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.

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.

CRN HIGHLIGHTS SAVINGS FROM SUPPLEMENTS USE

The CRN Foundation’s Supplement to Savings report identified up to US$17.7bn in annual net savings between 2022-30 from the use of specific dietary supplements by at-risk target populations most susceptible to coronary artery disease (CAD). Throughout February, American Heart Month, CRN will amplify the potential of dietary supplements to reduce the health impacts and healthcare costs of CAD. The chapters on CAD focus on four supplement regimens: 

• Average annual cost savings from the widespread daily use of preventative amounts of omega-3 fatty acids EPA+DHA could be US$4.47bn 
• Regular use of magnesium by specific at-risk populations amounts to average healthcare cost savings of US$2.32bn per year 
• Regular use of vitamin K2 by specific populations could generate estimated annual cost savings of US$9.48bn 
• The average cost savings from increased utilisation of soluble fibre for heart-health effects is US$1.47bn per year 

^{Source: CRN Foundation}

Nicholas Hall Writes: We talk a lot about the ability of the CHC industry to reduce the overall cost of public health as well as improving access, but it’s always good to see hard figures with which we can agree or disagree. Even if these estimates are too high – which I’m not saying is the case – a saving of up to US$18bn from coronary artery disease alone, and an even more important saving of lives, are to be greatly desired. To quote Steve Mister, the CRN’s President & CEO: “Today, most of our healthcare resources are spent after people are already afflicted with an ailment. We hope the broader medical community will take notice and evaluate how supplements can enhance nutrition and improve the overall health of their patients.”

I like Steve Mister’s terrier-like defence of dietary supplements, which we witnessed a second time this week when he (rightly) criticised the FDA for its unwillingness to take responsibility for regulating CBD. It is one thing to say that existing regulations cannot provide a pathway for CBD, although one wonders why it took four years to reach this conclusion, but where then is the pathway? Unless the FDA takes hold of this emerging category, it will continue to display all the characteristics of the Wild West, when we are seeking to avoid a “Gunflight at the CBD Corral”. And until firm but fair regulations are put in place, we are unlikely to attract major consumer players to this sector.

Monitor the latest launches across VMS with our dedicated innovation benchmarking tool, CHC New Products Tracker, which features almost 40,000 launches, all graded with a star rating. Subcategories such as CBD, eye health, omega-3 and various herbal supplements are tracked, plus many others. To find out more, or to set up a demo, please contact david.redford@NicholasHall.com.

Stark 2023 growth warning from IMF head

The Managing Director of the International Monetary Fund has cautioned that 2023 is going to be a “tough year”, with one-third of the world economy expected to be in recession. The three big economies, USA, EU and China, are slowing simultaneously, translating to negative trends globally. Kristalina Georgieva added in an interview with the CBS News programme Face the Nation that, while USA is most resilient and may avoid recession, the strong labour market is a “mixed blessing” as interest rates could remain tight to lower inflation.

Meanwhile, half of the EU – severely hit by the war in Ukraine – will be in recession this year and China, which in 2022 slowed dramatically because of its zero Covid policy, will slow down further (+4.4% growth in 2023 projected) as the relaxation of restrictions leads to soaring coronavirus cases. Overall, IMF forecasts that Advanced Economies will grow by 1.1% in 2023, while Emerging Market and Developing Economies will rise by 3.7%, led by India (+6.1%) but dragged down by Russia (-2.3%).

When asked what leaves her hopeful, Georgieva said: “I know when we work together, we can overcome the most dramatic challenges. In 2020, the world came together in the face of tremendous threat and was able to overcome this threat. In 2023, we have to do the same.” 

Nicholas Hall Writes: For most of 2022 I wrote in CHC.Newsflash about a market performing surprisingly well, but there was an implicit warning that the party would come to an end one day. Kristalina Georgieva, head of the IMF, has issued a stark warning of tough times ahead economically, but that is light reading compared with Nouriel Roubini’s new book, “Megathreats”, which highlights the 10 trends that imperil our future. Known by some as Dr Doom, Roubini prefers to be known as Dr Realistic, but in my estimation he is Dr Right as he called out many past mistakes with great foresight, including the debt binge that has made the global economy today almost unmanageable.

So how will these megathreats affect Consumer Health? In one sense, we are privileged as healthcare is a must-have category, and self-care will fill part of the vacuum left by the inability of healthcare providers to meet the needs of a growing and demographically-unbalanced population, about which Dr Roubini also writes persuasively. But consumers can only spend the money in their pockets, regardless of whether it is earned or borrowed, which is why I am so concerned about the future of CHC brands and why generics and private labels are now seen as the new growth segment.

I’m also concerned about the viability of retailers and even e-Commerce platforms, as the economic crisis will lower customer footfall and push up costs including the cost of borrowing, forcing thousands of outlets to close. We are already seeing that as a sub-plot of today’s global medicine shortages. Partly this is a story of unpredictable demand caused by the afterwave of the Covid-19 pandemic, but it also seems to me that the supply chain has become very fragile as companies look for ways to cut costs by reducing inventory to breaking point. So our 2023 mission here at the Nicholas Hall Group is to reassess the Strategic Narrative for Consumer Health and offer advice to clients and the industry at large on how to survive mega- and microthreats.

We are pleased to announce that experts from Haleon, Perrigo and PAGB, plus our sponsors Pharmalinea will take the stage alongside Nicholas at our 33rd European CHC Conference! See the all-new agenda here. Taking place in London on 19-21 April 2023, save with the early bird booking discount when you book your place before 19 January! For more information, or for group booking discounts and sponsorship opportunities, please contact elizabeth.bernos@NicholasHall.com.

CRN 2022 survey: Vitamin D in high demand

To mark World Vitamin D Day (2nd November), CRN published initial findings from its 2022 Consumer Survey on Dietary Supplements, which was conducted (in collaboration with Ipsos) in August 2022 among 3,133 US adults aged 18+ years. This includes 2,342 who report consuming dietary supplements seasonally, occasionally or regularly. The survey highlighted the Top 5 single ingredient supplements (see chart below), while also indicating that more than half of consumers (52%) who take supplements report taking a specialty supplement, the most reported of which are omega-3s, probiotics, melatonin and fibre.

CRN states that many more people could experience enhanced quality of life, as well as healthcare cost savings, if they were to follow the dietary supplement regimens discussed in the CRN Foundation Supplements to Savings report. For example, if all US adults aged 50+ years took calcium 1,000mg and vitamin D 15mcg per day, the US healthcare system could save US$17.3bn and avoid 361,507 medical events on average per year from 2022–30. “A steadily growing body of clinical research shows investing in preventive care through supplementation helps Americans avoid chronic conditions. This strategy is what we call a no-brainer,” said CRN SVP Scientific & Regulatory Affairs Andrea Wong.

Nicholas Hall Writes: As CHC.Newsflash reported recently, overall supplement usage stands at 75% of the entire US population, an astonishingly high level. Multivitamins remains the top dietary supplement (taken by 70%) and reported consumption of immunity-boosting supplements – including vitamin D, vitamin C and zinc – remains steady vs last year. Immune health is a top reason for taking supplements (40%), second only to overall health & wellness (44%). Yet there is still room for more growth, which would benefit both individual consumers and our industry, and the healthcare system at large. According to CRN, the annual savings from wider usage of calcium and vitamin D could reach US$17bn.

This data joins a torrent of basically good news about consumer health that makes me think that we are at the beginning of a golden age for our industry, which is how I described our prospects when I gave the final presentation at the Ceuta London conference. We used to say that CHC was dependent on three main drivers of growth. It is true that the cough & cold market is once again boosting demand, but we now no longer rely on the Emerging Markets to the same extent, and Rx-to-OTC is virtually non-existent. No, it is the broader acceptance of self-care by the US and European population that is delivering the most impressive results this year.

In just over two weeks, you can log on to hear from Nicholas and industry experts during our Asia-Pacific e-Conference on 23 November! Topics on the agenda include the go-to-market model, self-care collaborations and sustainability through accessibility. For more information, or to register, please contact elizabeth.bernos@NicholasHall.com without delay.

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.

CRN Survey: Branded ingredients favoured by VMS consumers

The Council for Responsible Nutrition has revealed initial findings from its 2022 Consumer Survey on Dietary Supplements. The survey was conducted online in August 2022 among 3,133 US adults aged 18+ years, including 2,342 who report consuming dietary supplements seasonally, occasionally or regularly.

Liz Cummings, our Regional VP North America, reports from CRN’s Now New Next conference: 

US dietary supplement use has reverted to the pre-pandemic level of 75%, with multivitamins remaining the favourite among users. A wealth of regulation, science, economic and consumer insights was unveiled over the 3-day conference, which will be shared in future NHC publications. However, with CHC Newsflash highlighting the dynamic activity related to ingredients suppliers such as DSM, Kerry and ChromaDex, we thought it was timely to share the following results from the CRN survey: 

• 71% of supplement users agree that they “find more confidence using supplements made with branded ingredients”

• 62% perceived that supplements with branded ingredients cost more because they are more effective and better quality, and men were more likely to say that branded ingredients work better

• 61% are willing to pay higher prices for branded ingredients. Adults aged under 55 years are willing to pay more for branded ingredients

^{Source: CRN / Ipsos}

Nicholas Hall Writes: It seems we are awash with consumer research that confirms the importance of self-care, especially with regards to immunity, even though demand is returning to pre-pandemic levels. In many respects, consumers seem ahead of marketers (let alone regulators) in how they respond to the mega-trends of the day: the pandemics, economic pressures and the energy crisis.

As I wrote last week: “I see a paradox in matching this consumer U&A data with the relative failure of specific immunity products such as antiviral nasal sprays … So why is it that consumers who fear Covid-19, and who subscribe to the concept of immunity, are content to rely on, say, a multivitamin the category grew by 13.5% globally in Year 1 of the pandemic — and not divert to specialist products? I am still searching for an answer.” Another paradox is that, while the top CHC players are reporting excellent sales and the global sales data for the 12 months to June 2022 which we reported in late September is at a record high, retailers and e-Commerce platforms are reporting reduced traffic. And there are signs that many consumers are trading down to smaller packs or cheaper generics and private labels, which you would expect in a recession.

One of the joys of working in consumer health is its resilience. It truly is a “must have” category, but it is in the detail where we will make or lose our reputations. It seems that we must switch focus from macro-trends to the micro and to understand better what makes everything tick rather than the size of the clock. So, expect more springs, wheels and cogs to be presented in the autumn and winter months ahead.

Immune health is the focus of our recent Immunity hot topic report. With profiles of key brands across categories including antivirals, vitamins, foods & beverages and probiotics for immunity, our report explores the latest trends & developments, predicting likely future scenarios. To order your copy, or for further details, contact melissa.lee@NicholasHall.com.

CDC Report Shows Further Falls In US Life Expectancy

Life expectancy in USA has fallen for the second consecutive year, according to provisional data published by the US Centers for Disease Control & Prevention. For 2021, US life expectancy at birth was 76.1 years, the lowest since 1996 and down from 77.0 years in 2020. Male (73.2 years) and female (79.1) life expectancy also declined to levels not seen since 1996.

The almost one-year decline between 2020-21 was primarily owing to increases in mortality because of Covid-19 (50% of the negative contribution), unintentional injuries, heart disease, chronic liver disease & cirrhosis and suicide. This would have been greater were it not for the offsetting effects of decreases in mortality owing to influenza & pneumonia, chronic lower respiratory diseases, Alzheimer’s & Parkinson’s disease and perinatal conditions.

Source: https://www.cdc.gov/nchs/data/vsrr/vsrr023.pdf

Nicholas Hall Writes: Does falling life expectancy matter? Yes, it matters a lot, to individuals and their friends and families; and to society, especially as some of the early deaths are among members of the economically-active population who financially support both the younger and older age groups. It also matters to our industry in that it continues to change the demographics, which may present new marketing opportunities.

As is his wont, tech billionaire Elon Musk has repeated his warning of a global underpopulation crisis, most recently tweeting that “population collapse due to low birth rates is a much bigger risk to civilisation than global warming”. Experts disagree. Demographer Joseph Chamie hit back: “He’s better off making cars … than at predicting the trajectory of the population. Yes, [in] some countries, their population is declining, but for the world, that’s just not the case.” This is backed by the UN’s World Population Prospects 2022 report, as we reported back when it was first published in July, which predicts that on 15th November 2022 the global population will reach 8bn and that it could grow to around 8.5bn in 2030 and 9.7bn in 2050, before peaking at around 10.4bn people during the 2080s.

Benchmark leading brands and track competitor activity across major and local players with CHC New Products Tracker. Featuring 36,000+ entries, this ultimate competitive intelligence tool allows you to create your own customised searches. Please contact david.redford@NicholasHall.com to set up a demo.