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Gilead Rises After Hepatitis Data Open New Test Options

Gilead Sciences Inc. (GILD) jumped 12 percent after the company said it will keep options open to advance its hepatitis C research rather than commit to a trial with Bristol-Myers Squibb Co. (BMY) after promising results from a joint study on the liver disease.

Gilead’s drug known as 7977 and Bristol-Myers’s daclatasvir showed a 93 percent cure rate among patients with the most common form of the disease in the U.S. after 24 weeks of therapy combined with the antiviral ribavirin, Bristol-Myers said today at the European Association for the Study of Liver meeting in Barcelona. Between 91 percent and 100 percent of patients remained clear of the virus four weeks after treatment ended.

“We’re very encouraged by the data,” John McHutchison, Gilead’s senior vice president for liver disease, said in an interview at the meeting. “We have lots of different options. We’re going to work out what the best options are rather than committing to a phase-three program with something when we have all those resources internally,” he said, referring to other Gilead compounds that show promise.

Bristol-Myers also gained on the data, rising 1.1 percent to $33.93 at 4 p.m. New York time. Gilead rose $5.64 to $52.25, it its biggest increase since October 2008.

The study results, which stem from an interim analysis and therefore aren’t final, contrast with data released in February that showed six out of eight patients had a viral relapse within four weeks of stopping a 12-week regimen of 7977 and ribavirin.

Bristol-Myers, which led the joint study, is “very interested” in pursuing a bigger, more advanced trial on the drug combination, said Douglas J. Manion, the New York-based company’s development head of neuroscience and virology.

New Generation

“Gilead would need to be a willing participant in that, but we think it would be a terrific thing,” Manion said in an interview in Barcelona. “We want to get into phase 3 validation of as many viable regimens that contain our drugs as possible.”

Bristol-Myers is also “very open-minded” about conducting a combination study with a class of drugs known as cyclophilin inhibitors, which target host proteins that are involved in the growth of the hepatitis C virus, Manion said. Therapeutic vaccines are also “high on our radar screen,” Manion said.

Abbott Laboratories (ABT), Bristol-Myers, Gilead, Medivir AB (MVIRB) and Boehringer Ingelheim GmbH are among drugmakers working on a new generation of hepatitis treatments designed to act more quickly with fewer side effects than the current standard of care, which combines ribavirin with interferon, an immune-boosting protein, for as long as 48 weeks. Interferon needs to be injected and can cause flu-like side effects.

Achillion Declines

Achillion Pharmaceuticals Inc. (ACHN), another developer of hepatitis C drugs, fell 13 percent after UBS analyst Matthew Harrison said positive data from Gilead and Bristol-Myers “suggest a lack of strategic value” for its medicines.

The shares dropped $1.20 to $8.30.

The results from the study of daclatasvir and Gilead’s 7977 show the combination “should be viewed as the regimen with the strongest potential efficacy, convenience and safety,” Michael Yee, an analyst with RBC Capital Markets in San Francisco, wrote in a note to clients on April 10.

Bristol-Myers yesterday agreed to conduct two trials in collaboration with Medivir and Johnson & Johnson’s protease inhibitor TMC435, expanding on an agreement with J&J announced last year.

“We want to mix and match with every class,” Manion said.

Blocking Protein

Daclatasvir, or BMS-790052, hinders a protein called NS5A that creates a scaffolding as part of the virus’s replication process. Foster City, California-based Gilead’s drug, 7977, integrates itself into the virus’s replicating process, preventing it from churning out copies.

Hepatitis is a viral infection that can cause liver swelling and inflammation and can lead to damage of the organ, cancer and death, according to the U.S. National Institutes of Health.

The disease is most commonly transmitted through contaminated blood transfusions, organ transplants, contaminated syringes and needle-injected drug use, according to the World Health Organization. More than 170 million people are infected.

To contact the reporters on this story: Makiko Kitamura in Barcelona via mkitamura1@bloomberg.net; Ryan Flinn in San Francisco at rflinn@bloomberg.net

To contact the editors responsible for this story: Phil Serafino at pserafino@bloomberg.net; Reg Gale at rgale5@bloomberg.net

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