Teva Pharmaceutical (NYSE:TEVA) said last week that it hopes to win U.S. approval for its version of Mylan‘s (NSDQ:MYL) EpiPen by late 2017 or early 2018.
Mylan’s EpiPen holds an estimated 94% market share in the U.S.; an alternate device from Teva could threaten the product’s dominance.
Teva’s application for its epinephrine injector has been in question since February, when the FDA cited “major deficiencies” with the 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.
Teva did not get an immediate response from the federal safety watchdog, but after “the media attention in the last 2 weeks, the FDA has come back to us and we will have a meeting very, very quickly,” he said.
Mylan has come under fire in recent weeks for raising the price of the EpiPen nearly 500% since 2008, from $100 to as much as $600 today. In late August, Sens. Amy Klobuchar (D-Minn.) and Charles Grassley (R-Iowa) pressed Mylan to release a cost analysis of the device. Klobuchar also penned a letter to the U.S. Federal Trade Commission to investigate whether Mylan violated antitrust laws.
Last week the US Senate investigations panel launched a “preliminary inquiry” into the company’s pricing of the EpiPen.
Teva’s announcement came on the same day that Grassley, the chair of the US Senate Judiciary Committee, called Mylan’s response to his call for a cost analysis “incomplete.”
“It’s an incomplete response and wouldn’t satisfy my constituents who are upset about the EpiPen price increases. It doesn’t provide the full picture that I requested, and it doesn’t answer all of my questions,” Grassley said in prepared remarks.
Amid the criticism, Mylan CEO Heather Bresch maintained that the price increases are justified because of improvements Mylan made to the device. The company announced in August that they would expand existing patient assistance programs and develop a generic that would cost around $300 for a pair of injectors.
Mylan’s shares dropped 10% to $42.64 apiece when the criticism began in August. Since then, shares have slowly but steadily declined. The stock was trading at $40.60 per share in mid-morning activity today, up 1.78%.
Material from Reuters was used in this report.
