The US FDA on Thursday approved Teva Pharmaceuticals’ (TEVA) generic version of EpiPen and EpiPen Jr auto-injector for the emergency treatment of allergic reactions in adults and pediatric patients who weigh more than 33 pounds. Teva’s generic version will compete with EpiPen maker Mylan (MYL), which has got its own authorized version of the auto-injector and accused of its monopoly in this area. Teva shares rose more than 5% today after the FDA’s approval, while Mylan stock dropped about 1%.
“Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval,” said FDA Commissioner Scott Gottlieb.
Earlier in 2016, the Israel-based pharma firm’s EpiPen generic version application was rejected by FDA. The EpiPen is intended to automatically inject a dose of epinephrine into a person’s thigh to stop an allergic reaction. The FDA has approved several epinephrine auto-injector products under new drug applications to treat life-threatening allergic reactions, including EpiPen, Adrenaclick, and Auvi-Q, which are not considered as generics.
Also, Teva Pharma and its partner Regeneron Pharmaceuticals (REGN) announced positive topline results from a Phase 3 Fasinumab trial in patients with chronic pain from osteoarthritis of the knee or hip. The study met both co-primary endpoints and all key secondary endpoints. Regeneron and Teva are jointly developing Fasinumab as part of a global collaboration agreement. Shares of Regeneron rose about 3% today.
It’s worth noting that Warren Buffett increased its stake in Teva Pharma to 43.2 million shares earlier this week from 40.5 million shares at the end of March. Also, today Cantor Fitzgerald analyst Louise Chen maintained his ‘Hold’ rating on Teva shares and set a price target of $25, while Mizuho Securities reiterated its ‘Buy’ rating with a price target of $28. Teva Pharma stock has surged 27% so far in this year and 38% in the past one year.
