OTC bulletin, 23 October 2016

24
Celesio grows in Portugal 3 with Grupo Holon network Hanmi to build facility in China 3 WBA to shake up its 4 global store offering GSK changes tack in India 5 to drive OTC sales growth ProPhase moves into supplements 5 Omega reveals plan 6 to boost 2016 sales Alibaba expands South-East Asia reach 6 Merck unveils its plans 7 to expand in Indonesia Pfizer and Allergan merger 8 scuppered by US tax move Alliance Pharma targets 9 expansion in Asia GENERAL NEWS 10 NZSMI voices opposition 10 to repackaging proposal JSMI outlines OTC priorities 10 French self-care model 11 could save C1.5bn mHealth consumers 12 identified in the US MARKETING NEWS 14 Kobayashi grows OTC line 14 with pain and acne options Science focus for Sensodyne 14 Omega’s Dermalex targets 15 UK’s adult acne sufferers Ratiopharm has rival to 15 Boehringer brand ACCC proposes A$6m fine 16 after RB misled consumers GSK simulates migraines 17 for US Excedrin campaign Premium option joins Loxonin S 17 FEATURES 20 Clear vision drives 20 GSK’s OTC ambitions REGULARS Events – Our regular listing 19 People – Pfizer’s Varma to replace 23 Mann as chair of WSMI T he US Food and Drug Administration’s (FDA’s) Nonprescription DrugsAdvisory Committee (NDAC) has voted unanimously to recommend switching adapalene gel 0.1% as a topical acne treatment. At its 15 April meeting, the committee said data in Galderma’s supplemental new drug application (sNDA) for adapalene gel 0.1% supported an acceptable benefit/risk profile for non-prescription use by consumers. The proposed OTC use of the product is “for the treatment of acne and to clear up acne pim- ples and acne blemishes” in those aged 12 years and above. Adapalene is the active ingredient in Gal- derma’s Differin acne medicines. The NDAC’s recommendation – which the FDA does not have to accept, but generally does – comes as New Zealand’s regulatory author- ity, Medsafe, prepares to consider a proposal to reclassify the ingredient at a meeting on 3 May (OTC bulletin, 4 March 2016, page 9). Pharmacy retail group Green Cross Health and switch consultant Natalie Gauld have sug- gested that adapalene be available without a prescription in “medicines containing not more than 1mg/g and when supplied in a pack of not more than 30g by a pharmacist”. The proposed use is for the “topical treat- ment of comedo, papular and pustular acne (acne vulgaris) of the face, chest and back”. Adapalene 0.1% is already available with- out a prescription in Georgia, Russia and Thai- land, while Germany recently rejected an appli- cation to switch adapalene mono preparations in concentrations of up to 0.1% with a maxi- mum pack size of 25g (OTC bulletin, 5 Feb- ruary 2016, page 11). W algreens Boots Alliance (WBA) has taken a step into the Russian retail pharmacy market by swapping its Alliance Healthcare Russia wholesale business with Pharmacy Chain 36.6 in exchange for a 15% stake in the leading Russian pharmacy chain. Headquartered in Moscow, Alliance Health- care Russia served more than 60 Russian cities, 36.6 said, adding that the deal was a good fit with its long-term aim of strengthening its wholesaling operations. Adding Alliance Healthcare Russia to the business would “significantly increase the num- ber and volume of direct contracts with phar- maceutical manufacturers” that 36.6 had in Russia, the company noted. “Undoubtedly this transaction will contri- bute to the development and improvement of 36.6 in all areas of the business,” commented the Russian company’s director general, Vladi- mir Kintsurashvili. With WBA now holding a 15% stake in 36.6, Kintsurashvili said the company would have access to “the experience and expertise of one of the leading international pharmaceuti- cal wholesale and retail firms”. The firm’s acquisition of Alliance Health- care Russia comes less than one month after 36.6 announced it wanted to “vigorously dev- elop” its wholesale business. Speaking in March, Kintsurashvili said 36.6 had set its sights on becoming a top-three phar- maceutical distributor in Russia within the next three years. “Expanding the wholesale business seems like a logical step for the development of the company,” Kintsurashvili insisted. “We have established productive relationships with manu- facturers,” he noted, “which gives us a solid foundation on which to build the business.” 36.6 is poised to become Russia’s largest drugstore chain after it agreed earlier this year to merge with local rival A5 Pharmacy Retail (OTC bulletin, 5 February 2016, page 5). Completion of the deal is subject to regula- tory approval. 22 April 2016 COMPANY NEWS 3 WBA makes Russian move with stake in retailer 36.6 FDA committee backs OTC adapalene

Transcript of OTC bulletin, 23 October 2016

Page 1: OTC bulletin, 23 October 2016

Celesio grows in Portugal 3with Grupo Holon networkHanmi to build facility in China 3WBA to shake up its 4global store offeringGSK changes tack in India 5to drive OTC sales growthProPhase moves into supplements 5Omega reveals plan 6to boost 2016 salesAlibaba expands South-East Asia reach 6Merck unveils its plans 7to expand in IndonesiaPfizer and Allergan merger 8scuppered by US tax moveAlliance Pharma targets 9expansion in Asia

GENERAL NEWS 10

NZSMI voices opposition 10to repackaging proposalJSMI outlines OTC priorities 10French self-care model 11could save C1.5bnmHealth consumers 12identified in the US

MARKETING NEWS 14

Kobayashi grows OTC line 14with pain and acne optionsScience focus for Sensodyne 14Omega’s Dermalex targets 15UK’s adult acne sufferersRatiopharm has rival to 15Boehringer brandACCC proposes A$6m fine 16after RB misled consumersGSK simulates migraines 17for US Excedrin campaignPremium option joins Loxonin S 17

FEATURES 20

Clear vision drives 20GSK’s OTC ambitions

REGULARS

Events – Our regular listing 19People – Pfizer’s Varma to replace 23Mann as chair of WSMI

The US Food and Drug Administration’s(FDA’s) Nonprescription Drugs Advisory

Committee (NDAC) has voted unanimously torecommend switching adapalene gel 0.1% asa topical acne treatment.

At its 15 April meeting, the committee saiddata in Galderma’s supplemental new drugapplication (sNDA) for adapalene gel 0.1%supported an acceptable benefit/risk profile fornon-prescription use by consumers.

The proposed OTC use of the product is “forthe treatment of acne and to clear up acne pim-ples and acne blemishes” in those aged 12 yearsand above.

Adapalene is the active ingredient in Gal-derma’s Differin acne medicines.

The NDAC’s recommendation – which theFDA does not have to accept, but generally does– comes as New Zealand’s regulatory author-

ity, Medsafe, prepares to consider a proposal toreclassify the ingredient at a meeting on 3 May(OTC bulletin, 4 March 2016, page 9).

Pharmacy retail group Green Cross Healthand switch consultant Natalie Gauld have sug-gested that adapalene be available without aprescription in “medicines containing not morethan 1mg/g and when supplied in a pack of notmore than 30g by a pharmacist”.

The proposed use is for the “topical treat-ment of comedo, papular and pustular acne(acne vulgaris) of the face, chest and back”.

Adapalene 0.1% is already available with-out a prescription in Georgia, Russia and Thai-land, while Germany recently rejected an appli-cation to switch adapalene mono preparationsin concentrations of up to 0.1% with a maxi-mum pack size of 25g (OTC bulletin, 5 Feb-ruary 2016, page 11).

Walgreens Boots Alliance (WBA) hastaken a step into the Russian retail

pharmacy market by swapping its AllianceHealthcare Russia wholesale business withPharmacy Chain 36.6 in exchange for a 15%stake in the leading Russian pharmacy chain.

Headquartered in Moscow, Alliance Health-care Russia served more than 60 Russian cities,36.6 said, adding that the deal was a good fitwith its long-term aim of strengthening itswholesaling operations.

Adding Alliance Healthcare Russia to thebusiness would “significantly increase the num-ber and volume of direct contracts with phar-maceutical manufacturers” that 36.6 had inRussia, the company noted.

“Undoubtedly this transaction will contri-bute to the development and improvement of36.6 in all areas of the business,” commentedthe Russian company’s director general, Vladi-mir Kintsurashvili.

With WBA now holding a 15% stake in36.6, Kintsurashvili said the company would

have access to “the experience and expertise ofone of the leading international pharmaceuti-cal wholesale and retail firms”.

The firm’s acquisition of Alliance Health-care Russia comes less than one month after36.6 announced it wanted to “vigorously dev-elop” its wholesale business.

Speaking in March, Kintsurashvili said 36.6had set its sights on becoming a top-three phar-maceutical distributor in Russia within thenext three years.

“Expanding the wholesale business seemslike a logical step for the development of thecompany,” Kintsurashvili insisted. “We haveestablished productive relationships with manu-facturers,” he noted, “which gives us a solidfoundation on which to build the business.”

36.6 is poised to become Russia’s largestdrugstore chain after it agreed earlier this yearto merge with local rival A5 Pharmacy Retail(OTC bulletin, 5 February 2016, page 5).Completion of the deal is subject to regula-tory approval.

22 April 2016

COMPANY NEWS 3 WBA makes Russian movewith stake in retailer 36.6

FDA committee backs OTC adapalene

OTC22-04-16p1_OTC15/11/2005 p1&24 19/04/2016 16:09 Page 1

Page 2: OTC bulletin, 23 October 2016

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Page 3: OTC bulletin, 23 October 2016

Celesio is set to expand its presence in Portu-gal after agreeing to acquire for an undis-

closed sum the Grupo Holon virtual pharmacychain. Completion of the deal is subject to clear-ance by the Portuguese Competition Authority.

By sharing the same brand, image and phar-macy concept, Holon’s network of 380 inde-pendent pharmacies enjoyed access to “attract-ive offers on products, services and buyingterms”, the German pharmaceutical wholesalerand retailer pointed out.

Strict regulations govern pharmacy chainsin Portugal, prohibiting individuals or com-panies from owning more than four pharmaciesin the country.

The acquisition of Holon, Celesio said, wouldexpand its “expertise and capabilities” in Port-ugal’s retail pharmacy market and enhance itsEuropean pharmacy network.

In addition, Holon would “strengthen thecustomer base” of Celesio’s wholesale busi-ness, OCP Portugal, the company insisted, andimprove its relationships with manufacturers.

“Holon will help OCP Portugal to achieve itsgoal of rendering additional and better servicesto Portuguese pharmacies,” Celesio explained.

As a result, the firm said, Portuguese con-sumers would “benefit from greater professionalhealthcare services and more choice”.

Celesio’s network includes around 2,000wholly-owned pharmacies – in Belgium, Ire-land, Italy, Norway, Sweden and the UK – plusmore than 4,300 affiliated partner pharmacies inFrance, Germany and Norway. It has wholesaleoperations in more than 10 European countries.

The company reported turnover up by 6.8%to C16.2 billion in the nine months ended 31December 2015. Earnings before interest andtax (EBIT) advanced by 28.8% to C332 millionin the period.

Celesio is now operating as part of Mc-Kesson and is housed in the US wholesaler’sDistribution Solutions division.

McKesson acquired Celesio in 2014 (OTCbulletin, 7 February 2014, page 1).

322 April 2016 OTC bulletin

COMPANY NEWS OTC

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Mergers & Acquisitions

Celesio grows in Portugalwith Grupo Holon network

Celesio has snapped up the Grupo Holon virtualpharmacy chain to expand its presence in Portugal

OTC

South Korea’s Hanmi Pharmaceutical hasannounced plans to build a new manufac-

turing plant to meet growing demand for itsOTC and prescription medicines in China.

In a short statement, the company revealedit had snapped up for US$10.0 million (C8.8million) a substantial plot of land in the Yan-tiai Economic and Technological DevelopmentZone in Shandong province to construct thenew facility.

Noting that it planned to invest US$200 mil-lion in the construction process, Hanmi saidit would “build facilities for the production ofchemical and biologic drugs and health supple-ments, as well as a research and developmentcentre for new drug development”. The sitewould supply Hanmi’s products to China andother “global markets”, the firm pointed out.

Commenting on the rationale behind themove, Hanmi claimed that the new facilitieswould help it to become a “more globalisedpharmaceutical company”.

Hanmi reported turnover up by 73.1% toKRW1.32 trillion (C1.02 billion) in 2015, thanksto better sales of prescription medicines.

The company’s OTC portfolio includes Al-lercon eye drops, the Maxibupen analgesic,Medilac anti-diarrhoeal, and the TenTenG diet-ary supplement.

Business Strategy

Hanmi to buildfacility in China

OTC

OTC22-04-16p3-9_Layout 1 20/04/2016 09:11 Page 3

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4 OTC bulletin 22 April 2016

OTC COMPANY NEWS

Offering “enhanced services” and “innova-tive” products will help Walgreens Boots

Alliance (WBA) globally to drive consumersinto its stores and stay ahead of the competition,according to the company’s chief executive offi-cer Stefano Pessina.

Speaking as the US-based wholesale and re-tail giant reported the results for its secondquarter ended 29 February 2016, Pessina saidit was “essential for the sustainable future” ofWBA to find “innovative and valuable offeringsto continue to bring consumers into our stores”.

The company was intent on “reviewing andrejuvenating” both its retail and pharmacy oper-ations in store, Pessina insisted, to “further dif-ferentiate” WBA in the market.

“We need to enhance our patient offering,”he explained, “and then ensure that we maxi-mise the value of that interaction both to thepatients and to the company through value-add-ed services.”

“In the front of our stores, we need to focusour offering, be clear what we stand for anddefine our areas of expertise and differentia-tion,” Pessina said. “And we need to offer thesethrough whatever medium or interface the con-sumer wants.”

“We must do this with strict vigilance andvigour so that we achieve our goals without dis-rupting the extraordinary level of service ourcustomers have come to expect,” he added.

US market is a priorityNoting that WBA would implement this

strategy globally, Pessina admitted that its im-mediate priority was the US, as this was the mar-ket where the company had “the most immedi-ate opportunities”.

“But this does not mean we are neglectingour other markets; far from it,” Pessina insisted.“In the UK, the team is working hard on strate-gies to keep Boots stores and the Boots brandportfolio not just ahead of the market, but themost relevant to its consumers.”

Commenting on the company’s plans for itsRetail Pharmacy USA unit – which comprisesWalgreens and Duane Reade drugstores – AlexGourlay, president of Walgreens, said WBAwas “focused on removing unprofitable itemsto try and simplify the offer”.

“We want to get consumers to re-evaluatethe offer inside Walgreens to see it as moreunique and more differentiated,” he maintained.

As part of this plan, the company wouldcontinue to introduce its “differentiated beautyoffering” – led by the Boots No.7 brand – to

a further 1,600 Walgreens stores from the sum-mer. This would increase the total number ofstores with this beauty offering to around 2,000by the end of 2016, Gourlay noted.

Turning to WBA’s second-quarter results,Pessina reported a performance “pretty much inline with expectations”, with sales up by 13.6%to US$30.2 billion (C26.5 billion), after elimi-nations of US$632 million.

While the firm still had “plenty more to do”in integrating the Alliance Boots and Walgreensbusinesses, following the completion of theirmerger deal (OTC bulletin, 17 April 2015, page5), Pessina said “good progress” had alreadybeen made in “reducing costs and establishingmore efficient working practices”.

Turnover at the Retail Pharmacy USA divi-sion advanced by 2.1% to C21.5 billion in thethree months. Prescription sales, which account-ed for 65.0% of the total, had increased by3.2%, WBA noted, while prescription sales incomparable stores had improved by 3.7%.

The division’s operating income moved for-ward by 2.1% to US$1.6 billion in the period.

As of WBA’s financial year ended 31 Aug-ust 2015, Retail Pharmacy USA was operating8,173 drugstores across all 50 US states, theDistrict of Columbia, Puerto Rico and the USVirgin Islands.

WBA announced late last year it was toexpand significantly Retail Pharmacy USA afteragreeing to buy drugstore rival Rite Aid in atransaction valued at around US$17.2 billion,including acquired debt (OTC bulletin, 6 Nov-ember 2015, page 1).

Pessina said at the time that the purchaseof Rite Aid would “accelerate” WBA’s long-term objective to strengthen its “presence andcoverage nationally across the US”.

“The addition of Rite Aid,” Pessina insisted,“will accelerate our strategy by completing ournetwork; providing a larger and more compre-hensive portfolio; and by creating a more com-prehensive and stronger platform for the dev-elopment of our brand presence and the futuregrowth of the business.”

Synergies “in excess of US$1 billion” wereexpected from the transaction, Pessina pointedout, adding that the firm would make decisions“over time” about integrating the two companies,with the aim of “creating a fully-harmonisedportfolio of stores and infrastructure”.

Commenting on the Rite Aid deal, Pessinasaid it was “progressing as planned”, with RiteAid’s shareholders approving the transactionon 4 February. The company expected the ac-

quisition to close in the second half of 2016,he added.

Meanwhile, WBA reported sales of US$3.7billion at its Retail Pharmacy International div-ision – consisting of health and beauty chainsin eight countries, the largest of which is BootsUK – in the three months.

Sales at the unit had been driven by “par-ticularly strong growth in the UK and Ireland”,the company noted.

Commenting on Boots UK’s performance,WBA said the business had benefitted frombetter sales of the No.7 and Soap & Glory skin-care brands and the “continued growth” of theboots.com website.

Driven by higher sales in Ireland and theUK, Retail Pharmacy International posted anoperating income of US$335 million for thethree months.

As of 31 August 2015, the division was op-erating 4,582 health and beauty stores acrossChile, Ireland, Lithuania, Mexico, the Nether-lands, Norway, Thailand and the UK.

Meanwhile, WBA’s Pharmaceutical whole-sale unit – which mainly operates under theAlliance Healthcare brand – generated salesof US$5.6 billion in the second quarter.

The division reported an operating incomeof US$155 million in the period.

WBA pointed out that the PharmaceuticalWholesale division supplied medicines, otherhealthcare products and services to more than200,000 pharmacies, doctors, health centres andhospitals from over 350 distribution centreslocated in 19 countries.

WBA’s total operating income for the periodamounted to US$2.12 billion, after eliminations.

Business Strategy/Second-Quarter Results

WBA to shake up its global store offering

Stefano Pessina, Walgreens Boots Alliance’schief executive officer, said the firm was intent on“reviewing and rejuvenating” the retail and pharmacyoperations in its stores

OTC

OTC22-04-16p3-9_Layout 1 19/04/2016 16:33 Page 4

Page 5: OTC bulletin, 23 October 2016

■ CIPLA has sold for an undisclosed sum a26.11% stake in its consumer healthcare sub-sidiary, Cipla Health, to Mauritius-based FILCapital Investments.

GlaxoSmithKline (GSK) Consumer Health-care will place a greater focus on OTC

medicines to take its business in India to the nextlevel, according to Zubair Ahmed, head of theunit in Asia-Pacific, the Middle East and Africa.

Speaking to the Economic Times, Ahmedsaid that GSK could secure “faster” growth inIndia if it invested more heavily in its Wellnesscategory – which contains the bulk of its OTCmedicines – rather than relying disproportion-ately on its Horlicks nutrition brand.

Horlicks accounts for a significant propor-tion of GSK Consumer Healthcare’s sales inIndia, which reached INR41.4 billion (C545 mil-lion) in the 12 months ended 31 March 2015.

While Horlicks remained a “core” brand,which the firm would continue to develop andsupport, Ahmed said GSK would “invest in OTCbrands disproportionately” to drive growth. Thefirm also wanted to get more out of its OralCare portfolio, he added, and in particular itsSensodyne toothpaste.

“In spite of our best efforts, the Wellnessbusiness is still underleveraged and it is verydependent on Horlicks,” Ahmed explained. “InOral Care, our share of India’s toothpaste mar-ket is in the low-single digits.”

GSK was “totally underleveraged in bothWellness and Oral Care” in India, he admitted,but the firm did see an opportunity to increaseits share in these markets.

To do this, GSK had identified four ‘powerbrands’ – Otrivin, Panadol, Sensodyne and Volt-

aren – that it would prioritise, Ahmed explain-ed. The firm would also look to “diversify” itsWellness offering, he revealed, and exploreopportunities to introduce to the Indian mar-ket its allergy and smoking-cessation brands.

Noting that India was a “priority market”for GSK, Ahmed said the company was keento apply lessons it had learnt in other countries tohelp the Indian business reach its potential.

GSK’s successes in China – particularly withe-commerce – had the potential to be replicatedin India, he noted.

Last month, Ahmed revealed that GSK was“poised for sizeable growth in China” after heav-ily investing in the country (OTC bulletin, 4March 2016, page 7).

522 April 2016 OTC bulletin

COMPANY NEWS OTC

Business Strategy

Zubair Ahmed, head of GlaxoSmithKline’s ConsumerHealthcare business in Asia-Pacific, the Middle Eastand Africa, revealed the firm planned to invest moreheavily in OTC medicines in India

GSK changes tack in Indiato drive OTC sales growth

OTC

ProPhase Labs is looking to reduce its de-pendence on its core Cold-EEZE brand

by moving into the dietary supplements space,the company’s chief executive officer, Ted Kar-kus, has revealed.

Speaking as the US-based firm reported2015 sales down by 6.8% to US$20.6 million(C18.2 million), Karkus said the company hadbecome over-reliant on its Cold-EEZE homo-eopathic cold and flu range and needed to div-ersify its portfolio.

“In order to offset the seasonality of ourcurrent revenues and our dependence on theseverity of the cold and flu season,” Karkusexplained, “we are launching a new productline of OTC dietary supplements that will lever-age our existing infrastructure, retail relation-ships and sales force.”

Describing dietary supplements as a “largeand growing category”, Karkus said he believedthe firm’s offering, under its TK Supplementsbrand, had the potential to disrupt the market.

The first product to be launched under theTK Supplements umbrella would be LegendzXL, he revealed, a supplement for “male sex-ual enhancement”. Karkus said the companyhad conducted placebo-controlled trials to sup-port its claim that the product boosted penileblood flow within 60 minutes.

ProPhase had developed a set of televisionspots for Legendz XL and hoped to launch thebrand on direct-response television and onlinein the second half of 2016, he noted.

“As brand awareness increases over time,”Karkus explained, “our next goal will be tointroduce Legendz XL in retail stores, leverag-ing our existing infrastructure and retail distri-bution platform.”

While the firm would initially focus itsefforts on Legendz XL, Karkus revealed thatProPhase had developed “additional dietarysupplements for future introduction at the ap-propriate time”. One of these was a supplementfor prostate health, he noted, while another wasan “energy and endurance” product.

Denmark’s LEO Pharma has completed itsC675 million acquisition of Astellas Phar-

ma’s global dermatology business, in a movethe firm claims will extend its reach to “mil-lions” of additional consumers.

Describing the deal – announced in Nov-ember (OTC bulletin, 27 November 2015, page3) – as a “pivotal step” for LEO, the firm saidadding Astellas’ dermatology range would cre-ate a “strong foothold in markets such as Chinaand Russia” while adding “critical scale” inmany other markets.

LEO noted that it would continue to workclosely with Astellas over the coming months

to “secure an effective transition with contin-ued supply to patients”.

Astellas’ dermatology portfolio comprisesthe Lacobase OTC dry-skin product, as well asa range of prescription brands, including theProtopic eczema treatment and Zineryt topicalsolution for acne.

Noting that the transaction was the largestin LEO’s over 100-year history, the companysaid Astellas’ range would boost its annual turn-over by more than a fifth.

In 2015, LEO reported turnover up by 6%to DKK8.46 billion (C1.14 billion).

Mergers & Acquisitions

LEO Pharma boosted by Astellas deal

Business Strategy/Annual Results

ProPhase movesinto supplements

OTC

OTC

IN BRIEF

OTC

OTC22-04-16p3-9_Layout 1 19/04/2016 16:33 Page 5

Page 6: OTC bulletin, 23 October 2016

Building “strong” European OTC brandsand continuing to invest in its core prod-

ucts will help Omega Pharma to grow its mar-ket share in 2016, according to the Belgian con-sumer healthcare firm.

Announcing its 2015 results, Omega – whichwas last year acquired by Perrigo (OTC bul-letin, 17 April 2015, page 3) – said the “maindriver” of its growth would be a “continuedfocus on, and investments in, our top-20 brands”.

Omega’s top-20 includes brands such asAbtei dietary supplements, Lactacyd feminine-hygiene products, Solpadeine pain relievers andParanix head-lice treatments.

“These brands represent approximately 59%of the company’s turnover,” Omega pointedout, “and are considered the main drivers forthe future strategy and growth.”

Launch in new marketsOmega would look to take the top-20 into

new European markets, the firm revealed, sup-ported by “high promotional spending” to createbrand awareness.

In addition to investments in its top-20brands, the company said it would “continue tobuild strong European brands, with a focus onqualitative new product developments”.

Noting that it had invested C37 million inresearch and development in 2015, Omega in-sisted that such activities were an “essentialcornerstone of the company’s strategy”.

Omega revealed its plans for 2016 less than

two months after Perrigo’s chairman and chiefexecutive officer, Joseph Papa, described theBelgian firm’s fourth-quarter results as a “per-sonal disappointment” (OTC bulletin, 4 March2016, page 1).

Speaking in February, Papa said the companyhad failed to meet “internal expectations” andwas clearly facing “challenges” that neededto be addressed.

To get Omega back on track, a range of in-itiatives would be implemented to transformthe business’ “organisational design, businessprocesses and product-resource allocation”, Papasaid. These plans included a management shake-up and offloading underperforming brands.

“I recognise that my actions will speak loud-er than words,” Papa admitted, “so I am com-mitting a significant allocation of my time overthe next six months to be in Europe, where Iwill actively work with the business’ executiveteam and country managers to drive these initia-tives forward.”

Omega reported 2015 turnover down by4.5% to C1.22 billion. The company blamed thedecline on lower sales in markets such as Bel-gium, France, Germany and Russia, in combi-nation with a fall in turnover from distributinggenerics in Belgium.

On a more positive note, Omega said it hadenjoyed a “strong sales performance” in theNetherlands, Sweden, Turkey and the UK.

Turnover from the firm’s top-20 brands im-proved by 8.8% in the 12 months and account-

ed for 59% – or around C721 million – ofOmega’s total sales.

Omega pointed out that the basket of brandsPerrigo had picked up from GSK last year(OTC bulletin, 12 June 2015, page 1) – whichOmega distributes in Europe – had contributedC35.3 million to group sales, while the Yokebedietary supplement brand, also acquired last year(OTC bulletin, 14 August 2015, page 7), hadgenerated C5.9 million in turnover.

Separately, Omega announced that its plansto bring a novel skin-lesion treatment to mar-ket had taken a step closer, after the productwas granted a European CE mark.

The Belgian firm snapped up the rights tothe product, BL-5010, in Australia, Europe andother selected markets last December, afterstriking a licensing agreement with Israeli dev-elopment firm BioLineRx (OTC bulletin, 16January 2015, page 6).

BioLineRx said it expected Omega wouldnow launch BL-5010 in Europe “by mid-2016”.

Commenting on the agreement betweenOmega and BioLineRx when it was announced,Mark Couke, Omega’s chief executive officer,claimed the firm was adding a “promising”skin-lesion treatment to its existing range ofskin-care products.

“We were very impressed with the data fromthe product’s clinical trials to date,” Couke noted,“and believe it can gain quickly a prominentposition as an OTC treatment for a variety ofbenign skin lesions.”

6 OTC bulletin 22 April 2016

OTC COMPANY NEWS

Business Strategy/Annual Results

Omega reveals plan to boost 2016 sales

OTC

Alibaba Group is set to snap up a control-ling stake in e-commerce platform Lazada,

which a number of consumer healthcare firmsuse to sell their products in South-East Asia.

Under the terms of the deal, Alibaba willinvest US$1.0 billion (C886 million) in Lazadato acquire US$500 million of existing sharesand US$500 million of newly-issued shares.The firm has entered into a ‘put-call’ arrange-ment with Lazada shareholders, giving Alibabathe right to purchase the shares it does not ownin Lazada within the next 18 months.

Lazada currently operates e-commerce web-sites in Indonesia, Malaysia, the Philippines,Singapore, Thailand and Vietnam offering con-sumers a range of products including booksand clothing, as well as health and beauty lines.

Reckitt Benckiser (RB) uses Lazada to mar-ket its Durex range of sexual-health productsto South-East Asian consumers, while Pfizersells on the site its Caltrate and Centrum dietarysupplements. Blackmores, GNC and Herbalifeare among the other consumer healthcare firmsoperating on the platform.

Commenting on the deal, Michael Evans,president of Alibaba, said acquiring Lazadawould give the company “access to a platformwith a large and growing consumer base out-side China and a solid foundation for futuregrowth in one of the most promising regionsfor e-commerce globally”.

“This investment is consistent with our strat-egy of connecting brands, distributors and con-sumers wherever they are and will support our

expansion in South-East Asia,” Evans insisted.Lazada offered a “unique solution”, he claim-

ed, for global brands and distributors seekingto enter what was a “rapidly growing” region.

Alibaba’s own Tmall e-commerce websiteis used by numerous consumer healthcare firmsto sell their products in China. Pfizer recentlyrevealed that the Tmall platform had allowedthe company to reach Chinese consumers moreeasily (OTC bulletin, 8 April 2016, page 1).

Earlier this month, Alibaba abandoned plansto transfer its online pharmacy marketplacefrom Tmall to its affiliate Alibaba Health, cit-ing “substantial regulatory uncertainties” inrelation to the country’s healthcare market.

Alibaba said it would instead look to handover to Alibaba Health a portion of its dietarysupplements, health foods and nutritional prod-ucts business, which is currently operated byTmall (OTC bulletin, 8 April 2016, page 7).

Mergers & Acquisitions

Alibaba expands South-East Asia reach

OTC

OTC22-04-16p3-9_Layout 1 19/04/2016 16:33 Page 6

Page 7: OTC bulletin, 23 October 2016

Expanding its portfolio of strategic brandsand launching new products will help Merck

KGaA to take its Consumer Health business inIndonesia to the next level, the firm has claimed.

Describing Indonesia as Consumer Health’s“largest and most important market in Asia”,the German firm told OTC bulletin that it hadbig plans to “sustain the strong growth momen-tum” it was currently enjoying in the country.

While Merck does not give sales figures forits Consumer Health operations in individualcountries, the company said the Indonesia unithad enjoyed a 16% rise in sales in 2015.

“We were particularly proud of this strongperformance,” Merck said, noting that growthhad been driven by “integrated marketing andsales campaigns” in support of its Neurobionand Sangobion strategic brands.

Focused on “engaging consumers by creat-ing high awareness on specific nerve- and blood-health related symptoms” the campaigns for theNeurobion vitamin B line and Sangobion an-aemia supplement had been particularly suc-cessful, the firm noted.

Commenting on the company’s plans to takea larger slice of the OTC market in Indonesia,Merck said it would this year launch two newproducts under the Neurobion and Sangobionbrand names.

Although the company would not give spe-cific details of the launch for competitive rea-sons, Merck did reveal that both products would“focus on pain”, and one would be a specificwomen’s health line.

In addition to new product launches, Merckexplained it would grow the Indonesia business

by adding the Seven Seas cod liver-oil line toits strategic brands roster.

“We are planning notable efforts to estab-lish Seven Seas as a stronger brand in Indone-sia’s vitamins, minerals and supplements mar-ket,” the firm insisted. Noting that Seven Seashad built a small presence in the country, Mercksaid it was intent on “driving further growth”.

The promotion of Seven Seas to strategicstatus, Merck claimed, would support its long-term goal of implementing Consumer Health’sglobal ‘3x3’ strategy in Indonesia. Under its3x3 strategy, Merck Consumer Health wants todevelop a minimum of three leading brands inkey categories and to achieve at least a 3% mar-ket share across the company’s top 15-20 markets.

Expanding on its long-term plans for Indone-sia, Merck said it would evaluate opportunitiesto introduce a greater number of its global strate-gic brands to the market, while also continuingto grow Neurobion, Sangobion and Seven Seas.

722 April 2016 OTC bulletin

COMPANY NEWS OTC

Business Strategy

Merck unveils its plansto expand in Indonesia

Merck KGaA intends to grow its Consumer Healthbusiness in Indonesia by promoting its Seven Seasrange to strategic brand status

OTC

Brazil’s Aché has strengthened its positionin its domestic market by snapping up

OTC and prescription medicines manufacturerNortis Farmacêutica for an undisclosed sum.

Under the terms of the deal, Aché has gainedNortis’ portfolio of antibiotics, non-prescriptionmedicines and nutraceuticals, plus its manu-facturing plant in Londrina.

Nortis’ range of OTC products includes theGastroplus heartburn product, Golden Vit diet-ary supplement and the Kalopé wart treatment.

Commenting on its plans for Nortis, Achésaid it would invest BRL80 million (C19.7 mil-lion) in the Londrina facility to boost capacityin an effort to lift group sales by 15% in 2016.

Aché reported sales up by 9.3% to BRL2.3billion in 2015, thanks to new product launchesacross its non-prescription and prescriptionmedicines businesses.

The company’s OTC portfolio includes theAccuvit multivitamin and Dorilax analgesic.

Mergers & Acquisitions

Aché grows in Brazil with Nortis buy

Aspen Park Pharmaceuticals is set to mergewith the Female Health Company (FHC),

in a deal that the two US-based firms describedas “transformational”. The financial details ofthe transaction were not disclosed.

The proposed merger – which is expectedto close in the third quarter of 2016 – willbring together female condom manufacturerFHC with OTC and prescription medicines dev-elopment firm Aspen Park.

Consumer healthcare products currently be-ing developed by Aspen Park include wipes forreducing the incidence of premature ejacula-tion – which the company plans to launchlater this year under the Preboost brand name –and a sexual-health dietary supplement.

Under the terms of the merger agreement,FHC and Aspen’s shareholders will own 55%and 45% respectively of the shares of the com-bined company.

Commenting on the deal, Aspen Park’schief executive officer, Mitchell Steiner, saidthe merger would “strategically join” the firm’s“multiple high-profile drug candidates” withFHC’s “market leading” FC2 female condom.

“I am excited by the prospect of advancingthe combined company’s promising productdevelopment programme,” Steiner insisted,“while at the same time expanding the marketfor FC2 and leveraging a state-of-the-art, modu-lar manufacturing facility and global distribu-tion network.”

Large development portfolioO.B. Parrish, FHC’s chairman and chief ex-

ecutive officer, said the merger would createa “powerful company with solid cash flowsand a deep product development portfolio”.

“The strategic benefits of the transaction de-liver on our objective to add a diversified andcomplementary mix of products that has thepotential to substantially expand our revenuebase and grow our business,” Parrish added.

“We believe merging with Aspen Park,” con-tinued Parrish, “will provide the company withexciting new opportunities.”

Based in Chicago, US, FHC reported salesup by 33% to US$32.6 million (C40.8 million)in the 12 months ended 30 September 2015.

According to its most recent US Securitiesand Exchange Commission (SEC) filing, pri-vately-held Aspen Park generates less thanUS$1.0 million in annual sales.

Mergers & Acquisitions

Aspen Park andFHC to merge

OTC OTC

OTC22-04-16p3-9_Layout 1 19/04/2016 16:33 Page 7

Page 8: OTC bulletin, 23 October 2016

Pfizer and Allergan have terminated “bymutual agreement” their planned US$160

billion (C140 billion) merger in the wake ofmeasures announced by the US Treasury andInternal Revenue Service (IRS) to limit tax-inversion transactions.

The deal had been scheduled to close duringthe second half of this year (OTC bulletin, 27November 2015, page 9). Pfizer will reimburseAllergan US$150 million for expenses asso-ciated with the transaction.

Allergan still expects to sell its Actavis gen-erics unit – including its international OTCbusiness – to Teva for US$40.5 billion by June(see left).

On 4 April, the US Treasury announced thatit was taking action to “limit inversions by dis-regarding foreign parent stock attributable torecent inversions or acquisitions of US compa-nies”. This move, it said, would prevent foreigncompanies from acquiring US firms in share-based transactions and then using their increas-ed size to avoid current inversion thresholdsfor subsequent US acquisitions.

The Treasury aims to “address earnings strip-ping” through measures including new rules ondebt, interest deductions and due diligence.

“Transactions should be driven by genuinebusiness strategies and economic efficiencies,

not a desire to shift the tax residence of a par-ent entity to a low-tax jurisdiction simply toavoid US taxes,” insisted the Treasury, whichurged Congress “to move forward with anti-inversion legislation this year”.

Through the merger, Allergan and Pfizer hadexpected to reduce their combined tax rate byadopting Allergan’s Irish tax domicile.

Following its move to pull the plug on theAllergan deal, Pfizer announced it had broughtforward a planned decision on whether to splitits Established and Innovative business seg-ments. The company’s Consumer Healthcareunit sits within the Innovative segment.

Ian Read, the firm’s chairman and chiefexecutive officer, said Pfizer now planned tomake a decision “by no later than the end of2016”, consistent with the firm’s original time-frame prior to reaching its agreement with Aller-gan towards the end of last year. After theagreement was reached, Read said that no deci-sion would be made before the end of 2018,due to the scale of integrating Allergan.

Pfizer’s Global Established Products busi-ness comprises legacy brands that “have lostor will soon lose market exclusivity in bothdeveloped and emerging markets, branded gen-erics, generic sterile injectable products, bio-similars and infusion systems”.

8 OTC bulletin 22 April 2016

OTC COMPANY NEWS

Mergers & Acquisitions

Pfizer and Allergan mergerscuppered by US tax move

OTC

Allergan “fully expects” to complete thesale of its Actavis generics business to

Teva during the first half of this year, presidentand chief executive officer Brent Saunders hasstated in the wake of Allergan’s merger withPfizer collapsing.

Addressing investors shortly after measuresunveiled by the US Treasury tightening the re-strictions around inversion deals caused Aller-gan and Pfizer to mutually terminate the merger(see right), Saunders maintained that the Act-avis deal would close by June.

“We think that Teva has done a very goodjob at working diligently to clear the antitrustauthorities around the world, they have securedapproval in Europe, they are working hardwith the US Federal Trade Commission (FTC)and we are very confident that they will get thisdeal closed in the coming weeks,” he insisted.

Approval from the European Commission,albeit with significant conditions attached inIceland, Ireland and the UK, came a monthago (OTC bulletin, 25 March 2016, page 4).However, at the same time, Teva said thatFTC approval of the deal could take until June,three months later than originally anticipated.

Announcing the US$40.5 billion (C35.6 bil-lion) acquisition last year (OTC bulletin, 14August 2015, page 3), Teva noted the deal in-cluded Allergan’s “Actavis global generics busi-ness, including the US and international gen-erics commercial units, third-party supplierMedis, global generics manufacturing opera-tions, the global generics research and develop-ment unit, the international OTC commercialunit – excluding eye-care products – and someestablished international brands”.

Meanwhile, when quizzed by an investor onthe provisions and terms that would “allow Tevato walk away” from the deal, Saunders stressedboth parties’ dedication to complete the trans-action. “Just to be clear, Teva does not want towalk away, we do not want to walk away, bothmanagement teams are absolutely aligned ongetting this deal [completed],” he said.

Mergers & Acquisitions

Allergan set toclose Teva deal

OTC

■ DAIICHI SANKYO is to establish newUS headquarters in Basking Ridge, New Jer-sey. The new site will incorporate the firm’sexisting offices in Edison and Parsippany.

IN BRIEF

OTC

Adcock Ingram has agreed to sell the salesand marketing arm of its Cosme Farma

operation in India, Adcock Ingram Healthcare,to local private-equity firm Samara Capital Part-ners for INR1.51 billion (C20.1 million) in cash.

The South African firm, which expects thetransaction to close “by the end of July 2016”,subject to certain closing conditions, will retainCosme’s regulatory services business covering“quality control and assurance, medical affairs,information technology support and researchand development services”.

Just under a year ago, Adcock revealedthat it was looking to offload Cosme, whichhad been hit with asset-impairment charges ofZAR74.4 million (C4.51 million) and ZAR278million in the firm’s financial years endingJune 2015 and 2014, respectively.

Commenting on the agreement with Samara,Adcock explained that Cosme’s sales and mar-keting arm did not “meet the company’s currentinvestment criteria”, and “as a result, the com-pany has decided to exit this business”.

Adcock paid INR4.80 billion, plus INR480million in taxes and charges, for the Cosmeoperation in 2012, in a bid to diversify thefirm’s operations outside of South Africa (OTCbulletin, 27 July 2012, page 8).

Mergers & Acquisitions

Adcock Ingram offloads Cosme operation

OTC

■BIOSTIME – the Chinese owner ofAustralia’sSwisse Wellness – reported sales up by 1.8%to RMB4.82 billion (C657 million) in 2015.

IN BRIEF

OTC

OTC22-04-16p3-9_Layout 1 19/04/2016 16:33 Page 8

Page 9: OTC bulletin, 23 October 2016

Alliance Pharma is intent on expanding itsOTC business in China and the “fast-grow-

ing” markets of South-East Asia, according tochief executive officer John Dawson.

Speaking to OTC bulletin as the firm re-ported its 2015 results, Dawson said Alliancewould look to build on its “growing strength”in China and South-East Asia by going afteracquisitions to bolster its OTC and prescriptionbusinesses in those markets.

“We recognise that part of the world as beingvery fast-growing and exciting,” Dawson noted.

Alliance had people on the ground in Shang-hai “looking for opportunities that would suitour business”, he revealed, and was opening anoffice in Singapore to do the same.

While the firm had been “progressively”building its presence in China over the pastfew years, Dawson said the business had re-cently been given a shot in the arm by Alliance’sacquisition of Sinclair IS Pharma’s HealthcareProducts business.

The deal – announced in December (OTCbulletin, 11 December 2015, page 3) – hadadded to Alliance’s portfolio the scar-treatmentbrand Kelo-Cote, he noted, which sold “partic-ularly well” in China. “China is Kelo-Cote’sbiggest market, so its addition really is a boostfor the operations we previously had in thecountry,” Dawson noted.

The company also offers the Forceval sup-plement for pregnant women in China, as wellas a number of infant-formula products suchas Suprememil.

Acquiring Sinclair’s Healthcare Productsbusiness had also had a beneficial effect on Al-liance’s South-East Asia operation, Dawsonpointed out, adding to the portfolio the Kelo-Stretch stretch-mark treatment.

“In South-East Asia, we used to sell ourproducts very much at arms length, as we didn’thave anyone on the ground in the region,” heexplained. “The Sinclair deal gave us a base inSouth-East Asia and we have just recruited alocal manager to run that business.”

Away from Asia, Alliance remained “open toopportunities” to expand its dominant WesternEurope business, Dawson noted. The Sinclair dealhad helped it to realise its ambition to have apresence in the “big five” European markets, hesaid, by adding infrastructure in Italy and Spain.

With the firm now operating in these mar-kets, as well as in France, Germany and theUK, Alliance had become a “much better con-tender for [acquisition] opportunities” in Europe,Dawson insisted.

Commenting on the type of deals that wouldinterest Alliance, Dawson said the firm was opento both transformational and tuck-in acquisitions.

“Small bolt-ons are very useful as they canbe easily integrated,” he pointed out. “But giventhe scale-up that we’ve achieved through theSinclair deal, we now have the wherewithal totackle things that would have been out of reachone or two years ago.”

While the firm was still on the look-out foropportunities, Dawson insisted that Alliance’sshort-term priority was completing the integra-tion of Sinclair’s Healthcare Products business.

Turning to Alliance’s annual results, Daw-son reported turnover up by 11% to £48.3 mil-lion (C60.5 million), thanks to better sales of theHydromol emollient brand and the addition ofSinclair’s Healthcare Products business.

While the firm does not break down its pre-scription and consumer healthcare sales, Dawsonrevealed that non-prescription products account-ed for around 25% of the company’s turnover.

The firm’s consumer healthcare portfolio

includes the Ashton & Parsons teething powders,Lypsyl skin-care brand and Macushield eye-health supplement, as well as Forceval, Kelo-Cote and Kelo-Stretch.

Acquiring Macushield before the Sinclairdeal had helped boost consumer healthcare turn-over, Dawson said, with the brand generating£3.5 million in 10 months.

Noting that Macushield had “major poten-tial for internationalisation”, Dawson said heexpected sales of the product to “grow sig-nificantly” in the next few years.

While Macushield helped to drive up groupturnover, sales of both Ashton & Parsons andLypsyl had remained flat in the 12 months,Dawson reported.

Sales of Ashton & Parsons had “levelled-off”at £1.5 million, he noted, after strong growthin 2014. Lypsyl’s turnover had remained staticat £1.1 million, Dawson added, as Alliancefocused its efforts on repositioning the brandfor its relaunch later this year.

922 April 2016 OTC bulletin

COMPANY NEWS OTC

Business Strategy

Alliance Pharma targets expansion in Asia

OTC

OTC22-04-16p3-9_Layout 1 19/04/2016 16:33 Page 9

Page 10: OTC bulletin, 23 October 2016

Recommended dietary reference values(DRVs) for vitamin D have been put for-

ward by the European Food Safety Authority(EFSA) for public consultation.

Noting that average requirements (ARs) andpopulation reference intakes (PRIs) for vitaminD could not be derived, EFSA’s panel on Diet-etic Products, Nutrition and Allergies (NDA) hasproposed in its draft scientific opinion AdequateIntakes (AIs) for adults, children and infants,as well as for pregnant and lactating women.

For adults – including pregnant or lactatingwomen – an AI for vitamin D is set at 15µg/

day. This is the same for children between oneand 17 years of age, while the AI for infants agedfrom seven to 11 months is set at 10µg/day.

The AIs for adults and children were basedon a meta-regression analysis, the NDA point-ed out, which was carried out on data “collectedunder conditions of minimal cutaneous vitaminD synthesis”.

In the presence of cutaneous vitamin D syn-thesis, the requirement for dietary vitamin Dwould be lower, the panel said, or even zero.

Comments should be submitted by 16 May.

10 OTC bulletin 22 April 2016

OTC GENERAL NEWS

Regulatory Affairs

EFSA puts forward AIs for vitamin D

OTC

The New Zealand Self-Medication Industry(NZSMI) is against the proposed changes

that would allow pharmacists to repackage re-stricted and pharmacy-only generic medicinesand sell them instead of proprietary brands.

A proposal put forward by the Pharma-ceutical Society of New Zealand (PSNZ) rec-ommends a change in classification wordingfor the restricted – pharmacist-only – medi-cines lansoprazole and promethazine to removethe requirement that the product should onlybe sold in the manufacturers’ original pack.

Pharmacy-only medicines coveredThe pharmacy-only medicines ibuprofen,

omeprazole and pantoprazole, as well as rani-tidine, were also proposed for removal of therequirement by the PSNZ.

However, smaller packs of ranitidine witha general-sale classification would still be soldin the manufacturer’s original pack.

Meanwhile, for sumatriptan, the PSNZ wantsto remove the requirement that the product hasto be sold in a pack that has received the con-sent of the minister or the director-general forits sale as a restricted medicine.

A similar request has been made for the phar-macy-only medicines opium and pholcodine.

The PSNZ insisted in its proposal that “nothaving to rely on the availability of, or con-form to the presentation of a specific pack, willmean for some patients a safer or more afford-able medicine may be provided”, and any re-quirements of supply – such as age restrictions,

indications and maximum dose size – wouldstill apply to the smaller or cheaper packs.

However, in a letter to the medicines regu-lator Medsafe – whose Medicines Classifica-tion Committee (MCC) is due to discuss theproposal at its meeting on 3 May – the NZSMI’sexecutive director Tim Roper argues that thelevel of detailed product information on manu-facturers’ packs will not be matched by phar-macists providing their own packs.

This may potentially deprive consumers ofa permanent source of product information forreference after purchase, Roper points out.

It will also raise questions as to what Con-sumer Medicine Information (CMI) a phar-macist would supply if the product was dis-pensed from a larger prescription pack, Ropernotes, and whether the pharmacist would beheld liable for any “misadventure” due to theuse of inappropriately-labelled products.

Noting that there are over 900 pharmacies inNew Zealand, Roper adds that the propoal willlead to inconsistent “practices when preparingand packing and labelling products for sale”.

Impossible to track packagesThe letter also claims that dispensing re-

packaged medicines may cause problems interms of post-market surveillance. It would alsoaffect traceability, as a recall of a particularpack through identification of batch numberwould be “impossible”.

Furthermore, the PSNZ’s proposal may “seri-ously” impact sales of OTC drugs, Roper warns.

Regulatory Affairs

NZSMI voices oppositionto repackaging proposal

OTC

Accelerating the prescription-to-OTC switchprocess is one of the Japan Self-Medication

Industry’s (JSMI’s) seven priorities to grow thecountry’s OTC industry in the next 12 months.

Outlining its policies for the coming year,the JSMI said that speeding up the switch pro-cedure would allow better choices for consum-ers to prevent “symptom manifestation in life-style diseases”, and improve the overall qual-ity of consumers’ lives.

The association said it would also explorewhether general diagnostic devices should bemade available OTC.

Furthermore, the JSMI wants to increaseengagement with medical professionals to helpencourage more consumers to self-care.

The association said it would call for moreconsultation rooms in pharmacies and drug-stores, and a “regional comprehensive caresystem” that would “enable co-operation andstronger collaboration” between doctors, phar-macists and nurses.

Turning to more regulatory matters, the JSMIsaid it wanted a review of the wording on labelsfor ‘quasi-drugs’ – such as vitamin and tonicdrinks – to enable consumers to choose appro-priate products and to differentiate these optionsfrom foods with functional claims.

The JSMI said it would also create an “ap-propriate advertising standard” and guidelinesfor promoting pharmaceuticals.

It would also help educate consumers onhow they could benefit from an income tax re-duction on the purchase of OTC drugs set tocome into force in January 2017, the JSMI said.

Meanwhile, the association is also encour-aging manufacturers to provide informationin other languages on product packaging to en-courage purchases by non-Japanese speakerswho live in, or are visiting, Japan.

Noting that Japanese OTC medicines were“highly trusted overseas, particularly in Asia”,the JSMI said information should be providedin Chinese, English and Korean.

To achieve this, product labelling shouldinclude codes that could be scanned by non-Japanese consumers using a ‘Uni-Voice’ smart-phone translator app, the JSMI explained. For-eign-language documents would also be provid-ed through a self-medication database, it added.

The association also plans to support thestandardisation of OTC pharmaceutical regu-lations in Asia.

Regulatory Affairs

JSMI outlinesOTC priorities

OTC

OTC22-04-16p10-13_Layout 1 19/04/2016 17:29 Page 2

Page 11: OTC bulletin, 23 October 2016

France’s self-medication sector is poised togrow and develop, but the country lacks the

“political willpower to place self-care at theheart of a new healthcare strategy”, accordingto a comprehensive ‘Manifesto’ document thathas been published by local self-medicationindustry association Afipa.

“In France, everything is ready to increaserapidly the development of self-care,” the docu-ment insists. “Patients, pharmacists, industry,distribution networks and even general practi-tioners (GPs) are gradually joining this trend.”

“Our healthcare system, while it is remark-able, suffers from an ever-increasing deficit,and its sustainability is threated by sociologi-cal challenges it is unable to meet,” Afipa pointsout. But the country lacks the political will tomake self-care a key part of France’s healthcarestrategy, the association believes.

“This is both surprising and unfortunate,as we know that promoting self-care means wecan provide a documented, solid, efficient, fed-erated response to the organisational and financ-ing issues faced by our healthcare system,” theManifesto states.

Nevertheless, Afipa maintains that it and itsmembers are “ready and willing to share theirexpertise, and support any political action aim-ing to develop self-care in France”.

To this end, Afipa’s Manifesto sets out threekey pillars of action that the association be-lieves will aid the development of France’s self-medication sector: to “reform the rules of finan-cial coverage and develop the offering of self-medication”; to “unite healthcare professionalsand patients”; and to “facilitate self-medicationand to ensure that it is financially accessible, andcapable of obtaining the support of patients”.

Under the first pillar, Afipa urges the Frenchauthorities to establish a list of “benign patho-logies” considered suitable for self-medication,and to make all molecules associated with thesepathologies available without prescription.

“A reform of the way healthcare costs arecovered must be implemented today, and patho-logy is the starting point,” Afipa believes. “Thecost of benign pathologies must be borne in-dividually,” the association insists.

“A list of these benign pathologies has beenproposed by Afipa, based in particular on thelist defined by the French healthcare productssafety agency (ANSM),” the Manifesto pointsout. These pathologies include minor and mod-erate acne; occasional adult constipation; anddry and irritating cough. “All the moleculeswhich treat these benign pathologies must no

longer be financed collectively,” Afipa insists.The association notes that self-medication

is “much less developed in France than in othercountries”, with self-medication volumes repre-senting 15.4% of the overall French market “ver-sus 32.3% on average in Germany, Belgium, theNetherlands, Spain, Italy, Sweden and the UK”.

“When compared with the situation in otherEuropean countries, the potential for the dev-elopment of self-medication in France is very sig-nificant,” Afipa believes, claiming in the reportthat “90 molecules could become available OTCif France were aligned with its neighbouringEuropean countries”.

This discrepancy between France and therest of Europe “illustrates the inadequacy ofthe French system, which does not respond tothe evolution of our society and the ever-in-creasing demand of the French people to takemore control of their healthcare”, Afipa says.

Unite all professionalsUnder the pillar of uniting healthcare pro-

fessionals and patients, Afipa proposes organ-ising “a large-scale conference on responsibleself-medication, gathering all healthcare profes-sionals in order to involve them in the reflectionprocess, and provide them with tools to supportthem in their daily practice”.

In particular, the association suggests provid-ing “decision trees” to facilitate the deliveryof OTC medicine, indicating self-medicationmedicines on a patient’s pharmaceutical andmedical records, implementing specific train-ing programmes relating to OTC medicines, andsetting-up an “annual GP consultation focusedon self-medication”.

Other important initiatives would includeincreasing the competencies of pharmacists bygiving them the option to deliver certain addi-tional products, provided that they completespecific training programmes.

Furthermore, Afipa also believes it is keyto “inform the French people about responsibleself-medication by reinforcing health educationvia an information campaign”. This could bedelivered by the French National Institute forPrevention and Health Education, Afipa sug-gests, and by “implementing dedicated educa-tional programmes”.

Finally, under the pillar of facilitating self-medication by ensuring that it is financially ac-cessible for patients, Afipa suggests applying“an appropriate value-added tax (VAT) rate” toself-medication. “The current rate of 10% istoo high,” the association believes.

Afipa proposes a self-medication VAT rateof “2.1%, as for prescription medicines, due tothe fact that self-medication medicines mustcomply with the same marketing regulationsand offer the same safety guarantees”.

Moreover, by including self-medication inFrance’s universal illness coverage ‘CMU’ in-surance programme, Afipa says the countrycould “provide free self-medication medicineto people with limited financial means”.

Taking into account all of Afipa’s proposalsto expand the scope of French self-medication,develop the use of OTC medicines and reformthe country’s healthcare financing model, theassociation believes “the model proposed herewould result in major savings exceeding C1.5billion in only one year”.

This would include savings on medical con-sultations as well as on reimbursement of medi-cines by public health insurance.

“On average, 16 out of 100 patients seen inconsultation suffer from a problem which couldbe solved with responsible self-medication, with-out involving a GP,” Afipa claims. “The devel-opment of self-care could therefore regulatehealthcare by improving access to GPs andlimiting congestion in emergency wards.”

“Resources exist, they are ready to be de-ployed and will enable the system to adapt andincrease its efficiency,” Afipa insists. “One ofthose remarkable resources is self-care – andmore precisely, self-medication – which has prov-en its efficiency in neighbouring European coun-tries, where it has rationalised healthcare pro-vision and generated substantial savings whilemeeting the needs of patients and consumers.”

Self-medication has the potential to “cre-ate the foundations of a sustainable, reformedhealthcare system”, Afipa’s Manifesto con-cludes, “able to mirror the evolution of ourpopulation, meet new health challenges, andtake into account economic constraints”.

Observing that the French self-medicationmarket has been “unstable for several years now”– with sales declining by 3% in 2013 and by0.3% in 2014, only to rebound and grow by5.2% in 2015 (OTC bulletin, 19 February 2016,page 20) – Afipa said this was because the mar-ket was simply reacting to events, such as theappearance of particular pathologies.

“In order to respond to French demand andfully realise its economic potential,” Afipa be-lieves, “the French self-medication market mustbe supported by strong political drive and con-crete measures.”

1122 April 2016 OTC bulletin

GENERAL NEWS OTC

Industry Associations

French self-care model could save C1.5bn

OTC

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Page 12: OTC bulletin, 23 October 2016

Over a third of US adults use apps, websites,wearable monitoring devices or smart-

phones to keep track of their health, with al-most half of users employing two or more plat-forms, according to new research from Kan-tar Health.

Findings of the firm’s National Health andWellness Survey showed that 37% of Americanadults used at least one website, app or wear-able device to manage their health and well-ness (see Figure 1).

Around 44% of those that used mHealthtools were using two or more, the companyadded, with websites the most popular platform.

Women were more likely to track their healththan men, the research found. In terms of age,‘health trackers’had an average age of 43, whilethose that did not had an average age of 49.

Furthermore, health trackers were less likelyto smoke, more likely to drink alcohol, and lesslikely to be obese than non-trackers, Kantarpointed out. Despite this, they were more likelyto be trying to lose weight and they were alsowatching their diet and exercising more often(see Figure 2).

Exploring health trackers’ motives, Kantarsaid that 46% were trying to lower their riskof developing certain health conditions. By com-

parison, 32% of non-users were also trying toreduce their risk, Kantar said.

Heart attacks or other heart problems toppedthe list of conditions mHealth users were try-ing to prevent, the company noted, followedby diabetes and stroke.

Interestingly, the survey showed that mHealthusers had a “slightly lower mental quality oflife”, Kantar revealed, with the more platformsa person used, the lower their mental quality oflife, but the higher their physical quality of life.

Furthermore, mHealth users were less pro-ductive at work, Kantar said, with users also re-porting higher levels of absenteeism.

Despite mHealth’s growing popularity withconsumers – the mHealth market is expectedto be worth over US$50 billion (C44 billion)by 2019 – US physicians were still not entirelyconvinced on the benefits of mHealth plat-forms, especially when it came to wearable de-vices, Kantar revealed.

“Cost is a significant factor for why physi-cians would not recommend wearables, with59% saying they are too expensive for manypatients,” Kantar pointed out. “Technologyissues are also an influence, with 42% of physi-cians saying there are too many technologyhurdles to patients using wearable devices cor-rectly or consistently.”

Misled patients on health statusA third of physicians also worried that the

use of mHealth devices could mislead patientsinto believing they were healthier or unhealth-ier than they actually were, the survey found.

If the US Food and Drug Administration(FDA) were actively to regulate and approvemHealth or wearable devices, Kantar noted,21% of physicians would strongly considerrecommending them.

Kantar said three key mHealth platforms– activity trackers, web-connected glucose mon-itors and web-connected blood-pressure mon-itors – offered healthcare firms big opportunities.

Activity trackers was the leading categoryof wearable healthcare devices, Kantar pointedout, with sales in 2015 more than doubling.

Typically available as watches, bracelets orclip-ons, activity trackers can track steps taken,heart rate, sleep, calories consumed and burned,and stress levels.

As Figure 3 shows, the most common usefor activity trackers was measuring steps takenduring the day. Tracking fitness goals and mon-itoring calories burned during exercise werealso popular.

12 OTC bulletin 22 April 2016

OTC GENERAL NEWS

Market Research

mHealth consumers identified in the US

Figure 1: mHealth tools used by Americans to manage their health and wellness (Source – Kantar Health)

Insurance mHealth Health and Exercise Insurance Health and Exercise tips Nothingprovider app wearable wellness app app on provider wellness or routineson smartphone technology on smartphone smartphone website website on website

11%2%

12%8%

14%9%

7%

63%

Figure 3: Breakdown of what users of activity trackers use the products for (Source – Kantar Health)

Food Monitoring Monitoring Monitoring Monitoring Tracking Tracking Trackingdiary blood pulse heart rate sleep fitness goals calories burned steps taken

pressure during exercise during day

44%

11%

57%

26%

58%

31%

15%

81%

Figure 2: Behaviour of users and non-users of mHealth platforms (Source – Kantar Health)

All mHealth users All mHealth non-users

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Yet, while activity trackers had a high pro-file, actual use was somewhat low, with only7% of American adults saying they used suchdevices, Kantar revealed. Of that figure, overhalf of users were women (see Figure 4).

However, in defined population groups, thelevel of use increased, the company noted. Peo-ple that suffered from certain chronic condi-tions were more likely to use activity trackerscompared to the general population, it added,citing the 9% of adults with migraines and7.5% of adults with asthma that were users.

Use of wearables also had benefits to soci-ety in general, Kantar claimed, pointing out thatthose who used activity trackers had a highermental and physical quality of life than the over-all population. They also enjoyed higher pro-ductivity rates at work.

The market for activity trackers still hadplenty of room for development, Kantar explain-ed, with new products entering the market thatcould correct a user’s technique during exer-cise, monitor breathing, and measure body fatpercentage, muscle mass and body mass.

Ingestible activity trackersLooking further ahead, the future of activity

trackers could move away from the classic wear-able model, the company said, noting that Ho-sain Rahman, chief executive officer of activitytracker firm Jawbone, had claimed that the nextgeneration of such products could be ingestible.

“The first thing you have to crack throughis actually getting people to wear [the tracker],”Rahman pointed out, “but if the product is onall the time, the amount of information youget about the user is staggering.”

Turning to web-connected blood-glucosemonitors, Kantar pointed out that physicianswere now recommending them to diabeticpatients. However, the vast majority of suffer-ers – 72% – were not aware that such moni-tors existed.

Diabetics also remained unsure about shar-ing their personal-health data, the company

noted. Only 23% of diabetics said that theywere interested in having their glucose read-ings securely recorded, with 51% saying theywere not interested.

The survey also found that diabetic patientswho were using web-connected glucose moni-tors seemingly had less control of their condi-tion than those who were not aware of thesetools, Kantar claimed.

Although both groups were testing with the

same frequency, patients using web-connecteddevices were more likely to experience a hypo-glycemia episode that required them to seekassistance from another person.

Web-connected blood-pressure monitors suf-fered from the same low profile as glucosemonitors, Kantar said, in that the majority ofpatients with hypertension were unaware thatsuch devices were available (see Figure 5).

Unsurprisingly, those that used web-connect-ed blood-pressure monitors checked their bloodpressure more frequently than those who didnot use such devices (see Figure 6).

A quarter of users said that they checkedtheir blood pressure daily, Kantar pointed out,compared with just 10% of those who werenot aware of such devices.

Some patients might be using web-connectedblood-pressure monitors because they had ex-perienced hypertension-related complications,Kantar said. Nevertheless, users with a historyof complications were less likely to treat theircondition with prescription medicines and weremore likely to use OTC products than patientswho did not use monitors.

1322 April 2016 OTC bulletin

GENERAL NEWS OTC

Figure 5: Awareness of web-connected blood-pressure monitors among hypertensives (Source – Kantar Health)

Yes, I am familiar and currently using

Yes, I am familiar and currently not using, but I intend to in the future

Yes, I am familiar and currently not using, and I do not intend to in the future

Yes, I’m interested in having my blood pressurerecorded via a smartphone for easy access

I’m not sure whether I’m interested in having my blood pressurerecorded via a smartphone app for easy access

No, I’m not interested in having my blood pressurerecorded via a smartphone app for easy access

No, I am not aware

24%

4%

27%

49%

17%

6%

74%

Figure 4: Breakdown of users of activity trackers (Source – Kantar Health)

Figure 6: Frequency that users and non-users of web-connected blood-pressure monitors measure their bloodpressure (Source – Kantar Health)

Not aware of web-connectedblood-pressure monitors

Currently using web-connectedblood-pressure monitors

Daily Monthly

Weekly Only at the doctor’s office

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Page 14: OTC bulletin, 23 October 2016

■ ORTHOMOL PHARMA is offering Ger-man pharmacists who order its Orthomol Arth-roplus joint-health product the opportunity tohave light-up shoe clips to give away to cus-tomers. The waterproof and “unbreakable” shoeclips had a blue LED light that flashed withevery step to ensure athletes and active peoplewere visible, the German firm explained, mak-ing them an “ideal companion for sports activ-ities at dawn and dusk”. The shoe clips areavailable until the end of May.

Japanese firm Kobayashi has grown its OTCoffering in its domestic market with topical

products for pain and acne.To expand its pain-relief portfolio, the firm

has added a NEO option – available as a lotionin two sizes and a gel – to its Anmerutsu line.

Classified as category II medicines – thosewith side effects that may possibly cause healthhazards to the extent of disrupting daily life –Anmerutsu NEO is claimed by the companyto be the first range in Japan to combine dic-lofenac sodium with three ingredients to stimu-late blood circulation.

Meanwhile, Anmerutsu NEO lotion wasavailable in a ‘Long’ 90ml bottle with a length-ier neck, Kobayashi noted, enabling consumersto reach the back more easily.

Anmerutsu NEO lotion provides 1g diclo-fenac sodium and 5g l-menthol as analgesics,as well as 100mg tocopherol acetate, 12mg non-anoic acid vanillylamide and 10mg nicotinicacid benzyl ester per 100g.

The Anmerutsu NEO gel offers per 100mgthe same amounts of the ingredients in the lotion,with the exception of 6g menthol.

The odourless products can be applied three-to-four times a day to relieve various types ofpain, including bruises, muscle pains, sprains,stiff necks, and tendonitis.

Anmerutsu NEO is suitable for use by thoseaged 15 years and over. The range is not recom-mended for use during pregnancy.

The Anmerutsu line also includes heat patchesand a Gold EX lotion, which is formulated withfelbinac and nonanoic acid vanillylamide.

Available in pharmacies and drugstores, An-merutsu NEO has recommended retail pricesof ¥1,404 (C11.43) for a 46ml bottle, ¥2,502for a 90ml bottle and ¥1,404 for the gel.

Meanwhile, Kobayashi has rolled out a Sena-kyua spray that is intended to treat acne onthe back and décolletage.

Senakyua – which is also a category II drug– contains 0.5g salicylic acid, 22.84g ethanoland 0.2g allantoin per 100g, is claimed to fightbacteria, smooth skin and reduce redness.

The spray should be used morning andevening, Kobayashi recommends, noting thatthe product’s format allowed it to be widelyapplied to the hard-to-reach back area.

A 100ml bottle of Senakyua spray has a rec-ommended retail price of ¥1,296 without tax.

14 OTC bulletin 22 April 2016

OTC MARKETING NEWS

Product Launches

Kobayashi grows OTC linewith pain and acne options

Reckitt Benckiser (RB) will promote its recently-launched E45 Fast Acting 24H Spray Moisturiserrange in the UK between June and August with a£1.6 million (C2.0 million) television campaign.

“The intense protection of E45, now in a fast-absorbing spray” will be the tagline of the campaign,which will support the Derma Protect and IntenseRecovery variants.

E45 Derma Protect Fast Acting 24H SprayMoisturiser was “clinically proven to lock in moistureand help repair dry and sensitive skin”, RB explained,adding that it was also suitable for eczema-prone skin.

Meanwhile, the Intense Recovery option helpedto “relieve and repair very dry skin and replenish theskin’s natural barrier”, the firm claimed.

RB added that other promotional activity wouldinclude pharmacy detailing – beginning in May – aswell as in-store point-of-sale activity and “digital andsocial media support”, which would start in June.

Public-relations activity was already underway,RB pointed out.

The firm said the campaign would focus inparticular on 24-44 year olds suffering from “dry/sensitive” and “very dry” skin.

GlaxoSmithKline (GSK) is educating UKconsumers on the science behind its Senso-

dyne Repair & Protect sensitive-teeth range witha £2.3 million (C2.9 million) campaign.

As part of the marketing push, a televisionadvertisement features Jonathan Earl, Senso-dyne’s science and research lead, explaining thecauses of tooth sensitivity.

The commercial – which will air until Aug-ust – was being supported by digital activityuntil May, the firm pointed out. There wouldalso be print advertising, GSK noted.

Despite over two-thirds of the UK popu-lation suffering with “signs of sensitivity”, thecompany claimed only 19% of people withtooth sensitivity used a toothpaste designed totackle the problem.

Pointing out that shoppers found it difficultto differentiate between oral-care variants andselect the option that was right for their needs,the firm maintained that educating consumerson the science behind sensitivity would helpthem to understand the cause and subsequentlyto choose “appropriate products”, such as Senso-dyne Repair & Protect.

Meanwhile, from August, the SensodyneRepair & Protect range would be further sup-ported by a television campaign featuring adentist, GSK pointed out.

This advertisement was likely to air until theautumn, the firm said, with supporting digitalactivity set to begin in September.

Formulated with Novamin – a bioactiveglass – and sodium fluoride, the Sensodyne Re-pair & Protect toothpaste line is said by GSK tobe clinically proven to provide long-lasting sen-sitivity relief and daily protection from dentinehypersensitivity when used twice daily.

Marketing Campaigns

Science focusfor Sensodyne

OTC

Both the Anmerutsu topical analgesics and Senakyuaacne spray are category II OTC drugs

OTC

OTC

IN BRIEF

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Page 15: OTC bulletin, 23 October 2016

1522 April 2016 OTC bulletin

MARKETING NEWS OTC

Adult acne sufferers are Omega Pharma’starget market for an Acne Treatment addi-

tion to its Dermalex dermatology line in the UK.Noting that Dermalex Acne Treatment – a

medical device – could be used by all agegroups, the firm said that while an “interna-tional study” had shown a fifth of adults wereaffected by acne, most OTC solutions werepositioned for the teenage market.

Created with an “MEC4 complex”, the“breakthrough” product – which does not con-tain benzoyl peroxide or salicylic acid – wasclinically proven to treat mild-to-moderate acnesymptoms such as spots, redness and swelling,Omega noted, without drying out the skin ormaking it sensitive to the sun.

Comprising ingredients such as krameriaextract, glyceryl stearate and the PPG-12/SMDIcopolymer, the MEC4 complex treated acne’sroot causes, Omega said, by creating “a pro-tective layer unfavourable for acne bacteriagrowth” and decreasing sebum production.

Omega added that Dermalex Acne Treatment– which has recently also been launched inSouth Africa – helped restore the skin’s natu-ral flora and pH balance.

Clinical trials had shown that 76% of adult

acne sufferers saw a reduction in acne symp-toms after four weeks of using Dermalex AcneTreatment, Omega claimed.

Like the existing Dermalex range – whichincludes products for eczema, psoriasis and ros-acea – the “easily-absorbed” and “non-greasy”Dermalex Acne Treatment was also steroid-,paraben- and perfume-free, the firm pointed out.

A launch campaign for Dermalex AcneTreatment would include print and digital ad-vertising, Omega said, as well as public-rela-tions activity.

The product is available in Boots and onboots.com, priced at £18.99 (C23.89).

Product Launches

Omega’s Dermalex targetsUK’s adult acne sufferers

Teva’s Ratiopharm is offering an alternativeto the BoxaGrippal ibuprofen and pseudo-

ephedrine combination that Boehringer Ingel-heim introduced in Germany three years ago(OTC bulletin, 31 May 2013, page 16).

Like BoxaGrippal, RatioGrippal contains200mg of ibuprofen and 30mg of pseudoephe-drine hydrochloride per coated tablet.

The pharmacy-only medicine is indicatedfor relieving nasal congestion, headaches andfever in adults and children aged from 15 years.

Ratiopharm has set recommended retail

prices for the cold remedy of C3.58 for 10 tab-lets, and C6.97 for a pack of 20.

The Teva affiliate’s price for the larger packrepresents approximately a 45% discount to theC12.59 recommended for the same size packof BoxaGrippal.

It is also a tenth lower than the C7.72 pricethat Pfizer Consumer Healthcare recommendsfor a box of 20 SpaltGrippal tablets, which havethe same formulation.

In March 2013, Germany amended thecountry’s prescription order to switch ibupro-fen and pseudoephedrine combinations – witha maximum single dose of 400mg of ibuprofenand 60mg of pseudoephedrine – from prescrip-tion-only to OTC status. This followed a recom-mendation by its expert committee for prescrip-tion in mid-2012 (OTC bulletin, 29 June 2012,page 16).

Product Launches

Ratiopharm has rival to Boehringer brand

OTCPharm has grown its presence in Rus-sia’s cold and flu market by adding a child-

ren’s syrup to its Maxicold line and a double-size pack to its Codelac Neo cough brand.

Containing 100mg ibuprofen per 5ml ofsyrup, Maxicold for Children is said to ease feverand pain associated with colds, such as sorethroats or ears; headaches; and aching muscles.

It could also be used for other types of painsuch as teething, the firm pointed out, as wellas to reduce swelling and redness.

Maxicold for Children – which is availablein orange or strawberry flavours – was suitablefor children aged from three months up to 12years, OTCPharm noted.

The product is said by OTCPharm to havea “rapid onset of action,” with effects that couldlast for up to eight hours.

A two-way metering spoon – allowing mea-surements of 2.5ml and 5.0ml – is provided inevery pack of Maxicold for Children.

Other products in the Maxicold range in-clude tablets with paracetamol and phenyle-phrine hydrochloride – suitable for those agedover nine years – as well as Rino hot-drinkpowders with paracetamol, pheniramine maleateand phenylephrine hydrochloride, which can betaken by people over 12 years old.

There is also a hexetidine-containing Maxi-cold ENT spray, which can be used from threeyears of age.

Meanwhile, the addition of a 200ml syrupto the Codelac Neo dry-cough range, OTCPharmnoted, meant that the Codelac Neo line nowoffered the “same choice of liquid dosage forms”as the leading brand for dry cough on the Rus-sian market, GlaxoSmithKline’s (GSK’s) buta-mirate-based Sinecod.

Like Sinecod, Codelac Neo is also availablein a 100ml bottle and as drops.

Codelac Neo drops are suitable for thoseaged over two months, while the syrup can beused by people over three years old.

OTCPharm also offers Codelac Neo tabletsfor consumers aged over 18 years old.

The Codelac line in Russia also includesBroncho tablets and syrup for mucus cough. Thefirm said it also planned to launch a 200ml ver-sion of Codelac Broncho syrup – which includesambroxol and glycyrrhizic acid – in the future.

A Codelac Pulmo Gel, containing naturalingredients such as Siberian fir oil and camphor,is also available.

Product Launches

Maxicold andCodelac expand

OTC

Dermalex Acne Treatment – which does not containbenzoyl peroxide or salicylic acid – is said to be clinicallyproven to treat mild-to-moderate acne symptoms

RatioGrippal contains 200mg ibuprofen and 30gpseudoephedrine hydrochloride per tablet

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Page 16: OTC bulletin, 23 October 2016

■ GLAXOSMITHKLINE (GSK) aims toeducate Filipino mothers on how they can takecare of their families’ common ailments usingits Ambrolex and Virlix brands with its ‘Ex-pert Mom’campaign. This includes a ‘Mommy-

Doc’ Facebook page with “expert, but practi-cal” advice on how to address coughs and al-lergies, the firm pointed out, as well as “trademerchandising efforts”.

Reckitt Benckiser (RB) should be fined A$6million (C4.1 million) for misleading con-

sumers over its Nurofen ‘Specific Pain’ prod-ucts, the Australian Consumer CompetitionCommission (ACCC) has told the country’sFederal Court.

The commission made its demands at a re-cent hearing to determine RB’s penalty, afterthe Federal Court of Australia ruled late last yearthat the firm had made “misleading represen-tations” by claiming that each Specific Painvariant had been formulated to treat a particulartype of pain, despite all products containing342mg ibuprofen lysine (OTC bulletin, 15 Jan-uary 2016, page 15).

Stating that the four Specific Pain prod-ucts – Back Pain, Migraine Pain, Period Painand Tension Headache – were sold at almostdouble the price of standard Nurofen variants,the ACCC’s legal representatives told the courtthat consumers had been financially harmedover the space of five years, and that there need-ed to be a “serious taking away of profit”.

Nurofen’s competitors were also disadvant-aged, the court was told, as there was less avail-able shelf space.

In its decision on the case brought by theACCC last March (OTC bulletin, 20 March2015, page 10), the court ordered that the fourSpecific Pain products should be removed fromshelves, adding that RB should publish correct-ive notices on its website and in newspapers, im-

plement a consumer protection compliance pro-gramme, and pay the ACCC’s costs.

An “interim packaging agreement” – in theform of stickers – was arranged with RB for usefollowing the removal of the products. Thesewould clearly disclose to consumers that theproducts were “equally effective” for other pain.

However, the ACCC’s lawyers claimed atthe hearing that the stickers were being coveredup in some retailers.

In response, RB’s barristers argued that“rational” consumers would not think a pain-specific product was any more effective thana pain-relief product without such claims, butthat specific indications made the selection pro-cess easier.

A spokesperson for UK-based firm toldOTC bulletin that RB had also proposed at thehearing a much lower fine of A$1.1 million.

The fine amount is expected to be decidedby the end of April.

Meanwhile, the company is also facing aclass action lawsuit from Australian consum-ers over the range.

The action, launched by Bannister Law lastmonth (OTC bulletin, 25 March 2016, page 12)is calling for a full refund for the Specific Painproducts that the consumers purchased, claim-ing that they “would not have purchased theproduct if they had known that it was not moreeffective on targeted pain than any of the otherNurofen products in the range”.

16 OTC bulletin 22 April 2016

OTC MARKETING NEWS

Legal Cases

ACCC proposes A$6m fineafter RB misled consumers

Stada Arzneitmittel’s Aesthetics business haslaunched in Germany the Skin Infusion nutricosmeticsline, which are the division’s first OTC products.

Available in pharmacies and from cosmeticdermatologists, the Skin Infusion range comprises aBeauty drink and capsules.

Formulated with ingredients such as collagen,glucosamine, chondroitin and hyaluronic acid, theBeauty drink could be dissolved in liquid or stirredinto yogurt, Stada Aesthetics explained.

A sachet should be taken per day for two-to-threemonths, the firm instructs, to tighten sagging skinand tackle pale complexion, wrinkles and cellulite.

Meanwhile, the vegan capsules includedextracts of nettle, asparagus, pumpkin and chlorella– as well as vitamin C – Stada Aesthetics pointed out,to “counteract tired eyes, puffiness, enlarged poresand cellulite”.

It is recommended that three capsules are takenon an empty stomach in the morning.

Targeted “primarily” at women, Skin Infusion wasbeing supported by a “broad” public-relations campaignfor consumers, pharmacies and doctors, StadaAesthetics noted, as well as print activity.

There was also a Skin Infusion Facebook page andwebsite, the company pointed out.

The firm said it expected the range to be availablein Austria, Italy, the Nordics and the UK by July.

A lidocaine cream is the latest addition to Chattem’sIcyHot analgesics range in the US.

Indicated to temporarily relieve minor pain, IcyHotLidocaine is formulated with 4% lidocaine hydrochlorideand 1% menthol, and is said by Sanofi’s US subsidiaryto be both fast-acting and long-lasting.

The product’s packaging highlights that IcyHotLidocaine – which is suitable for use by thoseover 12 years old – contains “maximum strengthlidocaine”, “numbs away pain” and “desensitisesaggravated nerves”.

Meanwhile, the brand website icyhot.comencourages consumers to “Lidocaine your pain”.

A thin layer of IcyHot Lidocaine should be appliedto the affected area every six-to-eight hours, Chattemadvises, and no more than three times in a 24-hourperiod. The product should not be used for more thanone week without consulting a doctor.

The current IcyHot line in the US includes patchesand creams based on ingredients such as menthol,camphor and methyl salicylate. Chattem also offersIcyHot SmartRelief transcutaneous electrical nervestimulation (TENS) machines.

OTC

OTC

Laboratoires Bouchara-Recordati has added to itsHexa range in France by launching an exotic-fruitflavoured spray for sore throat under the nameHexaspray Fruits Exotiques.

Suitable for adults and children over six years ofage, the biclotymol-based spray is meant to be usedfor two sprays at a time, three times a day, withtreatment lasting no longer than five days.

The product is listed in France as a ‘free access’medicine, meaning it is available for self-selection inpharmacies under the scheme that was started inmid-2008 (OTC bulletin, 31 July 2008, page 17). Ithas a recommended retail price of C5.70.

OTC

OTC

OTC

IN BRIEF

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Page 17: OTC bulletin, 23 October 2016

■ OMEGA PHARMA is offering Belgianconsumers the chance to win a “dream trip”worth C15,000 to Rio de Janeiro to support theBelgian national team at this year’s Olympicgames. To enter the contest, consumers shouldpurchase at least two products from two differ-ent participating brands – either the Bibi babybottle and dummy line, the Bodysol skin-careselection, or the Etixx sports-nutrition series –

which the firm noted were official suppliersto Team Belgium. A photo of the purchase re-ceipt should be emailed to a specific competi-tion address. Entrants must also register theirdetails online and answer a contest questionand a tie-breaker. Five runners-up will receivea ‘Rio edition’ Samsonite suitcase. The contestruns until 25 June 2016.

GSK is boosting awareness among US con-sumers of its Excedrin headache-relief

brand with its ‘Migraine Experience’ campaign,which uses what is claimed to be the world’sfirst augmented-reality migraine simulator.

The firm claims Excedrin is its first brand to“leverage augmented-reality technology to con-ceptualise a health condition”, with the aim offostering “a new level of understanding betweenthose affected by migraine and non-sufferers”.

Claiming that migraines were “an extremelypersonal, isolating experience” for the 36 mil-lion sufferers in the US, GSK said it used thetechnology to allow non-sufferers, for the firsttime, to see what it was like to have a migraine.

Said to replicate the symptoms of a migraine– “everything but the pain” – the Migraine Ex-perience simulator was created from input fromselected migraine sufferers, GSK explained,on what they most often experienced during an“episode”, such as aura, disorientation, sensi-tivity to light and blurred vision.

These symptoms were then replicated, viaan augmented-reality headset, for a person thesufferer knew – such as a family member or part-ner – in a controlled environment, GSK noted.

The reactions of sufferers’ counterparts wererecorded, GSK explained, and featured in anational television commercial that was current-ly airing. Other full-length videos could befound on the brand website, excedrin.com, whereconsumers can also sign up to receive a freesample of Excedrin Migraine tablets.

GSK added that the Excedrin Migraine Ex-perience was also being promoted on socialand digital platforms such as Facebook, Insta-gram and Twitter, as well as YouTube and thelifestyle website sheknows.com.

In addition, the US-only campaign included“in-store activation” and the launch of a Mi-

graine Experience app, GSK explained. Thiswould allow users to experience the simula-tion via their smartphones, using the GoogleCardboard virtual-reality platform.

The Migraine Experience app would beavailable to download from May for both Appleand Android devices, the firm revealed.

GSK said the television spot – as well as apublic-relations programme – would run untilJune 2016, adding that television and radio hostAndy Cohen had been signed up as a spokes-person for the Excedrin Migraine Experience.

The firm said it hoped that the campaignmaterial would go viral, with “all those whosuffer from migraines” getting the opportunityto watch and share the content.

“We normally see relatively average engage-ment in social media for our category,” the com-pany told OTC bulletin, “but we believe we’llget hundreds of thousands of consumers towatch, share and talk about this unique andpowerful campaign.”

The Excedrin range in the US includes PMHeadache, Tension Headache, Migraine andExtra Strength options.

Formulated with aspirin, caffeine and para-cetamol, Excedrin Migraine is claimed to startrelieving pain in just 30 minutes, cut sensitivityto light and sound, and also relieve nausea.

1722 April 2016 OTC bulletin

MARKETING NEWS OTC

Marketing Campaigns

GSK simulates migrainesfor US Excedrin campaign

Reactions to the migraine experience feature in atelevision advertisement, and also appear online

OTC

IN BRIEF

Daiichi Sankyo has added a Premium vari-ant to its Loxonin S loxoprofen sodium-

based analgesics range in Japan.A category I drug – an OTC product that

is deemed to hold the highest degree of risk– Loxonin S Premium was formulated with68.1mg loxoprofen sodium hydrate per two-tablet dose, the Japanese firm explained, as wellas 60mg allyl isopropyl acetyl urea and 50mganhydrous caffeine, to “enhance the analges-ic effect”.

Two tablets also contained 100mg mag-nesium aluminometasilicate, Daiichi Sankyopointed out, to make the product gentler onthe stomach.

Loxonin S Premium is suitable for thoseover 15 years old, and is indicated to relievepain such as headaches, menstrual pain, tooth-ache and joint pain. The tablets also had anantipyretic effect in cases of fever, DaiichiSankyo pointed out.

The product joins the Loxonin S Plus optionlaunched last year (OTC bulletin, 24 July 2015,page 15) and the original Loxonin S tabletsrolled out in 2011, following the prescription-to-OTC switch of loxoprofen sodium.

A 12-tablet pack of Loxonin S Premiumhas a recommended retail price of ¥698 (C5.68)without tax, while 24 tablets are ¥1,180.

Line Extensions

Premium optionjoins Loxonin S

OTC

OTCSporty people are the target for Quiris Healthcare’slatest addition to its CH-Alpha line in Germany.

CH-Alpha Sport drinkable ampoules contain a“tri-complex” of collagen, magnesium and silicic acid,as well as vitamin C, pantothenic acid and zinc.

Quiris said the collagen helped to regeneratecartilage in joints, while magnesium supportedmuscles and bones, and silicic acid strengthenedligaments and tendons.

The food supplement is free from gluten and lactose,and is also included on Germany’s Kölner Liste registerof products that it is safe for competitive people totake within doping regulations.

A month’s supply of 30 one-a-day ampoules has arecommended retail price of C52.80.

OTC

OTC22-04-16p14-17_Layout 1 19/04/2016 17:53 Page 5

Page 18: OTC bulletin, 23 October 2016

Recognising the best in the global genericsand biosimilars industries

Presented by Generics bulletin in association with IMS Health

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entering an award and joining us on the night:Visit: www.generics-bulletin.com

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Page 19: OTC bulletin, 23 October 2016

10 May■ FDA: Marketing

Authorisation in the USKöln, GermanyUS Food and Drug Administration(FDA) regulations will be compar-ed with European Union (EU) lawat this one-day seminar.Contact: Forum Institut für Management.Tel: +49 6221 500 680.Fax: +49 6221 500 555.Email: [email protected]: forum-institut.com.

10 May■ Introducing

PharmaceuticalLegislationBonn, GermanyPharmacovigilance and regulationsfor the delivery of drugs will bediscussed at this one-day meeting,run by Germany’s medicines man-ufacturers’ association, the BAH.Contact: BAH.Tel: +49 228 957 4556.Email: [email protected]: bah-bonn.de/widi-services/fachseminare.

10-12 May■ Vitafoods Europe

Geneva, SwitzerlandA three-day exhibition and confer-ence focusing on nutraceuticals,and functional foods and drinks.Contact: Informa Exhibitions.Tel: +44 20 3377 3616.Email: [email protected]: vitafoods.eu.com.

12-13 May■ An Essential Overview

of the Medical Deviceand the PharmaceuticalIndustryLondon, UKDay one of this two-day seminarwill provide an overview of themedical device industry, whilst daytwo will focus on the drug dev-elopment process in the pharma-ceutical industry.Contact: Management Forum.Tel: +44 20 7749 4730.Email: [email protected]: management-forum.co.uk.

15-18 May■ DIA China

8th Annual MeetingBeijing, ChinaSpeakers from China’s Food andDrug Administration (CFDA),AstraZeneca, Boehringer Ingel-

heim and Sanofi will attend thisfour-day meeting, run by the DrugInformation Association (DIA).Contact: DIA Global.Tel: +86 10 5704 2652.Email: [email protected]: diaglobal.org.

17-18 May■ Russian Pharmaceutical

ForumSaint Petersburg, RussiaSpeakers from Boehringer Ingel-heim, IMS Health, Pfizer, Sanofi,Stada and Takeda will attend thistwo-day event.Contact: Adam Smith Conferences.Tel: +44 20 7017 7444.Email: [email protected]: russianpharma.com.

23-24 May■ Pharmaceutical

Regulatory Affairsin the Middle EastLondon, UKCountries to be discussed at thistwo-day conference will includeEgypt, Iran, Qatar and SaudiArabia.Contact: Management Forum.Tel: +44 20 7749 4730.Email: [email protected]: management-forum.co.uk.

6-7 June■ Pharma Marketing

Frankfurt, GermanyTopics to be covered at this two-day event will include: ‘Buildinga global healthcare brand’; ‘Evenmajor OTC brands can grow’; and‘Facing the future’.Contact: Inspirato.Tel: +49 6172 981 96 80.Fax: +49 6172 981 96 89.Email: [email protected]: inspirato.de/pharma-marketing-2016.

13-14 June■ EuroPLX 61

Valletta, MaltaThis two-day meeting 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 6221 426 2960.Email: [email protected]: europlx.com.

13-17 June■ MedTech Summit

Brussels, BelgiumA five-day summit focusing onmedical device regulatory affairsin Europe and globally.Contact: Informa Life Sciences.Tel: +44 207 017 7481.Email: [email protected]: meddevregs.com.

14-17 June■ Fispal Technologia

São Paulo, BrazilPharmaceuticals, personal care, diet-ary supplements, and sports nutri-tion will be covered at this four-day exhibition.Contact: Informa Exhibitions.Tel: +55 11 3598 7800.Fax: +55 11 3598 7801.Email: [email protected]: fispaltecnologia.com.br.

16 June■ Drug Label and

Package DesignBonn, GermanyThis one-day event is being run byGermany’s medicines manufactur-ers’ association, the BAH.Contact: BAH.Tel: +49 228 957 4556.Email: [email protected]: bah-bonn.de/widi-services/fachseminare.

20-22 June■ Pharmacovigilance

London, UKA three-day course covering phar-macovigilance and drug safety.Contact: Management Forum.Tel: +44 20 7749 4730.Email: [email protected]: management-forum.co.uk.

22-24 June■ The Medical Devices

Introductory CourseLondon, UKThis three-day course is run byThe Organisation for Professionalsin Regulatory Affairs (TOPRA).Contact: TOPRA.Tel: +44 20 7510 2560.Fax: +44 20 7537 2003.Email: [email protected]: topra.org.

26-30 June■ 52nd DIA

Annual MeetingPhiladelphia, USA five-day annual meeting org-anised by the Drug InformationAssociation (DIA).Contact: DIA Global.Tel: +1 888 257 6457.Fax: +1 215 442 6199.Email: [email protected]: diaglobal.org/en/flagship/dia-2016.

27-29 June■ Dietary

SupplementsNew York, USPost-conference workshops willaccompany this three-day event,which will look at legal and reg-ulatory development in the diet-ary supplements industry.Contact: Council forResponsible Nutrition (CRN)or American Conference.Tel: +1 888 224 2480.Fax: +1 877 927 1563.Email: [email protected]: americanconference.com/dietarysupplements.

1922 April 2016 OTC bulletin

EVENTS OTC

JUNE

MAY 31 May-2 June■ 52nd AESGP Annual Meeting

Athens, Greece‘The future of self-care: Shaping the new environment’ is the theme of thisthree-day event being organised by the Association of the European Self-Medication Industry, the AESGP.

The conference will include sessions on: ‘The European market place:How to be successful in a competitive environment’; ‘Big becomingbigger: Mergers and acquisitions in the consumer health and pharma-ceutical industry’; and ‘Digital strategies to make the market move’.

Speakers will include: Alexandra Nikolakopoulou of the EuropeanCommission; Jan Smits and Jurate Svarcaite of the PharmaceuticalGroup of the European Union (PGEU); Michael Becker of Germany’s med-icines manufacturers’ association, the BAH; Alfred Grün and GerhardLötsch of the Austrian Self-Care Association; Brian McNamara of Glaxo-SmithKline (GSK); Erica Mann of Bayer Healthcare; Vincent Warneryof Sanofi; Laurent Faracci of Reckitt Benckiser; Briain de Buitleir of PGTHealthcare; Jörg-Thomas Dierks of Meda; and Francine O’Brien of IMS.Contact: AESGP. Tel: +32 2 735 51 30. Fax: +32 2 735 52 22.Email: [email protected]. Website: aesgp.eu/events/Athens52/.

OTC22-04-16p19_Layout 1 19/04/2016 17:43 Page 2

Page 20: OTC bulletin, 23 October 2016

“The whole vision of bringingGlaxoSmithKline (GSK) Con-sumer Healthcare and Nov-artis Consumer Health togeth-

er, leveraging the capabilities of both and be-coming an industry leader, is coming to fru-ition,” according to Brian McNamara, regionhead of Europe and the Americas at the UK-based company.

Speaking to OTC bulletin a little over ayear after the consumer healthcare joint venturebetween GSK and Novartis was established(OTC bulletin, 6 March 2015, page 1), McNa-mara said that while integration projects werestill ongoing, the enlarged company had “clearstrategies” in place that would ensure growth.

“We have been very clear on our priorities,”he pointed out, “with a focus on our sevenpower brands, 12 core brands, and on our prior-ity countries – six emerging and six developed.”

“Furthermore, we are focused on five globalcategories – pain relief, oral care, respiratory,nutrition/gastrointestinal and skin health,” he said.

Internally, layers of management had beenreduced and areas of responsibility had beenincreased, McNamara explained, with the intentof “speeding up decision making and gettinga much tighter focus on driving growth and de-livering to the consumer and the retailer”.

Established through a three-part deal betweenGSK and Novartis, the joint operation – in whichGSK holds a controlling 63.5% stake – gener-ated 2015 sales of £6.0 billion (C7.5 billion).

The deal also saw GSK divest its Oncologyportfolio to Novartis for US$16 billion (C14billion) and acquire the Swiss company’s Vac-cines business for US$5.25 billion, plus up toUS$1.8 billion in milestone payments.

Led by chief executive officer Emma Walm-sley, GSK Consumer Healthcare now generatesaround 90% of its sales from its seven globalpower brands – Otrivin, Panadol, Parodontax,Poligrip, Sensodyne, Theraflu and Voltaren –and 12 core regional brands (see Figure 1).

The seven power brands are all leaders intheir respective categories, the company claims,and are present in between 70 and 140 coun-tries. They are also expected to deliver double-digit growth rates.

The other 12 regional lines are known as‘core brands’, and are primarily local in natureand likely to be less “margin accretive”. Rolling

them out into new markets is not a priority, ac-cording to the company.

These local brands – while not a top invest-ment priority – would play their role in grow-ing the business, McNamara insisted, with thecompany wanting to win in the local marketswhere it played, aided by the innovation thatwould come from its global power brands.

“One of our key global brands is Sensodyne.It’s a brand that has grown by double-digitsfor the past 10 years and has done an incredi-ble job of holding the competition at bay,” heexplained. “We also have the global pain-reliefbrand Voltaren, which has generated double-digitgrowth every year over the past 10 years.”

“These two brands are the most global innature and are available in most markets aroundthe world,” he added. “With other categories,such as cough and cold, where the regulatoryenvironment does not encourage globalisation,we have to be much more pragmatic.”

Created successful global brands“We have been successful in creating these

global brand models, especially in oral care andpain relief,” McNamara claimed, “and the effi-ciencies are amazing if you have the modelright and you execute it consistently.”

“We also have a flexible business structure,so if we come across an issue in a priority mar-ket where things aren’t working, we are prag-matic and fix it,” he stated. “In the end, we arefocused on winning in the marketplace and bet-ter meeting consumers’ and retailers’ needs.”

“It is not a case of global for global’s sake,”he insisted. “If there is a local brand or carrierthat it makes sense to expand, we will bring inan innovation from a global brand to do that.”

“If you look at Theraflu, it’s the number-one cough/cold product in Russia, with a greatpresence in the US. And we have a great oppor-tunity to take it into other markets in Europe,”McNamara explained.

“Theraflu can be an innovation platform forthe Beechams cold-and-flu range in the UK,”he added. “We can take the Theraflu equity andleverage that through the Beechams brand.”

“We already launched Theraflu under theTermalgin name in Spain a few years ago,” hepointed out, “and it’s called NeoCitran in Cana-da and Switzerland.”

“So with brands like Theraflu and Excedrin,

which is the number-one migraine brand in theworld, we can expand their geographic reach byusing their innovation pipelines, the equity andthe toolkits of those brands to launch them underestablished local names,” McNamara added.

Reviewing the markets for which he hasresponsibility, McNamara said the US had en-joyed a “phenomenal” 2015.

“Proforma in the US, we reported 20%growth driven by the Flonase switch, whichhas been an unbelievable success,” he noted.“Overall, the US is a really healthy businesswith Excedrin gaining share and with the addi-tion of Theraflu syrups.”

While Europe had been more challenging,McNamara said that he believed the historiccapabilities of these two companies – GSK’s“tremendous ability” in terms of getting expertrecommendations from dentists and doctors, andNovartis’ pharmacy focus – were the founda-tions from which the enlarged business wouldmake strong gains the region.

“If we look at Germany, where we are thenumber-one OTC company and the number-one oral-care player, we have the ability to lever-age our capability in the vital pharmacy chan-nel and get more recommendations,” he insisted.

However, McNamara admitted: “Centraland Eastern Europe (CEE), which includesRussia, is probably the biggest challenge ona macro-economic level.”

“In Russia, we have a strong position afterbringing the two companies together. I’m prettyconfident in our ability to grow in that countrythis year in a tough and challenging environ-ment,” he claimed. “My view is everyone iscompeting in the same environment and somewill win and some will lose.”

Brazil was another priority market for thecompany, McNamara said.

“Russia and Brazil are both emerging mar-kets and we have different strategies for both,”he noted. “What it takes to win in Russia will

20 OTC bulletin 22 April 2016

OTC BUSINESS STRATEGY

Clear vision drives GSK’s OTC ambitionsA year after GlaxoSmithKline (GSK) Consumer Healthcare and NovartisConsumer Health joined forces, Brian McNamara, the company’s head ofEurope and the Americas tells Matt Stewart how the combined business willreach its potential and lead the OTC industry.

Brian McNamara, region head of Europe and theAmericas at GSK Consumer Healthcare, said the firmwanted to be the “partner of choice for switch”

OTC22-04-16p20-23_Layout 1 19/04/2016 18:38 Page 2

Page 21: OTC bulletin, 23 October 2016

be different to how we will win in Brazil.”“In Brazil, we have a really strong position

with a lot of opportunity,” McNamara explain-ed, “especially with the Eno pain-relief brand,which is a massive product growing at healthydouble-digits.”

“While both countries have macro-economicand devaluation issues, we have the right port-folio to win in those countries, and that willbe our focus,” he said.

Asked whether organic growth would besufficient, McNamara said that while the existingportfolio was the focus, GSK was always opento bolt-on acquisitions “if they make sense”.

“We have priority markets and categories, andto a degree there is an intersection between thosetwo. If there was an opportunity to make an ac-quisition, we would look at it,” he said.

“The focus is really on winning organicallywith what we already have, and we have hugeopportunities within the portfolio,” McNamaraunderlined. “We will look for acquisitions, butwe are not looking for anything big.”

Turning to the possibility of trimming theenlarged portfolio, McNamara admitted thatthere were still “some opportunities to simplify”,but insisted that there was no major stream-lining needed.

“We are very happy with what we have andthe growth opportunities the portfolio provides,”he said. “In categories like denture care, thereare big gains to be made. While 20% of thepeople in the world have dentures, only a frac-tion of them use denture-care products.”

“Furthermore, GSK Consumer Healthcarejust carried out a big pain-relief study globallyand found that 88% of adults experience painat least once a week,” he pointed out, “but only50% treat the pain. With brands like Volta-ren, we think the portfolio is set up for reallygood growth.”

One area where GSK is looking for big op-portunities is in prescription-to-OTC switches.Fresh from the hugely successful US switchof Flonase Allergy Relief (fluticasone propi-onate), which was rolled out a year ago (OTCbulletin, 13 February 2015, page 1), McNamarasaid that GSK had a firm ambition to be the“partner of choice for switch”.

“We have proven to the world that we canswitch successfully,” McNamara insisted. “Ifyou look over the past 25 years, GSK has donenine switches, so that is a switch every two-and-a-half to three years.”

Pointing out that GSK Consumer Health-care’s chief executive officer Emma Walmsleyhad set a target of a switch every five years(OTC bulletin, 22 May 2015, page 1), McNa-mara said that prescription-to-OTC switcheswould play a key role in growing the businessand that the company would seek out switch

opportunities both internally and externally.“I can’t comment exactly on our strategy

in this area,” he said, “but personally I believewe need to deliver one switch every five yearsand with our scientific expertise I hope we cando better than that.”

Looking at the regulatory challenges forswitches, McNamara explained that while inthe US there was a clear path, in other marketsthere was an opportunity for industry to workwith regulators to make the switch process“clearer and more streamlined”.

“There is still the appetite within the indus-try for innovative switches that create new cat-egories,” McNamara said. “I hope over time– as healthcare systems evolve and we see in-creasing cost burdens on governments – thatwe can expand the switch landscape.”

“From an industry perspective, we funda-mentally believe that there are more places wecan go,” he insisted.

Will look at new categories“At GSK we are not opposed to switching

something in an entirely new category,” McNa-mara revealed. “We have a group evaluatingour overall switch agenda and strategy, and weare open to going where the consumer is andwhat makes sense.”

All of GSK’s ambitions, however, camedown to ensuring consumers trusted the com-pany and its brands, McNamara said.

“If consumers trust our brands, we can edu-cate them on the right things to do to main-tain their health,” he claimed. “We use thattrust as a way of continuing to drive self-care,as we fundamentally believe education is im-portant for healthcare worldwide.”

“There is no question that consumers aregetting better educated thanks to the amountof information that’s available,” he pointed out.“Consumers have more information on a smart-phone in their pocket than they had on a desk-

top computer 10 years ago.”“Frankly, for me, better-educated consumers

are good,” McNamara said. “It’s good for theindustry, it’s good for healthcare systems andit’s good for consumers.”

“As a company and an industry we have toconstantly evolve the ways in which we connectwith consumers,” he insisted, “in how we mar-ket to them and how we reach them in the re-tail environment and in a digital world.”

“Everything that is happening digitally canhave a huge impact on our industry, and so itis a priority and a focus for us. We want tomake sure we deliver in that space,” McNa-mara stated, adding that it was important toGSK to be close to consumers in the placeswhere they lived, online and offline.

“Understanding their behaviour, learning howthey interact with our products and discoveringthe issues they are dealing with are critical forus,” McNamara explained, “along with under-standing how they shop for our products in storeand how they want to receive information.”

“Our strategy is to be the first choice amongexperts, consumers and retailers,” McNamarasaid, “and we have stated that we want to beamong the top-three consumer healthcare salesforces in every country in the world, in bothpharmacy and mass-market.”

“It is a huge priority for us to be a greatpartner to our retailers. It is about how we ex-pand categories and how we mutually growour businesses,” he explained.

“Furthermore, we are also taking a hard,strategic look at the e-commerce environmentright now to see exactly where we want to goand how we want to do it,” added McNamara.

All these elements played into the vision laidout when the joint venture was created, McNa-mara said. “In the end, what we want to do isprovide better healthcare solutions to consum-ers and for healthcare systems around the world.”

2122 April 2016 OTC bulletin

BUSINESS STRATEGY OTC

Figure 1: GlaxoSmithKline Consumer Healthcare is now focused on seven power brands – Otrivine, Panadol,Parodontax, Poligrip, Sensodyne, Theraflu and Voltaren/Voltarol – and 12 ‘core brands’ (Source – GSK)

OTC

OTC22-04-16p20-23_Layout 1 19/04/2016 18:38 Page 3

Page 22: OTC bulletin, 23 October 2016

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Page 23: OTC bulletin, 23 October 2016

Suneet Varma, president and general man-ager of Pfizer Consumer Healthcare, has

been elected chairman of the World Self-Medi-cation Industry (WSMI).

Varma will take over from Erica Mann, pres-ident of Bayer Consumer Health, in June. Manntook on the role in June 2014 (OTC bulletin,16 June 2014, page 23).

Commenting on his election, Varma saidthat he looked forward to building on the legacyleft by Mann and promised that the associa-tion would continue to “realise the value ofself-care in strengthening the sustainability ofhealth care systems around the world”.

Dr Gerald Dziekan, the WSMI’s director-general, said that the association would benefitfrom Varma’s “passion, energy and unwaveringcommitment to self care”.

These traits, Dziekan added, would be “crit-ical in sustaining and accelerating the importantwork we are doing to help people improve their

health and wellness”.Varma joined Pfizer in 2007 as president of

the company’s Consumer Healthcare businessin Canada. He was appointed regional presidentfor the Asia-Pacific and North America regionin 2010, before taking up his current role inMay 2015.

Prior to joining Pfizer, Varma held a numberof senior leadership roles at Wyeth ConsumerHealthcare, which was acquired by Pfizer in2009 (OTC bulletin, 29 January 2009, page 1).

2322 April 2016 OTC bulletin

PEOPLE OTC

Industry Associations

Pfizer’s Varma to replaceMann as chair of WSMI

Alan Hicks, a leading figure behind numer-ous innovative prescription-to-OTC switches

in a career that spanned 40 years, has passedaway aged 68.

Hicks was responsible for the first prescrip-tion-to-OTC switch in the UK in 1983, when

Imodium was made available without a pre-scription. He would go on to play a key role inother switches, including Daktacort, Daktarinand Ovex. As a consultant, Hicks also guidedthe switch of the Levonelle morning-after pill.

Having entered the OTC industry in 1977,he set up Janssen’s OTC division in 1984, whichsubsequently became part of Johnson & John-son’s Consumer business.

A major advocate of pharmacy staff edu-cation, Hicks felt it was vital for all pharmacystaff be able to share health advice with con-sumers. He created the Glaxo PharmAssist edu-cation programme for pharmacy staff and theProfessional Learning Programme for the Pro-prietary Association of Great Britain (PAGB).

Obituary

Obituary: Alan Hicks

Suneet Varma

Alan Hicks

OTC

OTC

Bayer has appointed Paul Capelli, formerlyvice-president of corporate communica-

tions for shopping channel QVC, as vice-pres-ident of communications for the ConsumerHealth division in the US.

Reporting to Raymond Kerins, Bayer’shead of US communications, government rela-tions and policy, Capelli will also be part of thecompany’s US communications, governmentrelations and policy leadership team.

Commenting on the appointment, Kerinssaid the company was “excited to have some-one of Capelli’s experience and professional-ism join the Bayer team”.

“Capelli knows this industry well and hasall the skills necessary to push Bayer’s repu-tation to even greater heights,” he added.

Having spent more than a decade in retailcommunications, Capelli has worked acrossvarious communications and public relationsroles for online retailer Amazon, television net-work CNBC and marketing agency Ketchum.

Manufacturers

Bayer adds tocommunications

Deutsche Homöopatie-Union (DHU) hasannounced that Peter Braun has taken

over as managing director with responsibilityfor marketing and sales.

The German homoeopathy specialist saidthat Braun had replaced Patrick Krauth, whohad been in the role for three years.

An independent consultant before takingthe leadership role at DHU, Braun started hiscareer at Nestlé in 1990, before moving to theNovartis eye-care subsidiary Ciba Vision.

From 1999 to 2004 he led the medical de-vice company Sinus Point before becominga management consultant at Malik.

In March 2008, he took over responsibilityfor DHU rival Weleda’s business in Switzer-land, before becoming interim chief executiveofficer of the whole Weleda group.

Following the appointment of Ralph Hein-isch as chief executive officer, Braun led Wel-eda’s pharmaceutical business until August2012, before leaving to become an indepen-dent consultant.

Manufacturers

DHU announcesmanaging director

OTC

OTC

■ UPSA – the European OTC business of Bris-tol-Myers Squibb (BMS) based in France – hasappointed Fabrice Dal-Mas as managing direc-tor. Dal-Mas has worked at BMS for 18 years,becoming director of operations and operationalexcellence in 2015.

■ NZSMI – the New Zealand Self-Medica-tion Industry – has named Scott Milne as itsexecutive director effective from 1 May 2016.Milne will replace Tim Roper who is retiringfrom the role after an eight-year tenure.

IN BRIEF

OTC

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Page 24: OTC bulletin, 23 October 2016

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