Nicoventures set to enter smoking-cessation space

26 September 2014

Alliance targets 3Europe-wide presenceFutura to launch 4Blue Diamond condomOTCPharm makes an impact in Russia 5GSK reveals investigation 7into Chinese CHC divisionJ&J to expand Consumer unit 7Aspen reports rise 8in a difficult marketBoehringer Ingelheim posts 8sales increaseBayer to focus entirely on 9its Life Science business

GENERAL NEWS 11

France’s Afipa calls for clarity 11on OTC switchingASMI highlights importance 11of vitamin DIndustry identifies areas to 12improve European systemCanada closes cough lawsuit 12Bayer hit with court action 13for US supplement claims

MARKETING NEWS 16

Omega’s Verona to boost 16Australian feminine marketNelsons makes its debut 17in UK colic-relief marketMentholatum launches 17lavender chest rubHansaplast works with 18Spanish Red CrossCovonia’s latest addition 19is sugar- and alcohol-free

FEATURES 22

AESGP sets out 22fresh herbals agendaStada banks on brands 24to get ahead

REGULARS

Events – Our regular listing 21People – Merck to give Oschmann 27group-wide responsibilitiesPeople – Europe names 27pharma leader

COMPANY NEWS 3

E-cigarette firm Nicoventures is set toenter the UK OTC smoking-cessation

market, now its partner Kind Consumer’sVoke Nicotine Inhaler (0.45mg nicotine) hasbeen approved as a medical device by theMedicines and Healthcare products Regu-latory Agency (MHRA).

Nicoventures – a division of British Amer-ican Tobacco – holds the worldwide distributionrights to Voke Nicotine Inhaler, which has beenlicensed in the UK for use to relieve and/orprevent craving and nicotine-withdrawal symp-toms associated with tobacco dependence.

Kind said that Nicoventures was now in theprocess of drawing up marketing plans for theproducts and ensuring that manufacturing cap-acity was in place.

Look and feel like a cigaretteNicoventures’ chief medical officer, Kevin

Bridgman, told OTC bulletin that Voke was anicotine-replacement therapy (NRT) that hadbeen designed to “look and feel like a cigarette”.

Bridgman said Voke attempted to replicatethe “rituals and behaviours of smoking”. Smok-ers were addicted to these behaviours, he saidas well as being addicted to nicotine.

“The Voke stick is the size and shape of acigarette, and the packaging looks like a cigar-ette pack,” Bridgman said. “There’s no other[NRT] product out there that looks and feelslike that,” he claimed.

In addition to the physical similarities witha cigarette, Voke also simulated the experienceof smoking a real cigarette, Nicoventures said.

“The product is designed to deliver the samefeel at the back of the throat and in the lungsthat people experience when they inhale cig-arette smoke,” Bridgman explained.

Indicated to “aid smokers wishing to quit orreduce prior to quitting, to assist smokers whoare unwilling or unable to smoke, and as a saferalternative to smoking for smokers and thosearound them”, Voke would be available for gen-eral sale, Nicoventures noted.

“Voke involves no heat or combustion, andso produces no ash or smoke,” the firm said. “It

also requires no battery or other energy source;it is activated simply by the user inhaling.”

Voke was not an e-cigarette, Bridgman waskeen to point out, and was a “really good stepforward” from that type of product as it oper-ated without heat.

“Heating is a bit of a challenge for e-cig-arettes,” Bridgman said, “because if you don’theat nicotine formulations in the right way youend up with breakdown products that are toxic.”

Explaining how Voke operated, Bridgmansaid the product comprised a stick and a charg-ing pack. By pressing the stick into the charg-ing pack, the user could load it with a nico-tine formulation.

Micro-valve technologyThe propellant used in the device was hydro-

fluoroalkane-134a, often used in asthma inhalers,Bridgman noted. When a user inhaled throughthe stick, the micro-valve technology containedin the device delivered the formulation into themouth and lungs, he said.

Users would get six to eight puffs from thestick after each charge and the device couldbe charged up to 20 times, Bridgman explained.In this way, Voke would attempt to “replicate theexperience of a pack of 20 cigarettes”, he said.

Bridgeman said Voke would be available toconsumers in “general retail, pharmacy andwherever cigarettes are sold”. Wide availability

■ Continued on page 9

Nicoventures set to entersmoking-cessation space

Nicoventures says its Voke Nicotine Inhaler will rivale-cigarettes and smoking-cessation brands when itenters the UK OTC market

OTC26-09-14p1_OTC15/11/2005 p1&24 24/09/2014 09:15

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In five years’ time, Alliance Pharma will bewell-established across all the major Euro-

pean markets, according to chief executive offi-cer John Dawson.

Speaking to OTC bulletin as the firm posteda 14.8% rise in sales for the first half of 2014,Dawson said that Alliance had people on theground in both France and Germany who wereon the look out for deals to expand the com-pany in each country’s OTC market.

“They have come up with a lot of good leadsthat we are looking at in those countries and weare also looking at some in the UK,” Daw-son noted. “It is part of a pan-European strategythat in five years’ time will ensure Alliance ispretty well established across the big EuropeanUnion (EU) countries.”

Expand business in ChinaFurthermore, Alliance was keen to expand

its fledgling business in China, Dawson said,where the firm – which operates through ajoint-venture company called Unigreg – wasestablishing a mother and baby range, built onthe Forceval supplement for pregnant women.

Alliance had recently taken a stake in aShanghai and Hong-Kong-based infant-formulafirm called Synthasia International, Dawsonpointed out, which complemented Forceval.

“We are exposing ourselves to that rapidly-growing market, but with quite limited invest-ments,” he added.

Commenting on the infant-milk-formula jointventure, Dawson said the “highly scientific andvery high-quality product imported from Switz-erland” appealed to middle-class Chinese par-ents who “paid a lot of attention to the dietarymake-up of infant-formula milk”.

Now a base had been established in China,Alliance would look to acquire more localbrands, Dawson said, but would not be averseto introducing its own or other brands from out-side the country.

Asked if there were other markets outsideChina and the EU it was looking to enter, Daw-son said that while the focus was on thosecountries, the company had always had an “op-portunistic bent”. If “really good opportunitiescame up”, that were slightly outside this focus,and the firm was confident it could “handle themand run them well”, a diversion would be made.

Turning to its recently-expanded OTC prod-uct portfolio, Dawson said that non-prescriptionproducts now accounted for around a tenth ofthe company’s first-half sales of £22.5 million(C28.6 million). The firm’s consumer healthcareportfolio includes the Ashton & Parsons teethingpowders and MolluDab skin-infection treat-ment, as well as the Lypsyl skin-care brand.

Alliance paid Novartis US$3.0 million (C2.0million) for the Lypsyl range in the UK andIreland at the end of last year (OTC bulletin,17 January 2014, page 3).

The company had made “steady progress”

with Lypsyl in the first six months of the year,Dawson said, with a lot of work done to widendistribution, improve the market positioningand to gain an insight into what consumersthought of the brand.

“We see a good turnaround potential withLypsyl because the brand has phenomenalawareness,” Dawson claimed. “It was the mar-ket leader several years ago, but it is down tosixth or seventh in the league table now. How-ever, people still think they have Lypsyl in theirhandbag even when it is another brand.”

Revamp the Lypsyl rangeThe company was in the process of revamp-

ing the physical characteristics of the Lypsylrange, Dawson noted, adding that the new-lookLypsyl line would be rolled out into storesgradually in 2015.

Meanwhile, marketing activity behind thefirm’s Ashton & Parsons teething powderswould be ramped up in the coming months.

Production problems which had hamperedthe teething powders had been overcome, henoted, and the firm was focused on ensuring re-tailers knew that the products were availableagain. Digital marketing was being used to driveawareness with consumers. A wider consumermarketing campaign would be launched later inthe year, Dawson said, which would include“traditional” as well as digital marketing activity.

326 September 2014 OTC bulletin

COMPANY NEWS OTC

26 September 2014 Number 429

Editor: Matt StewartEditor-in-Chief: Aidan FryProduction Editor: Jenna MeredithAssistant Editors: Liudmila Kotko, Marie McEvoyBusiness Reporter: Tom GallenContributing Editor: David WallaceAdvertising Controller: Debi MinalDirector of Subscriptions: Val DavisGroup Sales Manager: Anisa ShanAwards Manager: Natalie CornwellManaging Director: Mike Rice

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Business Strategy/First-Half Results

Alliance targets Europe-wide presence

OTC

OTC26-09-14p3-10xxx_Layout 1 23/09/2014 18:51

Futura Medical is set to launch its CSD500erection-maintaining condom online in some

European markets under the company-ownedbrand name Blue Diamond later this year.

Speaking to OTC bulletin, James Barder,the UK development firm’s chief executive offi-cer, said that the product would be sold onlinethrough a distributor led by a team of formerSSL employees with experience in marketingcondoms. SSL and its Durex brand of condomswas acquired by Reckitt Benckiser (RB) in2010 (OTC bulletin, 30 July 2010, page 1).

“We consider the longer-term opportunity foronline sales to be substantial,” Barder noted. “Inthe initial stages, it will also provide useful feed-back for driving sales in other regions for bothFutura and our distribution partners.”

Stand-alone Blue Diamond websiteThe online distributor will market the Blue

Diamond condom via a dedicated website whichmay be extended to include more territories.

Containing the erectogenic gel Zanifil,CSD500 was authorised for sale across Europeand in a number of other countries with thegrant of a CE mark (OTC bulletin, 25 October2013, page 7).

The product is set to be launched in someEuropean markets by Church & Dwight – ownerof the Trojan condom brand – which snappedup the rights to CSD500 in North America andparts of Europe a year ago (OTC bulletin, 12April 2013, page 3).

CSD500 could also soon be available in anumber of Middle Eastern and North Africancountries, after Futura agreed a deal in Sept-ember 2013 with an unnamed local partner.

Late last year, Futura also expanded its re-lationship with Ansell – which already holdsthe global rights to Futura’s PET500 topicalspray to delay male ejaculation (OTC bul-letin, 28 February 2011, page 3) – by grant-ing the US-based company the exclusive rightsto market CSD500 in China. Earlier this month,it granted the South Korean rights to KwangDong Pharmaceutical.

In total, distribution agreements for CSD500were now in place in 33 countries, Barder noted,covering all of North America and substantialparts of Europe, the Middle East and Asia.

However, while Futura was happy to launch,its partners were reluctant until the product’sshelf life had been extended to two years.

Currently, the manufactured product had ashelf life of just one year, he explained, butin laboratory conditions it had been proven

to be able to last for four years.What was crucial, Barder said, was being able

to replicate what had been proven in the labora-tory in the general manufacturing process.

Progress had been made, but the companyand its manufacturing partners were “not quitethere yet”, Barder pointed out. However, Futurawas confident that launches by its partnerswould begin in 2015, he insisted.

Meanwhile, one product that was already onthe market in the US, the PET500 topical sprayto delay male ejaculation, was becoming asource of some frustration, Barder revealed.

While Ansell had launched the productunder its Epic brand name, the firm felt thatits potential was being held back somewhat bya lack of promotional activity, Barder said.

Epic formed part of Ansell’s Lifestyles rangeof products, Barder explained. It was design-ed to take effect rapidly and to delay maleejaculation, thereby offering the user enhanc-ed sexual control.

Ansell had trialled Epic in some US tradechannels last year, he noted, and had now startedrolling it out in stores across the US and online.

Furthermore, Ansell had developed a com-bination product called Uphoria, in which Epicwould be packaged with Lifestyles’ Excite, apersonal lubricant designed to promote and en-hance stimulation and sensitivity for women.

However, Futura was “frustrated with thelevel of sales”, he admitted.

Raise awareness of PET500“We want it to be better and we are having

discussions with Ansell about how to makeawareness of the product greater,” he pointedout. “For us, this is a very good product butyou have got to make the awareness there, whichis something that we are keen that Ansell spendmore time doing,” he said.

Turning to the company’s erectile dysfunc-tion gel MED2002, Barder said the productwould be made available for doctors to supplyon a “named patient basis”.

Asked whether the firm would now abandonany ideas of selling MED2002 without a pre-scription, Barder said that the possibility of anOTC version had not been ruled out.

There was a clear unmet demand from the7.5% of erectile dysfunction sufferers whocould not be prescribed any of the PDE5 in-hibitors due to contraindications with other med-ications that they took, Barder noted. This de-mand was why the company was keen to getit on the market, he explained, especially through

doctors who generally had first point of con-tact with those patients.

The clinical work to gain regulatory ap-proval was in “full swing”, Barder noted, add-ing that it would be “premature to make a pre-diction” on whether MED2002 would end upas an OTC or prescription-only product.

“We know that in certain territories it couldbe OTC,” he pointed out, “but our options areopen and many factors will play a part in thefinal decision.”

Elsewhere, Futura is continuing to developits three OTC topical pain-relief products to“build greater value into the portfolio prior tomaking a licensing decision”.

In July last year, Barder said that the threepain-relief products – methyl salicylate-basedSPR300, ibuprofen-based TIB200 and dic-lofenac-based TPR100 – worked faster andwere more effective than the current leadingOTC topical painkillers (OTC bulletin, 26 July2013, page 9).

The products had generated a lot of interest,Barder admitted, but having previously sufferedthrough some frustrating development expe-riences with large pharmaceutical firms – Futurabroke off deals with both RB and GlaxoSmith-Kline (OTC bulletin, 14 September 2012, page3; OTC bulletin, 26 July 2013, page 9) – Futurawas in “no great hurry to license the products”.

“It’s all about certainty,” Barder said. “Youdon’t want to develop a product, get some verystrong marketing claims and then talk to a part-ner and they say that’s not what they wanted.”

“So a lot of this product development isgoing on slightly hand-in-hand, so we under-stand what people want as we develop it, andthe clinical work we do supports the strong-est possible marketing claims for the product,”he explained.

4 OTC bulletin 26 September 2014

OTC COMPANY NEWS

Business Strategy

Futura to launch Blue Diamond condom

OTC

Futura’s chief executive officer, James Barder,said its CSD500 condom would be available online inselect European markets later this year

OTC26-09-14p3-10xxx_Layout 1 23/09/2014 18:51

Recently-established Russian consumerhealthcare firm OTCPharm claimed its

proforma sales made it the second-largest OTCoperation by value in its domestic market in2013, and by far the biggest local player.

Formerly part of Pharmstandard, OTCPharmcame into being in December last year after theRussian pharmaceutical giant spun-off its brand-ed OTC business (OTC bulletin, 17 January2014, page 6).

Pharmstandard first announced plans to spinoff its OTC business in July last year, when italso revealed that it was set to pay US$630million (C491 million) for Singapore-based ser-vices company Bever Pharmaceuticals (OTCbulletin, 26 July 2013, page 6).

Bever has since been transferred to OTC-Pharm, giving the business its own source ofactive pharmaceutical ingredients.

OTCPharm’s portfolio covers a range ofOTC segments and includes the Afobazol anx-iety product, the anti-viral Amixin, the influenzabrand Arbidol and the Pentalgin analgesic.

OTCPharm said it had taken 5.3% – basedon proforma sales – of the Russian OTC mar-ket in value terms in 2013 (see Figure 1), sec-

ond only to Novartis, which held an 8.3% share.The company pointed out the Russian OTCmarket was worth US$10.4 billion in valueterms in 2013, based on figures from IMS.

Meanwhile, OTCPharm said its turnoverhad moved forward by 8% to RUB6.33 billion(C128 million) in the first half of 2014, thanksto higher sales of analgesics and treatments forfungal infections.

Sales of Pentalgin had advanced by 19% to

RUB1.24 billion in the six months, OTCPharmsaid, giving the brand a 28.4% share of the Rus-sian OTC analgesics segment (see Figure 2).

Pentalgin held the leading position in thesegment, OTCPharm noted, ahead of ReckittBenckiser’s (RB’s) Nurofen with a 20.1% shareand Sopharma’s Tempalgin with 6.9%.

OTCPharm’s turnover had also been boostedin the first half by rising sales of the antifungalbrand Flucostat, the firm noted. Sales of Fluco-stat had moved forward by 13% to RUB449million, giving the brand a 42.0% share of theRussian OTC fungal infections segment.

Meanwhile, the company said the growthof its key Arbidol brand had been held backduring the period due to lower incidences ofwinter illnesses.

Sales of Arbidol had dropped back by 53%to RUB538 million, OTCPharm pointed out,causing the brand to lose its status as the lead-ing OTC cold and flu brand in Russia by mar-ket share (see Figure 3).

Arbidol held an 11.2% share of the coldand flu market in the first half of 2014, OTC-Pharm noted, the same percentage as Novartis’Theraflu brand. Both brands sat behind Near-medik Plus’ Kagocel, which had grown itsshare to 13.1%.

OTCPharm’s turnover had also been hit bythe weaker performance of its leading multi-vitamin Complivit, whose sales were down by9% to RUB660 million.

Despite falling sales, Complivit had becomethe joint second-largest brand in the Russianmultivitamins segment, OTCPharm pointed out,with a market share of 18.0%.

Bayer’s Supradyn also had an 18.0%share, the firm noted, behind Unipharm USA’sVitrum, which had grown its share to 26.5%.


COMPANY NEWS OTC

First-Half Results

OTCPharm makes an impact in Russia

OTC

Figure 1: Leading companies in the Russian OTC market by value sales in 2013 (Source – OTCPharm/IMS Health)

Novartis/Sandoz

OTC Pharm

Sanofi

Bayer

Stada

Menarini

Teva

Johnson & Johnson

Market share (%)0 2 4 6 8 10

8.3%

5.3%

4.9%

4.3%

3.3%

3.2%

2.7%

2.6%

Figure 3: Leading brands in the Russian cold and flu segment in 2013 and in the first six months of 2014(Source – OTCPharm/IMS Health)

Mar

ket

shar

e(%

)

Kagocel Arbidol Theraflu Anaferon Oscillococcinum Amixin Maxycold

7.0% 7.2% 6.8%

4.3% 4.5%

0.6% 0.8%

8.6%

11.2%11.3%

13.1%

2013 First half of 2014

11.2%

13.9%16

12

8

4

0

Figure 2: Leading brands in the Russian analgesics segment in 2013 and in the first six months of 2014(Source – OTCPharm/IMS Health)

Mar

ket

shar

e(%

)

Pentalgin Nurofen Tempalgin Next Alka-Seltzer Solpadeine Ascophenum-P

2013 First half of 2014

27.5% 28.4%

21.2%

7.3% 6.9%

3.5% 4.1% 3.5% 2.8% 3.5% 2.8% 2.3% 2.3%

20.1%

30

20

10

0

11.8%

OTC26-09-14p3-10xxx_Layout 1 23/09/2014 18:51

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OTC House Ad AUGUST 2014_Layout 1 03/09/2014 10:02 Page 1

China’s Nutrastar has taken a step closer to-wards selling its traditional Chinese medi-

cines (TCMs) outside of China, after the coun-try’s Ministry of Commerce registered the com-pany as a foreign trade operator.

The firm said it would now seek approvalto trade outside of China from the Chinesecustoms, tax and foreign exchange offices. Oncethese steps had been completed, Nutrastar ex-plained, the company would be able to beginexporting its product portfolio worldwide.

Based in Harbin, Heilongjiang province,Nutrastar markets in more than 10 Chinese prov-inces the TCM cordyceps militaris and a rangeof functional health drinks and organic foods.

Cordyceps militaris is claimed by Nutrastarto “strengthen the immune system and combatharmful effects from fatigue and ageing”.

Nutrastar said exporting “premium consumerproducts” to new markets was part of the com-pany’s “long-term strategic growth plan”.

Allegations of bribery at GlaxoSmithKline’s(GSK’s) Chinese Consumer Healthcare

business were investigated in 2012 by US gov-ernment officials, the UK-based firm has said.

The investigation was related to a US De-partment of Justice (DOJ) and Securities and Ex-change Commission (SEC) inquiry into possi-ble violations of the anti-bribery Foreign Cor-rupt Practices Act (FCPA), GSK noted.

A spokesperson for GSK told OTC bulletinthat the firm had conducted its own investiga-tion into procurement practices at the ChineseConsumer Healthcare unit, but had not foundevidence of “unethical conduct”. As part of theinquiry, ‘preservation notices’ – an instructionto preserve relevant documents when litigationis anticipated – had been issued to GSKemployees, the spokesperson noted.

“The preservation notices issued in 2012relate to allegations around adherence to pro-curement policies with our Chinese ConsumerHealthcare business,” the spokesperson explain-ed. “Issuing preservation notices is routine insuch circumstances to ensure our enquiry is asthorough as possible.”

“We investigated using resources inside andoutside the company,” the spokesperson contin-ued, “and did not find evidence of unethicalconduct, but did identify some non-compliancewith our procurement procedures and remedialaction was taken as a result.”

GSK confirmed that the inquiry was uncon-nected to the investigation launched in 2013by the Chinese government into allegations ofcorruption at the firm’s Chinese business.

Announcing the outcome of the investiga-

tion earlier this month, GSK said its Chinesebusiness had been found guilty of “bribing non-government personnel”.

The Changsha Intermediate People’sCourt in Hunan Province, China, ruled thatGSK China had “offered money or propertyto non-government personnel in order toobtain improper commercial gains”.

As a result of the verdict, GSK China hasbeen ordered to pay a fine of £297 million(C377 million) to the Chinese government.

Commenting on the outcome, GSK said theillegal activities of its Chinese business had beena “clear breach of GSK’s governance and com-pliance procedures” and contrary to the “valuesand standards” expected from employees.

GSK said it had “co-operated fully” withthe authorities during the investigation and had“taken steps to comprehensively rectify the issuesidentified at the operations of GSK China”.

“This includes fundamentally changing theincentive programme for the salesforce; signif-icantly reducing and changing engagement act-ivities with healthcare professionals; and ex-panding processes for review and monitoring ofinvoicing and payments,” the company noted.

In July, GSK hired an external law firm toconduct an independent review into its Chi-nese business.

GSK said the review had identified “somefraudulent behaviour relating to expense claims”and this had resulted in employee dismissals.

“We have zero tolerance for any kind of cor-ruption in our business and we have many pro-cedures and controls in place to monitor this andtake actions against any breaches,” GSK stated.


COMPANY NEWS OTC

Legal Cases

GSK reveals investigationinto Chinese CHC division

OTC

Johnson & Johnson will look to grow its Con-sumer business, but only when the consent

decree related to manufacturing problems inits US OTC unit has been satisfied, accordingto chief financial officer Dominic Caruso.

Speaking at the Morgan Stanley HealthcareConference, Caruso said the firm was “excitedabout the possibility of Consumer becoming abigger part” of the group.

However, Consumer was still running a“first-things-first” strategy, Caruso pointed out,and more work was needed to get the division“back in shape”.

Johnson & Johnson’s OTC business has beenoperating under a consent decree filed by theUS Department of Justice and the Food andDrug Administration (FDA) for over three years(OTC bulletin, 17 March 2011, page 1).

This was filed as a result of the company’sfailure to comply with good manufacturing prac-tice (GMP) requirements at its Fort Washing-ton plant in the US and its Las Piedras facil-ity in Puerto Rico.

A string of product recalls by Johnson &Johnson’s OTC business during 2010 and 2011prompted a government investigation and theclosure of the company’s Fort Washington facil-ity. Manufacturing problems at Fort Washing-ton had led to the withdrawal of the bulk ofJohnson & Johnson’s OTC portfolio.

In 2013, Johnson & Johnson returned ap-proximately 75% of its US OTC portfolio tothe shelves, the company pointed out.

“By the end of the year, we’ll have complet-ed almost all the work required under the FDAconsent decree,” Caruso said, “and we need toget those products back in the market with theright kind of promotional activity.”

Once that had been done, the firm wouldlook at expanding the business, Caruso noted,highlighting the opportunities presented by thespending power of consumers in emerging mar-kets and by the “broader definition” of con-sumer healthcare that had emerged as peoplebegan taking a more active role in their health.

Expanding on how the firm would growConsumer, Caruso said it would buy brands“within local markets” to enable it to “buildscale” within those markets. This mirrored thecompany’s strategy in China, Caruso noted,where in 2008 it established a base by acquir-ing skin-care firm Beijing Dabao Cosmetics(OTC bulletin, 31 October 2008, page 6).

Business Strategy

J&J to expandConsumer unit

OTC

Business Strategy

Nutrastar seeks international expansion

OTC

OTC26-09-14p3-10xxx_Layout 1 23/09/2014 18:51

South Africa’s Aspen Pharmacare said thatdomestic sales of its non-prescription health

and nutrition products had advanced by 12%in the 12 months ended 30 June 2014, despite“diminishing” consumer spending.

Turnover at the firm’s South African Con-sumer division had increased to ZAR1.31 bil-lion (C92.2 million), Aspen pointed out, reflect-ing a “good performance” in the “private mar-ket” for pharmaceutical and consumer products.

Aspen said turnover in the private SouthAfrican OTC market had risen by 4.8% in the12 months ended 30 June 2014, with IMS valu-ing the market at ZAR8.3 billion in the period.

The Consumer unit’s growth had continuedin the 12 months, Aspen noted, as the companybolstered its infant-nutrition portfolio by snap-ping up a number of brands from Nestlé.

Completed in January, the deal gave Aspenthe exclusive rights in Australia and SouthernAfrica to a portfolio of infant-nutrition brandsincluding SMA, S26 and S26 Gold.

Speaking as the transaction was announcedin April last year, Stephen Saad, Aspen’s chiefexecutive officer, said the deal was in line withthe firm’s ambitions to grow its infant-nutritionbusiness (OTC bulletin, 26 April 2013, page 6).

“We understand the potential of these prod-ucts as we are familiar with the brands, havingmarketed them in South Africa under licencein the recent past,” Saad noted.

The Consumer division accounted for 18%of Aspen’s total sales in South Africa, whichedged up by 1% to ZAR7.45 billion (see Fig-ure 1). Aspen’s South African Pharma business

generated the remainder, with turnover down1% to ZAR6.14 billion.

Away from South Africa, Aspen said gainingmore infant-nutrition brands from Nestlé inAugust last year had helped to lift total turn-over in Latin America to ZAR3.49 billion, upfrom ZAR1.57 billion in the prior-year period.

Under the terms of the deal, Aspen gainedthe exclusive rights to Nestlé’s S26 and SMAbrands in a number of Latin American marketsincluding Chile, Mexico and Venezuela.

Aspen does not break down its Consumer orOTC sales outside of South Africa, but notedthat in Brazil – its largest Latin American mar-ket – OTC turnover had been boosted by afull-year contribution from the Phillips’ Milk ofMagnesia brand acquired from GlaxoSmith-Kline (GSK) in 2012.

In April 2012, Aspen announced that itwould expand its OTC business in South Africa

and a number of markets outside of North Am-erica and Europe by paying £164 million (C208million) for a basket of OTC brands fromGSK (OTC bulletin, 30 April 2012, page 1).

The portfolio of acquired brands includedthe Cartia low-dose aspirin line, Dequadin throatlozenges, Phillips’ Milk of Magnesia, Solpa-deine pain relievers, and Zantac indigestion andheartburn medicines.

Rising turnover in Latin America – plus gainsin Europe/Commonwealth of Independent States(CIS) and Rest of world – lifted sales at Aspen’sInternational region to ZAR12.4 billion, up fromZAR3.58 billion in the prior-year period.

Meanwhile, Aspen said a full-year contribu-tion from the acquired GSK brands had helpedto push up turnover at its Asia-Pacific business,which posted sales up by 14% to ZAR8.80.

In Australia and New Zealand – Aspen’sbiggest Asia-Pacific market in terms of sales –the GSK OTC brands had helped to boost thecompany’s local sales, which advanced by 11%to ZAR7.88 billion.

Aspen recently agreed to divest its HerronOTC range to Perrigo in Australia and NewZealand for US$51 million (C40 million) (OTCbulletin, 17 March 2014, page 3) as part ofits strategy to trim its pipeline of products thatwere unlikely to “achieve medium-term growthfor stakeholders”.

Aspen Asia had posted sales up by 63% toZAR923 million, the company pointed out,thanks to “strong” double-digit organic growthin all markets.

Aspen’s full-year group sales – includingSub-Saharan Africa, as well as Asia-Pacific,the International region and South Africa – in-creased by 53% to ZAR29.5 billion. Operatingprofit grew at a slightly slower rate, rising by47% to ZAR7.43 billion.


OTC COMPANY NEWS

Annual Results

Region Annual sales Change Operating profit Change(ZAR millions) (%) (ZAR millions) (%)

Europe/CIS 7,200 >100 – –Latin America 3,485 >100 – –Rest of world 1,745 >100 – –International 12,430 >100 3,633 >100

Asia-Pacific 8,799 +14 1,812 +13

South Africa 7,451 +1 1,653 -12

Sub-Saharan Africa 2,753 +30 327 +33

Eliminations -1,918 +31 – –

Aspen 29,515 +53 7,425 +47

Figure 1: Aspen’s sales in its financial year ended 30 June 2014 broken down by region (Source – Aspen)

Boehringer Ingelheim said sales at its Con-sumer Health Care business in the open-

ing six months of 2014 had improved by 3.0%when adjusted for currency effects.

Consumer Health Care’s turnover jumpedto C683 million in the first half of the year, theprivately-owned German firm said, accountingfor a tenth of its total group sales, which haddeclined by 3.0% when adjusted for currencyeffects to C6.5 billion.

Boehringer’s Consumer Health Care busi-ness currently sits just outside the world’s top-five in terms of sales, with organic sales ofC1.47 billion in 2013.

In May, Dr Joachim Hasenmaier, who has re-

sponsibility for Boehringer’s Consumer HealthCare division, told OTC bulletin that the firmwas “not concerned about the ongoing consoli-dation process” in the industry, claiming thatin the OTC business, size did not necessarilyrepresent the “best recipe to generate growth”.

Hasenmaier insisted that success in this in-dustry was “more about leading positions in keycategories, strong brands, executional excellenceand the agility to adapt quickly to a new mar-ket environment”.

“In all those areas we are well set up for theupcoming challenges,” he said. “Of equal impor-tance is to be, and to remain, attractive for talent.”

OTC

Aspen reports rise in a difficult market

First-Half Results

Boehringer Ingelheim posts sales increase

OTC

OTC26-09-14p3-10xxx_Layout 1 23/09/2014 18:52

Bayer said it intended to focus entirely onits Life Science businesses – including its

consumer healthcare interests – as it announcedplans to spin-off its MaterialScience unit.

By floating the MaterialScience business onthe stock market, Bayer claimed it would posi-tion itself as a “world leader” in the fields ofhuman, animal and plant health.

Bayer’s Life Science interests compriseits CropScience and HealthCare businesses.HealthCare includes the company’s global Con-sumer Care, Pharmaceuticals, Medical Care andAnimal Health units.

Explaining the rationale behind the move,Bayer said in recent years the firm’s focus had“greatly shifted” towards its Life Science activi-ties, citing the pending acquisition of Merck &Co’s Consumer Care unit (OTC bulletin, 9 May2014, page 1) as a prime example of this.

Bayer noted that it planned to “continue

the positive development” of its Life Sciencebusinesses in the future through “further in-vestment in growth”.

The planned separation would benefit bothBayer and the MaterialScience unit, the firmsaid, adding that the stock market floatationwould take place “by 2016 at the latest”.

Life Science represents 69%Bayer’s Life Science businesses generated

combined 2013 sales of C27.7 billion, account-ing for 69% of the group’s total turnover in the12 months. Life Science also generated 90%of group earnings before interest, tax, depre-ciation and amortisation (EBITDA) in 2013.

MaterialScience reported annual sales ofC11.2 billion in 2013 from its portfolio of poly-urethanes, polycarbonates and raw materialsfor coatings and adhesives.


COMPANY NEWS OTC

Business Strategy

Bayer to focus entirely onits Life Science businesses

OTC

■ Continued from front page

of Voke was important, Bridgeman noted, soconsumers could find the product “in the placesthat they would normally find e-cigarettes”.

Asked when Voke would hit retail shelves,Bridgman said he couldn’t give an exact date.“But it is more likely to be months rather thanyears,” he added.

Nicoventures would now submit a variationto Voke’s MHRA licence to “support full-scalecommercialisation”, Bridgman explained. Thefirm had made minor changes to the product tomake it suitable for mass production, he added.

Vype launched in pharmacyVoke is the latest addition to Nicoventures’

product portfolio, which also includes the Vypee-cigarette. The company launched Vype inleading UK pharmacy chain Lloydspharmacyin January and the product is now availablethrough 15,000 general retail and pharmacy out-lets (OTC bulletin, 7 February 2014, page 24).

Speaking to OTC bulletin at the time ofVype’s launch, the firm’s head of UK and Ire-land, Nigel Hardy, insisted Nicoventures hadbeen established as a healthcare company andoperated as a healthcare company.

Hardy said Nicoventures was keen to engagewith the regulatory authorities as there were clearbenefits to having licensed products. The firmcould prove to consumers the safety and efficacyof its products through licensing, he noted.

Turning to Nicoventures’other pipeline prod-ucts, Bridgman revealed that the company hadsubmitted a licence application to the MHRAfor a new e-cigarette product. Having a medi-cines licence for an e-cigarette would give con-sumers “assurances about the product’s qualityand safety”, he explained.

20% of smokers use e-cigarettes“Around 20% of smokers are dabbling with

e-cigarettes,” Bridgman pointed out, “but thosewho are not using the devices are concernedabout the safety and quality of the products.”

Asked when Nicoventures hoped to gain itslicence, Bridgman said the company had sub-mitted its application around one year afterthe Voke submission.

“There’s ongoing dialogue,” Bridgemannoted. “The MHRA has already responded withquestions about the product and we’re work-ing with them to answer those questions.”

Business Strategy

Nicoventures toenter OTC space

OTC

OTC26-09-14p3-10xxx_Layout 1 23/09/2014 18:52

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Queisser Pharma can continue to marketginkgo biloba as a food supplement sold

under its Doppelherz umbrella brand, a region-al court in Düsseldorf, Germany, has ruled.

Schwabe Pharma – which markets the mar-ket-leading Tebonin ginkgo biloba medicine– had challenged Queisser’s right to marketDoppelherz Aktiv Ginkgo + B-Vitamine +Cholin, a supplement containing eight nutrients,including ginkgo-leaf extract.

In its legal complaint, Schwabe had allegedthat Queisser’s marketing claim that the sup-plement had a positive effect on “the brain,nerves, concentration and memory” impliedthat such properties were due in large part tothe presence of ginkgo.

Queisser, by contrast, insisted that the claimsrelated only to the presence in its Doppelherzsupplement of B vitamins and zinc, both ofwhich enjoyed approved health claims.

While the Düsseldorf court rejected Queis-ser’s argument that the two companies werenot in direct competition, it also dismissedSchwabe’s complaint and denied the herbalmedicines specialist’s request for damages.

The supplement’s full marketing claim, thecourt pointed out, was “B vitamins and zinc forthe brain, nerves, concentration and memory”.

Such assertions for B vitamins and zinc,the court concluded, were in line with the listof permitted health claims contained in theannex to the European Union’s Health ClaimsRegulation 432/2012.

France’s government must clearly define thescope of self-medication and pursue a more

active policy on switching if the country’s OTCsector is to achieve its potential, according tolocal industry association Afipa.

Following its fourth annual self-care forum(OTC bulletin, 12 September 2014, page 16),Afipa has released a list of four proposals aspart of a call for action to “support sustainablyand meaningfully” the country’s self-medica-tion industry.

Clearly defining which indications should bethe subject of “personal financial responsibility”was “fundamental to a better understanding ofself-medication by patients”, Afipa insisted,adding that this would lead to improved sav-ings from healthcare costs.

Afipa also urged France to adopt a “strongswitch policy”, including creating a dedicatedunit within French medicines agency ANSM, aswell as introducing a mutual-recognition processlinked to switches in other European countries.

Reducing VAT on non-reimbursable medi-cines to 2.1% – the same rate as reimburs-able medicines – would help to stem an “art-ificial price increase” caused by growing tax

rates, the association suggested.Finally, Afipa said government policy should

ensure a “fiscal advantage” for patients that usedself-medication such as a tax deduction.

Separately, the association has also voicedits support for France’s pharmacy distributionmodel for self-medication “in the light of re-cent government announcements on a possiblechallenge to the pharmacy monopoly”.

Emphasising the “essential role” played bypharmacists in advising users of self-medication,Afipa warned against “purely political” actionsthat could threaten the country’s healthcare sys-tem. A recent study by France’s General Inspec-torate of Finances (IGF) had suggested thatlarge retailers should not necessarily be blockedfrom selling certain self-medication products.

Afipa rejected claims that France’s pharmacydistribution model led to higher prices, repeat-ing its insistence that the average cost of aFrench self-medication product was lower thanthe average among eight neighbouring Europeancountries (OTC bulletin, 25 July 2014, page 21).Meanwhile, French pharmacy unions includingCNGPO, UDGPO and USPO have also voicedtheir opposition to the IGF’s conclusions.


GENERAL NEWS OTC

Industry Associations

France’s Afipa calls forclarity on OTC switching

OTC

Legal Cases

Queisser canmarket ginkgo

OTC

Rising cases of osteoporosis among Aus-tralians has prompted the Australian Self-

Medication Industry (ASMI) to emphasise theimportance of vitamin D for bone health given.

Responding to a report published by theAustralian Institute of Health and Welfare(AIHW) highlighting the prevalence of osteo-porosis in Australia, Steve Scarff, ASMI direc-tor of regulatory and scientific affairs, noted thatvitamin D – in combination with calcium –played a vital role in maintaining bone density.

The metabolism of calcium – required forthe normal development and maintenance of

the skeleton – was dependent on vitamin D,Scarff pointed out.

The AIHW report estimates the prevalenceof osteoporosis among those aged 50 and overto be 23% of women and 6% of men. The num-ber includes both diagnosed and undiagnos-ed cases of osteoporosis.

Noting that nearly a quarter of Australianshad a vitamin D deficiency, Scarff said for thosenot obtaining adequate vitamin D from naturalsources, supplementation was a “highly effec-tive” way to fill the gap and to help maintainhealthy bone density.

Research

ASMI highlights importance of vitamin D

OTC

■ CRN – the US Council for ResponsibleNutrition – said that settlement costs ofUS$438 million (C341 million) had been paidto the Federal Trade Commission since 2003

in cases related to misleading advertising claimsfor weight-loss supplement products. Immunityclaims were next in line, the CRN pointed out.

IN BRIEF

OTC

■ PRAC – Europe’s Pharmacovigilance RiskAssessment Committee – said it would continueto review the benefit-risk balance of ambroxoland bromhexine. The review was started inApril following a growing number of reportsin Belgium (OTC bulletin, 25 April 2014,page 11) of allergic reactions associated withambroxol-containing medicines – which areavailable OTC in a number of markets includ-ing Belgium, France, Germany and Italy. Sincebromhexine gets mainly converted into am-broxol in the body, and there were some re-ports linking the use of bromhexine with aller-gic reactions, the Belgian agency requestedthat the review should also cover medicinescontaining bromhexine.

IN BRIEF

OTC

OTC26-09-14p11-13_Layout 1 24/09/2014 09:17 Page 2

Asurvey of 47 European pharmaceuticalindustry stakeholders has found more dia-

logue, better scientific data and greater trans-parency would help improve Europe’s regu-latory system for medicines, according to theAssociation of the European Self-MedicationIndustry, the AESGP, and the European Fed-eration of Pharmaceutical Industries and As-sociations (EFPIA).

At a workshop discussing a recent surveysponsored by the two associations and carriedout by TI Pharma’s Escher project – which isdesigned to identify, evaluate and remove reg-ulatory bottlenecks hampering the efficiencyin pharmaceutical innovation – participantshad identified 12 “areas in high need of im-provement”, the AESGP pointed out.

Of those 12 areas, participants in the work-shop – which included representatives fromindustry, regulatory authorities, academia, con-sultancies and patient organisations – had cho-sen five to become case studies, the AESGPsaid, three of which were relevant to the self-care sector: experience with the mutual-rec-ognition and decentralised procedures (MRP-DCP); pharmacovigiliance; and the cost effec-tiveness of post-authoritsation safety studies(PASSs) for new active substances in Europe.

Expanding on the three relevant case stud-ies, the AESGP said that the survey had shownthat a limited number of MRP-DCP attempts hadresulted in a negative outcome after a Co-ordi-nation group for Mutual recognition and Decen-tralised procedures – human (CMDh) referralprocedure, although a withdrawal in one or moremember states had occurred more frequently.

Meanwhile, “considerable differences be-tween member states were observed with re-spect to the time to national approval after apositively concluded MRP-DCP procedure”,the AESGP pointed out.

The workshop sub-group which had discussedthe MRP-DCP issues had mostly focused on thelong national phase, including translation, whichwas seen as the major issue, the AESGP noted.

Consensus had formed around the idea todesign a Common European Submission Plat-form- (CESP-) like system – or one that couldcomplement the existing CESP – for handlingsubmissions and timelines, the association ex-plained, as this would increase transparency.

Information which was known by the appli-cant and the agencies receiving it would be

centralised, the AESGP said, and “provide great-er evidence for decision markers”.

One year after the pharmacovigilance legis-lation had come into force, 95% of respondentshad experienced an increase in workload, theassociation noted, referring to the survey.

Furthermore, the AESGP said, the resultshad shown both foreseen changes in pharmaco-vigilance activities – such as an increase in thenumber of risk management plans (RMPs) sub-mitted annually per company – and unforeseenchanges, such as an increase in the number ofhours spent per periodic safety update report(PSUR), now known as the periodic benefit-risk evaluation report (PBRER).

No concrete solution had been proposed bythe workshop sub-group on pharmacovigilance,the association noted, but a number of key start-ing points for reflection had been outlined.

The sub-group had found, the AESGP added,that it would be necessary to assess the publichealth impact of any pharmacovigilance changes.

Meanwhile, on PASS, the survey results hadindicated that 52% of all PASS requests had re-sulted in a change to the product’s summary ofproduct characteristics (SmPC), the AESGPpointed out, which represented 9.5% of all post-marketing safety-related label changes.

Total costs of conducting the 31 PASSs, theassociation noted, were estimated to be in “therange of C84 million to C126 million”. Thishad resulted in an “incremental cost-effective-ness ratio of C6.5 million to C18 million peradditional SmPC change”.

Overall, delegates at the workshop had con-cluded that three key things were needed to helpimprove the system, the AESGP said: more dia-logue between senior authorities and industry;better scientific data to document issues; andgreater transparency as a means of solving issues.


OTC GENERAL NEWS

Regulatory Affairs

Industry identifies areas toimprove European system

The US Food and Drug Administration(FDA) is to hold a series of workshops to

help the agency get a better grasp of how thee-cigarette market is developing.

Noting that the workshops would not“inform the agency’s rulemaking” related to“deeming additional tobacco products to besubject to the Federal Food, Drug and Cos-metic Act (FD&C Act)”, the FDA said it was“aware of the recent significant increase inprevalence of e-cigarette use” and that therewas “much to be learnt about these relativelynew entrants to the market”.

The first workshop – to be held on 10 and11 December – would cover product science,the FDA said, along with product packaging,constituent labelling and environmental impact.

Regulatory Affairs

FDA wants to gete-cigarette insights

Aclass action lawsuit brought by a groupof Canadian consumers against Wyeth

and other OTC firms has been rejected by theSupreme Court of Canada.

The plaintiff Lana Wakelam – representingthe consumer group – sought damages aftermanufacturers of OTC medicines – includingWyeth, Johnson & Johnson, Novartis and Proc-ter & Gamble – in 2008 relabelled their med-icines to instruct consumers that they shouldnot be used by children under six years of age.The manufacturers made the labelling changein response to a request by Canadian med-icines regulator Health Canada.

Wakelam alleged “deceptive acts or prac-tices in the supply, solicitation, offer, adver-tisement and promotion” of the sale of thesemedicines prior to 2008.

In 2011, the British Columbia SupremeCourt certified Wakelam’s case as a class actionlawsuit. However, this certification was over-turned by the British Columbia Court of Appealin January this year after Wyeth – which wasacquired by Pfizer in 2009 (OTC bulletin, 30October 2009, page 3) – appealed the decision.

Wakelam sought leave to appeal to theSupreme Court of Canada, but the Court dis-missed the application on 4 September.

Legal Cases

Canada closescough lawsuit

OTC

OTC

OTC

■ MHRA – the UK’s Medicines and Health-care products Regulatory Agency – is leadinga consortium of organisations including Euro-pean medicines regulators, academics and thepharmaceutical industry in a three-year projectcalled WEB-RADR aimed at using smart-phones, apps, and social media to gather infor-mation on suspected adverse drug reactions.

IN BRIEF

OTC

OTC26-09-14p11-13_Layout 1 23/09/2014 17:36 Page 3

Bayer says it will defend itself “vigorously”in an action filed against it by the US

Department of Justice (DoJ) for allegedly mak-ing unsubstantiated claims for its Phillips’ ColonHealth probiotic supplement.

The firm said it disagreed “strongly” withthe DoJ’s decision to file the court motion, whichstates that the nationwide advertising campaignand packaging for Phillips’ Colon Health hasexpressly claimed over the past six years thatthe product could help “defend against” occa-sional constipation, diarrhoea, and gas and bloat-ing, despite a lack of “competent and reliablescientific evidence”.

Companies which sought to “gain an unfairadvantage over their competitors by promotingto consumers unsubstantiated claims about thehealth benefits of their products” would not betolerated, the motion adds.

Bayer argued that probiotic bacteria had a“long and well-documented safety record, com-plemented by volumes of clinical studies ontheir digestive benefits”. Meanwhile, the USConsumer Healthcare Products Association(CHPA) commented that it was “alarmed” at the“increasingly rigid application of the principleof ‘competent and reliable scientific evidence’and the undue emphasis on multiple controlledtrials for such non-pharmaceutical products”.

Television and print advertisements for Phil-lips’ Colon Healthcare are also said to haveimplied that the supplement, which contains a“proprietary blend” of lactobacillus gasseri,bifidobacterium bifidum and bifidobacteriumlongum, could prevent, treat or cure constipa-tion, diarrhoea, and gas and bloating.

Bayer is alleged to have violated a consentdecree it entered into in 2007, which prohibited

the firm from making any claims about theperformance or efficacy of any of its dietarysupplement, multivitamin or weight-controlproducts unless it held “competent and reliablescientific evidence” at the time the claim wasmade. The firm had also agreed to pay aUS$3.2 million (C2.5 million) civil penalty.

Furthermore, the motion states, as Bayerrepeatedly advertised the Colon Health productalongside the Phillips’ Milk of Magnesia lax-ative and docusate sodium-containing Phillips’Stool Softener – both of which were “familiarOTC drugs” – the consumer was likely to con-sider Phillips’ Colon Health as being in thesame category as products that were indicatedto prevent, cure or treat disease.


GENERAL NEWS OTC

Legal Cases

Bayer hit with court actionfor US supplement claims

OTC

Phillips’ Colon Health is said to help “defend against”symptoms such as occasional constipation and diarrhoea

OTC26-09-14p11-13_Layout 1 23/09/2014 17:36 Page 4

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Awards categories cover a wide range of disciplines inthe OTC industry, including television advertising,trade advertising, pharmacy training, public relationsinitiatives, sponsorship, packaging design anddigital & social media.

New this year is a celebratory OTC LifetimeAchievement Award, marking the first 20 years of theOTCMarketing Awards. This Award will be presentedto the brand that has made the greatest contribution toOTC excellence by winning the most OTCMarketingAwards since they began in 1995.

It’s now time to start preparing your entries. Our entrydeadline of 5th December 2014 probably seems along way ahead, but you need to start thinking aboutturning your latest campaign into a prestigiousAward winner. The winners will be announced at aGala Dinner & Awards Presentation on Thursday,5th March 2015 at London’s Park Lane Hotel.

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“Tension-type headaches” (TTH) and theneed to treat them from their onset are

the focus of Reckitt Benckiser’s (RB’s) latestUK pharmacy campaign for its Nurofen Ex-press ibuprofen analgesics.

Claiming that 80% of people were affectedby TTH – caused by muscles in the head andneck – from “time to time”, RB said there wasa need for pharmacy staff to help consumersdifferentiate between TTH and other types ofheadache, such as cluster headaches.

Research had indicated that paracetamol wasthe headache treatment most recommended bypharmacy staff, RB added, while a consumer

survey had shown that paracetamol was usedby 55% of respondents for head pain, with lessthan a third choosing ibuprofen.

Furthermore, nearly three-quarters of respon-dents waited 20 minutes or more before treat-ing a headache, the UK-based consumer-goodsgiant pointed out.

As a result, the firm is looking to emphasisethe speed and efficacy of its Nurofen Expresscapsules and soluble oral powders, which bothcontain 400mg ibuprofen, in treating TTH.

Noting that 53% of consumers had saidthey would be happy for a member of pharmacystaff to approach them with headache adviceand support, the company said it would launcha TTH module on its online pharmacy trainingportal, rbforhealth.co.uk, in early October.

Resource packs and support materials willalso be supplied to pharmacists, while the com-pany expects to launch an educational cam-paign for consumers in 2015.

RB is also highlighting that ibuprofen isrecommended in guidelines by the British As-sociation for the Study of Headaches as one ofthe first-lines of treatment for TTH, rather thanproducts containing codeine and caffeine.

RB expects to launch a TTH module on its onlinetraining portal, RBforHealth, in October


OTC MARKETING NEWS

Omega Pharma wants the roll-out of itsVerona line of lactic acid-based feminine

intimate washes to have grown the Australianfeminine-hygiene market – claimed to be worthA$12.9 million (C9.0 million) at retail – by atleast A$2.0 million by the end of 2015.

Comprising Balanced, Fresh, Hydrating andSensitive washes, Verona’s product range was“similar to what we have started to marketunder Lactacyd in Europe”, a spokesperson forthe Belgian firm told OTC bulletin. Omegagained the European rights to Lactacyd in2012, as part of a basket of brands it acquir-ed from GlaxoSmithKline (OTC bulletin, 16March 2012, page 1).

Verona was the only brand on the Aust-ralian market that acknowledged different stagesin a woman’s life – such as pregnancy andmenopause – Omega added, and catered forall of her intimate-hygiene needs.

Positioned as a range of preventive prod-ucts rather than treatments, Verona – which isalso available in New Zealand – would competewith brands such as Combe’s Vagisil, Church& Dwight’s Femfresh and Fleet Laboratories’Summer’s Eve, Omega pointed out, adding thatVerona complemented its existing Replens vag-inal moisturiser and RepHresh vaginal gel.

Noting that the Australian feminine intimate-wash category was “highly underdeveloped” –with current usage of such products at around4% – the firm said there was great potential to

“educate and empower women to use a pre-ventive product range like Verona”.

Over A$1.0 million would be spent across12 months to support the product line, Omeganoted, focusing on breaking down the “stig-ma” of the feminine intimate-wash category,which many people felt was a “taboo subject”.

Using the tagline “because confidenceshows”, the marketing campaign will encompasstelevision, digital and radio advertising, as wellas social-media activity across Facebook, Pinter-est, Twitter and YouTube. There will also be apublic-relations drive and pharmacy training.

Product Launches

Omega’s Verona to boostAustralian feminine market

The Verona line in Australia comprises Balanced, Fresh,Hydrating and Sensitive intimate-hygiene washes

OTC

Marketing Campaigns

Nurofen drivesTTH awareness

OTC

France’s Urgo has extended its Humex rangeof cough and cold treatments by launch-

ing a Humex flu treatment. This comprisesparacetamol, vitamin C and pheniramine and

goes under the name of HumexLib Etat Grippal.Available in packs of eight sachets of pow-

der for oral solution, each 13.1g sachet containsthe same amount of paracetamol, vitamin Cand pheniramine – 500mg, 200mg and 25mgrespectively – as Bristol-Myers Squibb’s Fer-vex brand. The product can be dissolved inhot or cold water.

Indicated for adults and children over 15years old, HumexLib Etat Grippal soothes head-aches and reduces fever, as well as helping toclear a blocked nose. One sachet should betaken two or three times each day, for no morethan five days.

Product Launches

Urgo’s HumexLib rivals French Fervex

HumexLib contains the same amount of paracetamol,vitamin C and pheniramine as Fervex OTC

OTC26-09-14p16-19_Layout 1 23/09/2014 17:52 Page 2


MARKETING NEWS OTC

Natural healthcare firm Nelsons has madeits debut in the UK colic-relief arena with

what is said to be the first remedy available forthe condition in a granule format.

Claiming that “more and more” parents werelooking for natural healthcare options for theirbabies’ ailments, Nelsons maintained ColicaColic Granules – containing 30c citrillus colo-cynthis and 30c dioscorea villosa per sachet –were an “important addition” to the colic-reliefcategory, which was estimated to be worth £9.3million (C11.7 million) at retail in 2013.

Indicated for the symptomatic relief of colicin babies over one month of age, the homoeo-pathic orodispersible granules will compete withForest Laboratories’ Infacol simeticone drops,Dentinox’ dimethicone-containing Colic Dropsand Woodwards’ Gripe Water, which containsdill seed oil and sodium bicarbonate.

Currently only available in the UK, Colicaextends the firm’s current product portfolio forbabies, which includes its Teetha granules andgel for teething pain and Sootha cough syrup.

Noting that parents often looked for a solu-tion online when their child had colic, Nelsons

pointed out that it had partnered with parentingwebsite babycentre.co.uk as part of Colica’slaunch campaign, which will run until Decem-ber. Targeted advertisements would appear onrelevant sections of babycentre.co.uk, includ-ing its home page, the firm explained.

Promotional articles in “key” parenting mag-azines such as Mother & Baby and Prima Baby& Pregnancy would also feature Colica.

A pack of 24 sachets has a recommendedretail price of £5.80.

Vitabiotics aims to establish “firmly” its Perfectilsupplements as a part of UK consumers’ daily beautyroutines with its first-ever national televisioncampaign for the brand.

“Enrich your routine with Perfectil” is the messagein the 30-second spot, which highlights that the range– comprising Perfectil Plus Skin, a recently-launchedPlus Hair variant, as well as Perfectil Plus Nails –provides “triple-action micronutrients” such as biotin,zinc and selenium.

It also points out that Perfectil is “the UK’snumber-one skin, hair and nails formula”, accordingto IRI figures.

Targeting women aged between 18 and 45 years,the Perfectil campaign follows the UK-basedsupplement firm’s first-ever television promotion forits Pregnacare line earlier this year (OTC bulletin, 9May 2014, page 17). Both brands also feature inVitabiotics’ current sponsorship idents – running until31 October – for the ITV channel’s national weather.

The spot would air across channels such asChannel 5, ITV and Sky, Vitabiotics pointed out, andcomplemented the existing promotional activity– including outdoor advertising and sampling – forthe Perfectil line.

The creative would be rolled out into selectedinternational markets “in due course”, the firm added.

OTC

Product Launches

Nelsons makes its debutin UK colic-relief market

The launch of Nelsons’ Colica Colic Granules marksthe firm’s debut in the UK colic-relief arena

OTC

Mentholatum claims it is providing USconsumers with “an alternative to the

medicinal smell traditionally associated witha chest rub” with the launch of its lavender-scented Nighttime Vaporizing Rub.

Containing 5.3% camphor, 1.3% eucalyptusoil and 2.8% menthol – as well as lavenderoil – Mentholatum Nighttime Vaporizing Rubwould draw new consumers into the chest-rub category, the company insisted, who mightpreviously have avoided such products due to

their strong medicinal odour.The initial packaging for the product would

include a ‘scratch and sniff’ sticker so consum-ers could “experience the pleasing lavenderscent at the time of purchase”, the firm said,along with a US$1.00 (C0.77) discount coupon.

Claimed to provide “maximum-strength”cough relief for up to eight hours in those agedtwo years and above, as well as to help usersto relax and fall asleep, the lavender-scentedrub extends the existing Mentholatum line oftopical cough- and cold-relief products. Thiscomprises an Original Ointment and a CherryVaporizing Rub for children.

Beginning on 5 October, a US-wide market-ing campaign would run throughout the coughand cold season to support the launch of Men-tholatum Nighttime Vaporizing Rub, the firmsaid. This would include public relations andonline activity, it added, as well as product sam-pling in selected retailers.

Product Launches/Line Extensions

Mentholatum launches lavender chest rub

Mentholatum’s lavender-scented Nighttime VaporizingRub is claimed to provide “maximum-strength” coughrelief, as well as to help users to relax and fall asleep OTC

Dutch firm Serrix has launched its Sorefix treatmentfor cold sores into the French market. The lip balm– which is available either in a 10ml jar or 6ml tube –is being distributed in France by Procter & Gamble.

Pharmacy-press advertising using the slogan“goodbye cold sores, hello smile!” emphasises thepatented zinc-based formula’s “two unique actions”that both prevent and treat cold sores.

OTC

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OTC MARKETING NEWS

Busy UK women aged 25 years and oversuffering from muscular tension in their

neck and shoulders are Mentholatum’s targetmarket for a heat-patch addition to its DeepHeat Muscle Rescue sub-brand.

Claiming that neck and shoulder pain wasthe second most common pain experienced bywomen – with back discomfort the most preva-lent – the company explained its non-medi-cated Deep Heat Muscle Rescue Neck & Shoul-der Heat Patch was a “natural extension” tothe Neck and Shoulder Cream and Bath Soakvariants launched two years ago (OTC bulletin,17 May 2012, page 17).

Said to provide eight hours of “sensational,warming relief to ease everyday muscular ten-sion”, the odourless, self-adhesive patch hadbeen designed to “sit comfortably and adheresecurely over the neck and shoulder area with-out being bulky”, Mentholatum added.

Marketing activity to support the launch ofthe Deep Heat Muscle Rescue Neck & Shoulder

Heat Patch will begin in November and last untilthe end of February 2015. This will include aprint campaign in women’s consumer maga-zines as well as trade-press publications, alongwith social-media activity across Deep HeatMuscle Rescue’s Twitter and Facebook pages.

Mentholatum said there would also be sam-pling activity at “female lifestyle shows”.


UK women are target forMuscle Rescue heat patch

The non-medicated Deep Heat Muscle Rescue Neck &Shoulder Heat Patch will be targeted at women aged 25years and over with tense neck and shoulder muscles

OTC

Heavyweight television and consumer-pressadvertising is supporting Hermes Arzneimittel’sintroduction of an ‘ultra’ 400mg variant of its BiolectraMagnesium food supplements range in Germany.

Television commercials created by the VonMannstein agency for Hermes depict a busy womanwho takes Biolectra Magnesium to prevent crampswhile she is doing yoga, working in an office,shopping, jogging and cycling.

“Meine Muskeln haben noch viel vor”, or “Mymuscles have a lot ahead of them”, is the openingand closing message.

Supporting consumer-press advertising appearsin current-affairs, women’s and pharmacy customertitles including Bunte, Focus and Apotheken Umschau.

Biolectra Magnesium 400mg Ultra comes ascapsules and sachet-sticks. Recommended retailprices for the pharmacy-exclusive supplement areC34.00 for 100 capsules, as well as C10.50 andC18.70 for packs of 20 and 40 granule sachets.

OTC

Beiersdorf aims to establish its Hansaplastfirst-aid brand as the “expert in wound

care” in Spain through a first-aid awarenessprogramme created in partnership with human-itarian organisation Cruz Roja Española, or theSpanish Red Cross.

The aim of the initiative – which uses thetagline “together we add more” – was to helpprevent minor accidents in “different areas oflife, especially in the home”, Beiersdorf noted.

According to a survey for the Spanish Con-sumer National Institute, the company pointed

out, over 1.5 million accidents – such as burns,cuts and falls – occurred in the home eachyear, with the most vulnerable groups beingchildren aged under four years, women andthe elderly.

Created leaflets for consumersWith this in mind, Hansaplast has created a

set of leaflets to be distributed to consumersthrough pharmacies. Featuring the Hansaplastlogo, the leaflets offer information on admin-istering first aid for injuries sustained in thehome; by children; through playing sports; orwhen outdoors.

Hansaplast will also provide pharmacistswith point-of-sale materials and educational in-formation packs.

The initiative will be publicised until atleast the end of the year on Cruz Roja’s web-site, cruzroja.es, and its social-media profiles,as well as on Hansaplast’s Spanish website,hansaplast.es. It will also be promoted inhealth-press publications and through public-relations activity.

Sponsorship Campaigns

Hansaplast works with Spanish Red Cross

Hansaplast has created leaflets offering informationon treating minor injuries OTC

NBTY’s NatureSmart subsidiary has extended itsportfolio of children’s gummy vitamins in the US withthe launch of a Star Wars range.

Comprising three ‘Complete’ multivitamin variantsas well as an immune-support formula, the Star Warsgummy vitamin range features shapes inspired bythe film franchise’s characters, such as Darth Vader,Yoda and Chewbacca.

As the product labels – which also feature Star Warscharacters – would change with each new film release,the bottles would have “the appeal of a collectors’item”, noted NatureSmart, which also manufacturesDisney-, Pixar- and Marvel-licensed gummies.

A print and digital campaign will support thelaunch until the release of the Star Wars EpisodeVII film in December 2015, the firm added.

Recommended retail prices for the gummies arebetween US$9.99 (C7.71) and US$10.69.

OTC

OTC26-09-14p16-19_Layout 1 23/09/2014 17:52 Page 4


MARKETING NEWS OTC

Drinkable ampoules containing 50mg of aronia-juiceextract are the latest addition to Queisser Pharma’sDoppelherz System range of pharmacy-exclusivehealthcare products in Germany.

Each one-a-day 25ml ampoule provides 500mg ofvitamin C and 10mg of zinc which, along with vitaminD and selenium, are claimed to support the immunesystem. The fruit-flavoured drink also contains Bvitamins and biotin to help maintain mucousmembranes during the winter.

Recommended retail prices for packs of 10 and30 ampoules are C13.95 and C39.95 respectively.

OTC

Thornton & Ross hopes to grab a largerslice of the UK sugar-free cough-remedy

category – claimed to be worth over £9.0 mil-lion (C11.4 million) at retail – by extendingits Covonia brand with a sugar-free versionof its Chesty Cough syrup that also containsno alcohol.

Although Covonia held the number-twoposition behind Johnson & Johnson’s Benylin– according to IRI – in the total £91.8 millioncough-liquid market, Thornton & Ross noted,the brand’s current sugar-free product portfolioaccounted for less than 1% of the sugar-freecough-remedy sub-category. This range includesliquids for Dry Cough and Cold & Flu, as wellas non-medicated lozenges.

Suitable for those aged over 12 years, Cov-onia Chesty Cough Sugar Free – which con-tains 200mg guaifenesin per 15ml – was thefirst cough liquid from a leading brand to beboth sugar- and alcohol-free, the firm claimed.

Noting that the UK had a diabetic popula-

tion of around 2.9 million – which was ex-pected to grow to 5.0 million by 2025 – and aMuslim population that was forecast to rep-resent 8.2% of the UK by 2030, Thornton &Ross said there was a “strong demand” forcough remedies that were “suitable for nicheaudiences and those with restrictive diets”.

Over £4.0 million would be spent on anational campaign until March to support thecomplete Covonia range, added the firm, whichwas acquired by Stada in August last year(OTC bulletin, 23 August 2013, page 1).

A television advertisement will air fromNovember until February and be backed bypress and social-media activity, while public-relations support will focus mainly on promot-ing Covonia Chesty Cough Sugar Free.

Updated pharmacy training would also “re-inforce winter health knowledge and enablepharmacy assistants to identify and advise cor-rectly on niche-customer scenarios”, Thorn-ton & Ross noted.


Covonia’s latest additionis sugar- and alcohol-free

OTC

OTC26-09-14p16-19_Layout 1 23/09/2014 17:52 Page 5

16 October■ A Quality Dietary

SupplementBrisbane, AustraliaA one-day symposium organisedby the Council for ResponsbleNutrition International (CRN-I),subtitled ‘Before you start andafter it’s marketed’.Contact: CRN-I.Tel: +41 91 610 94 70.Email: [email protected]: www.crn-i.ch/2014symposium/.

28-29 October■ Pharmaceutical

LabellingBerlin, GermanySpeakers from Boehringer Ingel-heim, GlaxoSmithKline, Meda,the Proprietary Association ofGreat Britain (PAGB), ReckittBenckiser and Sanofi will attendthis two-day seminar.Contact: Informa UK.Tel: +44 20 7017 7481.Fax: +44 20 7017 7823.Email: [email protected]: www.informa-ls.com/pharmalabelling.

28-29 October■ Pharmaceutical

Regulatory Affairsin the Middle EastDubai, UAECountries to be covered at this two-day conference include Egypt, Ku-wait, Libya, Oman, Qatar, SaudiArabia, Syria and Yemen.Contact: Management Forum.Tel: +44 1483 730071.Fax: +44 1483 730008.Email: [email protected]: www.management-forum.co.uk.

28-31 October■ OTC Pharma China

Shanghai, ChinaTopics to be discussed at this four-day event will include marketingand branding strategies for newlaunch products; prescription-to-OTC switch strategies and oppor-tunities; regulatory strategies forherbal OTC products; traditionalChinese medicinal products; andexpansion strategies from Asiaand beyond. OTC bulletin sub-scribers can enjoy a 15% discountby quoting P46252OB.Contact: IBC Asia.Tel: +65 6508 2401.Email: [email protected]: www.otcpharmachina.com.

5 November■ Marketing Authorisation

for Human Medicinesin Latin AmericaFrankfurt, GermanyArgentina, Brazil, Colombia andMexico will be covered.Contact: Forum Institut für Management.Tel: +49 6221 500 680.Fax: +49 6221 500 555.Email: [email protected]: www.forum-institut.com.

5-8 November■ CRN’s Annual

Symposium for theDietary SupplementIndustryCalifornia, USA four-day conference organisedby the US Council for Responsi-ble Nutrition (CRN).Contact: CRN.Tel: +1 202 204 7700.Fax: +1 202 204 7701.Email: [email protected]: www.crnusa.org/2014events/.

13-14 November■ 9th Ceuta Healthcare

International AllianceConferenceBerlin, GermanyThis two-day meeting will bring

together manufacturers, outsourcesales and marketing service provid-ers (distributors) and industry opin-ion leaders in health and beauty.Contact: Ceuta Healthcare.Tel: +44 1202 449 709.Email: [email protected]: www.ceutaalliance.com/2014_conference_berlin.html.

17-18 November■ EuroPLX 56

Nice, FranceThis two-day conference will pro-vide a forum for business devel-opment decision makers for dis-cussing and negotiating collabor-ative agreements in licensing, mar-keting, and distribution of patentedmedicines, generics, biosimilars,OTC products, medical devicesand food supplements.Contact: RauCon.Tel: +49 6222 9807 0.Fax: +49 6222 9807 77.Email: [email protected]: www.europlx.com.

18 November■ Meeting the Challenges

of Preparing QualityDossiers forHerbal MedicinesLondon, UKSpeakers from the UK’s Med-

icines and Healthcare productsRegulatory Agency (MHRA) willattend this one-day workshop.Contact: HFMA.Tel: +44 208 481 7100.Fax: +44 208 481 7101.Email: [email protected]:www.hfma.co.uk/events.asp.

18 November■ ASMI Annual

ConferenceSydney, Australia‘Self-Care: A brighter and health-ier future’ is the theme of thisone-day conference organised bythe Australian Self-Mediation In-dustry (ASMI).Contact: ASMI.Tel: +61 2 9922 5111.Fax: +61 2 9959 3693.Email: [email protected]: www.asmi.com.au/events/.

27 November■ mHealth: Driving

wellness in aconnected worldLondon, UKJoin OTC bulletin at this one-dayevent and discover how to jointhe mHealth revolution and drivethe global wellness agenda.Contact: OTC bulletin.Tel: +44 1564 777 550.Fax: +44 1564 777 524.Email: [email protected]: www.otc-bulletin.com.

1-3 December■ Pharmacovigilance

London, UKDrug safety monitoring in theEuropean Union (EU), Japan andthe US will be discussed at thisthree-day course.Contact: Management Forum.Tel: +44 1483 730071.Fax: +44 1483 730008.Email: [email protected]: www.management-forum.co.uk.

9-12 December■ Good Manufacturing

Practice and GoodDistribution PracticeLondon, UKA three-day event run by the UKMedicines and Healthcare prod-ucts Regulatory Agency (MHRA).Contact: Glasgows.Tel: +44 1772 767715.Email: [email protected]: www.mhragmdp.co.uk.


EVENTS OTC

OCTOBER 7-8 October■ AESGP Conference

Brussels, Belgium‘Herbal (medicinal) products, food supplements and self-care medicaldevices: Paving the way towards a coherent system’ is the theme of thistwo-day event run by the Association of the European Self-MedicationIndustry, the AESGP.

There will be sessions on: ‘Finding the right balance for herbal (med-icinal) products, food supplements and self-care medical devices’; and‘Adjusting the medical device legislation to consumer needs’.

Speakers will include: Basil Mathioudakis and Paola Testori Coggi ofthe European Commission; Werner Knöss of the Committee on HerbalMedicinal Products (HMPC); and Ioanna Chinou of the European Med-icines Agency (EMA).Contact: AESGP. Tel: +32 2 735 51 30. Fax: +32 2 735 52 22.Email: [email protected]. Website: www.aesgp.eu/events/Brussels2014/.

21-22 October■ Maximise Self-Care Potential:

Through Asia Regulatory HarmonisationPhuket, ThailandThe 10th World Self-Medication Industry (WSMI) Asia-Pacific RegionalConference will form part of this two-day event, which will include sessionson: ‘Asia self-medication market trends, health policy and consumer prac-tice’; ‘Value and potential of OTC’; ‘Communication, education and part-nership in self-care’; ‘Regulatory challenges and opportunities in the OTCindustry’; and ‘Prescription-to-OTC switches and borderline products’.Contact: WSMI. Tel: +33 450 284 728. Fax: +33 450 284 024.Email: [email protected]. Website: www.tsmia.or.th/Phuket2014/main.html.

NOVEMBER

DECEMBER

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Tackling a number of key issues in-hibiting the development of food sup-plements needs to be high on thelegislative agenda of the newly-elect-

ed European Parliament, according HubertusCranz, director general of the Association of theEuropean Self-Medication industry, the AESGP.

Europe’s legislators also need to ensure thatthe new rules proposed for regulating medi-cal devices do not harm the consumer end ofthe devices sector, Cranz insists.

Speaking ahead of the AESGP’s Octoberconference on herbal medicines, food supple-ments and self-care medical devices, Cranzsays progress has been made over the pastthree years, but a “number of key issues re-main unharmonised”.

Thorny botanicals issueThe new Parliament must address these

issues, Cranz says, and the baton picked up bythe new European Commission proposed bypresident-elect Jean-Claude Juncker.

Top of the agenda at the upcoming AESGPmeeting – “Paving the way for a coherent sys-tem”, to be held in Brussels on 7-8 October –will be the thorny issue of botanicals.

A number of national initiatives will be pre-sented at the meeting, including the so-called‘Belfrit’ project, and Cranz insists that a solu-tion needs to be found.

A harmonised list of over 1,000 botanicalsfor use in food supplements has come out ofthe Belfrit initiative, following a joint researcheffort between Belgium and France. The Bel-frit list has also been adopted by Italy.

The problem with botanicals is that botan-ical ingredients were being treated differentlyunder the food claims regulation than they wereunder legislation covering traditional herbal med-icines (OTC bulletin, 15 October 2010, page 1).

In response to the concerns, the EuropeanCommission announced in 2010 that the com-munity list of permitted general health claimsfor foods would be established in two steps.The list for all substances other than botani-cals would be adopted in a single step, it ex-plained, with claims for botanicals consideredonce the first step had been completed.

The first step was finally completed at theend of 2011, when a list of 222 permitted health

claims was put before the European Parliament(OTC bulletin, 19 December 2011, page 1).The 222 health claims were all that had survivedan assessment process, which saw EuropeanFood Safety Authority (EFSA) reject the vastmajority of the nearly 3,000 submissions in-volving substances other than botanicals.

Meanwhile, the evaluation of 2,078 Article13(1) general-function health claims for bot-anicals has remained on hold. More than 18months after the hold was put in place, morequestions than answers were raised by the Euro-pean Commission when it announced a further“reflection” on the issue in the summer of 2012(OTC bulletin, 10 August 2012, page 1).

Furthermore, since 2010, a number of indi-vidual botanical applications for Article 13(5)‘new function’ and Article 14 ‘disease risk-reduction’ claims have been rejected by EFSA.

However, in November last year, EFSAfinally issued its first positive evaluation of abotanical health claim for disease risk-reduction(OTC bulletin, 29 November 2013, page 13).

This was significant as it showed that thecurrent approach to assessing health claims –using scientific evidence from human studies– could be used in relation to all foods includ-ing botanical substances.

French firm Vivatech received a mostly pos-itive opinion for its health claim that its Tran-sitech (hydroxyanthracene derivatives) productcould improve bowel function, after EFSA’sPanel on Dietetic Products, Nutrition and Aller-gies, the NDA, said a cause and effect relation-ship had been established. The Panel alloweda modified claim, but questioned the effective-ness of some of the product’s ingredients.

Non-botanical issues relating to implement-ing the EU’s food claims regulation also needto be addressed, Cranz points out, noting thatBasil Mathiodakis, the head of unit nutrition,food composition and information at the Euro-pean Commission, will point out that as of Junethis year, 30 nutrition claims had been autho-rised and 254 health claims allowed.

The list of non-authorised health claims wasnow 1,995, while 2,162 health claims were underconsideration. A further 2,095 claims were “onhold”, with 2,078 of those related to botanicals.

Turning to herbal medicines, Cranz notesthat there are now more than 1,000 traditional

herbal medicines registered in the EuropeanUnion (EU).

The European Medicines Agency’s (EMA’s)Committee on Herbal Medicinal Products(HMPC) recently released an overview of itspriority list of assessment work which showedthat 127 final monographs had now been ad-opted, while a further 10 entries on the list oftraditional herbal ingredients had been finalised.A total of 14 final public statements had alsobeen published. Four monographs were close tofinalisation, with assessments complete, theEMA overview shows.

Away from herbals and food supplements,Cranz notes another pressing issue of particularinterest to the AESGP is the ongoing discussionson medical devices legislation. New rules onsubstance-based medical devices have possibleimplications for the self-care sector, he says.

Amendments adopted by ParliamentIn April 2014, commenting on the outcome

of the European Parliament’s plenary, theAESGP said it had been pleased with the deci-sion to adopt a number of amendments putforward in October last year. In particular, itwelcomed the deletion of Rule 21 (in AnnexVII) which classified many self-care medicaldevices in the highest risk class, and deletionof the need to comply with medicines legisla-tion, Directive 2001/83/EC.

A year earlier, the European Parliament’senvironment, public health and food safety(ENVI) committee proposed a massive 762amendments to the legislation, on top of the145 amendments that had been proposed byrapporteur Dagmar Roth-Behrendt (OTC bul-letin, 31 May 2013, page 14).

These provisions would have impacted anumber of medical devices such as gels forvaginal discomfort, certain nasal sprays, andthroat lozenges, Roth-Behrendt said.

However, the AESGP pointed out that it


OTC REGULATORY AFFAIRS

AESGP sets out fresh herbals agendaAs a new European Parliament gears up for the beginning of anotherfive-year term, the Association of the European Self-Medication Industry,the AESGP, is calling for action on claims for botanicals in food supplementsand on new legislation for medical devices. Matt Stewart reports.

Hubertus Cranz, director general of the the Associationof the European Self-Medication Industry, the AESGP,who wants “key issues harmonised”

OTC26-09-14p22-27_Layout 1 23/09/2014 19:00 Page 2

remained “concerned about the possibility forthe Commission to determine, by means of animplementing act, whether or not a specificproduct or category or group of products – in-cluding borderline products – falls within thedefinitions of ‘medical device’ or ‘accessory toa medical device’ without any defined involve-ment of manufacturers in the procedure”.

The adopted amendments formed part ofthe European Parliament’s final position on thedevices legislation, which was published indraft form in late 2012 (OTC bulletin, 12 Oct-ober 2012, page 7).

Speaking at the 50th Annual Meeting ofthe AESGP in June, Neven Mimica, EuropeanCommissioner responsible for consumer policy,said that rapid adoption of the new rules con-cerning medical devices was “essential” to re-storing public confidence in the regulatory sys-tem and to aid the development of innovativeproducts (OTC bulletin, 16 June 2014, page 11).

Mimica said the existing legislation hadallowed the recent PIP breast implants scandalto remain undetected for 10 years. This delaywas unacceptable, Mimica insisted.

Furthermore, rapid adoption of the proposednew regulations on medical devices, he noted,was also in the interests of industry.

“Legal uncertainty is not conducive to thedevelopment of innovative products or to the

investment climate,” Mimica admitted, “so Ihope for your support in helping to move thefile forward swiftly.”

“I can assure you that the Commission con-tinues to place high priority on these proposalsand I’m grateful for the efforts to move this com-plex and important file forward,” Mimica said.

However, Mimica remained unhappy withthe progress made in the Council of the EU,despite what he described as “valuable effortsfrom many sides”.

The European Parliament had dealt with thefile with “great enthusiasm”, he claimed, and hadbeen ready to enter into ‘trilogues’ – betweenthe Parliament, Council and Commission – asearly as the end of last year.

“Even if progress in the Council could be ac-celerated, it would take some years until the leg-islation fully enters into force,” Mimica said.

As the new Parliament beds in, Cranz notesthat there is a “certain scepticism” within theEuropean Commission and some member statesas to the regulatory framework of substance-based medical devices.

The legislation will now move forward toa second reading, with Glenis Willmott takingover as rapporteur following Roth-Behrendt’sdecision to retire from Parliament.

Cranz maintains that the AESGP believesthat a “stratification of the risk on the basis of

[substance-based medical devices] duration ofuse” – which will be discussed at the meet-ing – could help win the doubters round.

■ For more information contact: AESGP, 7 avenue de

Tervuren B-1040 Brussels, Belgium Tel: +32 2 735 51 30.

Fax: +32 2 735 52 22. Email: [email protected].


REGULATORY AFFAIRS OTC

Herbal (medicinal) products, food supplements andmedical devices: Paving the way towards a coherentsystem takes place in Brussels on 7-8 October

OTC

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Branded Products is “changing theface of Stada”, according to theGerman firm’s chief financial officerHelmut Kraft. With the division now

providing the company with over half of itsadjusted operating profit and a growing pro-portion of its sales, the German firm is eagerto build the business even further.

Speaking earlier this month, Kraft said thatStada had big ambitions for its Branded Prod-ucts division, with the company targeting annualsales of over C1.0 billion from its portfolio ofbrands in the coming years.

Create true beacon brandsStada wanted to create “true beacon brands

for aspirational consumers”, Kraft insisted, andbecome “a leader in brand management”.

The division would operate with an “inter-national footprint and mind-set”, he added,and eventually account for around two-thirdsof Stada’s group operating profit.

Since 2012, Stada has been paying partic-ular attention to its Branded Products business– which contains both non-prescription andprescription products – as it seeks to lessen itsreliance on its core Generics business, whichhas been hit by government cost-cutting nation-al health service budgets.

Although Stada added the Eunova dietarysupplement and Cetraben dermatology rangesto the Branded Products business in 2009 and

2011, the starting gun was fired on its Brand-ed expansion plans at the start of 2012, whenit snapped up a portfolio of Grünenthal brandscovering Central and Eastern Europe (CEE)and the Middle East (OTC bulletin, 10 Feb-ruary 2012, page 3).

The Grünenthal deal marked the start of atwo-and-a-half year buying spree which sawthe company splash out over C750 million onbranded assets across Europe (see Figure 1).

This rapid expansion has seen sales andprofits at Branded Products easily outpace therest of the business, with the division postingturnover up by 14% to C382 million in the open-ing six months of 2014 and an adjusted operat-ing profit up by 11% to C95.6 million.

Many of the deals struck over the past fewyears have expanded Branded Products’ reach,particularly in CEE and Russia.

As Figure 2 shows, the division accountsfor two-thirds of the company’s sales in Russia– which is Stada’s second-biggest market interms of sales behind Germany – and a fifthof its turnover in Serbia.

However, while the Commonwealth of In-dependent States (CIS)/Eastern Europe is cur-rently Branded Products’ biggest region in termsof sales (see Figure 3), the political instabilityin the area is somewhat tarnishing its appeal.

With that in mind, the company has turnedits attention to “Central Europe” – excludingGermany – and in particular to the platform

provided by its C226 million acquisition of UK-based OTC specialist Thornton & Ross last year(OTC bulletin, 23 August 2013, page 1).

Explaining the rationale behind the deal,Luc Slegers, Stada’s senior vice-president forCentral Europe, said that the company’s ex-isting UK business, Genus, had reached itslimit in terms of growing market share in theprescription area, but its brands – such as theCetraben emollient range – had potential inthe OTC sector.

However, Genus had no real OTC platform,Slegers noted, and would have been hamperedby paying high costs to third-party manufac-turers if it had tried to make an impression inthe UK OTC space.

Platform to expand brandsEnter Thornton & Ross, which provided not

only the OTC platform to extend the productlife of the Genus brands, Slegers pointed out,but also the manufacturing capabilities to makethe move financially viable.

Based in Huddersfield, Thornton & Rossgenerated sales of around £66 million (C84 mil-lion) in the year ended 31 March 2013, primarilyof OTC brands including Covonia cough medi-cines, Hedrin head-lice treatments, Metaniumnappy-rash products and Radian B topical an-algesics (OTC bulletin, 31 May 2013, page 24).

Although 75% of the company’s sales aregenerated by its OTC portfolio, its biggest op-portunity could be in its prescription drugs busi-ness – which accounts for 11% of sales – andthe work it has done to get its Altoderm sodiumcromoglycate-based cream in a position to filefor authorisation as a treatment for atopic der-matitis and eczema.

Thornton & Ross was also “the largest inde-


OTC BUSINESS STRATEGY

Stada banks on brands to get aheadIn the past two and a half years, Stada Arzneimittel has aggressivelyexpanded its Branded Products division as its seeks to become increasinglyless dependent on its core Generics business. In UK-based Thornton & Ross,it has found the platform to drive further growth. Matt Stewart reports.

Year Acquisitions Purchase price Region Categories(Cmillions)

2009 Eunova 12 Germany Dietary Supplement

2011 Cetraben 35 UK Eczema and dry skin

2011/2012 Grünenthal branded 312 CEE*, Painproducts portfolio Middle East

2012 Ingavirin, Safocid, 10 Russia, VariousTranexam, Vuka Drive, Eastern Europe,Vuka Vuka CIS**

2012 Branded products portfolio 15 Ukraine Women’s health

2013 Thornton & Ross 226 UK Various

2013 Aqualor 131 Russia, Eastern Sprays and drops for theEurope, CIS** treatment of sinusiis

2014 Flexitol 13 UK & Ireland Hand- and foot-care

* Central and Eastern Europe ** Commonwealth of Independent States

Figure 1: Breakdown of Stada’s key acquisitions in the Branded Products space (Source – Stada)

Stada’s chief financial officer, Helmut Kraft, saidthe firm’s Branded Products division was “changingthe face of Stada”

OTC26-09-14p22-27_Layout 1 23/09/2014 19:00 Page 4

pendent pharmaceutical manufacturer in theUK” before Stada came along. It makes nearlyeverything it markets in Huddersfield – exceptfor tablets and capsules – with core competen-cies in liquids, gels, creams and suppositories.

The deal made Stada a key player in the UKOTC market, Slegers added. The addition ofthe Genus range to Thornton & Ross’ ownportfolio had now lifted the company intofourth place in the British OTC market.

The strength of the Thornton & Ross plat-form in the UK would now be used to drivethe expansion of Stada’s Branded Productsbusiness in Central Europe, Slegers revealed.

This would be achieved in two ways,Slegers said, with the roll out of Thornton &Ross’ products into new markets and the launchof Stada’s existing branded products into theUK through Thornton & Ross.

“Wherever it is possible to obtain market-ing authorisations, Stada affiliates outside theUK will launch products out of the Thornton &Ross range,” Slegers added.

In 2015, the head-lice treatment Hedrinwould be launched in the Baltics, Poland, Ro-mania and Slovakia, he noted. Furthermore, inmarkets where Thornton & Ross had licensingdeals, these would be honoured, Slegers said.

Bring Ladival to the UKComing the other way, Slegers said, was

Stada’s Ladival brand of dermatology and sun-protection products – Branded Products biggest-seller (see Figure 4) – and its Lactease foodsupplement designed to break down the lactosein milk and milk products.

Furthermore, the company was currentlydeveloping a range of cough and cold products,he noted, which could be launched throughThornton & Ross in 2015.

To facilitate this shift towards a more inter-national outlook at Thornton & Ross, the firm’sinternational sales operation had been restruc-tured, Slegers said.

International control of some of the Thornton& Ross brands had been shifted to some ofStada’s regional units, he noted, pointing outthat distribution of Hedrin, Radian B, Cerumoland Metanium in the Middle East and NorthAfrica had been switched to Stada’s existingunit in the region to help “optimise” sales.

Looking ahead, Slegers said that Thornton& Ross would become the home of a “centreof OTC excellence” for Stada, with the aim ofgenerating “product innovations on a mid-to-long-term basis”.

Expanding on the objectives of the centre ofexcellence, Dieno George, Thornton & Ross’chief executive officer, said the facility wouldprovide the “leadership, competence, infras-tructure and technical capabilities to delivernew opportunities throughout the Stada group”.

Built around an “interdisciplinary commit-tee” of experts in OTC and dermatology, thecentre would provide Stada with “strategicdecisions from international perspectives”,George claimed, to help grow the business.

The centre would “analyse potential OTCand dermatology markets”, he pointed out, and“stimulate global, target-oriented internal de-velopment projects”, while providing the oppor-tunity for all Stada affiliates to submit productideas at any time.

Links to universities – and in particular Hud-dersfield University – would also be developedand maintained, George added, to help drivelong-term pipeline development.

The development of the centre of excellence,coupled with the steady “internationalisation”of Thornton & Ross, Slegers said, would pro-vide Stada with the reliability it wanted from itsBranded Products division as it sought to shielditself from the regulatory interventions impact-ing its Generics business.


BUSINESS STRATEGY OTC

Country Group sales Change Branded Products’ Change Branded Products’(Cmillions) (%) sales (Cmillions) (%) share in Stada (%)

Germany 200 -10 68 +2 34

Russia 164 -16 108 -8 66

Italy 94 +8 15 +18 16

Belgium 74 +3 4 +14 6

UK 61 >100 53 >100 86

Spain 57 +9 7 +20 12

France 46 -2 8 +40 17

Serbia 45 +11 8 +28 19

Others 262 – 111 – 42

Total Stada 1,003 +4 382 +14 38

Figure 2: Breakdown of sales by Stada and its Branded Products division in the first half of 2014, together withthe proportion of group sales accounted for by Branded Products (Source – Stada)

Rank Branded product First-half sales Change Indication(Cmillions) (%)

1 Ladival 24.1 +57 Sun protection

2 ApoGo (prescription) 23.6 +15 Parkinson’s disease

3 Grippostad 14.7 -23 Cough and cold

4 Aqualor 13.5 – Rhinitis

5 Snup 13.2 +9 Rhinitis

6 Vitaprost (prescription) 10.3 +3 Prostate hyperplasia

7 Hirudoid 9.8 +10 Inflammation of veins

8 Chondroxide 9.7 -9 Muscular joint pain

9 Tramal (prescription) 9.0 +81 Chronic pain

10 Care 8.7 – Umbrella brand

Figure 4: Stada’s Branded Products division’s top-10 biggest-selling brands in the first half of 2014 (Source – Stada)

Figure 3: Breakdown of sales at Stada’s BrandedProducts division in the first half of 2014 by region(Source – Stada)

CIS/Eastern Europe38.3%

C146.2 million

Central Europe37.6%

C143.3 million

Germany20.9%

C79.8 million

Asia-Pacific3.2%

C12.3 million

Stada plans to launch Thornton & Ross brands – suchas Hedrin – into new markets OTC

OTC26-09-14p22-27_Layout 1 23/09/2014 19:00 Page 5

Analysethe past…

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Essential Business Development Tools For The OTC Industry

The OTCToolbox website gives OTC decision-makersworldwide immediate online access to authoritativebusiness development tools. Our information services –Deals Database, News, News Extras, Briefings, Reports,Events and Useful Contacts – can help you...

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NEW IDEASBETTER WAYSHow OTC leadersview innovation

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INNOVATIONS

Edition 1, July 2014

The first-ever edition of ourquarterly OTC Innovations review– NEW IDEAS BETTER WAYS –discusses the need for a broadinnovation strategy in the globalnon-prescription market, exploresviews on innovation at some of theleading global OTC players, andlooks at approaches to early-stageinnovation in consumer healthcare.

How OTC leadersview innovation

NEW IDEASBETTER WAYS

New Ideas Better Ways is anew quarterly OTC Innovations reviewfrom OTCToolbox, which will keepyou informed about news, views,technological developments andinnovative products.

Edition 1 discusses the need for abroad innovation strategy in the globalnon-prescription market, explores viewson innovation at some of the leadingglobal OTC players, and looks atapproaches to early-stage innovationin consumer healthcare.

A4 nn vati nsAd-0 0 14.indd 1 0 /0 /2014 15:02

Merck KGaA has shaken up its manage-ment team in a move that will see Stefan

Oschmann, currently chief executive officerof the German firm’s Pharma business, take onthe new role of deputy chief executive officer ofthe group and vice-chairman of the manage-ment board from 1 January 2015.

In his new post, Oschmann would sharestrategic management functions with chairmanof the executive board Karl-Ludwig Kley,Merck said, and would represent the firm with“politicians and international organisations”.

Belén Garijo, chief executive officer ofMerck Serono – the company’s biopharmaceu-ticals business – will take over from Oschmannas chief executive of the Pharma business, whichincludes the firm’s Consumer division, as wellas its Allergy, Biosimilars and Serono units.

Commenting on the moves, Merck said thatOschmann – who had led a successful turn-around of the company’s Pharma business –would familiarise himself with group-widefunctions and “increasingly assume external re-sponsibilities for the company”.

Meanwhile, Garijo had a proven track rec-ord in developing Merck’s business. In her new

role she would contribute significantly to the“sustainable success” of the Pharma business,the company added.


PEOPLE OTC

Manufacturers

Merck to give Oschmanngroup-wide responsibilities

Stefan Oschmann

Belén Garijo

OTC

Celesio is to establish a leadership team com-prising members of its country manage-

ment teams and group function staff. It will “de-fine the strategic and operating priorities” of thepan-European wholesaler and retailer.

Explaining the rationale behind the move,Marc Owen, chairman of Celesio’s manage-ment board, said the leadership team would“strengthen the position of Celesio as a leadinginternational wholesale and retail company inthe pharmaceutical and healthcare sectors”.

“The individuals who are joining the teamwill bring a wealth of experience, energy andpassion to their new roles,” he added. “I feelvery confident that with this team in place wewill be able to continue to chart the right coursefor the firm, to strive to always better serve ourpatients, pharmacies and manufacturing part-ners, and to develop our leadership talent andmake Celesio an even better place to work.”

The move is the latest shake-up at the top

of Celesio after the US pharmaceutical whole-saler McKesson took over the Germany-basedbusiness earlier this year (OTC bulletin, 7 Feb-ruary 2014, page 1).

Owen – previously president of McKes-son’s Speciality Health business – took chargeof Celesio in July, replacing Dr Marion Helmes(OTC bulletin, 30 May 2014, page 27).

Celesio’s operation – which includes 2,200wholly-owned pharmacies, and an over 4,000-strong virtual-pharmacy network – will becomepart of McKesson’s Distribution Solutionsdivision, led by group president Paul Julian.

Further to the set-up of the leadership team,Celesio announced that Stephan Borchert,member of the management board and thefirm’s chief marketing and sales officer, hadleft the company. The decision, the firm said,was made in a mutual agreement with thesupervisory board.

Wholesalers & Retailers

Celesio to establish new leadership team

OTC

Elzbieta Bienkowska is set to take re-sponsibility for the pharmaceuticals and

medical devices industry across the EuropeanUnion (EU) after being named Commissioner-designate for the Directorate-General (DG)Enterprise and Industry.

One of a list of new Commissioner-desig-nates revealed by recently-elected EuropeanCommission president Jean-Claude Juncker,Bienkowska – a former deputy prime minis-ter of Poland – will oversee the pharmaceu-tical and medical devices industry for the Com-mission, as well as the European MedicinesAgency (EMA).

Bienkowska’s appointment comes as a num-ber of units responsible for pharmaceuticals andmedical devices are transferred to DG Enter-prise and Industry from DG Health and Con-sumers, also known as DG SANCO.

Responsibility for the ‘Medicinal Products– Authorisations and the EMA’ Unit and the‘Medical Products – Quality, Safety and Effi-cacy’ Unit moves from DG SANCO to DGEnterprise and Industry.

In addition to overseeing DG Enterpriseand Industry, Bienkowska will also hold respon-sibility for DG Internal Market and Servicesand the relevant parts of the Executive Agencyfor Small and Medium-Sized Enterprises.

Meanwhile, Vytenis Andriukaitis – a form-er health minister in Lithuania – has been nom-inated as European Commissioner for Healthand Food Safety, in charge of food-relatedissues at DG SANCO and its relationship withthe European Food Safety Authority (EFSA).

Each Commissioner-designate will appearat an individual hearing before European Parlia-ment’s Committees in the upcoming weeks.

The new College of Commissioners is ex-pected to take office on 1 November 2014.

European Commission

Europe namespharma leader

OTC

■ HEVERT ARZNEIMITTEL is now led bybrothers Marcus and Mathias Hevert as jointmanaging directors. Having returned from head-ing the German natural products specialist’soperations in the US, Marcus has assumed re-sponsibility for production, logistics, adminis-tration and regional policy. Mathias will con-tinue to oversee sales, marketing, exports, sci-ence and policy at national and European level.

OTC

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Nicoventures set to enter smoking-cessation space

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