perrigo considers its future as mylan offers us$29bn · 2018. 11. 19. · billion (c488 million)...

Mylan has offered US$205 per share(C192 per share) for Perrigo in a cash-

and-shares bid that values Perrigo at almostUS$29 billion, based on Perrigo having 140.8million shares outstanding as of 30 January2015. The combined firm would have 2014proforma sales of US$15.3 billion.

Perrigo said its board would meet to discussMylan’s “unsolicited, indicative proposal”.

Both firms have now made filings to therelevant authorities regarding the potential deal.

According to Mylan, its offer represents apremium of more than 25% to Perrigo’s clos-ing share price on 3 April, the last trading daybefore Mylan’s executive chairman, RobertCoury, wrote to Perrigo’s president, chief exec-utive officer and chairman, Joseph Papa, out-lining the non-binding takeover bid.

“This proposal is the culmination of a num-ber of prior discussions between Mylan and Per-rigo about the compelling strategic and financiallogic of this combination,” Coury commented.

Critical mass in OTCCombining the two firms, he said, would

“produce a company with critical mass in spe-ciality brands, generics, OTC and nutritionalproducts; a powerful commercial platform withreach across all customer channels; an excep-tional, high-quality operating platform; andopportunities to generate enhanced growth”.

In his letter to Papa sent on 6 April, Couryargues that “in an environment where scale andreach are becoming increasingly important, thecombination of our companies would resultin an unmatched global platform, substantialrevenue and operating synergies, and enhancedlong-term growth potential”.

Promising “a very significant cash paymentto Perrigo shareholders”, Coury said the com-bined entity would possess a “powerful com-mercial platform with strong reach across mul-tiple channels”.

This would be “an increasingly importantstrategic advantage in light of the evolving dis-tributor and payor dynamics across geogra-phies”, he insisted.

Papa would serve as co-chairman, Courysuggested, with Mylan’s chief executive offi-cer Heather Bresch and president Rajiv Malikretaining their current positions.

He expressed hopes that Perrigo’s chieffinancial officer Judy Brown and general coun-sel Todd Kingma would take up “importantroles” within the combined entity, alongside“members of Marc Coucke’s Omega Pharmamanagement team”.

Mylan’s proposed offer comes shortly afterPerrigo expanded its presence in Europe’sbranded OTC market by closing its C3.8 bil-lion acquisition of Omega (see page 3). Papasaid the deal had created an “industry-leadingglobal healthcare company” with the structureand cash flow to accelerate its internationalgrowth “even further”.

Explore OTC opportunitiesIn mid-2014, Mylan said that it intended

to explore opportunities to build an OTC oper-ation in Europe to complement its US$5.3 bil-lion purchase from Abbott of a roster of morethan 100 mature brands and branded genericsin developed markets (OTC bulletin, 15 Aug-ust 2014, page 3).

At the time, Bresch told investors that Mylanthought OTC was an “interesting channel” that

■ Continued on page 5

17 April 2015

Perrigo ready for growth 3as it closes Omega dealP&G clears out Vicks VapoSteam 3Walgreens Boots Alliance 4open to dealsReckitt looking to China 5to provide global ideasMoberg sees potential 6for OTC growthAlliance looks for more 7OTC productsKrka posts OTC decline 8as currency effects hitNBTY to expand use of 9Holland & Barrett name

GENERAL NEWS 10

PRAC proposes updating 10high-dose ibuprofen adviceFDA approves bladder device 10Mail-order buys drive 11German marketGerman doctors identify 12value in recommendingASMI backs new omega-3 research 12Australia’s regulations 13are “anti-competitive”JSMI welcomes switch agenda 13

MARKETING NEWS 14

Omega adds liquid option 14to Nytol sleep-aid rangeRescue Remedy debuts on UK TV 14Kowa grows OTC portfolio 15in Japan with two additionsBrazilians offered 15“extra analgesic power”Anthisan patches set for 16launch in major retailersGSK offers Thai consumers 17“new-generation” analgesic

FEATURES 20

Bestway helps Co-op Pharmacy 20get Well

REGULARS

Events – Our regular listing 19People – AS Watson selects Gray 23to head international health

COMPANY NEWS 3 Perrigo considers its futureas Mylan offers US$29bn

Robert Coury, Mylan’s executive chairman, saidacquiring Perrigo would create an “unmatchedglobal platform”

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Perrigo is well placed to “accelerate” its in-ternational expansion, following the com-

pletion of its deal for Omega Pharma, accordingto the firm’s chief executive officer Joseph Papa.

Speaking as the US store-brand specialistclosed its C3.8 billion acquisition of the BelgianOTC firm, Papa said the deal had created an“industry-leading global healthcare company”with the structure and cash flow to accelerate itsinternational growth “even further”.

Omega’s “strong and established” commer-cial, regulatory and distribution platforms pro-vided Perrigo with “multiple opportunities” tolaunch its existing portfolio in the “high-barrier-to-entry European OTC market”, Papa claimed.

Noting that the deal – which was announc-ed late last year (OTC bulletin, 28 November2014, page 1) – had given Perrigo “critical mass”in all “key” European countries, Papa said thefirm would now enjoy greater opportunities for“continued strategic bolt-on acquisitions”.

The combination of Perrigo and Omega cre-ated a “top-five global OTC company”, Papapointed out, noting that with Omega on board,Perrigo’s total annual sales would increase toaround US$5.7 billion (C5.2 billion).

Sales would also be more evenly split be-tween the US and the rest of the world, Papa

noted, with 43% of Perrigo’s turnover comingfrom markets outside the US.

Omega gives Perrigo a diverse range of OTCbrands covering a number of categories – in-cluding analgesics, cough and cold remedies,skin-care treatments, and vitamins, mineralsand supplements (VMS) – that generated salesof C1.27 billion in 2014.

The bulk of Omega’s sales are generated inBelgium, France and other Western Europeanmarkets. The firm also has a growing interestin a number of emerging markets, includingthose of Latin America.

Commenting on the deal, Papa said acquir-ing Omega would immediately increase Per-rigo’s scale and footprint in Europe, giving thebusiness access to an “established commercialnetwork connected to 211,000 pharmacists,105,000 retail stores and 3,900 parapharmacies”.

“In one transaction, we acquire a compre-hensive commercial European infrastructure, aleading portfolio of OTC brands and country-by-country regulatory experience,” Papa noted.

Furthermore, the deal would enhance thecompany’s “already sizeable” OTC offering and“accelerate the distribution” of both Omegaand Perrigo’s products.

317 April 2015 OTC bulletin

COMPANY NEWS OTC

17 April 2015 Number 441

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Mergers & Acquisitions

Perrigo ready for growthas it closes Omega deal

OTC

Procter & Gamble has sold its Vicks Vapo-Steam liquid-inhalant business in the US

for an undisclosed sum to the consumer prod-ucts firm Helen of Troy.

The consumer goods giant has also grantedHelen of Troy a licence for its Vicks VapoPadsscented pad products in the US.

The vast majority of Vicks VapoSteam andVapoPads products are used in Vicks humid-ifiers, vaporisers and other healthcare devicesalready marketed by Helen of Troy.

Helen of Troy said that the Vicks VapoSteambusiness generated annual sales of approxi-mately US$10 million (C9.4 million).

The two products were part of a wider Vicksrange of allergy, cold and flu products – includ-ing the DayQuil and NyQuil lines – which Proc-ter & Gamble continues to market in the US.

Cut number of brandsProcter & Gamble announced in August last

year that it planned to cut radically its port-folio of brands and focus on just 70 to 80 corebrands organised into a dozen business units(OTC bulletin, 15 August 2014, page 9).

The company said that the 70 to 80 corebrands were “consumer-preferred and custom-er-supported”. However, it did not provide alist of which brands would stay with the firm.


P&G clears outVicks VapoSteam

OTC

OTC17-04-15p2-9_Layout 1 14/04/2015 18:15

If any “big opportunities” for mergers andacquisitions emerge, Walgreens Boots Alli-

ance (WBA) “will be ready” to capitalise onthem, according to acting chief executive offi-cer Stefano Pessina.

Speaking as the US-based wholesale and re-tail giant reported the results for its secondquarter ended 28 February 2015, Pessina saidthat if WBA identified an acquisition target itwould go after it.

Noting that the firm was still in the earlystages of integrating the Alliance Boots andWalgreens businesses, following the completionof a merger deal (OTC bulletin, 16 January2015, page 5), Pessina insisted that this wouldnot stand in the way of any potential mergersor acquisitions.

“It will take a while to build a solid WBAplatform,” Pessina admitted, “but just becausewe haven’t finished the job, it doesn’t mean wecan’t pursue new opportunities in the meantime.”

Open to joint venturesIn addition to acquisitions, WBA would also

consider any opportunity to establish a jointventure, Pessina revealed.

“We are open to [working with] any kind oforganisation which can improve the value of ourcompany,” he explained.

Prior to the formation of WBA, when hewas in his previous role as executive chairmanof Alliance Boots, Pessina said big deals inEurope were no longer possible, adding that ifthe company wanted to be truly global, it neededto have scale in the Americas and Asia (OTCbulletin, 31 May 2012, page 4).

“Global wholesalers and multinational re-tailers can thrive,” Pessina said at the time, “butwe need scale.”

Commenting on the progress that had beenmade since the completion of the merger, Pess-ina said WBA had “achieved much in a shorttime” and had already identified areas of thebusiness that needed attention.

WBA planned to “refresh and reinvest” inits retail stores in the US “to improve the cus-tomer experience and expand retail margins”,Pessina explained.

The firm would also restructure its cost base,he noted, with a focus primarily in the US, to“create a more efficient cost model and be-come a more agile company”.

Meanwhile, Pessina said WBA was in the“process of reviewing candidates” to find thefirm’s first permanent chief executive officer.

Searching for new chief executiveWBA is searching for a chief executive

after the former head of Walgreens, GregoryWasson, decided to retire and not take up therole (OTC bulletin, 16 January 2015, page 19).

Pessina admitted that it had been “chal-lenging to find suitable candidates with the re-quired attributes”.

However, WBA “remained confident” thatin “due course” it would find “the right personfor the job”, he insisted.

Turning to WBA’s second-quarter results,Pessina reported a “solid start for our new firm”with turnover of US$26.6 billion (C25.1 billion),excluding intersegment sales of US$387 million.

George Fairweather, WBA’s global chieffinancial officer, noted that the second-quarterfigures included the results of Alliance Bootsfor two months – January and February – on afully consolidated basis and one month, Dec-ember, as equity income from Walgreens’ pre-merger 45% interest.

Noting that WBA began recording sales asa consolidated entity part-way through the quar-ter, Fairweather said comparing the figures tothe results in the prior-year period was “a chal-lenge and of little use”.

Turnover at the company’s Retail PharmacyUSA division – which comprises Walgreensand Duane Reade drugstores and online salesin the US – advanced by 7.4% to US$21.0 bil-lion in the three months.

Prescription sales, which accounted for64.4% of the total, had increased by 10.1%,WBA noted, while prescription sales in com-parable stores improved by 9.7%.

The division generated an operating incomeof US$1.29 billion in the three months.

As of 28 February 2015, the division wasoperating 8,232 drugstores across all 50 USstates, the District of Columbia, Puerto Rico andthe US Virgin Islands.

Pessina noted that the company had identi-fied “opportunities for cost savings” in the Re-tail Pharmacy USA division that would gen-erate US$500 million by the end of WBA’sfiscal 2017.

Alex Gourlay, president of Walgreens, re-

vealed that the company had decided to close200 drugstores in the US after conducting a“thorough review” of all its outlets.

These would be replaced by “around 200”new stores in locations where there were moreopportunities for growth, Gourlay explained.

Meanwhile, Pessina reported sales of US$2.0billion at WBA’s Retail Pharmacy Internationaldivision – consisting of health and beauty chainsin eight countries, the largest of which is BootsUK – after two months of operation.

Retail Pharmacy International posted an op-erating income of US$8 million for the period.

As of 28 February 2015, the division wasoperating 4,559 health and beauty stores acrossChile, Ireland, Lithuania, Mexico, the Nether-lands, Norway, Thailand and the UK.

Commenting on WBA’s plans for BootsUK – the country’s biggest pharmacy chain –Pessina said the company would continue todevelop the retailer’s online offering.

WBA wanted to integrate Boots UK’s onlinepresence with its physical stores to “enhanceconsumer choice”, he noted.

The firm was already working to keep BootsUK’s product offering “fresh” through inno-vation, Pessina explained, so the chain couldcontinue to grow in the “extremely competitiveUK retail market”.

Outside of the UK, Pessina said WBA hadidentified “strong opportunities for growth” inLatin America through its two pharmacy chainsin the region.

Alliance Boots snapped up Chile’s Farma-cias Ahumada and Mexico’s Farmacias Bena-vides pharmacy chains from Mexican whole-saler and retailer Grupo Casa Saba for MXN8.3billion (C488 million) last September (OTCbulletin, 12 September 2014, page 8).

Mexico’s third-largest chainAt the time of the deal, Alliance Boots noted

that as the third-largest retail pharmacy chain inMexico, Farmacias Benavides operated around1,000 stores across 21 of the country’s 31 states.

Farmacias Ahumada was one of the threebiggest pharmacy chains in Chile, the companysaid, with approximately 400 stores.

Noting that Latin America was one of Alli-ance Boots’ “priority areas for investment”,Pessina said at the time that the acquisitionwould give the company a “major presence”in what was an “attractive market”. The dealalso represented a further step towards AllianceBoots’ goal of achieving a “truly global foot-print”, he added.

4 OTC bulletin 17 April 2015

OTC COMPANY NEWS

Business Strategy/Second-Quarter Results

Walgreens Boots Alliance open to deals

Based in Illinois, US, Walgreens Boots Allianceoperates in more than 25 countries worldwide

OTC17-04-15p2-9_Layout 1 14/04/2015 18:15

Reckitt Benckiser (RB) will use China as atest bed for new ideas that have the poten-

tial to be rolled out around the world, accord-ing to chief executive officer Rakesh Kapoor.

In the UK-based, consumer-goods firm’srecently-released annual report, Kapoor pointsout that RB is witnessing a “revolution indigital commerce” in China, noting that afifth of the company’s revenue in the countryis generated online.

As a result of this shift, RB would nowtake what it had learnt in China, Kapoor ex-plains, and seek to apply these lessons to itsbusinesses elsewhere in the world.

“This is a reversal of the traditional model,”he claims, “which saw most business ideastravel in the opposite direction.”

Meanwhile, RB has already started to “mas-sively” step-up its investments in digital media,Kapoor says, as the company has seen howdigital marketing provided opportunities to“build more engaging relationships with ourconsumers at lower cost”.

“The digital revolution we are all witnessingis disrupting many industries and creating op-portunities in others,” Kapoor claims. “Insome markets, we are now delivering over 50%of our media impressions in digital media,” headds, “rather than in traditional print or broad-cast channels.”

“This shift is driven by both strategic andcommercial considerations,” he points out.

These ideas, Kapoor says, all play intothe firm’s recently-announced ‘Project Super-charge’ (OTC bulletin, 6 March 2015, page

4), which has been designed to reduce com-plexity and cut costs.

Under the plan, RB’s innovation and prod-uct-launch functions will be centralised to re-duce the workload of the company’s countryunits and enable them to focus better on gettingproducts into stores.

The aim, Kapoor explained at the projectlaunch in March, was to create a firm that wouldbe “as global as possible, as local as needed”.

Furthermore, the project was set to lead tosavings of up to £150 million (C203 million)annually by streamlining supply and productionprocesses, including job cuts.

The company has also reduced the numberof its geographic businesses to two from three bymerging its RUMEA unit – which currentlyconsists of the Middle East, North Africa andTurkey, Russia and the Commonwealth of In-dependent States (CIS), and Sub-Saharan Africa– with the LAPAC region, which covers Aus-tralia/New Zealand, Latin America, North Asia,and South and South-East Asia.

The merged unit is called Developing Mar-kets, or DvM.

As part of this process, Australia/New Zea-land and Russia/CIS have been moved into theEurope and North America (ENA) operation.

Commenting in the annual report on ‘ProjectSupercharge’, Kapoor says that as the worldchanges, RB has “no intention of standing still”.

“We continue to sharpen our portfolio focus,”he adds, “and ensure we are organised in a waythat allows us to be even faster and more con-sumer-centric.”

Meanwhile, Pessina said that WBA’s Phar-maceutical Wholesale division – which mainlyoperates under the Alliance Healthcare brand –had generated sales of US$3.9 billion after twomonths of operation.

The division generated an operating incomeof US$81 million in the period.

WBA noted that its Pharmaceutical Whole-sale division supplied medicines, other health-care products and related services to more than140,000 pharmacies, doctors, health centresand hospitals from 299 distribution centres in12 countries.

Synergies on trackTurning to group-wide synergies, Pessina

said combined synergies from the merger hadtotalled US$310 million in the six months end-ed 28 February 2015, and were “on track” toreach at least US$650 million in the year end-ing 31 August 2015.

Pessina pointed out that the company wastargeting synergies of “at least” US$1 billionby 31 August 2016.

WBA’s total operating income for the periodamounted to US$1.37 billion, after eliminations.


COMPANY NEWS OTC

Business Strategy/Annual Report

Reckitt looking to Chinato provide global ideas

Stefano Pessina, Walgreens Boots Alliance’s actingchief executive officer, said the firm would be readyto capitalise on any acquisition opportunities

OTC

■ HI-TECH PHARMACEUTICALS – theUS-based dietary supplements and OTC prod-ucts firm – is set to acquire Mexico’s Advanc-ed Pharmaceuticals and Nutritionals (APN)for an undisclosed sum. The deal would en-hance Hi-Tech’s international presence, thecompany noted, and would give the firm crit-ical mass in “all key Latin American coun-tries”. APN distributed a range of cough/cold,gastrointestinal, nutritionals, pain-relief, sports-nutrition and weight-management brands, Hi-Tech pointed out, across Mexico, Central Am-erica and South America.

IN BRIEF

OTC

■ Continued from front page

in “some respects is even more interestingoutside the US”.

“The Abbott transaction certainly gives usa beginning foothold in OTC,” Bresch stated.“We have got real opportunities to look at someof these brands that we have acquired, as wellas perhaps to add some products that would bevery strategic and would allow us to build uponthe Mylan equity through all channels.”

The bulk of the proposed combined com-pany’s OTC turnover would come from Per-

rigo, whose store-brand Consumer Healthcarebusiness reported sales up by 6% to US$2.22billion in the year ended 28 June 2014, themajority of which was generated in the US(OTC bulletin, 12 September 2014, page 4).

Consumer Healthcare accounted for 55% ofthe Perrigo’s annual turnover of US$4.06 bil-lion, with the remainder coming from its Pre-scription Pharmaceuticals, Nutritionals and Act-ive Pharmaceutical Ingredients divisions, as wellas other smaller operations.


Perrigo considers US$29bn Mylan takeover

OTC

OTC

OTC17-04-15p2-9_Layout 1 15/04/2015 09:19

“Significant growth opportunities” existfor Moberg Pharma in what remains a

“highly fragmented” global market for OTCproducts, according to the firm’s chief execu-tive officer Peter Wolpert.

Speaking as the Sweden-based company re-leased its 2014 annual report, Wolpert said Mo-berg planned to move its OTC business forwardby building strong brand equity and pursuingbolt-on acquisitions.

“We will continue to seek out in-licensingand acquisition opportunities as importantsources of new products that will expand ourportfolio,” Wolpert explained.

Moberg would focus on three “strategicareas” – foot care, dermatology and pain man-agement – Wolpert said, noting that the com-pany planned to expand its portfolio into newcategories “over time”.

Turning to the firm’s 2014 results, Wolpertsaid the double-digit rise in sales to SEK200million (C21.4 million) had been driven by animproved performance in two of its three glo-bal business regions.

The company’s sales advanced by 27%, ledby growth in the North and South Americaand Rest of World regions.

Wolpert said an increase in sales of 57%to SEK148 million in North and South Amer-ica had been driven by the performance of itsKerasal Nail anti-fungal product.

Widening distribution had given Kerasal Nail– known as Emtrix or Nalox in a number ofmarkets – a 22% market share of the US re-tail fungal-nail segment, Wolpert explained.

Acquired three brandsMoberg’s US turnover had also been boost-

ed by sales of the three OTC brands the com-pany acquired from Bayer in December 2013(OTC bulletin, 13 December 2013, page 1),Wolpert noted.

The acquired portfolio consisted of theDomeboro topical anti-itch irritation brand,the Fergon iron supplement and the Vanquishoral analgesic.

Meanwhile, sales in the North and South Am-erica region had also been lifted by the launch

of Emtrix in Canada during 2014, Wolpert said.The introduction had been a “tremendous

success”, Wolpert insisted, noting that the brandnow held a 50% market share of the Canadianretail fungal-nail segment.

Turning to Moberg’s Rest of World sales,Wolpert reported turnover up by 12% toSEK22.0 million for the 12 months, thanks tothe launch of Kerasal Nail in China, Hong Kongand Malaysia.

Moberg expected Asia to become the firm’s“fastest-growing” market in 2015, Wolpert ex-plained, with product launches currently beingprepared for a number of countries in the region.

By contrast to Moberg’s Rest of World andNorth and South America regions, sales at thefirm’s European business slipped back by 30.8%to SEK30.1 million.

The company did not give a reason for thedecline in turnover.

Despite the drop in sales, Wolpert said theapproval in May 2014 of an expanded indi-cation for Nalox provided prospects for futuregrowth in the region.


OTC COMPANY NEWS

Business Strategy/Annual Report

Moberg sees potential for OTC growth

OTC

OTC17-04-15p2-9_Layout 1 14/04/2015 18:15

Alliance Pharma will continue to add to itsgrowing OTC product portfolio and will

consider acquiring not only brands, but alsosmall companies to boost its range, accordingto chief executive officer John Dawson.

Speaking to OTC bulletin as the firm posteda 4% drop in 2014 sales to £43.5 million (C59.9million), Dawson said that the UK-based com-pany wanted a “good fraction” of its sales tocome from consumer healthcare products tohelp shield the firm from the price pressureson its prescription business.

“It’s good to have a range of different clubsin the bag,” Dawson insisted, “and we recognisethe attraction of consumer products.”

Having acquired the MacuShield supple-ment said to be for treating age-related dry mac-ular degeneration, consumer healthcare prod-ucts now accounted for a fifth – around £8.7million – of the company’s turnover, Dawsonnoted, up from just a tenth previously.

Alliance paid £5.5 million for MacuShield,a figure that could rise to £6.0 million if cer-tain sales targets are met, which Dawson wasconvinced would be the case.

“MacuShield meets a very real medical needand the largest cause of blindness in the elderly,”Dawson pointed out. “We liked the dynamicsof the product, the scientific backing it has gotand the opportunity for growth it presents.”

Alliance was also well set up to sell theproduct, Dawson claimed, as the company knewhow to promote to specialists, which was howinitial sales of MacuShield were made.

“It is those eye-care specialists who initiallyrecommend that patients use the product andthereafter it becomes a consumer product,” hepointed out. “This hybrid nature really suitsthe blend of skills we have in the company.”

MacuShield also had great potential geo-graphically, Dawson said, noting that three-quarters of its sales were currently generated inthe UK and the rest via distributors in Europe.

“There is a big opportunity to expand thesales outside the UK,” Dawson insisted. “Alli-ance is a much bigger organisation than theone that sold the product to us – we have morereach and experience – so we see strong inter-national potential.”

Geographic expansion was also a key strate-gic ambition for Alliance as a whole, Dawsonnoted, adding that it remained on track to havea company presence in all the major Europeanmarkets within the next five years.

Dawson said that the company had “goodleads” on potential acquisitions across the “big

five” European Union (EU) markets and he was“confident that within that timeframe we willhave found the right products on which to basea small infrastructure across these five”.

“We already have a presence in France, Ger-many and the UK, so we are confident of find-ing platforms in Italy and Spain,” he insisted.

Outside of Europe, Alliance’s fledgling busi-ness in China was performing well, Dawsonsaid, and the firm was keen to expand it further.

In China, Alliance – which operates througha joint-venture company called Unigreg – wasestablishing a mother and baby range, built onthe Forceval supplement for pregnant women.

The firm had also taken a stake in a Shanghaiand Hong-Kong-based infant-formula firm call-ed Synthasia International last year, Dawsonpointed out, which complemented Forceval.

A recent Chinese government review of theimported infant formula market had seen a num-ber of competitors taken off the shelves, Dawsonnoted, which meant its Suprememil brand wasnow operating in a much friendlier environment.

Looking for buys in ChinaAlliance now had two people on the ground

in China looking at leads for other mother andchild products, Dawson said, adding that whilea deal would not be “struck tomorrow” the ac-quisition environment was “very encouraging”.

Turning to the 2014 results, Dawson saidthat Alliance’s non-prescription products hadperformed well. The firm’s consumer health-care portfolio includes the Ashton & Parsonsteething powders and MolluDab skin-infectiontreatment, as well as the Lypsyl skin-care brand.

Alliance paid Novartis US$3.0 million (C2.0million) for the Lypsyl range in the UK andIreland at the end of 2013 (OTC bulletin, 17January 2014, page 3).

Lypsyl had generated sales of around £1.0million in the 12 months, Dawson pointed out,as the company stabilised distribution.

The product was starting to reappear in stores,he noted, but there was still more work to do asthe brand was not as ubiquitous as it once was.

“We have been doing a lot of work on re-positioning it, finding the best place for it in themarket,” Dawson explained, “while also improv-ing the physical characteristics of the product.”

However, Dawson said that Alliance wouldnot start really pushing the brand until 2016.

Meanwhile, marketing activity behind thefirm’s Ashton & Parsons teething powders wouldbe ramped up during 2015, he revealed.

Production problems which had hampered

the teething powders had been overcome, henoted, and this had enabled the company to re-turn the product to wider distribution. This hadhelped triple sales to £1.4 million.

A large consumer marketing campaignwould be launched later in the year, Dawsonsaid, which would be built around the brand’sefficacy and its long history which dated backto the 1890s.

While the smaller consumer healthcare sideof the business had performed well in 2014,the company’s prescription products had hada more difficult year, Dawson acknowledged,leading to the drop in group sales.

Generic competition had damaged sales ofits Nu-Seals brand, he noted, while one of itstoxicology brands had suffered from the lossof a tender.

Pre-tax profits had also declined, Dawsonsaid, falling back by 10% to £10.8 million.


COMPANY NEWS OTC

Business Strategy/Annual Results

Alliance looks for more OTC products

OTC

John Dawson, Alliance Pharma’s chief executiveofficer, said the firm was on the look out for brands andsmall companies that would bolster its OTC business

■ KARO BIO – a Swedish development firm –has acquired drug-research company Tanomedand its in-development product to tackle thecommon cold. Karo said Tanomed’s “uni-que product” would help “relieve and pre-vent” the progression of a cold by “reinforcingthe body’s own defences” and help fight com-mon cold viruses. The patented technology usedin the product was based on research conductedwith the University of Umeå, Karo pointed out,which showed that when the enzyme glucoseoxidase was used in combination with glucose,it effectively counteracted “rhinovirus infec-tions and other viral and bacterial pathogens”.Karo acquired Tanomed in an all-share deal.It said Tanomed’s product should be on themarket within 18 months.

IN BRIEF

OTC

OTC17-04-15p2-9_Layout 1 14/04/2015 18:15

Krka reported turnover from non-prescrip-tion products – including self-medication

lines and cosmetics – down by 16% to C122million in 2014, caused by currency changesin key markets.

Local currency devaluation in Russia andUkraine – the firm’s two largest markets for non-prescription products – had hit sales, the Slove-nian company explained in its annual report.

This had been compounded by lower inci-dences of cold and flu across Europe, Krka said.

Sales in Russia dropped back from just underC60 million in 2013 to just over C40 million in2014 (see Figure 1).

Meanwhile, turnover in Ukraine slipped fromjust under C20 million in 2013 to just above C10million in 2014.

On a more positive note, Krka reported high-er sales of non-prescription products in four ofits 10 biggest markets, with the best growth re-corded in Romania and Uzbekistan.

Turnover in Romania had been boosted bythe launch of the Septanazal nasal decongestantproduct, Krka said, while sales in Uzbekistanhad benefitted from the release of a line exten-sion to the firm’s Herbion cough and cold brand.

Herbion remained Krka’s biggest-sellingnon-prescription brand, the company noted,adding that the herbal cough syrup line wasavailable in 30 markets.

During 2014, the Herbion Ivy Syrup prod-uct had been launched in Kazakhstan, Poland,Serbia and a number of other Eastern Europeanmarkets, Krka said, while the Herbion IcelandMoss Syrup variant for sore throats and hoarse-ness had been taken into Bosnia and Herze-govina, Ukraine and Uzbekistan.

Ginkgo biloba-brand Bilobil was Krka’s

second-biggest non-prescription seller in the 12months, the firm pointed out, having retained itsmarket-leading position across Central, Easternand South-Eastern Europe.

Bilobil had been extended in Russia andMongolia during the year with the Bilobil In-tense variant, Krka noted.

Turning to sales of non-prescription prod-ucts by therapeutic category, Krka pointed outthat cough and cold products led the way, gen-erating turnover of C25.3 million in the 12months. Cough and cold products accountedfor 20.7% of Krka’s total non-prescription salesin 2014 (see Figure 2).

Vitamins and minerals accounted for 19.0%of sales, with products for improving circula-tion generating 15.0% of turnover.

Non-prescription products represented 11%of Krka’s Human Health sales in 2014, whichdeclined by 1.2% to C1.11 billion.


OTC COMPANY NEWS

Annual Report

Krka posts OTC declineas currency effects hit

Annual salesC122 million

Alimentary tractand metabolism

13.4%

Analgesics12.9%

Sorethroat12.1%

Hair andscalp2.4%

Other4.5%

Cough and cold20.7%

Vitamins andminerals19.0%

Circulatoryproducts15.0%

Figure 2: Krka’s non-prescription sales of C122million in 2014 by therapeutic claim (Source – Krka)

2010 2011 2012 2013 201470

60

50

40

30

20

10

0

Ann

uals

ales

(Cm

illili

ons)

Figure 1: Krka’s non-prescription sales in its 10 biggest markets from 2010 to 2014 (Source – Krka)

OTC

Russia Ukraine Romania Slovenia Poland Kazakhstan Uzbekistan Germany Belarus CzechRepublic

UK supplements firm Vitabiotics has signeda deal to distribute its products in Asia

through expansion specialist DKSH.Under the terms of the agreement, DKSH’s

Healthcare unit will provide marketing, sales,distribution, logistics and regulatory servicesfor Vitabiotics in Hong Kong and Malaysia.

DKSH claimed it would broaden Vitabi-otics’ “established market position” in HongKong by increasing the distribution of the UKfirm’s products to more pharmacy outlets.

Noting that Vitabiotics was currently seek-ing approval to sell its products in Malaysia,DKSH said it would begin distribution in themarket as soon as approval was granted.

Commenting on the deal, Robert Taylor,Vitabiotics’ vice president, said working withDKSH would allow the firm to “accelerate” itsgrowth and “enter new strategic markets”.

“The diverse Asian market shows excellentlong-term growth potential for Vitabiotics’products,” Taylor added.

Andrew Frye, head of DKSH’s Healthcareunit, said the company would use its “broadcapillary distribution” networks and capitaliseon the knowledge of its local experts in HongKong and Malaysia to “spur further growth”for Vitabiotics in Asia.

Distribution Agreements

Vitabiotics toexpand in Asia

Sohm – a manufacturer of generic pharma-ceutical, nutraceutical and cosmeceutical

products – said its Indian unit had taken on themanufacture of a range of nutraceuticals foran unnamed local company.

Shailesh Shah, Sohm’s president and chiefexecutive officer, said the firm’s Indian oper-ations would produce 10 nutraceuticals for itsnew partner and that the deal would add signif-icantly to its revenues.

The Indian nutraceuticals market was setto be worth almost US$3 billion (C2.8 billion)in value terms by 2016, Sohm claimed, with thewider nutraceuticals, supplements and vitaminsmarket expected to achieve a compound annualgrowth rate (CAGR) of 9% for the 2013-2018period as demand increased.

Manufacturing Agreements

Sohm gets the nodfor nutraceuticals

OTC

OTC

OTC17-04-15p2-9_Layout 1 15/04/2015 09:19

NBTY is set to grow its Holland & Barrettchain to over 900 stores, after announc-

ing plans to rebrand all of its De Tuinen andEssenza outlets.

Noting that all 167 stores from its DutchDe Tuinen chain and its Belgian Essenza linewould be rebranded as Holland & Barrett out-lets, NBTY said the process would begin thismonth and take around 18 months to complete.

Acquired De Tuinen in 2003The US-based natural products wholesaler

and retailer has operated in the Netherlandsfor 12 years, after it snapped up De Tuinen in2003. The retailer moved into Belgium in 2013,with the acquisition of health and wellness chainEssenza (OTC bulletin, 17 June 2013, page 3).

Commenting on the move, Colinda Hoegee,chief operating officer of De Tuinen and Essen-za, said both chains would benefit from the

“international recognition and strong heritage”of the Holland & Barrett name.

In addition, NBTY would be able to takeits “innovative” Holland & Barrett brandedproducts into Belgium and the Netherlands,she added.

NBTY currently operates over 750 Holland& Barrett stores in the UK and franchise outletsin a number of countries including China,Malta and the United Arab Emirates (UAE).

Holland & Barrett was the “leading vitamins,minerals and supplements (VMS) speciality re-tailer” in the UK, NBTY claimed, and offeredconsumers a “broad range” of products amount-ing to over 4,800 stock-keeping units (SKUs).

NBTY acquired Holland & Barrett from theGerman firm Gehe in 1997 (OTC bulletin, 29August 1997, page 3), when the chain hadaround 400 stores.


COMPANY NEWS OTC

Business Strategy

NBTY to expand use ofHolland & Barrett name

UK-based Green Light Pharmacy has ex-panded its presence in London, UK, after

snapping up two pharmacies in the capital foran undisclosed sum.

Noting that the deal took its total number ofoutlets to seven, Green Light said it plannedto rebrand both pharmacies – which were cur-rently operating as independents – under itsown name and increase the services on offerto consumers.

Sanjay Ganvir, a director at Green Light,told OTC bulletin that the firm planned torefit both pharmacies with “consulting booths”next to the counter to give consumers moreprivacy when discussing ailments and purchas-ing medicines.

Green Light was a “clinically-focused” phar-macy chain, Ganvir explained, so neither storewould offer cosmetics or perfumes.

Established in 1999, Green Light now gen-erated annual turnover in excess of £4.0 mil-lion (C5.5 million), Ganvir pointed out, and hadambitious plans for growth.

Carry on expanding“Absolutely we want to carry on expanding,”

Ganvir insisted, noting that the company had seta target of operating 20 branches by 2020.

John Foreman, founder of Green Light, saidthe firm’s ambition was to “change the predom-inant pharmacy model from its narrow focus onprescriptions and retailing to a model that putswellness, education and prevention at its focus”.

By doing this, Green Light had gone from“strength to strength”, Foreman pointed out,and had secured backing from a number ofestablished financiers.

Expanding on this approach, Ganvir claimedthat pharmacy had an important role to play inpatient education and in encouraging self-care.

“Self-care is about having a two-way con-versation with patients about medicines andtheir health, and educating them so that they canmake an informed decision,” Ganvir explained.

When it came to promoting self-care, phar-macy was an “amazing asset” that was cur-rently being “underutilised”, he argued.

Noting that the UK was facing a generalpractitioner (GP) crisis – with not enough medi-cal students choosing general practice – Gan-vir said the National Health Service (NHS)needed to “think differently” and encouragepatients with minor ailments to visit pharmacies.


Green Light getstwo pharmacies

OTC

OTC

OTC17-04-15p2-9_Layout 1 14/04/2015 18:16

Medsafe – New Zealand’s medicines reg-ulator – has added guaifenesin to its

medicines monitoring scheme following reportslinking the OTC expectorant to tinnitus.

The agency said that a patient who had beentaking 600mg guaifenesin for an upper respira-tory-tract infection had reported experiencing“profound tinnitus followed by deafness in theright ear with facial and outer-ear numbness”.

In a second report, another patient who hadbeen using guaifenesin for a different problemhad experienced hearing loss in their right ear,Medsafe noted, after the dose had been in-creased to 600mg twice daily.

There had been no “relevant literature re-ports of tinnitus, deafness or numbness with useof guaifenesin”, the agency pointed out.

Medsafe said that guaifenesin had beenplaced on the medicines monitoring scheme toobtain further information on this “possible ad-verse reaction”.

Used primarily to relieve the symptoms ofa productive chesty cough, guaifenesin is avail-able OTC in New Zealand as a single ingredi-ent or combination product.

Single-ingredient guaifenesin brands include:Johnson & Johnson’s Codral Relief Mucus Cough20mg/ml; Reckitt Benckiser’s Mucinex 600mgand Maximum Strength Mucinex 1200mg;Pfizer’s Robitussin Chesty Cough 20mg/ml; andProcter & Gamble’s Vicks Cough Syrup HoneyFlavour Chesty Cough 13.33mg/ml and VicksFormula 44 for Chesty Coughs 1.333%w/v.


OTC GENERAL NEWS

Regulatory Affairs

New Zealand monitors guaifenesin

ApexM – a medical device to treat urinaryincontinence in women – is now available

OTC in the US, after the Food and Drug Ad-ministration (FDA) approved the product forsale without a prescription.

InControl Medical, the US-based manufac-turer of the device, said the FDA had clearedApexM for OTC sale to treat “stress, urge andmixed urinary incontinence in women”.

The device provided “muscle stimulationthrough a customisable probe”, InControl ex-plained, “to strengthen the pelvic floor andcalm spasms of the bladder muscle”.

ApexM was one of only three devices avail-able to female consumers in the US to treaturinary incontinence, InControl claimed, add-ing that only ApexM was available withouta prescription.

Commenting on the approval, Herschel Peddi-cord, president of InControl, said by simul-taneously treating stress, urge and mixed uri-nary incontinence, ApexM “rendered unnecess-ary” expensive urodynamic testing to diagnosethe type of incontinence.

“This product is highly efficacious, simpleto use and by far the least expensive treatmentavailable for female urinary incontinence,” Peddi-cord claimed.

Citing figures from the National Associationfor Continence, InControl said “up to 40 mil-lion” women in the US had experienced bladder-leakage issues “at some point in their lives”.

Earlier this year, Bayer discontinued its over-active bladder treatment Oxytrol for Womenin the US following poor sales (OTC bulletin,6 March 2015, page 1).

Oxytrol was launched to great fanfare inthe autumn of 2013 (OTC bulletin, 11 Octo-ber 2013, page 15) having become the world’sfirst oxybutynin-based OTC product when itwas switched earlier that year (OTC bulletin,8 February 2013, page 1).

Regulatory Affairs

FDA approvesbladder device

The product information provided with ibu-profen medicines looks set to be updated

to warn of the small increased risk of cardio-vascular problems associated with taking highdoses of the anti-inflammatory.

Following a review instigated just under ayear ago (OTC bulletin, 27 June 2014, page 8),the European Medicines Agency’s (EMA’s)Pharmacovigilance Risk Assessment Commit-tee (PRAC) said that while the benefits of ibu-profen continued to outweigh the risks, it feltthat the advice on the use of high-dose ibu-profen – 2,400mg per day or higher – should beupdated to minimise the cardiovascular risk.

High doses of ibuprofen should also beavoided in patients with serious underlyingheart or circulatory conditions, such as heartfailure, heart disease and circulatory problems,the PRAC pointed out, or in those who hadpreviously had a heart attack or stroke.

At its June 2014 meeting, the PRAC decidedto begin a review to evaluate the cardiovascularrisks linked with regularly taking 2,400mg ibu-profen per day for long periods.

Noting at the time that ibuprofen was usu-ally taken at lower doses and for short periodsof time, the PRAC insisted that there was “nosuggestion of a similar cardiovascular risk withibuprofen as used by the overwhelming maj-ority of patients”.

“Ibuprofen is one of the most widely-usedmedicines for pain and inflammation,” thePRAC pointed out, “and has a well-knownsafety profile, particularly at usual doses.”

However, the PRAC said that data – inparticular the results of an analysis of clinicaltrial data – had suggested that the cardiovascu-lar risk with the non-steroidal anti-inflamma-tories (NSAIDs) diclofenac and high-dose ibu-profen might be “similar to the known risk” withanother form of NSAID, COX-2 inhibitors.

In 2013, the PRAC considered the data inrelation to diclofenac and recommended thatpatients with serious underlying heart condi-tions should not use the anti-inflammatory dueto a small increased risk of heart attack andstroke (OTC bulletin, 26 July 2013, page 13).

Meanwhile, the PRAC said it had also re-viewed evidence of the interaction of ibupro-fen with low-dose aspirin, taken to reduce therisk of heart attacks and strokes.

Laboratory studies had shown that ibupro-fen could reduce the anti-clotting effects ofaspirin, the PRAC reported, but it “remaineduncertain whether the long-term use of ibupro-fen reduced the benefits of low-dose aspirinin preventing heart attacks and strokes”.

However, the committee recommended thatinformation on the interaction should be in-cluded in the product information.

Regulatory Affairs

PRAC proposes updatinghigh-dose ibuprofen advice

OTC

■ GNC – the US-based natural supplementsretailer – has agreed with the US state of NewYork to use DNA barcoding to authenticateplants used in its herbal supplements. Themove comes after accusations the products didnot contain the ingredients claimed (OTC bul-letin, 13 February 2015, page 18).

IN BRIEF

OTC

OTC

OTC

OTC17-04-15p10-13_Layout 1 14/04/2015 16:22 Page 2

Purchases made through mail-order services,both online and by telephone, were largely

responsible for Germany’s pharmacy OTChealthcare market expanding by 2.5% to almostC11.8 billion at retail prices last year.

Mail-order sales climbed by 11.0% to C1.25billion, accounting for 11% of the total market,according to data just released by market re-searcher IMS Health (see Figure 1).

Non-prescription medicines and healthcareproducts were largely responsible for the mail-order growth with an 11.6% increase to approx-imately C960 million.

Mail-order retailers achieved double-digitvalue growth in product categories includinganalgesics, gastrointestinal remedies, skin-care,eye-care and vitamins, minerals and supple-ments (VMS).

Turnover of cosmetic and body-care productsthrough mail-order pharmacies rose by 12.1%to C183 million, boosted by strong demand for

hair-care products, especially products for hairloss and lice infestations.

Sales of nutritional products advanced by10.9% to around C35 million. But sales of medi-cal equipment such as tests and thermometersalmost stalled at about C75 million.

OTC rise in community pharmacyIn community pharmacies, turnover of all

OTC healthcare products increased by a rela-tively modest 1.6% to C10.5 billion, as growthin gastrointestinal remedies and analgesics help-

ed to offset lower cough and cold sales.The market’s value improvements came de-

spite a 1.0% overall volume decline to 1.15 bil-lion packs in the OTC healthcare market.

A 7.5% volume rise for mail-order outlets to122 million packs was not sufficient to offsetfully a 1.9% volume slide to 1.03 billion packsthrough community pharmacies (see Figure 2).

“A major reason for the volume decline incommunity pharmacies is that the previousyear’s strong wave of colds and flu was notrepeated in 2014,” IMS Health commented.

Within the mail-order segment, non-pre-scription medicines and healthcare productswere once again the key driver with an 8.4%increase to around 96 million packs, or almostfour out of every five packs sold through thistype of retailer.

Mail-order sales of cosmetic and body-careproducts, nutritional products and medical equip-ment each showed low single-digit advances.


GENERAL NEWS OTC

Market Research

Mail-order buys drive German market

Figure 1: Germany’s OTC healthcare market in 2014 by retail channel at retail selling prices (Source – IMS Health)

Retail channel Annual sales Change Proportion(Cmillions) (%) of total (%)

Community pharmacy 10,539 +1.6 89

Mail order 1,249 +11.0 11

OTC healthcare market 11,788 +2.5 100

Figure 2: Breakdown by retail channel of Germany’s OTC healthcare market in 2014, measured by millionsof packs (Source – IMS Health)

Retail channel Annual sales Change Proportion(million packs) (%) of total (%)

Community pharmacy 1,029 -1.9 89

Mail order 122 +7.5 11

OTC healthcare market 1,151 -1.0 100

OTC

Co-operation in the fields of traditionalmedicine and homoeopathy is the object-

ive of a new agreement between India and Mau-ritius, according to the Indian government.

A ‘Memorandum of Understanding’ signedby the two countries, the Indian governmentexplained, would provide a framework to ex-plore the health benefits of both Indian andMauritian traditional medicines.

Traditional medicines cultureIndia and Mauritius shared a “common

culture” when it came to traditional medicine,India said, noting that the agreement would be“mutually beneficial” to both parties.

The Indian government pointed out that itwould finance research into the health bene-fits of traditional medicines currently used inboth countries.

India has previously signed similar Mem-

orandums of Understanding related to tradi-tional medicines and homoeopathic productswith a number of countries including China,Hungary and Malaysia.

In an attempt to boost exports of traditionalmedicines, India announced plans late last yearto establish a quality control regulator to man-age such products (OTC bulletin, 28 Novem-ber 2014, page 14).

Harsh Vardhan, government minister forHealth and Family Welfare, said at the timethat the creation of a dedicated traditional medi-cines regulator would provide better oversightand give the sector “pride of place” in India’smainstream healthcare system.

Manufacturers of traditional medicines wouldalso be given “financial support”, Vardhan prom-ised, to “enhance the quality” of their productsand help them to “meet global standards”.

India signs agreement with Mauritius

OTC

Regulatory Affairs

■ FDA – the US Food and Drug Administra-tion – has warned consumers not to use a diet-ary supplement for muscle growth due to a riskof serious liver injury. Tri-Methyl Xtreme,distributed by Las Vegas-based Extreme Prod-ucts Group, was said to contain anabolic ster-oids, the agency pointed out, and was availableonline and in some retail stores and gyms.The FDA said it had begun an investigationto identify the manufacturer of the productafter it received adverse event reports fromconsumers in California, New Jersey and Utah.Charles Lee, a senior medical advisor at theFDA’s Center for Drug Evaluation and Re-search’s Office of Compliance, warned that an-abolic steroids could cause a “range of seriousadverse events on many organ systems” andthat the damage might be irreversible. The FDAhas advised consumers who suspect that theyare experiencing problems associated with theproduct to consult a healthcare professional.

OTC

IN BRIEF

OTC17-04-15p10-13_Layout 1 14/04/2015 16:22 Page 3

Two-thirds of German general practitioners(GPs) believe recommending non-prescrip-

tion medicines to their patients saves the health-care system money, according to a survey con-ducted by Sempora Consulting and market re-searcher GfK.

Just over half of the 150 GPs questionedfelt that proposing that patients use an OTCmedicine was a “useful addition to therapy”.

And just 3% of doctors were against rec-ommending non-prescription medicines becausethey did not feel there was a sufficient correla-tion between cost and effectiveness.

“The result is that of an average of 75 patientstreated each day, 15 patients leave the surgerywith an oral recommendation to self-medicate,of whom 12 act on that advice,” Sempora andGfK commented.

Two-thirds of the 203 pharmacists interview-ed said it was difficult to convince customersto accept an alternative to a particular OTC medi-cine that a doctor had recommended.

Furthermore, two-fifths of pharmacists saiddoctors’ recommendations for specific brandsimproved the image and standing of those prod-ucts’ producers.

When questioned about the relevance ofdoctor-initiated self-medication, more than four-fifths of the 45 OTC firms that participated inthe study felt it was important or very important.

Moreover, 62% of the firms expected the

relevance of doctor-initiated self-medication torise over the next few years.

“For 75% of companies it is clear,” Semporaand GfK stated. “They will raise their effortsto increase doctors’ recommendations.”

When asked about the strategic benefits ofendorsement by general practitioners, 86% ofthe firms believed recommendations would helpto combat OTC medicines being “trivialised”.

According to GfK’s Medic*Scope panel,German patients bought almost 96 millionpacks of non-prescription medicines last yearon the advice of a doctor. This accounted for16% of all OTC purchases, making doctorsalmost as influential as pharmacists in initiat-ing self-medication.

Outlining three key effects of doctor-initi-ated self-medication, the researchers said firstlyconsumers paid up to 54% more than on aver-age when buying a specific product that hadbeen recommended.

Secondly, the number of packs they pur-chased was up to 55% higher when done soon the advice of a doctor.

And thirdly, consumers remembered recom-mendations for far longer than they recalledadvertising messages, with only a fifth of patientsacting on a doctor’s advice within two days,but three-fifths not making a purchase untilat least three months after their doctor had sug-gested a particular product.


OTC GENERAL NEWS

Market Research

German doctors identifyvalue in recommending

OTC

Vitamin Shoppe has removed all dietarysupplements containing the herb acacia

rigidula from its stores and website due to con-cerns that they may contain an amphetamine.

The retailer said it was acting “out of anabundance of caution” in response to a studywhich found the amphetamine isomer β-methyl-phenylethylamine (BMPEA) in a number ofdietary supplements labelled as containing theingredient acacia rigidula.

“We are concerned by the findings outlinedin the study – published in Drug Testing andAnalysis – which state that some acacia rigi-dula containing products may also containBMPEA,” Vitamin Shoppe explained.

“If these findings are confirmed by the USFood and Drug Administration (FDA), theseproducts should not be sold as dietary supple-ments,” the firm insisted.

Vitamin Shoppe pointed out that it requiredall manufacturers of products sold in its retailstores or through its branded website to “com-ply with all applicable laws”.

The study analysed 21 brands of acaciarigidula supplements and found that 52.4% ofthe tested products contained BMPEA.

Consumers of these supplements “may beexposed to pharmacological dosages of an am-phetamine isomer that lacks evidence of safetyin humans”, the study’s authors say.

“The FDA should immediately warn con-sumers about BMPEA,” the authors insist, “andtake aggressive enforcement action to eliminateBMPEA in dietary supplements.”

The study’s authors claim that the FDApreviously identified BMPEA in acacia rigi-dula supplements in 2013 but that the agency“has yet to warn consumers”.

Product Recalls

Vitamin Shopperecalls products

OTC

Claims in a new study that omega-3 diet-ary supplements are beneficial to people

with certain cardiovascular conditions have beenbacked by the Australian Self-Medication In-dustry (ASMI) .

The association said it was “pleased” that thestudy’s authors supported omega-3 supplement-ation “in patients with heart failure and forthose with high levels of blood triglycerides”.

Published in the journal Heart, Lung andCirculation, the study examined the importanceof dietary fish oils for cardiovascular health.

The study’s authors found that an “adequatedietary intake” of fish was consistently foundto be of benefit for protection from heart dis-

ease and stroke and that a higher intake of fishwas associated with lower rates of heart failure.

The study recommended that to lower theirrisk of coronary heart disease, all Australiansshould consume 500mg of omega-3 fatty acidsa day through a combination of: two or threeservings of oily fish per week; fish-oil capsulesor liquids; and products enriched with marinen-3 polyunsaturated fatty acids.

“With the majority of Australians continu-ing to not eat enough fish, omega-3 supple-ments still play an important role in helpingpeople to consume marine-sourced omega-3,”the ASMI claimed.

Research

ASMI backs new omega-3 research

■ TGA – Australia’s Therapeutics GoodsAdministration – is calling for comments onplans to amend the scheduling of weight-lossdrug orlistat 120mg or less from schedule 3– pharmacist-only medicine – to a schedule 2pharmacy medicine. Comments are also beingsought on proposals to delete the currentschedule 3 entry for codeine and reschedulethe medicine as a schedule 4 or prescription-only product. The agency is also looking atwhether to amend codeine’s schedule 2 status.

IN BRIEF

OTCOTC

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The Proprietary Association of Great Britain(PAGB) has defended the marketing of

branded OTC painkillers in the UK, followingclaims on a BBC television programme that con-sumers were being tricked into buying productsthat claimed to target certain types of pain.

Responding to the accusations made in theshow The Truth About…Your Medicine Cabi-net broadcast on 9 April, Matthew Speers, thePAGB’s chief executive, insisted that the mar-keting of all OTC medicines was “strictly reg-ulated to ensure a responsible approach to self-medication” and was “not misleading”.

“Claims made in advertising and on pack-aging about what the product can be used totreat, how fast the product works and how longit works for must reflect the product’s Summaryof Product Characteristics (SmPC),” Speers said,“which is part of the marketing authorisation

that is granted by the Medicines and Health-care products Regulatory Agency (MHRA).”

Research had also found that people lookedfor products to treat specific symptoms, such asheadaches, migraines or period pain, he noted,and therefore different labelling and packaginghelped people navigate the range more easily.

Speers also defended OTC cough medi-cines, which the programme claimed were onlyas good as many simple homemade remediessuch as honey and lemon.

“Cough medicines will not cure a cough,”Speers admitted, “but they can help relieve thesymptoms and provide people with a ready-to-use product that is easy to access.”

“Some OTC cough medicines also containa combination of ingredients to treat the mostcommon symptoms of a cold,” he added.


GENERAL NEWS OTC

Industry Associations

PAGB defends UK OTC marketing

Current restrictions on the ownership andlocation of pharmacies in Australia are

anti-competitive and should be removed, ac-cording to a government review of the coun-try’s competition laws.

The Competition Policy review says thatthe existing regulations on the location of phar-macies are “anti-competitive”, and the require-ment that only pharmacists can own pharma-cies, are “not needed to ensure the quality ofadvice and care provided to patients”.

“Such restrictions limit the ability of consum-ers to choose where to obtain pharmacy productsand services and the ability of providers to meetconsumers’ preferences,” the review argues.

Replace location rulesThe pharmacy ownership and location rules

should be replaced with regulations that donot unduly restrict competition, it states, andthat “ensure access to medicines and advice re-garding their use”.

“In particular,” the review argues, “tender-ing for the provision of pharmacy services inunderserved locations and/or funding througha community service obligation should be con-sidered by the authorities.”

Noting that access to medicines is less likelyto be an issue in urban areas, the review saysthe rules targeted at pharmacies in such loca-tions should continue to be eased. At the sametime, mechanisms should be established toaddress issues concerning access to medicinesin rural locations, it insists.

Pointing out that negotiations for the Com-munity Pharmacy Agreement – between thegovernment and the Pharmacy Guild of Aus-tralia – are underway, the review says thisprovides an opportunity to implement “target-ed relaxation of the location rules, as part ofa transition towards their eventual removal”.

Negotiated every five years, the Commu-nity Pharmacy Agreement regulates many as-pects of the pharmacy sector in Australia.

“If changes during the initial years of thenew agreement prove too precipitate, thereshould be provision for a mid-term review toincorporate easing of the location rules lateron,” the review argues.

The review points out that the recent Nation-al Commission of Audit also recommended“opening up the pharmacy sector to competi-tion, including through the deregulation of own-ership and location rules”.

Regulatory Affairs

Australia’s regulationsare “anti-competitive”

OTC

OTC

Proposals by the Japanese government tomake more medicines available OTC in the

country have been welcomed by the JapanSelf-Medication Industry (JSMI).

Motohito Nishizawa, senior advisor at theJSMI, told OTC bulletin that the association“appreciated” plans put forward by Japan’s Min-istry of Health, Labour and Welfare (MHLW)to help increase the number of medicinesswitched from prescription-to-OTC status.

Under the MHLW’s proposals, consumersand health insurers in Japan will be able tosuggest prescription medicines that they wouldlike to see available OTC.

These suggestions will then be assessed bythe MHLW and those medicines that are con-sidered suitable for OTC status will be switched.

Currently, only pharmaceutical companiescan put forward applications to switch medi-cines from prescription to OTC status in Japan.

Noting that it intended to start acceptingsubmissions later this year, the MHLW said itwas looking to switch medicines that treatedeasily identifiable symptoms and that could beeasily administered by consumers.

According to press reports in Japan, thecountry’s National Federation of Health Insur-ance Societies intends to take advantage of theMHLW’s plans and will request that six medi-cines – including eye drops and digestive medi-cations – be switched to OTC status.

Nishizawa noted that in the past, industry hadnot seen eye-to-eye with the Japanese govern-ment, due to a lack of “substantial progress” inapproving more prescription-to-OTC switches.

Despite these problems, Nishizawa insist-ed that Japan’s OTC industry supported theMHLW’s plans as it “sincerely” believed thatthe promotion of prescription-to-OTC switcheswould improve access to medicines.

Nishizawa explained that the MHLW’s pro-posals to reinvigorate OTC switches in Japanreflected the government’s current healthcarepolicy of promoting self-medication.

Switches

JSMI welcomesswitch agenda

OTC

■ EMA – the European Medicines Agency –has released a draft second revision of the guide-line on the use of the Common Technical Doc-ument format in the preparation of a registra-tion application for traditional herbal medicines.

IN BRIEF

OTC

OTC17-04-15p10-13_Layout 1 14/04/2015 16:22 Page 5


OTC MARKETING NEWS

Natural products company Nelsons is en-couraging UK consumers to “stop and

take a moment” in the first television advert-ising campaign for its Rescue Remedy flower-essence range.

Voiced by British actress Emilia Fox, the30-second commercial begins with the state-ment: “And…stop” before the screen is filledwith yellow – the colour of the Rescue Remedybrand – accompanied by silence.

“Take a moment every day with RescueRemedy,” the voiceover then instructs, beforethe dropper and Soothing Pastilles variantsappear on screen.

Pointing out that “97% of people who tryRescue Remedy would buy it again,” thevoiceover adds: “Isn’t it time you tried it?”

The creative “disrupts the advertising breakwith a moment of calm”, Nelsons claims, whilealso positioning the Rescue range – whichincludes a Rescue Night dropper, Gummy Starsand chewing gum, as well as balm and creamoptions – as “products to use every day”.

Targeting women who recognised “the de-mands of juggling their busy lives”, the tele-vision commercial builds on the current ‘I cando this’ themed campaign first rolled out lastyear (OTC bulletin, 28 March 2014, page 14),which includes print advertisements, samplingand posters at London Underground stations.

The firm is also running a Facebook com-petition until 1 May. Entrants who completethe “Stop, take a moment and win” games with-in 80 seconds, have the chance either to winone of four £100 (C138) Champneys spa vouch-ers, one of two Amazon Kindle Fire electronicreaders or one of 20 tins of Rescue Pastilles.

Meanwhile, Nelsons has returned its ani-mated ‘apologetic tooth’ character to UK tele-vision screens for the third consecutive yearto support its Teetha homoeopathic teething-pain gel and granules.

The 30-second spot – first aired in summer2013 – shows a tooth apologising to parentsof teething children for making their babiescry (OTC bulletin, 25 April 2014, page 18),and offering the Nelsons Teetha Gel as a prod-uct to help soothe teething pain.

Airing throughout April and May, the com-mercial was supported by print advertisingfeaturing the granule variant in titles such asMother&Baby, the firm noted, as well as a digi-tal campaign.

Marketing Campaigns

OTC

Omega Pharma says its Nytol Herbal Sim-ply Sleep & Calm Elixir will appeal to UK

customers wishing to treat their sleeping prob-lems with a liquid format rather than a tablet.

Indicated for the temporary relief of symp-toms of mild anxiety and to aid sleep, thegeneral-sale list (GSL) Elixir – containing 1.5mlof tincture from dried valerian root per 5ml –was aimed at women aged over 35 years,Omega noted, as difficulty sleeping was “par-ticularly prevalent amongst this group as aresult of their busy lifestyles”.

Two spoonfuls of Nytol Herbal SimplySleep & Calm Elixir should be taken threetimes a day with water or fruit juice, the com-pany advises, to treat mild anxiety in adultsaged over 18 years.

To aid sleep, two spoonfuls should be taken30 minutes before bedtime, with an earlier doseduring the evening if necessary. The maximumdose is four single doses per day.

The line extension was being supported bya £1.5 million (C2.1 million) television cam-paign promoting the entire Nytol range of sleepaids, Omega noted.

Featuring ‘Joan’, the animated characterfrom previous Nytol commercials created byproduction company Aardman Animations, the

television commercial uses the overall tagline“Good mornings follow a good Nytol”.

This is followed by a shot of the Elixir nextto a book on a bedside table, with the messagethat the product is “new to Nytol”.

The Nytol range also includes GSL Herbaltablets and pharmacy-only (P) Nytol Originaland One-A-Night tablets, with 25mg and 50mgof diphenhydramine, respectively, as well asthe Anti-Snoring Throat Spray launched justover two years ago (OTC bulletin, 22 Feb-ruary 2013, page 18).

A 100ml bottle of Nytol Herbal SimplySleep & Calm Elixir has a recommended re-tail price of £4.99 excluding VAT.

Product Launches/Line Extensions

Omega adds liquid optionto Nytol sleep-aid range

Nytol Herbal Simply Sleep & Calm Elixir is includedin a £1.5 million television campaign promoting theentire Nytol range

Animated cold and flu “virus-monsters” are showntraining in the gym in OTCPharm’s latest televisionadvertisement for its Arbidol Maximum antiviralcapsules in Russia.

The 10-second national commercial played onthe popular belief that cold and flu viruses became“stronger” every year, the Russian firm noted.

A pack of Arbidol Maximum is shown landing onthe viruses and squashing them, before the creativesigns off with the message: “Colds subside quicklywith Arbidol Maximum.”

Launched earlier this year, Arbidol Maximumcontains 200mg of the active ingredient umifenovirper capsule – double the amount in the originalArbidol variant – and is indicated to act on the maincause of colds, flu and other acute respiratoryinfections by “inhibiting the multiplication of viruses”.

Queisser Pharma’s Doppelherz System pharmacy-exclusive supplement brand in Germany now includeshyaluronic acid capsules to help promote healthy skin.

In addition to 70mg of hyaluronic acid to “care forcells from within”, each one-a-day Doppelherz SystemHyaluron capsule provides 30mg of co-enzyme Q10,40mg of vitamin C, 5mg of zinc and 100µg of biotin.

A month’s supply of 30 capsules has arecommended retail price of C14.95.

Queisser is supporting the launch withconsumer- and trade-press advertising, as well aswith point-of-sale displays.

OTC

Rescue Remedydebuts on UK TV

OTC

OTC

OTC17-04-15p14-17_Layout 1 14/04/2015 17:32 Page 2

“Quick action and extra analgesic power”is Hypermarcas’ promise to Brazilian

consumers about its Doril Enxaqueca migrainepain-relief tablets.

Claiming that an estimated 70% of womenand 50% of men suffered at least once a monthfrom headaches, the Brazilian firm pointed outthat each Doril Enxaqueca tablet combined

250mg acetylsalicylic acid with 250mg para-cetamol and 65mg caffeine to relieve mild-to-moderate pain and migraines. The recommend-ed dose is two tablets.

The Enxaqueca variant complements theoriginal Doril product, which contains 500mgacetylsalicylic acid and 30mg caffeine and isindicated as an analgesic and antipyretic.

Available in pharmacies nationwide, DorilEnxaqueca is being supported by a televisioncampaign starring Brazilian actor ReynaldoGianecchini. He was a “credible personality”who reinforced “the strength of the Dorilbrand”, Hypermarcas explained.

The television spot would be backed furtherby advertisements in magazines, the firm noted,as well as radio spots and online activity.

Japanese firm Kowa has grown its domesticOTC portfolio with additions to its Unakowa

insect bite-relief range and Q&P line.Indicated to relieve itching caused by bites

from insects such as mosquitoes and ticks, Una-kowa Cool Punch contained double the amountof lidocaine per ml – 10mg – than that pro-vided by the original Unakowa Cool topicalantipruritic, Kowa noted.

The latest addition to the lidocaine- and di-phenhydramine-based Unakowa range – whichincludes the α, Ace G and Ace L variants –is formulated with 20mg diphenhydramine and20mg camphor per 1ml, in addition to lido-caine. It also contains 40mg menthol, whichis 10mg more than in Unakowa Cool.

Kowa added that Unakowa Cool Punch’ssoft brush-tip applicator ensured a more ac-curate and hygienic distribution of the product.

Recommended retail prices for 30ml and50ml packs of Unakowa Cool Punch, withouttax, are ¥580 (C4.52) and ¥900, respectively.

Meanwhile, the firm has extended its Q&Pline of supplements with an iPlus variant.

Suitable for adults and children aged over15 years, the Q&P-iPlus tablets – said to helprelieve conditions such as eye strain and stiffnecks – contained an updated formulation tothat of the original Q&P-i product, Kowa noted.

In addition to vitamins B1, B12 and E, gar-lic extract, magnesium-potassium aspartate andgamma-oryzanol (rice bran oil) – which are allpresent in Q&P-i – the company has addedhepuronikato, a vasodilator, to iPlus.

This new ingredient caused the peripheralblood vessels to expand, Kowa claimed, whichresulted in increased blood flow to the eye.

Q&P-iPlus complements Kowa’s nine-strongQ&P supplement range. This includes productsfor joint pain, fatigue, and energy, as well asthe original Q&P-i product, which also con-tains vitamins B2 and B6.

A pack of 27 Q&P-iPlus tablets has a rec-ommended retail price of ¥1,200, while 80- and180-tablet packs have recommended retailprices of ¥2,600 and ¥5,500, respectively.


MARKETING NEWS OTC


Kowa grows OTC portfolioin Japan with two additions

Unakowa Punch treats itching caused by insectbites, while Q&P-iPlus is positioned to help relieveeye strain and stiff necks

Vitamin D3 supplement drops are the latestaddition to Crosscare’s Colief infant-care

line in the UK and Ireland.Pointing out that the UK Department of

Health (DoH) had identified “a number of spe-cific groups who could be at risk of vitamin Ddeficiency” – including infants and young child-ren aged under five years and all pregnant andbreastfeeding women – the firm said the ColiefVitamin D3 Drops, containing 2µg (80IU) ofvitamin D3 per drop, provided a “competi-tive and relevant” solution for consumers.

Four drops a day met the current guidelinesfor vitamin D supplementation in young child-ren, Crosscare noted, while five drops pro-vided mothers and pregnant women with therequired amount. The product could be mixed

easily with food or liquids for children andmothers and given directly by mouth to youngbabies, the company added.

Available in pharmacies nationwide, ColiefVitamin D3 Drops would be supported through-out the year by a “comprehensive” public-re-lations and advertising campaign beginningnext month, the firm noted.

Using the current tagline, “Mums know tocall on Colief”, the campaign would coverthe entire Colief product range, Crosscarepointed out, which includes the the lactase-based Infant Drops for colic and Baby ScalpOil, as well as the Vitamin D3 Drops.

In stores, the brand would be backed bypoint-of-sale materials, the company added.

A 20ml bottle of Colief Vitamin D3 Dropscontains the equivalent of five months’ supplyfor infants and children and a four-month sup-ply for pregnant women and breastfeedingmothers, and has a recommended retail priceof £9.99 (C13.68).

Noting that the drops were currently onlyavailable in the UK and Ireland, Crosscaresaid it “may launch in other countries in 2015”.

OTC


Vitamin D dropsadded to Colief

OTC


Brazilians offered “extra analgesic power”

Doril Enxaqueca is being supported by a televisioncampaign starring Brazilian actor Reynaldo Gianecchini

Colief Vitamin D3 Drops are said to provide 2µg(80IU) of vitamin D3 per drop

OTC

OTC17-04-15p14-17_Layout 1 15/04/2015 09:21 Page 3


OTC MARKETING NEWS

Amaximum-strength variant has been addedto Omega Pharma’s XLS-Medical weight-

loss range in the UK.Formulated with the “patented organic plant-

based complex” clavitanol, XLS-Medical MaxStrength – a class IIb medical device – is saidby the firm to be “up to 33% more effectivefor weight loss” compared with the originalXLS-Medical Fat Binder variant, which con-

tains the “natural fibre complex” litramine.The Max Strength addition – which is al-

ready available in other markets such as Franceand Greece – reduces the breakdown of dietarycarbohydrates, sugar and fat to lower calorieintake, Omega claims. It is also said to lowerblood glucose and insulin levels to help curbfood cravings.

Launched in 2012, the original XLS-Medi-cal Fat Binder product is positioned as help-ing consumers potentially lose “three times asmuch weight as dieting alone” (OTC bulletin,12 October 2012, page 10).

The XLS-Medical range also comprises aCarb Blocker variant launched in 2013 (OTCbulletin, 13 September 2013, page 15) and aDirect sachet variant of the Fat Binder, whichwas introduced last year as the first-ever “on-the-go” orodispersible weight-loss powder prod-uct (OTC bulletin, 12 September 2014, page 18).


Max Strength addition boosts XLS-Medical

Sanofi Consumer Healthcare says it is “liais-ing with major UK retailers” to launch its

Anthisan Citronella Patches in time for summer.The latest addition to the Anthisan bite- and

sting-relief range – which also includes themepyramine maleate-based Anthisan Bite &Sting Cream – had been “well received” whenit was rolled out into independent pharmaciesin June last year, the firm told OTC bulletin.

Positioned as “a natural preventative prod-uct suitable for the whole family”, the trans-parent, self-adhesive strips contained “micro-encapsulated” natural essential oils to deter in-sects, Sanofi pointed out, and gradually releas-ed the fragrance of citronella up to a 50cmradius for up to 12 hours.

Suitable for adults and children aged oversix months, Anthisan Citronella Patches wouldappeal particularly to mothers who preferredto use natural remedies on their children ratherthan biocide- or diethyltoluamide (DEET)-basedproducts, Sanofi claimed. The patches’ reseal-able pouch packaging made them convenientfor travelling, the firm added.

A “dedicated” digital and public-relationscampaign would support the entire Anthisan

range, the company explained, targeting bothtrade and consumer audiences throughout the“key bite and sting season”.

The digital campaign would focus on web-sites such as BootsWebMD and the music-streaming service Spotify, Sanofi pointed out,as well as on “relevant websites relating tobites and stings”.

Pharmacies would also be provided withpoint-of-sale materials and literature for con-sumers, the firm noted.

A pack of 24 Anthisan Citronella Patches hasa recommended retail price of £3.99 (C5.49).


Anthisan patches set forlaunch in major retailers

Sanofi’s Anthisan Citronella Patches have been availablein independent pharmacies since June last year

“Rennie räumt den magen auf” – which translates as“Rennie clears up stomachs” – is the tagline forBayer Healthcare’s first German television campaignto support its Rennie Direkt orodispersible antacid.

In the 15-second creative, an animated stomach– Bayer’s ‘happy tummy’ character – quickly eats ameal in an airport lounge, causing it to suffer fromheartburn as it rushes to board the plane.

As the character is shown taking a portablestick-pack of Rennie Direkt – which each contain680mg of calcium carbonate and 80mg of magnesiumcarbonate – the advertisement highlights that theproduct’s ‘micro-granule’ formula quickly dissolves onthe tongue and then gets to work immediately oncontact to “free you from heartburn”.

Rennie Direkt is depicted as having a coolingeffect as it travels down the oesophagus, allowingthe ‘happy tummy’ to board the plane completelyrelieved of excess acid.

Scheduled to run throughout 2015, the creativewould target adults who occasionally suffered fromheartburn and indigestion and were “looking for anuncomplicated treatment”, Bayer pointed out. Itwould be supported by point-of-sale materials.

Launched earlier this year, Rennie Direkt was claimedby Bayer to be Germany’s first antacid in granularform (OTC bulletin, 13 February 2015, page 21).

Sanofi has stopped marketing its Avibon vitamin Askin ointment in France.

After batches of the ointment were recalled in March2013 due to “product stability” problems, Sanofi’s“various attempts at improvement” had not resultedin “a product that met current quality standards”, aspokesperson for the French firm told OTC bulletin.

Sold exclusively in France in 30g and 60g tubes,Avibon contains 1 million IU of retinol (vitamin A) per100g of ointment, and is indicated for “adjunctivetreatment of irritant dermatitis”.

OTC

OTC

OTC

■ BOOTS is encouraging UK consumers tomake sure they are “ready for hayfever season”by offering an own-brand Hayfever Care Kituntil 26 May. Priced at £11.99 (C16.56), thekit – containing Boots Pharmaceuticals One-A-Day Allergy Relief loratadine tablets andsodium cromoglicate-containing Allergy ReliefEye Drops, as well as the drug-free AllergyBarrier Nasal Spray launched last year (OTCbulletin, 25 April 2014, page 16) – is said to“protect, treat and relieve your symptoms”.

IN BRIEF

OTC

OTC

XLS-Medical Max Strength is claimed to be up to athird more effective for weight loss than the originalXLS-Medical Fat Binder

OTC17-04-15p14-17_Layout 1 15/04/2015 09:21 Page 4


MARKETING NEWS OTC

“Anew-generation pain reliever” is howGlaxoSmithKline (GSK) is positioning

its PanadolActifast analgesic caplets in Thailand.Indicated to relieve mild to moderate pain

– including headache, migraine, muscle pain andtooth pain – as well as to reduce fever, the prod-uct’s formulation of 500mg paracetamol and sod-ium bicarbonate per caplet meant that it could beabsorbed into the bloodstream at twice the speedof conventional paracetamol, GSK claimed.

Targeted at “upper-middle class” adults agedover 20 years, Panadol Actifast, which is avail-able in various other markets including Aus-tralia – where it is known as Panadol Rapid –Malaysia and the UK, had been launched to“respond to today’s consumers’ busy lifestyles”,the firm pointed out.

Launching the Actifast variant – which wassuitable only for those aged over 12 years –meant that the Panadol range in Thailand nowoffered “pain-relief products for consumersacross all age groups”, GSK added.

The Panadol line also includes infant dropsfor children up to two years, as well as twoPanadol Children suspensions – for childrenaged six months to six years and between sixand 12 years, respectively – and 500mg para-cetamol tablets, which can be used by those

aged six years and above.A television campaign began this month to

support the latest line extension. This was sched-uled to run until October, GSK noted, and wouldbe supported by out-of-home advertising ontrain station billboards until June and by on-line videos until August.

Advertising banners would feature on web-sites until the end of the year, the firm added.The Panadol website has also been updated.

A box of eight caplets has a recommendedretail price of TBH39.00 (C1.11).

Claiming the “growth rate of high-end medi-cines” in the Thai oral pain-relief market – saidto be worth TBH3.0 billion – was “higher thanthat of general products”, GSK pointed out thatconsumers were willing to pay extra for optionsthat delivered “fast and effective relief”.


GSK offers Thai consumers“new-generation” analgesic

One-a-day tablets are Schaper & Brümmer’s latestaddition to its Remifemin herbal medicine in Germany.

Each Remifemin mono tablet contains 5mg ofdried cimicifuga root extract. The pharmacy-onlymedicine is indicated for relieving complaintsassociated with the menopause, such as hot flushesand excessive sweating.

Packs of 30, 60 and 90 tablets have recommendedretail prices of C12.48, C19.88 and C27.81 respectively.

The Remifemin range also includes two-a-day2.5mg tablets, Remifemin Plus tablets that combinecimicifuga extract with St John’s wort, andRemifemin FeuchtCreme, a witch hazel cream forvaginal dryness that Schaper & Brümmer launched inOctober last year.

OTC

A “purifying” nasal spray has been added toLaboratoire Gomenol’s tea-tree oil-basedaromatherapy range in France.

Claiming that the essential oil was used as anantiviral and antibacterial to fight against respiratory-tract infections, the French firm pointed out that SprayNasal Gomenolé was indicated to help promote “morecomfortable breathing” by moistening and clearing thenasal mucosa in those suffering from colds and rhinitis.

Suitable for use by adults only, the spray adds toLaboratoire Gomenol’s existing range of joint and footcreams, muscle-relief gels, and products for ‘heavy’ legs.

One to two sprays should be administered up tothree times a day, the firm pointed out, adding thatthe product was not recommended for use for morethan five consecutive days.

OTC

OTC

Panadol Actifast had been launched to respond toThai consumers’ busy lifestyles, GSK claimed

23andMe has expanded the reach of its ep-onymous genetic-testing kit in the UK by

launching the product in Superdrug, its firstretail partner.

The kit – first made available in the UKlate last year through the company’s website,23andme.co.uk (OTC bulletin, 12 December2014, page 14) – could now be found in thepain-relief aisle of over 600 Superdrug stores,the firm noted, priced at £124.99 (C171.18).

23andMe said that the product would be sup-ported in stores through point-of-sale materials.

Positioned as providing “affordable accessto personal genetic information”, the kit enablesconsumers to take samples of saliva, which arethen sent back to the company for analysis.Once the analysis is complete, the user canaccess more than 100 reports, covering “health,trait and ancestry information”.

The Personal Genome Service (PGS) couldreveal “risk factors” for diseases or conditionssuch as Alzheimer’s, Parkinson’s and blood clott-ing, 23andMe claimed, and could test for genesassociated with certain inherited conditions, in-cluding cystic fibrosis and sickle-cell anaemia.

Furthermore, the test could allow consum-ers to learn more about certain traits, the com-pany noted, including why a person might bea frequent smoker, how they metabolised caf-feine and how their body responded to dietand exercise.

It also provided a full genetic ancestry re-port, 23andMe explained, so a user could pot-entially discover and communicate with newrelatives as part of its DNA Relatives service.

Commenting on the Superdrug deal, AndyPage, president of 23andMe, said the collab-oration with the retailer marked a “significantmilestone” for the company and would “im-prove accessibility for UK consumers”.

Last month, 23andMe said it had taken an“important first step” towards returning thekit to the US market, after the Food and DrugAdministration (FDA) approved the productto test for Bloom syndrome (OTC bulletin,6 March 2015, page 13).

In 2013, the FDA banned the sale of theproduct – five years after its launch – for vio-lating the Federal Food, Drug and CosmeticAct, as most of the intended uses for PGSlisted on the company’s website made the prod-uct a class III medical device that required ap-proval from the agency.

Product Launches

23andMe findsUK retail partner

OTC

OTC17-04-15p14-17_Layout 1 14/04/2015 17:32 Page 5

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5-7 May■ Vitafoods Europe

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

8 May■ Marketing

AuthorisationBerlin, GermanyCountries to be covered at thisone-day course include Azerbai-jan, Georgia, Kazakhstan, Turkeyand Uzbekistan.Contact: Forum Institutfür Management.Tel: +49 6221 500 680.Fax: +49 6221 500 555.Email: [email protected]: www.forum-institut.com.

11-12 May■ Pharmacovigilance,

Drug Safety andRisk ManagementLondon, UKSpeakers from Novartis, Pfizerand Takeda will attend this two-day conference.Contact: SMi Group.Tel: +44 20 7827 6000.Fax: + 44 20 7827 6001.Email: [email protected]: www.smi-online.co.uk.

14-15 May■ 2015 Regulatory

Scientific and QualityConferenceWashington DC, USThe future of consumer healthcare,collaboration, innovation, and qual-ity will be discussed at this two-day conference, organised by theUS Consumer Healthcare ProductsAssociation (CHPA).Contact: CHPA.Tel: +1 202 429 9260.Fax: +1 202 223 6835.Email: [email protected]: www.chpa.org/rsq.

19-21 May■ EU Pharmaceutical

Law ForumBrussels, BelgiumA three-day seminar focusing oncompetition law and patent liti-gation, regulatory frameworks and

licensing agreements.Contact: Informa UK.Tel: +44 20 7017 7481.Fax: +44 20 7017 7823.Email: [email protected]: www.informa-ls.com/pharmalaw.

19-21 May■ Russian Pharmaceutical

ForumSaint Petersburg, RussiaSpeakers from GlaxoSmithKline,IMS Health, Janssen, Pfizer, Stada,Takeda and Teva will attend thisthree-day event.Contact: Adam SmithConferences.Tel: +44 20 3377 3182.Fax: +44 20 7017 7447.Email: [email protected]: www.russianpharma.com.

21 May■ Basics of

PharmaceuticalRegulatory AffairsLondon, UKThis one-day course is run by TheOrganisation for Professionals inRegulatory Affairs (TOPRA).Contact: TOPRA.Tel: +44 20 7510 2560.Fax: +44 20 7537 2003.Email: [email protected]: www.topra.org.

28-29 May■ Pharmaceutical

Regulatory Affairsin the Middle EastLondon, UKCountries to be discussed at thistwo-day meeting include Bahrain,Egypt, Israel, Kuwait, Lebanon,Saudi Arabia and Yemen.Contact: Management Forum.Tel: +44 1483 730071.Fax: +44 1483 730008.Email: [email protected]: www.management-forum.co.uk.

1-2 June■ EuroPLX 58

Munich, GermanyThis two-day conference will pro-vide a forum for business devel-opment decision makers for dis-cussing and negotiating collabor-ative agreements in licensing, mar-keting, and distribution of patentedmedicines, generics, biosimilars,OTC products, medical devices

and food supplements.Contact: RauCon.Tel: +49 6221 426 2960.Fax: +49 6222 9807 77.Email: [email protected]: www.europlx.com.

9 June■ FDA: Marketing

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

14-18 June■ 51st DIA Annual

MeetingWashington DC, USThis five-day annual meeting isorganised by the Drug Informa-tion Association (DIA).Contact: DIA.Tel: +1 888 257 6457.Fax: +1 215 442 6199.Email: [email protected]: www.diahome.org.

18-19 June■ EU Pharmaceutical

RegulationsLondon, UKA two-day course providing anoverview of the European regu-latory environment, proceduresand obligations.Contact: Management Forum.Tel: +44 1483 730071.Fax: +44 1483 730008.Email: registrations@management-

forum.co.uk.Website: www.management-forum.co.uk.

22-24 June■ Pharmacovigilance

London, UKThis three-day event will look atthe principles and practice of glo-bal pharmacovigilance for thoseworking in drug safety.Contact: Management Forum.Tel: +44 1483 730071.Fax: +44 1483 730008.Email: [email protected]: www.management-forum.co.uk.

25 June■ OTC Medicines

Growth PerspectiveLondon, UKOTC drugs, food supplements,medical devices and prescription-to-OTC switches will be coveredat this one-day workshop.Contact: SMi Group.Tel: +44 20 7827 6000.Fax: + 44 20 7827 6001.Email: [email protected]: www.smi-online.co.uk.

14-15 October■ AESGP Conference

Brussels, BelgiumThis two-day conference, subtitled‘Substance-based medical devices:An important part of self-care’,is being organised by the Associ-ation of the European Self-Med-ication Industry, the AESGP.Contact: AESGP.Tel: +32 2 735 51 30.Fax: +32 2 735 52 22.Email: [email protected]: www.aesgp.eu/events/Brussels2015/.


EVENTS OTC

MAY

OCTOBER

JUNE

26-28 May■ 51st AESGP Annual Meeting

Barcelona, Spain‘Citizen empowerment: A megatrend of the 21st century’ is the themeof this three-day event run by the Association of the European Self-Medication Industry, the AESGP.

There will be sessions on: ‘New technology – new guidance – betterself-care’; ‘Self-care medical devices and food supplements: New driversin the self-care market?’; and ‘Switching: A mega trend?’.

Speakers will include: Werner Knöss, Andreas Pott and June Raineof the European Medicines Agency (EMA); Bernhard Url of the Euro-pean Food Safety Authority (EFSA); Dagmar Roth-Behrendt, formermember of European Parliament; Jaume Pey of the Spanish self-medi-cation association (ANEFP); Roger Scarlett-Smith of GlaxoSmithKlineConsumer Healthcare Europe; Brian McNamara of GlaxoSmithKline Con-sumer Healthcare; Sastry Chilukuri of McKinsey; Vincent Warnery ofSanofi; and Andy Tisman of IMS Health Consumer Health.Contact: AESGP. Tel: +32 2 735 51 30. Fax: +32 2 735 52 22.Email: [email protected]. Website: www.aesgp.eu/51.

OTC17-04-15p19Events_Layout 1 14/04/2015 17:20 Page 2

“OTC manufacturers need toknow that we are deter-mined to grow. So if theyinvest in us, Well will in-

vest in them, and both parties will benefit as weacquire more pharmacies and gain more mar-ket share,” is the message to OTC firms fromJohn Nuttall, chief executive officer of the UK’snewest pharmacy chain, Well.

Talking exclusively to OTC bulletin, Nutt-all said that Well’s parent company Bestway hadnot placed a limit on how big the chain couldget, but that growth would be achieved in a man-aged way that took advantage of the chain’sconnection with the communities it served.

“Part of what we are trying to do is deliversomething a bit different,” Nuttall claimed, “bytaking the best of what we have got – and webelieve we are giving the best service out therein the community currently – and adding it toour local connections and building around that.”

“We are taking the business more towardshealth and wellbeing,” he added, “and ensuringthat we can deliver the agenda laid out by theNational Health Service (NHS).”

Bestway – a privately-owned UK-basedwholesaling conglomerate – snapped up the780-store Co-operative Pharmacy chain for£620 million (C850 million) in July last year(OTC bulletin, 25 July 2014, page 1). The dealwas struck barely five months after the trou-bled Co-operative Group put the business upfor sale (OTC bulletin, 17 March 2014, page 3)and shortly before the group reported its worst-ever annual results.

The deal has brought a new player into aUK pharmacy market that is led by the 2,385-

strong Boots chain and the 1,650-memberLloydsPharmacy chain. Boots and LloydsPhar-macy are backed by the US-based drugstoreretailer Walgreens Boots Alliance and US phar-maceutical wholesaler McKesson respectively.

Bestway is the UK’s 18th largest privately-owned company with sales of £2.4 billion anda pre-tax profit of £53.5 million. Adding the Co-operative Pharmacy to the group would helplift sales to around £3.4 billion, the firm noted.

The company claims to be the UK’s second-largest independent wholesaler, serving 125,000independent retailers and caterers from 64 ware-houses nationwide.

Furthermore, the firm operates Pakistan’ssecond-largest cement manufacturing business

with sales of US$282 million (C209 million)and its second-largest private bank with assetsunder management of US$10.3 billion.

Explaining why Bestway had entered thepharmacy arena, Nuttall said that the companyhad been keen to “diversify” its UK businessand balance its business-to-business side witha retail offering.

“Bestway looked at the health sector anddecided that it was a market that had longevityand potential thanks to the UK’s demographictrends,” he added. “Furthermore, the companywas looking for a sizeable business that sharedthe same community-based ethos and values.”

Bestway unveiled the Well brand in Febru-ary, along with plans for a five-year, £200 mil-lion investment in the chain with the goal of lift-ing its turnover from £750 million to around£1.0 billion by 2019 (OTC bulletin, 6 March2015, page 6).

The £40 million-a-year investment plan dem-onstrated Bestway’s determination to grow theWell chain, Nuttall said, noting that the moneywould be spread across a number of areas,including store acquisitions.

“A significant chunk of the investment fundwill be going to acquire pharmacies to growour market share,” Nuttall said, “but we are alsolooking at expanding in care-home provision,

as it is an area where we are under-represent-ed. We need to invest in both people and prem-ises to drive that part of the business.”

“The balance will go on rebranding – themajority of that work will be carried out thisyear – and investing in our existing estatethrough refurbishments and relocations,” he said.

Expanding on the improvements the com-pany had planned, Nuttall explained that it was“working on a number of formats” and hadbegun piloting “a variety of different offers,all of which position Well as a health and well-being provider”.

Former Co-operative Pharmacy chief Nuttallsaid that further details on the store formatswould not be released until the pilot schemeshad been completed. However, he did revealthat the services that Well pharmacies providedwould play a key role in the offering.

“We need to find the right combination ofprivate paid-for services,” he pointed out, “aswe believe people will really respond posi-

tively to that. But at the sametime, we are aware that com-petitors have tried this beforeand have not been successful,so we have to look carefullyat that type of offer.”

Furthermore, Well would consider howbest it could deliver services that the NHS waskeen for pharmacies to provide to the public,Nuttall said.

“I do believe we are going to see some sig-nificant changes this year. Pharmacy will beplaying a bigger role in the NHS and this issomething we have been campaigning for be-hind the scenes,” he stated.

“I’m not sure all community pharmacies areready for it,” Nuttall warned, “but we certainlywant to be in a position to take advantage.”

Piloting of store formats would continuethroughout 2015, Nuttall said, adding that thecompany would have a “clear idea” by the endof the year how it wanted to change its retailformat to “best align Well to what customersare asking for and what the brand stands for”.

“I’m confident that at the end of the yearwe will be at a place where we know what ourproposition looks like and we can get busy land-ing that in the business,” he insisted.

Whatever the final format turned out to be,it would be flexible, Nuttall noted.

“We have to have flexibility,” he pointedout, “as we recognise that local variances mat-ter a lot and mistakes have been made in thepast with ‘one-size-fits-all’ offers which werenot necessarily what our customers wanted.”


OTC RETAILERS

When the Co-operative Pharmacy was put up for sale just over a year ago,the future of the UK’s third-largest pharmacy chain was uncertain. However,having been snapped up by wholesaler Bestway and rebranded as Well,things are now looking bright, Well’s chief John Nuttall told Matt Stewart.

Bestway helps Co-op Pharmacy get Well

The Co-operative Pharmacy chain grew to become theUK’s third-biggest before its parent company sold itto Bestway for £620 million last year

“A significant chunk of the £40 million-a-yearinvestment fund will be going to acquirepharmacies to grow our market share”

OTC17-04-15p20-23_Layout 1 14/04/2015 15:59 Page 2

“We have to look at the communities weare in and ask: ‘What do the people want?’ and‘What works in a particular community?’ Butwe also need to retain an element of centralcontrol so we can maximise the value of whatwe are doing,” Nuttall pointed out.

One key element of any new format wouldbe making the pharmacist more accessible tothe consumer, Nuttall said.

“How to bring the pharmacist into the frontof the store is an ongoing challenge across thesector,” Nuttall claimed, “and to overcome itwe have to find better ways of managing theprescription-end of the business.”

“We are tackling this in an intelligent way,”he explained. “Where we have electronic pre-scription services, we are looking at how we canmanage the workload in a more efficient way.Where possible we want to manage patients’repeat-prescription cycles for them.”

“This allows us to control the work and itallows the pharmacist more time to get front andcentre, and talk to customers,” Nuttall said.

“Another area where we have had a lot ofsuccess is where we have piloted non-pharma-cist managers,” Nuttall revealed. “This allowsthe pharmacist to express their clinical free-dom without the burden of the management ofthe store and commercial activities.”

“It is not something that will work for every-body but we are presenting it as an option inthe business and we can see it working for uscommercially,” he pointed out.

Pharmacy assistants would also play a keyrole in the growth of Well, Nuttall insisted.“They are the engine room of our business andthey are absolutely vital,” he added. “How weengage and motivate them is very importantas they are the face of the company.”

Supported by wholesale unitWell’s retail pharmacy chain will also be

backed up by its own pharmaceutical whole-saling arm, Nuttall noted.

The wholesaling business would be basedat Well’s existing national distribution centre,Nuttall pointed out, so would not be overlycapital-intensive.

“The Co-operative Pharmacy had alreadybuilt up a pretty good relationship with its in-dependent pharmacy colleagues through the dis-tribution centre,” he said, “and we plan to lever-age that and offer them something we don’t thinkthey are getting currently, which is the best valuebusiness-to-business offer that is out there.”

“The national distribution centre has thecapacity to serve double the number of pharma-cies it is at the moment,” Nuttall pointed out.“We built it with growth in mind.”

“The Co-operative Group was less focus-ed on a business-to-business offer,” Nuttall

claimed. “It always saw itself as a consumer-only business.”

“But now we are free to get into the whole-sale market,” he said. “We understand it andwe are the largest independently-owned phar-macy chain, so our buying power is significantand we can share that with our independentpharmacy colleagues and give them somethingthey are not getting from their short-line ormajor wholesaler.”

“I think Well is going to be the business towatch in the pharmaceutical wholesaling arena,”Nuttall insisted.

Turning to how best consumer healthcarecompanies could work with Well, Nuttall reiter-ated that the pharmacy chain’s growth plansshould demonstrate to suppliers that Well wasworth investing in.

“Where you see some sectors of the marketin flat and negative growth, then the opportu-nities we are opening up for suppliers are some-thing they should to look forward to.”

“As we change our proposition on the con-sumer healthcare side, it gives us the opportunityto test new ranges, explore new product areasand build on the work we have done in the paston how we allocate space in our stores,” he said.

“We are looking to give more space to medi-cines, more space to health,” Nuttall insisted,“and we are seeing some very positive numbersoff the back of that.”

“The key is how our suppliers engage withour in-store colleagues that sell products,” Nutt-all explained. “There is a clear opportunity todo more in that area.”

“Remember, those counter assistants arethe mechanism to get healthcare products topatients in an effective way,” he maintained.

“Better training and engagement with theproduct is also key,” Nuttall said. “Hands up, inthe past we have not been as active as we shouldhave been in that area,” he admitted, “but it’san open door now for suppliers to talk to usand we will make it happen on the ground.”

The future of consumer healthcare in theUK is going to rely on how well the industryand the NHS educate the consumer on how bestto self-care, Nuttall pointed out.

Pass services to pharmacy“We also have to ask about the affordability

of healthcare in the UK and what we can passdown the chain to the lower-cost providers,”he added.

“I think the answer is pretty clear,” Nuttallinsisted. “If you go to see your doctor about aminor ailment, it costs the NHS £45, but if yougo to a pharmacist the whole process costs con-siderably less.”

“Why are we allowing our accident andemergency departments and doctor’s surgeriesto be blocked up with people presenting withminor ailments?” Nuttall asked.

“It’s up to the NHS to signpost to pharmacy,engage with us, and get a package that worksas it is doing in Scotland,” he argued. “Let’s getthe public coming into pharmacy to talk aboutminor ailments and get the products they need.”

“It has worked in Europe,” Nuttall pointedout. “We just need a different engagement strat-egy and for our NHS policy makers to drivethis home.”

Nuttall said he believed that there would besome “clear opportunities in 2015 for pharmacyto engage with consumers in a different way”.

“Doors will be opened by the NHS and it’s


RETAILERS OTC

John Nuttall, chief executive officer of Well, said that its owner Bestway had not put a limit on how big thechain could get and was keen to invest in the UK pharmacy sector

OTC17-04-15p20-23_Layout 1 14/04/2015 15:59 Page 3

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OTC BC House Ad AUGUST 2014_Layout 1 15/10/2014 10:30 Page 1

■ SANTEN has appointed Shigeo Taniuchito lead the Japanese firm’s European business.Since joining the company in 1996, Taniuchihad held a number of posts within Santen,

the firm noted, and brought “15 years of top-level management experience and global lead-ership” to his new role.

Steve Gray, currently Superdrug’s healthcaredirector, will take up the newly-created posi-

tion of international healthcare director at theretailer’s parent company, AS Watson, in Jan-uary 2016.

Pointing out that Gray’s appointment in thenew role reflected the “growing importance ofhealth” to AS Watson’s future strategy, the firmsaid he would work “closely” with its chief op-erating officer, Malina Ngai, to “accelerate theincrease of healthcare sales” across the group.

After joining Superdrug in 2012, Gray hadgrown the retailer’s health division by over afifth, AS Watson – the retail subsidiary of HongKong-based Hutchison Whampoa – pointedout, through the development of its Wellbeingconcept store, as well as building successfullyits “online health offer” with its Online Doc-tor web service.

Gray would “continue to concentrate on de-livering health-category growth in Superdrugfor the remainder of 2015,” the company added.

Currently, AS Watson operates 20 healthand beauty retailers, including Kruidvat, Super-drug and Watsons, with over 11,000 stores in33 markets worldwide.

Most recently the company expanded itspresence in the Netherlands by gaining the 50-strong Dirx Drugstore chain for an undisclosedsum (OTC bulletin, 2 February 2015, page 3).

Prior to joining AS Watson, Gray held therole of chief operating officer at LloydsPhar-macy’s parent company Celesio.


PEOPLE OTC

Retailers

AS Watson selects Gray tohead international health

incumbent upon us as a profession to deliver,”he warned. “What we can’t do is approach itas we may have done in the past in a haphaz-ard and half-baked way. We have to land thisand make it work.”

“When you look at medicines-use reviews(MURs), the level of take-up at first across theprofession – including ourselves – was reallypoor,” Nuttall admitted. “But looking backnow, they have been really effective and havebeen a success across the UK.”

“What the NHS wants,” Nuttall claimed, “isthe confidence that we will deliver when some-thing new is presented to us.”

Asked whether the recent reverse-switchof the oral analgesic diclofenac by the UK’sMedicines and Healthcare products Regula-tory Agency (MHRA) showed a lack of con-fidence in pharmacy, Nuttall was clear that hefelt the decision was simply the act of a risk-averse regulator.

Pharmacy market over-regulatedHowever, Nuttall said he did believe that

the UK pharmacy market was “over-regulated”.“The volume of information we have to dealwith on a daily basis has gone up exponentiallyover the past few years and there are well-doc-umented reasons for that.”

“But if you are the regulator, you are risk-averse,” Nuttall conceded. “I think it’s for us asa profession to get ourselves to a place wherewe can deliver and I think it’s coming.”

“I feel more confident now about pharmacythan at any point in my career,” Nuttall said,“and that is a long time!”

OTC

Steve Gray

OTC

Walgreens Boots Alliance (WBA) haselected John Lederer, chief executive

officer of food distributor US Foods, to itsboard of directors.

Prior to his current position, Lederer hadserved as chairman and chief executive officer

of New York-based drugstore chain DuaneReade, which was acquired by Walgreens in2010 (OTC bulletin, 17 March 2010, page 9),WBA pointed out.

He had also spent 30 years – six as presi-dent – at Loblaw Companies, the firm noted,which was Canada’s largest food distributor.

Commenting on the election, Jim Skinner,WBA’s executive chairman, said Lederer’s “suc-cessful record of leading and transformingmajor retail and wholesale companies” wouldhelp the newly-established global enterprise– created through Walgreens’ takeover of Alli-ance Boots at the end of last year (OTC bul-letin, 16 January 2015, page 5) – “realise itsvision to be the first choice for pharmacy, well-being and beauty”.

Wholesalers & Retailers

Lederer joins WBA board of directors

John Lederer

OTC

Well will benefit from a five-year, £200 millioninvestment plan that will be focused on growing the780-store chain

IN BRIEF

OTC

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OTCBulletin_VMS_297x210mm.indd 1 30/03/2015 15:30:32

perrigo considers its future as mylan offers us$29bn · 2018. 11. 19. · billion (c488 million)...

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