Covid-19: France advises against ibuprofen to treat symptoms

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France’s Health Minister Olivier Véran delivered a message via his Twitter account over the weekend, advising against taking anti-inflammatory medicines (ibuprofen, cortisone, etc) to treat Covid-19 symptoms, as they could be an aggravating factor for the infection. His advice for those with a fever was to take paracetamol instead. Patients already on anti-inflammatory drugs for other illnesses, or anyone with any questions, are advised to seek advice from their doctor.

Public health interventions like this, with directives specifically citing which OTC medicines to take or not take, are rare and so the story was picked up by major news outlets in the UK (Guardian), USA (New York Times) and elsewhere. According to a report in The Local, Véran’s tweet prompted several members of the public to ask for the source of his reasoning on not taking ibuprofen to treat Covid-19 symptoms. The main concern appears to be that anti-inflammatories have an “immunosuppressive effect“, plus the background in France is that medicines agency ANSM has already removed medicines containing paracetamol, ibuprofen and / or aspirin from the self-selection list in January 2020 to reinforce the advisory role of the pharmacist and guarantee safe use.

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Meanwhile, the effect of the Covid-19 pandemic on sales and availability of painkillers in other markets is already becoming evident, with UK retailer Boots imposing a limit of two items per customer on cough & cold and pain medicines and US marketer J&J reporting a spike in demand for its Tylenol range and other self-care products. In the wake of the Covid-19 outbreak, and India’s decision last week to restrict the export of some ingredients (including paracetamol), there have been fears of shortages and disruptions to supply chains, but J&J said it did not anticipate a shortage of Tylenol and that it was taking all possible measures to maximise availability of its consumer healthcare range.

The good news is that we have extended the campaign entry criteria and deadline for our 2020 Marketing Awards! Coinciding with the new event dates, the Awards will now be presented on 30 September during our 31st European Conference in Athens on 29 September–1 October 2020. If you’re proud of your latest campaign or brand, ensure that you enter before the new deadline of 14 August! For more information on entry criteria, contact jennifer.odonnell@NicholasHall.com without delay.

Combination OTC painkillers gaining ground

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Following the approved switch of Voltaren Arthritis Pain by the FDA in mid-February, there was more positive news for GSK’s US analgesics portfolio over the weekend with the FDA approval of Advil Dual Action. This is the first FDA-approved OTC combination of ibuprofen and paracetamol (acetaminophen) in the USA, and GSK is expected to launch the product later this year.

Franck Riot, Head of R&D at GSK Consumer Healthcare, said: “For decades, many consumers have been using ibuprofen and acetaminophen (paracetamol) to get the benefits of both active ingredients when safely treating their headaches, muscle aches, backaches, arthritis and other joint pain. Now Advil, the No. 1 selling OTC pain reliever, will offer US consumers the first-ever alternative option – a single, fixed-dose combination pain reliever.” According to the reported clinical research, this fixed-dose combination achieves superior efficacy compared to the individual monocomponents of ibuprofen (250mg) and acetaminophen (500mg) alone.

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Dolostop Plus, another recent combination launch

Another combination OTC painkiller we tracked recently, formulated with both ibuprofen and paracetamol, is Kern’s September 2019 launch of Dolostop Plus in Spain. Indicated to provide symptomatic relief from mild to moderate pain in adults, these film-coated tablets are formulated with paracetamol 500mg and ibuprofen 150mg, with a stated dose of 1-2 tablets every 6 hours, and claimed to be the first and only OTC paracetamol and ibuprofen combination available in Spain.

In several markets around the world, such as the UK, Russia, Japan and Indonesia, combination paracetamol + ibuprofen OTC remedies are already well-established, but these recent developments in the USA and Spain point to growing acceptance among global regulators about the safety of fixed-dose OTC analgesic combinations.

Where will NPD take the CHC market in the future? Find out in our upcoming report, Innovation in CHC: NPD & Innovation in CHC under the Spotlight! This report, drawing on Nicholas Hall’s CHC New Products Tracker, assesses the global picture of CHC innovation in 2019, featuring ingredient trends, delivery format trends, analysing innovation trends by region and by marketer, plus much more! To pre-order your copy and save with the pre-publication discount, or for more information, please contact melissa.lee@NicholasHall.com.

GSK and Alcon get FDA approval for US switches

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Following on from our recent blog highlighting the need for a new wave of Rx-to-OTC switches to kickstart growth in the global consumer healthcare industry, this week we cover the welcome news that the FDA has approved three drugs for non-prescription use. As well as GSK’s topical analgesic gel Voltaren Arthritis Pain (diclofenac sodium 1%), two Alcon eye care allergy products (available as solution / drops) have also switched to OTC status – Pataday Twice Daily Relief (olopatadine 0.1%) and Pataday Once Daily Relief (olopatadine 0.2%).

Karen Mahoney, Acting Deputy Director of the Office of Nonprescription Drugs at the FDA’s Center for Drug Evaluation & Research, said: “Approval of a wider range of non-prescription drugs has the potential to improve public health by increasing the types of drugs consumers can access and use that would otherwise only be available by prescription. This includes providing the millions of people that suffer with joint pain from arthritis daily over-the-counter access to another non-opioid treatment option.”

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Olopatadine is available OTC in a handful of other countries worldwide, but this is the first time it’s been switched in a major market. One of the countries where the ingredient can be purchased without a prescription is Singapore, which approved the Rx-to-OTC switch of olopatadine 0.1% and 0.2% in December 2016. More recently, Poland’s Office for Registration of Medicinal Products, Medical Devices & Biocidal Products (URPL) approved the Rx-to-OTC switch of Polfa Warszawa’s Starelltec Alergia eye drops (olopatadine 1mg / ml; 5ml bottle) in July 2019 and Adamed’s Oftahist eye drops (olopatadine 1mg / ml; 5ml bottle) in November 2019.

Voltaren currently ranks fifth among the world’s leading consumer healthcare brands, according to CHC DASHBOARD, and this switch could see it move up the rankings and even move ahead of its new GSK stablemate Advil into the No.3 position globally within the next few years. While the US switch of Voltaren has long been mooted, the news is all the more welcome at a time when the world’s No.1 CHC market is in desperate need of an injection of growth, and US arthritis sufferers are also in need of a wider pool of OTC non-opioid treatment options.

For the full story, be sure to read tomorrow’s edition of CHC.NewDirections, a weekly e-newsletter sent out every Tuesday. CHC.NewDirections focuses on innovation, science and regulation, and coverage spans Rx-to-OTC switch, CBD, relevant medical research, probiotics, medical devices, digital health / AI, e-cigarettes and much more! For more information, or to arrange a free trial, please contact Melissa.Lee@NicholasHall.com

Rx-to-OTC switch outlook for 2020

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One of the factors contributing to lower global consumer healthcare growth in recent years has been a falling-off in Rx-to-OTC switch activity in key markets like Japan and the USA. Looking ahead, however, there are reasons to be positive. In December 2019, Sanofi CEO Paul Hudson cited the company’s “plans to accelerate the over-the-counter switches for Cialis and Tamiflu” in order to fulfil its ambition of growing faster than the CHC market over the mid-term. In light of the current coronavirus epidemic, the benefits of wider OTC access to flu remedies is all the more evident.

Sexual health is another category with huge Rx-to-OTC switch potential, notably erectile dysfunction medicines and daily oral contraceptives. Though the switch of Cialis (tadalafil) has been stuck at the FDA for several years now since its submission, sildenafil (Viagra) is enjoying ever wider OTC availability, especially in Europe. After switching in Poland in 2016, sildenafil was launched as Viagra Connect (Pfizer) in the UK in 2018 and will be launched OTC as Viagra Reseptfri in Norwegian pharmacies in early 2020.

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There is also renewed interest in OTC triptans for migraine. A handful of switches took place in the mid-2000s but were held back by OTC purchase limits (a 2-tablet emergency pack). Over the past year, various countries have again began discussing triptan switches including Australia, Ireland and Germany (which is expected to expand the number of triptan molecules in the OTC sector), though major expansion of the segment is unlikely without larger pack sizes.

All that said, reverse-switch remains a threat and one OTC ingredient of ongoing concern is codeine. In late 2019, New Zealand’s Medicines Classification Committee, following Australia’s lead, recommended that all codeine-containing medicines should be reverse-switched from OTC to Rx. In January 2020, citing “widespread concern about the abuse of codeine-containing preparations nationally and globally”, the South African Health Products Regulatory Authority said it is reviewing the scheduling status of codeine and codeine-containing medicines which are available without a prescription.

CHC.NewDirections is an e-newsletter sent every Tuesday, with a focus on innovation, science and regulationCoverage spans Rx-to-OTC switch, CBD, relevant medical research, probiotics, medical devices and new delivery formats, digital health / AI, e-cigarettes and much more! For more information, or to arrange a free trial, please contact Melissa.Lee@NicholasHall.com

Time’s 100 Best Inventions of 2019

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Time magazine has just published its annual round-up of the 100 best innovations – based on key factors such as originality, creativity, influence, ambition and effectiveness – and healthcare was the best represented category with 10 innovations in 2019. Most have been designed for use in primary care settings, such as GE Healthcare’s new Senographe Pristina with Dueta mammogram, but there were several innovations designed for consumer use.

One of these is Tivic Health’s ClearUp, which was added to our OTC New Products Tracker database following its launch in September 2019. Positioned as a drug-free handheld device to treat sinus pain owing to allergic rhinitis, ClearUp delivers microcurrent waveforms to sinus nerves under the cheek, nose and brow bone. The medical device provides three intensity levels for personalised usage, and each treatment takes five minutes to perform and lasts for up to six hours.

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Tivic Health’s ClearUp for sinus pain

Also on the Time Best 100 Innovations of 2019 list were portable ultrasound device Butterfly iQ, Theranica’s drug-free migraine treatment Nerivio and handheld doctor examination kit TytoCare. The latter retails for US$299 and has been designed to eliminate the need for a doctor visit by examining the lungs, ears, skin and throat with special adapters and then video­conferencing a doctor to monitor the metrics in real time. According to TytoCare CEO Dedi Gilad: “It transforms primary care by putting health in the hands of consumers.”

As for Nerivio, it was described as the “first smartphone-controlled acute migraine-relief wearable device” when it gained de novo FDA approval in May 2019. The medical device, which is not suitable for people with chronic migraine, is placed on the upper arm and uses smartphone-controlled electronic pulses to create a Conditioned Pain Modulation (CPM) response. Alon Ironi, CEO and co-founder of Theranica, has said the product will be launched at an “affordable price” when it comes to market in 2020.

Don’t miss out on the chance to save 30% on a subscription to the ultimate tool for tracking consumer healthcare innovation, OTC New Products Tracker! We’ve recently hit over 20K entries and made some innovative improvements within the past year, including powerful new graphs, additional filter options, PowerPoint export, Save & Search options and monthly customised innovations reports. Until the end of 2019 we are offering an exclusive 30% discount off list price — please contact waisan.lee-gabell@nicholashall.com to find out more!

France clamps down on OTC painkillers

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First came a public consultation launched by French medicines agency, ANSM, in August 2018 on how to increase consumer awareness of the risks of paracetamol misuse or overdose. Then followed the decision in July 2019 that, within 9 months, all paracetamol-based medicines must carry a prominent warning on packaging, to inform consumers about risks associated with paracetamol overdose, particularly hepatotoxicity. Paracetamol is the most commonly prescribed and used medicine in France, and the change affects more than 200 medicines.

Now, the ANSM has decided that, to reinforce the advisory role of the pharmacist and guarantee safe use of medicines containing paracetamol, ibuprofen and / or aspirin (in particular to avoid the risk of overdose), such products should be removed from the OTC self-selection list from January 2020 and kept behind the counter in pharmacies. ANSM has launched a consultation period with marketers, who have one month to comment.

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According to our estimates, the decision (if implemented) could affect around 90 SKUs on the French market. This includes the trio of leading paracetamol-based brands – Doliprane, Dafalgan and Efferalgan – as well as the top OTC ibuprofen-based (Nurofen, Advil) and aspirin-based (Aspirine Upsa) analgesics. Various OTC generics from the likes of Biogaran, Sandoz and Mylan, as well as systemic cold & flu remedies (Fervex, HumexLib) and topical analgesics, could also be affected.

The true effect that this decision could have on sales of OTC systemic analgesics remains to be seen, but it would clearly not be welcome news for marketers active in a category that remains in persistent decline, in part because of another regulatory decision (reverse-switch of codeine in July 2017). Leading brands such as Doliprane (Sanofi) and Efferalgan (formerly BMS, now Taisho) are available in both semi-ethical (reimbursed) and pure OTC versions, the latter often backed by TV ads, and it’s these latter SKUs which marketers have invested in over recent years that are most at risk.

Rapid regulatory change will be one of the themes at Nicholas Hall’s upcoming OTC.NewDirections Executive ConferenceTaking place in London on 14 November, the meeting will ultimately focus on the latest CHC Innovations and Technologies, with presentations from RB, Mundipharma, J&J and many more experts from CHC and beyond. To book your place or find out more, please contact jennifer.odonnell@NicholasHall.com without delay.

BMS to sell French subsidiary?

According to an exclusive report in Reuters, BMS is looking to sell its French OTC subsidiary, Upsa, in a potential deal which could exceed €1bn (US$1.2bn). Deutsche Bank and Jefferies are said to be preparing the auction process, which will begin after the summer. It is rumoured that potential bidders may include Stada, Zentiva, Mylan and P&G, while Recordati could also decide to make a play for the company.

Upsa has been in operation for over 80 years and the company itself is a well-established brand in France, by far BMS’s key OTC market. According to DB6, BMS generated global OTC sales of US$477mn in 2017, 60% of which were generated in France (US$285mn). BMS’ next two biggest OTC markets are Belgium and China.

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Upsa’s key brands are Dafalgan and Efferalgan analgesics (both paracetamol), as well as the paracetamol-based Fervex systemic cold & flu line. According to the latest OTC DASHBOARD trend report, Upsa is the No.2 OTC marketer in France behind Sanofi but sales there fell by 4.8% in 2017, with mid-single digit declines for Dafalgan and Efferalgan.

Price cuts for reimbursed semi-ethical painkillers like Dafalgan and Efferalgan have contributed to the decline in France, causing marketers like Upsa to shift focus from reimbursed options to pure OTCs; reimbursed Efferalgan SKUs were rebranded as Efferalganmed in October 2015. In December 2017, the marketer also rebranded Fervex medical device options as Les Élémentaires, in response to rising concerns about the use of umbrella branding which could confuse consumers.

With M&A activity in the CHC industry rapidly increasing, it might be the right time for your business to explore interesting and suitable growth opportunities coming from M&A. Our specialist M&A boutique is working with a number of strategic and financial partners to assess potential opportunities — for buyers and sellers — and is well placed to discuss the current business climate and possible synergies. To find out more, please contact ammar.basit@NicholasHall.com.