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 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.
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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)
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