Teva Pharmaceutical Industries Ltd (TEVA.TA) said Friday it aims to win U.S. approval by late 2017 or early 2018 for its version of Mylan NV's (MYL.O) EpiPen device for treating severe allergic reactions, a move that would challenge the branded product's overwhelming market dominance.
EpiPen's list price has soared from less than $100 when Mylan acquired the product in 2007, to more than $600 now, sparking outrage from patients, consumers and politicians.
But without strong competitors, Mylan's EpiPen still holds an estimated 94 percent market share in the United States.
Teva's application for a copycat version has been in question since February, when the Food and Drug Administration flagged "major deficiencies" in the Israeli drugmaker's device.
"We requested a meeting with the FDA," Sigurdur Olafsson, Teva's head of global generic medicines, said in a webcast overview of the company's generics medicines business. He said Teva did not get a response, but after "the media attention in the last two weeks, the FDA has come back to us and we will have a meeting very, very quickly."
Given the recent "political noise on EpiPen," the FDA may now be more inclined to approve Teva's generic version, Evercore ISI analyst Umer Raffat said in a webcast message to clients.
Analysts had expected Teva to alter its autoinjector's design to remedy a dosing issue cited by the FDA, but Olaffson said the company was not planning any modifications to its device at this point.
The FDA declined to comment, citing the proprietary nature of drug application information.
With the EpiPen, a dose of epinephrine is injected into the thigh to counter dangerous allergic reactions, including to peanuts and bee stings.
A range of politicians, including U.S. Democratic presidential candidate Hillary Clinton, have criticized Mylan's EpiPen pricing.
Amid the growing controversy, Mylan said on Aug. 29 that within weeks it would launch its own $300 generic version of EpiPen.
Responding to a list of questions from Senate Judiciary Committee Chairman Chuck Grassley, Mylan, in a seven-page letter released on Friday, repeated its assertions that EpiPen prices are justified given the company's investment in life-saving research and patient education.
"I'll continue to ask questions until a fuller picture of what happened with this product's prices comes in," Grassley said in a statement. "In the meantime, I’ll continue to work on my two pending bills that would help bring more generic drugs to the market to help consumers."
Wall Street analysts have predicted that Teva’s product, if approved and priced cheaper than EpiPen, could eat up a significant portion of the branded product’s market share.
"We are working with the FDA on a path forward," Olaffson told investors on the call.
(Reporting by Ransdell Pierson; editing by Diane Craft and Mary Milliken)