Tuesday, November 23, 2010

Vertex Files Telaprevir® With FDA; Seeks "Fast Track" -- Likely To Get It

This is an amazing moment in medical history, as in about seven months, and perhaps even sooner -- most patients suffering with Hep C will see a cure. It will come quickly, and it will be permanent. Heady stuff for the over four million people in the US alone, afflicted with the debilitating condition. And hard news for Whitehouse Station -- as it may not be ready to file with FDA until early 2011. This is -- when it gets rolling -- likely an annual $3 billion revenue stream, and at very high margins.

Per The Street's reporting, this morning (H/T Ed, over at Pharmalot):

. . . .The timing of the telaprevir approval filing to the U.S. Food and Drug Administration was widely expected. Vertex asked FDA for priority review, which if granted, would mean an approval decision could be made by June 2011.

"This submission is a milestone in our more than 15-year effort to change the way hepatitis C is treated," said Vertex CEO Matthew Emmens. . . .

It is hard to overstate the significance of this moment, for people suffering with hepatitis C -- and for all those that do not yet know they have it. There are over four million chronic carriers of hepatitis C in the US. Almost 15,000 individuals die from viral hepatitis in the U.S. each year. The most common reason for liver transplants in the U.S. is cirrhosis caused by Hep C.

And. . . this is effectively the cure moment. While not a vaccine, in any sense, this is not entirely unlike the day a polio vaccine was submitted for testng (1957) and approval in 1962.

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