Monday, March 14, 2011

Hepatitis C Drugs FDA Will Review; Merck's boceprevir on April 27 and Vertex's telaprevir on April 28

FDA Panel To Review Merck, Vertex Hepatitis Drugs In Late April
By Thomas Gryta

Published March 14, 2011
Dow Jones Newswires

NEW YORK -(Dow Jones)- A U.S. Food and Drug Administration panel will review two hepatitis C drugs in development from Vertex Pharmaceuticals Inc. (VRTX: 45.61, -0.85, -1.83%) and Merck & Co. Inc. (MRK: 32.28, -0.30, -0.91%) in late April, as the companies race to compete against each other in a potentially lucrative market.

The agency's Antiviral Drugs Advisory Committee will review Merck's boceprevir on April 27 and Vertex's telaprevir on April 28. The widely expected reviews will have outside experts recommend whether the agency should allow the drugs on the market.

Both drugs have shown success in increasing the cure rates of the liver disease when added to current treatments.

They are expected to come to the market at similar times and be widely used, creating a market share battle. Merck said in early January that it was granted a six-month review; Vertex is getting a similar review and expects a decision by May 23.

Many on Wall Street believe that clinical trials show Vertex's telaprevir is the preferable drug, although Merck's Chief Executive Kenneth Frazier has repeatedly stated his confidence in boceprevir's prospects.

Wells Fargo recently projected $1.4 billion in U.S. sales next year for telaprevir. Vertex owns the North American rights to the drug and would get a royalty on overseas sales from partner Johnson & Johnson (JNJ: 59.00, -0.69, -1.16%).

Hepatitis C is a blood-transmitted virus that causes liver inflammation and can lead to cirrhosis, cancer and liver failure.

Both the Merck and Vertex drugs are known as protease inhibitors, which are designed to block an enzyme that helps the hepatitis C virus replicate. Standard treatment is a combination of the drug pegylated interferon and ribavirin, but adding the new drugs may improve cure rates and shorten the duration of treatment.

Copyright © 2011 Dow Jones Newswires

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