- An approval of Mylan's generic Advair copy by the Food and Drug Administration should be coming any day now, the drugmaker said Monday, seeking to head off questions from investors about the status of its application.
- Even as the FDA waves through record numbers of generic drugs, Mylan is still hung up on securing an OK for its knockoff version of GlaxoSmithKline's Advair. Twice before, the FDA has issued a Complete Response Letter in response to Mylan's application, setting back its hopes to steal away some of Advair's blockbuster revenue.
- While the market opportunity has waned, winning approval for generic Advair would give Mylan a lift at a time when its stateside business is struggling mightily. In August, the company's board of directors began a strategic review process to identify ways of reversing Mylan's share price decline.
Following receipt of a Complete Response Letter in June, Mylan resubmitted its Advair (fluticasone/salmetrol) generic application to the FDA in mid-July, setting up an expected decision by the middle of October.
That window of time is closing quickly, spurring "multiple inquiries" that Mylan indicated led it to issue a statement on its application's status.
"Mylan confirms it has not received any new information request or complete response letter from the FDA and continues to believe that FDA approval is imminent," the drugmaker said on Oct. 22.
While Mylan signaled all is well, investors appeared less sure.
"The silence post the apparent passing of an FDA action date is somewhat unusual in the post GDUFA world suggesting lingering uncertainty on the approval," wrote Raymond James equity analyst Elliot Wilbur in an Oct. 23 note to clients.
Wilbur noted that, by issuing such a statement, Mylan's leaders must "have more than a hunch" that an approval is still forthcoming. If not, the analyst implied, investors could lose further faith in the company.
That nuance didn't appear to be reflected in early trading Tuesday morning. Shares in Mylan slid by as much as 2.5%, extending a 20% drop in the company's stock since a recent peak of $39.48 per share hit Sept. 5.
Part of the difficulty lies with Advair itself, a combination product delivered via an oral inhaler. Winning approval for copycat versions of such complex products is a challenge, even as the FDA works to ease sticking points in its review process.
Complex generics also tend to be higher-value products, such as Advair or Teva's multiple sclerosis drug Copaxone (glatiramer acetate).
Advair, for instance, still earns blockbuster revenues despite eroding sales due to branded competition. Raymond James' Wilbur believes a generic, if approved, could represent a $225 million to $250 million opportunity for Mylan.