Thursday, April 28, 2011

FDA Panel Backs Approval Of Telaprevir For Hepatitis C

By Jennifer Corbett Dooren, Of DOW JONES NEWSWIRES
WASHINGTON -(Dow Jones)-

A Food and Drug Administration panel unanimously backed the approval of Vertex Pharmaceuticals Inc.'s (VRTX) proposed hepatitis C-drug telaprevir, saying it showed strong effectiveness, a day after also endorsing a similar product from Merck & Co. (MRK).

The panel of non-FDA medical experts voted 18-to-0 on a question that asked whether the available data support approval of the telaprevir in combination with other hepatitis C drugs, pegylated interferon and ribavirin. The vote amounts to a recommendation that the agency approve telaprevir. The FDA usually follows the advice of its advisory panels but isn't required to.

Wall Street analysts widely expect FDA to approve telaprevir and Merck's boceprevir as both have demonstrated significant effectiveness in improving the cure rates in patients who use standard therapy for hepatitis C. One panel member called telaprevir "stunning advance" in the treatment of hepatitis C.
Both drugs are known as protease inhibitors and are designed to block an enzyme that helps the hepatitis C virus replicate. Vertex owns the North American rights to the telaprevir and would get a royalty on overseas sales from partner Johnson & Johnson (JNJ).

The approval of the drugs, which could come in May, would pit Cambridge, Mass., Vertex against Merck, one of the world's biggest drugmakers, in a market that could triple to $12 billion after the introduction of the latest batch of drugs, according to Goldman Sachs.

The two main studies Vertex submitted to the FDA in support of telaprevir showed more patients responded to treatment by achieving a so-called sustained virologic response -- essentially a cure -- and in a shorter period of time than current hepatitis-C therapy. A third study looked at extending treatment with a telaprevir-based regimen.

One study that involved previously untreated patients showed 79% of patients receiving telaprevir in addition to current standard treatments of pegylated interferon and ribavirin had a sustained virologic response compared to 46% of patients not receiving telaprevir as part of their treatment regimens. In some cases, patients were successfully treated in a total of 24 weeks rather than the current 48 weeks of hepatitis C therapy.

The agency said the risks of telaprevir were associated with skin reactions, such as rash, and anemia. The agency said such side effects were "common, sometimes severe, and in some cases treatment limiting." Anemia is a decrease in the number of red-blood cells.
Vertex said rashes was managed in most patients with antihistamines and topical corticosteriods. The company said the significantly higher effectiveness of telaprevir. "In all subject categories has the potential to offer many more patients the benefits of eradicating [hepatitis C] and achieving a viral cure," the company said.

Hepatitis C is a liver disease caused by infection with the hepatitis C virus, which is transmitted through contaminated blood. The infection can cause liver failure, liver cancer and is the leading cause of liver transplants, FDA said. About 3.2 million Americans are infected with hepatitis C.
--By Jennifer Corbett Dooren; Dow Jones Newswires, 202-862-9294;
(END) Dow Jones Newswires
04-28-111545ET Copyright (c) 2011 Dow Jones & Company, Inc.

FDA panel endorses Vertex hepatitis C drug


Updated 04:20 p.m., Thursday, April 28, 2011

WASHINGTON (AP) — Federal health experts say an experimental hepatitis C drug from Vertex Pharmaceuticals Inc. is a significant step forward in treating the virus, despite a high rate of rashes among patients taking the tablet.

The Food and Drug Administration's panel of experts voted unanimously, 18-0, that telaprevir is a safe and effective treatment for hepatitis C. The agency generally follows the recommendations of its panels. A final decision is expected by May 23.

Panelists commended the Massachusetts-based drugmaker for developing a drug that appears to raise the cure rate for hepatitis C from roughly 40 percent with current therapies to nearly 80 percent.
The most significant side effect with the tablet-based drug was a rash, which affected more than half of all patients. Panelists said the issue could be addressed by educating patients and doctors through materials and a toll-free hotline.

The FDA convened its two-day meeting to review two new drugs that block the enzyme which allows the hepatitis virus to reproduce. On Wednesday the same panel unanimously recommended approval for Merck's drug boceprevir. Both Merck and Vertex have spent more than 15 years developing more effective therapies for the virus that infects about 3.2 million people in the U.S., or about 1.5 percent of the population.

Like HIV drugs, the new drugs from Merck and Vertex will be prescribed as part of a cocktail with two older drugs to help lower viral levels.

Thursday's panel discussion highlighted several advantages of Vertex's drugs over its Merck counterpart. The cure rate for new patients taking telaprevir ranged between 75 and 79 percent, compared with 60 and 65 percent for boceprevir. Additionally, most panelists said that patients who had previously failed treatment for the virus could likely achieve a cure within six months — half the time needed with older drugs — when taking telaprevir. When reviewing Merck's drug Wednesday, the panel said those patients would likely need a full year's worth of treatment with the entire drug cocktail.
Elsewhere in Thursday's discussion, Vertex executives said they were exploring a twice-daily regimen of telaprevir. The drugs presented this week by both Vertex and Merck require patients to take three tablets a day.

Vertex Pharmaceuticals' telaprevir is expected to garner sales of up to $3 billion annually. That's more than the $700 to $800 million expected for Merck's boceprevir, based on analyst estimates.
Vertex Pharmaceuticals is based in Cambridge, Mass., and was founded in 1989 by a former Merck & Co. scientist. If approved, telaprevir would be the company's first commercialized product in the U.S.
Vertex holds marketing rights for North America, while Johnson & Johnson will market the drug in other parts of the world. Eli Lilly and Co. will receive an undisclosed percent of royalties because of its collaborative work on the drug between 1997 and 2002.

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