Sanofi licenses OTC Tamiflu rights for the US market

Sanofi has made a bold play to bolster its consumer health business, licensing non-prescription rights to Roche’s influenza drug Tamiflu – even though there’s no guarantee it will be approved for over-the-counter use.

The French pharma group will take over responsibility for negotiating with the FDA to switch Tamiflu (oseltamivir) from prescription to OTC status, as Roche switches its attention to Tamiflu follow-up Xofluza that was approved in the US last October.

Sanofi isn’t saying how much it is paying for the OTC rights to Tamiflu in the US, but explained that a successful switch would “support our global cough and cold strategy by expanding into flu with a sustainable point of difference in the market.” It has also taken an option for the right to first negotiations for switch rights in “other selected markets.”

Tamiflu was a blockbuster product for Roche over a number of years, peaking with sales of around $3 billion a year when it was being stockpiled by governments around the world fearful of a flu pandemic, but has latterly been in fairly steep decline thanks to generic competition.

Roche is hoping Xofluza (baloxavir marboxil) will help it retain market share in the influenza treatment market as Tamiflu continues to decline, with the older brand reduced to just $179m in the first quarter of this year, with just $24m of that total coming from the US.

Xofluza hasn’t exactly leaped out of the starting blocks, bringing in around $6 million in the first three months of 2019, and analysts have suggested that it just isn’t differentiated enough from Tamiflu to make much headway yet.

The drug was able to shorten the time to alleviation of symptoms compared to placebo in the CAPSTONE-1 trial, but didn’t improve on Tamiflu for that endpoint. That means Roche is hoping its administration as a single dose within 48 hours of symptom onset will win out over Tamiflu’s twice-daily dosing over at least five days.

Analysts have suggested that Roche’s slow take-up is in part because with cheap oseltamivir available there is less incentive for governments to stockpile the new drug, even though Roche has priced its drug at around the same as a five-day generic course ($150).  

Having an OTC version of Tamiflu looks likely to exacerbate Xofluza’s uptake problem, despite its assertions that Xofluza has a superior clinical profile.

Tamiflu has been approved in New Zealand as an OTC drug since 2007, and that will likely assist Sanofi as it tries to persuade the FDA that switching the drug in the US is a good idea.

A study published in the Journal of Antimicrobial Chemotherapy five years after Tamiflu debuted as an OTC drug in New Zealand found that there was no increase in resistance to the drug and no reduction in immunisation rates.

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