Merck, Vertex Prep for Hep C Drug Panels

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Algemeen advies 21/04/2011 15:08
BOSTON (TheStreet) -- A new era of hepatitis C treatment and the potential for billions of dollars in sales are on the line next week as an independent panel of experts meets to scrutinize new drugs from Merck(MRK_) and Vertex Pharmaceuticals(VRTX_).

The U.S. Food and Drug Administration advisory panel meets Weds. April 27 to review Merck's hepatitis C drug boceprevir. The same expert panel reconvenes on Thurs. April 28 to judge Vertex's telaprevir.

Prior to every advisory panel, the FDA publishes briefing documents, including a review of the drug(s) in question. Expect to see the FDA's review of boceprevir and telaprevir on Monday, April 25, posted to the agency's web site.

Both boceprevir and telaprevir are the most advanced entrants in a new class of oral drugs that act directly against the hepatitis C virus and promise to radically improve cure rates while cutting treatment duration. Both drugs could be approved and launched later this year, transforming the way hepatitis C is treated and leading to blockbuster sales.

Telaprevir is expected to generate more than $1 billion in sales in 2012, according to one buy-side investor survey conducted recently, illustrating the heavy demand for new Hep C drugs expected to come from doctors and patients.

The following is a primer to help investors prepare for next week's FDA advisory panels:

Why is the FDA holding an advisory panel for boceprevir and telaprevir? Are there any serious doubts that these two drugs work?

No, not really. Both boceprevir and telaprevir are effective against the Hep C virus. Data from multiple phase III studies conducted by Merck and Vertex, presented and published widely, prove that point beyond doubt. With that said, both drugs represent entirely new ways of treating Hep C and each has unique side effect or safety issues. For these reasons, FDA decided wisely to convene advisory panels.

Investors absolutely expect both panels to recommend the approval of both boceprevir and telaprevir. A negative vote for either drug will be a shocking surprise. But even though the overall outcome of next week's panels are not in serious doubt, the discussions about safety and potential labeling claims are important and could throw some curveballs into the way the Street views the commercial potential of both drugs.






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