Poland approves world-first OTC switch of tadalafil

We continue with the theme of Rx-to-OTC switch this week with news from Poland, where the Office for Registration of Medicinal Products, Medical Devices & Biocidal Products (URPL) has approved Adamed’s Tadalafil MaxOn ED treatment (tadalafil 10mg; film-coated tablets; 2- and 4-count SKUs) as an OTC medicine, effective 1st February 2022. This will join Adamed’s sildenafil options MaxOn Active (25mg) and MaxOn Forte (50mg), which launched in May 2016 and April 2020, respectively. Tadalafil is claimed to get to work within 30 minutes for up to 36 hours, vs claims for sildenafil that it works within 30-60 minutes for up to five hours.

Poland was again one of the most active Rx-to-OTC switch markets in 2021, with only China ahead of it last year in terms of number of launched products reclassified from prescription to OTC status. Three of the six products launched post-switch in Poland in 2021 were erectile dysfunction treatments, including Hasco-Lek’s Mensil Max, Aflofarm’s Inventum Max and Polpharma’s Maxigra Max (all sildenafil 50mg). In addition, there were two digestive health switches – Teva’s antidiarrhoeal Gastrolit and Polpharma’s antacid Famotydyna Ranigast – and Polpharma’s cold sore treatment Heviran Comfort Max.

Source: Nicholas Hall’s CHC New Products Tracker

Nicholas Hall’s Touchpoints: Last week our lead story was the likely switch of HRT in the UK, which we singled out as a pioneer. The latest news this week is from Poland, another switch centre of excellence and where the ED treatment tadalafil will be available in a non-prescription version for the first time anywhere in the world. Tadalafil was launched as a prescription medicine under the trademark Cialis, and Sanofi later acquired the CHC rights from Lilly, but the switch application in the USA has been held up for many years by the FDA.

My colleague Maryna Marriott of the CHC Insight Europe team tells me: “Poland continues to lead the way in switch innovation. The tadalafil approval follows a number of sildenafil 25mg and 50mg switches, with the Polish ED category totalling US$27.7mn in MAT Q3 2021, according to DB6, an increase of 28.5% vs the year-ago period. Men’s health clearly remains high on the consumer health agenda, and it seems likely a number of other tadalafil switches will follow in Poland.”

Switch is an expensive process in the USA, which is why it is subdued there at present. On the other hand, there has been renewed switch activity in Europe and parts of Asia. The problem for the CHC industry has always been that the benefits given to US companies gaining switch status – the cost to the patient-as-consumer drops substantially and there is often three years marketing exclusivity, whereas the ingredient can no longer be prescribed for the same indication – are not available to marketers in the rest of the world. That leads to the curious situation of some switches being regulatory wins but commercial failures. Let’s hope that Adamed is blessed with decent sales for its latest innovation.

Find solutions for success in this competitive CHC landscape with Nicholas and the team in Athens on 4-6 May 2022 for our 32nd European CHC Conference & Action Workshop! Meet with peers and hear from industry experts, including sessions from Bayer, Teva, J&J and many others face-to-face! For more information, or to reserve your seat, please contact elizabeth.bernos@NicholasHall.com.

NPD roundup: Women’s Health in 2020

To mark International Women’s Day, our blog this week rounds up some of the most notable women’s health NPD activity in the global CHC market in 2020, with examples from all four major regions (Europe, Asia-Pacific, North America and Latin America), as provided by our CHC New Products Tracker service.

Probiotics & prebiotics was a particularly lively source of women’s health innovation, including Farmoquimica’s late 2020 launch of Simbiofem in Brazil, positioned to balance female intestinal flora and claimed to be the first probiotic in the market for women’s health. In Spain, FertyPharma unveiled Fertybiotic Mujer Plus in early 2020, uniquely positioned to improve the fertility of women with PCOS (polycystic ovarian syndrome), while in South Korea Huons launched Elruby Menolacto Probiotics in Q4 2020, offering the benefit of an original formula to help support menopausal women. In the USA, a particularly innovative women’s health probiotic launch was HUM Private Party, with a unique formulation that combines a proprietary women’s probiotic blend with cranberry extract, which is positioned to support healthy vaginal and urinary tract health.

As for digital health solutions, which are profiled in one of the chapter’s of our upcoming Innovation in CHC report, a notable women’s health development in the UK was Velieve (Healthy.io), an at-home service for women to determine if they have a UTI (urinary tract infection). Velieve was test marketed in London first and is available as a kit (containing a urine collection cup, dipstick and colour board), which is delivered within 3 hours of ordering online, and the user is then required to download the Velieve app to guide them through the test, turning their smartphone into a medical device to read the dipstick.

Finally, looking at VMS, there were also several notable women’s health developments in China in 2020, including GSK’s extension of calcium supplement Caltrate with Caltrate Women, Unilever’s rollout of Olly The Perfect Women’s Multi and Eu Yan Sang’s launch of Gold Label Bak Foong Small Pills (a plant-based formula positioned as a treatment to alleviate menstrual pain).

Seize your last chance to save on our forthcoming report from Nicholas Hall’s CHC New Products Tracker, Innovation in CHC 2021. Putting innovation and NPD activity from 2020 under the microscope, click here to pre-order your copy without delay. For more information, or to place your order, please contact Melissa.Lee@NicholasHall.com

Switch: 2020 Review and 2021 Prospects

According to our CHC New Products Tracker tool, which covers 20 key markets globally, 2020 was a relatively good year for Rx-to-OTC switch activity, not quite at the level of particularly active years like 2018, but above average in terms of switch-related launch developments, and with some notable breakthroughs such as GSK’s switch of Voltaren Arthritis Pain (diclofenac) in the USA and Glenmark’s Momate Rhino Advance Nasal Spray (mometasone + azelastine) switch in Russia.

Thanks to the Rx-to-OTC reclassification of Voltaren Arthritis Pain, as well as eye allergy itch relief range Pataday (Alcon), the US market led the way in terms of switch developments in 2020, along with Poland, Germany and China. As for category switch trends, looking at Tracker data for the past 8 years (2013 to 2020), allergy remedies has been by far the most active OTC subcategory in producing new products following switch activity, with double the amount of NPD activity as the next nearest subcategory, cough remedies.

Looking ahead to 2021, one of the first switch developments this year will again be an allergy remedy. The UK’s Medicines & Healthcare products Regulatory Agency granted GSL status to Sanofi’s Allevia tablets for seasonal allergic rhinitis (fexofenadine 120mg; 12+ years; 1 tablet per day) in late December 2020. Once Allevia and other OTC fexofenadine products are launched, they will enjoy mass market distribution from the outset (it is more common in the UK for switched ingredients to be granted pharmacy-only OTC status). This is the second Rx-to-GSL UK allergy remedy switch in as many months, following approval for J&J’s Rhinocort Aqua budesonide 64mcg nasal spray in November 2020 (to be marketed as Benacort Hayfever Relief).

In addition, Poland remains at the forefront of global switch activity, with the country’s medicines agency (URPL) recently approving the Rx-to-OTC switch of Famotydyna Ranigast film-coated tablets (Polpharma; famotidine 20mg). Claimed to relieve indigestion, heartburn and hyperacidity for up to 12 hours, this is the first famotidine option available OTC in Poland. Meanwhile, Australia’s TGA is seeking comments until 27th January 2021 on proposed amendments to the Poisons Standard, which will be discussed at the March 2021 meeting of the Advisory Committee on Medicines Scheduling, including adding the following pharmacist-only medicines to Appendix H to permit consumer advertising: prochlorperazine and metoclopramide for the treatment of nausea associated with migraine; and chloramphenicol for ophthalmic use.

We are delighted to announce that our annual European e-Conference 2021 will take place online on 28 & 29 April! With options for individual and corporate site or global access, take the chance to keep up with what’s happening in consumer healthcare today and contact elizabeth.bernos@NicholasHall.com

Digital strategy: Examples from China

In Sanofi’s recent Q3 earnings call, new head of Consumer Healthcare Julie Van Ongevalle said the company’s CH operation had “untapped potential”, and that her previous experience in the beauty industry would help with the strategy of leveraging consumer insights and maximising the digital and e-Commerce channel. In this week’s blog, we summarise three examples of innovative digital strategies by three companies (Alibaba, GSK and Bayer) operating in China.

Alibaba has kicked off its 11.11 Global Shopping Festival with new features to meet rapidly-changing consumer needs. These include the participation of Alipay’s digital lifestyle platform, broader consumer reach, as well as livestreaming technology creating more engagement for Chinese consumers, and with the largest international presence to date. A new sales window will be added from 1st-3rd November, ahead of the main event on 11th November, to provide merchants – specifically new brands and small businesses – the opportunity to showcase their products and tell their brand stories amid the pandemic. For many brands, 11.11 is the single biggest growth driver. This year, more than 2mn new products will be introduced, double the amount compared to last year.

OTC marketers are also building ties with local digital shopping platforms in China. GSK CH and Dingdang Kuaiyao have agreed a new strategic co-operation, which will utilise their R&D and data capabilities to drive growth and improve consumer access to healthcare products. Initially, the companies will focus on the concept of “Internet + Medicine” and work together to build brands and content, as well as consumer traffic and experiences. In 2021, the collaboration will cover brand awareness, global marketing, consumer trust and consumption scenarios. The news comes a month after GSK CH became an Alibaba “digital captain” after agreeing a joint business plan with its marketing technology platform, Alimama.

In addition, under a strategic co-operation agreement with digital shopping platform Meituan, Bayer CH aims to become a full-service healthcare solutions provider to help individuals better manage their own health. The businesses will work with 20+ chain pharmacies to integrate online and offline healthcare products and services by exploring digitalisation options, expanding consumer services and developing a new era of pharmaceutical retail. The co-operation aims to reach consumers more efficiently under the “new normal”, which has resulted in growing public awareness of healthcare issues, rising demand for healthcare products and a change in consumption habits, with online purchasing increasing significantly.

We are pleased to announce the next round of savings in our special Q4 promotional event, running until the end of the year! Plus, for November only we are offering a 25% discount on annual subscription rates for our combined CHC.Newsflash and CHC.NewDirections news service! If you would like additional information on any of our publications or subscriptions, or would like to place an order, please contact Melissa.Lee@NicholasHall.com

Market Movers in MAT Q2 2020

To mark the publication of our latest Market Movers update, which picks out 6 brands driving growth in the global CHC market in the MAT Q2 2020 period, as well as 6 brands in fast decline, our blog this week examines the trends that are driving these exceptional changes.

Among the fastest-growing brands, one common thread is immunity positioning, with at least four of the six products highlighted below – Dabur Chyawanprash (India), Yiling Lianhua Qingwen (China), Airborne (USA) and Arbidol (Russia) – boosted by heightened demand for products that boost immunity during the pandemic.

TCM Yiling Lianhua Qingwen, available in China as capsules and granules, was listed in 2020 in the country’s Novel Coronavirus Pneumonia Diagnosis and Treatment Scheme, while in April 2020, the National Medical Products Administration of China approved a new indication for “mild and common Covid-19” to be added on the basis of its originally approved indications. Sales for the brand in the MAT Q2 2020 period were up 68%.

Ayurvedic formulation Dabur Chyawanprash (Dabur) saw sales more than double (+169%) in MAT Q2 2020, driven by strong Covid-related demand and the launch of Dabur Immunity Kit in Q2 2020, to become India’s No.1 CHC brand. Likewise, umifenovir-based medicine Arbidol (OTCPharm), which is positioned for flu as well as acute respiratory and viral infections, also saw sales more than double (+103%) in the MAT Q2 2020 period and the brand now ranks in the Top 5 in Russia.

As for products that suffered falling sales in MAT Q2 2020, notable examples were tonics & cure alls in China – such as Dong-e E-Jiao – hit by rising raw material costs and falling demand, as well as ranitidine-based antacids – such as Sanofi’s Zantac 150 – owing to concerns around NDMA and Takeda’s Alinamin EX vitamin B supplement in Japan, affected by demographic changes and a fall in tourist spending.

If you would like to review the latest launches and NPD surrounding all the leading brands in the global CHC market, take a look at CHC New Products Trackerthe ultimate competitive intelligence tool! Featuring 26,000+ launches and innovations, products are graded with a star rating, and you can search according to your specific requirements. Please contact waisan.lee@NicholasHall.com to set up your demo.

CHC market shows resilience in Q2 2020

In the 12 months to end-June 2020, the global retail CHC market grew by 4.6%. This marked a slowdown vs MAT Q1 (+5.6%), but Celine Waller, Group VP, DB6, said “the market has remained far more resilient than many expected”. A boom in prevention categories such as antiseptics & disinfectants (+38.7%) and immune supplements (+38.6%) has helped to mitigate the effect of “pantry unloading” following consumer stockpiling in Q1, while strong US growth in Q2 offset weaker performances in China and Western Europe.

Western Europe decelerated to 1.2% triggered principally by a decline in CCA as lockdowns and increased hygiene measures resulted in reduced incidence of respiratory pathologies. Low growth in Germany (+1.5%) and the UK (+1.9%) offset moderate declines in Italy (-0.8%) and France (-1.3%).

Asia-Pacific slowed to 2.7% hindered by a weak performance in China and declines in both Japan (-2.9%) and Australia (-1.3%) caused by loss of revenue from Chinese travellers. However, India was up 11.3% driven by chyawanprash, which more than doubled thanks to its immunity positioning.

North America posted a 6.4% upturn with strong US growth spearheaded by VMS (+8.8%) and Derma (+8.4%) – the latter boosted by a doubling in sales of antiseptics & disinfectants.

Central & Eastern Europe achieved growth of 8.6% with inflation-driven growth in Russia (+10.9%) offset by a comparatively weak performance in Poland (+5.2%), while the Middle & East Africa experienced a slight slowdown (+6.9%).

Latin America grew by 11.8% with both Brazil (+12.0%) and Mexico (+11.0%) up by double digits. VMS was the key contributor growing by 16.7% in the region.

We are pleased to announce Nicholas Hall’s Asia-Pacific webinar, which will be held on 12 November! Nicholas will be joined by several regional industry experts to explore key trends in the region, including a look at regional WOW! brands, growth prospects, distribution and much more. For further details, or to register, please contact elizabeth.bernos@NicholasHall.com.

Focus on Japan: Q2 results point to further CHC decline

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According to government data released today, GDP in Japan fell 7.8% quarter on quarter in Q2 2020 (April to June), with Covid-19 having an impact both on domestic consumer spending and exports. Japan’s economy is heavily dependent on exports, especially to China, and demand there has remained subdued during Q2. This downturn does not bode well for the world’s No.3 CHC market, which had already failed to match the boost in OTC spending seen in Europe and North America in Q1, with Japan recording flat sales in MAT Q1 2020 owing to the loss of in-bound tourists from China and Taiwan.

Japan’s OTC market has not outperformed the wider economy, as has been the case in other regions during Covid-19, with several key local marketers reporting Q2 declines in line or in excess of Japan’s 7.8% GDP fall. Daiichi Sankyo saw OTC revenues decrease by 7.3% in fiscal Q1 2020 (Apr-Jun 2020), owing to the impact of Covid-19, while Taisho reported an even more dramatic fall in its Q2 domestic Self-Medication sales, with its OTC portfolio in Japan down 16.4% in fiscal Q1 2020 (Apr-Jun 2020). Tonic drink Lipovitan and CCA range Pabron both led the decline, impacted by Covid-19.

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Takeda outlined size of OTC divestitures still to come

While Takeda no longer reports on the performance of its Self-Medication business in its quarterly results, it did reveal in its Q2 results presentation the value of the various regional portfolios of non-core and OTC products that it plans to divest in the near future. In late 2019, Takeda sold a portfolio of non-core OTC and Rx products to Swiss-based Acino, covering what the describes as its North Europe, Middle East & Africa (NEMEA) region, as well as a larger portfolio to Stada, covering Russia / CIS. Takeda now intends to complete even larger divestments in Latin America and Europe.

In late July, it was announced that Taisho is reportedly in advanced talks to acquire Takeda’s Consumer Healthcare unit in Japan, according to people familiar with the matter. Blackstone, Bain Capital and CVC Capital Partners were also understood to be among the final bidders. If Taisho does secure the deal for Takeda’s CHC portolio in Japan – which DB6 valued at US$571mn in the MAT Q1 2020 period – it will extend its domestic dominance as Japan’s No.1 CHC marketer but still remain the global No.7 behind P&G. Either way, Taisho will be looking to move beyond the business uncertainty caused by Covid-19 and M&A, with a view to reviving growth in Japan’s CHC market in H2 2020.

If you are interested in making an acquisition, or need licensing or business development support, Nicholas Hall’s Consultancy team is available to give confidential advice. We work with a number of strategic and financial partners to evaluate potential opportunities for buyers and sellers in the M&A, licensing and fundraising space. To find out more contact kayleigh.griffinhooper@NicholasHall.com

How will CHC supply chains evolve in Covid-19’s wake?

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Supply chain issues are high on the agenda of consumer healthcare marketers in the wake of the Covid-19 pandemic. Bayer said in its Q1 results that its Consumer Health division was able to respond very flexibly to significantly higher volumes and shifts in the product mix thanks to its supply chain operation. In addition, RB last week appointed Sami Naffakh as Chief Supply Officer and member of the Executive Committee, effective 1st July 2020. RB CEO, Laxman Narasimhan, said: “Throughout the Covid-19 pandemic, the global supply chain teams have worked tirelessly to step up for our consumers and our customers. As we continue to ‘navigate our new normal’, we must also start to focus on our medium-to-longer-term supply needs across the entire, diverse portfolio.”

Novartis’ supply chain has also coped well during the pandemic, thanks to the extraordinary efforts of its staff – as outlined in this report – but some companies have been harder hit. In February 2020, Blackmores downgraded its FY2020 forecast saying that, while the outbreak has increased demand for key immunity products, this has been countered by supply chain disruptions that the company expected would continue to affect China sales for at least 2-3 months.

As our graphic below shows, China is a key producer of active ingredients (APIs), and absolutely vital to the world supply of ascorbic acid (vitamin C), for example. India, which imports most of its APIs from China, has been hit hard by disruptions in the supply chain, and in March 2020 the Government banned the export of 20+ APIs to protect the supply of essential medicines in the domestic market. This had knock-on effects around the globe, however last week India’s Directorate General of Foreign Trade lifted restrictions on the export of active pharmaceutical ingredients of paracetamol.

China, IndiaIn a recent report by the Economist Intelligence Unit (EIU), called “The Great Unwinding”, more and more companies are said to be moving parts of their supply chains away from China, a trend accelerated by Covid-19, with multinationals seeking to build “quasi-independent regional supply chains in the Americas and Europe”, to ensure future resilience. In addition, the report indicates that another long-lasting impact of Covid-19 will be companies looking to store inventory in “strategic locations from where it can be easily accessed and delivered to customers”.

The pharmaceutical industry is also facing rising prices of raw material. According to data from India’s Pharmaceutical Export Promotion Council (Pharmexcil), the cost of paracetamol went up up 50-60% at the start of the Covid-19 pandemic, and the prices of vitamins increased by 40-50%. As the EIU report indicates, companies will need to think strategically about pricing models, given that “both the regionalisation of supply chains and the build-up of strategic inventories will push up final goods prices, denting a product’s competitiveness”. However, one of the upsides to this change is that “a more regionalised supply chain will offer opportunities for companies to focus more on local tastes amid a greater capacity for product differentiation”.

Very soon we will be publishing the second edition of our hot topic review, Coronavirus 2020 and its potential impact on CHCThis report from our Competitive Intelligence & Market Analysis (CIMA) division explores the response to the pandemic from CHC brands and marketers as well as the overall impact on CHC to date. You will also be able to read about trends observed so far (key categories impacted, how consumer behaviour has changed etc), how key CHC players performed in Q1 and projections for the near and longer-term.  If you have purchased the original Coronavirus 2020 Review, you will receive the 2nd edition free of charge. For more information, or to purchase your copy, please contact Melissa.Lee@NicholasHall.com

Assessing Covid-19’s impact on the VMS industry

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Despite various countries going into lockdown, governments are still allowing “essential” services and businesses to remain operational, putting the role of the dietary supplements industry in the spotlight. In some countries, like New Zealand, supplement marketers are allowed to maintain their operations as long as they are supplying “essential” businesses, such as pharmacies and supermarkets. However, according to the guidance provided by New Zealand Natural Health Products, health food stores do not fit the description of “essential” businesses.

The situation is similar but more complex in the USA, home to the world’s No.1 VMS market. While essential food and drug suppliers are open for business during Covid-19 restrictions, industry leaders are working to ensure that the same applies to speciality health food stores and cannabis dispensaries. No specific federal regulation is in place, but “essential business” status is being determined at state and local level. While California most decisively classified workers supporting cannabis and dietary supplement retail as essential workers, and Illinois added licensed medical cannabis dispensaries and cultivation centres to its essential healthcare operations list, not all states have set such guidelines.

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In a letter to state governors, industry associations including the Consumer Healthcare Products Association urge that supplement supply chains remain open in all states, arguing that now more than ever, consumers need essential nutrients to stay fit and healthy and proactively reduce their risk of chronic diseases without burdening an already overstretched healthcare system. They write: “As each of you plan your own approach to this challenging issue, we respectfully request you mirror White House / Centers for Disease Control & Prevention guidelines and make special accommodation for critical infrastructure industries that specifically include not only conventional foods but all subcategories of food, including dietary supplements, infant formulas, medical foods and spices & flavours.”

As for how the Covid-19 crisis will affect the VMS market, it’s clear that some categories stand to benefit more than others. Herbal & natural immune stimulants and vitamin C supplements are likely to see the biggest boost, as long as supply chains can be maintained. In certain markets, such as India and China, there is likely to be a rise in sales of country-specific natural remedies (Ayurvedic medicine and TCM) positioned for immunity support, though marketers will have to be wary of government clampdowns on products that are claimed to prevent or cure Covid-19.

For a full analysis of Covid-19’s impact on the global CHC market, pick up a copy of our all-new Hot Topic review Coronavirus 2020 and its potential impact on CHC from Nicholas Hall’s CIMA division. Buyers of this report will also receive a situation update in six months time. For more information, or to purchase your copy, please contact melissa.lee@NicholasHall.com.

Does CBG offer hope against antimicrobial resistance?

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According to a recent WHO press release, a lack of innovation in the development of new antibiotics, allied with declining private investment, is undermining efforts to combat drug-resistant infections. The breaking news from China of a sharp rise in diagnoses of an emergent strain of coronavirus, and new reported cases in Japan and Thailand, has raised fears of another outbreak similar to SARS in 2003, which infected more than 8,000 people and killed more than 700.

WHO has raised concerns about a weak pipeline for antibiotic agents, with 60 products in development (50 antibiotics and 10 biologics) that it deems bring little benefit over existing treatments and very few that target the most critical resistant bacteria (Gram-negative bacteria). However, some positive news came from an unlikely quarter over the weekend – an as yet unpublished study that found that CBG (cannabigerol) cured mice of MRSA infections as effectively as vancomycin, a drug widely considered to be the last line of defence against drug-resistant microbes.

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One of our recent blogs looked at the potential of a new emerging class of cannabinoids beyond CBD – including CBG, CBN (cannabinol) and CBC (cannabichromene) – and this new study boosts the attractiveness of the cannabinoid industry even further. Eric Brown, the microbiologist who led the research at McMaster University said cannabinoids were “clearly great drug-like compounds”, but noted it was early days in assessing the compounds for use in the clinic.

Brown found that CBG and other cannabinoids did not work well against gram negative multi-drug resistant bugs. However, the study shows that when CBG is used along with small quantities of polymyxin B, an existing antibiotic that targets “the cytoplasmic membrane of Gram-positive bacteria”, the cannabis compound wiped out the drug-resistant pathogens. “We are now pursuing the required paperwork to work with a wide variety of cannabinoids,” Brown said.

What is the current regulatory status of CBD in global markets? Find out in Nicholas Hall’s upcoming report, CBD 2020: The 20 Most Important Questions about CBD in the Future of CHC! You can also read about the main challenges faced by CBD players, the current and forecast size of the market, and much more! Pre-order your copy before 30 January to save with the pre-publication discounted rate! To find out more, or purchase your copy, please contact melissa.lee@NicholasHall.com.