OTC hormone replacement therapy now available in UK

Following a landmark reclassification by the UK’s Medicines & Healthcare products Regulatory Agency in July 2022, postmenopausal women in the UK can for the first time access a low-dose, locally applied hormone replacement therapy without a prescription. Effective 8th September 2022, leading health & beauty retailer Boots (Walgreens Boots Alliance) is offering Gina vaginal tablets (Novo Nordisk, estradiol 10mcg) OTC to women aged 50+ years who have not had a period for at least one year.

The tablets, which cost £29.99 (US$34.60) for a pack of 24 plus applicators, treat vaginal atrophy, which is experienced by around half of postmenopausal women. Symptoms include dryness, soreness, itching, burning and uncomfortable intercourse caused by oestrogen deficiency. Boots Pharmacy Director Anne Higgins described the move as “another important milestone in women’s health”.

Novo Nordisk’s new OTC brand Gina

Comment from Proprietary Association of Great Britain CEO, Michelle Riddalls: This is a huge step forward helping women to take control over their health by enabling and supporting self-care. The pandemic forced us all to rethink the way that healthcare is delivered and brought to light the central role that self-care can play in managing health issues. Our research has shown that this is what consumers want. It has also brought huge benefits to patients, healthcare providers and to taxpayers via more efficient and effective use of NHS resources.

Nicholas Hall Writes: This week I am writing very little as a mark of respect for our beloved Queen Elizabeth. I know – the show must go on! But what a show that was, running for 70 years through good times and bad, almost never putting a foot wrong despite a vastly changing world, not to mention wayward family members. I am spellbound by what the Queen stood for and achieved. But we will have dried our tears by this time next week, when it will be business as usual, even though the memories will never fade!

In just over a month’s time, you can sharpen your skills and increase your understanding of Self-Care at the CHC Training Academy workshop in Bucharest. Taking place on 26 October, the workshop will be followed by a free 1-day conference, hosted by RASCI, focusing on Health Literacy, opening with a keynote speech from Nicholas Hall. To register, or for more information on group booking rates, please contact elizabeth.bernos@NicholasHall.com without delay.

UN: World population to reach 8bn in 2022 and 10bn by 2050

The UN’s World Population Prospects 2022 report predicts that on 15th November 2022 the global population will reach 8bn. The report also shows that India is on course to surpass China as the world’s most populous country in 2023. The latest UN projections suggest that the global population could grow to around 8.5bn in 2030 and 9.7bn in 2050, before peaking at around 10.4bn people during the 2080s.

More than half of the projected increase up to 2050 will be concentrated in eight countries: the Democratic Republic of the Congo, Egypt, Ethiopia, India, Nigeria, Pakistan, the Philippines and the United Republic of Tanzania. While 2022 is a milestone year, the global population is growing at its slowest rate since 1950, having fallen to less than 1% in 2020. As well as fertility, which has dropped markedly in recent decades for many countries, the pandemic has had an effect on population change: global life expectancy at birth fell to 71 years in 2021 (vs 72.9 in 2019).

Nicholas Hall’s Touchpoints: The UN tells us that the global population will reach 8bn this year. As always, the demographic mix is important and by 2050 the number of over 65’s globally will be more than twice the number of children under the age of five and around the same as those aged under 12. Further reductions in mortality will increase average global longevity to around 77.2 years in 2050. But we don’t have to wait until 2050 to feel the effects of the ageing population, as all countries in the developed world are already experiencing high demand on healthcare services and medical products from a large cohort that expects a high quality of life for an extended period of time. This has been a discussion point throughout my 5 decades in this industry, and Big Pharma seems to defy gravity by always introducing better products at higher prices and sustaining or even growing margins.

But this cannot last, and the recent drive by the FDA to encourage more Rx-to-OTC switches is one of the most important emerging trends in our industry. As my colleague MaryAlice Lawless has written recently, the old switch model just won’t work any more, and the FDA has put the ball firmly in our court to come up with new regulatory and marketing models. That’s why the US switch application for the daily oral contraceptive is so important. Perrigo’s HRA subsidiary is in the forefront of this new category, having launched the first OTC version globally in the UK in 2021.

We are pleased to announce that the all-new agenda for our Asia-Pacific e-Conference has been released! Nicholas will be joined on 23 November by industry experts to explore expanding possibilities for CHC across the region. This event will also include the presentation of our Regional CHC Creative Marketing Award. For more information, or to register, please contact elizabeth.bernos@NicholasHall.com.

CHC regulation: News from EFSA and FDA

The European Food Safety Authority has stated that its scientists “cannot currently establish the safety of cannabidiol as a novel food owing to data gaps and uncertainties about potential hazards related to CBD intake”. Following the submission of numerous applications under novel food regulations, the European Commission asked ESFA to give its opinion on whether CBD consumption was safe for humans. EFSA’s expert Panel on Nutrition, Novel Foods & Food Allergens (NDA) believes there is insufficient data on the effect of CBD on the liver, GI tract, endocrine and nervous systems and psychological wellbeing. While studies in animals show significant adverse effects especially in relation to reproduction, it is important to determine if these effects are also seen in humans.

In other notable CHC regulatory news, the FDA has placed Sanofi’s Actual Use Trial to support the Rx-to-OTC switch of ED treatment Cialis (tadalafil) on hold, owing to concerns about the protocol design. Cialis is the only PDE-5 inhibitor that offers men a choice when it comes to treatment for ED – for use as needed and for once daily use. The AUT has not yet recruited any patients, but Sanofi noted that it “continues to work with the FDA to move the programme forward and will engage the agency in upcoming meetings as it determines the next steps”.

Source: EFSA

Nicholas Hall’s Touchpoints: Why am I not surprised at the latest EFSA ruling on CBD? Even though the Chair of the NDA Panel, Professor Dominique Turck, has let a crumb of comfort drop from his high table when he said, “It is important to stress at this point that we have not concluded that CBD is unsafe as food”, the announcement will have disappointed an industry and the many manufacturers who have sunk millions into proving the unique benefits of this new class of consumer healthcare products. This is, after all, the organisation that won’t allow probiotics to be named as probiotics on packaging, although it seems to me highly significant that the authorities in Spain and Netherlands are leading the way to override this ridiculous ruling by the Dr.No’s at EFSA. 

In much the same way, California is pioneering the move for hemp-derived CBD to be treated as supplements and eventually brought under the DSHEA umbrella. This is another crumb of much-needed comfort at a time when the FDA seems in a state of paralysis regarding the regulation of medicinal cannabis. And I’m extremely concerned with the recent news that the FDA has stopped Sanofi’s Actual Use Trial for the switch of Cialis, which my good friend Mary Alice Lawless believes could be a threat to the whole switch process in USA.

Explore the best CBD and lifestyle launches from 2021 in the Innovation Showcase featured in our recent Innovation in CHC report. Drawn from CHC New Products Tracker, you can also explore innovation by marketer, region and country. To order your copy, or for further information, please contact melissa.lee@NicholasHall.com.

Future and Cooper in European MED3000 licensing agreement

Futura Medical has entered into an exclusive licensing agreement with French-based Cooper, a leading European independent self-care company, for the rights to commercialise its gel-based ED treatment MED3000 throughout the European Economic Area, UK and Switzerland (where it will be marketed as Eroxon). Under the agreement, Futura will receive an (undisclosed) upfront payment, as well as cumulative sales milestone payments and will manufacture and supply the product (through its 3rd party contract manufacturers) to Cooper. In compliance with EU competition law, the initial licence agreement term is five years.

Nicholas Hall’s Touchpoints: This is an outstanding product, which my colleague Ian Crook, who authored our recent Sexual Health & Fertility report, describes as: “The first clinically-proven topical device for erectile dysfunction.” He tells me that MED3000 has the potential to shake up the ED market and that Futura believes it has identified a significant unmet need for an ED treatment that is efficacious, well-tolerated and works within minutes.

Six months after securing its first licensing agreement with Co-High Investment Management in China and SE Asia (March 2021), Futura struck a deal with US-based specialty biopharmaceutical company m8 to exclusively develop and commercialise MED3000 in Brazil and Mexico. This latest deal with Cooper, covering EEA, UK and Switzerland, brings the marketer a step closer to a planned launch in Europe, after the product received CE mark approval as a Class II(b) medical device in May 2021. Several positive factors – medical device status, lack of an active ingredient (the brand’s mode of action utilises a unique evaporative mechanism) and the fact that once approved it will be available without a prescription – contribute to MED3000’s sizeable potential.

Sexual health is one of the most dynamic sectors in the CHC market and a product like this is “la crème de la crème”: unique features and benefits, excellent performance, easy to use, no appreciable side-effects and – above all – significant need and high unmet demand. It is with highly innovative new products like this that we can look forward to industry growth even greater than our latest 5.5% forecast (all channels of distribution).

ED products are among the categories analysed in our recent Sexual Health & Fertility report. With reviews of other key categories including contraception, menopause, FemTech and intimate care, the report also highlights key trends and NPD. For further details, or to place your order, please contact melissa.lee@NicholasHall.com.

Two Rx-to-OTC allergy switches approved by FDA

In a clear sign of a more favourable attitude to Rx-to-OTC switch, the US FDA last week approved two new allergy products for non-prescription use.

Lastacaft alcaftadine ophthalmic 0.25% solution (Allergan / AbbVie) is now available without a prescription online and in retail stores for individuals aged 2+ years with ocular allergies. As demonstrated in clinical studies, one drop works in as little as three minutes to provide relief from itchy eyes for up to 16 hours. Following the recent FDA Rx-to-OTC switch approval, the original patented prescription-strength formulation of Lastacaft is available in a 5ml multidose bottle containing a 60-day supply, as well as a twin pack with two 5ml multidose bottles.

Perrigo also received final approval last week from the FDA for the OTC use of Nasonex 24HR Allergy (mometasone furoate monohydrate 50mcg). This marks the first branded Rx-to-OTC switch for the company, which expects to begin offering the nasal spray later this year. Nasonex is a registered trademark of Organon and is used by Perrigo and its affiliates under licence.

Nicholas Hall’s Touchpoints: This development will no doubt lead to an increase in switch activity after House and Senate committee members cited concerns that “very few products in recent years have switched from prescription drugs to nonprescription drugs” and pointed out that the FDA is expected to “meet the goals of the Fall 2021 Unified Agenda and publish and subsequently finalise the proposed rule titled Nonprescription Drug Product with an Additional Condition for Nonprescription Use.”

The appropriations committees are also: “Concerned about dietary supplement products that are adulterated or misbranded, in particular with imported products. The agreement provides an increase of US$2mn in the FDA’s budget [US$6.1bn in total] to be used for inspections, as well as enforcement of the Dietary Supplement Health & Education Act of 1994”. My sense is that in the biggest market for both switch and dietary supplements, we could see a correction in the prevailing trend from treatment to prevention.

Take a look at the latest CHC innovations in our forthcoming 2022 edition of Innovation in CHC from CHC New Products Tracker. This report offers a look at Rx-to-OTC switch activity, as well as innovation by region, marketer and 20 individual countries. To pre-order your copy and save up to £1,350 with the pre-publication discount, or for further information on this report, please contact melissa.lee@NicholasHall.com.

Poland approves world-first OTC switch of tadalafil

We continue with the theme of Rx-to-OTC switch this week with news from Poland, where the Office for Registration of Medicinal Products, Medical Devices & Biocidal Products (URPL) has approved Adamed’s Tadalafil MaxOn ED treatment (tadalafil 10mg; film-coated tablets; 2- and 4-count SKUs) as an OTC medicine, effective 1st February 2022. This will join Adamed’s sildenafil options MaxOn Active (25mg) and MaxOn Forte (50mg), which launched in May 2016 and April 2020, respectively. Tadalafil is claimed to get to work within 30 minutes for up to 36 hours, vs claims for sildenafil that it works within 30-60 minutes for up to five hours.

Poland was again one of the most active Rx-to-OTC switch markets in 2021, with only China ahead of it last year in terms of number of launched products reclassified from prescription to OTC status. Three of the six products launched post-switch in Poland in 2021 were erectile dysfunction treatments, including Hasco-Lek’s Mensil Max, Aflofarm’s Inventum Max and Polpharma’s Maxigra Max (all sildenafil 50mg). In addition, there were two digestive health switches – Teva’s antidiarrhoeal Gastrolit and Polpharma’s antacid Famotydyna Ranigast – and Polpharma’s cold sore treatment Heviran Comfort Max.

Source: Nicholas Hall’s CHC New Products Tracker

Nicholas Hall’s Touchpoints: Last week our lead story was the likely switch of HRT in the UK, which we singled out as a pioneer. The latest news this week is from Poland, another switch centre of excellence and where the ED treatment tadalafil will be available in a non-prescription version for the first time anywhere in the world. Tadalafil was launched as a prescription medicine under the trademark Cialis, and Sanofi later acquired the CHC rights from Lilly, but the switch application in the USA has been held up for many years by the FDA.

My colleague Maryna Marriott of the CHC Insight Europe team tells me: “Poland continues to lead the way in switch innovation. The tadalafil approval follows a number of sildenafil 25mg and 50mg switches, with the Polish ED category totalling US$27.7mn in MAT Q3 2021, according to DB6, an increase of 28.5% vs the year-ago period. Men’s health clearly remains high on the consumer health agenda, and it seems likely a number of other tadalafil switches will follow in Poland.”

Switch is an expensive process in the USA, which is why it is subdued there at present. On the other hand, there has been renewed switch activity in Europe and parts of Asia. The problem for the CHC industry has always been that the benefits given to US companies gaining switch status – the cost to the patient-as-consumer drops substantially and there is often three years marketing exclusivity, whereas the ingredient can no longer be prescribed for the same indication – are not available to marketers in the rest of the world. That leads to the curious situation of some switches being regulatory wins but commercial failures. Let’s hope that Adamed is blessed with decent sales for its latest innovation.

Find solutions for success in this competitive CHC landscape with Nicholas and the team in Athens on 4-6 May 2022 for our 32nd European CHC Conference & Action Workshop! Meet with peers and hear from industry experts, including sessions from Bayer, Teva, J&J and many others face-to-face! For more information, or to reserve your seat, please contact elizabeth.bernos@NicholasHall.com.

Estradiol to switch to OTC in UK?

The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has launched a consultation on proposals to reclassify Danish-based Novo Nordisk’s Gina (estradiol 10mcg) vaginal tablets. This would mean that for the first time, women in the UK could access a local hormone replacement therapy at a pharmacy without a prescription. The tablets treat vaginal atrophy, which can cause dryness, soreness, itching, burning and painful intercourse. It affects around half of post-menopausal women, but many do not discuss the problem with their doctor.

The consultation seeks views from general practitioners, pharmacists and the public on making Gina available OTC to women aged 50+ years who have not had a period for at least one year. The MHRA stressed that as this is the first time such a change has been considered, it is important that as many opinions as possible are heard.

Proposed labelling for Gina. Source: MHRA

Nicholas Hall’s Touchpoints: When I read this story, my first reaction was concern about the safety profile of a consumer version of this formulation. I’m reassured by the Commission on Human Medicine’s statement that “it is safe for this product to be made available as a Pharmacy (P) medicine”, but I can fully understand why the MHRA is consulting widely. In fact, there seems to be a decent measure of consumer and professional support for the switch as far as I can tell.

Coming hard on the heels of last year’s switch of the daily oral contraceptive in the UK, Novo Nordisk’s Gina – if approved – will be launched into an important intersection of sexual and women’s health. Women are responsible for 60% of CHC consumption globally, but with relatively few specific products designed for them, and account for about 85% of purchasing. It also reminds us that the UK is now the premier switch market in the world, at a time when our industry’s interest in switch is at an all-time low.

For a more detailed consideration of the consultation process and the pro’s and con’s of this switch, please read CHC.NewDirections. The markets for contraception, intimate care, pregnancy and fertility products, among others, are also explored in our newly-published Sexual Health & Fertility report. For further details, or to place your order, please contact melissa.lee@NicholasHall.com.

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.