Gilead Gains After Drug Trial Stopped Early on Benefits

Gilead Sciences Inc., the world’s largest biotechnology company by market value, gained the most in 11 months after patients benefited enough from the cancer drug idelalisib to end a late-stage study early.

Gilead jumped 6.5 percent to $62.74 at 4 p.m. New York time for the biggest increase since Nov. 12. The shares of the Foster City, California-based company have risen 71 percent this year.

Gilead is stopping the late-stage study in patients with chronic lymphocytic leukemia after an interim analysis showed those taking idelalisib plus another medicine, Rituxan, survived longer without their cancer progressing than those taking Rituxan alone, the company said yesterday in a statement.

“We view this as a de-risking event,” Joel Sendek, an analyst with Stifel Nicolaus & Co., wrote today in a research note. He estimates the market for CLL drugs will grow to $10 billion as more enter the market, including one from Johnson & Johnson and Pharmacyclics Inc. called ibrutinib. “We expect Gilead will file within two months and receive accelerated approval by August 2014.”

The trial, from the third and final stage generally required for regulatory approval, was in patients who have tried other medicines and who aren’t fit for chemotherapy. A cancer of the bone marrow and white blood cells, CLL is the second-most common type of leukemia in adults and usually affects people in middle age or older, according to the National Institutes of Health.

Unmet Need

“Given the significant unmet medical need in CLL, particularly in this population of patients who are not fit for chemotherapy, we are pleased that idelalisib has shown a clinically meaningful benefit for patients,” Norbert W. Bischofberger, Gilead’s chief scientific officer, said in the statement.

The company said it has applied for approval of idelalisib in non-Hodgkin’s lymphoma and will talk with U.S. regulators about a filing for the drug in chronic lymphocytic leukemia. Sendek said he increased his estimate for idelalisib sales next year to $200 million from $157 million based on two additional months on the market.

Those in the trial will continue receiving the cancer drug and those who were receiving Roche Holding AG’s Rituxan alone will be eligible to receive idelalisib in an extension study, Gilead said.

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