In Austria, Stada has launched Aurasin Akut (zolmitriptan 2.5mg tablets; 2-count SKU; suitable for consumers aged 18-65 years), which is indicated for the acute treatment of the headache phase of migraine attacks, with or without aura. Said to be a “game changer” by the marketer, this is the first non-prescription triptan in Austria after Stada received OTC authorisation for Zolmitriptan Stada 2.5mg in April 2021, while other zolmitriptan-based products remain Rx. A+P support will include radio, print and online activity from August 2021. This development brings Austria in line with the rest of DACH subregion: in Germany sumatriptan was switched from Rx-to-OTC status, and age restrictions (18-65 years) for almotriptan and naratriptan were removed, effective November 2020; while in Switzerland, as of July 2021, multiple triptans can be dispensed without a prescription following face-to-face consultation with the pharmacist.
Comment from Head of Consumer Healthcare at Stada Austria, Ulrich Grottenthaler: With the introduction of Aurasin Akut, a targeted, OTC, well-tolerated treatment for acute migraine attacks is made possible for the first time. The active ingredient zolmitriptan is already well established and also acts where the migraine pain originates. This sets us apart from other non-Rx painkillers. With Aurasin Akut, we enable patients who have once been diagnosed with migraine to get the best therapy for acute migraine attacks in an uncomplicated way and without a prescription in Austrian pharmacies — simply and quickly!
Now is your last chance to join this week’s hot topic webinar focusing on Immunity & Other Drivers of Consumer Healthcare for Europe. Taking place Wednesday 21 July, topics on the agenda will include WOW! brands, e-Commerce and disinfection, plus much more. To register, or to find out more, please contact elizabeth.bernos@NicholasHall.com.
CVS Health’s just-published 2021Health Care Insights Study, which asked 1,000 consumers and 400 providers for their thoughts on the state of healthcare and how they are navigating this evolving landscape, reveals preferences for a more personalised, customisable and accessible experience.
Even as access to health insurance coverage (55%) and location of care (43%) remain among the top factors that influence consumer healthcare decisions, more people are exploring different avenues of care, with a slight movement away from primary care providers (PCPs) to other healthcare resources. Routine care from PCPs has dropped since last year (56% vs 62%), while the use of online resources (19% vs 12%), community health centres (19% vs 15%) and local pharmacies (17% vs 11%) have grown in preference.
Other findings include:
77% said the pandemic has led them to pay more attention to their health in general, while 50% indicated previous stay-at-home orders helped them achieve their health goals
In addition to increased substance use, feelings of stress have been pervasive, especially for men, who reported slightly higher levels of stress vs female respondents over the significant shifts that took place during quarantine
Young adults (18-34 years) were most impacted by the pandemic and the most likely age group to report depression (35%) and a higher rate of mental illness (28%) vs total respondents (23%)
Comment from CVS Health President & CEO, Karen Lynch: Over the past year-and-a-half, we have witnessed a dramatic shift in consumer healthcare preferences and needs. These shifts towards personalised care have the potential to impact our healthcare system well past the pandemic, with many people taking a more engaged approach to their own health. Going forward, we have an opportunity to take what we’ve learned and continue to foster an integrated health model that is centred around the needs of the individual.
Will consumer interest in boosting immunity outlast Covid? Is the shift to prevention products sustainable? These important questions will be explored in our forthcoming hot topic report focusing on Immunity. A number of categories including antivirals, immune supplements and vitamins C & D will be featured, alongside the latest launch activity and much more. To pre-order your copy and save with the pre-publication discount, or to find out more, please contact Melissa.Lee@NicholasHall.com.
According to Nicholas Hall’s global sales database DB6, the retail (bricks & mortar) CHC market generated global sales of US$148bn, down by -0.6% versus a year ago. Further heavy decline for cough, cold & allergy (-14.5%), especially in North America and Western Europe, was largely responsible for the global fall in CHC sales. The Americas declined by -0.4%, driven by a -1.9% fall in North America, but slightly offset by a positive performance by LatAm markets (+8.5%), notably double-digit growth in Brazil (+10.6%).
Asia remained relatively weak (+2.6%); despite strong growth in China (+7.1%), the region continues to be impacted by loss of revenue from overseas visitors in key markets Japan (-9.1%) and Australia (-8.0%). Europe saw a significant downturn (-5.5%), heavily impacted by declines in CCA and analgesics in Western Europe. Key markets Germany (-13.3%) and UK (-13.9%) fell by double-digits during the MAT Q1 2021 period. In C&E Europe, meanwhile, Russia continued to post a positive performance (+4.1%), albeit at a slower rate than year-end.
As for global performance by major category, vitamins, minerals & supplements (+5.3%) remained the fastest-growing category – albeit at a slower rate than year-end 2020 – with immune-associated categories continuing to benefit from greater consumer focus on wellness maintenance and protection. Dermatologicals increased by +4.5%, its buoyancy largely attributed to the performance of antiseptics & disinfectants (+53.1%) during the pandemic. Lifestyle CHC grew by +2.4%, driven by double-digit increases in sedatives & sleep aids (+14.5%) as well as smaller categories such as obesity treatments, emergency hormonal contraception and erectile dysfunction.
Gastrointestinals returned a low level increase (+1.2%), while analgesics saw a decline of -1.8% globally, with systemics down -4.3%, largely owing to the effects of pantry loading at the start of the pandemic. Cough, cold & allergy saw the strongest decline, with sales falling by -14.5% in the 12 months to end March. Pantry loading, as well as the effects of lockdown restrictions, social distancing, mask wearing and hygiene measures resulted in significantly reduced incidence of respiratory pathologies.
At a time when consumers are highly aware of the importance of maintaining their immune system, we are pleased to announce that Immunity will be the focus of our next hot topic report! We will review a number of categories including antivirals, immune supplements and vitamins C & D and explore the latest launch activity, plus much more. To pre-order your copy and save with the pre-publication discount, or to find out more, please contact Melissa.Lee@NicholasHall.com.
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.
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.
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
Google is making a big move into healthcare with its announcement last week of a new AI skin care tool, Derm Assist, which is set to launch in Europe later this year. The new tool received a Class I medical device CE mark from European regulators, and is backed by landmark research that was published in Nature Medicine this time last year, showing how Google’s AI model was trained on more than 16,000 real-world dermatology cases and achieved accuracy on a par with US board-certified dermatologists. Another more recent study in JAMA Network indicated the AI tool also significantly improved diagnostic accuracy of non-derma specialists such as GPs.
In its blog announcement, Google said: “With our CE marked AI-powered dermatology assist tool, a web-based application that we aim to make available for early testing in the EU later this year, it’s easier to figure out what might be going on with your skin. Simply use your phone’s camera to take three images of the skin, hair or nail concern from different angles. You’ll then be asked questions about your skin type, how long you’ve had the issue and other symptoms that help the AI to narrow down the possibilities. The AI model analyses all of this information and draws from its knowledge of 288 conditions to give you a list of possible conditions that you can then research further. It’s not meant to be a replacement for diagnosis, but rather a good place to start.”
Google said that it sees billions of Google Searches every year related to skin, nail and hair issues, but that it remains difficult for people to describe what they see on their skin through words alone. According to the FT, Google cited studies showing that people only diagnose themselves correctly 13% of the time when it comes to skin conditions, presenting a huge opportunity for the Derm Assist tool. In the blog announcement, Google provided a visual walkthrough of how the tool will work on smartphones, starting with a prompt to submit a picture of your “skin concern” (examples include moles, birthmarks and rashes), with the visual information then analysed by the AI before being converted into a gallery of suggested conditions.
Google is keen to emphasis the inclusivity of its AI model, stating: “To make sure we’re building for everyone, our model accounts for factors like age, sex, race and skin types – from pale skin that does not tan to brown skin that rarely burns. We developed and fine-tuned our model with de-identified data encompassing around 65,000 images and case data of diagnosed skin conditions, millions of curated skin concern images and thousands of examples of healthy skin – all across different demographics.”
Review New Product Activity and the latest digital health developments across the industry with Innovation in CHC 2021, the latest report from CHC New Products Tracker. For more information, or to order your copy, please contact melissa.lee@NicholasHall.com
Five of the Top 6 global CHC marketers have now reported their Q1 2021 results, and the clear common theme is a difficult start to the year as a result of the downturn in cough, cold & allergy sales. Global No.1 GSK reported that Consumer Healthcare sales were down 9% as a direct result of the year-on-year “pantry-loading” comparison, including accelerated purchases across all categories driven by the pandemic, combined with a historically weak cold & flu season. GSK’s Respiratory Health portfolio was down 42% in Q1, with Theraflu and Robitussin declining in double-digits, and Contac hit by a high single-digit fall, all adversely impacted by a lower cold & flu season.
Global No.2 J&J reported that Consumer Health worldwide operational sales were down 2.9%, primarily driven by negative prior-year comparisons related to Covid pantry loading in Q1 2020, mainly in OTC products, which declined by 14.8% in Q1 2021 as a result of lower cough, cold & flu incidences. This was partially offset by growth in Listerine mouthwash, Johnson’s baby care products, international skin health / beauty products and Nicorette sales outside the USA.
Sanofi’s Consumer Healthcare sales decreased by 7.3% in Q1 2021, primarily reflecting the weak cough / cold season, as well as a high base for comparison in Q1 2020 and divestments of non-core products. Allergy fell by 6.2%, while Cough & Cold sales were down 59.4% in Q1 2021. This heavy decline was offset by gains for Digestive Wellness (+14.6%), Physical Wellness and Mental Wellness (+18.8%) products. In USA and Rest of the World, growth of the Digestive and Mental Wellness categories partially offset lower Cough / Cold and Pain sales, but in Europe CHC sales fell by 19.3% in Q1.
Reckitt Q1 2021 net revenue was up 4.1% (like-for-like), and e-Commerce was +24%, accounting for 13% of total net revenue, driven by increased investment. Health fell 13.0%, reflecting a volume decline of 14.2% and price / mix improvements of 1.2%, as overall price growth was offset by relatively higher trade investment in North America. The OTC portfolio fell by just under 40%; in addition to challenging comparatives owing to significant pantry-loading in March 2020, this reflects an exceptionally weak cough, cold & flu season – estimated to be around 90% lower than the prior year – resulting in declines for Strepsils, Nurofen and Mucinex.
P&G’s Health Care organic sales were up 3% in Q1 2021, while Personal Health Care organic sales fell by mid-single digits, primarily owing to pandemic-related increases in consumer and retailer inventories in the base period and a weaker than average cough, cold & flu season. Representing 14% of global sales, e-Commerce sales increased by around 50% fiscal year-to-date, with no noticeable change in shopping trends in the quarter. CFO Andre Schulten said in an earnings call that a portion of the impact of commodity cost challenges in the next fiscal year would be offset with price increases in the baby care, feminine care and adult incontinence businesses, which will go into effect in mid-September 2021.
Celine Waller VP, DB6 comments: The poor CHC results reported were set against a robust performance in Q1 2020 when consumers were stockpiling ahead of lockdown restrictions (J&J’s OTC business increased operationally by 25.8% in Q1 2020!) and we expect that they will improve as the year goes on. However, 2021 is expected to be affected by a very weak cough / cold season as lockdowns (still in effect in many markets), social distancing, hygiene measures and mask-wearing continue to suppress incidence of respiratory illnesses, while there are some doubts about whether the high consumption levels of disinfectants and immune-boosting supplements can be sustained. As such, we have lowered our expectations of CHC growth in 2021 to 2.3% in the retail market. However, as highlighted in the P&G results, the 2020 boom in e-Commerce sales is continuing into the current year and we forecast that combined CHC sales in all channels will come out at a respectable 4.0% in 2021.
We are pleased to announce that our annual bestselling report, Nicholas Hall’s CHC Yearbook 2021, is now published digitally! You can analyse key players’ performance, hot topics, global retailing, the Top 15 markets and much more! Print copies will follow soon. For more information, or to order your copy, please contact melissa.lee@NicholasHall.com.
The world is still failing to develop desperately-needed antibacterial treatments, despite the urgent threat of antibiotic resistance, according to a World Health Organisation report. None of the 43 antibiotics in clinical development sufficiently address drug resistance in the most dangerous bacteria. The majority offer limited clinical benefit over existing treatments, while 82% of recently-approved antibiotics are derivatives of older products with well-established drug-resistance.
WHO highlights 27 non-traditional antibacterial agents, ranging from antibodies to bacteriophages, and therapies that support the patient’s immune response and weaken the bacteria’s effect. However, while there are some promising products in development, only a fraction will make it to the market, owing to economic and scientific challenges. The low return on investment from successful products has limited the interest of major private investors and most large pharma players, and the small to medium-sized companies driving the pipeline often struggle to finance their products through to regulatory approval.
Nicholas Hall Writes: “Just when you thought it was safe to go back in the water (to quote the movie “Jaws”), the World Health Organisation reminds us that there could be more and worse to come. The worldwide pharma industry has responded magnificently to Covid, and if a fraction of that effort went into the search for new antibiotics, we could perhaps avoid the next and possibly much worse pandemic, when superbugs attack mankind. I’m not referring to hacking from within the Dark Web, but bacteria for which existing antibiotics will be unable to cope! One medical expert has described this as making Covid look like a vicarage tea party!
To quote WHO: “Opportunities emerging from the Covid-19 pandemic must be seized to bring to the forefront the needs for sustainable investments in R&D of new and effective antibiotics … We need a global sustained effort including mechanisms for pooled funding and new and additional investments to meet the magnitude of the AMR (antimicrobial resistance) threat.” So I hope that Big Pharma will recycle the windfall from Covid vaccines into new antibiotic research, otherwise we will have many more years of lockdown!”
Immunity will be the focus of our next round of regional hot topic webinars, starting with a focus on Asia-Pacific on 19 May, followed by the Americas on 23 June and Europe on 21 July. Please contact elizabeth.bernos@NicholasHall.com to find out more about these upcoming sessions.
Following our recent blogs on Sanofi’s plans to switch erectile dysfunction treatment Cialis and flu antiviral Tamiflu to OTC status in the USA within the next three years, and the UK MHRA announcement it has launched a public consultation on the reclassification of two progestogen-only contraceptive pills containing desogestrel, here we round up other recent OTC switch developments from around the world (Japan, Russia, China and Argentina).
In Japan, a panel under the Ministry of Health, Labour & Welfare’s Pharmaceutical Affairs & Food Sanitation Council has approved the switch from Rx to OTC (Instruction-Required Drugs with 3-year post-marketing surveillance period) of the following products:
Kobayashi’s Ira-Kuna contains itopride hydrochloride for the treatment of gastrointestinal symptoms (e.g. bloating and heartburn)
BUP-4 Lady Yuli-less (Taiho / Otsuka) formulated with propiverine hydrochloride 10mg (half the dosage of Rx versions) for urinary problems caused by overactive bladder
Nasivin Medi an oxymetazoline hydrochloride + chlorphenamine maleate nasal spray for rhinitis. Sato launched Japan’s first OTC oxymetazoline nasal spray, Nasivin M Spray, in April 2011 (then a Merck-owned brand, now P&G)
The Rx-to OTC switches of itopride hydrochloride and propiverine hydrochloride were approved in 2018, but this is the first time that products containing these ingredients have been approved for OTC sale.
In China, the NMPA has approved the Rx-to-OTC switch of miconazole nitrate 0.1g tablets for vaginal use. Relevant marketers must provide revised package inserts to health authorities by 1st December 2021. Companies that market this formulation Rx include China Resources Double Crane and Yun Shin Pharm.
In Russia, Janssen (J&J), Bayer and RB are among the companies behind the creation of the Association of Healthcare Product Manufacturers, which is designed to promote responsible self-medication in Russia and form an adequate regulatory framework regarding the availability of OTCs, medical devices and supplements. This includes shortening the registration time for well-established ingredients with proven safety and efficacy, and creating clear criteria for Rx-to-OTC switch activity.
And finally, in Argentina, Elea has extended women’s health brand Eva with EvaCare Gyno capsules (fluconazole 150mg) – Argentina’s first OTC oral VYI treatment. A TV A+P campaign highlights its convenient format – “1 capsule, 1 dose, 1 day” – for treating the symptoms of vaginal candidiasis. The product will compete with clotrimazole-based Empecid Gyno (Bayer; GynoCanesten globally) and Lomecan V (Genomma) creams and vaginal ovules.
Review case studies of successful Switches in our forthcoming report from Nicholas Hall’s CIMA team, written in association with switch expert Joe McGovern of Biograph Inc. Pre-order your copy of Rx-to-OTC Switch: A Hot Topic Report before 31st March to save with our pre-publication discount! For more information, or to purchase your copy, please contact melissa.lee@NicholasHall.com.
2020 was a tough year for the CBD industry, with Covid causing disruptions to supply chains as well as lower footfall in bricks & mortar retailers, and these setbacks were reflected in greater hesitancy from CBD marketers in terms of NPD activity – according to our CHC New Products Tracker service – with launch activity in 2020 much lower compared to 2019. However, recent regulatory developments in Australia and Mexico, and the uptick in M&A activity in the CBD industry over recent weeks, suggest 2021 will see a revival in NPD activity and sales.
For example, Curaleaf, a leading US provider of consumer cannabis products, last week signed a definitive agreement to acquire EMMAC, the largest vertically-integrated independent cannabis company in Europe, for around US$286mn. Curaleaf Executive Chairman, Boris Jordan, commented: “[This acquisition] provides an advanced base to reach scale within the nascent European cannabis market and transform Curaleaf into a truly international cannabis consumer packaged goods company. The consumer and political liberalisation trends around cannabis that are sweeping USA are also increasingly taking hold in Europe … The European cannabis market has the potential to exceed the US cannabis market over the long-term and will help fuel our growth for years to come.”
In addition, a wholly-owned subsidiary of British American Tobacco last week subscribed for around 58.3mn common shares – a 19.9% equity interest – of Organigram, a leading licensed cannabis producer, for C$221mn (US$176mn). The companies have also entered into a Product Development Collaboration Agreement, under which a Centre of Excellence will be established to focus on developing the next generation of cannabis products, with an initial focus on CBD. “The cannabis industry is still in the nascent stages of product development. We believe that product innovation backed by core fundamental R&D is necessary to establish a long-term competitive advantage in the cannabis industry,” said Organigram Chief Strategic Officer Paolo De Luca.
Another M&A CBD development from last week was MediPharm, a research-driven global leader in cannabis extraction, entering into a GMP white-label supply and contract manufacturing agreement with Cannim. The company has also commenced registrations for the launch of next-generation OTC products in Australia in 2021. Under the 3-year agreement, with options to extend, MediPharm will supply a full range of specially-formulated CBD and THC cannabis oil products, sold initially under Cannim’s Lumir brand. MediPharm will also provide Cannim with contract manufacturing options.
Finally, a bill that would legalise the recreational use of cannabis was approved in Mexico’s lower house of Congress last week and will move to the Senate for final approval. The legislation would enable users aged 18+ years with a permit to carry up to 28g of cannabis and grow up to eight plants at home for personal use. President Andres Manuel Lopez has argued that the bill could help to curb Mexico’s violent and powerful drug cartels. John Walsh, Director of Drug Policy for the Washington Office on Latin America, a US advocacy group, said: “Mexico, given its size and its worldwide reputation for being damaged by the drug war, to take this step is enormously significant. North America is heading towards legalisation.” Canada and Uruguay are the only countries in the world to have legalised cannabis for recreational use. With its liberal switch environment, Mexico could be an early adopter of OTC cannabis, possibly the second or third market after Australia.