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July 23, 2019updated 24 Jul 2019 10:30am

Sanofi gains OTC rights to Roche’s Tamiflu in US

Sanofi has entered an agreement to obtain the exclusive over-the-counter (OTC) rights for Roche’s Tamiflu medicine, which will be used to help prevent and treat influenza in the US. 

Sanofi has entered an agreement to obtain the exclusive over-the-counter (OTC) rights for Roche’s Tamiflu medicine, which will be used to help prevent and treat influenza in the US.

Tamiflu is a prescription medicine available to treat individuals aged two weeks and above who have had flu symptoms for no more than two days. It is also indicated to minimise the risk of flu in people aged above one year.

The medication is currently sold by Roche subsidiary Genentech.

As part of the latest agreement, Sanofi will carry out activities related to Tamiflu’s OTC switch. Such activities include the US regulatory discussions, marketing, scientific engagement and distribution of the drug.

Sanofi will also lead the clinical programme and sponsor all trials required for the OTC switch in the US.

Sanofi Consumer Healthcare executive vice-president Alan Main 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.”

Main added that the OTC switch will help mitigate the risk of flu. It will also facilitate earlier treatment during the initial 48 hours, without the need for visiting a hospital.

Under the deal, Roche will retain rights to market Tamiflu in all ex-US countries. Meanwhile, Sanofi will hold the rights for first negotiations on switch rights in additional markets.

In January this year, Sanofi secured the US regulatory approval for its 0.5ml Fluzone Quadrivalent vaccine. The vaccine is intended to treat influenza in children aged between six and 35 months.

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