FDA panel approves Opill switch

The FDA Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive & Urologic Drugs Advisory Committee last week voted unanimously that the benefits of making daily oral contraceptive Opill (norgestrel 0.075mg) available for OTC use outweigh the risks. Perrigo affiliate, French-based HRA Pharma, filed an application in July 2022 for OTC use of the progestin-only drug. While not binding, the panel’s vote will be considered by the FDA when making its final decision regarding the potential approval of Opill for OTC use, which is expected later this year.

If approved, Opill would be the first daily birth control pill available OTC in USA. Perrigo President & CEO Murray Kessler said during a Q2 2022 earnings call – at the time the switch application was filed – that he expected the FDA evaluation would take 10 months. Opill is “in the process of being filed in at least three more countries in Europe”, although “they’re not on as fast a track”, he said at the time.

Comment from Regional VP, North America, Liz Cummings: HRA’s application for the Rx-to-OTC switch of Opill featured a model showing that if 100,000 women were to continue to use existing birth control methods with high failure rates, there would be 37,624 unintended pregnancies. However, if all of them used OTC progestin-only pills with a failure rate of 7%, this would fall to 7,000. Citing this study while representing HRA, physician Professor Anna Glasier noted that OTC availability showed an 81% reduction of pregnancies in the rhetorical cohort of women and would serve an unmet need for many. She added: “Birth control is a great milestone in the history of medicine. It is extremely safe and HRA demonstrated that it does work … let’s make a little more history today and approve the pill as an OTC.”  

During the hearing, HRA presented evidence showing that Opill has a strong safety profile, supported by OC Rx availability for 63 years and consumers (including adolescents) were able to appropriately self-select and use it. Actual use by study participants was measured by self-recording adherence to daily use and time of ingestion, with results showing rates within the scope of normal Rx adherence. However, the FDA felt that HRA’s studies did not comply with its switch guidance and the agency’s analysis showed less confidence in the accuracy in self-selection and daily adherence. Deputy Director of the FDA’s Office of Nonprescription Drugs, Dr Karen Minerve Murry, noted that the FDA was presented with many challenges by the actual use studies submitted, but emphasised that it knows the importance of OTC access. The FDA’s disagreements with HRA study results means it may be some time before final approval, but given the public health benefit, we could have a positive result by end-2023.

Nicholas discusses some of the challenges and opportunities faced by the CHC industry in the aftermath of the pandemic in an exclusive preview clip ahead of the publication of his upcoming New Paradigms report. To explore full coverage, pre-order your copy at a discounted rate, or to find out more about optional add-on presentations and quarterly updates, please contact melissa.lee@NicholasHall.com.

LUMIFY SEES RECORD REVENUES

Bausch + Lomb revenues were C$931mn (US$684mn) in Q1 2023, reflecting a 5% increase; excluding the unfavourable impact of foreign exchange, revenues rose by around 8% on a constant currency basis. Vision Care advanced by 5% (+8% cc) to C$587mn (US$431mn), driven by both the consumer and contact lens portfolios. According to EVP & CFO Sam Eldessouky, Consumer grew by 8% (cc), with Lumify (brimonidine tartrate ophthalmic solution 0.025%), PreserVision and Biotrue multipurpose solution continuing to hold market-leading positions.

Lumify revenues grew by 23% globally to a record C$38mn (US$28mn) and in USA, the brand reached a market share of 50% in the redness reliever category. To leverage the brand platform, B+L is in the early stages of launching the Lumify Eye Illuminations beauty line. Artelac, a key brand in the dry eye franchise in Europe, grew by 29% (cc). Reported revenues from eye vitamins PreserVision and Ocuvite were flat but up low-single digits on a constant currency basis.

Nicholas Hall’s Postcard from New York: A sure sign that the pandemic is almost over is that I’ve started travelling again. Earlier this week I was in San Diego for a client’s global leadership forum, and now I’m in New York for executive meetings and hopefully to spend a few hours in the company of Picasso, Matisse and Monet at the Museum of Modern Art. There have to be some consolations for so many hours spent in aeroplanes, although it’s wonderful to be face to face with friends and clients again!

The Pick of the News section this week leads with a recent Switch success, Lumify, and the bold launch of OTC Cialis in UK, which we must look upon as a bellwether for the brand in USA, assuming the FDA ever gives its seal of approval. Switch was historically one of the main drivers of growth in consumer healthcare, and after several years of famine it’s good to see higher yields. But I’m choosing my words carefully here as, although the number of switches has started to increase, we have yet to see a mega-brand emerge. The last one of those was Flonase.

We are delighted to announce that the all-new website for CHC New Products Tracker is now live! Featuring almost 40,000 launches, all graded with star ratings, subscribers will not only benefit from a fresh look but greater accessibility across devices. To find out more, or to set up a demo, please contact david.redford@NicholasHall.com.

Retail CHC growth set for mid-single digits in 2023

GLOBAL: The soon-to-be published market forecasts from Nicholas Hall’s Global CHC database DB6 indicate that the global retail CHC market is expected to perform well in 2023, advancing by 5.7%, softening slightly from the strong return in 2022 (+7.2%). Although likely to maintain good growth, we expect a slowdown in the comparatively high rates observed in categories such as cough, cold & allergy and analgesics, and expect others to maintain consistent performances or advance over 2022. Inflation remains a factor in many markets globally, impacting the nominal DB6 projections, and helping to keep the short-term outlook buoyant.

In the longer term, the market is forecast to grow by CAGR 27/22 of 5.2% and CAGR 32/27 of 5.7%, in part driven by Rx-to-OTC switch, most notably of erectile dysfunction and daily oral contraceptives. Projections for the broader CHC market, encompassing all channels and CBD is being finalised, but is expected to push the 2023 global projection to a higher level, and will continue to be spearheaded by the dynamic internet & mail-order channel. 

Nicholas Hall Writes: As you can imagine, I’m fully focused on this week’s London conference; and what a pleasure to be able to hold meetings face-to-face! It’s a year since we met in Athens, which felt like an enthusiastic group of friends and colleagues who had been let out of school after three years. One year on, my sense is that executives still do not travel as much as before and I know that the atmosphere will be very good in London. As well as excellent presentations, we’ve lined up amazing networking opportunities, and the delegate dinner will be held on a river boat, always a favourite destination for participants. 

In terms of content, there are too many highlights to list here, but I’m particularly looking forward to unveiling our new Strategic Narrative, showing the prevailing opportunities and relatively new threats to consumer health, which continues to hold up remarkably well. According to our lead story this week, 2023 is forecast to be well ahead of the pre-pandemic years, which is an outstanding achievement bearing in mind the many threats faced by our industry. Of course, store retail is only part of the picture, although by far the biggest. When we add in e-Commerce and CBD, and the less dynamic multi-level sector, our growth forecasts for the next 5 and 10 years will impress those within our industry and those looking in from the outside.

Hear from Frank Bacuet, Global Growth & Strategy Director at PricingOne, during our 33rd European CHC Conference, taking place in London next week! You can also expect to hear from experts from companies including J&J, Haleon and Perrigo. See the latest agenda here, or to register without delay, contact elizabeth.bernos@NicholasHall.com.

UK TO FAST TRACK INNOVATIVE MEDICAL PRODUCTS

UK: The Government has awarded an extra £10mn (US$12mn) to the Medicines & Healthcare products Regulatory Agency to help bring innovative new medicines and medical technologies to patients quickly. In the Spring Budget 2023, Chancellor of the Exchequer Jeremy Hunt said: “From 2024 [the MHRA] will move to a different model, which will allow rapid, often near automatic sign-off for medicines and technologies already approved by trusted regulators in other parts of the world such as USA, Europe or Japan. From next year, a swift new approval process will be set up for the most cutting-edge medicines and devices to ensure the UK becomes a global centre for their development. And with an extra £10mn of funding over the next two years, [the MHRA] will put in place the quickest, simplest, regulatory approval in the world for companies seeking rapid market access. We are proud of our life sciences sector, which received more inward investment than any in Europe last year.”

Nicholas Hall Writes: The UK is without doubt the most liberal regulatory environment in the world – although sometimes it doesn’t feel like it on the ground. The UK is predominant in Rx-to-OTC switch: HRT and the daily oral contraceptive have been switched as global or regional firsts. Last week, we announced that Cialis had been approved in the UK as a global pioneer (although the ingredient tadalafil is already available OTC in Poland), and the UK is home to the topical ED treatment, MED3000, which has the potential to challenge sildenafil and tadalafil as it claims comparable efficacy without side-effects. There are blind spots, of course, including melatonin and CBD, but the good news continues to roll.

^{Futura Medical’s MED3000 (brand name Eroxon) will roll out across Europe in the coming months}

The switch of Gina, the first HRT treatment, is especially important, although Novo Nordisk seems an unlikely OTC pioneer. Perhaps that is why the company has run into difficulties in the weight loss sector. In recent editions of Newsflash, we’ve commented on the growing incidence of obesity and excess weight, now of almost stratospheric proportions; but new treatments have failed to take off. That is why the launch of Novo’s Wegovy is so important, and at some stage could be a switch candidate. Let’s hope that the suspension of Novo Nordisk by the Association of the British Pharmaceutical Industry is just a slap on the wrist and doesn’t dent the reputation of this interesting new product or lessen Novo Nordisk’s enthusiasm to invest in the UK.

And the latest news from the British government is that it is looking for an even faster route to market for innovative new products, piggybacking on approvals given by trusted regulatory authorities in other jurisdictions. This is a sure sign that the UK government continues to be amongst the most progressive in healthcare and has been since 1985.

ED treatments is one of the categories explored in our recent Sexual Health & Fertility report. Other categories reviewed include daily OCs, male & feminine intimate care and menstrual products. To order your copy, or for more information, contact melissa.lee@NicholasHall.com.

CIALIS TOGETHER GRANTED OTC REGISTRATION IN UK

According to the UK’s Medicines Health products Regulatory Agency’s latest list of authorisations, published at end-February 2023, Cialis Together (tadalafil 10mg, Opella Healthcare / Sanofi) has been granted P (Pharmacy medicine OTC) registration. This is the second such OTC approval globally, following the world first Rx-to-OTC switch of Adamed’s Tadalafil MaxOn ED treatment (tadalafil 10mg; film-coated tablets; 2- and 4-count SKUs) by Poland’s Office for Registration of Medicinal Products, Medical Devices & Biocidal Products (URPL) in February 2022; it is now available OTC (launched in October 2022) alongside a rival version from Polpharma’s Maxigra, which launched first in June 2022.

OTC activity in the erectile dysfunction category is intensifying globally. Futura Medical, which is aiming for its topical gel formulation MED3000 – branded as Eroxon – to become the first major ED treatment available OTC in USA, said in late 2022 that the FDA had confirmed the dossier was under formal review and “indicated that [it] had successfully passed the initial technical screening”. Granting of US marketing authorisation was said to be on track to be achieved by end-Q1 2023.

^{Polpharma’s Tadalafil Maxigra 36h is claimed to get to work in 16 minutes and last for 36 hours}

Nicholas Hall Writes: I’m interested in our lead story as we’re all keen to know what will happen when Viatris’ Viagra meets stiff competition in its UK lead switch market, where Viagra was first to launch and has attracted no branded competitors, so that it virtually dominates the market. Poland was a different matter as Viagra came relatively late into the marketplace, by which time there were a number of sildenafil brands, sold at lower prices with mass advertising, followed by the first switch anywhere in the world of tadalafil. Not surprisingly, Viagra has had only modest results in Poland.

Now we face the prospect of OTC Viagra meeting strong branded competition in its lead market, with a formulation that might not be as well known, but in medical terms is generally recognised as superior. Will Sanofi launch Cialis Together with saturation advertising, or with a more muted campaign that seeks a secondary position in the market? This is an interesting proposition in its own right, but especially as Viagra in Europe may well change ownership in the next year.

There is still time to save up to GB£1,350 when you pre-order the 2023 edition of our Innovation in CHC report, publishing soon! Drawn from CHC New Products Tracker, this report explores innovation by marketer, region and country. It showcases 10 major ingredient trends, 5 delivery format trends and 100 key innovations from 2022. For more information, or to pre-order your copy with the pre-publication discount, contact melissa.lee@NicholasHall.com.

Alli granted final marketing approval in Japan

Following the recommendation of orlistat for direct-to-OTC approval in Japan, anti-obesity drug Alli has been granted final marketing approval by the Ministry of Health, Labour & Welfare. Taisho, which gained the rights to develop and market orlistat in Japan from GSK in 2009, is yet to announce the product’s release date.

Victoria Blake, head of Competitive Intelligence & Market Analysis (CIMA), writes: The World Health Organisation reports that worldwide obesity has almost tripled since 1975 – in 2016, almost 2bn adults were overweight. However, a report in 2020 found that across 7 major markets (France, Germany, Italy, Spain, UK, Japan and USA), Japan had the lowest total prevalence of obesity at 4%. While orlistat is a welcome innovation to the self-care market as a scientifically-proven solution to weight loss, it is notable that the target audience appears to be significantly smaller than in some Western markets (prevalence was reported at 40% for the USA). Nevertheless, serious government concerns regarding the economic healthcare impact of obesity in Japan’s older population led to the Metabo Law in 2008, which attempts to address obesity concerns through regular monitoring of waist size in those aged 40-74 years. Alli was switched in the USA in 2007 and in the EU in 2009 (the first drug to go through the EU Centralised procedure). Lack of repeat purchases was a key factor behind limited growth for the brand, consumers prone to expecting “miracle cures” and rapid results when it comes to weight loss vs faith in longer-term, proven regimen. We watch with interest to see how Taisho’s strategy unfolds for orlistat in this new market.

Nicholas Hall Writes: I wanted to lead with this story this week, not because Alli is a wonder brand – sadly, it failed in the consumer market – but because of the huge unmet demand for effective weight loss products, which is rightly pointed out by my colleague Victoria Blake. In fact, there is no other sector in consumer health where demand is so high and delivery so poor. In all other sectors we have great products and the job is communicating their benefits to consumers. This is the exact reverse, where demand is almost unlimited among an increasingly overweight population, but where we just don’t have safe and effective products in consumer health or indeed in the prescription market. So no one who reads this column will be surprised that weight loss and obesity is to be a major topic covered in my signature report, New Paradigms 2023 – the Future Resumed. 

One of the problems that Alli faced was honesty. The brand was marketed in terms of delivering major benefits, but those benefits could only be achieved if consumers modified their lifestyle as well. This they were largely unwilling to do, and there is a great deal of anecdotal evidence that consumers taking a weight loss product feel empowered to consume more of their favourite foods and drinks, even though contrary to the necessary changes that enable it to be effective. And, of course, weight loss brands stress simplicity, not the complex set of lifestyle changes necessary to deliver benefits.

We are delighted to announce that Nicholas will explore “The Future Resumed” in the upcoming 2023 edition of his signature New Paradigms report! Offering insights into unmet consumer needs, demographic drivers, emerging markets and more, this report will provide an essential strategic review of key factors impacting the CHC industry. To pre-order your copy at a discounted rate, or for more information, please contact melissa.lee@NicholasHall.com.

H&B REPORT: WOMEN’S HEALTH A TOP WELLNESS TREND IN 2023

According to Holland & Barrett’s (LetterOne) Wellness Trends Report 2023, areas of particular interest to consumers this year will include:

• Women’s wellness – a big business in 2022 – will ramp up even further, with personalised solutions and FemTech founders continuing to help lead the revolution on breaking down taboos around menopause, menstrual health, fertility and more

• Wellness tech gets personal. From patches tracking dietary biomarkers to carbon levels in the breath determining metabolic function, the future is all about using health data for optimum health. Health tech innovation is also becoming more focused on key target groups, such as those suffering from, or at risk of, chronic conditions

• Sleep As well as vitamin D and magnesium, newly-trending ingredients include glycine, spearmint and plant polyphenols, EGCG and l-theanine. Meanwhile, consumers are keeping orthosomnia — the worry about getting enough sleep — at bay with remedies containing lavender, chamomile and CBD. There will also be an increase in smart tech to synchronise circadian routines

• Ayurveda Ayurvedic remedies such as ashwagandha and curcumin, combined with scientific scrutiny, are experiencing a rise in popularity 

• Beauty from within Collagen’s status as a skin-smoothing beauty superhero is here to stay, but people are also starting to understand the broader benefits, and younger customers are using type 2 collagen supplements to keep their joints in optimal health

^{To read the full report, click here.} 

Nicholas Hall Writes: Last Wednesday we held the NHC Start of the Year Meeting at our Southend-on-Sea HQ. What a pleasure after three years to have 35 team members in the room and most of the rest of our global team dialing-in. One of our main objectives was to brainstorm a new Strategic Narrative for the CHC industry, which will drive our Global Trends roadshow after the new DB6 data is published in early April. And, of course, the Strategic Narrative will be at the heart of New Paradigms for CHC 2023, which we have just scoped and which will be published in July. As usual I will write almost every word of this completely revised 4th edition, supported by what I truly believe to be the biggest and best market analysis and creative solutions team in the CHC industry – 54 out of our total headcount of 65 plus numerous network partners, associates and freelancers.

And many of the overarching issues to be discussed in New Paradigms are illustrated in the latest edition of CHC.Newsflash: women’s health, MedTech and FemTech, lifestyle products, natural remedies, sustainability and China (reviewed at a time when Dr Nouriel Roubini warns us in his latest book, Megathreats, of the dangers of deglobalisation). And even before we publish the new report, I hope to meet as many of you as possible at our April conference in London, when we will give you a sneak peek of the new Strategic Narrative.

I will be joined on stage in London by speakers from PAGB, Haleon and Perrigo, plus other industry experts, for our 33rd European CHC Conference 19-21 April. Exploring The Future Resumed, you can review the full agenda or explore group booking options by contacting elizabeth.bernos@NicholasHall.com.

GSCF publishes v2.0 of Self-Care Readiness Index

The Global Self-Care Federation has launched the second edition of the Self-Care Readiness Index, examining how self-care policies are being implemented across the world. Both editions, together covering 20 countries, demonstrate very clearly that there is a widespread lack of a coherent view of self-care and its benefits. The SCRI is a research and policymaking tool, which explores the key enablers of self-care in support of designing a better model for healthcare systems. It evaluates countries based on four self-care enablers – stakeholder support and adoption, consumer & patient empowerment, comprehensive self-care health policies, and the appropriate regulatory environment – supported by measurable indicators of self-care readiness. The new SCRI is available here.

This latest version of the SCRI report highlights the regulatory environment as one of the key enablers of self-care, advising countries to “focus on regulations and processes governing approval of new health products, from prescriptions to over-the-counter medications.” For example, the approval time for Rx-to-OTC switch applications can vary from as little as one month in Mexico to 11-13 months in Germany and 24-30 months in Canada.

Nicholas Hall Writes: The concept of self-care needs additional drive, which is why we support the excellent work of the Global Self-Care Federation. As GSCF Director General, Judy Stenmark, said when announcing the second edition of the Self-Care Readiness Index: “Self-care has to be a political priority for every single government across the world.”

In many respects we are pushing against an open door! The latest survey of US consumers shows that they want to live longer, but are unaware that their current lifestyles mean that the last lap of life will most likely be miserable. Our industry can help and prosper by meeting the needs of a growing and highly-demanding older population.

Trevor Gore, Founder of Maestro Consulting is part of the online presenting panel joining Nicholas for our upcoming Asia-Pacific e-Conference on 23 November, exploring Opportunities with Collaboration in the Self-Care space. For more information, or to register, please contact elizabeth.bernos@NicholasHall.com.

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).

^{Source: UN World Population Prospects 2022}

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.