Lifestyle OTCs still the best hope for OTC switch revival

2019 has been a slow year for Rx-to-OTC switch news, with activity dropping off markedly in the key US market in recent years, and Asia-Pacific (especially China, Japan and Indonesia) and Europe (Poland especially) the main source of developments. In this context, it was welcome news last week that Norway will become the second European market for OTC Viagra, after the Norwegian Medicines Agency approved the OTC sale of Viagra Reseptfri (Pfizer, sildenafil 50mg) erectile dysfunction treatment to men aged 18+ years, with this to be accompanied by pharmacist advice.

Pfizer plans to launch Viagra Reseptfri in pharmacies in early 2020, while Rx Viagra will remain available. The medicines agency recommends that men have a check-up with their doctor within six months of purchase so that any potential underlying conditions can be investigated. Viagra Reseptfri will be the first medicine available in Norway under the country’s new category of non-prescription medicine with guidance, and the Rx-to-OTC switch follows similar measures elsewhere in Europe. In Poland, sildenafil 25mg is available OTC from a number of domestic players, with initial launch from Adamed in May 2016, while Viagra Connect was launched in the UK in March 2018.

Of the 20 key markets covered by OTC New Products Tracker every month since the start of 2013, Poland has been the most active in terms of Rx-to-OTC switch activity, with 54 products reclassified to non-prescription status. A liberal switch environment has helped bring about a raft of Rx-to-OTC switches since 2014, including Europe’s first OTC erectile dysfunction brand and Poland’s first OTC systemic cold sore treatment.

Despite some notable failures (such as urinary product Flomax Relief), so-called “lifestyle” drugs remain the primary source of switch activity, helping to extend the reach of the OTC market into new categories such as contraception, erectile dysfunction and cardiovascular disease. A key switch development in 2019 was the downscheduling in Japan of Taisho’s hyperlipidaemia treatment Epadel T (ethyl eicosapentaenoate) to Class I OTC, where sales are permitted in pharmacies (and online) after professional consultation. Downscheduling may have come just in the nick of time – sales data suggest Epadel T had failed to make any noticeable impact on the OTC market in its almost six years as an Instruction-Required Drug.

There also remains hope that Sanofi may one day market Eli Lilly’s erectile dysfunction treatment Cialis as an OTC medicine (it owns the rights to market Cialis OTC in the USA, UK, Canada and Australia), but is switch application has been stuck at the FDA a full five years since its submission. In July 2019, Sanofi also signed a deal with Roche for the exclusive OTC rights to Tamiflu (oseltamivir 75mg capsules, Genentech / Roche Group) for flu prevention and treatment in the USA. Under the terms of the agreement, Sanofi will be responsible for leading negotiations with the US FDA for the OTC switch and subsequent exclusive marketing, scientific engagement and distribution of Tamiflu OTC in the USA. Let’s hope for the sake of OTC growth that its negotiations go smoothly.

Clear your diary for Nicholas Hall’s 31st European Conference, which will be held in Athens on 28-30 April 2020, on the theme of Advancing in CHC: The Must-Dos and  Reasons Behind Them. To register your interest in this event, or for more information on sponsorship opportunities, please contact jennifer.odonnell@NicholasHall.com.

Natural & Organic a focus for M&A and innovation

Continuing our series of blogs on the 10 Infinity Zones for future CHC growth recently outlined by Nicholas Hall, in this edition we take a closer look at natural & organic products. This is by no means a new trend, but it’s certainly one increasingly on the radar of multinationals, as exemplified by J&J’s recent purchase of Zarbee’s Naturals.

Among herbal & natural cough remedies, Zarbee’s has been gaining share on rivals such as Little Remedies, Hyland’s and Chestal, while also growing faster than most medicated OTC cough remedies. Another growth driver in the US market is Maty’s all-natural and organic range, including honey-based cough remedies, while Unilever recently bought Olly Nutrition, another range of VMS products with a strong emphasis on natural ingredients, such as the 10 phytonutrients in its Super Foods Multi line.

A+P for most herbal & natural products often emphasises the importance of quality standards and – increasingly – organic and responsibly-­sourced ingredients. In China, the No.1 probiotic brand Biostime (Health & Happiness for Institut Rosell) is promoted on the basis of the organic sourcing of its ingredients, while marketing involving brand ambassador Juliette Binoche also emphasises the natural heritage of the brand.

According to OTC New Products Tracker, the number of launches that include the word “organic” either in their branding or list of ingredients is growing fast, with 246 innovations in 2018 vs 168 in 2017 and just 81 in 2016. Over half of these products are unsurprisingly classified as vitamins, minerals & supplements, however there is also a growing number of “organic” Lifestyle OTCs, especially among medical cannabis products, sedatives & sleep aids and stimulants.

Last chance to pre-order Nicholas Hall’s New Paradigms for CHC 2019: Over the Horizon, written by Nicholas himself! Examine each aspect of the CHC industry in 20 chapters, with a focus on major issues including Regulation, Pharmacy Point-of-Care, M&A, Switch and much more. Nicholas will also unveil the “infinity zones” he has identified as being crucial to the future growth of the industry. In addition to this, you can upgrade your purchase to include a customised in-house presentation or webinar with Nicholas for an additional GB£10,000. To find out more or to place your order, please contact melissa.lee@NicholasHall.com.

Prevention better (and growing faster) than cure

For many years now, Nicholas Hall has been highlighting how OTC subcategories focused on prevention are growing faster than those directed towards treatment or intervention. This long-term trend in the CHC industry continues to take root, thanks to the growing power of categories like probiotics (another Infinity Zone, covered in last week’s blog).

At this year’s Vienna conference, Nicholas Hall presented a slide of the fastest-growing OTC subcategories by CAGR (2014-18), comparing those focused on prevention with those centred around treatment, and this showed that seven of the Top 10 most dynamic subcategories in recent years had a preventive focus. Sexual health is a relatively new driver of this trend, with two subcategories in the Top 5 – erectile dysfunction and emergency hormonal contraception.

Vitamins, minerals & supplements have long been the main driver of this prevention trend, with probiotics and vitamin D the two key subcategories. Innovation and niche product positioning (i.e. to prevent allergies, candidiasis, age-related illnesses, etc) have helped fuel probiotics growth, while the dynamism of vitamin D sales has been driven by rising awareness of the high levels of deficiency in many markets and the benefits  of supplementation.

Herbal memory & brain health is an increasingly attractive subcategory, as exemplified by RB’s recent launch of Neuriva, a new product designed to support “brain fitness” and prevent cognitive decline. Royal jelly is taken widely in Europe and Asia-Pacific as a way to prevent fatigue, while just outside the Top 10 in CAGR terms are magnesium, zinc, pregnancy vitamins and hair & beauty supplements. According to OTC New Products Tracker, the latter was the fifth most active OTC subcategory in 2018 in terms of launch activity, with 150 innovations.

Last chance to pre-order Nicholas Hall’s New Paradigms for CHC 2019: Over the Horizon, written by Nicholas himself! Examine each aspect of the CHC industry in 20 chapters, with a focus on major issues including Regulation, Pharmacy Point-of-Care, M&A, Switch and much more. Nicholas will also unveil the “infinity zones” he has identified as being crucial to the future growth of the industry. In addition to this, you can upgrade your purchase to include a customised in-house presentation or webinar with Nicholas for an additional GB£10,000. To find out more or to place your order, please contact melissa.lee@NicholasHall.com.

Sleep disorders on the rise globally

According to a new in-depth analysis of the global sleep aids market by Nicholas Hall’s Reports, sleeplessness and sleep disorders are on the rise, with approximately one third of the world’s population affected. Many consumers are happy to self-medicate, increasingly opting for a variety of herbal & natural, homeopathic and medical device brands, driving OTC growth in key markets like Brazil and Spain (see sample pages).

In terms of sales, sleep aids & sedatives generate an OTC total of over US$2.3bn globally, but have been characterised by low growth in recent years, and are in need of rejuvenation via new product development, adjacencies or connected health solutions. The self-medication sleep aids market (registered OTCs and a variety of supplements) also suffers from regulatory diversity across markets for common sleep aid ingredients.

Genuine innovation is thin on the ground, but generics and “me-toos” launch frequently. Adjacencies focused on sleep offer alternatives, with other categories also entering the fray including nighttime analgesics, cough & cold remedies, menopause and other supplements. Connected Health is a key area of expansion. Sleep aid brands partnered with technology – passive (e.g. analysing sleep patterns / providing feedback) or active (improving sleep) – may break the low-growth cycle.

Comment from Ian Crook, Managing Editor, Nicholas Hall’s Reports: Sleep is a health area that lends itself easily to self-medication via sedating antihistamines and herbal & natural ingredients such as melatonin and valerian, while medical devices and digital health focused on sleep are seeing increased investment. With widespread concern over the “sleep loss epidemic” and significant implications for overall health from lack of sleep, it is imperative that consumers have access to tools to help them sleep. Raised levels of stress, anxiety and smartphone / tablet use ensure rising demand that can be tapped into by the right self-care solutions.

The full report, Sleep: Exploring Opportunities for Growth in Sleep Aids & Sedatives, is available now and more details can be found here. To order your copy, please contact melissa.lee@NicholasHall.com

2018 Trends: Medical Cannabis

One trend to watch in 2018 is the growing number of medical cannabis consumer healthcare products, with launch activity focused on North America. A recent development was the licensing deal between Level Brands, a marketing and licensing company that provides branding for businesses, and Canadian-based company Isodiol, which commercialises 99%+ pure, bioactive pharmaceutical grade cannabinoids, with products including body balm, tincture, skin care, nano-mist and functional beverages.

Isodiol will work with Level Brands to develop consumer products for kathy ireland Health & Wellness, a licensor to Level Brands, and for Level Brands subsidiary I’M1, a lifestyle brand for men. During the 5-year term of the agreement, Level Brands will receive an initial US$2mn in the form of Isodiol shares, then US$750,000 per quarter (also in the form of Isodiol shares) and a 3% royalty on gross sales. The new Isodiol kathy ireland Health & Wellness and I’M1 products are expected to debut in mid-to-late spring 2018 online and in select retail stores.

Outside North America, Q4 2017 saw a number of significant developments in the medical cannabis category, which will likely translate into increased launch activity in 2018. In October 2017, biotech start-up CIITECH announced the availability of Herbalica’s non-psychoactive, cannabidiol supplements to UK consumers via www.essentialcannabinoids.co.uk. The range of 5 supplements includes products for anxiety, ovulation pain and insomnia. The CBD compound is considered a powerful anti-inflammatory and anti-anxiety agent, with researchers suggesting it could ease chronic pain. Israeli-based Herbalica’s parent company HerbalTune has developed and supplied a range of therapeutic, botanical products to the local market for the past three years.

In Asia-Pacific, the New Zealand Government introduced a bill earlier this month to legalise medicinal cannabis in the country. The bill seeks to amend the Misuse of Drugs Act to make a specific exemption for any person with a qualifying medical condition to grow, process or use cannabis plants and products for therapeutic purposes, provided they have support from a registered medical practitioner. The move, which follows Australia’s legalisation of medicinal cannabis in 2016, aims to make the ingredient more readily available for those suffering with chronic pain or terminal illness. At the same time, Australia announced that it aims to become the fourth country after Uruguay, Canada and the Netherlands to legalise exports of medicinal cannabis.

Voice-activated tech shows potential for diabetes care

Diabetes affects 422mn people worldwide, including 14% of the US adult population and people in low and middle-income countries such as China, India, Brazil and Indonesia. To successfully manage diabetes, people living with it need to be mindful of and track myriad things throughout their day, from blood sugar levels to counting calories. In recent years voice-activated technologies have become an important way of helping sufferers manage their disease.

In this regard, Danish pharmaceutical company, Novo Nordisk, has teamed up with Health Innovation Technology Lab (HITLAB) to launch the 2017 HITLAB World Cup of Voice-Activated Technology in Diabetes, awarding prizes totalling US$75,000.

Participating innovators have been told to focus on enhancing patient outcomes, lowering healthcare costs and making the management of patients more efficient, with the goal of improving health and quality of life for diabetes sufferers.

Amy West, Senior Director, Patient Centric Marketing & Digital Health at Novo Nordisk commented: “We are constantly striving to provide solutions that minimise the burden for people living with diabetes, and believe that digital health, and specifically voice-activated technologies can be important tools for managing diabetes.”

HITLAB has helped leading organisations create and evaluate technology-based solutions to pressing healthcare challenges for the past 25 years. Last year, 74 teams from 14 countries presented technology innovations that ranged from a tech-enabled dynamic scoliosis brace to a tool that uses 3D imaging and data analytics to better diagnose ear infections. Past winners have since raised over US$50mn in follow-on investment funding.

The submission period is currently open and will close on Wednesday 11th October. Finalists will be announced on 23rd October. They will make pitches at the HITLAB Innovators Summit, which will be held in New York City. Pitches will be judged by a panel of healthcare experts assigned by Novo Nordisk and HITLAB.

HIV / AIDS home test kits seized over potential false results

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has seized 114 Hightop HIV/AIDS Home Test Kits, which could be potentially misleading in providing false results. The agency has advised that anyone who has used the kit should seek a further HIV test at a local sexual health clinic or through a GP.

A statement issued by the MHRA stated: “All UK based stock of Hightop HIV/AIDS Home Test Kit have been seized by MHRA and all sales of the product into the UK market have been stopped by the manufacturer”

The statement continued: “The HIV kits, manufactured by Qingdao Hightop Biotech Co Ltd, do not have a valid CE mark which means the product has not met a number of regulatory requirements concerning test performance, labelling and instructions for use.”

Self-testing kits for HIV became legal in the UK from 6 April 2014, but buyers have always been warned to carefully check the CE mark before purchasing any kit. Self-test kit users who purchase kits online or from the high street should know what they are buying is safe and reliable. MHRA is currently investigating the issue with experts at Public Health England.

John Wilkinson, MHRA’s director of devices commented: “If you are concerned you may have used an unreliable test kit, speak to your GP, sexual health clinic, pharmacist or other healthcare professional”. He further added: “Make sure the kit has a CE mark and clearly states that it is intended for home self-testing. Don’t use a test kit if it’s damaged or the seal is broken.”

MHRA strongly suggests consumers should only buy a self-test kit from a reputable source, such as an online pharmacy registered with the MHRA. In the UK, online pharmacies must be registered with the MHRA and display the European common logo on every page of their website. While home self-test kits for HIV and STIs have many benefits, including letting people test in their own space and on their own terms, there’s equal concern surrounding their use.

According to recent surveys there are more than 100,000 people living with HIV in the UK and around a quarter of them don’t know they’re HIV positive.

Wearable Sensor Device Helps Visually Impaired Sense Environment

VTT TecVTT Technical Research Centre of Finland has developed a wearable assistive device for the visually impaired, which enables them to sense their environment and move around more safely. The device, which is worn like a heart rate monitor, has been clinically tested.

The device functions on the basis of a radar system developed by VTT. The radar sends information to the user in the form of vibrations or voice feedback. It senses a majority of obstacles in the user’s surroundings, however difficulties do however remain in sensing objects such as thin branches and bushes.

“The novel aspect lies in a wearable sensor device which functions based on radio waves, so the signal is able to pass through clothing. This means that it can be worn discreetly under a coat, for example,” says Tero Kiuru, a Senior Scientist at VTT.

The radar has already been clinically tested in device trials approved by the National Supervisory Authority for Welfare and Health (Valvira), in which VTT’s partners were Kuopio University Hospital and the Finnish Federation of the Visually Impaired (FFVI). The test group included a total of 25 visually impaired people, of whom 14 were blind, 7 partially sighted and 4 were deaf-blind.

“A clear majority of the testers felt that the radar improved their ability to perceive their environment and increased their self-confidence when moving around,” says Kiuru. A total of 92% of the trial users felt that the device helped them to perceive their surroundings, 80% felt that their trust in their ability to move around independently had increased and 32% would immediately start using the test device in its current form.

On the other hand, they were not satisfied with distance control and vibration-based feedback. The research will continue with selected test users and the device will be further developed. A global market is believed to exist for the radar, since there are around 300 million visually impaired people in the world.

FDA takes steps to improve hearing aid accessibility

The U.S. Food and Drug Administration (FDA) have announced important steps to better support consumer access to hearing aids. The FDA will consider creating a category of OTC hearing aids that could deliver new, innovative and lower-cost products to millions of consumers.

The agency also announced important steps to better support consumer access to hearing aids. In a guidance document, the agency explains that it does not intend to enforce the requirement that people aged 18+ years receive a medical evaluation or sign a waiver prior to purchasing most hearing aids. Under the new guidance, the FDA will continue to enforce the medical evaluation required for people under 18 years of age.

The agency also requires that consumers are provided with information and instructions about hearing aids before any purchase from a licensed hearing aid dispenser. This guidance is effective immediately.

FDA Commissioner Robert Califf, M.D commented “Today’s actions are an example of the FDA considering flexible approaches to regulation that encourage innovation in areas of rapid scientific progress,”Califf continued “The guidance will support consumer access to most hearing aids while the FDA takes the steps necessary to propose to modify our regulations to create a category of OTC hearing aids that could help many Americans improve their quality of life through better hearing.”

The FDA has cited that hearing loss affects some 30 million people in the United States and can have a significant impact on communication, social participation and overall health and quality of life.

Male Contraceptive Has Moderate Trial Success

The next frontier of sexual liberation is close – the male contraceptive is almost here!

For decades now, scientists have been progressively working towards developing birth control for men, and the recent news that the injected male contraceptive is now just as effective as its female counterpart is groundbreaking.

In a trial of 320 men, aged between 18 and 45, researchers found that, over a one-year period, a new hormone-based injection was 96% effective in preventing pregnancy.

The hormones injected into the men on the trial were shown to dramatically lower their sperm count by “switching off” the male reproductive system.

The drugs did however cause some unpleasant side-effects, meaning that the trial had to be halted early. Of the 320 participants, 20 experienced mood swings, depression, muscle pain and acne. Despite this, 75% of the participants said they would be happy to take the male contraceptive on a regular basis.

Richard Anderson, a professor of clinical reproductive science and author of the study, said: “If you’re comparing it to other reversible male methods, it’s far better than the condom and it puts it in the same ballpark as the pill.”

The male contraceptive is not the only new and innovative form of protection that is set to be on offer. The predominantly male condom is now available in female form. The disposable contraceptive device, which is marketed by The Female Health Company, is the only female condom approved by the US FDA and cleared by the World Health Organization.

The condom provides dual protection against unintended pregnancy and sexually transmitted infections, offering what it claims to be a thoroughly safe sexual experience for both parties.