Nasal sanitisers niche opens up post-Covid

One of the fast-emerging OTC niches in the CCA category is oral & nasal sanitisers, with several notable innovations in 2020 and 2021, including two more nasal sanitiser launches announced recently.

Australian-based Starpharma’s Viraleze nasal spray will become available online in the UK this week ahead of a retail rollout in April 2021, under an exclusive sales & distribution agreement with the retail chain, LloydsPharmacy (McKesson). This will be the product’s first appearance in Europe, although a regional launch is expected soon following its registration in the European Economic Area in February.

Comment from CHC Insight Managing Editor, Chris Allan: Viraleze contains the same antiviral ingredient (SPL7013 / astodrimer sodium) that features in Starpharma’s VivaGel products. Its powerful claim to deactivate “>99.9% of Sars-CoV-2 within one minute” is likely to attract wider media interest given the continuing national focus on the pandemic, and LloydsPharmacy has committed to “significant” marketing investment.

Separately, in Israel, SaNOtize has received interim approval to sell its nitric oxide nasal spray (NONS) in pharmacies. NONS protects users from viruses that enter the body through the upper nasal pathways. Local manufacturing under the brand name Enovid has begun in partnership with Nextar Chempharma Solutions and the spray is expected to appear on pharmacy shelves by the summer.

Meanwhile, in New Zealand the Ministry of Health denied claims by the Canadian-based biotech company that Enovid had been cleared for immediate OTC sale. Newshub quotes a MoH spokesperson: “Based on the therapeutic claims made for the product, its claimed mode of action and the nitric oxide ingredient, Enovid nasal spray would be a prescription medicine under New Zealand law (Medicines Act 1981) … Medsafe has received no applications for approval of this product for sale, supply or use in New Zealand.”

Comment: SaNOtize and Ashford & St Peter’s Hospitals NHS Foundation Trust in the UK recently announced results of clinical trials indicating that NONS represents a safe and effective antiviral treatment that could prevent the transmission of Covid-19, shorten its course and reduce the severity of symptoms and damage in those already infected.

Oral & nasal sanitisers is one of the delivery formats trends covered in our new Innovation in CHC 2021: NPD & Launch Activity under the Spotlight report. Seize the last chance to save GB£1,350 when you pre-order this forthcoming report before 31st March. To review the table of contents or pre-order your copy, please contact melissa.lee@NicholasHall.com

CBD industry revving up again in 2021

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.

Discover who the main CBD players are, and how big the market could get in our recent report, CBD 2020: The 20 Most Important Questions about CBD in the Future of CHC. To find out more, or to order your copy, please contact melissa.lee@NicholasHall.com.

Rx-to-OTC switch: Fortacin in EU, CBD in Australia

Rx-to-OTC switch activity has shown signs of revival so far in 2020, and two more positive news stories emerged last week. First, the European Commission has approved the Rx-to-OTC switch of Fortacin topical spray for premature release in adult men (owned by Plethora Solutions and marketed under licence by Recordati; lidocaine 150mg/ml + prilocaine 50mg/ml), following the July 2020 recommendation from the EMA’s Committee for Medicinal Products for Human Use. Recordati will reportedly begin the OTC launch of Fortacin in January 2021. This is the fifth brand to receive switch approval via the EU centralised procedure, and the first since 2015 when ellaOne (HRA Pharma) was given the rubber stamp.

Secondly, a delegate of the Secretary to Australia’s Department of Health has released an interim recommendation to switch plant-derived or synthetic CBD ≤60mg (up to 30 days’ supply, adults aged 18+ years) from Rx to Schedule 3 (Pharmacist-only), with a proposed implementation date of 1st June 2021. The ingredient will also be added to Appendix M of the Poisons Standard, with supply limited to medicines registered on the Australian Registry of Therapeutic Goods.

Source: CHC New Products Tracker

Comments are being sought until 13th October 2020 on this proposed CBD switch in Australia, as well as the following recommendations:

  • Switch migraine treatment eletriptan ≤40mg (up to two tablets) from Rx to S3 and include the ingredient in Appendix H to permit consumer A+P (1st February 2021)
  • Permit the S2 (Pharmacy-only) sale of immediate-release ibuprofen ≤400mg (up to 12 dosage units) when labelled not for children under 12 years (1st February 2021)
  • Do not switch sildenafil 50mg (up to four dosage units) from Rx to S3 and include the ingredient in Appendix H and Appendix M
  • Do not permit general sale of oxymetazoline ≤0.05% nasal sprays
  • Do not permit the S2 sale of clotrimazole ≤1% preparations for vaginal use

One of the key reasons behind the TGA’s establishing Appendix M in January 2018 was to facilitate future switch activity by helping ingredients meet the S3 Scheduling Policy Framework criteria through the provision of additional pharmacist controls or supply requirements. This channel has had some success, with CBD appearing to be the latest ingredient to benefit. Some stakeholders had also hoped that additional controls would finally sway opinion on the OTC availability of ED medicines but the scheduling delegate did not think the risk mitigation strategies outlined in the Appendix M entry assessed the risks associated with sildenafil use.

Nicholas Hall Writes: Last week I presented the key conclusions from last year’s New Paradigms report and my client asked, what will be the really high growth categories in the post-Covid CHC market? That is a really good question, and it seems to me that there are six emerging sectors each with sales potential of over US$10bn at MSP:

  1. CBD
  2. Sexual health
  3. Sleep, stress & mood
  4. Food allergy & intolerance
  5. Probiotics
  6. Immunity

Each of these presents opportunities, each of these presents formidable obstacles. In the case of CBD, the major hurdle is regulatory. So if this news from Australia is borne out, and CBD becomes a registered OTC category — the first in the world — we will have overcome the first barrier in the long journey to regulate and regularise this awesome opportunity, and I use the word awesome in its original sense, not as a teenage throwaway remark!

Don’t miss out on your chance to save up to GB£1,800 when you pre-order our upcoming report, Cough, Cold & Allergy before 30 September! For more information, or to pre-order your copy, please contact melissa.lee@NicholasHall.com.

Tamiflu to switch to OTC in USA?

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With 2018 a barren year for Rx-to-OTC switch, it is welcome news that Sanofi has signed a strategic 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. Roche will continue to market Tamiflu in the rest of the world and Sanofi will retain the rights to first negotiations for switch rights in other selected markets. Sanofi’s Executive VP for Consumer Health, Alan Main, noted that: “A successful switch of Tamiflu to OTC would support our global cough and cold strategy by expanding into flu with a sustainable point of difference in the market.”

As Nina Stimson, OTC.NewDirections Consulting Editor, commented: “To some extent this was an unexpected development, but welcome insofar as (if approved), OTC Tamiflu will help expand the boundaries of consumer healthcare. Of course, in certain conditions (such as the swine flu pandemic in 2009-10) Tamiflu has sometimes been available from pharmacists without a prescription; New Zealand was one such country to permit OTC supply on a temporary basis.” 

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Tamiflu’s patent in the USA and some other markets expired in 2016 and, as the chart above indicates, this has led to a steady decline in sales over recent years, with US Tamiflu sales falling by 29% in 2018 to total CHF168mn (US$170mn). Generic competition intensified in the USA in 2017 and continues to grow, while Tamiflu brand sales are now also in decline in Japan and internationally. Roche is now focusing its efforts on Tamiflu’s successor, Xofluza, which was approved by the FDA in late 2018.

If Tamiflu can switch to OTC successfully in the USA, then similar reclassifications will likely follow elsewhere. In 2009, in the midst of the global swine flu pandemic, Australia’s State of Victoria issued a public health emergency order allowing pharmacists to supply Tamiflu (oseltamivir) without a prescription. There has also long been talk of Tamiflu switching to OTC in Europe – in 2008, at the AESGP meeting in Sweden, the EMA’s Executive Director Thomas Lonngren cited Tamiflu as a possible candidate for the EU’s then newly created centralised procedure for Rx-to-OTC switch.

Explore the latest CHC Innovations and Technologies at our OTC.NewDirections Executive Conferencetaking place in London on 14 November 2019. Nicholas Hall and Nina Stimson will be joined by experts from companies including Bayer, Mundipharma and J&J to review key issues impacting our industry and ensure that you are Keeping Consumers in the Spotlight. Book your place before 13 September to take advantage of our early bird booking discount and save GB£100! To find out more, or to reserve your place, please contact Elizabeth.Bernos@NicholasHall.com.

Perrigo to revive flagging OTC allergy sales?

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According to the latest MAT Q1 2018 data, global growth of OTC allergy remedies has slowed to just +0.2%, compared with a rate of +3.7% in the year-ago MAT Q1 2017 period, and +10.3% in the MAT Q1 2016 period. A drop-off in Rx-to-OTC switch activity has been a key factor, so last week’s news that Perrigo has signed an agreement with Merck & Co for exclusive rights to market, sell and distribute a non-prescription version of Nasonex (mometasone furoate monohydrate) in the US will be a welcome boost for the category.

Financial terms were not disclosed and the deal is subject to receipt of all necessary regulatory approvals. Nasonex is currently available on prescription only in USA, where it is marketed by Merck & Co. The corticosteroid anti-inflammatory nasal spray is indicated for the treatment of the symptoms of seasonal allergic or perennial allergic rhinitis in people aged 18+ years. In those markets where the product is available OTC, such as Australia, it is marketed by Bayer.

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Perrigo has often been first to launch private label equivalents of recently switched OTC brands – generic versions of Flonase and Zegerid OTC were launched in 2016, while a copy of Nexium 24HR was launched by the company last summer – but this deal marks a new phase for Perrigo into switching brands.

As Perrigo Executive VP & President, Consumer Healthcare Americas, Jeff Needham, commented: “This product in-licence is the first of its kind for Perrigo. As other similar products that have previously switched from prescription to OTC status, we are working diligently to bring this important product to consumers and customers more quickly than the average 5-year OTC switch timeframe. This strategic investment into the OTC category creates an innovative product offering for Perrigo. We expect to execute the Rx-OTC-switch, fully penetrate this market with a branded offering and provide a future store brand alternative.” 

Comment from Ian Crook, Managing Editor, Nicholas Hall’s Reports: Nasonex enjoys dynamic growth in the handful of markets where it has been switched to OTC by Bayer and generated sales of US$23mn in 2017 (+28% CAGR 2013-17). In the brand’s largest market, Australia (where it switched in 2014), award-winning advertising helped it build a strong presence among consumers; it ranked 4th with sales of US$10mn (+5%) in 2017, comfortably the No.1 in the nasal sprays segment. How the brand will fare in the USA — if and when Perrigo successfully navigates the switch process — remains to be seen. Nasal steroid switches in the USA have historically driven high growth among allergy remedies, but later arrivals like Nasonex are unlikely to make as big a splash as previous INS switches.

Perrigo is one of the Top 20 OTC players profiled in the 2018 version of our bestselling OTC YearBook. This essential annual report also gives an extensive, up-to-date overview of the OTC industry across the globe, including reviews of M&A activity, Top 15 markets and major OTC categories, plus much more. For more information or 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.

Isodiol

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.

OTC in Action Episode 4: OTCs in Excess

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This week, a friend told me how she fought the severe cold that ruined her weekend. Saturday morning she took ibuprofen. A few hours later she took more ibuprofen, then took some aspirin a little while later, knowing that it was too soon to take more ibuprofen. Still suffering at the end of the day, she took some antibiotics that were in the medicine cabinet. This treatment continued throughout the weekend – “I don’t remember how many (brand name ibuprofen) I took but I was still sick!” – until she saw a doctor for proper treatment on Monday.

This college-educated mother of four is your typical adult, trusting that all OTCs are safe and too busy to investigate the risks.

So, OTCs in Action is pleased to report two measures taken to ensure easy access to OTCs, while limiting risk to consumers:

The Australian Therapeutic Goods Administration (TGA) released its review of cardiovascular risks of non-steroidal anti-inflammatory drugs and found that OTC NSAIDs are safe when they are used according to the recommended doses for short durations, as instructed on the labels (somewhat good news for my friend). However, the TGA also noted that inappropriate use or overuse of these medicines can pose a significant health risk (bad news for my friend), and announced a public consultation to explore options to reduce these risks (http://www.tga.gov.au/safety/medicines-review-nsaid.htm#.VDVtGr7IaFI).

Elsewhere in the world, the chances of my friend accidentally overdosing her daughter when treating a sore throat at 3am has been minimised by the FDA’s publication of a Draft Guidance this week. Although not yet a final rule, the FDA’s draft guidance will protect against accidental overdose of liquid acetaminophen by recommending concentration standardisation, container labels and carton labelling, as well as improved packaging. Industry has already voluntarily adopted these guidelines over the past couple of years and acetaminophen overdose rates for children have declined.

On a final note, some other news this week illustrates how, if my friend lived in Cairo, she could have purchased a full course of antibiotics as soon as she felt ill. Egypt Today has published the following article (http://egypttoday.com/blog/2014/09/01/abusing-antibiotics/) about the abuse of antibiotics, stating that:

[Antibiotics are] widely available over-the-counter at Egyptian pharmacies, and often regarded as a fast remedy for the fever and flu. They’re given to children by concerned mothers, and gulped down by adults who don’t want to bother or don’t have the money to first consult a doctor for a prescription. But the rampant misuse of antibiotics is actually endangering our health.

The pharmacies in Downtown Cairo are about as numerous as the kiosks and cafés. If anyone in the neighbourhood is running errands, they can stop there to pick up some grape-scented shampoo or a new toothbrush. If they come down with a respiratory infection or fever, they can also pick up some powerful antibiotics if they just complain to the pharmacist behind the counter of their pains and answer a few simple questions. They may realise popping antibiotics isn’t exactly healthy. But most probably don’t know that this practice is contributing to antimicrobial resistance, a global problem so serious that the World Health Organization (WHO) says it “threatens the achievements of modern medicine”.

For more news about the regulations, science, business and consumers that send OTCs into Action, visit http://www.NicholasHall.com to learn more about our OTC.Newsflash and OTC.NewDirections weekly e-newsletters.

Hello and best wishes for 2014 from INSIGHT Asia-Pacific

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The start of a new year is the ideal time to reflect on events of the previous 12 months and consider what might happen in the year ahead. INSIGHT Asia-Pacific has done just that in the just-published January edition by asking industry experts to share their views on the major trends & developments and their likely impacts in core regional OTC markets.

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