Pfizer Building Viagra As Pan-European Consumer Health Brand with Rx-To-OTC Switch in Norway TOM GALLEN [email protected]

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Pfizer Building Viagra As Pan-European Consumer Health Brand with Rx-To-OTC Switch in Norway TOM GALLEN Tom.Gallen@Informa.Com No. 34 • 9 September 2019 Pfizer Building Viagra As Pan-European Consumer Health Brand With Rx-To-OTC Switch In Norway TOM GALLEN [email protected] and expertise of its new consumer health joint venture partner GlaxoSmithKline PLC, however, as OTC versions of Viagra are ex- cluded from the scope of the deal. MANDATORY CHECKLIST FOR PHARMACISTS As Norway has classified Viagra Reseptfri as a non-prescription medicine with guid- ance – a new OTC category introduced last year by the country’s medicines agency, Statens legemiddelverk – consumers look- ing to purchase the product will be re- quired to speak to a pharmacist and com- plete a checklist to ensure its suitability. “The purpose [of the checklist] is to clarify whether the consumer has illness- es or uses medicines that prevent him from using Viagra Reseptfri,” the agency fizer Inc.’s blockbuster erectile dys- Norway is the second country in the explained. “If the conditions for non-pre- function treatment Viagra will soon world to switch Viagra, with the UK reclas- scription purchase are not met, the con- Pbe available without a prescription sifying the sildenafil-based drug at the sumer will be advised to contact a doctor.” in Norway after the firm secured the first end of 2017. (Also see “Viagra Connect hits The checklist (in Norwegian) comprises Rx-to-OTC switch into the country’s newly UK shelves” - HBW Insight, 13 Apr, 2018.) seven questions which the pharmacist created “non-prescription medicines with And now there are calls for Sweden to fol- must ask before Viagra Reseptfri can be guidance” category. low its neighbor’s lead in switching Viagra. supplied. If a consumer answers “yes” to Pfizer revealed that it was aiming to Sweden rejected a switch application any of the questions – which include “Have launch OTC sildenafil – under the brand from Pfizer in 2017 but the Association of you had a heart attack or stroke in the last name Viagra Reseptfri, which translates Swedish Pharmacies says the country’s 6 months?” and “Are you taking medicines as Viagra Prescription-free – in Norwegian medicines agency should review its de- containing ritonavir for HIV infection?” – pharmacies “in early 2020.” cision and make the drug available OTC the pharmacist cannot sell the product. Viagra Reseptfri (sildenafil 50mg) will with mandatory pharmacist advice. For those men judged suitable for Vi- be available from a pharmacist (in store The Norwegian approval means Pfizer agra Reseptfri, the pharmacist will still or online) without a prescription for men can now begin to build Viagra as pan- advise a visit to their doctor within six aged 18 years or older suffering from erec- European consumer health brand and months for a check-up given that erec- tile dysfunction. The maximum dose is potentially open up erectile dysfunction tile dysfunction can be an early sign of one tablet a day, with a pack size of up to as a new OTC category across Europe. The health problems such as cardiovascular eight tablets. firm will have to do so without the support CONTINUED ON PAGE 4 FOR THE LATEST INSIGHT ON OTC, DIETARY SUPPLEMENTS AND COSMETICS VISIT: HBW.PHARMAINTELLIGENCE.INFORMA.COM HEALTH BEAUTY WELLNESS Future Still Looking Bright For UK CBD Suits Challenge ‘THC-Free’ Claims As FDA Decides CBD Regulatory Switch, Even After Brexit – Q&A With After Users Fail Drug Tests; Plaintiffs Path, Sales March On For Suppliers, PAGB’s Michelle Riddalls, p. 4 Bar May Just Be Warming Up, p. 10 Retailers, p. 18 Global Regulatory and Compliance Insight for Fast Regulatory Approval Successfully navigate the complex world of Pharmaceutical Regulatory and Compliance with access to worldwide intelligence for approved and pipeline drugs. 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To fi nd out more, visit: www.pharmaintelligence.informa.com/ pink-sheet JN2181 Pink Sheet Advert HBW A4.indd 1 2019/06/05 12:57 20 10 15 21 Global Regulatory and inside: COVER / Pfizer Building Viagra As Pan-European Consumer Health Brand With Rx-To-OTC Switch In Norway Compliance Insight for exclusive online content Health Study Takes Measure Of Supplement Size Fast Regulatory Approval 4 Future Still Looking Bright For UK Switch, And Link To Swallowing Problems Even After Brexit – Q&A With PAGB’s Michelle Riddalls https://bit.ly/2lYD3lr FDA, CDC Analysis of 20,791 AERS for supplements 6 Private-Label OTCs ‘Extremely Popular’ With German from 2006 through 2015 found 3,962, 19.1%, indicated Consumers, Says McKesson, As It Extends Own-Brand Line Successfully navigate the complex world of Pharmaceutical swallowing problems. Regulatory and Compliance with access to worldwide 7 Latest Aleve PM Copy Could Have 180-Day Exclusivity From Additional Generic Competition intelligence for approved and pipeline drugs. Coty Elevates Advertising Over Promotion 9 Perrigo Wakes Up UK Sleep Category With Liquid Nytol In Consumer Beauty Reboot Tracking product progress from submission to approval, our https://bit.ly/2kvM3y1 exclusive network of worldwide analysts and journalists cover Coty has been too dependent on promotion versus critical areas of regulatory insight and analyse the implications advertising and shy about taking pricing – but no longer, Beauty says CEO Pierre Laubies. of worldwide developments on your business. 10 CBD Suits Challenge ‘THC-Free’ Claims After Users Fail Drug Tests; Plaintiffs Bar May Just Be Warming Up Anticipate challenges, minimize risks and maximize Clear Eyes Recall Adds Clarity To Extent opportunities. 11 Accused Lab Operator: Like FDA, Of Impact From Altaire Sterility Concerns He Didn’t Find Falsified Sunscreen Results https://bit.ly/2kh9afT Numbers of containers recalled vary from nearly 6.7m bottles 12 IFRA’s 49th Amendment To Safety Standards of Clear Eyes Redness Relief to 1,752 of brand’s Maximum Coming Soon With QRA2 Updates Itchy Eye Relief. To fi nd out more, visit: 14 Coty Begins Portfolio Pruning; Farewell, Younique www.pharmaintelligence.informa.com/ Lumity Supplement Clinical Study Shows 15 Natura Making Strong Headway In The Body Shop pink-sheet Improvements In Skin, Energy Levels Transformation; Next Up, Avon https://bit.ly/2lB4QrZ Participants using Lumity Life’s anti-aging supplements reported skin appearance improved 92% and energy levels Wellness 84% in 12-week clinical study firm. 18 As FDA Decides CBD Regulatory Path, Sales March On For Suppliers, Retailers Sunscreen Test Lab Used Fewer Subjects Than Reported, US Prosecutors Allege 19 CBD Industry Group Commits To Compliance https://bit.ly/2k16t1H With EU Novel Food Law AMA Labs owner arrested on wire fraud and conspiracy charges following release of indictment in New York federal 21 Hershey’s Latest Nutritional Space Sweet Spot: court. Four employees arrested on similar charges pleaded $397m For One Brands guilty in May. 22 Cambridge Esthechoc Beauty Chocolate Anti-aging Claims Unpalatable In UK HBW-Insight @HBWInsight hbw.pharmaintelligence.informa.com 9 September 2019 | HBW Insight | 3 JN2181 Pink Sheet Advert HBW A4.indd 1 2019/06/05 12:57 HEALTH (OTC DRUGS) CONTINUED FROM PAGE 1 terfeit drugs, the UK’s Medicines and potential for unintentional misuse and disease or diabetes. As purchases of Vi- Healthcare products Agency noted at possible abuse of the drug for recre- agra Reseptfri will not be documented the time of the switch. ational purpose. in medical records, pharmacists will rec- Making Viagra Connect available with- Meanwhile in the US, encouraging ommend that consumers inform their out a prescription would “help direct men signs that Pfizer and its France-based doctor that they are using the product. who might not otherwise seek help into rival Sanofi might be gearing up for an the healthcare system”, the MHRA claimed, erectile dysfunction drug switch are yet PHARMACIST GUIDANCE “and away from the risks that come with to lead to anything concrete. In 2016 we REDUCES RISK buying medicines from websites operat- reported that Sanofi was seeding the Commenting on the rationale for approv- ing illegally.” field for potential introduction of an OTC ing OTC sale of Viagra, Statens legemid- Cialis (tadalafil) with a US survey show- delverk said the move would promote SILDENAFIL SWITCH - A ing nearly 75% of men say sexual health self-care, while the requirement for man- GLOBAL OPPORTUNITY is “critical” to their happiness, while at datory pharmacist guidance at the point Around the world sildenafil remains the same time Pfizer was recruiting a of purchase would “reduce the risk of mis- largely a prescription-only drug. Po- “global sexual health” brand manager use and side effects.” land became the first country to allow with responsibilities including shep- The guidance category gives con- men to buy sildenafil OTC in 2016 with herding market expansion through an sumers an extra layer of protection not the switch of Adamed’s MaxOn Active Rx-to-OTC switch. included within Norway’s historical OTC product, which is available at the lower Holding back a US switch could be the categories of pharmacy-only and gen- strength of 25mg. country’s drug classification system which eral sales list. Prior to the ‘true’ prescription-to-OTC does not subdivide its OTC category with Making Viagra available OTC would switch of sildenafil in Poland, New Zealand pharmacy-only and general-sales list clas- help to reduce “illegal and dangerous” had come closest to granting OTC status. sifications as is common across Europe. online purchases of erectile dysfunction Sildenafil, however, remains partially re- Therefore, any firm seeking to switch an drugs, the agency explained. “Illegal drugs stricted in the country. It is still a prescrip- erectile dysfunction treatment must con- are found in one of four controlled mail- tion medicine “except when supplied by a vince the US Food and Drug Administra- ings, and in many cases these are erectile pharmacist who has successfully complet- tion that a consumer can safety self-select dysfunction drugs.
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