Roche has been hoping its new drug Xofluza can pick up flu sales lost to Tamiflu generics. But under an exclusive deal with Sanofi, it might end up competing with over-the-counter Tamiflu, too.
Sanofi picked up OTC marketing rights to Tamiflu in the U.S., aiming to persuade the FDA to switch the flu fighter to nonprescription status. Sanofi will handle FDA negotiations for the OTC switch and all future marketing, and it has first dibs on OTC rights in other markets.
“[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,” Alan Main, executive vice president of Sanofi consumer healthcare, said in a statement. Currently available OTC flu products only alleviate symptoms, while Tamiflu deals with the virus itself.
The deal could allow Sanofi to enter the U.S. OTC cough, cold and flu market. Its Mucosolvan cough brand is currently only sold in the EU, Asia and Russia.
Switching a prescription drug to nonprescription status isn’t easy. The FDA will review the application based on safety and efficacy established for the original approval but might require new clinical studies, too. Tamiflu has safety points that could help it win nonprescription status; it's the only antiviral flu drug the Centers for Disease Control and Prevention recommends for pregnant women because of its clear safety profile.
But OTC drugs also need consumer-friendly labeling—and Sanofi will have to carry out studies showing consumers can understand its Tamifu labeling message and choose the product accordingly.
The company has held initial discussions with selected regulatory bodies and key experts, a Sanofi spokesperson told FiercePharma.
Sanofi's been here before, though. As a consumer healthcare giant, the French drugmaker has built up expertise in the prescription-to-OTC switch. Back in 2011, for instance, it successfully nabbed the FDA’s permission to sell its blockbuster allergy treatment Allegra over the counter.
Sales of the prescription version of the drug—available outside of the U.S.—plummeted 17.7% at constant currencies in 2018 to €124 million ($139 million), while its consumer health sister brought in €396 million, up 1.2% at unchanged exchange rates.
After Allegra, Sanofi also won FDA permissions to sell allergy treatments Nasacort and Xyzal as OTC meds. Meanwhile, through a 2014 deal with Eli Lilly, Sanofi holds OTC rights to the erectile dysfunction blockbuster Cialis. And it's on the hunt for an executive to lead its global Rx-to-OTC switch projects, Sanofi's employee recruitment website shows.
With an antiviral drug like Tamiflu, there is likely the additional question of whether wider use by consumers might increase the risk of viral resistance. But a 2012 study in New Zealand—the first country to make Tamiflu available without a prescription—found that five years of nonprescription Tamiflu didn’t appear to spur development of resistance or trigger a decline in influenza immunization rates.
Roche, for its part, is looking to focus on its newly approved Xofluza; after all, after generics hit, Tamiflu’s sales dropped a whopping 29% in 2018 to just 378 million Swiss francs ($385 million).
With just a single dose, Xofluza could alleviate flu symptoms as fast as Tamiflu, which usually requires twice daily dosing for five days. The drug also beat placebo at preventing the onset of symptoms in patients exposed to a family member with the flu.
Partnerships and licensing deals, such as the Tamiflu one with Sanofi, “allow us to continue our investment in innovative R&D, enabling the development of novel medicines,” Roche said in a statement.