Medical cannabis products legal in UK

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Three hot topics we focus on at OTC DASHBOARD, in our blogs and infographics, are OTC adjacencies, e-commerce and new technology. Medical cannabis falls within the sphere of OTC adjacencies, and here at Nicholas Hall & Company we believe that this category will progressively become part of the consumer healthcare market.

Recent legislative moves show that government attitudes to cannabis use are becoming more and more liberal. Just last week, the UK Home Secretary made the decision to allow the legal prescription of cannabis-derived medicinal products by specialist doctors. The UK’s regulatory agency, MHRA, is now working on a clear definition of what constitutes a cannabis-derived medicinal product.

The UK has also been one of several markets that have seen the launch of innovative cannabidiol (CBD) products, such as CannaQIX (Precision Healthcare / Creso). Launched in April 2018, CannaQIX is formulated with CBD organic hemp extract, as well as vitamins and minerals. Available as lozenges, the product is positioned as a cognitive booster that maintains mental and nervous function, reduces fatigue and releases energy. The product is also available in Switzerland and being rolled out across Europe.

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Other key countries for CBD products include Germany, Israel, Australia and the USA, with 45 products in the latter market already listed in our OTC New Products Tracker archive, in a variety of innovative formats including pens, vaporisers and gummy bears.

Canada is another country becoming more liberal in its approach to cannabis. In June 2018, legislation permitting Canadians to consume cannabis for recreational purposes was finalised, the final step that will pave the way for official legalisation in October 2018. The regulatory package is 390 pages long and provides details about how cannabis may be grown, harvested, processed and sold.

Looking ahead, Europe and North America are likely to be at the forefront of market development. According to a report from Prohibition Partners, the European cannabis market will be worth €115.7bn (US$135bn) by 2028, with the majority of European states expected to pass legislation to legalise medical cannabis programmes and recreational cannabis in that time. For more details, see the full report here.

Nicholas Hall’s upcoming OTC.NewDirections Executive Conference will reflect rising interest in the fast-developing cannabis market worldwide with two presentations on this key topic, from Canada and Israel. Being held on 12 September in London, this one-day meeting will explore Where Innovation Meets Regulation. For details of the full agenda or to reserve your place contact lianne.hill@NicholasHall.com

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Competition rises in sleep devices category

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Now available to buy in the US and selected European markets via the Nokia Health store, the new Nokia Sleep device is a sensor pad that can be placed under the mattress to monitor sleep patterns, track heart rate and detect snoring. 

It also syncs up to Nokia’s Health Mate app and provides smart home control via IFTTT (if this then that) integration, which allows for automatic thermostat regulation and light adjustment. The app also allows the user to view their Sleep Score to get an insight into what makes a good night’s sleep and how to improve night after night.

Packaged as a sensor pad with USB charger, Nokia Sleep retails at $99.95 (USA), €99.95 (Europe) and £99.95 (UK), and the brand website indicates that there are plans to roll out the product in key Asia-Pacific markets like China and Japan.

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Facing stiff competition in the smartphone market from Apple, Google and Chinese manufacturers, Nokia – the former king of mobile phones – is looking to further diversify its business.

Nokia Sleep was due to launch earlier this year, but news of a strategic review of Nokia’s Digital Health business in February 2018 put the rollout in doubt. Nokia will be monitoring closely how this new product fares against established competitor Beddit, which was acquired by Apple in 2017.

Whether you want to find out more about the latest innovations, benchmark the competition or simply keep abreast of new launches, Nicholas Hall’s extensive OTC New Products Tracker is an essential competitive intelligence tool that you simply must trial. Subscribers can also benefit from a newsletter highlighting the key product innovations affecting the industry. Find out more or set up your free trial today by contacting david.redford@NicholasHall.com

Flu Trends: USA, UK seeing 2018 spike

Though it’s difficult to build a comprehensive picture of flu trends across the globe, reports suggest that January 2018 has seen a spike in flu activity in North America and Europe. In its full-year 2017 results, J&J also cited growth for its upper respiratory category as one of the trends underpinning a 3.7% rise (+2.6% organically) for its OTC division in 2017. This included strong Q4 growth for its CCA brands in the Asia-Pacific region, suggesting that cold & flu activity is robust across the northern hemisphere.

According to reports, the US is in the grip of its strongest cough, cold & flu season for almost a decade. In mid-January, Brenda Fitzgerald, Director of the Centers for Disease Control & Prevention, said: “We are currently in the midst of a very active flu season. With much of the country experiencing widespread and intense flu activity … so far this season, influenza A, H3N2, has been the most common form of influenza. These viruses are often linked to more severe illness, especially among children and people age 65 and older. When H3 viruses are predominant, we tend to have a worse flu season with more hospitalizations and more deaths. While our surveillance systems show that nationally the flu season may be peaking now, we know from past experience that it will take many more weeks for flu activity to truly slow down.”

As the chart above shows, the percentage of US patients visiting their doctor with ILI (influenza-like illness) has peaked sharply in late 2017 / early 2018, reaching levels not seen since the 2009-10 flu season. Similarly, in the UK, reports suggest this has been the worst flu season for seven years – since the 2010-11 swine flu epidemic – with doctors visits for suspected flu rising sharply in certain parts of the country (in Wales, they recorded a fourfold increase to 64.9 cases per 100,000).

As we make our way through Q4 2017 results season, we’ll keep a close eye on how this spike in flu activity is reflected in the CCA performance of various OTC marketers, though it may be that we have to wait until the Q1 2018 results come in to see the full effect of this trend.

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.

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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.

Belfast scientists say aspirin could reverse tooth decay

Aspirin has long been prized for its painkilling properties, while low-dose aspirin is a popular systemic cardiovascular treatment, but new research shows that it could also reverse tooth decay.

According to a BBC report, the effects of tooth decay could potentially be reversed by the use of aspirin and lead to fewer fillings being needed in the future, researchers in Belfast have said. Tooth decay, the most common dental disease, leads to the inflammation of the tooth nerve, causing toothache.

Initial research at Queen’s University found aspirin stimulates stem cells in teeth, enhancing tooth regeneration. Current treatment for tooth decay involves fillings, which may need to be replaced many times during the lifetime of the tooth.

The British Dental Association reported in 2016 that 72% of 15-year-olds in Northern Ireland have dental decay. That figure compared to 44% in England and 63% in Wales.

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Teeth naturally have limited regenerative abilities. They can produce a thin band of dentine, the layer just below the enamel, if the inner dental pulp becomes exposed, but this cannot repair a large cavity.

The research findings, to be presented later this week at the British Society for Oral and Dental Research annual conference, show that aspirin can enhance the function of those stem cells, thus helping self-repair by regenerating lost tooth structure.

The researchers collated large amounts of previous research data to identify aspirin as a compound that can induce the gene signature needed to generate new dentine.

 

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.”

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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.

Vitamin B3 could prevent miscarriages and birth defects

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An extra dose of vitamin B3 might help prevent certain kinds of complex birth defects, according to a new study. It is thought the vitamin can help compensate for defects in the body’s ability to make a molecule, nicotinamide adenine dinucleotide (NAD), which researchers have now linked for the first time to healthy fetal development in humans.

Every year 7.9 million babies are born with a birth defect worldwide. The discovery suggests the possibility that boosting levels of B3 in pregnant women’s diets might help lower overall rates of birth defects.

Researchers from the Victor Chang Institute in Sydney called it ‘a double breakthrough’ as they found both a cause and a preventative solution. The researchers analysed the DNA of four families where the mothers had suffered multiple miscarriages or their babies were born with multiple birth defects, such as heart, kidney, vertebrae and cleft palate problems.

They found mutations in two genes that caused the child to be deficient in a vital molecule known as Nicotinamide adenine dinucleotide (NAD), which allows cells to generate energy and organs to develop normally. Lead researcher Prof Sally Dunwoodie replicated these mutations in mice and found they could be corrected if the pregnant mother took niacin (vitamin B3).

“You can boost your levels of NAD and completely prevent the miscarriages and birth defects. It bypasses the genetic problem,” she said. “It’s rare that you find a cause and a prevention in the same study. And the prevention is so simple, it’s a vitamin,” she said.

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Back In 2005, Dunwoodie’s team dealt with a particularly severe case, a baby who had major defects in the heart, backbone, and ribs; the rib problems being so bad that the child’s lungs couldn’t fully inflate. The team found that the family carried a mutation in a gene related to the production of NAD, a molecule crucial for energy storage and DNA synthesis in cells. Both parents carried a mutation in one of their copies of the gene, and the affected baby had inherited two defective copies.

No one had reported any role for NAD in heart or bone development, Dunwoodie says. “We didn’t know what to do with it.”

To confirm the role of the mutations in organ and bone development, the researchers knocked out the two genes in mice to see whether similar birth defects appeared. At first all the pups were normal. But then the researchers realised that standard mouse chow is rich in niacin and that cells can use either niacin or nicotinamide—both known together as vitamin B3—to make NAD by an alternate pathway.

The work opens a potentially exciting new area of research for developmental biologists: Trying to understand how cell metabolism affects development