OTC24-07-15p1_OTC15/11/2005 p1&24 21/07/2015 12:26 Page 1

24 July 2015

COMPANY NEWS 2 AESGP backsOTC devices Consumer Healthcare unit 2 gets anew home at Sanofi Ciplatospin-offOTC operations 2 as EU advances legislation Future of P&G’s OTCbrands 3 almostsecureascullends EU to rule on Mylan/Perrigo 3 elf-caremedical devices in Europe are nasal sprays and throat lozenges, in the high- Sonce morefacing the threat of being est-risk category and argued that this proposal J&Jready for consumer opportunities 4 classified in the highest risk category –class was“neither appropriatenor justified by the ChinaNepstar’schairman 6 III–under fresh proposals by the European risk profile” of these products (OTC bulletin, to acquire drugstorechain Council of European Union (EU) Health 18 December 2012, page 10). Vemediagrows Belgianportfolio 6 Ministers. But the Association of the Euro- Six months later,the parliament’senviron- WBAonthe look out for acquisitions 7 pean Self-Medication Industry,the AESGP, ment, public health and food safety (ENVI) Manufacturingshake-up 8 said it would continue to resist such amove. committee proposed amassive 762 amend- behind RB’srise The Council had recently expanded the scope ments to the legislation, on top of the 145 that Fidiagetsmarketing rights 9 of Rule 21 in AnnexVII of the proposed medi- had been proposed by the legislation’sthen to Halykooportfolio in Italy cal-device legislation, the AESGP pointed out, rapporteur Dagmar Roth-Behrendt (OTC bul- Deliveriesliftsales at Probi 9 despite the European Parliament voting last letin,31May 2013, page 14). year to remove the rule (OTC bulletin,25April The European Parliament backed anumber GENERAL NEWS 10 2014, page 13). of the suggested changes in aplenary vote Label warnings for NSAIDs 10 last April, including the deletion of Rule 21 strengthened by US FDA New language hits OTC devices and of the need to comply with medicines legis- ASMI hits out at review 11 In newlanguage put forward by the Coun- lation, Directive 2001/83/EC. of advertising for OTCs cil, Rule 21 in AnnexVII would cover“all The AESGP said it would also focus its Canada looksat 11 devices that are introduced into the human lobbying efforts in the lead up to and during paracetamol cut body via abody orifice or applied on skin”, the the trilogue discussions on ensuring that de- mHealth is not amagic wand 12 AESGP said, in amove that would mean num- vices were subject to “reasonable requirements for Europe erous self-care medical devices would unnec- without referring to the pharmaceutical legis- NZ says no to oral 13 essarily come under the definition. lationand with no involvement from the Euro- contraceptiveswitch In addition,the classification depended on pean Medicines Agency(EMA)”. ill-defined terms such as ‘systemically absorb- Developing adequate rules for biologically- MARKETING NEWS 14 ed’, ‘not absorbed’ and ‘locally dispersed’, the viable substances would also be on the AESGP’s RB pairs with UK charityto 14 association pointed out. agenda, it added, along with the debate around driveheadache awareness The wider scope of Rule 21 wasone of a putting nano materials in only Class III in spec- Daiichi Sankyo adds to 15 number of Council proposals that could have ifically defined circumstances. LoxoninSrangeinJapan far-reaching consequences for the OTCmedi- Furthermore, the associationsaid it would GSKsupports FenbidinChina 15 cal devices industry,the AESGP argued. Its work to makesure that wheneverthere wasa Medical Devices Committee wasurgently re- “change concerning specific substances”, an Brand heritageis 16 keytorelaunch viewing the latest proposals ahead of trilogue adequate consultation took place and that the discussions on the legislation between the Coun- Unique Device Identifier system would only Elder outlines Shelcalplans 17 cil, the European Commission (EC) and Euro- be applied to substance-based medical devices Doc Ibuprofen campaign 18 pean Parliament, which were expected to begin in “well-justified cases”. highlightsproduct’sspeed in September. FEATURES 20 In its draft proposal, filed in 2012, the EC Position paper expected soon had noted that the line between medicinesand Details of the association’sapproach would France looks towards 20 medical devices was“difficult to draw”. nowbedeveloped into aposition paper,the Spanish model It then suggested –under Rule 21 in Annex AESGP said, which would be finalised by the VII –that substance-based medical devices end of July. REGULARS should be classified in the highest-risk class The AESGP noted that the Council’sprep- Events – Our regularlisting 19 as this wasappropriate to ensure ahigh level aratory bodies were nowlooking at the tech- People – WBAnames Pessina 23 of safety,regardless of their use. nical inconsistences and recitalswith aview as chiefexecutive officer The AESGP warned that Rule 21 would to reaching acomplete general approach by place manyself-care medical devices, such as the end of the summer. OTC24-07-15p2-9_Layout 1 21/07/2015 15:33 Page 2

OTC COMPANY NEWS

BusinessStrategy BusinessStrategy ConsumerHealthcareunit Cipla to spin-off getsanew home at Sanofi OTC operations ndia’sCipla is set to spin-offits consumer anofiisset to transfer its Consumer Health- Ihealthcarebusiness into awholly-owned Scare division into anewly-created global subsidiary,inamove the generics firm claims business unit on 1January 2016, as part of a will enable it to takeadvantage of the “shift shake-up instigated by the French firm’schief towardswellness and self-care”. executive officer,Olivier Brandicourt. Noting that its board had approvedthe plans, The General Medicines and Emerging Mar- Cipla said it expected the transfer to be com- kets global business unit will house Consumer pleted during the third quarter of 2015. Healthcare, alongside the firm’sEstablished Describing the move as an “exciting develop- Products and Generics operations. “All pharma- ment”, the near US$2 billion- (C1.8 billion-) ceutical businesses in Emerging Markets” will turnoverfirm said it would nowtodevelop con- also be in the newunit. sumer healthcare as a“strong, customer-focused General Medicines and Emerging Markets business with operational independence”.

is to be led by executive committee member, Sanofi’s vice-president of global commercial By operating independently,the consumer Peter Guenter,who has for the past twoyears operations, Peter Guenter,istolead the company’s healthcarebusiness would also be in abetter served as Sanofi’svice-president of global com- newly-created General Medicines and Emerging position to “develop expertise” in the fast-mov- mercial operations. Markets global business unit ing consumer goods (FMCG) segment, Cipla said. Four other global business units will also Earlier this year,Brandicourt promised to While the business would initiallyonly op- be created: SanofiGenzyme, headed by David conduct afull strategic reviewofthe company, erate in its domestic market, aspokesperson Meeker,which will cover‘speciality care’; San- including the Consumer Healthcare division, to forCipla told OTC bulletin that the firm had ofiPasteur for vaccines, which will continue “understand the challenges and opportunities” not ruled out geographic expansion. to be led by Olivier Charmeil; Merial animal that lay ahead for Sanofi(OTC bulletin,22 “Upon achieving significant scale and brand health, which will retain its current chief Car- May 2015, page 7). equity in our home market,”the spokesperson sten Hellmann; and aDiabetes &Cardiovas- Commenting on Brandicourt’sappointment explained, “our consumer healthcareproducts cular unit led by Pascale Witz. shortly after it wasannounced, Vincent Warn- may be launched in other markets where Cip- “The neworganisation simplifies and focuses ery,head of SanofiConsumer Healthcare, said la’s distribution strength and brand equity can Sanofitooptimise growth,”said Brandicourt, he wasconfident that the newchief executive be leveraged.” who has led the firm since April (OTC bul- would be abig supporter of the business (OTC Cipla’sOTC portfolio currently consists of letin, 6March 2015, page 23), following the re- bulletin,3April 2015, page 22), and would one product –smoking-cessation treatment movalofChris Viehbacher by Sanofi’sboard takeanactive interest in Consumer Healthcare. Nicotexnicotine gum –which the company (OTC bulletin,7November 2014, page 1). OTC launched last year into the Indian market. Aswitch from Cipla’sprescription medi- cines business, Nicotexhad already generated sales of INR350 million (C5.10 million) since its launch, the firm pointed out. Noting that Cipla had other consumer health- care products “in the pipeline”, the spokes- person said the companywas planning anum- ber of launches “from next year onwards”. OTC

IN BRIEF ■ HI-TECH PHARMACEUTICALS –the US-based sports nutrition firm –has expanded its brand portfolio by acquiring Sports One and its range of premium sports nutrition and diet-aidproducts for an undisclosed sum. Est- ablished in 1990, Sports One had developed a line of “state of the art, high-performance sports supplements”, Hi-Tech claimed, which were “backed by science” and aimed at “hardcore, competitive athletes and fitness enthusiasts”. OTC

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COMPANY NEWS OTC

Mergers&Acquisitions BusinessStrategy/Mergers&Acquisitions EU to rule on FutureofP&G’s OTC brands Mylan/Perrigo almost secureascull ends uropean Union (EU) competition regula- Etors will decide by 29 July whether My- he future of Procter &Gamble’sconsum- Asked what Moeller’scomments meant for lan’shostile takeoverbid for Perrigo should Ter healthcare brands is looking slightly Procter &Gamble’sOTC brands –which in- be allowed to go ahead, according to the Euro- more secure, with the firm indicatingthat its clude Align, Clearblue, Metamucil,Pepto-Bis- pean Commission. brand cull is “essentially” over. mol, Prilosec OTCand Vicks –aspokesperson The Commission’sdirectorate-general for Having announced last year that the com- for the consumer goods giant told OTC bul- competition said that Mylan had requested EU panywas to “harvest, partner out, discontinue letin the firm had no comment on its plans clearance on 23 June for its proposed acquisi- or divest” 90 to 100 brands to focus on just 70 for its consumer healthcare portfolio. tion of the US store-brand specialist. to 80 core brands (OTC bulletin,15August Moeller explained that after closing the Coty Both Mylan and Perrigo are domiciled in 2014, page 9), Procter &Gamble’schief finan- deal, Procter &Gamble would have “focused” the EU. Mylan is registered in the Netherlands, cial officer,Jon Moeller,said earlier this month its portfolio “on 10 categories and 65 brands while Perrigo is headquartered in Ireland. thatthe sell-offwas “essentially complete” after that best leverage our core competencies”. Mylan has seen anumber of bids for Perrigo the firm agreed to offload 43 of its beauty brands “Wehaveleading global positions in these rejected, butsaid in May that it wascommitted to US companyCoty. categories,”heexplained, “with consumer-pre- to making the deal happen (OTC bulletin,22 The transaction includes Procter &Gamble’s ferred products and the leading brands in the May 2015, page 3). Cosmetics, Fine Fragrance,Retail Hair Color largest markets.” Last month, Abbott stated its intention to and Salon Professional businesses, along with Following the close, a“reshaped”Procter & use its 14.5% stakeinMylan to support the selected hair-styling brands. Gamble would “operate with avery focused latter’splanned bid for Perrigo (OTC bulletin, Following completion of the deal with Coty portfolio, where just sevencategories represent 26 June 2015, page 9). –which is valued at US$12.5 billion (C11.2 85% of sales and profit”, Moeller said. Mylan is itself subject to ahostile take- billion) –“93 out of approximately 100” brands Procter &Gamble’sconsumer healthcare over bid by Israeli generics giant Teva (OTC that the companyhad planned to offload would interests are split between its wholly-owned US bulletin,22May 2015, page 3). have been “sold, discontinued or consolidated”, OTCunit and PGT Healthcare, the OTCjoint However, agroup of eight US consumerand Moeller pointed out. venture it establishedwith Teva Pharamceuti- public-interest organisations has argued in alet- So farthe cull has left Procter &Gamble’s calIndustries in 2011 (OTC bulletin,16Nov- ter to the US Federal Trade Commission (FTC) consumer healthcare business relatively unscath- ember 2011, page 1). that Teva’s proposed takeoverofMylan would ed, with only the Vicks VapoSteam liquid-in- PGT operates in essentially all markets out- “increase prices for generic as well as speciality halant being offloaded to consumer products side of North America and is led by chief ex- drugs” and “exacerbate drug shortages”. firm Helen of Troy.The deal also included a ecutive Briain de Buitleir. OTC licence for Vicks VapoPads in the US. OTC

24 July 2015 Number 446 Individual subscriptions Te rms &Conditions: An annual subscription comprises: These can be viewedinfull at Editor: Matt Stewart www.OTC-bulletin.com/subscribe. Editor-in-Chief: Aidan Fry ■ 20 OTC bulletin newsletters; ■ AND at least 45 weekly news@OTCbulletin No partofthis publication maybe copied, reproduced, Production Editor: Jenna Meredith stored in aretrieval system, distributed or transmitted by electronic newsflashes containing the week’s Assistant Editors: To mGallen, Marie McEvoy anymeans, including electronic,mechanical, photocopying top news stories (currentlydelivered by email). Contributing Editor: David Wallace or recording, without the prior written permission of the publisher,orunder the terms and conditions of Advertising Controller: Debi Minal Choice of formats aGlobal Site Licence or of alicence issued by the Director of Subscriptions:ValDavis The 20 OTC bulletin newsletters are available: Copyright Licensing Agency (CLA) in London, UK, or Group Sales Manager: Rob Coulson ■ EITHER as the digital OTC bulletin-i for rights bodies in other countries that have reciprocal Awards Manager: Natalie Cornwell online access by desktop,and tablet and agreements with the CLA. Managing Director: Mike Rice smartphone.Mobile devices can have Apple or Neither maythis publication be exported, distributed Android operating systems. or circulated by anymeans without the prior written Editorial enquiries: OTC bulletin, ■ OR in traditional hard-copyprint format, permission of the publisher. 4Poplar Road, Dorridge,Solihull, delivered by airmail. While due care has been taken to ensure the accuracy West Midlands B93 8DB, UK. of information contained in this publication, the Website: www.OTC-bulletin.com Corporate and multiple subscriptions publisher makes no claim that it is free of errorand Te l: +44 (0)1564 777550 Global Site Licences are available to companies. disclaims anyliability whatsoeverfor anydecisions or Fax: +44 (0)1564 777524 These provide in-house electronic access for actions taken as aresult of its contents. Email: [email protected] staff to OTC bulletin and news@OTCbulletin. ©OTC Publications Ltd. All rights reserved. ® Please ask foraquotation. OTC bulletin is registered as atrademark in Advertising enquiries: the European Community. Discounted multiple subscriptions are available to As above,[email protected] ISSN 1742-0784. OTC bulletin-i at the same location. SUBSCRIPTIONS Companyregistered in England No 2765878. Subscription rates are published at Subscription enquiries: Printed by Warwick Printing CompanyLimited, www.OTC-bulletin.com/subscribe. Contact [email protected] Leamington Spa CV31 1QD,UK.

24 July 2015 OTC bulletin 3 OTC24-07-15p2-9_Layout 1 21/07/2015 15:33 Page 4

OTC COMPANY NEWS

J&JBusinessStrategrey/Secoadynd-QuarterResul forts consumer opportunities

emographic trends and changes in the way the companymovestowards completing the re- Despite the recalls, Johnson &Johnson’s Dconsumers manage their health are creat- quirements of aconsent decree filed by the US OTCbrands in the US continued to be “loved ing newopportunitiesfor Johnson &Johnson’s Department of Justice (DoJ) and the Food and by consumers” and professionals, Peterson said, Consumer business, according to the company’s DrugAdministration (FDA) in 2011 (OTC bul- with Tylenol, Children’sTylenol, Children’s group worldwide chairman Sandi Peterson. letin,17March 2011, page 1). Motrin and Zyrtec all the number one health- Speaking as the companyannounced its sec- Johnson &Johnson wasissued with the con- care professional-recommended brands in their ond-quarter results, Peterson said that the firm’s sent decree for failing to comply with good respective categories. “consumer expertise and insights” were “highly manufacturing practice (GMP) requirements at “Last year,Johnson &Johnson’sOTC port- valuable to payers and providers” in what was its Fort Washington plant in the US and its Las folio grewfour-times faster than the OTCcat- arapidly-changing healthcare environment. Piedras facility in Puerto Rico. egory as awhole in the US,”Peterson pointed Picking up on Peterson’scomments, John- Astring of product recalls by Johnson & out, “and that strength has continued this year son &Johnson’schief executive officer,Alex Johnson’sOTC business during 2010 and 2011 with 13% growth in the first half of the year Gorsky, insisted that the firm’sConsumer unit prompted agovernment investigation and the and 16% in the latest quarter.” remained of “strong strategic importance”. closure of the company’sFort Washington facil- Expanding on what had been achievedin “When you think about the role of consum- ity. Manufacturing problems at Fort Washing- the US, Gorskysaid that he believedthat John- ers and healthcare utilisation going forward,” ton led to the withdrawalofthe bulk of Johnson son &Johnson would be “one of, if not the only, Gorskysaid, “and when you think about the &Johnson’sOTC portfolio. large OTCcompany” successfully to navigate way[aconsumer business] is able to drive aconsent decree and regain abig chunk of its innovation and you think about the reach that it Facilities given all clear market share. givesyou –particularly in the emerging markets Noting that the Lancaster and Las Piedras But Consumer’ssuccess wasnot just aUS and the fast-growing markets –wethink that plants had recently been cleared by the FDA story,Peterson insisted, highlighting the signif- there are alot of opportunities.” (OTC bulletin,12June 2015, page 7) and that icant progress the companyhad made in glob- Furthermore, the Consumer business not the Fort Washington facility had recently under- alising the management of 12 “megabrands only operated to drive growth internally, butit gone asuccessful inspection, Peterson said that focused on 11 consumer need states”. also could be used to increase sales across the over80% of the withdrawn brands were now These brands had entered newmarkets and group’sother businesses, he added. back on the market and the Tylenol Arthritis had made strong share gains in the beauty,oral- Gorsky’sand Peterson’scomments came as line would be relaunched in the near future. care and OTCcategories, Peterson claimed.

Business Second-quarter sales Change Operational Currency (US$ millions) 2014/2015 (%) change (%) effect (%) OTC–US366 +15.8 +15.8 – OTC–International 608 -11.5 +4.7 -16.2 Total OTC974 -2.9 +8.2 -11.1 Skin Care–US491 -3.0 -3.0 – Skin Care–International 403 -12.8 +1.2 -14.0 Total Skin Care 894 -7.6 -0.9 -6.7 Baby Care–US104 -2.8 -2.8 – Baby Care–International 439 -12.2 -1.0 -11.2 Total Baby Care 543 -10.5 -1.2 -9.3 Oral Care–US147 +3.5 +3.5 – Oral Care–International 244 -10.0 +5.0 -15.0 Total Oral Care 391 -5.3 +4.5 -9.8 Wound Care/Other –US240 +0.8 +0.8 – Wound Care/Other –International 121 -30.1 -19.2 -10.9 Total Wound Care/Other* 361 -12.2 -7.6 -4.6 Women’sHealth –US7-36.4 -36.4 – Women’sHealth –International 313 -5.4 +11.4 -16.8 Total Women’sHealth 320 -6.4 +9.9 -16.3 Total Consumer 3,483 -7.0 +2.3 -9.3 Consumer –US1,355 +2.7 +2.7 – Consumer –International 2,128 -12.2 +2.1 -14.3 *Now includes Nutritionals, which waspreviously grouped with OTC

Figure2:Breakdown of sales by Johnson &Johnson’s Consumer division in the second quarter of 2015 (Source –Johnson &Johnson)

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COMPANY NEWS OTC

“For example, we are growing by 11% glob- adding that size wasnot an issue as long as any Pharmaceutical ally and gaining share in the global feminine- deal met the firm’scriteria. Consumer 45% 20% US$7.94 billion protection category in markets such as Germany, “Weare lookingatavariety of different op- US$3.48 billion India, Poland and South Africa,”she pointed portunities nowthat the business is stabilising out, “while the Band-Aid wound-care brand has and growing again,”Peterson admitted. “We beenrevitalised in the US and has gained two believe we are in aposition where we can look share points overthe past year.” at these things alittle more.” Investment in the company’sbrands would As Figure 1shows, Johnson &Johnson’s continue, Peterson said, noting that as the man- Consumer division reported worldwide second- ufacturing restrictions tied to the consent decree quarter turnoverdownby7.0% to US$3.48 were relaxed, production efficiencies would en- billion (C3.19 billion) as negative currencyef- able the Consumer division to boost margins fects wiped out a2.3% operational gain. Medical Devices 36% without reducing brand support. Arise in US Consumer sales of 2.7% to US6.36 billion Furthermore, the firm wasbuilding newmar- US$1.36 billion failed to offset a12.2% drop keting capabilities, she added, such as in digital. in international turnovertoUS$2.13 billion. Figure3:Johnson &Johnson’s sales in the second quarter of 2015 –US$17.8 billion –broken down by “Wedoubled our digital media investments Operationally,internationalsales advanced by business segment (Source –Johnson &Johnson) anddigital channels with an emphasis on social 2.1%, butthis waswiped out by a14.3% neg- and mobile,”she explained. “Today,40% of our ative currencyeffect (see Figure 2). Skin Care posted worldwide turnoverdown digital advertising spend is on mobile and more Louise Mehrotra, Johnson &Johnson’svice- by 7.6% to US$894 million, as a12.8% fall in than 90% of our Facebook adveristements are president of investor relations, pointed out that, international sales wascompounded by a3.0% served up on either smartphones or tablets.” excluding divestments, Johnson &Johnson’s drop in the US. The international decline had “This global centralised marketing approach worldwide Consumer sales grewoperationally been entirelydue to negative-currencyeffects, is bringing our belovedbrands to their full poten- by 3.1%, with US sales increasing by 2.9% and the firm pointed out, as operationally,sales had tial,”Peterson insisted. international turnoverimproving by 3.2%. actually improvedby1.2%. The Consumer division’sproduct pipeline Looking at Consumer’sindividual businesses, Johnson &Johnson attributed the decline wasalso looking robust, Peterson claimed, with the OTCunit posted an 8.2% operationalrise in in US Skin Care turnovertothe “timing of “20 keyproduct launches”planned for this worldwide sales, drivenbystrong sales of Zyr- trade inventory build”. year, including Listerine whitening formula in tec in the US, and other upper-respiratory prod- Lower sales of cleansersand creams, cou- Africa, Europe, Latin America and the Middle ucts in international markets. However, aneg- pled with softer turnoverinChina, had led to East, along with Motrin Liquid Gels and Neu- ative currencyeffect of 11.1% restricted report- the 10.5% drop at Consumer’sglobal Baby trogena Hydro Boost in the US. ed turnovertoa2.9% gain to US$974 million Care business to US$543 million. Looking ahead, Peterson said the Consumer for the quarter. Meanwhile, worldwide Oral Care turnover business would continue to “rebuild its com- slipped back by 5.3% to US$391 million, as petitive edge” to takefull advantage of the op- US OTC sales grow acurrency-drivendecline in international sales portunitiesthrown up by the “underlying en- In the US, OTCsales had advanced by offset gains in the US. vironmentaldrivers” such as the developing 15.8% to US$366 million, Mehrotra said, with Oral Care turnoverincreased by 3.5% to middle-classes in emerging markets and the Johnson &Johnson’sshare of the US adult US$147 million in the US, while international growing consumer desire to live a“healthier, analgesics market in the quarter reaching 12%, sales fell by atenth to US$244 million. more vibrant life”. up from 11% in the prior-year period. Operationally,internationalOral Care sales Finding the right additions to the Consum- In addition,she noted, the firm had taken a had advanced by 5.0%, Johnson &Johnson er business wasalso on the agenda, Peterson 44% share of the paediatricanalgesics market, said, thanks to newproduct launches. revealed, with afocus on the firm’spriority up from 39% in the prior-year period. Consumer’sWound Care/Otherunit posted geographies and condition categories. Outside the US market, international OTC worldwide sales down by 12.2% to US$361 The companywas on the look-out for brands sales declined by 11.5% to US$608 million. million, as the divestment of Benecol in Nov- that could be tucked into the Consumer business Operationally,turnoverhad movedforward by ember 2014 caused international turnoverto to drive growth in certainmarkets or in certain 4.7%, the companynoted, howeverthis growth slump by 30.1%. US sales edged up slightly by categories, she explained, while also searching had been entirelywiped out by a16.2% neg- 0.8% to US$240 million. for technologies that could be in-licensed to ative-currencyeffect. Turning to Women’sHealth, Johnson & improve product innovation. Along with the OTCunit, all of Johnson & Johnson reported worldwide sales at the busi- Acquiring companies wasalso an option John- Johnson’sother Consumer units reported ade- ness down by 6.4% to US$320 million, follow- son &Johnson waslooking at, Peterson noted, cline in sales in the three months. ing the sale of its North Americansanitary- protection product unit. Business Second-quarter Change Operational Currency Thesell-offcontributed to a36.4% slump in sales (US$ millions) (%) change (%) effect (%) Women’sHealth turnoverinthe US during the three months, while international sales declined Pharmaceutical 7,946 -6.6 +1.0 -7.6 by 5.4% due to negative-currencyeffects. Medical Devices 6,358 -12.2 -4.7 -7.5 The Consumer division accounted for 20% Consumer 3,483 -7.0 +2.3 -9.3 of Johnson &Johnson’sworldwide sales in the Total Johnson &Johnson 17,787 -8.8 -0.9 -7.9 second quarter,which fell by 8.8% to US$17.8 billion (see Figure 3). Figure1:Johnson &Johnson’s sales in the second quarter of 2015 (Source –Johnson &Johnson) OTC

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OTC COMPANY NEWS

Mergers&Acquisitions Mergers&Acquisitions Vemedia grows ChinaNepstar’s chairman Belgian portfolio to acquiredrugstorechain emedia Consumer Health has expanded Vits presence in the Belgian OTCmarket hina Nepstar is weighing up atakeoveroffer overproposal. However, the firm cautionedits by snapping up Labima for an undisclosed sum. Caimed at taking the drugstore chain private. shareholders against trading their shares as The deal includes Labima’sbrands, its contract- The retailer said that its board of directors “no decisions” had yet been made regarding manufacturing operation and its manufacturing had receiveda“preliminary non-binding pro- the company’sresponse to the offer. facility in Vorst, Belgium. posal” from chairman of the board, Simin Nepstar made its announcement against a Yvan Vindevogel, the Netherlands-based Zhang, and his Neptunus Holding investment backdrop of turmoil in China’sstock market. firm’sexecutive chairman, said the deal added vehicle to acquire all of the company’soutstand- In the past month, shares on the Shanghai arange of niche OTCproducts –led by the ing ordinary shares and AmericanDepositary Stock Exchange have plunged by approximate- “fast-growing” R-Calm anti-nausea brand and Shares (ADS). ly 30%, with the government imposing sev- Nustasium sleep aid –toVemedia’sBelgian Noting that Neptunus had already snapped ere limits on trades and stopping initial pub- portfolio. This includes the Excilor nail-fungus up 50 million Nepstar shares on 3July,Zhang lic offerings (IPOs). line, Méréprine cough and cold products, Osteo- said he wasoffering US$1.30 (C1.16) in cash Nepstar reported turnoverupby9.4% to plus joint-care range and Valdispert sleep aids. per share and US$2.60 in cash per ADS. CNY2.95 billion (C431 million) in 2014, with Noting that Labima had been arespected same-store sales improving by 9.0% compared player in Belgium’sOTC market for many Offer represents apremium with the previous year. years, Vemedia said adding its ownmarket- This price represented apremium of about OTCdrugs accounted for 40.1% of the ingskills and commercial strength would help 18.2% overNepstar’sclosing price on 2July, firm’ssales, with prescription drugs, dietary sup- lift Labima’sbrands to a“higher level” and Zhang pointed out, and provided an “attractive plements and convenience products generating help “realisetheir full potential”.There were opportunity” for the firm’sshareholders. the remainder. alsoopportunitiestotakeLabima’sbrands into Nepstar said that its board of directors As of 31 March 2015, Nepstar wasoperat- newmarkets, it added. would form a“special committee” consisting ing 1,969 stores across China. OTC of independent directorstoconsider the take- OTC

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COMPANY NEWS OTC

WBABusinessStrategy/Thir ond-QuarterR theesults lookout for acquisitions

algreens Boots Alliance (WBA) is on the closed by the end of the firm’sfinancial year. Wlookout for merger and acquisition oppor- Meanwhile, Pessina reported third-quarter tunities to expand its global footprint, accord- sales of US$3.3 billion at WBA’sRetail Phar- ing to chief executive officer Stefano Pessina. macyInternationaldivision, consisting of health Speaking as the US-based wholesale and and beauty chains in eight countries, of which retail giant reported the results for its third quar- the largest is Boots UK. The firm noted that ter ended 31 May 2015, Pessina –who has acomparison with sales in the previous year been appointed as permanent chief executive wasnot possible as the division had been op- (see page 23) –said that WBAwanted to capi- erational for less than six months. talise on the ongoing consolidation in the in- Sales at the unit had been drivenbya“good dustry and revealed that the companywas al- performance” from Boots UK in both the beauty ready seeing “a lot of opportunities”. and retail healthcare categories, WBAnoted. “Weare open to anykind of combination The increase recorded by Boots UK had which could improve the value of our company,” been complemented by “higher growth in em- Pessina revealed, “and we are looking actively erging markets”, the firm said, most notably in Stefano Pessina, Walgreens Boots Alliance’s chief around us at anumber of options.” its twopharmacychains in Latin America. executive officer,said the firmhad identified a number of acquisition opportunities “If we see an opportunity that fits with our Alliance Boots snapped up Chile’sFarma- strategy and that can create value, we will go cias Ahumada and Mexico’sFarmacias Bena- Turning to group-wide synergies, Pessina after it,”hepromised. vides pharmacychains from Mexican whole- said combined synergies from the merger had Turning to WBA’sthird-quarter results, Pess- saler and retailer Grupo Casa Saba for MXN8.3 totalled US$504 million in the nine months ina reported a“strong performance”, with sales billion (C488 million) last September (OTC ended 31 May 2015, and were “on track” to up by 48.4% to US$28.8 billion (C25.7 billion), bulletin,12September 2014, page 8). reach at least US$650million in the year end- after eliminations of US$606 million. At the time of the deal, Alliance Boots noted ing 31 August 2015. While the firm wasstill in the early stages of that as the third-largest retail pharmacychain in Pessina pointed out that the companywas integrating the Alliance Boots and Walgreens Mexico, Farmacias Benavides operated around targeting synergies of “at least” US$1 billion businesses, following the completion of their 1,000 stores across 21 of the country’s31states. by 31 August 2016. merger deal (OTC bulletin,17April 2015, Farmacias Ahumada wasone of the three WBA’stotal operating income for the period page 5), Pessina said the “benefits” of this work biggest pharmacychains in Chile, the company amounted to US$1.40 billion, after eliminations. were “already beginning to be seen”. said, with approximately 400 stores. Following the third-quarter results announce- Turnoveratthe company’sRetail Pharmacy Noting that Latin America wasone of Al- ment, WBArevealed that it had acquired UK USA division –which comprises Walgreens liance Boots’ “priority areas for investment”, firm Liz Earle Beauty,owner of the Liz Earle and Duane Reade drugstores as well as US on- Pessina said at the time that the deal would skin-care brand, for an undisclosed sum. line sales –advanced by 5.3% to US$20.4 bil- give the companya“major presence” in what Liz Earle wasan“award-winning premium lion in the three months. wasan“attractive market”. The deal also rep- skin-care range”, WBAnoted, and wasrec- Prescription sales, which accounted for resented afurther step towards the firm’sgoal ognised as one of the leading botanical brands 66.1% of the total, had increasedby7.0%, of achieving a“global footprint”,headded. in its domestic market. WBAnoted, while prescription sales in compa- Boosted by better sales in Latin America OTC rable stores had improvedby9.1%. and the UK, Retail PharmacyInternationalpost- The division generated an operating income ed an operating income of US$249 million for of US$1.3 billion in the period. the three-month period. IN BRIEF As of 31 May 2015, Retail PharmacyUSA As of 31 May 2015, the division wasoper- ■ DKSH –the market expansion services firm wasoperating 8,240 drugstores across all 50 ating 4,565 health and beauty stores across –has been appointed to drive sales of HawPar US states, the District of Columbia, Puerto Rico Chile, Ireland, Lithuania, Mexico, the Nether- Healthcare’stopical pain-relief brand Tiger and the US Virgin Islands. lands, Norway,Thailand and the UK. Balm in Myanmar.Under the terms of the deal, Pessina noted that the companywas pro- Meanwhile, Pessina said that WBA’sPhar- DKSH would provide marketing, sales, distri- gressing with its cost-reduction initiativefor maceutical Wholesale division –which mainly bution and logistics services for the entire Tiger the Retail PharmacyUSA division that wasex- operates under the Alliance Healthcarebrand – Balm product range in Myanmar,the Switzer- pected to save US$500 million by the end of had generatedsales of US$5.7 billion in the land-based companysaid. While Tiger Balm WBA’s2017 financial year. third quarter. wasoriginally developed in Myanmar,the brand As part of this cost-cutting plan, WBAan- The division reported an operating income had not been on the market in the country for nounced in April that the firm planned to close of US$171 million in the period. anumber of years, until HawPar reintroduced 200 drugstores in the US (OTC bulletin,17 WBAnoted that its Pharmaceutical Whole- it three years ago. DKSH would use its over April 2015, page 4). sale division supplied medicines, other health- 20 years of experience of operating in Myan- Nine stores had been closed during the third care products and services to more than 140,000 martoexpand the distribution of Tiger Balm quarter,Pessina revealed, with “approximately pharmacies,doctors, health centres and hospitals across the country,the firm pointed out. 70 to 80” additional stores scheduled to be from 299 distribution centres in 12 countries. OTC

24 July 2015 OTC bulletin 7 OTC24-07-15p2-9_Layout 1 21/07/2015 15:33 Page 8

OTC COMPANY NEWS

BusinessStrategy Manufacturingshake-up behind RB’s rise

uilding aglobal network of manufacturing under single leadership, reporting directlyto Bsites for its Health division has been the the executive vice-president of supply,” he said. “catalyst” behind the transformation of Reckitt “That wasthe biggest decision we made, be- Benckiser (RB) into amajor player in consumer cause it wasthe catalyst for alot of other deci- healthcare, according to the firm’sexecutive sions in terms of building capabilities, and in- vice-president of supply,Amedeo Fasano. vesting in people, processes and infrastructure.” Speaking at arecent analysts’ conference, One year on from the creation of the net- Fasano explained that the growth of RB’scon- work, RB snapped up SSL International, which sumer healthcare business had been built on a added the Durexand Scholl brands to the firm’s network of 12 plants across three continents, Health portfolio, and also brought with it 13 operating under single leadership and all adher- manufacturing sites (OTC bulletin,30July ing to uniform standards of quality. 2010, page 1). All sites had been fitted with arange of new “Our number of factories more than dou- Amedeo Fasano, Reckitt Benckiser’s executive manufacturing technology,henoted, enabling bled with the SSL acquisition and created quite vice-president of supply,said the firmhad been able RB to develop innovative products –such as acomplexnetwork,”Fasano admitted. repeatedly to deliver innovative OTC products, thanks the DurexRealFeel condom –and produce “Wenow had 19 plants,”hepointed out, “so to investments in its manufacturing network them on alarge scale. we decided to restructure the network and close letin,18December 2012, page 1). RB had been operating the network since anumber of the 13 sites we had inherited.” “When we bought Schiff, we gained afac- 2009, Fasano pointed out, when it wasestablish- Explaining the rationale behind this move, tory in Salt LakeCity,US, and it wasvery ob- ed to allowthe firm to have dedicated plants for Fasano said that the companyneeded to lever- vious that it wasaVMS manufacturing facility,” its OTCbusiness that were separate from its age its best assets. Fasano said, noting that the plant did not meet existing household products operation. the GMP standards required for consumer health- Up to that point, RB had been concerned with Invested in new technology care products. building towards its goal of becoming a“major “This wasthe best chance RB had to re- “Weconverted this factory to OTCstandards, player” in consumer healthcare, Fasano noted. main compliant,”hesaid, “and it allowed the as we would not accept the standards that we With its acquisition of Boots Healthcare firm to focus its efforts on areduced number of found,”henoted. International in 2006, RB added the Clearasil, sites and to invest in core competencies and “By upgrading, we gave ourselves the op- Nurofen and Strepsils brands, plus manufactur- newtechnology.” portunity to leverage the assets at the site to pro- ing sites in the UK and Thailand (OTC bulletin, One of the most important factories that RB duce OTCproducts, as well as VMS,”hesaid. 14 February 2006, page 3). had gained through the SSL deal wasthe site Fasano noted that at the time of the acquisi- This wasfollowed in 2008 with the acquisi- located in Bangpakong, Thailand, Fasano said. tion, Schiffwas not using the site to manu- tion of Adams Respiratory Therapeutics, bring- At the Bangpakong facility,the company facture its “iconic” MegaRed VMS brand and ing the Mucinexcough and cold brand and a had createda“research and development cap- wasinstead outsourcing the production. factory in Texas, US (OTC bulletin,15Febru- ability for sexual wellbeing”, Fasano noted, “For RB, this wasano-go,”Fasano explain- ary 2008, page 3). which allowed RB to experiment with different ed. “Wewant to be in control of our products. However, although RB nowhad the brands methods for making condoms. So we brought the technology behind Mega- to compete in the consumer healthcare space, In addition,Fasano explained that RB had Red in-house.” its infrastructure wasstill lacking, Fasano said. invested in newpolyisoprene condom technol- “By doing this, we created synergies and im- “Atthat time, we had an organisation that ogy at Bangpakong, making it the firm’sglobal provedthe cost profile of MegaRed,”heclaimed. wascentred on household manufacturing,”Fas- manufacturing centre for such products. The move had also givenRBaccess to the ano explained, “but we were entering the health- “By leveraging these investments, we were “interesting soft-gel technology” used in the care segment, which has very clear good man- able to drive innovation to create the RealFeel production of MegaRed, Fasano said, which ufacturing practice(GMP) standards.” condom,”Fasano explained. the companywas nowlooking at deploying At the time, RB’ssix consumer healthcare Based on the polyisoprene technology,the across other brands in its portfolio. manufacturing sites –located across Asia, RealFeelcondom had taken 24 months from Following the transformation of the Salt Europe and North America –“were not talking brief to sale, he pointed out. LakeCity site, RB wasnow running anetwork to each other as theyshould have been”, Fas- The product had nowbeen launched in 23 of 12 manufacturing facilities globally,all oper- anoadmitted. “Wewere facing strict regulatory markets, Fasano said, and the Bangpakong fac- ating to identical quality standards, Fasano said. andcompliance requirements on aglobal scale, ility had produced 70 million RealFeel con- “Even though our sites are in different while we were still operating our plants on a doms in 2014. countries, we have achieveduniformity,”Fasano very local basis.” The lessons learned at Bangpakong had pointed out, “and this has been central to RB’s “In order to manage this challenge, the solu- givenRBvaluable experience in transform- growth in consumer healthcare.” tion we found in 2009 wastocreate aglobal ing amanufacturing site, Fasano explained, “The manufacture and supply of products has manufacturing organisation for the Health div- which the firm then called on when it acquired been, and remains, akey partner in delivering ision,”Fasano explained. vitamins,minerals and supplements (VMS) RB’sconsumer healthcarestrategy,” he insisted. “Wetook these six sites and we put them companySchiffNutrition in 2012 (OTC bul- OTC

8 OTC bulletin 24 July 2015 OTC24-07-15p2-9_Layout 1 21/07/2015 15:33 Page 9

COMPANY NEWS OTC

First-HalfResults LicensingAgreements Deliveries lift Fidia gets marketing rights sales at Probi to Halykoo portfolioinItaly ubstantial”deliveries of probiotics to “Sits partners in the US helped almost to idia Farmaceutici has signed alicensing treble Probi’sConsumer Healthcaresales in the Fagreement allowing it to launch Applied opening six months of 2015, according to chief Pharma Research’sHalykoo range of paediatric executive officer Peter Nählstedt. herbal medicines in Italy. Turnoveratthe Swedish firm’sConsumer Under the terms of the deal, Fidia has gain- Healthcare operation had reached SEK109 mil- ed the promotion and marketing rights to the lion(C11.7 million) in the six months, up from Halykoo portfolio in its domestic market. Fidia will launch the Halykoo range of paediatric herbal medicines in Italy later this year SEK39.2 million in the prior-year period, Nähl- Describing the range –which includes Haly- stedt reported, thanks to large orders of probi- kooSoothing Throat Spray,Night-time Soothing with high-quality,safe and effective products otics from natural products retailer NBTY and Cough Syrup and Weather Protection Cream –as with innovative and child-friendly formulations, dietary supplements manufacturer Pharmavite. a“unique” line of products, Fidia noted that that offer reassurance to parents, manyofwhom NBTY had been stocking up with Probi’s the launch wasplanned for autumn 2015. are already acquainted with the Fidia brand probiotics during the period, Nählstedt explain- name,”Foresti added. ed, in preparation for the upcoming launch of Great opportunity in paediatric market “The Halykoo brand will integrate well into anew formulation of its Probiotic 10 product. Commenting on the agreement,Giorgio Fidia’sPersonal Care product portfolio,”hesaid, Noting that Probiotic 10 would nowinclude Foresti, Fidia’schief executive officer,said “which currently offers arange of treatment for the first time Probi’sprobiotic strains for launching the Halykoo range represented a options for skin and health.” digestive and immune health, Nählstedt said the “great opportunity” for the firm to compete suc- Fidia’sexisting OTCrange includes the product would be launched “progressively in cessfully in the paediatric market. SameLive dietary supplement, the WetGel nasal- various retail channels”overthe coming months. “Weare pleased to complementour portfolio dryness treatment and the WetMini nasal spray. In aseparate order,Probi had also delivered OTC “substantial volumes” of bacterial powder to NBTY for use in its Probiotic GX product, Nählstedt noted. Consumer Healthcare’ssales had also been boosted by consignments shipped to Pharma- vite, Nählstedt pointed out, for use in the firm’s newrange of probiotic products. Pharmavite has distributed the probiotic in the US under its Nature Made brand since 2012 (OTC bulletin,14September 2011, page 11). Meanwhile,awayfrom the US, Nählstedt revealed that during the six months Probi had expanded its agreementswith Sanofiand Dong- kook in South Korea to widen the distribution of the firm’sprobiotics. The “expanded” partnerships, Nählstedt ex- plained, would see “additional product variants for digestive health” launched onto the South Korean market during the third quarter of 2015. Sanofihas distributed Probi Digestis in South Korea under its ownCenovis line since 2014 (OTC bulletin,25April 2014, page 3), while Dongkook handles the distribution of Probi’s gut-health product Probi Mage in the country (OTC bulletin,11April 2014, page 9). The rise in Consumer Healthcare sales help- ed to boost Probi’stotal group turnoverto SEK128 million in the opening six months of 2015, up from SEK58.3 million in the prior- yearperiod. The Functional Foods division re- ported sales flat at SEK19.1 million. OTC

24 July 2015 OTC bulletin 9 OTC24-07-15p10-13_Layout 1 21/07/2015 15:46 Page 2

OTC GENERAL NEWS

Regulatory Af fairs Regulatory Af fairs France considers Labelwarnings for NSAIDs vasoconstrictors strengthened by US FDA ral vasoconstrictor cold remedies should Obe available in France on aprescription- he US Food and Drug Administration attack and stroke, especially at higher doses”. only basis, the country’s Académie Nationale T(FDA) has “strengthened” an existing label “Asalways, consumers must carefully read de Médecine has recommended. warning for non-aspirin, non-steroidal anti-in- the Drug Facts label for all non-prescription Noting that nasal vasoconstrictors were cur- flammatory drugs (NSAIDs) better to highlight drugs,”the FDApointed out. rently only available on prescription in France, that the products can increase the risk of heart “Consumers should carefully consider wheth- the advisory body pointed out that oral forms attack or stroke. er the drug is right for them, and use the medi- were nevertheless available as OTCmedicines. Noting that prescription NSAID labels would cine only as directed,”itmaintained. “Take the This wasdespite possible side-effects such as be revised to include newinformation –includ- lowest effective dose for the shortest amount hypertension, acute coronary syndromes, heart ingthat the risk of heart attack and stroke could of time possible.” rhythm disorders or stroke, which the Académie occur as early as during the first weeks of using The link between NSAIDs and an increas- said were rare butserious and unpredictable. an NSAID, and could increase with longer use ed risk of heart attack and stroke has recently The Académie therefore unanimously rec- or higher doses –the regulator said it would come under reviewinother countries. ommended that “orally-administered vasocon- request “similar updates”tobe made to the ex- In April this year,the European Medicines strictors, that have aless favourable risk-benefit isting Drug Facts labels of OTCproducts. Agency’s(EMA’s)Pharmcoviligance Risk As- balance than vasoconstrictors administered nas- sessment Committee (PRAC) said that the ally,should be available only via prescription”. Common OTC NSAIDs advice on the use of high-dose ibuprofen – France’sself-medication industry associa- These would include “common OTC 2,400mg aday or higher –should be updated tion, Afipa, emphasised that the Académie’s NSAIDs” such as ibuprofen –contained in to minimise the risk of cardiovascular prob- opinion wasnot binding, and that it wasupto Pfizer’sAdvil and McNeil’sMotrin brands – lems(OTC bulletin,17April 2015, page 10), national medicines agencyANSM to decide and naproxen, found in Bayer’sAleve range. while the UK’sMedicines and Healthcare prod- whether or not to followits recommendation. OTCand prescription NSAIDs already con- ucts Regulatory Agency(MHRA) withdrewin In 2014, Afipa said, 9.8 million packs of tain information on cardiovascular risks, as well February the pharmacy-only status of diclo- oral vasoconstrictors were sold in France, rep- as warnings about gastrointestinal issues and fenac, due to the “small risk of heart problems” resenting just under half of the 20 million packs potential skin reactions, following arequest by (OTC bulletin,2February 2015, page 1). sold across the entire cold market. the FDAin2005 (OTC bulletin,15April 2005, Meanwhile, Australia’sTherapeutic Goods OTC page 9). Administration (TGA) has proposed additional Noting that NSAIDs were “effective treat- statements to labelling for OTCNSAIDs to ments for pain, inflammation and fever”, the warn that excessive use of them in medicines Switches regulator said consumers could still take the for oral use could increase the risk of heart at- products as instructed. Consumers should be tackand stroke, as well as liverdamage (OTC Germany rejects aware, however, of the “increased risk of heart bulletin,26June 2015, page 13). colocynth switch OTC Regulatory Af fairs ermany’sexpert committee onprescrip- Gtion has recommendedagainst switching ASMI against point-of-origin labelling prescription medicines containing oral colo- cynth, or bitter apple, to non-prescription status. he AustralianSelf-Medication Industry pointed out, including overseas sites. By amajority decision, the committee ad- T(ASMI) has warned Australia’sfederal Scarffalso noted that the supply chains for vised health ministers against allowing colo- government against making it mandatory for therapeutic goods might be “complex” and in- cynth products to be sold OTCwith amaxi- labels on therapeutic goods to include the prod- volve “multiple parties, markets and TGA-ap- mum daily dose of 100mg and maximum treat- uct’scountry of origin. provedsites”. ment duration of 14 days. Steve Scarff, the ASMI’sregulatory and The more complexthe supply chain, the The herbal extract has laxative properties scientific affairs director,said that while the in- more difficult it would be to identify the point and is also used to treat colic. dustry body supported companies that wished at which the product was“substantially trans- Meanwhile, in aunanimous decision, the to include statements, graphics and visual rep- formed” and its “precise country of origin”, committee said that alfatradiol should have pre- resentations regarding aproduct’scountry of he maintained. scription-only status for all indications other than origin, this should be voluntary,asall therapeu- “Also, where alabel is used in more than as atopical treatment for androgenetic alopecia. tic goods were “already highly regulated for one market and acountry of origin statement is Alfatradiol is available in Germanyasan safety and quality”. included, then the statement will need to com- OTCmedicine for androgenetic alopecia under Furthermore, all products were manufactur- ply with the potentiallydivergent legalrequire- the Ell-Cranell and Pantostin brand names. ed in sites that had been approvedbythe Ther- ments in each of the markets,”Scarffadded. OTC apeutic Goods Administration (TGA), Scarff OTC

10 OTC bulletin 24 July 2015 OTC24-07-15p10-13_Layout 1 21/07/2015 15:46 Page 3

GENERAL NEWS OTC

Regulatory Af fairs Regulatory Af fairs Canadalooks at ASMI hits out at review paracetamol cut of advertising for OTCs educing the maximum recommended daily Rdose of paracetamol –also known as ace- egulators in Australiahave “fallen short” quest that the product be included in Appendix H. taminophen –isunder consideration by Cana- Rin their attempts to address a“keyindus- This application would be considered by the dian medicines regulator,Health Canada. try issue” concerning the advertising of sched- Advisory Committee on Medicines Scheduling The agencysaid it wasexploring anumber ule3–pharmacist-only –medicines, according (ACMS), the panel notes, which could impose of options –including revising the current to the country’sself-medication industry asso- conditions for advertising the medicine, such as dosage recommendations –tohelp reduce the ciation, the ASMI. ensuring pharmacists selling the product were amount of liverinjuries caused by oral and Responding to the first report to come from provided with training materials. rectal forms of paracetamol. the Australiangovernment’sreviewofthe coun- Criticising this proposal, the ASMI pointed Currently,the maximum recommendeddaily try’s medicines and medical devices regulations out that the panel had “acknowledged there was dose for paracetamol in Canada is 4g. –announced in October (OTC bulletin,7Nov- no evidence that the advertising of schedule 3 Other options under reviewbythe agencyin- ember 2014, page 17) –the ASMI said an oppor- medicines would lead to harm”. clude decreasing the unit dose for some paracet- tunity had been missed to “remove along-stand- “The panel also noted the efforts of the non- amol-containing products and requiring child- ing regulatory obstacle” which prevented the ad- prescription medicines industry in developing ren’sliquid paracetamol products to be sold vertising of schedule3medicines to consumers. aworld-first, information-based model for sched- with an accurate dosing device. ule 3advertising,”the association added. “Although acetaminophen remains asafe Appendix Hlisting “Despite this,”continued the ASMI, “the and effective medicine,”Health Canada explain- Under the current system, only schedule 3 panel recommended retention of existing ad- ed, “there are risks of serious liverinjury when medicines that are listed in Appendix Hofthe vertising restrictions.” it is not used as directed, such as exceeding the Therapeutic Goods Administration’s(TGA’s) “This means that Australia’sapproach to the recommendeddose or duration of use.” Poisons Standard can be advertised. advertising of schedule3medicines will remain Claiming that paracetamol wasthe “leading Only 10 substances are listed in Appendix out of step with manycomparable overseas juris- cause of all serious liverinjuries in Canada”, H, including diclofenac and hydrocortisone. dictions,”the association insisted. the agencypointed out that overfour billion In its report, the TGA’s expert panel recom- Following this first report, asecond report doses of the drug were sold each year in the mends that the “almost blanket ban” on direct- –reviewing the regulations covering comple- country,with non-prescription products account- to-consumer advertising of schedule 3medi- mentary medicines in Australia –isexpected ing for approximately 85% of these sales. cines be “relaxed” to allowfor more substances to be released“in the coming months”, accord- Health Canada said a“technical discussion to be added to Appendix H. ing to the TGA. with stakeholders” wasplanned for autumn The panel proposes that when asubmission The Australian government is planningto 2015, “to consider the feasibility of the pro- is made to down-schedule amedicine from pre- release aresponse to both reports towards the posed risk-minimisation options”. scription-only status, the applicant may also re- end of the year. “Inaddition, Health Canada will continue OTC to collaborate with stakeholders to further dev- elop our approach to educating consumers Regulatory Af fairs about acetaminophen,”the agencynoted. Canada’sannouncement follows Sweden’s FDA considers codeine safety in children decision earlier this year to ban the general sale of paracetamol in tablet form in response to an ough and cold medicines containing co- ommendation that codeine should not be used increase in poisoningcases (OTC bulletin,22 Cdeine are under investigation by the US to treat cough and colds in children aged under May 2015, page 15). Food and Drug Administration (FDA) due to 12 years due to an increasedrisk of side effects. Explaining the rationale behind the move the potential for serious side effects –includ- The FDAsaid it would “continue to evalu- at the time, Sweden’sMedical Products Agency ingslowed or difficult breathing –inchildren ate this safety issue” and consider the EMA’s claimed that there wasacorrelation between the aged under 18 years. recommendations, adding that final conclusions rise in cases of poisoningand the availability The safety assessment comes after the Euro- would be made once the reviewwas completed. since 2009 of paracetamol on general sale in gro- pean Medicines Agency’s(EMA’s)Coordina- In 2013, the FDAruled that the labels of cery stores and other non-pharmacyretailers. tion Group for Mutual Recognitionand Decen- codeine-containing products in the US should However, fellowScandinavian country tralised Procedures –CMDh –backed recom- highlight the risk of using them for post-oper- Norway ruled out restricting access to paracet- mendations by the agency’sPharmacovigilance ative pain in certain children who had under- amol in response to Sweden’sdecision. Risk Assessment Committee (PRAC) that child- gone atonsillectomy and/or adenoidectomy. The Norwegian Medicines Agencyclaimed renand adolescents between 12 and 18 years It had also echoed the PRAC’sviewthat co- that there was“no evidence” that the general who had breathing problems should not use deine should only be used to manage other sale of paracetamol led “to more cases of seri- codeine as acough or cold treatment (OTC types of pain in children if the benefits out- ous poisoning or death”. bulletin,1May 2015, page 10). weighed the risks. OTC The CMDh also backed the PRAC’srec- OTC

24 July 2015 OTC bulletin 11 OTC24-07-15p10-13_Layout 1 22/07/2015 09:08 Page 4

OTC GENERAL NEWS

Innovation mHealth is notamagic wand for Europe

obile health –ormHealth –devices and visits and less demand on healthcare services.” Mservices are not a“magic wand” that will Freeing up these resources meant theycould cure the endemic health problems plaguing be deployed more efficiently elsewhere, Crousse European Union (EU) healthcare systems. But said, pointing out that PriceWaterhouseCoopers theycan help people makebetter decisions when (PWC) recently forecast that mHealth had the it comes to looking after themselves, according potential to save C99 billion across the EU. to Sophie Crousse, industry executive,self-care Evidence wasalso coming to light that peo- advocate and blogger. ple were using these services in ever greater “These products can remind us to takeapill numbers, she added. or check our blood-sugar levels,”Crousse point- In the UK, the National Health Service ed out, “but theycan’tgorunning, eat ahealth- (NHS) had piloted ascheme called WebGP, ier diet or takethe pills themselves.” which allowed patients to get aconsultation To ensure that the opportunities presented by online. This had attracted “36,000 visits to the mHealth products and services were taken ad- website with 60% of those visitors taking up a Sophie Crousse said that work needed to be done vantage of, governments and industry had to remote consultation”, Crousse revealed. across the European Union to ensurethe benefits of address some keychallenges, most notably “This saveddoctors 400 hours of their own mHealth products werefelt health literacy,usability and regulation. time,” she pointed out, “freeing them up to help rectly.“An interesting model may be sex-edu- Crousse pointed out that according to con- needier patients or perform other tasks.” cation-type courses in schools butfocused on sumer testing website Myhealthapps.net there food, diet and taking care of oneself in general,” existed almost 100,000 mobile apps addressing Benefits for researchers Crousse suggested. “Such an addition to school health and wellbeing. It wasnot just consumers and governments curricula would benefit children and parents “These apps can help apatient accurately that could benefit from the proliferation of butalso ease the workload of doctors, nurses followaprescription,monitor their blood pres- mHealth products and services, Crousse pointed and other care professionals.” sure or check their heart rate,”she noted, “while out,noting that as people used these products, Crousse insisted innovators should also make allowing access to medical records, advice and vast amounts of data would be collected. sure these apps, devices and other services were information, without needing to be located near Researcherscould greatly benefit at little “easytouse”. The development of these prod- ahealthcare professional.” cost from the large volumes of data generated ucts needed to involveconsumers as well as This ubiquity could potentially be very use- by mHealth apps alone, Crousse said. healthcareand technology professionals. ful when it came to managing chronic condi- Already,researchers at Stanford University Finally,trust needed to be built between tions, Crousse pointed out, noting that the Euro- School of Medicine had used Apple’sResearch- user and developer,Crousse insisted, as people pean Commission estimated that EU member Kit platform to develop an app called MyHeart- wanted to knowthat their data wassafe and states spent around C700 billion annually –70%- Counts, Crousse said. This app collectedand what theywere signing up to. 80%oftheir total healthcarecosts –managing reported users’ personal heart data, she explain- Regulation would play akey role in develop- such illnesses. ed, for use in researching cardiovascular dis- ing that trust, Crousse said. However, anyregu- “For example, proper use of GlaxoSmith- eases, which were aleading cause of mortality. lation needed to be appropriate and not stifling, Kline’s(GSK’s) MyAsthma app –which pro- However, before these technologies could she argued, noting that the European Commis- vides practicaladvice and special monitoring be exploited fully,anamount of “debugging” sion’s“soft-lawapproach” to mHealth regula- tools to help control and manage asthma symp- had to takeplace, Crousse claimed. tion outlined in its Green Paper on the market toms –could mean fewer resources needing Investment in health literacyacross the EU seemed likea“sound choice” of direction. to be devoted to caring for asthma patients,”she wasneeded to ensure consumers could use and Again though, it wascrucial that all stake- claimed. “This would lead to fewer hospital understand mHealth products and services cor- holders played apart in developing the govern- anceofthe mHealth market, Crousse insisted. In an area where innovation wasoccurring Regulatory Af fairs every day,itwas crucial that regulators were flexible, she added, and that developers, patients, EFSA starts consultation on copper DRVs policyexperts and the pharma industry were all talking to each other to ensure the positive public consultation on the draft scientific day for infants aged 7-11 months to 1.3mg/day development of the sector. Aopinion on dietary reference values for for adolescent boys. copper has been launched by the European EFSA noted that it had been unable to de- ■ Sophie Crousse leads GSK Consumer Healthcare’s Food Safety Authority (EFSA). rive average requirements or population intakes communications and government affairs, public policy The draft scientific opinion has recommend- due to “the absence of appropriatebiomarkers and patient advocacyactivities. This article expresses ed an adequate intakefor copper of 1.6mg/day of copper status and the limitations of available her personal views. Youcan followher on Twitter for men and 1.3mg/day for women. balance studies”. @SophieCrousse and join her self-care blog on the Forinfants aged 7-11 months, children and The consultation will close on 6August. LinkedIn group ‘Enhancing self-care in Europe’. adolescents, adequate intakes range from 0.4mg/ OTC OTC

12 OTC bulletin 24 July 2015 OTC24-07-15p10-13_Layout 1 22/07/2015 08:57 Page 5

GENERAL NEWS OTC

Switches NZ says no to oral contraceptive switch

nabsence of support from major medical Cross –said it was“very disappointing” and a Safety issues were the main reasons for Aorganisations wasthe main reason why “real turnaround for NewZealand” in its ap- the rejection, the committee explained, noting arecent attempt to switch oral contraceptives proach to switching medicines. that it wasconcerned overthe potential for from prescription to non-prescription status in Despite the rejection, Green Cross would “hypersensitivity reactions” to nitrofurantoin. NewZealand failed, according to national medi- “continue to pursue the switch of oral contra- While it rejected the switch of nitrofurantoin, cines regulator Medsafe. ceptives”, Gauld told OTC bulletin. the committeesuggested that the supply of a At its May meeting –the minutes of which There wascause for optimism, Gauld insist- similar antibiotic used to treat urinary-tract in- have only just been released–Medsafe’sMedi- ed, as Green Cross had receivedsupport for fections, trimethoprim, should be extended. cines Classification Committee rejected an ap- its application from anumber of independent The committee agreed that the current crite- plication to switch selected oral contraceptives general practitioners as well as obstetricsand riafor trimethoprim supply by apharmacist –ethinylestradiol with norethisterone, ethiny- gynaecology specialists. should be revised. “Specifically,the criteria for lestradiol with levonogestrel, norethisterone, At the same meeting, the committee rejected women to have had no antibioticsinthe pre- levonorgestrel and desogestral–from prescrip- aseparate application by Green Cross to reclass- vious six months should be removed,”itstated. tion to restricted, or pharmacist-only,status. ify from prescription to restricted status the Medsafe reclassified trimethoprim in 2012 The committee said it could not give the antibiotic nitrofurantoin when used to treat un- from aprescription medicine to aprescription go-ahead to the applicationsubmitted by phar- complicated urinary-tract infections. The appli- medicine expect when supplied by apharmacist macyretail group Green Cross Health “in the cation wasfor apack of 20 tablets, each con- who has successfully completed atraining absence of support from the major medical taining 50mg or less of nitrofurantoin. course (OTC bulletin,15June 2012, page 9). representative bodies”. OTC While it noted that “consultation [by the applicant] with some primary practitioners had occurred”,the committeesaid that this consult- ation had not been “sufficient” and had not met the requirements set out by the committee ayear earlier,when it had rejectedasimilar applica- tion (OTC bulletin,16June 2014, page 10). However, the committee said that there ex- isted “a number of possible alternativestothis submission that could improve patient access Make sure your colleagues are to oral contraceptives, including prescribing via practicenurses”. as well informed as you Commenting on the committee’sdecision, switch consultant Natalie Gauld –who prepar- Make sure your fellow directors and executives get the latest ed the application in collaboration with Green consumer healthcare news and exclusive insights from OTC bulletin. Empower them to make informed decisions and take decisive actions to keep your business ahead of its competitors. Make sure your Market Research company has a Corporate Subscription.

Survey backs OTC Business benefits

❖ OTC bulletin is available pseudoephedrine electronically worldwide to all Executives in the company executives world’sleading OTC ore than two-thirds of US adults want companies are already ❖ Keeps your business up-to-date benefitting from a M“direct and immediate access” to non- with industry news and corporate subscription prescription medicinescontaining pseudoe- exclusive insights to OTC bulletin. phedrine to treat cough, cold and allergy symp- ❖ A fully-searchable archive offers toms, according to asurvey of over2,000 Am- in-house research facilities ericans carried out for the Asthma and Allergy ❖ Flexible formats –desktop, Foundation of America(AAFA). mobile and print options available The survey found that 71% of US adults who ❖ Flexible access –online or via ContactVal Davis, had experienced cough, cold or flu symptoms company intranet Subscriptions Director, or nasal allergies viewed pharmacies “some- ❖ Modest cost –available fora at [email protected] what or very unfavourably” that removedmedi- fraction of the price of multiple, or telephone +44 (0) 1564 777 550 cines containing pseudoephedrine. individual subscriptions OTC

24 July 2015 OTC bulletin 13 OTC24-07-15p14-18_Layout 1 21/07/2015 17:01 Page 2

OTC MARKETING NEWS

MarketingCampaigns RB pairs with UK charity to drive headache awareness

eckitt Benckiser (RB)’sNurofen Express provide “faster” headache relief at 400mg doses Ribuprofen-based analgesic brand has part- than a1,000mg dose of standard paracetamol. nered with headache charity Migraine Action The Nurofen Express range comprises 256mg in the UK to raise awareness among consumers sodium ibuprofen tablets and caplets, as well as and pharmacists of the need for “better man- higher-strength pharmacy-only (P) products, in- agement of headache and migraine”. cluding 400mg capsules. The UK-based consumer-goods giant has RB and Migraine Action’salliance builds Johnson &Johnson has joined forces with drugstore chain Walgreens to “encourage and rewardhealthy collaborated with the charity to promote Mi- on the company’s‘tension headache’ drive behaviour” among US consumers. graine Awareness Week, which runs from 6-12 launched earlier this year (OTC bulletin, 6 The US-based company said integrating its September 2015, and to highlight the importance March 2015, page 14) that is scheduled to run Johnson &Johnson Official 7Minute Workout fitness app within the retailer’s Balance Rewards for Healthy of treating headaches and migraine with the until September. Choices rewardprogramme now made it “easier for “right dose” of medication at the “right time”. The aim of the campaign is to educate con- consumers to make healthier choices”. Claiming that researchhad shown that more sumers on “the real cause” of headaches and to As aresult of the collaboration, members of the Walgreens programme can earnreward‘points’ by than one-third of headache and migraine suf- emphasise that Nurofen Express starts to “get completing an exercise routine via Johnson &Johnson’s ferers waited for more than 30 minutes after the to work” in 10 minutes. app, which syncs the workout information with the onset of pain before taking analgesics, and al- The companysaid it intended to “form a user’s Balance Rewards loyalty account. Consumers could also earnpoints by purchasing most two-thirds –63% –said theywould treat more long-term collaboration” with Migraine products from the Johnson &Johnson ‘healthy the conditions earlier if recommended to do so Action moving forward. essentials’ range –which included its Listerine and by ahealthcare professional, RB said the part- Meanwhile, RB is supporting its Gaviscon Neutrogena brands –the firmnoted, in Walgreens stores and online at Walgreens.com. nership would reinforcethe importance of re- heartburn and indigestion-relief brand through OTC sponsible advice from pharmacists to ensure apartnership with the British Curry Awards. ‘optimal treatment’ of both ailments. As part of the collaboration, Gaviscon would have an “on-stage presence” at the awards cer- Training and promotional materials emony, RB explained, which would be held in As part of the collaboration, RB and Mi- London on 30 November. graine Action had created training and promo- Furthermore, the Gaviscon logo would also tional materials, the firm pointed out, which feature in all marketing materials distributed would be distributed to 10,000 independent by the British Curry Awards, the firm said, pharmacies to help them run their ownin-store adding that print support would appear in the awareness week and position themselves as Awards’ newsletter, Spice Business. the “go-to” place for consumers to receive ad- While it wasanoverarching brand campaign, vice on headaches. RB noted, there would be afocus on the Gavis- Patient-information leaflets on both head- con ‘Double Action’ line of tablets and liquids, Indian firmDrReddy’s has launched its first OTC aches and migraines had also been developed containing sodium alginate, calcium carbonate, hair-growth supplement into its domestic market. for pharmacies,RBpointed out, while Simon and sodium bicarbonate. Targeted at men aged 30-50 years –morethan 58% of whom wereclaimed by the company to suffer Evans, chief executive officer of Migraine Act- Expected to run until the end of 2015, the from hair loss –the Hairootz ‘softlets’ areformulated ion, would also be taking part in radio inter- campaign would incorporateboth trade and with biotin, calcium pantothenate, folic acid, grape seed views closer to the Awareness Week. consumer public-relations activity to raise aware- extract, iron, protein hydrolysate, selenium and zinc. The product could also be used by women, RB is also looking to highlight that liquid ness of the collaboration, the firm pointed out, Dr Reddy’s pointed out. ibuprofen products –such as its Nurofen Ex- including aconsumer competition offering en- The company already markets in India the press general-sale list (GSL) 200mg capsules – trants the chance to attend the awards. Mintop (minoxidil) topical medicine, which is claimed OTC to be the number-one dermatologist-recommended brand in the country. Trading on this reputation, Hairootz’ packaging Bayer HealthCareisunifying its full Aspirin analgesics highlights that it is “from the makers of Mintop”. brand in Germany with updated green packaging. Alaunch campaign for Hairootz would include The revamp will bring the extended range into line “extensive” public-relations activity,the company with the firm’s coreAspirin tablets, which werelaunched noted, as well as direct marketing to consumers and in Germany last year with “new generation” packaging point-of-sale materials in retailers. (OTC bulletin,25July 2014, page 16). This new design Pointing out that the Indian hair-growth supplement had received an “excellent response” from both market was expanding at an average of 20%, Dr Reddy’s consumers and healthcareprofessionals, Bayer claimed, said it believed Hairootz could become a“significant adding that Aspirin’s refreshed look would be rolled out player” in this arena. across the entireacetylsalicylic acid-based line –which Hairootz has amaximum retail price of INR200 comprises Caffeine, Complex, Direct, Effect, Migraine, (C2.88) for 15 softlets. Plus Cand Protect products –bythe end of the year. OTC OTC

14 OTC bulletin 24 July 2015 OTC24-07-15p14-18_Layout 1 21/07/2015 17:01 Page 3

MARKETING NEWS OTC

MarketingCampaigns Line Extensions GSK supports Daiichi Sankyo addsto Fenbid in China Loxonin Srange in Japan man feeling trapped on an amusement Apark ferris wheel with his family is the apanese companyDaiichi Sankyo has grown focus of GlaxoSmithKline’s(GSK’s) national Jits Loxonin Sloxoprofen sodium-based an- television campaign to support its recently- algesics brand in its domestic market with an launched Fenbid Ibuprofen Chewable Tab- ‘S Plus’ variant. lets in China. Acategory 1medicine –anOTC product Scheduled to air until September, the ad- that is deemed to hold the highest degree of vertisement showed the man feeling ‘trapped’ risk –Loxonin SPlus contains 68.1mg loxo- by his headache as the ferris wheel doors profen sodium hydrate per tablet. Loxonin SPlus contains 33.3mg magnesium oxide as well as 68.1mg of loxoprofen sodium, Daiichi Sankyo closed, the companyexplained, before the “con- This is the same amount as contained in the says, so it is “moregentle on the stomach” venience and innovation” of Fenbid Ibuprofen original prescription Loxonin Sproduct, which Chewable Tablets –each containing 200mg wasswitched to OTCstatus in 2011. panyclaimed, approximately 70% of Japanese of the active ingredient –“came to the rescue” However, the Loxonin SPlus option was analgesics users still did not use the brand. to relieve his pain and allowhim to continue also formulated with 33.3mg of the antacid mag- Daiichi Sankyo said it had projected overall enjoying his day out. nesium oxide, Daiichi Sankyo pointed out, and brand sales of ¥4.1 billion (C30.3 million) in the Avoiceoverpoints out that Fenbid Ibupro- wasdesigned to be “more gentle on the stom- financial year 2015. Of this figure, ¥1.4 billion fen Chewable Tablets “easily relieve multiple ach”, while the smaller tablet size made it eas- wasexpected to be generated by the ‘S Plus’ pains, anytime, anywhere –all you need to do ier to swallow. option, the firm pointed out. is simply chew”. The creative, which ends with Pointing out that Loxonin Swas positioned Available nationwide, apack of 12 Lox- mainly for women in their twenties and thirties onin SPlus tablets has arecommended retail suffering from headaches and menstrual cramps, price of ¥698 excluding tax. the firm said it would target the SPlus variant Meanwhile, Daiichi Sankyo’sJapanese rival at those in asimilar demographic that were Kowa has extended its Colgen cold-relief brand looking for “reduced gastric discomfort” as well with aloxoprofen-sodium based LXα variant. as pain relief. Positioned as providing relief from sore Loxonin SPlus wasalso indicated for other throats and fever, the Colgen LXα analgesic pain such as toothache, stiffneck and neuralgia, and antipyretic –also acategory 1drug –con- and could be used as an antipyretic for chills tains 68.1mg loxoprofen sodium hydrate and Television advertising for Fenbid Ibuprofen Chewable and fever, Daiichi Sankyo pointed out. 140mg tranexamic acid per tablet. Tablets shows aman feeling ‘trapped’ by his headache The launch of Loxonin SPlus wascurrent- LikeLoxonin SPlus, the product is also in- the family watching fireworks together, also ly being backed by a15-second television cam- dicated to relieve other types of pain such as encourages viewers to “appreciate every sec- paign, Daiichi Sankyo noted. neuralgia and menstrual cramps. ond of your life”. Promotional materials were already avail- The Colgen range also includes products Targeted at consumers aged between 15-44 able in retailers, the firm added, to highlight for colds and rhinitis, formulated with ingredi- years who were looking for “a more conve- the“trustworthiness and premium image of the ents such as ibuprofen, dihydrocodeine phos- nient waytotreat pain”, the chewable variant Loxonin series”. phate, guaifenesin, and pseudoephedrine. wasalso being backed by ongoing activity Although 3.6 million packs of Loxonin S Abox of 12 Colgen LXα has arecommend- on Fenbid’ssocial platformsinChina such as had been sold overthe past four years, the com- ed retail price of ¥1,100 without tax. Weibo –asite akin to Twitter –and the We- OTC chat messaging app, GSK pointed out. Fenbid Ibuprofen Chewable Tablets would Pfizer Consumer Healthcarehas bolstered its also feature on science social-networking site Robitussin cough, cold and flu brand in the US with Guoke.com, the firm added, noting that “vibrant an extended-release 12-hour cough syrup. The launch of Robitussin 12-hour Cough merchandising”and pharmacy-training events Relief follows Pfizer’s recent license, supply and were further supporting the launch. distribution agreement with speciality pharmaceutical GSK said it would invest asignificant company Tris Pharma to market its 12-hour extended release dextromethorphan cough syrup under the amount throughout 2015 to back the line ex- Robitussin brand name. tension, which the companypointed out was Under the terms of the agreement, Pfizer will predicted to be a“growth driver” overthe next control sales, marketing and distribution of the syrup, while Tris Pharma is responsible for the three years. manufacturing and regulatoryactivities. TheFenbid range also includes sustained- Available in grape and orange flavours, the syrup release ibuprofen capsules, as well as an ibu- adds to the current Robitussin line, which includes Cough+Chest Congestion, Day &Night, Multi-symptom profen cream. Cold, and ‘Lingering Cold’ Long Acting options. OTC OTC

24 July 2015 OTC bulletin 15 OTC24-07-15p14-18_Layout 1 21/07/2015 17:01 Page 4

OTC MARKETING NEWS BrandProductRelaunches heritageiskey to arelaunch

strong brand heritage, amore attractive manyofthe elements of the Similasanprod- range –aswell as “smarter marketing” and a Aproduct and smarter marketing is driving ucts theyused before,”henoted. promise to “shakeup” the eye-care category. the success of the Similasan eye-care brand fol- Once overthe regulatory hurdles, the firm “If you’ve been amarket leader, you need to lowing its recent relaunch into the Netherlands, then had to tackle the challenges of re-estab- showhow the brand has evolved,”Schuurman according to Harm-Jan Schuurman, head of the lishing its distribution channels and reclaiming pointed out. “And it did help us get into trade, Swiss homoeopathic firm’sDutch subsidiary. its consumer base from competitors. because we could promise category growth. Speaking exclusively to OTC bulletin, To do this, Schuurman –who wasinitially We said, if you takeour products back onto the Schuurman pointed out that the firm had com- hired by Similasanasaconsultant –said he market, we are sure we can help you growthe bined these three elements to establish itself as had leveraged his network in the Netherlands category by 20%.” atop-fiveplayer in the eye-care category with of independent druggists and buyers, which he a10% share, following the return of its Simila- had built up over20years in the consumer Continued communication also key san Oogdruppels Nr.1 and Nr.2 eyedrops to the healthcareindustry. Continued communication with retailers was Dutch market in 2014 after atwo-year absence. “The first thing Idid wasspeak to them, also imperative to ensuring the firm secured Similasan’sexit from the Netherlands in to find out their ideas and views,”heexplain- shelf space, Schuurman added. 2012 came after the Dutch Ministry of Health ed, “and the impression wasthat theywere “Wehad to be committed to making it a placed restrictions on homoeopathic products happythat the products would be back.” success, because the trade wasnot waiting for which meant theywere no longer permitted “Wethen decided on what the strategy would us,”hemaintained. “Wekept trying to reach to include anymedicinal product indications be –the marketing strategy, the support pack- themday by day, and we were very persistent. or claims without supporting evidence. age –and offered this total package to retailers We did that for some weeks, and Ithink that At that time, the firm had been aleader in and wholesalers,”headded. is something that helped us to be taken seri- the C5.0 million eye-care market, Schuurman Despite Similasan’sprevious market position, ously by retailers.” noted, with a30% share through sales of its it still faced some “resistance” from retailers, This tenacity paid off, he noted, as the com- eponymous Nr.1 and Nr.2 products for ailments Schuurman admitted, partly as aresult of com- panysecured “100% distribution” through key such as tired, irritated and itchyeyes. petitors moving in to fill the gapleft by the brand. retailers, independents and drugstores during “All claims had to be removedfrom the While other firms such as Schwabe had also the first year. packs and the then current products had to be withdrawn products as aresult of the regula- However, Schuurman noted, the company takenfrom the market,”Schuurman pointed out. tory changes, Schuurman noted, rivalbrands had had to takea“big risk” to ensure it had “So we decided to takeastep back, and then –inparticular A. Vogel –had flourished. enough stock to satisfy demand from retailers see what we could do to bring them back.” “Vogel showed enormous growth the mo- before it even knewwhether theywould de- Forthis plan to return to the Dutch market, ment that Similasan wastaken from the mar- cide to list Similasanagain. Schuurman, amarketing and business develop- ket,”hemaintained. “Theyhaveamarket share “In the Netherlands, once the trade tells you ment expert, worked with his team alongside of roughly 30%, so theytook overour position.” ‘yes, we would liketobring your product back Gian Trepp of GBT Pharma, ahealthcare firm To earn its place back on retailers’ shelves, on the market’, you have to be very quick,” specialising in developing international markets Similasan had to bring a“more attractive prod- Schuurman pointed out. “Assoon as, for ex- for healthcare brands. uct” to the table, Schuurman noted. ample, Watsons decides to have your product With the brand performing well in other “There are lots of brands offered [to the back on their shelves, you cannot then start markets such as Canada, Switzerland and the retailers],”hepointed out. “Theytold us: ‘We’ve producing, because it will be too late.” US, Similasan opened its Dutch subsidiary – gotpeople likeyou every day asking us to launch With distribution secured, the firm then turn- led by Schuurman –inJanuary 2014 to re- products,’soyou really have to be different.” ed its attention to making consumers aware of launch the Nr.1 and Nr.2 eyedrops, butthis This newproposition included an emphasis the brand’sreturn. time as medical devices with altered formula- on Similasan’shistory as amarket leader and In line with the brand’syounger, fresher tions, yet with similar claims to the original. amore “premium” positioning –including re- feel, Similasan had decided to focus on amuch “Wewanted to offer the loyal consumers freshed silver packagingand abroader product younger age group –starting from 25 years of age –than its original target audience of those aged 50 and above,Schuurman noted. While the brand had anew website to re- flect its newpositioning –and apresence on social media –the platformsthrough which to communicate Similasan’savailability remained more traditional. “Wetried abit of social media,”Schuurman noted. “Wethought, of course, we have to be there, we have to makeuse of modern media tools, buttoreach the masses, we decided to

Similasan reintroduced its Nr.1 and Nr.2 eye drops to the Dutch market last year as medical devices in light of focus on radio and use email marketing.” new regulations regarding homoeopathic products Furthermore, as the Nr.1 and Nr.2 drops

16 OTC bulletin 24 July 2015 OTC24-07-15p14-18_Layout 1 21/07/2015 17:01 Page 5

MARKETING NEWS OTC

were “seasonal” products, Schuurman noted, the ProductLaunches firm had to be “flexible” with its marketing. “Wewere on the radio as soon as the weath- Elder outlines er forecast told us that it wassunny, dry or windy,” he explained. “Webought media aday before we wanted to be on the radio when the Shelcal plans weather changed, which Ithink wasanimport- ant part of the campaign’ssuccess.” lder Pharmaceuticals’ Shelcal calcium- This wassupported further by public-rela- Esupplement brand will makeits European tions activity and sampling, Schuurman added. OTCdebut in Bulgaria as part of plans to ex- “Sampling is an important part of our pro- port the line to 25 markets worldwide, accord- gramme,”Schuurman pointed out. “Once we ing to Alok Saxena, the Indian firm’schairman had the distribution in place and supported the and managing director. Similasan’s Harm-Jan Schuurman, head of the Swiss brand lots with radio, we later tried to convince homoeopathic company’s Dutch subsidiary, said the Speaking to OTC bulletin,Saxena pointed users to use the product through trialling it.” relaunch strategy for the brand focused on the its out that Elder wasworking with aBulgarian The firm wasalso looking to differentiate natural background and former market-leading position companytoregister the brand in the country. itself from competitors with a“full focus on getting agreat product that works for them, Once this wascomplete, Elder would look at eyecare”, Schuurman noted, highlighting the people’sattitudes tend to be understanding.” launching Shelcal into other European mar- recent launch of its ‘Optimoist’drops and a Noting that the Dutch market was“well- kets, he noted. spray for dry eyes, aimed primarily at contact- known as aprivate-label market” –with 50- Elder retained the international rights to lens wearers. 60% of the private-label category controlled Shelcal –aprescription brand in India –after Although rivals such as Schwabe, Vogel by Watsons –Schuurman added that Simila- it struck an INR20.0 billion (C284 million) deal andWeleda offered natural eye-care products, san’spremium positioning meant that such last year which sawitsell offits domestic for- he pointed out, these were part of huge over- products were not as much of athreat. mulations business to Torrent Pharma (OTC all product ranges for various conditions. “Assoon as there are cheaper products on bulletin, 17January 2014, page 3). “Webelieve in specific products for specific the market, then you have to showthat you are indications for specific target groups,”hein- better –that you are looking better, orthat you Freed up production capabilities sisted. “Similasan wants to be the category lead- have abetter offering,”hemaintained, “and The agreement had freed up the firm’spro- er –itwants to be the specialist in eyecare.” that is what Ithink we are doing, with anew duction capabilities, Saxena explained, to allow Claiming that the only brand to market a pack, abroader range, different indications and it to pursue its plans to extend the brand’sreach range consistingsolely of eye-care products different solutions.” into other markets. wasReckitt Benckiser’s(RB’s) Optrex, Schuur- “I believe there are only private labels if These included OTClaunches in Mauritius man said that Optrexoffered adifferent prop- there are good brands, and private labels are and South Africa, as well as across Europe. osition to the “natural background” provided followers,”hecontinued. “Asbrands, we have However, in “practically all” other countries by Similasan. to takethe initiative to differentiate and build Elder wastargeting –including Tanzania and This waswhere Similasandiffered from thecategory.Aslong as you are doing that, then Zambia –access to Shelcal would only be rivals, Schuurman noted, and this wasanother it’sokay to co-operatewith big retailers.” through healthcare professionals, Saxena said. wayinwhich the companycould be “smarter” Askedabout future ambitions for the brand, Three products would be rolled out across with its marketing. Schuurman said “all opportunities” were “open all markets, Saxena explained. These were the “What we focused on wasanatural back- to consideration”. original Shelcal variant –providing calcium ground, along and strong heritage and abroad “First, we will start with cementing further carbonate from oyster shells, as well as vita- range,”hemaintained. our place in the eye-care category,” Schuurman min D3 –along with the CT tablet and OS Although the firm wasnot permitted to pointed out. “Then we will see if there are other capsule line extensions, with calcitriol and alfa- make“natural claims”, Schuurman noted, it al- categories we can fill.” cidol, respectively. luded to the brand’snatural background through “This year, with afew newproducts and a Rather than marketing Shelcal as atypical the green leaf on the product packaging, and price higher than the average in the category, calcium-supplement range, Saxena pointed out, the tagline: “Similasan surroundsyour eyes we are working towards the 20% growth we the companywould position it for use during with care.” promised,”headded. pregnancy, lactation, the menopause, and by Meanwhile, the firm had underlined its pre- OTC those with osteoporosis. mium positioning –based on heritage, function- The marketing activity would include edu- ality and product design –with aprice in- IN BRIEF cational campaigns featuring keyopinion lead- crease, Schuurman pointed out, which reflect- ers and experts, he added, to highlight the im- ed the overall price changes in the market. ■ ARISTOPHARMA IBERIA –the Span- portance of calcium. “What I’ve learnt is that if consumers buya ish subsidiary of India’sAristo –has launched Shelcal waspredicted to generate around self-care product, theydon’tbuy it every week; a Tucalma eye-drop product based on chamo- US$20-25 million (C18-23 million) in the first theybuy it when theyhaveaspecific need,” mileextract. Suitable for contact-lens users, year,Saxena noted, and become the company’s Schuurman pointed out. “Sometimes it’sonce the drops are said naturally to relieve “minor “number-one export product” within the next ayear, sothe price leveloftheir previous pur- eyeirritation” caused by “environmental con- twoyears. chase will not be top of mind.” ditions” such as pollution and dust, as well Elder planned to reinvest 10-15% of Shel- “Aslong as you are comparablewith other as to relieve eyestrain. cal’srevenues in its marketing, he added. offerings in the market and consumers are OTC OTC

24 July 2015 OTC bulletin 17 OTC24-07-15p14-18_Layout 1 21/07/2015 17:01 Page 6

OTC MARKETING NEWS

MarketingCampaigns Doc Ibuprofencampaign highlights product’sspeed

erman firm Hermes Arzneimittel is empha- Gsising the speed and precision of its Doc Ibuprofen Schmerzgel topical analgesic in its latest national campaign. Olympic gold medallist Christian Taylor has been signed by US firmPrince of Peace as the latest spokesperson “Acts on the spot” is the tagline of the multi- for the Tiger Balm herbal pain-relief brand in the country. media campaign –that wascreated by advert- The triple-jump champion –who should compete ising agencyServiceplan Health &Life based in the 2016 Olympics in Rio de Janeiro, Brazil –would promote the brand via his social-media channels in in Munich. The campaign highlights that the the run-up to the games, as well as in person at 5% ibuprofen product’s“deep-action micro- The television spot for Doc Ibuprofen in Germany “numerous events and competitions”, noted Prince of gel” formulation penetratesquickly and directly shows amiddle-aged woman bowling Peace, which holds the exclusive US distribution rights to Tiger Balm from Singapore-based Haw Par. to the source of pain. pins spelling out the word ‘schmerz’, or ‘pain’. The partnership would also be publicised across the Targeted at “middle-aged women suffering The commercial ends with apack shot brand’s US Facebook, Pinterest, Twitter and YouTube from back, muscle and joint pain”, the market- and highlights that the gel is “precise”, “fast” profiles, the firmnoted. Furthermore, Taylor would appear in print and ing activity is led by a20-second television ad- and “well-tolerated”. digital advertising campaigns for Tiger Balm from the vertisement –airing across national channels Serviceplan Health &Life noted that print second quarter of 2016, Prince of Peace added, while such as ARD, SAT.1and ZDF –which features advertisements –featuring in women’scon- thebrand would also featureinadocumentaryfollowing Taylor’s journey to Rio. agroup of friends bowling. sumer titles such as Bunte and trade publica- The Tiger Balm range in the US includes amuscle As awoman goes to takeher turn, she is tions including Apotheken Umschau –also used rub, an ultra-strength ointment, and heat patches. shown clutching her back, before avoiceover the image of the woman bowling. Prince of Peace signed Tiger Balm’s other US spokesperson, professionalflatland BMX bike rider states that pain should be treated “immediately”. The Doc brand website, doc.de, has also been TerryAdams, in 2014. She then picks up apink bowling ball, fea- refreshed to reflect the campaign theme. OTC turing the Doc Ibuprofen logo, to knock down OTC

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18 OTC bulletin 24 July 2015 OTC24-07-15p19Events_Layout 1 21/07/2015 12:26 Page 2

EVENTS OTC

30 September-3 October SEPTEMBER 14-15 October ■ Expopharm2015 ■ AESGP Conference 10 September Düsseldorf, Germany Brussels,Belgium Afour-day international pharma- ■ Mutual Recognition & This two-day conference, subtitled ‘Substance-based medical devices: An ceutical trade fair and conference. Decentralised Procedure important part of self-care’, is being organised by the Association of Contact:Expopharm. Bonn, Germany the European Self-Medication Industry,the AESGP. Tel: +49 6196 928 830. Aone-day seminar focusing on There will be sessions on: ‘Medical devices: An important part of Fax: +49 6196 928 404. regulatory strategy. self-care’; and ‘Substance-based medical devices: Howtoestablish long- Email: [email protected]. Contact:Forum Institut für Management. term sustainability’. Website: expopharm.de. Tel: +49 6221 500 680. Speakers will include: Mairead McGuinness of the European Parlia- Fax: +49 6221 500 555. ment; Carlo Pettinelli of the European Commission; John Wilkinson of Email: [email protected]. OCTOBER the UK’sMedicines and Healthcare products Regulatory Agency(MHRA); Website: forum-institut.com. 5-6October and Judith NevesofPortugal’sInfarmed. 16 September ■ AFAMELA/WSMI Contact:AESGP. Tel: +32 2735 51 30. Fax: +32 2735 52 22. ■ Meet the Manufacturer Conference Email: [email protected]. Website: aesgp.eu/events/Brussels2015/. New Jersey, US Mexico City,Mexico Speakers from Bayer and Valeant ‘Advancing self-careand respon- will attend this one-day meeting, sible self-medication for ahealth- 13 October Contact:EHPM. which is only open to members of ierfuture’ is the theme of this two- ■ Global Generics & Tel: +322721 64 95. the Consumer Healthcare Products day conference,run by the Mexi- Biosimilars Awards 2015 Email: [email protected]. Association (CHPA). can non-prescription association, Madrid,Spain Website: ehpm.org. These Awards will recognise the Contact:CHPA. AFAMELA and the World Self- 29 October Tel: +1 202 429 9260. Medication Industry (WSMI). achievements of the global gen- CMA Annual Conference erics and biosimilars industries. ■ Fax: +1 202 223 6835. Contact:AFAMELA. Sydney,Australia Organised by Generics bulletin, Email: [email protected]. Tel: +52 55 5286 5297. “The next big thing” is the theme theywill reward business develop- Website: chpa.org/MTM/. Email: [email protected]. of this one-day meeting run by ment initiatives, cleverlicensing Website: afamela.org/index.php/afamela- ComplementaryMedicines Aus- 17-18 September deals and smart legalmanoeuvres. wsmi-conference. tralia (CMA). ■ Marketing Authorisation Contact: Generics bulletin. Contact:CMA. in Latin America 8October Tel: +44 1564 777 550. Tel: +61 26260 4022. Berlin,Germany ■ Marketing Authorisation Fax: +44 1564 777 524. Fax: +61 26260 4122. Legalframework, dossier require- Email: natalie.cornwell@generics- in Japan Email: [email protected]. ments and harmonisation will be bulletin.com. Frankfurt, Germany Website: cmaustralia.org.au. discussed at this two-day seminar. Clinical development, marketing Website: generics-bulletin.com/ Contact:Forum Institut für Management. authorisation and pricing will be generics-biosimilars-awards. NOVEMBER Tel: +49 6221 500 696. covered at this one-day meeting. 21-24 October Fax: +49 6221 500 555. Contact:Forum Institut für Management. CRN’s Annual Symposium 11 November Email: [email protected]. ■ ASMI Annual Tel: +49 6221 500 696. for the Dietary ■ Website: forum-institut.com. Fax: +49 6221 500 555. Conference 2015 Supplement Industry 22-23 September Email: [email protected]. Sydney,Australia Website: forum-institut.com. California, US This one-day conference organised ■ GMP and Recent Afour-day conference organised by the AustralianSelf-Mediation Inspection Findings by the US Council for Responsi- 12-14 October Industry (ASMI) will be followed for Human OTC Drugs ble Nutrition (CRN). ■ 12th TOPRA by the ASMI’sDiamond Awards. Contact:CRN. WashingtonDC, US Annual Symposium Contact:ASMI. Tel: +1 202 204 7700. Atwo-day workshop organised by Berlin,Germany Tel: +61 29922 5111. Fax: +1 202 204 7701. the Consumer HealthcareProducts Athree-day event run by The Org- Fax: +61 29959 3693. Email: [email protected]. Association (CHPA). anisation for Professionals in Reg- Email: [email protected]. Website: crnusa.org/2015events. Contact:CHPA. ulatory Affairs (TOPRA). Website: asmi.com.au/events/. Tel: +1 202 429 9260. Contact:TOPRA. 26-28 October 23-24 November Fax: +1 202 223 6835. Tel: +44 20 7510 2560. Vitafoods Russia &CIS Email: [email protected]. ■ EuroPLX 59 Email: [email protected]. Moscow,Russia ■ Website: chpa.org/mtm. Website: topra.org. Athree-day event covering diet- Athens,Greece This two-day meeting will pro- ary supplements, food supplements vide aforum for business devel- 3-5November and functional food and drinks. opment decision makers for dis- ■ 10th Ceuta International Contact:Adam Smith Conferences. cussing and negotiating collabor- Alliance conference Tel: +44 20 7017 7444. ative agreements in licensing, mar- Istanbul,Turkey Fax: +44 20 7017 7447. keting, and distribution of patented Delivering asolution to your international market management support Email: kristinag@adamsmith medicines, generics, biosimilars, or expansion plans. This unique event brings together leading health conferences.com. OTCproducts, medical devices and beauty,OTC and diagnostic manufacturers, keyindustry opinion 27 October and food supplements. leaders, retailers and outsource solution distributors from over100 global markets giving delegates an opportunity to meet like-minded people. ■ Food Supplements Contact:RauCon. Brussels,Belgium Contact:Ceuta Healthcare. Tel: +49 6221 426 2960. Aone-day workshop subtitled: Tel: +44 1202 449 709. Email: [email protected]. Fax: +49 6222 9807 77. “Trading more effectively through- Website: ceutahealthcare.com. Email: [email protected]. out the European Union (EU).” Website: europlx.com.

24 July 2015 OTC bulletin 19 OTC24-07-15p20-23_Layout 1 21/07/2015 17:08 Page 2

OTC MARKET RESEARCH Francelooks towards Spanish model

As France’sself-medication market continues to lag behind those of its shared a“close socio-economic context”, Afipa European neighbours, local industry association Afipa is seeking inspiration noted, adding that in both countries, 68% of overall spendingonpharmaceuticals wascover- from recent successesinSpain. David Wallace reports. ed by public funds. Despite generally unfavourable economic gainst abackdrop of falling sales at risk both financially and administratively”, conditions in Spain, Afipa pointed out, the mar- andadeclining share of the coun- while the association insists that astronger self- ketfor self-medication was“growing constant- try’smedicines market, France’s medication sector would represent both an im- ly”.AsFigure 1shows, the 11.7% volume share Aself-medication industry is looking portant source of savings and away to opti- of the overall pharmaceutical market captured forways in which it can improve its fortunes. mise France’shealthcare framework. by self-medication in Spain in 2014 represent- Having seen self-medication sales drop by 0.4% And in the latest report that has just been ed arise of three percentage-points compared to C2.12 billion in 2014 and volumes shrink by published by Afipa and market researcher Celti- to the 8.7% figure recorded for 2013 (OTC 0.7% to 462 million units (OTC bulletin,13 pharm – which compares France’sself-medi- bulletin,25July 2014, page 20). February 2015, page 24), local industry asso- cation market with those of sevenclose Euro- In contrast, France’sshare dropped by 0.3 ciation Afipa is under no illusions about the pean neighbours, based on data provided by points to 15.4%, which waswell belowthe sluggishness of the French market. national self-medication industry associations 32.3% average across all eight countries studied: France’s“political immobility” is prevent- as well as the Association of the European Self- Belgium, France, Germany, Italy,the Nether- ing the development of self-medication, Afipa Medication Industry,the AESGP –Afipa has lands, Spain, Sweden and the UK. believes. The association’spresident, Pascal seized on Spain as apotential model to emulate. Spain’simprovement, Afipa insisted, had Brossard, has acknowledged that “our model With similar populations and proportionate been “the fruit of political and administrative puts the sustainability of the healthcaresystem annual healthcare spending, France and Spain measures since 2012 that put self-medication at the heart of healthcarepolicy”, including making more medicines available without pre- scription and providing more healthcare infor- 70 mation to patients. 60 +2.1 Awaveofdelistings in Spain had contri- buted to stronger uptake, Afipa pointed out, as 50 +0.3 -0.9 had agreater emphasis being placed on self- -0.3 40 -1.0 medication by pharmacists, in the wake of price -0.3 cuts for prescription medicines. 30 57.8 44.8 These measures had responded to a“grow-

harmaceutical market (%) 41.2 20 38.0 37.5 -0.3 -0.1 +3.0 32.3 ing demand” on the part of Spanish patients to

eofp be more actively involved in governing their 10 15.4 12.3 11.7

Shar ownhealthcare, the French body stated, which 0 had been reflected throughout Europe, despite UK Italy Spain an overall “stagnation” in the region’sself- Sweden France Germany Belgium Average Netherlands medication market in 2014. In Germany, progress had been made in the Figure1:Volume shareofthe overall national pharmaceutical market captured by self-medication products in eight European countries in 2014, showing annual percentage-point rise (Source –Afipa/Celtipharm/AESGP) self-medication arena in 2014 against aback- drop of falling supplier rebates on prescription medicines, while strong sales in the pain and 16 cold categories had helped to bolster the Bel- 14.21 gian market. But it wasSpain that had shown itself to be 12 “particularly dynamic”, Afipa insisted, with 8.50 growth that outpaced all other countries in the 8.19 7.98 7.90 7.51 8 7.02 study, even if its absolute consumption of self- medication productsremained relatively low. 3.77 Spanish consumers bought just 3.02 packs Number of packs 4 3.02 of self-medication products on average in 2014, according to Afipa’sreport (see Figure 2). Mean- 0 while, the average number of self-medication packs bought by inhabitants of France – 7.02 – UK Italy France Spain Sweden Germany Belgium Average wasclose to the 7.51 average across the Euro- Netherlands pean countries studied, Afipa pointed out.

Figure2:Average number of self-medication packs bought by inhabitants of eight European countries Moreover, France remained “the second in 2014 (Source –Afipa/Celtipharm/AESGP) cheapest country in Europe”, Afipa observed,

20 OTC bulletin 24 July 2015 OTC24-07-15p20-23_Layout 1 21/07/2015 17:08 Page 3

MARKET RESEARCH OTC

with an average price of C4.58 for of self-medi-

cation pack (see Figure 3). This lowpricing level 10 9.40 demonstrated that the country’sself-medication 8.91 7.81 sector wasstill fully competitive,the association 8 insisted. Spain’sprices were 43% higher than 6.56 6.12 6.16 ) those in France, and Italy’swere 71% higher. C 6 Only the UK’saverage waslower at C2.69. 4.86 4.58

An average annual spend of C32.10 on self- 4 2.69

medication wasrecorded per French citizen, erage price ( Av which waswell belowthe European average 2 of C45.80, and put France ahead of only Italy

and Spain (see Figure 4). 0 “Despite genuine savings potential, France UK still lags behind in comparison to other Euro- Italy Spain Sweden France Germany Belgium Average pean countries,”Afipa admitted. Netherlands In particular,Brossard pointed out that “sav- ings of C535 million could be generated an- Figure3:Average retail prices including taxes of aself-medication product in eight European countries in 2014 (Source –Afipa/Celtipharm/AESGP) nually by making available in France medi- cines that are already dispensed without pre- scription in other European countries”. 100 Having calculated a‘common perimeter’ 79.9 of 208 molecules – all of which were available 80 70.4 for self-selection in at least one of the eight )

countries studied – the report found that 90 of C 60 these still had prescription-only status in France, 48.9 45.8 39.8 and were potentially eligible for self-medication. 40 32.1 Nevertheless, as Figure 5shows, France’s Spending ( 29.5 19.8 figure of 118 molecules wasstill better than the 20 average of 108 across all eight countries stud- ied. But France’sself-medication market remain- 0 ed “fragile”, Afipa insisted, and required greater Italy Spain Sweden France political will and “concrete policymeasures” Germany Belgium Average if it wastomeet its “significant potential”, Netherlands

which the association said had been particu- Figure4:Average annual spending on self-medication per person for inhabitants of seven European countries larly hampered by alack of anyprescription- in 2014 (Source –Afipa/Celtipharm/AESGP) to-OTC switches in 2014. Afipa has identified several specific opportu- Pain Respiratory Digestive Dermatology Other Self-medication potential nities for action in France, including acommu- nication campaign to better inform patients about UK (137) 26 33 29 31 71 self-medication, education for pharmacists and 18 healthcareprofessionals, and apublic pricing Germany study.“Self-medication is atool that deserves (124) 25 34 25 31 84 9 to be supported and encouraged,”itinsisted. Belgium “The conclusions of this report confirm the (118) 20 33 26 28 90 feasibility and, above all, the validity of the 11 France model that we are proposing,”Brossard said, (118) 21 32 28 22 90 emphasising the central role of the patient, the 15 Spain importance of pharmacists in helping to treat (114) 19 39 24 22 94 more “benign” ailments, and the importance of 10 Italy doctors in handling more serious illnesses. 20 29 24 22 108 (100) “The current situation is totally out of odds 5 Sweden with the waysociety has developed, and the 18 16 20 15 134 (74) increasing desire of people in France to play a 5 greater role in managing their health,”Bross- Netherlands 16 19 20 14 135 ard insisted. (73) 4 “Spain’sexample provesthat true change is Average 21 29 25 23 100 not only possible, butisessential,”heconclud- (108) ed. “It is time to takethe necessary steps to ac- 10 companyFrench citizens in their journeyto- Number of molecules

wards greater empowerment.” Figure5:Breakdown by therapeutic categoryofavailability of abasket of 208 self-medication molecules in OTC eight European countries in 2014, with total availability in brackets (Source –Afipa/Celtipharm/AESGP)

24 July 2015 OTC bulletin 21 Full Pg Adv.1 5-6-15_Layout 105/06/2015 16:54 Page 1

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Trade Associations Wholesalers&Retailers PGEU appoints WBA namesPessina as new secretary chief executive officer he Pharmaceutical Group of the European TUnion (PGEU) has appointed Jurate Svar- caite as its secretary general. She will takeup algreens Boots Alliance (WBA) has Stefano Pessina the role on 10 August. Wnamed executive vice-chairman, Stefano Having previously worked at the PGEU in Pessina,asits chief executive officer. an advisory role, Svarcaite had spent the past Pessina has been serving as acting chief ex- twoyears managing the pharmaceutical care ecutive officer of the US-based wholesaler and department at aleading pharmacychain in her retailer since January,after former Walgreens’ native Lithuania, the association pointed out. head Gregory Wasson announced his retire- In her newpost, Svarcaitewill be responsi- ment (OTC bulletin,16January 2015, page 19). ble for the day-to-day operations of the PGEU In his capacity as chief executive officer, as well as providing strategic direction and Pessina will continue to report to WBA’sexec- leadership for the association. utive chairman, James Skinner. Jurate Svarcaite Commenting on the appointment, Skinner Boots is proceeding exceptionally well,”Skin- said Pessina had “done an extraordinary job” ner noted. “In order to continue this momen- leading the firm in the period following Wal- tum and to recognise the progress that has al- greens’ full takeoverofUK-based wholesaler ready been made, the board concluded that andretailer Alliance Boots (OTC bulletin,16 Pessina wasthe very best person to achieve our January 2015, page 5). vision to be atruly global healthcare champion,” “The integration of Walgreens and Alliance he explained. OTC

Manufacturers OTC Galenica raids Boots for brandschief European Commission witzerland’sGalenica has named Walgreens Galenica’sProducts and Brands operation SBoots Alliance’s (WBA) Torvald de Cov- – which includes the G-Pharma business as EC shakes up its erly Veale as head of the newly-announced well as Vifor Consumer Health – isone of three Products and Brands division – which includes newdivisions at Galenica Santé, along with Re- management team the Vifor Consumer Health unit – atits Gal- tail and Services units. All three will begin op- enica Santé business. The appointment will be erating on 1September. avier Prats Monne has been appointed effective from 1September. Xdirector-general of the European Commis- Describing de Coverly Veale as an “extreme- Transfer Consumer Health business sion’s(EC’s) Directorate-General for Health ly experienced” manager,Galenica pointed out Earlier this year,Galenica said it would trans- and Food Safety –DGSANTE – inarecent that his 30-year career had seen him serveina fer its Consumer Health business from its Vifor shake-up of the commission’smanagement. number of international management positions Pharma pharmaceuticals division into its Galen- Prats Monne – who is Spanish – iscur- at Unileverbefore joining Alliance Boots in ica Santé unit by mid-2015 (OTC bulletin,2 rently director-general of the EC’sDGEduca- 2007 as director of international brands. February 2015, page 5). This would allowVifor tion and Culture and will takeuphis newrole Following the merger of Alliance Boots and Pharma to focus on its keyprescription brands. on 1September 2015, replacing LadislavMiko Walgreens in December 2014, de Coverly Veale Vifor Consumer Health, the companysaid who will return to his previous role as deputy wascharged with leading the international ex- at the time, would become the fourth “business director-general. pansion of WBA’sbeauty and healthcare brands sector” of Galenica Santé, alongside its exist- Meanwhile, the UK’s Lowri Evans will in China, Europe, the Gulf States, North Am- ing Retail, Logistics and HealthCare Inform- move from DG Maritime Affairs and Fisheries erica and South-East Asia. ation businesses. to become director-general of DG Internal OTC Market, Industry,Entrepreneurship and Small- and Medium-sized Enterprises (SMEs) –DG GROW – which is involved in discussionsrelat- IN BRIEF ed to pharmaceuticals, medical devices and food. ■ FAKOM –Germany’sprofessional asso- ■ EMA – the European Medicines Agency Alexander Italianer has been appointed ciation for complexhomoeopathy–has elected – has re-elected Dr June Raine as chair of as the newsecretary-general of the EC, follow- Hevert Arzneimittel’s Dr Jan-Christoph Woll- itsPharmacovigilance Risk Assessment Com- ing Catherine Day’s decision to retire. mann as its president. He takes overfrom Kay mittee (PRAC). OTC Uwe Kämmerer. OTC

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