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.

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.

Food Intolerance as Infinity Zone for Future CHC Growth

The parents of a 15-year old who died in 2016 from anaphylaxis have set up a groundbreaking £2.2mn (US$2.7mn) oral immunotherapy trial focusing on children and young people with milk and peanut allergies. The 3-year oral immunotherapy (OIT) trial is the first major study funded by The Natasha Allergy Research Foundation, a charity set up by Natasha’s parents. The aim is to prove that everyday foods containing peanut or milk, which when taken carefully according to a standardised protocol under medical supervision, can be used as an alternative to expensive pharmaceuticals to desensitise patients. “This project presents a unique opportunity to establish immunotherapy as a practical treatment that will allow people with food allergies to live a normal life,” said Professor Hasan Arshad from the University of Southampton, which is leading the trial in collaboration with partner universities and clinical allergy centres.

Nicholas Hall’s Touchpoints: Anyone who has attended one of my recent Global Trends presentations will know that I am passionate about “The Future Resumed”, picking up the Infinity Zones from the CHC New Paradigms report I co-wrote in 2019. These are as attractive today as they were then, with just a two-year delay in progress caused by Covid-19. One of the most exciting prospects is what we now call Health through Digestion, a broader category than just gut health, and stimulated by fairly new research proving that probiotics can assist the vital work of the gut-brain axis and deliver benefits to other parts of the human body. Conversely, food allergy and intolerance can have a negative influence on other parts of the body, which is why it is surprising that the CHC market for these conditions is so poorly developed.

When I reach this part in The Future Resumed presentation, I refer to a number of high-profile deaths of mainly young people, such as Natasha Ednan-Laperouse, who inadvertently ate unlabelled foods with what for them were toxic substances. These are extreme examples, of course, and most of us will experience very mild side-effects, but let’s not forget that almost every person on this planet has at least one form of food allergy or intolerance.

Preventing or treating this widespread condition divides into three parts:

  1. Diagnosis, which will tell us the foods and drinks to which we are allergic or intolerant. At the moment this is a clinical procedure, but there is no reason why consumer health products can’t take over and build a very successful early-stage franchise
  2. Prevention. The second part is to avoid eating the particular foods to which we are intolerant, or if that is impossible to take some form of preventive agent, such as Lactaid (J&J) or Beano (Prestige)
  3. Treatment. If prevention is not possible – and often it isn’t as we just don’t know what is included in restaurant and fast foods – there will be very high demand for treatment products. Indeed, along with products for sleep and mood, this is the greatest area of unmet consumer demand in CHC

I strongly believe that most of this market will roll out in the consumer sector, but our industry seems shy of investing in the necessary R&D and clinical work and unwilling to build successful brands in what could be a US$10bn market in 10 years’ time.

Our newly-published 2022 edition of CHC Yearbook offers a comprehensive overview of leading markets and companies, global retailing and category and brand reviews. To order your copy, or for more information, please contact melissa.lee@NicholasHall.com.

Nicholas Hall’s 2022 Marketing Awards

Nicholas Hall’s 32nd European CHC Conference took place last week in Athens, and below are the winners of this year’s awards for marketing and innovation in the consumer healthcare industry.

For the Colin Borg European Marketing Award, the top three awarded were as follows:

1st Place: Procto-Glyvenol from Recordati
2nd Place: Otrivin from GSK
3rd Place: Enandol from Menarini

The Winners of the Worldwide Marketing Award were as follows:

1st Place: Xyzal from Sanofi
2nd Place: Eno from GSK
3rd Place: Doril Enxaqueca from Hypera

We finally gave a Special Achievement Award to HRA Pharma (now owned by Perrigo) for Hana, with an honourable mention to Maxwellia’s Lovima, which has the same ingredient as Hana. For this award we celebrated the 360 degree marketing campaign run by HRA for Hana.

Nicholas Hall’s Touchpoints: “The Athens conference has been a very special meeting; as well as the high level of content and great foresights shared, just to be together as a community will remain fresh in our memories for months and years to come.

The awards we presented this year were particularly welcome as they celebrate achievements made under the extreme circumstances of the pandemic. Not least, we presented a Special Achievement Award for only the 7th time in the almost 35 years of holding events. Three of these awards were given to individuals who made outstanding contributions to the industry, and three to marketers of truly significant new brands. It was in this tradition that we presented the 7th Special Achievement Award to HRA for the launch of Hana, the world’s first OTC daily oral contraceptive supported with 360° marketing support. An honourable mention was given to Maxwellia’s Lovima.

The hope and expectation is that these two new brands will trailblaze a new CHC category, which is vital as our market goes forward. If you look at the DB6 forecasts (see this week’s Dashboard infographic) – growth at 2021 levels is unlikely to be sustained. The only way to put us onto a higher trajectory will be to launch more significant new products and entice increasingly large numbers of consumers to participate in the self-care revolution. Hana is a superb example of how this can be achieved.

We have now released DB6 forecasts to 2026 & 2031, following the recent publication of our year-end 2021 data. Arrange a demo to take a look for yourself, exploring the expanded channels dataset, which now includes internet & mail order, direct sales and CBD. DB6 offers over 150,000 pieces of data, with more than 30,000 records covering 13,000+ brands and 3,000 companies across 63 countries. To find out more, or to set up a free demo, please contact kate.fieldingsmith@NicholasHall.com.