Sanofi will be responsible for leading the clinical program and funding all studies needed to support the over-the-counter switch in the United States and will also be responsible for the regulatory submissions.
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France-based Sanofi struck a deal for the over-the-counter rights to Roche’s Tamiflu. The company will now be responsible for seeking approval from the U.S. Food and Drug Administration to sell the flu treatment without a prescription.
Currently, Tamiflu is marketed in the U.S. by Roche subsidiary Genentech. As of now, Tamiflu is only available with a prescription. Financial details of the rights agreement were not announced. Sanofi will be responsible for leading the clinical program and funding all studies needed to support the over-the-counter switch in the United States and will also be responsible for the regulatory submissions.
Alan Main, head of Sanofi’s consumer healthcare division, called the agreement with Roche a “strategic and important transaction” in order to continue bringing innovations to the market. Main noted that the United States has the largest over-the-counter drug market in the world. Successfully transitioning Tamiflu from a prescription drug to an over-the-counter treatment would bolster Sanofi’s current cough and cold strategy. Main said it would expand the company into the flu market 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,” Main said in a statement.
Currently, there are no effective over-the-counter anti-viral treatments for the flu. Citing the U.S. Centers for Disease Control and Prevention, Sanofi said more than 31 million people in the United States suffer from the flu annually, however, only about 7 million people were treated with an effective product like Tamiflu in 2017.
Roche will continue to market Tamiflu in the rest of the world. Sanofi will retain the rights to first negotiations for switch rights in other selected markets. Last year, Roche won approval from the FDA for Xofluza, a single-dose oral medication for the flu. Xofluza (baloxavir marboxil) was approved for the treatment of acute, uncomplicated influenza, or flu, in people 12 years of age and older. The approval of Xofluza marked the approval of the first new flu medication in the U.S. in two decades.
The flu represents a serious health threat each year. Globally, there are about 650,000 deaths from the flu worldwide and millions of people are hospitalized due to the illness. Earlier this year, the National Institutes of Health launched a trial to examine a potential universal flu vaccine candidate, known as H1ssF_3928. According to the NIH, the experimental vaccine is designed to “teach the body to make protective immune responses against diverse influenza subtypes by focusing the immune system on a portion of the virus that varies relatively little from strain to strain.” The hope is that H1ssF_3928 will provide long-lasting protection from many strains of the flu for all age groups.
