Tamiflu to switch to OTC in USA?

otcinaction

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.” 

Print

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.

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.

Vit D may prevent cold & flu

OTCinActionheader

“The sunshine vitamin”, also known as vitamin D, is vital for healthy bones and a strong immune system, says an analysis published in the British Medical Journal. This study also suggests that foods should be fortified with the vitamin.

Public Health England (PHE), however, argues that the infections data is not conclusive, although it does recommend the supplements to improve bone and muscle health.

According to the research, the immune system uses vitamin D to make antimicrobial weapons that puncture holes in bacteria and viruses. As vitamin D is made in the skin while out in the sun, many people, particularly in the UK, have low levels during colder seasons.

Trials on using supplements to prevent infections have so far given varied results, so researchers pooled data on 11,321 people from 25 separate trials to try to gain a more conclusive result. The team at Queen Mary University of London looked at respiratory tract infections, which covers a wide range of illnesses from a runny nose to flu to pneumonia.

db-200217-vit-d

The study overall said one person would be spared infection for every 33 taking vitamin D supplements. That is more effective than a flu vaccination, which needs to treat 40 to prevent one case, although flu is far more serious than the common cold.

There were more beneficial results for those taking pills daily or weekly, rather than in monthly super-doses and in people who were lacking vitamin D in the first place. The main purpose of vitamin D supplements is to normalise the level of calcium and phosphate in the body, which are crucial for the growth and maintenance of healthy bones, teeth and muscles.

In extreme cases, low levels of vitamin D can cause rickets in children, where the bones become soft and weak and, in some cases, misshapen as they continue to grow. In adults, vitamin D deficiency can lead to osteomalacia, which leads to severe bone pain and muscle aches.

One of the researchers taking party in the study, Professor Adrian Martineau, commented: “Assuming a UK population of 65 million, and that 70% have at least one acute respiratory infection each year, then daily or weekly vitamin D supplements will mean 3.25 million fewer people would get at least one acute respiratory infection a year.”

For more vitamin D developments, please follow this link.

Live life to the max… with OTCs

A recent CVS pharmacy survey has shown that over a quarter of Americans who get a flu shot every year or are planning to get one this year (60% of all respondents) cited the possibility of missing out on important life events such as birthdays and family gatherings as the reason for doing so.

While recent high unemployment in Southern Europe has led many cold & flu marketers to underline the importance of not skipping work through illness, not missing out on the good times and living life to the max is just as consistent a theme in European OTC ads as in the US.

Nicholas Hall’s Worldwide Marketing Award Winner way back in 2012 was Reckitt Benckiser, for its Don’t Lose A Day campaign backing Lemsip, Strepsils and Meltus brands, which highlighted the enjoyment of everyday activities unabated by cold & flu, from Tuesday dance classes to Friday night dates.

More recently, RB backed its Lemsip Cough Max entry with UK ads showing a mountain climber unable to make it to the summit owing cough, only to be boosted to the top with the aid of the Lemsip remedy.

Ricola used a slightly more surreal angle on the theme with its global Chrüterchraft (literally “the power of herbs”) campaign last year – also shown in the US – featuring naked ramblers and Nordic opera singers to emphasise Ricola’s ability to refresh, soothe, liberate and inspire.

Bayer’s more low-key TV ads for Aspirin Complex in 2014 leant on a Forsa survey showing that most Germans preferred to stay in bed when suffering from cold & flu, with the ads featuring a man miserably wandering around town in a duvet, featuring the tagline, “Live life to the full despite cold”.

Might CVS’ campaign prompt cold & flu marketers to focus their creativity more on individual “life events” rather than everyday ones? Or to further highlight the efficacy and relative convenience of tablets, syrups and lozenges as opposed to CVS syringes?

If you’ve launched an advertising campaign from 1st February 2015 or are planning to launch one before 31st January 2016, you could be up for a Nicholas Hall Marketing Award, which reward innovation and creativity throughout the consumer healthcare industry. For details on how to enter, contact jennifer.odonnell@NicholasHall.com.

For a full review of recent A+P campaigns for cold & flu brands in leading markets, why not pick up a copy of our Cough, Cold & Allergy report? Contact nino.hunter@NicholasHall.com for details on content & pricing.

Online eating in-store sales in Germany?

Despite OTC growth in Germany remaining sluggish in 2014, online sales are starting to make serious advances. Online sales now account for a little over 10% of the country’s total OTC market, according to industry sources.

While market share is still relatively modest in traditional categories like cold & flu and GIs, online turnover for a variety of lifestyle and VMS brands – for which there is no desperate need for immediate face-to-face interaction with a pharmacist – is around 50% of that generated through pharmacies and drugstores. While convenience is, of course, a major factor, price is also significant, as consumers are often able to save €15 on premium supplements online, with savings growing further on jumbo packs. It is also noticeable that many of these double-digit sales increases are being made by products positioned for Germany’s older consumers, in particular eye vitamins with Age Macular Degeneration positioning, joint health products – now equivalent to two-thirds of pharmacy turnover – as well as herbal memory & brain health, with several premium ginkgo-based options chalking up huge increases in 2014. For the potentially less mobile consumer in the 65+ age bracket, a steadily growing demographic in Germany, the home delivery element is crucial.

So just who are the online retailers making headway? German marketing agency Dr Kaske completed a survey analysis of the 15 largest in April 2015, scoring them according to price on a select basket of common OTCs, search engine optimisation, customer service, user-friendliness and, of course, actual visitor numbers. Leader in all categories was Shop-Apotheke, a subsidiary of Netherlands-based Europa Apotheek Venlo, although the more widely known DocMorris – sold by Celesio to Swiss pharmacy retailer Zur Rose in 2012 – was a close contender, featuring the best SEO. Medikamente-per-klick and Sanicare are also noteworthy, with the latter investing heavily in TV advertising in 2014.

For more insight into trends and developments in Germany and elsewhere in Europe, why not enquire about our monthly OTC INSIGHT Europe publication? Contact nino.hunter@NicholasHall.com.