Boston Business Journal - by Julie M. Donnelly
Date: Thursday, March 17, 2011, 4:26pm EDT - Last Modified: Thursday, March 17, 2011, 4:57pm EDT
Vertex Pharmaceuticals Inc. (Nasdaq: VRTX) will glean some important insight into the fate of its closely-watched potential treatment for hepatitis C on April 28. The U.S. Food and Drug Administration has announced it will hold an advisory panel meeting on the drug candidate, called telaprevir, on that date. A positive report from the panel would be a good indication that telaprevir is likely to gain approval from the regulatory agency as a whole on May 23.
The drug aims to treat chronic hepatitis C genotype 1 infection, in combination with two already-approved drugs, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
Vertex executives, investors and analysts are waiting with bated breath, because the approval of telaprevir would likely catapult Vertex into the elite of profitable biotech companies. Also waiting anxiously for an FDA decision is the city of Boston, which currently has a non-binding agreement with the Cambridge, Mass.-based biotechnology company to move across the river to the South Boston waterfront — but only if the drug is approved.
Vertex faces stiff competition in the hepatitis C space. The FDA advisory committee will discuss another potential treatment for hepatitis C, developed by Whitehouse Station, N.J.-based Merck & Co Inc (NYSE: MRK), on April 27.
In addition, Vertex saw its stock fall almost 5 percent March 8, after Princeton, N.J.-based Pharmasset Inc. (Nasdaq: VRUS) released positive late-stage data for its potential rival to Vertex’s drug candidate
Source
Also See: FDA Hepatitis Update - FDA Advisory Committee meeting to consider boceprevir and telaprevir, April 27 and April 28, 2011
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