Sanofi announced that it signed a deal with Roche for exclusive over-the-counter rights to Tamiflu to prevent and treat influenza in the U.S.
The company will now be responsible for negotiating the switch to over-the counter (OTC) with the FDA, in addition to marketing, scientific engagement, and distribution of Tamiflu OTC in the United States, according to the press release.
“This is a strategic and important transaction for us as we strive to continually bring innovations to the market,” Alan Main, executive vice president of consumer healthcare at Sanofi, said in a press release. “The U.S. 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.”
The agreement requires Sanofi to take responsibility for leading the clinical program and funding the studies necessary for the switch to OTC in the United States.
Sanofi announced that it signed a deal with Roche to for exclusive over-the-counter rights to Tamiflu to prevent and treat influenza in the U.S.
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The release stated that there is currently no effective OTC antiviral treatment for influenza available to consumers in the United States, although early treatment is essential to help stop the spread of the disease. The CDC found that 31 million people in the United States have influenza each year, but only 7 million took Tamiflu or another effective treatment in 2017, according to the press release.
“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 said. “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.”
Under the deal, Roche will continue to market Tamiflu outside of the United States and Sanofi has the rights to first negotiations in additional selected markets. – by Erin Michael
Disclosures: Alan Main is an employee of Sanofi.