When will Actelion get back on the FDA's good side?

A Victory For Gilead

Mar. 4 2011 - 11:21 am

By MATTHEW HERPER

When Gilead Sciences, the $8 billion (sales) maker of AIDS drugs, bought smaller drug developer Myogen for $2.5 billion in 2006, one rationale behind the deal was that Myogen’s lead drug, Letairis, would have a key safety advantage over its main competitor, Tracleer, from Actelion: a lack of a so-called “black box” warning about the risk of liver damage.

It didn’t happen. When the drug was approved in 2007, it carried the same boxed warning as its competitor, and that has led to disappointing sales. (Both drugs, which are used to treat a rare condition called pulmonary arterial hypertension that makes it hard for patients to breathe and can be lethal, also increase the risk of birth defects.)

But this morning Gilead announced that the Food and Drug Administration had agreed to remove the liver warning. “This change removes language concerning the potential risk of liver injury from the Boxed Warning. In conjunction with this label update, PAH patients receiving Letairis are no longer required to obtain monthly liver function tests.”

Mark Schoenebaum, the biotechnology analyst at ISI Group, says the change is “very meaningful” and that it could be worth as much as $2 a share, although that conclusion is tentative. It’s also possible that physician opinions about Letairis will be difficult to change, making it difficult to sell.

 

Too much weird shit has hit the Actelion fan since a yr or so ago...the feds served the subpoena at the US home ofc last Sept...Oct FDA warning ltr...now the FDA kicks Actelion in the teeth by giving Gilead the chance to relaunch Letairis...the SSF circle of executives is overdue answering the who, what, where, when, why & how questions employees, stockholders & regulators have