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.

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.

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.

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.

Spotlight on WBA, plus US and UK retail

In its latest results, Walgreens Boots Alliance announced that fiscal 2021 sales from continuing operations rose by 7.5% on a constant currency basis to US$132.5bn, exceeding expectations. In Q4 fiscal 2021 (June-August 2021), sales increased by 11.8% to US$34.3bn.

• United States had Q4 sales of US$28.8bn, up by 6.6%. Retail sales grew by 6.5%. Comparable sales were up 8.1%, reflecting an 8.9% rise in comparable pharmacy sales and 6.2% growth in comparable retail sales. Excluding tobacco & e-cigarettes, sales increased by 7.2%, reflecting broad-based growth across all categories. In particular, health & wellness sales were 14% ahead, aided by cough / cold & flu, at-home Covid tests and vitamins.

• International sales rose by 61.8% to US$5.5bn, including a favourable currency impact of 9.2%. Sales were up 52.6% (CC), including higher sales associated with the formation of the company’s wholesale j-v in Germany. Excluding this, sales rose by 9.3% (CC), reflecting the ongoing recovery in the UK market, where Covid restrictions were lifted in July 2021. Boots UK comparable retail sales were up by 15.0%, with footfall on the high street recovering although still below pre-Covid levels. Boots.com continued to perform ahead of expectations, with digital sales in Q4 more than doubling vs pre-Covid levels.

Both the US and UK CHC markets struggled for growth in the MAT Q2 2021 period – as per the chart below – but there were signs in the WBA results of a strong recovery in retail pharmacy sales in both markets in July and August 2021.

WBA has also announced its new consumer-centric healthcare strategy to drive sustainable, long-term growth. The plan features the launch of Walgreens Health, a technology-enabled care model powered by a nationally-scaled, locally-delivered healthcare platform. Walgreens Health will bring equitable, personalised, healthcare to communities across USA in-store, at home, in the doctor’s office and via a mobile app. WBA’s aim also includes reimagining retail through expanded health & wellness offerings and mass personalisation; accelerating WBA brands and digital offerings; and expanding the Transformational Cost Management programme.

In addition, WBA has increased its ownership stake in VillageMD from 30% to 63% to advance its strategic position in the delivery of value-based primary care, a fast-growing segment of the healthcare system. The US$5.2bn investment will accelerate the opening of at least 600 Village Medical at Walgreens primary care practices in 30+ US markets by 2025 and 1,000 by 2027, with more than half of those practices in medically underserved communities. 

Now is your final chance to enter our Nicholas Hall’s CHC Marketing Awards, taking place during our APAC e-Conference 2021 on 23 November! If you wish to put your brands in the spotlight, enter your campaign before 22 October. To find out more about this online meeting or awards criteria, please contact elizabeth.bernos@NicholasHall.com.

Seasonal respiratory viruses re-emerge post-Covid

Recent reports from the UK and USA suggest a severe cold & flu season may be in store during winter 2021-22. With lockdown restrictions, increased hygiene measures and social distancing in force for over a year to reduce the risk of contracting Covid-19, the incidence of common respiratory viruses has been very low. However, with the lack of exposure to illnesses (especially among young children), many of us have not built up antibodies and as a result our immune systems may have been inadvertently weakened.

This has prompted warnings of a potential surge in influenza as measures are lifted; data released this week by the UK’s Office of National Statistics show that in the week ending 11th June, 84 death certificates issued in England & Wales mentioned Covid, while 1,163 deaths involving flu and pneumonia were registered. Additionally, a recent study by the Houston Methodist Research Institute shows the rapid re-emergence of seasonal respiratory viruses following the relaxing of Covid-19 restrictions in Texas in March 2021.

Source: Houston Methodist Research Institute

This trend was also reported in a recent article in STAT, in which Trevor Bedford, a computational biologist who monitors which viruses are circulating via the Nextstrain service, was quoted as saying: “Just in the last month [May 2021] or so we’ve started to pick up small amounts of seasonal coronavirus, RSV, metapneumovirus, etc. It’s the first time since April 2020 where we’re starting to see other things circulating.”

There is particular concern that by the time universities, colleges, schools and nurseries reopen this autumn across the northern hemisphere, there will be perfect conditions for high transmission of seasonal respiratory viruses, particularly RSV (respiratory syncytial virus). Andrew Pavia, Chief of the Division of Pediatric Infectious Diseases at the University of Utah, warned: “There will be two years’ worth of kids who are naïve to RSV, instead of one birth cohort. That could be fertile ground for a big RSV year.”

Epidemiologist Professor Neil Ferguson of Imperial College, a member of the UK Government’s Scientific Advisory Group for Emergencies, said in a BBC interview that we must be prepared for a potentially “quite significant” flu epidemic and increased hospitalisations this winter. To help save National Health Service resources, researchers are investigating whether seasonal flu jabs and a Covid vaccine can be administered at the same time.

We are pleased to announce that our Eye Health report is now published and available to order! You can review case studies of key brands, NPD activity and much more. Plus, ensure you have registered for the free webinar on 30 June here to discuss the topline findings. For more information, please contact melissa.lee@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

Historically slow cough, cold & flu season

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

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

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

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

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

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

OECD: Covid’s impact on e-Commerce

A new report published last month by the OECD, entitled e-Commerce in the time of COVID-19, explores how the pandemic has caused an expansion of e-Commerce towards “new firms, customers and types of products, likely involving a long-term shift of e-Commerce transactions from luxury goods and services to everyday necessities”. Below we pick out some of the highlights that relate to medicines.

In the opening summary, the OECD says that, “while e-Commerce in the past for many consumer groups was centred on high tech goods, toys or books, it now increasingly involves goods for which availability is critical to a large share of the population, including groceries, medicine and other necessities.” There were two examples given by the OECD from Brazil and Germany showing how e-Commerce has disrupted the medicines market.

In Brazil, “around 54% of Internet users had bought food or food products over the Internet in 2020, substantially up from only 22% in 2018. Significant increases were also observed for cosmetics, toiletries and medicines. As convenience has always been one of the key drivers of e-Commerce participation, it is likely that many of the new users will keep ordering at least some goods online in the future.”

As for Germany, “online sales grew significantly for medicines and groceries, historically laggard sectors in terms of e-Commerce, while overall online sales contracted by around 18% in March 2020 in comparison to the previous year.” The OECD report also highlighted the impact of Covid-19 on e-Commerce’s share of total retail sales in the UK, USA and EU.

Writing in last Friday’s CHC.Newsflash, Nicholas Hall said: “Let’s take the best case point-of-view, that the incidence of Covid-19 will shrink dramatically during the middle of 2021, with a significantly lower death rate. How do we get back to normal? Will personal and professional life pick up where it left off? I doubt that very much. It seems to me that, at the very least, working from home is here to stay, which could mean the revival of suburban shopping, with lower footfall in city centres and out-of-town shopping malls. One impact on consumer health could be a marked revival in community pharmacy and online purchases growing from 9% to 19% of total CHC sales globally in the next 10 years, and from 11% to 27% in Asia. Another fascinating statistic courtesy of Eurostat is that, uniquely, the over-55 cohort is the largest purchasing group for medicines online, which runs counter to the theory that digital equals youth.“

Don’t miss out on the chance to save up to 50% on selected reports with our Q4 promotional event, which will run until the end of the year! Stay tuned for new deals coming in December! To find out what promotions are available, or to make a purchase, please contact melissa.lee@NicholasHall.com