Lifestyle OTCs still the best hope for OTC switch revival

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2019 has been a slow year for Rx-to-OTC switch news, with activity dropping off markedly in the key US market in recent years, and Asia-Pacific (especially China, Japan and Indonesia) and Europe (Poland especially) the main source of developments. In this context, it was welcome news last week that Norway will become the second European market for OTC Viagra, after the Norwegian Medicines Agency approved the OTC sale of Viagra Reseptfri (Pfizer, sildenafil 50mg) erectile dysfunction treatment to men aged 18+ years, with this to be accompanied by pharmacist advice.

Pfizer plans to launch Viagra Reseptfri in pharmacies in early 2020, while Rx Viagra will remain available. The medicines agency recommends that men have a check-up with their doctor within six months of purchase so that any potential underlying conditions can be investigated. Viagra Reseptfri will be the first medicine available in Norway under the country’s new category of non-prescription medicine with guidance, and the Rx-to-OTC switch follows similar measures elsewhere in Europe. In Poland, sildenafil 25mg is available OTC from a number of domestic players, with initial launch from Adamed in May 2016, while Viagra Connect was launched in the UK in March 2018.

Of the 20 key markets covered by OTC New Products Tracker every month since the start of 2013, Poland has been the most active in terms of Rx-to-OTC switch activity, with 54 products reclassified to non-prescription status. A liberal switch environment has helped bring about a raft of Rx-to-OTC switches since 2014, including Europe’s first OTC erectile dysfunction brand and Poland’s first OTC systemic cold sore treatment.

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Despite some notable failures (such as urinary product Flomax Relief), so-called “lifestyle” drugs remain the primary source of switch activity, helping to extend the reach of the OTC market into new categories such as contraception, erectile dysfunction and cardiovascular disease. A key switch development in 2019 was the downscheduling in Japan of Taisho’s hyperlipidaemia treatment Epadel T (ethyl eicosapentaenoate) to Class I OTC, where sales are permitted in pharmacies (and online) after professional consultation. Downscheduling may have come just in the nick of time – sales data suggest Epadel T had failed to make any noticeable impact on the OTC market in its almost six years as an Instruction-Required Drug.

There also remains hope that Sanofi may one day market Eli Lilly’s erectile dysfunction treatment Cialis as an OTC medicine (it owns the rights to market Cialis OTC in the USA, UK, Canada and Australia), but is switch application has been stuck at the FDA a full five years since its submission. In July 2019, Sanofi also signed a deal with Roche for the exclusive OTC rights to Tamiflu (oseltamivir 75mg capsules, Genentech / Roche Group) for flu prevention and treatment in the USA. Under the terms of the agreement, Sanofi will be responsible for leading negotiations with the US FDA for the OTC switch and subsequent exclusive marketing, scientific engagement and distribution of Tamiflu OTC in the USA. Let’s hope for the sake of OTC growth that its negotiations go smoothly.

Clear your diary for Nicholas Hall’s 31st European Conference, which will be held in Athens on 28-30 April 2020, on the theme of Advancing in CHC: The Must-Dos and  Reasons Behind Them. To register your interest in this event, or for more information on sponsorship opportunities, please contact jennifer.odonnell@NicholasHall.com.

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Tamiflu to switch to OTC in USA?

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With 2018 a barren year for Rx-to-OTC switch, it is welcome news that Sanofi has signed a strategic deal with Roche for the exclusive OTC rights to Tamiflu (oseltamivir 75mg capsules, Genentech / Roche Group) for flu prevention and treatment in the USA. Under the terms of the agreement, Sanofi will be responsible for leading negotiations with the US FDA for the OTC switch and subsequent exclusive marketing, scientific engagement and distribution of Tamiflu OTC in the USA. Roche will continue to market Tamiflu in the rest of the world and Sanofi will retain the rights to first negotiations for switch rights in other selected markets. Sanofi’s Executive VP for Consumer Health, Alan Main, noted that: “A successful switch of Tamiflu to OTC would support our global cough and cold strategy by expanding into flu with a sustainable point of difference in the market.”

As Nina Stimson, OTC.NewDirections Consulting Editor, commented: “To some extent this was an unexpected development, but welcome insofar as (if approved), OTC Tamiflu will help expand the boundaries of consumer healthcare. Of course, in certain conditions (such as the swine flu pandemic in 2009-10) Tamiflu has sometimes been available from pharmacists without a prescription; New Zealand was one such country to permit OTC supply on a temporary basis.” 

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Tamiflu’s patent in the USA and some other markets expired in 2016 and, as the chart above indicates, this has led to a steady decline in sales over recent years, with US Tamiflu sales falling by 29% in 2018 to total CHF168mn (US$170mn). Generic competition intensified in the USA in 2017 and continues to grow, while Tamiflu brand sales are now also in decline in Japan and internationally. Roche is now focusing its efforts on Tamiflu’s successor, Xofluza, which was approved by the FDA in late 2018.

If Tamiflu can switch to OTC successfully in the USA, then similar reclassifications will likely follow elsewhere. In 2009, in the midst of the global swine flu pandemic, Australia’s State of Victoria issued a public health emergency order allowing pharmacists to supply Tamiflu (oseltamivir) without a prescription. There has also long been talk of Tamiflu switching to OTC in Europe – in 2008, at the AESGP meeting in Sweden, the EMA’s Executive Director Thomas Lonngren cited Tamiflu as a possible candidate for the EU’s then newly created centralised procedure for Rx-to-OTC switch.

Explore the latest CHC Innovations and Technologies at our OTC.NewDirections Executive Conferencetaking place in London on 14 November 2019. Nicholas Hall and Nina Stimson will be joined by experts from companies including Bayer, Mundipharma and J&J to review key issues impacting our industry and ensure that you are Keeping Consumers in the Spotlight. Book your place before 13 September to take advantage of our early bird booking discount and save GB£100! To find out more, or to reserve your place, please contact Elizabeth.Bernos@NicholasHall.com.

CHPA Report & Conference

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Last week, to tie in with its Annual Executive Conference (AEC), the Consumer Healthcare Products Association released a white paper that found, on average, every dollar spent on OTC medicines saves the US healthcare system around US$7.20, resulting in nearly US$146bn in savings annually. CHPA President & CEO Scott Melville commented that the “healthcare system undervalues the contribution of our industry’s products”, and explained that the research will support legislative initiatives promoting financial incentives for consumers to buy OTCs using health insurance flexible spending plans.

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Done in partnership with IRI, the study was conducted in part to raise the profile of OTC products in USA. It found that around 90% of people who buy an OTC product for a condition would seek medical care if the OTC product had not been available. The study analysed nine OTC categories to identify the primary contributors of cost savings to the healthcare system. The categories include allergy, analgesics, antifungals, cough / cold / flu, lower GI, medicated skin, upper GI, sleep and smoking control. The research showed that OTC medicines provide additional value through expanded access to more than 27mn consumers who would otherwise forgo treatment – more than 13mn Americans for allergies alone.

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Writing from Florida, Nicholas Hall said: “Trust was a major theme of CHPA’s Annual Executive Conference … Edelman presented data showing that consumer trust of healthcare is improving after plummeting last year. Speakers agreed that trust goes beyond building brands. In a session I moderated on Tuesday, Bayer CH President Heiko Schipper said that our industry needs to, “articulate better what we do. We are doing a lot of good things like being responsible for the environment and employee diversity”.

Taisho Executive VP Ken Uehara agreed: “Trust can’t be built instantly, certainly for our company, it’s our most important asset.” Alan Main, Executive VP, Sanofi, commented that in the past it was about building the brand: “I still think the brand comes first in people’s minds, but we have to look after the brands, not just for five years but for 30-40 years.” Katie Devine, who is moving into a new leadership role at J&J, said companies can choose not to reply to every tweet, but should maintain a fact-based conversation about being responsible in the treatment of employees, the population and planet.

Other questions I addressed to the Leadership Panel concerned the lack of Rx-to-OTC switch (Alan Main said switch has an important role to play in the future of self-care); CBD (all panellists believe it will develop well beyond the current US$500mn quoted by IRI, although Katie’s point, “I know how to switch from Rx to OTC, but not from illegal to legal”, was well taken); and the number one item on their wish list — speed to market and improved innovation were favourites … I liked the concentrated format of this year’s AEC, with two half-day sessions, which allowed time for networking, and was proud to have been one of three Preferred Sponsors of the meeting, in the good company of Google and the Emerson Group.”

Nicholas Hall will discuss the latest Market Trends and Innovation impacting the CHC market at our annual North American CHC Conference (26-27 June) in collaboration with our partners EverythingHealth. As well as the chance to network with other industry players, you can hear from Google, Jefferson Health, Persuadable Research and other industry experts. Don’t hesitate — book before 31 March to save with our generous early-bird booking discount! To find out more about this event, please contact elizabeth.bernos@NicholasHall.com.

OTC Innovation Report 2018

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Lamenting the fact that Scott Gottlieb is stepping down as FDA Commissioner, Nicholas Hall commented in Friday’s OTC.Newsflash that: “Although producing few tangible results so far, FDA under Gottlieb has displayed a greater openness to finding new switch models at a lower cost and with shorter lead times, including the use of new technologies.” Nicholas Hall also said that “government support is vital to our industry” and that “more liberal regulations are at the heart of a successful self-care sector”.

A drop-off in switch activity over the past year is part of the explanation for lower levels of high-quality OTC innovation. In 2018, OTC New Products Tracker awarded just six products with 4 stars – eye care brands Lumify (USA) and Zabak Eye Drops (Poland), antacid Reza Band (USA) and antispasmodic Scopolan Compositum (Poland), plus Viagra Connect (UK) and allergy remedy Talerc (Brazil). Compared to previous years, this marked a falling-off in terms of 4-star innovations.

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The number of total OTC innovations (3,747) in 2018 was roughly in line with the previous year, and still much higher compared to 2014, 2015 and 2016. However, the number of 2* (528), 3* (94) and 4* (6) innovations was much lower, while the number of 1* innovations (3,119) was at an all-time high.

VMS continues to be a major source of innovation, with three of the Top 5 subcategories in 2018 – probiotics, multivitamins and hair & beauty supplements. Derma is another key source of innovation, with three of the Top 10 – acne remedies, eczema & psoriasis and lip care. The three other innovative subcategories which complete the Top 10 are sedatives & sleep aids, topical analgesics and sore throat.

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Please contact us for the full report. You can also review 17,000+ new launches and innovations with OTC New Products Tracker, the ultimate competitive intelligence tool! Products are given a star rating, with “me too” items ranked 1*; launches / line extensions in a new category / adjacency 2*; major launches / line extensions with strong new benefits / positioning 3*, and 1st Rx-to-OTC switches in a category, creation of a new OTC class or other major leaps in innovation 4*. With a recently-released major update including eye-catching new graphics and powerful search filters that help you visualise and explore the vast archive according to your exact requirements, now is the ideal time to set up your free trial. For a demo or more information, contact waisan.lee-gabell@NicholasHall.com.

Demand high for cannabis, but its self-care future in Canada is uncertain

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Since Canada’s introduction of the Cannabis Act, which came into force on the stroke of midnight on 17th October 2018, government-operated websites and private retailer portals powered by Shopify are reporting “hundreds of thousands” of orders, according to the company’s VP, Loren Padelford. In addition, long queues have been reportedly forming outside licensed retailers across the country, leading to shortages in some areas.

Canada is now the second country after Uruguay to legalise cannabis for recreational use by adults, who can possess up to 30g of legal cannabis, dried or equivalent in non-dried form in public; share up to 30g with other adults; purchase cannabis products from a provincial or territorial retailer; and grow up to four plants per residence (not per person) for personal use from licensed seeds or seedlings.

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At the same time, however, Health Canada has shut down all possible direct pathways for companies to market any cannabis-derived ingredient for health purposes. This, according to the department, is because the safety (and efficacy) of cannabis “is currently insufficient” once a health claim is added to a product label. This means that all levels of THC and CBD sold without a label claim can be sold to any adult but those with a claim may not.

Health Canada also ruled that all phytocannabinoids will be required to make an application for an Rx-to-OTC switch before consumer health claims could be granted through a further amendment to the Prescription Drug List. Of course, this requires a company to make an application under the New Drug regulations and pay significant fees for the processing the application. Not surprisingly, this decision lands all cannabis health products in the most expensive pathway to market access, likely only affordable to the largest of players.

For an in-depth report on this breaking story, see the forthcoming issue of OTC INSIGHT North America. If you work outside of North America, we also have titles covering Asia, Europe and Latin America. Click here to find out what key features OTC INSIGHT includes! To receive a sample issue or for details of subscription rates, please contact melissa.lee@NicholasHall.com

MAT Q1 2018: Global OTC growth steady at 4.1%

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According to Nicholas Hall’s global OTC database, DB6, the OTC market maintained 4.1% growth in the 12 months to end-March 2018. This steady but slower rate of global OTC growth compares to a faster pace during the first three quarters of 2017, when growth peaked at 4.6%.

The key factor in the persistent slowdown in Q1 2018 was lower OTC growth in the USA (+2.5% vs +2.8% for calendar 2017), with faster development held back by a weak allergy season. As highlighted in our OTC DASHBOARD market summary for North America, the impact of recent Rx-to-OTC switch activity in the US market has also been minimal.

Some positives emerged in the MAT Q1 2018 data. OTC growth in Western Europe improved to 1.8%, boosted by a high incidence of cough & cold in the first quarter of this year, while Latin America’s OTC market continued to increase strongly (+11.8%), with leading country Brazil up by 9.8%.

The OTC performance in Asia-Pacific (+4.7%) was mixed, with China (+6.3%) and India (+7.9%) improving upon their 2017 growth, however Japan and Australia remained flat in Q1 2018. Growth in the Middle East & Africa remained stable at 6.7%, while Central & Eastern Europe decelerated further to 5.5%, with weakening growth in both Russia (+3.5%) and Poland (+3.3%).

If you are not a subscriber and would like to find out more about what DB6 covers, please contact kayleigh.griffinhooper@NicholasHall.com for a free demo.

 

Further FDA delays to NSURE guidance on Rx-to-OTC switch

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One of the key topics at our North American OTC Conference to be held in Morristown, New Jersey this week (20-21 June) is Rx-to-OTC switch, and opportunities for marketers in the dynamic US regulatory climate. Hopes that the FDA would publish guidance this year on the Nonprescription Safe Use Regulatory Expansion (NSURE) were recently dashed after the Notice of Proposed Rulemaking date was changed to February 2019.

NSURE was introduced in 2012 to encourage utilisation of technology to “ensure” the safe use and self-selection of innovative Rx-to-OTC switches, but the programme has been stalled for several years.

At the Consumer Healthcare Product Association’s recent Regulatory, Science & Quality meeting, FDA Deputy Director for Regulatory Programs, Dr Doug Throckmorton, assured attendees that the 5-year delay had “nothing to do with our interest and support”, but was a result of administrative priorities. He encouraged sponsors to bring ideas to the FDA. This request has been voiced for several years, but manufacturers appear to be waiting for the draft guidance.

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For those that can’t make this week’s meeting, Nicholas Hall’s Opening Address will be live-streamed here at 8.30-9.10 on Wednesday 20 June.

Following this, you can also view these live presentations:

Dave Wendland, Hamacher Resource Group, will be presenting on Independent Pharmacy Opportunity: Myth or Reality? on Wednesday 20 June 09:40-10:10 here 

Join the CHC Institute Launch with Steve Sowerby and Ed Rowland on Wednesday 20 June 14:15-15:15 here 

See Joseph McGovern, Everything Health, review the Key Issues of Switch on Thursday 21 June 09:00-09:30 here 

Plus, join Everything Health’s Mary Alice Lawless & Joseph McGovern to review how you can Change the Words to Change the World in the move from OTC to Non-Prescription, followed by Nicholas Hall’s Summary & Close of the meeting on Thursday 21 June 12:40-13:30 here 

All timings EST. To ensure you enjoy the event in full (download the brochure here), including panel sessions and networking opportunities, reserve your place now by contacting lianne.hill@NicholasHall.com