Sanofi has signed an agreement with Roche for the exclusive over-the-counter (OTC) rights to Tamiflu for the prevention and treatment of influenza or flu in the US.
The agreement means Sanofi will be responsible for leading FDA negotiations for the OTC switch and subsequent exclusive marketing, scientific engagement and distribution of Tamiflu OTC in the US.
Additionally, Sanofi will be responsible for leading the clinical program and funding all studies needed to support the OTC switch in the US in consultation with leading experts in the field.
Tamiflu is currently sold in the US by Roche Group member Genentech for prescription use. Roche will continue to market Tamiflu in the rest of the world.
Alan Main, Executive Vice President 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.
“Tamiflu will offer a significant public health benefit once switched by providing increased access to a safe and efficacious treatment for the prevention and treatment of flu.
“People would be able to either reduce their chances of getting the flu or, at the first signals, appropriately treat as early as possible during the crucial first 48 hours without having to wait for a doctor’s appointment.”