Thursday, April 21, 2011

FDA Panel Is Set To Review Two New Hepatitis C Drugs

   By Thomas Gryta

NEW YORK (Dow Jones)--A U.S. Food and Drug Administration panel will review two hepatitis C drugs next week, recommending whether regulators should allow the drugs on the market.

The agency's Antiviral Drugs Advisory Committee will review Merck & Co. Inc.'s (MRK) boceprevir on Wednesday and Vertex Pharmaceuticals Inc.'s (VRTX) telaprevir on April 28. Both drugs are widely expected to be recommended for approval, as they have shown strong effectiveness in improving the cure rates in patients that use standard therapy for the liver disease.

But advisory committees are notoriously unpredictable. The briefing documents for the panel, coming from both the companies and FDA staff, will be posted early next week. The documents sometimes show data surprises or previously unknown concerns, and investors will be on the lookout for anything that may translate to a market advantage down the road.

The approval of both drugs, which could come in May, would pit Cambridge, Mass., Vertex against one of the world's biggest drug makers in a market-share battle. Vertex is widely seen as having an advantage, because of more-impressive clinical data, and thus grabbing the majority of usage.

"There is a belief that the efficacy is better," said Kris Jenner, portfolio manager of the T. Rowe Price Health Sciences fund, which owns both Merck and Vertex shares. "There's a general expectation that the market will have a preference for the Vertex compound and I generally agree with that."

Eliav Barr, vice president of Infectious Diseases research at Merck, said that boceprevir "represents a significant improvement over standard therapy" and the company looks forward to presenting data at the panel to support its use. A Vertex spokeswoman declined to comment on the upcoming panel.

Hepatitis C is a blood-transmitted virus that causes liver inflammation and can lead to cirrhosis, cancer and liver failure. The disease affects five million people in the U.S. and more than 200 million people in the world, and is the leading cause of liver transplants in the U.S., according to the Hepatitis C Association.

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.

The current standard therapy, a combination of pegylated-interferon injections and ribavirin pills over 48 weeks, achieves a cure in up to about 50% of patients, according to the Centers for Disease Control.
Treating the disease is big business. Goldman Sachs recently projected that the total hepatitis C treatment market will grow from its current level of $3 billion to a range of $10 billion to $12 billion following the introduction of the latest batch of drugs. Vertex owns the North American rights to the drug and would get a royalty on overseas sales from partner Johnson & Johnson (JNJ).

Merck is expected to get a decision in early May, while Vertex should get a decision by May 23, but there could be a delay in the rulings because of the proximity to the panel.

The panel is expected to review the data on the drugs, their effectiveness and side effects. With boceprevir being reviewed first, the tone and concerns that are discussed on Wednesday could foreshadow the focus of telaprevir's review the next day.

There is likely to also be some discussion of the use of the drugs in patients that haven't responded to prior therapy, as well as the potential for patients to develop resistence to the drugs or future treatments.
Telaprevir has been associated with a rash in some patients, while both drugs have been linked to increased anemia. Unlike telaprevir, the clinical studies of boceprevir included the use of erythropoietin, an anemia treatment sold by Amgen Inc. (AMGN) as Epogen and Johnson & Johnson as Procrit, in order to treat the side effect in some patients.

Merck is currently conducting a study of the safety of erythropoietin when used with boceprevir and its relationship to the drug's effectiveness. Some analysts expect the FDA will want to see that data, expected later this year, prior to approving boceprevir.

Merck has proposed a brand name of Victrelis for boceprevir, while Vertex hasn't yet disclosed its naming plans.

-By Thomas Gryta, Dow Jones Newswires; 212-416-2169;
--Peter Loftus in Philadelphia contributed to this article.

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