As a result of the agreement with Roche, Sanofi will lead negotiations with the US Food and Drug Administration (FDA) to switch the Tamiflu (oseltamivir) product to be available over-the-counter (OTC).
Sanofi would hold exclusive OTC rights to the flu prevention and treatment medication in the US, whilst also being responsible for clinical programs and the funding of studies needed to support the OTC switch.
Alan Main, EVP of Consumer Healthcare at Sanofi, said, “The US market is the largest OTC market in the world and 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.”
Sanofi holds a portfolio of ‘health and well being’ products, which includes medicine for allergies, digestive health, nutritionals, and pain care, in addition to cough and colds.
Roche will retain responsibility for the marketing of the product in the rest of the world, with Sanofi retaining the option for first negotiations for rights in other markets.
Licensing the product to Sanofi arrives shortly after Roche was able to post successful Phase III trial results for its Xofluza (baloxavir marboxil) investigational treatment for flu prevention.
Xofluza is a one-dose, oral treatment for influenzas types A and B, and it is already approved in Japan for the treatment of flu and in the US for the treatment of acute, uncomplicated influenza in those older than 12 years of age.
Roche is seeking to expand these indications through a supplemental new drug application (sNDA) for people at a high risk of complications from flu. A decision on this is expected by November 4, 2019.