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Hepatitis C drug from Merck passes test

Vertex treatment goes before FDA panel today

By Robert Weisman
Globe Staff / April 28, 2011

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SILVER SPRING, Md. — The hepatitis C drug on which Vertex Pharmaceuticals Inc. of Cambridge has staked its future is likely to face strong competition.

A medical advisory panel here yesterday recommended unanimously that the Food and Drug Administration approve a rival Merck & Co. tablet to treat the virus that may be carried by up to 3 million people in the United States and 100 million around the world.

The antiviral drugs advisory committee concluded Merck’s treatment candidate, called boceprevir, represents a significant advance over a pair of hepatitis C drugs now on the market and voted 18 to 0 to recommend approval. The panel will consider Vertex’s competing drug today.

“Looking at the faces of people who have had poor options, as a caregiver this makes you feel like you can come back to the office with hope,’’ said the advisory committee’s chairwoman, Dr. Victoria A. Cargill, a research director at the National Institutes for Health in Bethesda, Md. Hepatitis C causes liver scarring or liver cancer in many patients.

Merck, based in Whitehouse Station, N.J., is expecting a final FDA decision on boceprevir, which it will market under the brand name Victrelis, in mid-May.

“It’s a really, really big day for hepatitis C patients who can look to a much better therapy than what they’re getting right now,’’ Dr. Eliav Barr, vice president for infectious diseases at Merck Research Laboratories, said in an interview. “This is one of those medicines that will be a paradigm shift.’’

Barr wouldn’t compare Merck’s drug to Vertex’s, noting they have not gone head-to-head in clinical trials. Both act to block the protease enzyme that allows the hepatitis C virus to reproduce, and both will be prescribed in combination with two drugs now on the market: ribiviran and pegylated interferon.

Because it sells versions of the two current medicines, Merck could enjoy a marketing advantage by packaging the three drugs as a cocktail, though analysts have said clinical trials suggest the Vertex drug, called telaprevir, has a higher cure rate for first-time patients.

“We have a long history of working with physicians in this field,’’ Barr said. “They know us, and we know them. We’re not a new kid on the block.’’

Shares of Merck edged up 57 cents to $35.63, a gain of 1.6 percent on the New York Stock Exchange.

Vertex shares, which jumped more than 10 percent Tuesday, gained another 4.9 percent yesterday, closing up $2.62 at $55.54, indicating investors remain bullish on the prospects for its drug. Analysts have projected the two protease inhibitors will vie in a market that could top $2 billion a year.

Zachry A. Barber, a Vertex spokesman, declined to comment on the advisory panel’s recommendation of the Merck drug. “We’re looking forward to presenting our data,’’ Barber said.

Yesterday’s advisory committee hearing included warnings on side effects, such as anemia and a drop in white blood cell counts, from boceprevir in combination with the older drugs. Merck representatives insisted the side effects are manageable and said they would work with the FDA to guide physicians in treating them.

The panel also discussed concerns about antiviral resistance, meaning the virus could change so that it was no longer susceptible to the drugs, and how to treat patients who didn’t respond to the drug regimen, including African-Americans who had lower cure rates in clinical trials.

But committee members said those concerns were outweighed by the benefits of the drug, which in the late-stage trials cured more patients in a shorter time than existing drugs.

“This drug is exponentially going to improve the outcome of patients infected with hepatitis C,’’ said committee member Susan S. Ellenberg, associate dean for clinical research at the University of Pennsylvania School of Medicine in Philadelphia.

Robert Weisman can be reached at weisman@globe.com.