nivea and Euc-erin skincare brands – is streamlining its

product portfolio and realigning its regionalstructures.

A “comprehensive package of measures andinvestments” had been drawn up, the Germancompany pointed out, to help implement its new“Focus on Skin Care. Closer to Markets” con-sumer business strategy.

The entire skin and body care range hadbeen analysed, Beiersdorf said, and the deci-sion had been made to streamline the comp-any’s product offering and to exit the decora-tive cosmetics market in Germany. All otherlocal affiliates would decide the future of theirown decorative cosmetics businesses indepen-dently, the company noted.

Although the product portfolio would betrimmed, substantial investments in the com-pany’s skin and body care brands were plan-ned, Beiersdorf stressed, with a large numberof new products scheduled.

Implementing these changes would lead toadditional costs of approximately C270 millionup to 2012, Beiersdorf said, noting that roughlyC120 million of this amount would probablybe booked in 2010. The costs also include write-downs of intangible assets relating to the firm’sChinese business.

As a result of these additional costs, thecompany’s earnings before interest and tax(EBIT) margin was expected to be approxi-mately 9% in 2010, Beiersdorf stated, whilesales growth should be 2% to 3%.

Meanwhile, Beiersdorf has appointed ÜmitSubasi as its new executive board member foremerging markets.

As of 1 March 2011, Subasi would be re-sponsible for Africa, India, Latin America, theMiddle East and Turkey, as well as Russia andthe Commonwealth of Independent States.

Subasi will join Beiersdorf from SC John-son, where he was responsible for the central,northern and eastern European regions.

Merck KGaA said Stefan Oschmann wouldbecome the new head of its Pharmaceu-

ticals business sector on 1 January 2011, afterElmar Schnee had decided to leave the Ger-man company for “personal reasons” at the endof this year.

Oschmann, 53, will join the German firm’sexecutive board and become a general partnerin the company with overall responsibility forboth the Merck Serono and Consumer HealthCare divisions.

Merck noted that Oschmann would take full

control of the Merck Serono business, whilePeter Shotter would remain in charge of theConsumer Health Care business and would re-port to Oschmann.

Oschmann joins Merck KGaA from US-bas-ed Merck & Co, where he has served as pres-ident of emerging markets since 2009.

In a separate move, Merck said Kai Beck-mann had been appointed to the new positionof head of human resources. He would join theexecutive board and become a general partneron 1 April 2011, the company noted.

Merck KGaA gets new pharma chief

Business Strategy

Beiersdorf to cut offeringas it focuses on skincare

OTC

OTC

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McNeil Consumer Healthcare has recalleda number of its Rolaids products in Can-

ada and the US, and has halted production fol-lowing consumer reports of foreign materialsin the gastrointestinal remedies.

The news follows a series of product recallsand suspension of production at the Johnson &Johnson subsidiary’s Fort Washington manu-facturing facility in the US. As a result, US salesby Johnson & Johnson’s OTC & Nutritionalsbusiness are expected to decline by US$600million (C454 million) in 2010 (OTC bulletin,29 October 2010, page 4).

The latest recall includes all lots of RolaidsExtra Strength Softchews, Rolaids Extra Strengthplus Gas Softchews and Rolaids Multi-Symp-tom plus Anti-Gas Softchews distributed in the

US. It also applies to all lots of Rolaids UltraStrength SoftChews and Rolaids Ultra StrengthSoftChews plus Gas Relief sold in Canada.

McNeil said it had initiated the recall fol-lowing some consumer reports of foreign mate-rials in the product, including metal and woodparticles. The company stressed that while therisk of “serious adverse health consequences”was remote, consumers were advised to stopusing the recalled products.

An investigation had determined that thematerials had been potentially introduced intothe product during the manufacturing processat a third-party manufacturer, McNeil said.

While the investigation was ongoing, thecompany noted, production of all three prod-ucts had been suspended and would not be re-

started until the required corrective actions hadbeen implemented.

This latest recall comes less than a monthafter McNeil recalled a number of OTC medi-cines in the US, including products sold underthe Benadryl, Motrin, Rolaids and Tylenol brands(OTC bulletin, 30 November 2010, page 12).

Meanwhile, Johnson & Johnson-Merck Con-sumer Pharmaceuticals – the OTC joint venturebetween Johnson & Johnson and Merck & Co– has issued a wholesale and retail level recallof 12 Mylanta gastrointestinal liquid remediesand one AlternaGEL antacid liquid product.The recall affecting the US and Puerto Rico isdue to a labelling problem.

The recall had been initiated, the companysaid, after an internal review had revealed thatinformation about the presence of alcohol fromflavouring agents had not been noted on thepackaging.

It was unlikely that the use of these prod-ucts would cause either alcohol absorption oralcohol sensitivity-related adverse events, John-son & Johnson-Merck Consumer Pharmaceu-ticals stressed, adding the recall had not beenundertaken on the basis of adverse events.


OTC GENERAL NEWS

Stiefel Laboratories has announced the winner of itsMaxClarity Fresh Face Challenge in the US.

She is Cindy Reed (pictured above), whose storyabout her new-found confidence since tackling acnewith MaxClarity was “a clear favourite”. Reed haswon a shopping and pampering trip for two to LosAngeles or New York.

To take part in the challenge, acne sufferers hadto use MaxClarity for up to 30 days and submit theirself-defined “moment of clarity” – together withbefore and after photographs of their skin – to thecompany’s website www.freshfacechallenge.com. Apanel of judges selected the finalists, then visitors tothe website voted for their favourite.

Launched earlier this year, MaxClarity is claimedto be “the first non-prescription foam-based acnetreatment system with VersaFoam technology”.

The MaxClarity Foam Acne Medicationrange comprises a deep cleanser, an advancedacne treatment and a rejuvenating toner. Theproducts contain either benzoyl peroxide orsalicylic acid, which Stiefel said “penetrate the skinquickly and fight acne at the source before itbecomes a pimple”.

Stiefel said the range provided consumers with“an acne solution that is easy-to-use, effective andbacked by science from dermatology experts”.

■ Continued from front page

-aceutical operations, as president, chief execu-tive officer and director. A new non-executivechairman would be appointed before the endof December, Pfizer said.

Kindler’s departure comes a little over a yearafter Pfizer completed the US$68 billion (C52billion) acquisition of its smaller rival Wyeth(OTC bulletin, 30 October 2009, page 3). Thebuy broadened Pfizer’s portfolio, and returnedthe company to the consumer healthcare mar-ket just under three years after selling its ownglobal OTC business to Johnson & Johnson(OTC bulletin, 25 January 2007, page 6).

Explaining his departure after nine years atPfizer, including four and a half as chief exec-utive officer, Kindler said that he felt it was

time to “recharge my batteries, spend some raretime with my family, and prepare for the nextchallenge in my career”.

“Our team can proudly boast of some trans-formational accomplishments,” Kindler added.“However, the combination of meeting the re-quirements of our many stakeholders aroundthe world and the 24/7 nature of my responsi-bilities, has made this period extremely de-manding on me personally.”

Commenting on Read’s appointment, Pfiz-er’s lead independent director Constance Hor-ner said that over the past four years Read had“redefined” the company’s go-to-market ap-proach with the creation of global business unitsand had brought to product development a foc-us and commitment to advance only medicinesthat have clear value to our customers.

Read joined Pfizer in 1978, and was appoint-ed president of the company’s internationalpharmaceuticals group with responsibility forLatin America and Canada in 1996. In 2001,Pfizer made Read its corporate vice-presidentwith responsibility for Europe and Canada, andsubsequently added the Africa/Middle East andLatin America regions to his leadership respon-sibilities. He was promoted to head of Pfizer’sglobal biopharmaceutical operations in 2006.

Kindler makes abrupt departure from PfizerManufacturers

Product Recalls

McNeil recalls Rolaidsin Canada and the US

OTC

OTC

Ian Read

OTC

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GENERAL NEWS OTC

The UK’s Medicines and Healthcare prod-ucts Regulatory Agency (MHRA) says it

has slots available in 2011 in all therapeuticareas, including biologicals and OTC medi-cines, to act as reference member state (RMS)for decentralised licensing applications in theEuropean Union.

Companies which have completed dossiersready for submission, or can submit earlier thanoriginally anticipated, are invited to [email protected].

UK’s MHRA offersOTC ‘slots’ in 2011

Regulatory Affairs

OTC

Three pharmacy associations in the UK haveteamed up to establish a community phar-

macy organisation with “a stronger, unifiedvoice” for its members.

Set up by the Association of IndependentMultiple Pharmacies (AIMp), the CompanyChemists’Association (CCA) and the NationalPharmacy Association (NPA), Pharmacy Voicewill begin operating in the New Year.

The group had been established, said thethree bodies, to simplify and strengthen theway they represented their members.

Noting the National Health Service (NHS)was entering “a period of rapid change”, theysaid “community pharmacy must fulfil its pot-ential and play an expanded role as a health-care provider of choice in the new NHS”.

This would be achieved by “offering un-rivalled accessibility, value and quality for pat-ients and driving forward both the medicinesoptimisation and public health agendas”, thetrio added.

Pharmacy Voice will be led by chairman IanFacer and chief executive Rob Darracott. Faceris also chairman of the NPA, while Darracottserves as chief executive of the CCA.

Facer and Darracott were unanimously ap-pointed by the Pharmacy Voice board, whichconsists of two nominees each from the AIMp,the CCA and the NPA.

The three organisations highlighted that theywould continue to provide their members witha full range of other support services, such asinsurance, training, and information.

Retailers

Three pharmacy bodiesspeak with single voice

OTCNicorette 15mg Inhalator could soon go ongeneral sale in the UK, if the latest switch

proposal from the Medicines and Healthcareproducts Regulatory Agency (MHRA) is giventhe go-ahead.

Consultation document ARM 69 states thatMcNeil 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 ofNicorette 15mg Inhalator will provide “no add-itional safety risk or issues” because it deliv-ers the same dose of nicotine per puff as the10mg cartridge.

The benefit of a cartridge containing 15mgof nicotine is that it can be used for twice aslong 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 reduceprior to quitting”, says ARM 69, adding it will“assist smokers who are unwilling or unableto smoke”, and provide “a safer alternative tosmoking for smokers and those around them”.

If the switch is approved, Nicorette 15mgInhalator 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]).

Switches

MHRA consults ona Nicorette change

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OTC GENERAL NEWS

CONSUMER viewpoint ....................................................... erErectile dysfunction is the subjectof this month’s Consumer viewpointsurvey of ailments suffered byEurope’s consumers. The surveyappears exclusively in OTC bulletincourtesy of Ipsos MORI.

Figure 1: Proportion of men in France, Germany, Italy, Spain and the UK who say they have suffered fromerectile dysfunction within the past year (Source – OTC bulletin 2010/Ipsos MORI)

0.7%

0.8%

1.6%

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 anOTC, prescription or herbal remedy (Source – OTC bulletin 2010/Ipsos MORI)

France Germany Italy Spain UK

OTC Prescription Herbal

French men are more likely to say they havesuffered from erectile dysfunction during

the past year than their counterparts in Germany,Italy, Spain or the UK, according to our Con-sumer viewpoint European survey.

Of the five countries covered by the IpsosMORI survey, France has the highest proportionof men who say they have suffered from erec-tile dysfunction during the past year at 1.6%,followed by Italy and the UK at 0.8%, Ger-many at 0.7% and Spain at 0.4% (see Figure 1).

Sufferers are more likely to be aged over 65years in all five countries (see Figure 2).

The low incidence of erectile dysfunction inthe survey countries means the following resultsshould be treated with caution.

As can be seen from Figure 3, prescriptionproducts are the most popular treatment optionin the survey countries.

The UK has the highest proportion of menwho have treated the condition with an OTCremedy or a prescription product (see Figures4 and 5). Germany has the highest proportionof herbal treaters (see Figure 6).

OTC

0.4%

0.8%

France

Germany

Italy

Spain

UK

Proportion of sufferers (%) Index

Fra Ger Ita Spa UK Fra Ger Ita Spa UK

Male 100.0 100.0 100.0 100.0 100.0 – – – – –

Female – – – – – – – – – –

18-24 – – – – 5.4 – – – – 43

25-34 11.0 – – – – 58 – – – –

35-44 8.6 17.6 25.7 – – 45 88 130 – –

45-54 21.1 13.2 – – 20.5 137 73 – – 121

55-64 15.1 6.8 18.3 21.4 – 89 47 124 170 –

65+ 44.2 62.4 56.0 78.6 74.1 247 250 301 403 382

Figure 2: Consumers in France, Germany, Italy, Spain and the UK who say they have suffered from erectiledysfunction in the past year, analysed by sex and age. The index indicates the likelihood that a consumerin a specific population group will have suffered from erectile dysfunction, and is the ratio of theproportion of total sufferers in a population group to the proportion of that group in the population as awhole (Source – OTC bulletin 2010/Ipsos MORI)

0.0 0.5 1.0 1.5 2.0

Proportion of men who say they have suffered from erectile dysfunction (%)

60.0

50.0

40.0

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20.0

10.0

0.0

Pro

port

ion

ofsu

ffer

ers

trea

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Our Consumer viewpoint ailments survey appears exclusively in OTC bulletin courtesyof Ipsos MORI. The survey is based on research conducted in February 2009 using Capi-

bus, the market researcher’s weekly European omnibus service. Ipsos MORI carried out face-to-face interviews with 1,000 plus adults in each of the survey countries – France, Germany,Italy, Spain and the UK. An OTC remedy was defined as a product purchased over-the-counterfrom a pharmacy or off a shop shelf.

■ For more information on the research supplied by Ipsos MORI, please contact Susan Purcell (Tel: +44 208

861 8000; Fax: +44 208 861 5515; E-mail: [email protected]).

0.0%

14.1%

0.0%

9.6%

............................. erectile dysfunction

Figure 4: Proportion of men in France, Germany, Italy, Spain and the UK who say they have suffered from erectiledysfunction who have treated the condition with an OTC remedy (Source – OTC bulletin 2010/Ipsos MORI)

France

Germany

Italy

Spain

UK

0.0 3.0 6.0 9.0 12.0 15.0

9.5%

Ipsos MORI and the ailments survey

OTC

0 10 20 30 40 50 60

1

2

3

4

5 36.5%

15.0%

55.8%

18.3%

0.0%

Figure 5: Proportion of men in France, Germany, Italy, Spain and the UK who say they have suffered from erectiledysfunction who have treated the condition with a prescription remedy (Source – OTC bulletin 2010/Ipsos MORI)

0 2 4 6 8 10

1

2

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5

0.0%

0.0%

0.0%

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9.6%

Figure 6: Proportion of men in France, Germany, Italy, Spain and the UK who say they have suffered from erectiledysfunction who have treated the condition with a herbal remedy (Source – OTC bulletin 2010/Ipsos MORI)

France

Germany

Italy

Spain

UK

France

Germany

Italy

Spain

UK

0.0 10.0 20.0 30.0 40.0 50.0 60.0

GENERAL NEWS OTC

0.0 2.0 4.0 6.0 8.0 10.0

Claims made in Omega Pharma’s televisionadvertising for its Lyclear head-lice treat-

ment have been given the okay by the UK’sAdvertising Standards Authority (ASA).

Rival Thornton & Ross lodged three com-plaints with the ASA about the commercial forOmega Pharma’s Lyclear Spray.

Firstly, Thornton & Ross maintained thatOmega Pharma’s claim that Lyclear was “anunbeatable treatment for head lice” was mis-leading and could not be substantiated.

Noting that “unbeatable” was a top parityrather than a superiority claim, the ASA said itreferred to the 100% effectiveness rate of thetreatment only, and not the time or ease of use.As no treatment could exceed 100%, ruled theASA, the advertisement was not misleading.

Secondly, Thornton & Ross challenged theclaim that “Lyclear is guaranteed to remove100% of head lice and eggs”. Pointing out thategg removal was only possible with the use ofa comb, Thornton & Ross said the commercialimplied that a comb was not necessary.

However, the ASA rejected this challenge.The focus of the advertisement was the prop-erties of the treatment, commented the ASA,adding that it understood that most viewerswould be aware that a comb was needed.

The final complaint lodged by Thornton &Ross was that the commercial was misleadingbecause it did not distinguish between the ad-vertised spray and other less effective productsin the Lyclear range.

Rejecting this complaint, the ASA noted thatthe advertisement focused on the spray onlyand not the portfolio of products.

Advertising Complaints

ASA gives Lyclearthe all-clear in UK

Proportion of men suffering from erectile dysfunction who have treated the condition with a herbal remedy (%)

Proportion of men suffering from erectile dysfunction who have treated the condition with a prescription remedy (%)

Proportion of men suffering from erectile dysfunction who have treated the condition with an OTC remedy (%)

IN BRIEF

OTC

■ ASA – the UK Advertising Standards Auth-ority – has upheld three complaints about apress insert for Revitalise’s joint pain tabletsand cream. The ASA pointed out the companyhad made “breakthrough” claims – includingthat the products could reverse the effects ofarthritis, eliminate pain and had no known side-effects – that could not be substantiated andwere therefore misleading. Describing the in-sert as “irresponsible”, the ASA added that itcould discourage people from seeking essen-tial treatment for a serious medical condition.The ASA ruled that the insert must not appearagain in its current form.

OTC

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MSD Consumer Care has agreed to stopusing the “fast acting” claim for its Clar-

ityn Allergy Tablets in the UK, after a complaintwas made to the Medicines and Healthcare pro-ducts Regulatory Agency (MHRA).

The company recently used the claim on itspackaging and other marketing materials forClarityn Allergy Tablets.

Rival firm McNeil Products complained tothe MHRA because it believed the claim “Fastacting hay fever relief” used in point-of-salematerial for the 10mg loratadine tablets was notsupported by adequate evidence.

The MHRA upheld the complaint, pointingout that there was inadequate evidence to showthat symptomatic relief could be achieved withinaround 30 minutes after taking the tablets.

According to the MHRA, claims for fast act-ion for a hayfever product need to be support-ed by “evidence demonstrating that the averageconsumer would experience meaningful relief

from their symptoms within a period of around30 minutes after taking the product”.

The MHRA noted that it had taken action toensure the claims were removed from the pack-aging and advertising of other medicines con-taining loratadine.

McNeil’s competing products Benadryl Al-lergy Relief and Benadryl Plus, which both con-tain the active ingredient acrivastine, are claim-ed to start working in 15 minutes.

Meanwhile, the MHRA has upheld a com-plaint against the consumer goods companyMultibrands.

The firm had stated on a website that its Pan-odyne products, which are claimed to relievepain, were “tested and certified by MHRA”.However, the products were not authorised,said the MHRA, adding it did not test or cer-tify individual products.

Multibrands has agreed to withdraw the web-site until the products have been authorised.


OTC MARKETING NEWS

Reckitt Benckiser is backing the Durex Playlubricants and massage products it has just

acquired with a European advertising camp-aign that “explores the bewitching chemistrybetween lovers”.

Created by the agency McCann Manchester,the campaign includes two television commer-cials, which made their debut in the UK at theend of November and will be rolled out to oth-er countries in Europe over the next six months.The UK campaign, which is running for fourweeks, also includes in-store, online and socialmedia activity.

The commercials, which focus on DurexPlay lubricants and Durex Play Massage 2 in 1gels, are running terrestrially on Channel 4 andFive, as well as on satellite channels.

The commercial for Durex Play lubricantshighlights the sexual chemistry between twolovers. A scantily clad woman is seen strokingdifferent parts of a man’s body with the lubri-cant. Her touch produces a tingling sensationon his skin, followed by drawings of flamesand tigers.

“Discover new and exciting sensations witha magical range of Play lubes from Durex,”

states a sexy female voiceover.Meanwhile, television advertising for Durex

Play Massage 2 in 1 products features a pas-sionate couple undressing and massaging eachother with gel, leaving trails of “magic” overeach other’s bodies.

A female voiceover advises consumers to“get in the mood with the new Durex 2 in 1Massage range”.

Both commercials carry the sign-off mes-sage “Love sex. Durex”. The company hasjust introduced this as the first-ever brand sig-nature for Durex, marking a “strategic shiftaway from safe sex to more magical sex” (OTCbulletin, 30 November 2010, page 15).

Commenting on the campaign for DurexPlay, brand manager Katy Oliver, said “themagic of sexual connection is what makes thisDurex campaign so special”. “It is all too easyto get into the same routine, but sex shouldbe magical,” she explained.

Reckitt Benckiser gained the Durex ‘power-brand’ after purchasing SSL International in adeal worth £2.54 billion (C2.97 billion) (OTCbulletin, 30 July 2010, page 1).

Regulatory Affairs

Clarityn’s fast acting claimis stopped in UK by MHRA

OTC

Marketing Campaigns

Durex plays with bewitching chemistry

A tiger is one of the images that appear on aman’s skin in Reckitt Benckiser’s new televisioncommercial for Durex Play lubricants

A passionate couple are the stars of televisionadvertising for Durex Play Massage 2 in 1 gels

“Love sex. Durex” is the sign-off message for bothtelevision commercialsOTC

“A new and delicious way to help Americans reachtheir recommended daily calcium and vitamin Dintake,” is how Pfizer Consumer Healthcare describesCaltrate Soft Chews.

Pfizer highlighted that new US health guidelinesrecommended that consumers increased their dailyintake of vitamin D. The company said Caltrate SoftChews, which come in a choice of chocolate truffle orvanilla crème flavours, were “a great-tasting andconvenient way” to help them reach these goals.

Furthermore, pointed out Pfizer, each chewprovided “20% more essential calcium thanMcNeil Nutritional’s Viactiv” chews, and containedjust 15 calories.

Pfizer is backing Caltrate Soft Chews with atelevision commercial featuring the sign-off message“We put the yum in calcium”, as well as print andonline activity aimed at women.

Two of the soft chews provide 1,200mg calciumand 800 IU vitamin D.

A pack of 60 chews has a recommended retailselling price of US$8.00-US$9.00 (CC6.00-CC7.00).

Pfizer acquired the Caltrate range of calciumsupplements when it bought Wyeth for US$68 billionlast year (OTC bulletin, 30 October 2009, page 3).

OTC

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Prestige Brands Holdings is backing its re-cently-acquired PediaCare children’s cough

and cold remedies in the US with a new nationaltelevision advertising campaign.

Tim Connors, chief marketing officer of Pres-tige, pointed out that the commercials were onair just two weeks after the company had ac-quired PediaCare. “It is our plan to reach con-sumers now, at the beginning of the cough/coldseason, when parents are most in need of reme-dies for their children’s ailments,” he said, addingthat Prestige was “fully committed to supportand invest in PediaCare as a key brand”.

Prestige explained that the two new com-mercials – created by the agency VIA Group –“repositioned the brand for continued long-termgrowth” by “celebrating the joys of healthy andhappy children”.

The campaign had a “cinéma vérité style”,continued Prestige, adding that it captured “par-ent-child moments in a way that is reminiscentof a home movie shot by a mom or dad”.

The first commercial supports PediaCare In-

fants Fever Reducer Pain Reliever, which waslaunched in September and contains the activeingredient acetaminophen.

Based around a giggling baby who has justrecovered from a fever, the commercial featuresthe on-screen text “Goodbye: Fever” followedby the word “Hello” accompanied by a yellowsmiley logo. A voiceover points out new Pedia-Care infant drops with acetaminophen is “rec-ommended by paediatricians to reduce fever”.

Meanwhile, the second commercial focuseson PediaCare Children’s Fever Reducer PainReliever Plus Multi Symptom Cold.

Images of a young girl dancing to music areaccompanied by the on-screen message “Yes-terday: Scratchy throat, fever......Today: Danc-ing queen”. A voiceover states that PediaCareis “relied on by moms and paediatricians tohelp kids feel better”.

Prestige acquired PediaCare when it purch-ased Blacksmith Brands Holdings for US$190million (C122 million) (OTC bulletin, 29 Sept-ember 2010, page 1).

The launch of PediaCare Infants Fever Re-ducer Pain Reliever came soon after Johnson& Johnson’s McNeil Consumer Healthcare sub-sidiary recalled more than 40 OTC medicinesfor infants and children manufactured at itsFort Washington facility in the US. The recallincluded liquid Tylenol products containingacetaminophen, known as paracetamol in manymarkets (OTC bulletin, 14 May 2010, page 1).

Johnson & Johnson has since resumed ship-ping limited quantities of the acetaminophen-based Children’s Tylenol Grape Splash liquid(OTC bulletin, 15 October 2010, page 4).

In a separate development, Prestige Brandshas extended its Little Remedies range in theUS with a dietary supplement that is claimed tonaturally soothe infants’ coughs with honey.

The company said that Little Colds Honey

Elixir “brings the benefits of natural honey” tochildren aged one to four years – the groupmost often advised against taking medicatedproducts for a cough or sore throat.

The newcomer offered a “pleasant, sweettaste that makes taking the elixir easier for kidswho don’t like the taste of most medications”,Prestige commented.

Furthermore, added the company, the prod-uct did not contain any alcohol, saccharin, dyesand gluten.

New addition “soothes cough naturally”A packaging strapline highlights that the

newcomer is “Non-medicated”. Meanwhile,bullet-points state that it is “Safe for toddlers12 months & older”, “Soothes cough naturally”and “Calms fiery throats”.

Infants aged one to four years should takea teaspoon every two to four hours. The sup-plement is also suitable for children aged overfour years, who should take two teaspoons everytwo to four hours.

The recommended retail selling price for a120ml pack is US$6.99.


MARKETING NEWS OTC

Marketing Campaigns

Happy and healthy kidsstar in PediaCare spots

A giggling baby and a dancing girl are the stars ofPrestige’s first television campaign in the US for itsrecently-acquired PediaCare brand

A dietary supplement containing honey is thelatest addition to Prestige’s Little Remedies range forchildren in the US

German company Sophien-Arzneimittel saidit had achieved “clear success” with what

it claims is the country’s first scientifically-conducted observational study of a homoeo-pathic medicine. The study involved 64 con-

sumers who had bought Sophien’s Katimunhomoeopathic cold remedy in 14 pharmaciesspread throughout Germany.

Of this group of consumers, 11% reportedfeeling better on the first day after taking Kati-

mun, and nearly half – 47% – said there hadbeen an improvement two or three days aftertaking the product.

A further third of the group of consumersfelt better more than three days after takingthe licensed medicine, which contains extractsof boneset, bryony, jessamine, monkshoodand sorrel.

Homoeopathic Medicines

Study by Sophien supports Katimun

OTC

OTC

OTC16-12-10p12-13FIN.qxd 14/12/10 06:42 Page 3

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A‘free-access’ version of Zambon’s Bio-calyptol 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 thecough suppressant pholcodine. The non-reim-bursable, non-prescription medicine comes ina 200ml bottle.

France’s ‘free-access’ initiative, allowingself-selection displays of certain non-prescrip-tion medicines in pharmacies, was launched in2008 (OTC bulletin, 31 July 2008, page 17).

Flucalyptol Toux Sèche is suitable for adultsand children above six years of age. The medi-cine comes with a measuring cup that allowscough sufferers to prepare the correct dose.

The adult dose is 15ml up to four times a day.Children between 12 and 15 years of age cantake 5ml up to six times a day, while childrenyounger than 12 years of age can take 2.5mlup to six times a day. The maximum treatmentperiod is five days.

Other ‘free access’ cough syrups contain-ing pholcodine include Cooper’s Clarix Sirop,

Laboratoires Genévrier’s Codotussyl Toux Sèche,Laboratoires Urgo’s Toux Sèche Humex andSanofi-Aventis’ Rhinathiol Toux Sèche.

Zambon’s Biocalyptol is a reimbursable, non-prescription medicine.


MARKETING NEWS OTC

Long-lasting relief from dry, burning and painful eyesis the on-pack claim for Bausch & Lomb’s ArtelacRebalance eye drops in Germany.

The company explained that the artificial tearsused “an innovative two-polymer combination” ofhyaluronic acid and PEG 8000 to rebalance moisturelevels in the eye. While 0.15% hyaluronic acid is saidto offer rapid distribution across the eye’s surfacewith hydrophilic properties, PEG 8000 increases howthe acid remains on the cornea.

Bausch & Lomb noted that Artelac Rebalance’smoisturising effect was boosted by electrolytesincluding calcium, magnesium and potassium– as well as vitamins such as vitamin B12 – thatwere naturally found in tears.

According to the company, the artificial tearsused the “innovative preservative” Oxyd, which brokedown into the constituents of tears – water, oxygenand salts – upon coming into contact with the eye.

Bausch & Lomb said the 10ml bottle of eye dropswas portable and easy to use. It has a recommendedretail price of CC13.99.

The company is promoting the medical devicethrough advertising in the trade press andinserting laminated information cards inpharmacists’ magazines.

Furthermore, Bausch & Lomb is runningpromotions with certain online pharmacies, wherebycustomers who order Artelac Rebalance receive afree branded lip balm.

OTC

Launches

Flucalyptol offers France‘free access’ pholcodine

Zambon’s Flucalyptol is a non-reimbursable medicine

OTC

GlaxoSmithKline Consumer Healthcare hasreplaced its Contac 12 Hour Relief de-

congestant medicine with Contac Dual Reliefin the UK.

According to the company, Contac 12 HourRelief – a pharmacy-only (P) medicine con-taining 120mg pseudoephedrine hydrochlorideper prolonged-release capsule – had been dis-

continued because of “export restrictions in thecountry of manufacture”.

GlaxoSmithKline said the new non-drowsyformulation would provide “additional benefitsto consumers due to its dual-action formula”.

Contac Dual Relief comprises tablets con-taining 30mg pseudoephedrine hydrochlorideand 500mg paracetamol. Packaging highlightsthat the P medicine is a “New formula withparacetamol” that “Clears nasal and sinus con-gestion” and “Relieves headache and pain”.

The newcomer is suitable for adults andchildren aged over 12 years, who should taketwo tablets up to three times a day.

A pack of 18 tablets has a recommended re-tail selling price of £3.89 (C4.59).

Restrictions have been imposed on medi-cines containing pseudoephedrine in a numberof countries because of the potential for mis-use in the illegal manufacture of methylamph-etamine or ‘crystal meth’.

Relaunches

GlaxoSmithKline rethinks Contac in UK

New Contac Dual Relief tablets contain paracetamolas well as pseudoephedrine OTC

■ ASA – the UK’s Advertising Standards Auth-ority – has upheld a complaint about a pressadvertisement for NeoCell’s beauty supple-ment containing collagen. Rival company Vita-biotics challenged whether the headline “Theworld’s best selling natural beauty supplement”was misleading. The ASA noted that consum-ers might not realise the claim referred to col-lagen supplements only. Vitabiotics also ques-tioned whether claims that the product led to“the reduction of fine lines and wrinkles” and“repaired nails” could be substantiated. Theauthority concluded that NeoCell could not sup-port these claims, which were therefore mis-leading. The ASA ruled the advertisement mustnot appear again in its current form.

OTC

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OTC16-12-10p15FIN.qxd 14/12/10 06:43 Page 3

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Pfizer Consumer Healthcare has extendedits Anadin pain relievers in the UK with ef-

fervescent ibuprofen tablets that are claimed towork “four times faster than standard ibuprofen”.

The company is positioning Anadin Liqui-Fast Effervescent tablets, which each contain200mg ibuprofen, as “a perfect painkilling solu-tion” for people who have trouble swallowingcapsules or tablets. The newcomer can relieveback, muscle, period and dental pain.

Describing the effervescent tablets as “pow-erful” and “cleverly designed”, Pfizer said they“dissolve quickly and easily in water”, and “workfast to relieve your pain and let you get on withyour life”.

“Aside from easing pain,” Pfizer continued,the tablets “also help relieve inflammation byblocking prostaglandin production in the tis-sues of the body”.

A general-sales list (GSL) medicine, AnadinLiquiFast Effervescent is grapefruit flavoured.It has a recommended retail selling price of£3.49 (C4.19) for a pack of 10 tablets.

The tablets are suitable for adults and chil-dren aged over 12 years. Users should take one

or two tablets dissolved in a glass of water everyfour to six hours, and take no more than six ina 24-hour period.

Pfizer is currently backing the Anadin brandwith television, print and radio advertising bas-ed on the theme “Wherever your pain your ans-wer is Anadin” (OTC bulletin, 16 November2010, page 17).

The company has also recently repackagedthe range, revamped its website at www.anadin.co.uk and launched an iPhone application.

Pfizer acquired Anadin when it purchasedWyeth for US$68 billion last year (OTC bul-letin, 30 October 2009, page 3).


MARKETING NEWS OTC

Nicotine gum that helps to keep teeth whitewhile doubling the chances of quitting smokingis the latest addition to McNeil ConsumerHealthcare’s Nicorette portfolio of smoking-cessationaids in Germany.

Nicorette Kaugummi Whitemint comes in achoice of 2mg and 4mg nicotine strengths, andis said by McNeil to have an “irresistible freshmint flavour”.

The newcomer joins the existing Mint, Freshmintand Spicemint flavours, as well as the Classic andFreshfruit variants.

Launch trade-press advertising for Whitemintstresses that the flavour is “neu vom Marktführer”, or“new from the market leader”. The gum is said to“maintain the natural whiteness of teeth”.

Thirty-piece packs of the pharmacy-onlymedicine have recommended retail selling prices ofCC9.93 for the 2mg strength and CC11.00 for the4mg version.

Larger packs containing 105 pieces arealso available.

Procter & Gamble is backing its Pepto-Bis-mol stomach remedy in the US with a tele-

vision and digital marketing campaign focus-ing on “holiday party under-indulgence”.

The company explained that the humorouscampaign “aims to increase awareness aboutthis common buzz kill at all holiday parties”.It added that it had teamed up with actor KenJeong – who recently starred in the moviesKnocked Up and The Hangover – to fulfil this“very important initiative”.

“Under-indulgent tummies are as dead asa condemned disco club,” commented Jeong.“Enjoying your holiday parties includes enjoy-ing various meats and treats. Normal indulgingis fine and if you occasionally overdo it, Peptohas you covered.”

Created by the agency Publicis, the cam-paign includes a 15-second television commer-cial, which will run throughout December onchannels including ABC, CBS, FOX and NBC.

A man and woman holding virtually empty

plates at a Christmas party are interrupted byJeong, who bursts in between them and knocksthe plates out of their hands. “Pathetic. Callthis a holiday party? We need a help,” he says,pointing out “these people are under-indul-gers” who are “not enjoying the holidays”.

The party begins to liven up as Jeong ex-plains that “together, we can end under-indul-gence”. “And if you over-do it, Pepto-Bismol’sgot you covered,” he adds, grabbing a bottleof Pepto-Bismol.

The commercial ends with the sign-off mes-sage “Eat, drink & be covered”.

The company is also backing Pepto-Bismolwith a 30-second online video based aroundthe same theme. It is available on Facebook atwww.facebook.com/peptobismol and on You-Tube at http://www.youtube.com/peptobismol.

In addition, Procter & Gamble is running apublic relations campaign offering “search andrescue tactics to liberate under-indulgers”.

Effervescent tablets containing 200mg ibuprofen arethe latest addition to Pfizer Consumer Healthcare’sAnadin range of pain relievers in the UK

Line Extensions

Anadin gets a boost in UKwith effervescent ibuprofen

OTC

Marketing Campaigns

Pepto-Bismol puts a stop to American under-indulgence

Procter & Gamble’s humorous television commercial for Pepto-Bismol in the US stars Ken Jeong OTC

OTC

OTC16-12-10p17FIN.qxd 14/12/10 06:45 Page 3

Coughing animals highlight that ButtercupSyrup 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 onthe sign-off message “It’s soothing, by nature”.

The humorous campaign comprises a 30-second commercial together with a 10-secondcut-down version, both of which are runninguntil 23 January on channels including ITV1,ITV2, Fiver and Sky. It is voiced by comedi-ans Jon Culshaw and Kevin Bishop.

Filmed in the style of a nature programme,the commercial features different animals – in-cluding a stag and a bird – that cannot stopcoughing. After a pair of grebes joke about theanimals, the stag takes action by instructing theothers to “take Buttercup”.

A mouse then appears and advises consum-ers that “For an effective cough medicine withonly natural active ingredients, choose Butter-cup Syrup”. “It’s soothing, by nature,” states themouse, as packs of the medicine appear in thelandscape shot.

The commercial ends with the bird flying upinto the air and squawking excitedly: “I’m feel-ing better now.”

Commenting on the approach taken in the

campaign, Omega Pharma said the focus onsoothing – rather than fighting – coughs clearlydifferentiated the Buttercup brand from its com-petitors. “The intention of this campaign is tostand out by communicating a different and uni-que reason to purchase, and to engage consum-ers with humour and a refreshingly differenttone of voice,” the company added.


OTC MARKETING NEWS

Johnson & Johnson has replaced its AveenoEczema Care products in the US with a trio

of “clinically shown” moisturisers aimed atadults and babies.

The company said the “breakthrough for-mulas”, which contained natural colloidal oat-meal and oat essence, supported healthy devel-opment of delicate skin and helped relieve ir-ritation due to mild to moderate eczema.

The three products – Aveeno Baby EczemaTherapy Moisturizing Cream, Aveeno BabyCleansing Therapy Moisturizing Wash and Ave-eno Eczema Therapy Moisturizing Cream foradults – did not contain parabens, steroids orpropylglycol, added Johnson & Johnson.

Johnson & Johnson highlighted a clinicalstudy in which the baby wash and cream hadimproved multiple symptoms of eczema in

over 90% of babies who had been treated withthe products daily.

Packaging for the products carries the Nat-ional Eczema Association’s Seal of Acceptance.

Johnson & Johnson said it had teamed upwith the National Eczema Association to “edu-cate and empower” eczema sufferers about thecondition for the winter. The campaign in-cludes online videos – entitled ‘IntroducingAveeno Eczema Therapy’, ‘Revolutionary In-gredient’ and ‘Soothing Skin Testimonial” –which are available on the Facebook social-networking site.

The firm is also running consumer-press ad-vertising and public relations activity.

The cream for adults is supplied in a 7.3 oztube with a recommended retail selling priceof US$8.20 (C6.19). Supplied in a 5.0 oz tube,the cream for babies retails at US$5.99, whilean 8.0 fl.oz bottle of the wash for babies has aprice of US$4.99.

The discontinued Aveeno Eczema Care rangeoffered a body wash and cream suitable for bothadults and babies (OTC bulletin, 25 January2008, page 13).

An extra strong lotion that kills 100% of head licewithin just 15 minutes of a single application is thelatest addition to Cooper’s Pouxit range of head licetreatments in France.

Pharmacy-press advertising for Pouxit XF – whichstands for “extra fort” or “extra strong” – calls theproduct the “ultimate weapon” against head lice. Itpoints out Pouxit XF contains the additive Penetrol,which makes the eggs of head lice absorb the productmore effectively than other Pouxit treatments.

Clinical tests indicate that just one shampoo withPouxit XF kills all head lice within 15 minutes,Cooper claims, after which the product can be rinsedout of the hair. Other Pouxit products must be appliedfor an hour, and then reapplied seven days later to killyoung head lice that had not been affected by thefirst application.

The odourless, colourless and insecticide-freeproduct – which is available in a 100ml bottle of4% dimeticone lotion – can be used on children fromthe age of six months and is suitable for pregnantwomen and asthmatics.

Marketing Campaigns

Coughing animals promoteButtercup’s benefits in UK

“It’s soothing, by nature” is the theme of OmegaPharma’s new television advertising for ButtercupSyrup in the UK

OTC

A trio of moisturisers for adults and babies sufferingfrom eczema has been added to Johnson & Johnson’sAveeno portfolio in the US

Launches

J&J refreshes Aveeno eczema range in US

OTC

OTC

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20 January■ Herbal Products After

April 2011London, UKA one-day seminar organised bythe British Herbal Medicine Asso-ciation (BHMA) and the RoyalPharmaceutical Society (RPS). Itwill focus on the end of the tran-sitional period for the EuropeanUnion’s traditional herbal medic-inal products directive, and will ex-plore the borderline between med-icines, foods, cosmetics and med-ical devices.Contact: Royal PharmaceuticalSociety (RPS).Tel: +44 20 7572 2737.Fax: +44 20 7735 7629.E-mail: [email protected]: www.rpharms.com.

26 January■ Homoeopathic

MedicinesBonn, GermanySpeakers from Germany’s federalinstitute for drugs and medical de-vices, BfArM, will be at this one-day conference run by Germany’smedicines manufacturers’ associ-ation, the BAH. It will be conduct-ed in German.Contact: BAH.Tel: +49 228 957 45 0.Fax: +49 228 957 45 90.E-mail: [email protected]: www.bah-bonn.de.

26 January■ Marketing Authorisation

in TurkeyFrankfurt, GermanyClassification and pharmacovig-ilance in Turkey are on the agendafor this one-day conference.Contact: Henriette Wolf-Klein,Forum Institut für Management.Tel: +49 6221 500 680.Fax: +49 6221 500 555.E-mail: [email protected]: www.forum-institut.com.

27-28 January■ Latest Developments

in PharmacovigilanceLondon, UKA two-day event focusing on dev-elopments in Europe and the US.Contact: Management Forum.Tel: +44 1483 730071.Fax: +44 1483 730008.E-mail: [email protected]: www.management-forum.co.uk.

3 February■■ Basics of

Regulatory AffairsLondon, UKA one-day course from The Org-anisation for Professionals in Reg-ulatory Affairs (TOPRA).Contact: TOPRA.Tel: +44 20 7510 2560.Fax: +44 20 7537 2003.E-mail: [email protected]: www.topra.org.

8 February■ Introduction to

Medicines LawBonn, GermanyA one-day meeting organised byGermany’s medicines manufact-urers’ association, the BAH, andconducted in German.Contact: BAH.Tel: +49 228 957 45 0.Fax: +49 228 957 45 90.E-mail: [email protected]: www.bah-bonn.de.

10 February■ The Pharma

Summit 2011London, UKThis event will look at ‘Reinvent-ing pharma for a new generation’.Contact: Economist Conferences.Tel: +44 20 7576 8116.Fax: +44 20 7576 8472.E-mail: [email protected]: www.economistconferences.com.

17-18 February■ Pharmaceutical

Regulatory Affairsin the Middle EastLondon, UKCountries to be discussed at thistwo-day conference include Bah-rain, Iran, Israel, Saudi Arabia, Sy-ria and Yemen.Contact: Management Forum.Tel: +44 1483 730071.Fax: +44 1483 730008.E-mail: [email protected]: www.management-forum.co.uk.

22-23 February■ Variations Regulation

Bonn, GermanyPeter Bachmann and Cornelia Nop-itsch-Mai from Germany’s federalinstitute for drugs and medical de-vices, BfArM will speak at thistwo-day conference. Each day can

be booked separately.Contact: Henriette Wolf-Klein,Forum Institut für Management.Tel: +49 6221 500 680.Fax: +49 6221 500 555.E-mail: [email protected]: www.forum-institut.com.

24 February■ Hot Topics in

AdvertisingA one-day event run by the UK’sMedicines and Healthcare prod-ucts Regulatory Agency (MHRA).Contact: MHRA.Tel: +44 20 3080 6903.E-mail: [email protected]: www.mhra.gov.uk.

28 February-1 March■ EuroPLX 45

Lisbon, PortugalA two-day partnering and licens-ing forum focusing on OTC medi-cines, nutraceuticals, branded pre-scription drugs and generics.Contact: RauCon.Tel: +49 6222 9807 0.Fax: +49 6222 9807 77.E-mail: [email protected]: www.raucon.com.

10-12 March■ CHPA Annual

Executive ConferenceAventura, Florida, USThe Annual Meeting of the USConsumer Healthcare ProductsAssociation (CHPA) is only opento members.Contact: Phyllis Taylor, CHPA.Tel: +1 202 429 9260.Fax: +1 202 223 6835.E-mail: [email protected]: www.chpa-info.org.

22-23 March■ Regulatory Affairs in

India and ChinaFrankfurt, GermanyDay one of this two-day seminarwill discuss regulatory affairs, clin-ical trial regulation and variationsin India, while day two will focuson China. Each day can be book-ed separately.Contact: Henriette Wolf-Klein,Forum Institut für Management.Tel: +49 6221 500 680.Fax: +49 6221 500 555.E-mail: [email protected]: www.forum-institut.com.

28-30 March■ DIA Annual

EuroMeetingGeneva, SwitzerlandA three-day conference organis-ed by the Drug Information As-sociation (DIA). Wider access in-cluding generics and self-care med-icines will be one of the 15 paral-lel sessions at the conference.Contact: DIA European Office.Tel: +41 61 225 51 51.Fax: +41 61 225 51 52.E-mail: [email protected]: www.diahome.org.

8-10 June■ 47th AESGP

Annual MeetingRome, ItalyThe Annual Meeting of the Asso-ciation of the European Self-Med-ication Industry, the AESGP. Moredetails will be available soon.Contact: AESGP.Tel: +32 2 735 51 30.Fax: +32 2 735 52 22.E-mail: [email protected]: www.aesgp.be.


EVENTS OTC

JANUARY FEBRUARY

MARCH JUNE

1-2 February■ What Regulation for Food Supplements and Herbal

Medicinal Products in Europe?Brussels, BelgiumThis two-day meeting is organised by the Association of the EuropeanSelf-Medication Industry, the AESGP.

There will be sessions entitled: ‘Implementation/enforcement of thenutrition and health claims regulation’; and ‘A single market for herbalmedicines in Europe?’.

Speakers will include: Dagmar Roth-Behrendt of the European Par-liament; Basil Mathioudakis and Paola Testori-Coggi of the EuropeanCommission; Vittorio Silano of the European Food Safety Authority(EFSA); and Ioanna Chinou of the European Medicines Agency’s Com-mittee on Herbal Medicinal Products (HMPC).Contact: AESGP.Tel: +32 2 735 51 30. Fax: +32 2 735 52 22. E-mail: [email protected]: www.aesgp.be.

OTC16-12-10p19FIN.qxd 14/12/10 06:47 Page 3

Companies dominated the headlinesin 2010, with both good and bad sto-ries unfolding during the year. John-son & Johnson’s McNeil Consumer

Healthcare subsidiary had a truly terrible time,following a series of product recalls and sus-pension of production at its Fort Washingtonmanufacturing facility in the US. By contrast,Reckitt Benckiser finally acquired SSL Inter-national after years of speculation, and has justagreed to buy India’s Paras Pharmaceuticals(see front cover). Meanwhile, Sanofi-Aventiscontinued to grow its OTC business with acqui-sitions in Canada, China, Poland and the US.

People on the movePeople on the move in the OTC industry also

hit the headlines on a regular basis. One of thebiggest stories came in September, when John-son & Johnson announced that Colleen Gog-gins would step down as worldwide chairmanof its troubled Consumer division at the begin-ning of March 2011 (OTC bulletin, 29 Sept-ember 2010, page 25).

Goggins will leave Johnson & Johnson justover a year after the company received a Warn-ing Letter from the US Food and Drug Admin-istration (FDA) about McNeil Consumer Health-care’s plant in Las Piedras, Puerto Rico (OTCbulletin, 10 February 2010, page 22). A fewmonths after receiving the Warning Letter, Mc-Neil also announced that it had suspended pro-

duction at its Fort Washington facility after vol-untarily recalling over 40 OTC medicines forinfants and children made at the plant (OTCbulletin, 14 May 2010, page 1).

The recalls sparked an investigation by theCommittee on Oversight and Government Re-form within the US House of Representatives.Goggins told the committee hearing that the re-call was a “disappointment” and that McNeil’squality and process issues had been “unaccept-able” (OTC bulletin, 11 June 2010, page 11).She also apologised to parents for the “concernand inconvenience caused”.

As OTC bulletin went to press, Johnson &

Johnson had just announced more product re-calls affecting its Rolaids brand in Canada andthe US (see page 8).

As a result of its troubles, Johnson & John-son expects that US sales at its OTC & Nutri-tionals business will decline by US$600 mil-lion (C457 million) during 2010 .

Meanwhile, at the beginning of 2010, San-ofi-Aventis recruited Hans Regenauer – pre-viously worldwide head of Boehringer Ingel-heim’s Consumer Health Care division – to de-velop its OTC business. Regenauer took on thenewly-created post of vice-president, ConsumerHealth Care, Europe, and global development(OTC bulletin, 20 January 2010, page 22).

News of Regenauer’s appointment followedhard on the heels of the announcement that San-ofi-Aventis intended to enter the US OTC mar-ket by acquiring Chattem for around US$1.9billion (OTC bulletin, 20 January 2010, page1). Since then, Sanofi-Aventis has boosted itsOTC business by acquiring Poland’s Nepentesfor PLN420 million (C105 million) and Canada’sCanderm for an undisclosed sum. Last month,it unveiled plans to strengthen its presence inthe Chinese OTC market by acquiring BMPSunstone and its portfolio of cough/cold andwomen’s health brands for around US$520 mil-lion (OTC bulletin, 16 November 2010, page 1).

Merck & Co signalled its ambitions for itsrecently-acquired Consumer Care business inFebruary by recruiting Bridgette Heller to lead

the operation. Previously pres-ident of Johnson & Johnson’sglobal Baby business unit, Hel-ler has a brief to grow the Con-sumer Care business in non-US markets (OTC bulletin, 26

February 2010, page 1).The following month, GlaxoSmithKline an-

nounced that it had recruited the next world-wide head of its Consumer Healthcare divisionfrom cosmetics company L’Oreal. Emma Walm-sley – formerly leader of L’Oreal’s ConsumerProducts business in China – joined Glaxo-SmithKline on 1 May as European presidentand worldwide president designate of the world-wide Consumer Healthcare division (OTC bul-letin, 31 March 2010, page 1).

And in April, it emerged that Dirk Van dePut was leaving Novartis just eight months afterbecoming worldwide head of the company’s

OTC business unit (OTC bulletin, 30 April2010, page 23).

Although companies and people grabbed thelion’s share of the headlines in 2010, regulatoryissues also had their fair share of coverage.

Herbal medicines were recently back in thenews when Members of the European Parlia-ment (MEPs) probed John Dalli, European Com-missioner for health and consumer policy, aboutthe European Union’s simplified procedure forregistering traditional herbal medicinal products(OTC bulletin, 30 November 2010, page 12).

Two MEPs pointed out that no Chinese orIndian Ayurvedic medicinal products had so farbeen registered using the simplified procedure.They wanted to know whether the Commissionplanned to amend Directive 2004/24/EC to makeit more applicable to non-European herbal cul-tures before the transition period ended in Ap-ril of next year.

Products that were already on the marketwhen the directive entered into force have tocomply with its requirements by 30 April 2011.

Noting the simplified procedure was han-dled by member states, Dalli said the Commis-sion did not have information on the productslicensed by the member states. As a result, headded, it did not know whether there had beenapplications and registrations for Chinese orIndian products.

Does not reduce accessHowever, Dalli insisted that the European

Union’s simplified procedure for registeringtraditional herbal medicinal products did notreduce access to Chinese or Indian products.Neither did it reduce access to products of com-panies with reduced financial capacity, he said.

Dalli stressed that the simplified procedurefacilitated the possibility to place specific tra-ditional medicinal products on the Europeanmarket, and did not introduce new requirementsmore burdensome than the ones following fromthe marketing authorisation procedures.

“On the contrary,” Dalli maintained, “theaim of these rules is to safeguard public healthand at the same time facilitate the free circu-lation of traditional herbal medicinal productswithin the European market.”

Dalli was adamant that if a traditional herbalmedicinal product was not registered or autho-rised as such by 1 May 2011, then the productcould not be placed on the European market.

According to figures compiled by the Asso-ciation of the European Self-Medication Indus-try, the AESGP, the number of registrations inEurope is growing relatively fast but is still low.


OTC REVIEW OF THE YEAR

2010 turns out to be an eventful yearProduct recalls, mergers and acquisitions, people on the move,traditional herbal medicinal products and food claims have all been hottopics in 2010. Deborah Wilkes reports.

By 13 December 2010, 194 traditionalherbal medicines had been registered usingEurope’s simplified procedure

OTC16-12-10p20-21FIN.qxd 14/12/10 06:47 Page 2

The AESGP told OTC bulletin that 194 pro-ducts had been registered using the simplifiedprocedure by 13 December 2010. This is upfrom 162 at the end of April 2010 (OTC bul-letin, 30 June 2010, page 23), and 66 a year ear-lier (OTC bulletin, 19 June 2009, page 19).

The UK leads the way in terms of the num-ber of traditional herbal medicinal products reg-istered by 13 December 2010. The UK had reg-istered 73 products, almost double the numberachieved by second-placed Austria with 40.

Of the 194 traditional herbal medicinal prod-ucts registered, 129 contain only one plant and65 contain combinations of plants.

Some companies are taking their productsto market via alternative routes, such as autho-risation as a well-established herbal medicineor a food supplement. Dalli noted that herbalproducts may be placed on the market as foods,provided that they do not fulfil the definitionof medicinal products.

Companies are also tapping into the exist-ing pool of registrations. Schwabe Pharma UK,for example, said in October that it could sup-ply other firms with a ‘piggy-back’ variationto its registrations for Thisilyn Milk Thistle andThisilyn Maximum Strength Milk Thistle in theUK. “Some companies have already contactedus and are in a position to launch their own ver-sions of our milk thistle traditional herbal medi-cines before the April 2011 deadline,” com-mented the company (OTC bulletin, 15 Octo-ber 2010, page 15).

Schwabe Pharma UK highlighted that it al-ready had 18 registrations for traditional herbalmedicines, and planned to obtain more.

A portfolio of registrations for traditionalherbal medicines is also available from Dia-pharm. The German pharmaceutical servicesprovider recently announced that it had reg-istered Europe’s first traditional herbal medi-cinal product to be combined with minerals(OTC bulletin, 15 October 2010, page 8).

The traditional herbal medicine containing40mg hawthorn extract together with potas-sium and magnesium salts has just been reg-istered by Germany’s federal institute for drugsand medical devices, BfArM. It is indicated forsupporting cardiovascular function and protect-ing against climatic stress.

Diapharm said it planned to register the tra-ditional herbal medicine in other European coun-tries, including Austria and the UK.

Slow progress with herbal products was be-hind the European Medicines Agency’s (EMA’s)announcement in June of an action plan to in-crease significantly the “quality and number”of Community herbal monographs and list entriesproduced by its Committee on Herbal Medi-cinal Products (HMPC).

Community herbal monographs for tradi-

tional and well-established herbal medicinalproducts are not legally binding on memberstates of the European Union, but they shouldbe taken into account. By contrast, entries onthe Community list of herbal substances, prepa-rations and combinations for use in traditionalherbal medicinal products are legally binding.

Since directive 2004/24/EC came into forcesix years ago, only seven entries have been add-ed to the Community list (OTC bulletin, 31 May2010, page 15). The HMPC proposes entriesto the Commission, which then adds them tothe Community list.

Meanwhile, only around 70 monographshave been finalised (OTC bulletin, 15 Octo-ber 2010, page 9).

Full application of the directive would re-quire between 200 and 300 herbal monographs,the HMPC has said in the past.

The low number of herbal monographs – to-gether with the unwillingness of some coun-

tries to act upon them – is causing problemsfor industry. OTC bulletin understands thatgaining access to market for new herbal medi-cines, including traditional herbal medicinalproducts, is a key concern for industry.

Another hot topic during 2010 was foodclaims. The European Commission recently de-cided to change the process for adopting gen-eral health claims for foods (OTC bulletin, 15October 2010, page 1).

The move came after industry and somemember states complained about the Commis-sion’s progressive approach whereby claimswere set to be adopted in a number of batches.They pointed out that this approach could leadto market distortions between companies whoseclaims had been rejected and companies whoseclaims had not yet been assessed.

Botanicals were treated differentlyFurthermore, concerns had been expressed

that botanical ingredients were treated differ-ently under the food claims regulation thanthey were under the legislation for traditionalherbal medicinal products.

The Commission announced in October thatthe community list of permitted general healthclaims for foods would now be established intwo steps. The list for all substances other thanbotanicals would be adopted in a single step, itexplained, with claims for botanicals consid-ered once the first step had been completed.

The Commission noted that the EuropeanFood Safety Authority (EFSA) was expected

to finalise opinions on all claims other thanbotanicals by the end of June 2011. The Com-mission would then “immediately” follow upwith the necessary legislative measures.

The community list of permitted generalhealth claims for foods – covered by Article13.1 of regulation 1924/2006 – should havebeen completed by 31 January 2010. However,it became clear some time ago that the dead-line would not be met (OTC bulletin, 30 Oct-ober 2009, page 18).

The first batch of permitted general healthclaims was finally put forward for adoptionrecently. But the European Union’s StandingCommittee on the Food Chain and AnimalHealth (SCFCAH) did not adopt the claims(OTC bulletin, 30 July 2010, page 13).

Adoption was necessary for these generalhealth claims to be included in a communityregister, as described by Article 20 of the reg-ulation. Claims rejected by EFSA would have

featured in a negative list in thecommunity register and wouldhave had to have been with-drawn from the market.

The first batch was basedon the scientific opinions pub-

lished by EFSA last October. EFSA only gavethe go-ahead to a third of the first group of 500-plus general health claims assessed (OTC bul-letin, 16 October 2009, page 11).

EFSA published a second group of opinionsearlier this year (OTC bulletin, 17 March 2010,page 11). Only a handful of the 416 submissionsin the second group were given the okay.

When the third group of opinions was pub-lished in October, most of the 808 submissionshad been rejected (OTC bulletin, 29 October2010, page 9).

EFSA has now said no to 80% of the 1,745general-function health claims assessed to date.So far, the authority has assessed just over athird of the 4,637 health claims compiled byEuropean Union member states and the Euro-pean Commission.

The OTC industry will have a chance to airits views on both food claims and traditionalherbal medicinal products at a meeting organ-ised by the AESGP in Brussels on 1-2 Febru-ary. Speakers will include Basil Mathioudakisand Paola Testori-Coggi of the European Com-mission, and EFSA’s Albert Flynn (see page 19).

Ending on a positive note, 2010 saw thearrival of Boehringer Ingelheim’s Flomax Re-lief in the self-medication arena. The UK wasthe first country in the world to make 0.4mgtamsulosin hydrochloride a non-prescriptionmedicine for treating benign prostatic hyper-plasia (BPH), or an enlarged prostate (OTCbulletin, 31 March 2010, page 13).


REVIEW OF THE YEAR OTC

OTC

The OTC industry will have a chance to airits views on both food claims and traditionalherbal medicinal products in February

OTC16-12-10p20-21FIN.qxd:Layout 1 14/12/10 08:34 Page 3

NBTY has appointed Jeffrey Nagel as itsnew chief executive officer. Nagel succeeds

Scott Rudolph, who will continue as chair-man of the US-based nutritional supplementsmanufacturer and retailer.

The news of Nagel’s appointment comesshortly after NBTY was acquired by the private-equity company The Carlyle Group in a dealworth US$3.8 billion (C2.8 billion) (OTC bul-letin, 15 October 2010, page 2).

Commenting on the appointment, Rudolphsaid that Nagel would be able to “take NBTYto the next level of growth and performanceand further establish its position as a globalmarket leader”.

Joins from General ElectricNagel joins NBTY from General Electric

Company (GE), where he most recently servedas vice-president and general manager of GEOil & Gas Global Services. His previous posi-tions at the company included president andchief executive officer of GE Inspection Tech-

nologies, general manager of business devel-opment at GE Aircraft Engines, and presidentof GE Home Electric Products. Nagel joinedGE in 1997 as a manager in business develop-ment at GE Lighting.

Prior to joining GE, Nagel worked at EnergyBiosystems, Cannon Associates, Reid & Host-age, and Strategic Planning Associates (nowMercer Management).


OTC PEOPLE

China Nepstar said its chief financial offi-cer, William Weili Dai, had left the drug-

store chain due to “personal reasons”.Zixin Shao – vice-president and financial

controller of the company – has been promoted

to chief financial officer. He joined in 2003.Previously, Shao worked as a director, vice

general manager and chief financial officer inChina Resources Supermarket (Suzhou) Co.

Prestige Brands Holdings has recruited RonLombardi as the replacement for its retir-

ing chief financial officer Pete Anderson.The US-based company said that Lombardi

brought extensive financial management expe-rience to his new role. Most recently, he servedas chief financial officer for Waterbury Inter-national Holdings, a private equity-owned firm.

Commenting on the appointment, MatthewMannelly, president and chief executive offi-cer of Prestige, described Lombardi as a “re-sults-orientated financial professional”. “His

extensive background in business development,acquisitions and divestitures, and debt and equitystructuring will serve Prestige well as we moveinto our next phase of growth following our re-cent acquisition of Blacksmith Brands,” he said.

Prestige acquired Blacksmith Brands Hold-ings and its portfolio of OTC brands for US$190million (C122 million) (OTC bulletin, 29 Sept-ember 2010, page 1).

Mannelly noted that Anderson had made“many significant contributions to Prestige”during his 10 years with the company.

Jeffrey Nagel

Andy Wines

Manufacturers/Retailers

NBTY names Nagel asits new chief executive

OTC

Manufacturers

Prestige recruits new finance chief

Retailers

China Nepstar changes finance head

OTC

OTC

Manufacturers

Wines movingto Seven SeasOmega Pharma’s Andy Wines is moving

to Seven Seas as marketing director at thebeginning of 2011.

Wines has been Omega’s marketing direc-tor for the UK and Ireland since November2009. Together with the team at Omega, hehas revamped the consumer marketing camp-aigns for a number of brands including JungleFormula and Wartner (OTC bulletin, 11 June2010, page 8).

He pointed out that his eight years at RocheConsumer Health would be valuable when deal-ing with the Seven Seas portfolio of food sup-plements. Wines held the positions of market-ing director, global head of category marketingand group brand manager at Roche ConsumerHealth, which is now part of Bayer Health-Care, and worked on the company’s Beroccaand Sanatogen food supplements.

Wines has also had global marketing postsat Johnson & Johnson and Reckitt Benckiser.

OTC

■ TBWA\PALING WALTERS said its chair-man and chief executive officer, Mike Paling,had received the Judge’s Award for Outstand-ing Contribution to Pharmaceutical Marketingat the UK’s Pharmaceutical Marketing Excel-lence Awards (PMEAs). At the end of this year,Paling will hand over the running of the healthcommunications agency – which he founded 30years ago and is now part of the TBWA\Lon-don Group – to managing director Andy Hay-ley. Paling will continue to advise and supportthe UK-based agency in a non-executive chair-man’s role.

OTC

IN BRIEF

OTC16-12-10p22-23FIN.qxd 14/12/10 06:48 Page 2

Merck & Co has promoted Kenneth Fra-zier to chief executive officer with effect

from 1 January 2011. He will also remain pres-ident of the US-based pharmaceutical company.

Frazier will replace Richard Clark, whowill continue in his role as chairman. Clark hasbeen chief executive officer since 2005.

Merck said Frazier’s appointment was theresult of a “long-term thoughtful succession-planning process”.

Frazier has spent 18 years with Merck in anumber of senior posts, including general coun-sel from 1999-2007. He was appointed execu-tive vice-president and president of Global Hum-an Health in 2007, before becoming presidentof Merck earlier this year (OTC bulletin, 14May 2010, page 27).

Merck pointed out that he had played a keyrole in the firm’s US$41 billion (C32 billion) ac-quisition of Schering-Plough (OTC bulletin,17 March 2009, page 1).

The company also noted that Frazier hadimproved the effectiveness of its three largestworldwide divisions responsible for pharma-

ceutical and vaccine sales and marketing, re-search and development, and manufacturingand supply.

Merck said that in his new position Frazierwould “take the helm and guide the continuedimplementation of our long-term strategy”.

The company’s strategy includes expandingthe reach of its Consumer Care business in Eur-ope and emerging markets (OTC bulletin, 18August 2010, page 1).


PEOPLE OTC

Walmart has taken legal action against CVSCaremark over its appointment of Hank

Mullany as president of the CVS/pharmacy re-tail operations in the US.

Mullany, 52 – former executive vice-pres-ident and president of Walmart North – hasbeen temporarily suspended from joining CVSafter Walmart filed a lawsuit in the Court ofChancery in Delaware claiming that he is inbreach of a contract forbidding him from work-ing for a competitor for two years. Mullanyworked at Walmart until 5 November.

Allegations are “without merit”CVS insisted that the allegations in the law-

suit were “without merit”.If Mullany is granted permission to join CVS

following a preliminary hearing on 15 Decem-ber, he will bring nearly 30 years of retail ex-perience to the US pharmacy chain.

Noting that Mullany had “a strong back-

ground in operations, finance and strategicplanning”, CVS pointed out that he had beenresponsible for the operation of 1,300 storesacross 19 states in his role at Walmart.

Earlier in his career, Mullany held a num-ber of senior management roles, including aspresident of Genuardi’s Family Markets.

Larry Merlo, president and chief operat-ing officer of CVS Caremark, said Mullany und-erstood the many demands and challenges ofthe retail business. “His expertise, along withhis demonstrated ability to execute strategiesand produce outstanding results, make him theright candidate to drive continued growth in ourretail business and further our industry lead-ership for many years to come,” he added.

Mullany is set to succeed Merlo, who willreplace Tom Ryan as chief executive officerat CVS’ meeting of shareholders in May 2011(OTC bulletin, 31 May 2010, page 31).

Tony Mottram has stepped down as themanaging director of Numark less than

18 months after taking up the post. The UK-based virtual pharmacy chain said Mottram hadleft to “pursue other business interests”.

He has been replaced by John D’Arcy, com-mercial director of sister company RowlandsPharmacy. D’Arcy had been managing direc-tor of Numark on an interim basis prior to Mot-tram’s promotion from the post of commercialdirector in June 2009 (OTC bulletin, 15 May2009, page 22).

D’Arcy was interim managing director formore than a year following the death of SimonColebeck in 2007 (OTC bulletin, 25 January2008, page 21).

Commenting on his appointment, D’Arcysaid he had rejoined Numark at a “challeng-ing time for community pharmacy, particu-larly the independent sector”. “Numark hasa key role in equipping its members with thetools needed not just to rise to the challengesahead,” he added, “but also to maximise theopportunities.”

Paul Smith, chairman of Numark, said thatD’Arcy would provide “clarity and leadershipfor Numark, its membership and staff”.

Manufacturers

Merck raises Frazier tochief executive officer

Kenneth Frazier

John D’Arcy

Tony Mottram

OTC

Retailers

Walmart sues CVS over Mullany

OTC

Retailers

D’Arcy heads Numarkafter Mottram departs

OTC

OTC16-12-10p22-23FIN.qxd 14/12/10 06:48 Page 3

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