North America Conference Report

Nicholas Hall’s North America e-Conference was held last week, with various speakers giving inspiring presentations on the latest trends in the CHC market, innovations, rising brands, keys to brand success, modern marketing strategies and future growth categories.

Nicholas Hall began the webinar by unpacking current key trends in the industry, such as high interest in probiotic & prebiotic products and CBD, despite markets for both flatlining. He examined how many jumped on the immunity bandwagon in response to the pandemic, with brands such as elderberry-based Sambucol experiencing great success in 2020, but also how this category has seen a slowdown in the first few months of 2021. Nicholas concluded with a look ahead at Infinity Zones (future growth categories), which include probiotics, food allergy & intolerance, cannabis, sexual health and obesity (among others).

The following talks focused on the non-prescription imperative, and how the current challenge of access to health treatment in the USA may best be addressed. Mary Alice Lawless discussed the new and exciting capabilities of Biograph by Amwell, which uses fully customisable, layered frameworks for proper implementation of labelling strategies and allows for communication and education to be personalised to an individual profile. Jim Parker and Joseph McGovern discussed the issue of undertreatment in the USA and the steps that can be taken to increase and improve access to treatments on a non-prescription basis, including CHC product development and advances in technology to help consumers self-diagnose conditions and ensure proper self-selection. Clark Richardson finished this section of the webinar, concluding that the next crops of OTC switch candidates will require different tools to help consumers safely select and use medications, and that comprehension studies, self-selection studies and actual use studies must be undertaken.

The Non-Prescription Imperative: Switch to return as key driver of US OTC growth

Next up, Douglas Stukenborg gave insight into the keys to success he discovered when helping to create the Welly plaster brand. His tips included the need to start with the problem in a category rather than the answer, to limit/leverage distribution to manage risk and to launch fast & fix fast. Second in the segment on Challenger Brands, Daniel Hassan described how brands IB Gard, REMfresh and Fiber Choice became successful while 85% of new CPG brands fail. His advice included building enduring brands in the drug free space, creating patented prescription-quality innovations, winning support in the medical community, and providing science to allow educated consumers to believe in products and to allow doctors to recommend products.

Anna Mayo and Corinne Shindelar then discussed online sales trends, movement towards subscription services for vitamin products, the increasing popularity of click and collect and DTC brands, the trend towards clean and natural and plant-based products among younger consumers, the growth of the natural/organic industry, the increase in herbal supplement sales in the USA and the growth of consumer interest in GMO-free, cruelty free and vegan products. Finally, Michelle Bottomley described the “Modern Marketer’s Tool Kit”, with focus shifting from product-centric to consumer-centric, and from product sales to consumer portfolio growth. She also discussed how modern marketing can flex across a continuum of art & science to utilise multiple channels and integrate all communications to give 360-degree surround of the target consumer with a seamless, personalised experience at every point of contact. Steve Sowerby rounded off the conference with a helpful summary of each speaker’s contributions and some interesting closing thoughts for the industry moving ahead.

If you were unable to join, contact us to purchase a recording of the North America session. Next on the agenda is our APAC e-Conference 2021 on 23 November and the Latin America e-Conference 2021 on 14 December. To find out more about these conferences, entry submission criteria for any of the awards, or to book your place, please contact elizabeth.bernos@NicholasHall.com.

Rx-to-OTC switch drivers

Allergy and sexual health are two areas of the global CHC market that continue to expand in sales thanks to Rx to non-prescription switch activity in various markets. In Japan, the Ministry of Health, Labour & Welfare’s Evaluation (MHLW) Review Conference will discuss the potential Rx-to-OTC switch of emergency hormonal contraceptives at a meeting this week.

According to CHC Insight Asia-Pacific Senior Editor, Nicola Allan: “In June 2019, an MHLW steering committee permitted pharmacists to dispense EHCs during a face-to-face transaction after the consumer has had an online consultation with a doctor. Previously, the patient had to see a doctor face-to-face to obtain a prescription to give to the pharmacist. More than 9,000 pharmacists have undertaken training that allows them to participate in the new scheme, which has prompted the MHLW to consider further liberalisation of EHC sales.”

Meanwhile, in the UK, following an application from Sanofi, the Medicines & Healthcare products Regulatory Agency last week reclassified Nasacort Allergy Relief (triamcinolone acetonide 55mcg / dose) nasal spray from Pharmacy medicine to General Sales List. The suspension can be used for the relief of symptoms associated with seasonal allergic rhinitis, including sneezing, itchy and runny nose, itchy red or watery eyes, nasal congestion or sinus discomfort in adults aged 18+ years.

In terms of switch drivers, governments seeking to reduce healthcare costs remains a primary factor, but also important is the empowerment of consumers as they increasingly use digital solutions to improve and monitor their health, a trend that is being leveraged into test & treat models. Commenting on the just-published Rx-to-OTC Switch Hot Topic Report, CIMA Senior Market Analyst Victoria Blake said the report “considers the impact of Covid on struggling healthcare systems, and the increased burden on the undertreated population. While traditional mechanisms have proved too slow in recent years, the next generation of switches – such as statins, triptans, oral contraceptives and CBD – require new thinking and a different approach.”

According to Nicholas Hall, “we could be entering a Golden Age. Voltaren Arthritis Pain Relief Gel’s successful US launch; OTC approval for low-dose cannabis in Australia; the possibility of OTC oral contraceptives in a major Western market for the first time; plus recent statements by Sanofi on the likely switches of the antiviral Tamiflu and the erectile dysfunction treatment Cialis. These are just the tonic this industry needs as the recovery from Covid gets underway.”

Our hot topic report Rx-to-OTC Switch is now published! Written by Nicholas Hall’s CIMA team in association with switch expert Joe McGovern of Biograph Inc, you can access information on the historic and current switch environments in key global markets, including an overview of pipeline and strategic considerations. For more information, or to purchase your copy, please contact melissa.lee@NicholasHall.com

Sexual health OTC revolution

Building on the news covered in last week’s blog that Sanofi is planning to implement the US Rx-to-OTC switch of erectile dysfunction treatment Cialis by end-2024, this week we look at another major development in the OTC sexual health & fertility category – the announcement by the UK’s MHRA that it has launched a public consultation on the reclassification of two progestogen-only contraceptive pills containing desogestrel, marking the first time the agency has considered such a change.

MHRA is asking the public and stakeholders for their views on whether two continuous-use oral contraceptives – HRA Pharma’s Hana and Maxwellia’s Lovima, both as 75mcg film-coated tablets in 28-count packs – should become pharmacy medicines and available OTC, without a medical prescription (although, in parallel, desogestrel 75mcg will also remain available on prescription, with women potentially able to switch between prescription or pharmacy supply at different times). The agency notes that if the products are reclassified, pharmacists will have access to training materials and a checklist to help them to identify women who can receive the two medicines safely. Two separate consultations are open until 5th March (Hana link; Lovima link).

Following the switch of Adamed’s Maxon Forte (sildenafil 50mg) in Poland in early 2020, the rollout of OTC Viagra (Viatris) to Norway and Ireland in 2020, plus the EU centralised Rx-to-OTC switch of Fortacin (Recordati for Plethora Solutions) for premature ejaculation – formulated with lidocaine 150mg + prilocaine 50mg – in September 2020, the past year has seen a rapid expansion in the availability of OTC sexual health & fertility medicines. With OTC ED on the near horizon in the US market, the UK approval of the daily contraceptive pill as an OTC medicine could lead to a wave of similar approvals worldwide, and inject substantial growth into the global CHC market over the coming years.

CHC.NewDirections Consulting Editor, Nina Stimson adds: This really is an exciting proposal – not only a first for the UK, but also the first significant bid to offer oral contraceptives without prescription outside the Asia Pacific region – China and South East Asian markets lead the way, although sales in most markets are relatively small. If the proposal is approved, will UK pharmacists actively support the switch and help build OTC supply (and will the pharmacy protocol be sufficiently user-friendly not to push women back to the doctor)? And will any price differential between Rx or OTC supply be a factor? Not all ambitious switches in the UK have succeeded in the past, but we have high hopes for this one. Time will tell …

You can save up to GB£1,350 when you pre-order our forthcoming report from CHC New Products Tracker, Innovation in CHC: 2020’s NPD & Launch activity under the spotlight before 31st March! As well as looking in more depth at the latest OTC sexual health & fertility developments, the report also showcases the top 100 innovations in 2020 and features major ingredient trends, delivery format trends and much more. For more information, or to pre-order your copy, please contact melissa.lee@NicholasHall.com.

Sanofi CHC on track to be standalone unit by end-2022

At Sanofi’s Capital Markets Day 2021, the company’s Head of Consumer Healthcare, Julie Van Ongevalle, shared her vision for the business: “With the ongoing implementation of our fully integrated standalone model, we look forward to being more agile and reducing the complexity of our portfolio to drive growth with our consumer-centric, data-driven marketing approach.” The aim is to divest around 150 brands (from the current 250) in the next two years to focus on “priority categories”, such as allergy, body pain, general pain and mental wellness – particularly sleep aids – via a “granular approach”.

Rx-to-OTC switch has already been a key factor in driving growth in one of Sanofi’s priority categories, allergy remedies, thanks to the successful global OTC rollout of Allegra (first available in the USA in 2011) and launch of Xyzal Allergy 24HR (USA, 2017). Josephine Fubara, Chief Science Officer at Sanofi CHC, noted that Sanofi continues to make progress in bringing two potential OTC switches to the market in the coming years, erectile dysfunction treatment Cialis and flu antiviral Tamiflu, presenting a blockbuster opportunity with a combined sales potential of €1bn in the US market alone.

Source: Sanofi Capital Markets Day 2021 presentation

Sanofi also stated that it is on track with its plans to be a standalone CHC business by end-2022. The company said that the overall planning for the transition was complete, and that the majority of its standalone CHC legal entities would be operational by end-2021. Among the benefits that Sanofi believes this transition will bring include the agility to reignite its innovation engine and reduce time-to-market by around 20%.

Looking ahead, Sanofi is targeting above average market growth, driven by its focus on priority categories and Rx-to-OTC switch, with a view to becoming the best-in-market CHC performer by 2024-25. Supporting this objective will be a focus on consumer insights, an emphasis on e-Commerce and digital channels and the operational independence provided by Sanofi’s standalone model.

Save up to GB£1,350 when you pre-order our forthcoming report from CHC New Products Tracker, Innovation in CHC: 2020’s NPD & Launch activity under the spotlight before 31 March. The report showcases the Top 100 innovations in 2020 and features major ingredient trends, delivery format trends, and much more. For further details, or to pre-order your copy, please contact melissa.lee@NicholasHall.com.

Historically slow cough, cold & flu season

Now that four (P&G, J&J, GSK and Sanofi) of the world’s Top 6 consumer healthcare marketers have reported their latest quarterly results, two of the key takeaways are that 1) industry growth has proven very resilient in the face of the challenges posed by the pandemic, and 2) we are in the middle of an historically slow cough, cold & flu season in 2020-21, and CHC marketers with portfolios that skew heavily towards CCA products will continue to feel the impact of this trend on overall growth.

Figures from the WHO’s FluNet service show the quasi-total wipeout of flu at a global level. Despite some signs of very low levels of flu circulation in certain regions tracked by WHO, including Africa and the Western Pacific, the overall picture at a global level is stark, with an almost complete drop-off in global infections since Q1 2020. The data shown in the WHO chart below are provided remotely by National Influenza Centres (NICs) of the Global Influenza Surveillance and Response System (GISRS) and other national influenza reference laboratories collaborating actively with GISRS, or are uploaded from WHO regional databases.

Source: FluNet (www.who.int/flunet), GISRS

This trend is backed up by recent reports at a country level too. According to data obtained by The Times newspaper, UK flu cases are down by 95%; in the second week of January – the peak of the season – the number of reported influenza-like illnesses was 1.1 per 100,000 people vs a 5-year average rate of 27. This reflects similar trends in many other countries, including USA. While a billion people typically get flu globally each year, “much less than a tenth” of that figure will do so, according to leading expert John McCauley. There are a number of theories for the decline; lockdown restrictions, social distancing and the wearing of masks, and an increased focus on good hygiene practices have helped to prevent Covid, but also reduce the spread of other contagious illnesses. A major fall in international travel has curbed infections, while there has also been a huge take-up of the influenza vaccine. Meanwhile, some experts believe the spread of Sars-CoV-2 may have raised immunity against other viruses.

Nicholas Hall said: “Before Covid, we thought we knew the dynamics of consumer healthcare very well. I’ve given endless presentations quoting the three practical drivers of demand: Switch, the Emerging Markets and very importantly Cold & Flu pandemics. It’s fair to say that, without Covid, we would by now be lamenting a year of poor CHC sales. The actuality is that, with the exception of Voltaren Arthritis Pain and Differin in USA, there have been no significant switches in the past 3-4 years. The Emerging Markets still deliver, of course, but not at the stellar levels of the recent past; and we would by now be reading of the low impact on sales of the cough, cold & flu season.”

Explore the impact of lockdown on cases of cold & flu, and what the implications may be for CHC medicines, in our recently published Cough, Cold & Allergy report. For more information, or to order your copy, please contact melissa.lee@NicholasHall.com.

Switch: 2020 Review and 2021 Prospects

According to our CHC New Products Tracker tool, which covers 20 key markets globally, 2020 was a relatively good year for Rx-to-OTC switch activity, not quite at the level of particularly active years like 2018, but above average in terms of switch-related launch developments, and with some notable breakthroughs such as GSK’s switch of Voltaren Arthritis Pain (diclofenac) in the USA and Glenmark’s Momate Rhino Advance Nasal Spray (mometasone + azelastine) switch in Russia.

Thanks to the Rx-to-OTC reclassification of Voltaren Arthritis Pain, as well as eye allergy itch relief range Pataday (Alcon), the US market led the way in terms of switch developments in 2020, along with Poland, Germany and China. As for category switch trends, looking at Tracker data for the past 8 years (2013 to 2020), allergy remedies has been by far the most active OTC subcategory in producing new products following switch activity, with double the amount of NPD activity as the next nearest subcategory, cough remedies.

Looking ahead to 2021, one of the first switch developments this year will again be an allergy remedy. The UK’s Medicines & Healthcare products Regulatory Agency granted GSL status to Sanofi’s Allevia tablets for seasonal allergic rhinitis (fexofenadine 120mg; 12+ years; 1 tablet per day) in late December 2020. Once Allevia and other OTC fexofenadine products are launched, they will enjoy mass market distribution from the outset (it is more common in the UK for switched ingredients to be granted pharmacy-only OTC status). This is the second Rx-to-GSL UK allergy remedy switch in as many months, following approval for J&J’s Rhinocort Aqua budesonide 64mcg nasal spray in November 2020 (to be marketed as Benacort Hayfever Relief).

In addition, Poland remains at the forefront of global switch activity, with the country’s medicines agency (URPL) recently approving the Rx-to-OTC switch of Famotydyna Ranigast film-coated tablets (Polpharma; famotidine 20mg). Claimed to relieve indigestion, heartburn and hyperacidity for up to 12 hours, this is the first famotidine option available OTC in Poland. Meanwhile, Australia’s TGA is seeking comments until 27th January 2021 on proposed amendments to the Poisons Standard, which will be discussed at the March 2021 meeting of the Advisory Committee on Medicines Scheduling, including adding the following pharmacist-only medicines to Appendix H to permit consumer advertising: prochlorperazine and metoclopramide for the treatment of nausea associated with migraine; and chloramphenicol for ophthalmic use.

We are delighted to announce that our annual European e-Conference 2021 will take place online on 28 & 29 April! With options for individual and corporate site or global access, take the chance to keep up with what’s happening in consumer healthcare today and contact elizabeth.bernos@NicholasHall.com

Rx-to-OTC switch: Fortacin in EU, CBD in Australia

Rx-to-OTC switch activity has shown signs of revival so far in 2020, and two more positive news stories emerged last week. First, the European Commission has approved the Rx-to-OTC switch of Fortacin topical spray for premature release in adult men (owned by Plethora Solutions and marketed under licence by Recordati; lidocaine 150mg/ml + prilocaine 50mg/ml), following the July 2020 recommendation from the EMA’s Committee for Medicinal Products for Human Use. Recordati will reportedly begin the OTC launch of Fortacin in January 2021. This is the fifth brand to receive switch approval via the EU centralised procedure, and the first since 2015 when ellaOne (HRA Pharma) was given the rubber stamp.

Secondly, a delegate of the Secretary to Australia’s Department of Health has released an interim recommendation to switch plant-derived or synthetic CBD ≤60mg (up to 30 days’ supply, adults aged 18+ years) from Rx to Schedule 3 (Pharmacist-only), with a proposed implementation date of 1st June 2021. The ingredient will also be added to Appendix M of the Poisons Standard, with supply limited to medicines registered on the Australian Registry of Therapeutic Goods.

Source: CHC New Products Tracker

Comments are being sought until 13th October 2020 on this proposed CBD switch in Australia, as well as the following recommendations:

  • Switch migraine treatment eletriptan ≤40mg (up to two tablets) from Rx to S3 and include the ingredient in Appendix H to permit consumer A+P (1st February 2021)
  • Permit the S2 (Pharmacy-only) sale of immediate-release ibuprofen ≤400mg (up to 12 dosage units) when labelled not for children under 12 years (1st February 2021)
  • Do not switch sildenafil 50mg (up to four dosage units) from Rx to S3 and include the ingredient in Appendix H and Appendix M
  • Do not permit general sale of oxymetazoline ≤0.05% nasal sprays
  • Do not permit the S2 sale of clotrimazole ≤1% preparations for vaginal use

One of the key reasons behind the TGA’s establishing Appendix M in January 2018 was to facilitate future switch activity by helping ingredients meet the S3 Scheduling Policy Framework criteria through the provision of additional pharmacist controls or supply requirements. This channel has had some success, with CBD appearing to be the latest ingredient to benefit. Some stakeholders had also hoped that additional controls would finally sway opinion on the OTC availability of ED medicines but the scheduling delegate did not think the risk mitigation strategies outlined in the Appendix M entry assessed the risks associated with sildenafil use.

Nicholas Hall Writes: Last week I presented the key conclusions from last year’s New Paradigms report and my client asked, what will be the really high growth categories in the post-Covid CHC market? That is a really good question, and it seems to me that there are six emerging sectors each with sales potential of over US$10bn at MSP:

  1. CBD
  2. Sexual health
  3. Sleep, stress & mood
  4. Food allergy & intolerance
  5. Probiotics
  6. Immunity

Each of these presents opportunities, each of these presents formidable obstacles. In the case of CBD, the major hurdle is regulatory. So if this news from Australia is borne out, and CBD becomes a registered OTC category — the first in the world — we will have overcome the first barrier in the long journey to regulate and regularise this awesome opportunity, and I use the word awesome in its original sense, not as a teenage throwaway remark!

Don’t miss out on your chance to save up to GB£1,800 when you pre-order our upcoming report, Cough, Cold & Allergy before 30 September! For more information, or to pre-order your copy, please contact melissa.lee@NicholasHall.com.

Rx-to-OTC switch outlook for 2020

CHCINACTION

One of the factors contributing to lower global consumer healthcare growth in recent years has been a falling-off in Rx-to-OTC switch activity in key markets like Japan and the USA. Looking ahead, however, there are reasons to be positive. In December 2019, Sanofi CEO Paul Hudson cited the company’s “plans to accelerate the over-the-counter switches for Cialis and Tamiflu” in order to fulfil its ambition of growing faster than the CHC market over the mid-term. In light of the current coronavirus epidemic, the benefits of wider OTC access to flu remedies is all the more evident.

Sexual health is another category with huge Rx-to-OTC switch potential, notably erectile dysfunction medicines and daily oral contraceptives. Though the switch of Cialis (tadalafil) has been stuck at the FDA for several years now since its submission, sildenafil (Viagra) is enjoying ever wider OTC availability, especially in Europe. After switching in Poland in 2016, sildenafil was launched as Viagra Connect (Pfizer) in the UK in 2018 and will be launched OTC as Viagra Reseptfri in Norwegian pharmacies in early 2020.

Screen Shot 2020-02-03 at 12.31.46.png

There is also renewed interest in OTC triptans for migraine. A handful of switches took place in the mid-2000s but were held back by OTC purchase limits (a 2-tablet emergency pack). Over the past year, various countries have again began discussing triptan switches including Australia, Ireland and Germany (which is expected to expand the number of triptan molecules in the OTC sector), though major expansion of the segment is unlikely without larger pack sizes.

All that said, reverse-switch remains a threat and one OTC ingredient of ongoing concern is codeine. In late 2019, New Zealand’s Medicines Classification Committee, following Australia’s lead, recommended that all codeine-containing medicines should be reverse-switched from OTC to Rx. In January 2020, citing “widespread concern about the abuse of codeine-containing preparations nationally and globally”, the South African Health Products Regulatory Authority said it is reviewing the scheduling status of codeine and codeine-containing medicines which are available without a prescription.

CHC.NewDirections is an e-newsletter sent every Tuesday, with a focus on innovation, science and regulationCoverage spans Rx-to-OTC switch, CBD, relevant medical research, probiotics, medical devices and new delivery formats, digital health / AI, e-cigarettes and much more! For more information, or to arrange a free trial, please contact Melissa.Lee@NicholasHall.com

CHC trends in 2020

otcinaction

In Nicholas Hall’s recent signature New Paradigms report, there were 15 Infinity Zones identified as offering substantial growth opportunities for the consumer healthcare market over the next decade, against a backdrop of uncertainty in the industry caused by the recent wave of mega-mergers. These include the development of new CHC products for diabetes and food intolerance, as well as a further uptick in activity for probiotics, MedTech and e-Commerce. In this week’s blog, we look at three trends that may boost the consumer healthcare market in 2020.

CBD and beyond

2019 was the year of CBD, as evidenced by our CHC New Products Tracker service, which logged over 300 new CBD products in the US market alone last year. A recent article in US pharmacy trade publication, Drug Store News, suggests that CBD is just the tip of the cannabinoid iceberg, with various other cannabinoids set to take off over the coming year. These include cannabigerol (CBG), which is said to produce a stimulant effect, cannabinol (CBN), claimed to show benefits as a sleep aid, and cannabichromene (CBC), claimed to be an effective pain reliever.

Inner-DNA.jpg

Veganism on the rise

A UK-based campaign that has received a lot of celebrity endorsements, Veganuary, is encouraging people to try veganism in the month of January. One of the benefits of the rise in veganism for VMS marketers is increased awareness of the nutrients we require, many of which can be lacking in a vegan diet. For instance, several leading proponents of veganism like The Vegan Society recommend taking vitamin B12 supplements while adopting a vegan diet. Our CHC New Products Tracker service has also recorded a strong rise in vegan-friendly supplements in the past two years, a trend that looks set to accelerate in 2020.

Uptick in switch activity?

One of the trends responsible for the slowdown in global CHC market growth these past 3-4 years is the drop-off in Rx-to-OTC switch activity, especially in the world’s No.1 market, USA. There are signs this is about to change – for example, Viagra is due to lose its final patents in the USA in 2020. In Japan, the world’s No.3 CHC market, there has been a similar falling off in switch activity, with just two ingredients approved for reclassification in 2018 and 2019. However, 2019 saw the first ingredient to be switched under a new system set up by Japan’s drugs agency, MHLW, which has nominated over 30 ingredients as eligible for switch. With the Tokyo Olympics also on the horizon in summer 2020, this year could see a revival in Japan’s sluggish CHC market.

With options available for complete access to all 20 markets covered by CHC New Products Tracker, or a subscription for selected categories or countries, contact waisan.lee-gabell@NicholasHall.com today to find out more or set up a free trial!

Lifestyle OTCs still the best hope for OTC switch revival

otcinaction

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.

Viagra Norway

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.