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Bristol Wins U.S. Yervoy Approval as First-Line Metastatic Melanoma Drug

Bristol-Myers Squibb Co. (BMY) won U.S. approval for ipilimumab, the first drug proven to extend the lives of patients with advanced melanoma, the most deadly form of skin cancer. The shares rose the most in nine months.

The Food and Drug Administration cleared the medicine for patients with widely spread melanoma, the agency said today in a statement. The approval covers first-line, or initial treatment, said Elliott Sigal, Bristol-Myers’s chief scientific officer. Yervoy will cost $30,000 a dose, or $120,000 for a four-dose course of treatment, the company said.

Ipilimumab, marketed as Yervoy, is in a new class of drugs designed to fight cancer by removing molecular brakes that prevent immune system cells from destroying tumors. The drug may reap $1.7 billion by 2015, said Tim Anderson, an analyst with Sanford C. Bernstein, in a March 22 report.

“The label is substantially broader than we expected and from a pricing perspective it is more than twice what we had anticipated,” said Tony Butler, an analyst with Barclays Capital in New York, in a telephone interview today.

New York-based Bristol-Myers rose 86 cents, or 3.3 percent, to $27.29 at 4 p.m. in New York Stock Exchange composite trading, the biggest single-day increase since June 7.

Photographer: Daniel Acker/Bloomberg

The building which houses Bristol-Myers Squibb Co. at 345 Park Avenue. Close

The building which houses Bristol-Myers Squibb Co. at 345 Park Avenue.

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Photographer: Daniel Acker/Bloomberg

The building which houses Bristol-Myers Squibb Co. at 345 Park Avenue.

Most Difficult

Melanoma that has spread beyond the skin to other organs and tissue has been among the most difficult types of cancers to attack. It is typically treated with the chemotherapy drug dacarbazine and interleukin-2, an immunotherapy. Neither has been proven to extend survival.

The broad label “is a very important surprise for the company,” Sigal said in a telephone interview. “This is not what we went in for.”

Sigal said the approval of Yervoy may be the beginning of a new wave of treatments that spur the immune system against cancer. Bristol-Myers will be combining Yervoy with other treatments in trials to improve its efficacy, he said. It is also testing the drug in patients with prostate cancer.

“This is going to be very significant for oncology,” Sigal said. “For certain patients, if their own immune systems can be unleashed to fight their cancer cells, they have a chance to go into prolonged remission.”

Trial Results

In a 676-patient trial Bristol-Myers used to seek approval, patients on ipilimumab had a median survival time of 10 months, versus 6.4 months for those who didn’t receive the medicine, according to results published the New England Journal of Medicine in August.

Side effects included colon inflammation, diarrhea and skin rashes. Twelve melanoma patients on ipilimumab died of side effects related to their treatment. The FDA required the company implement a plan to inform doctors and patients of the drug’s risks.

“Late-stage melanoma is devastating, with very few treatment options for patients, none of which previously prolonged a patient’s life,” Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, said in the statement. “Yervoy is the first therapy approved by the FDA to clearly demonstrate that patients with metastatic melanoma live longer by taking this treatment.”

Separately, Bristol-Myers reported on March 21 that a study found the medicine also improved survival when used as an initial melanoma treatment. The American Cancer Society says that 68,000 Americans develop melanoma and 8,700 die from it each year.

Sought-After Therapy

“The demand for the drug will be high,” Antoni Ribas, an oncologist at the University of California, Los Angeles, said in an e-mail.

In addition to melanoma, Bristol-Myers is testing ipilimumab against advanced prostate cancer in two trials in the last of three phases of tests generally needed for marketing approval. The company also plans to begin a final-stage trial in lung cancer this year.

“This is a major step forward after a long run of bad news” for melanoma drugs, said Timothy Turnham, executive director of the Melanoma Research Foundation in Washington, D.C., in a March 23 interview.

Survivor’s Story

Some patients who received ipilimumab in clinical trials have survived for years. Gavin McGrath, a 51-year-old schoolteacher who lives in Spring Lake Heights, New Jersey, was diagnosed with advanced melanoma inside his right shoulder in November 2005. His doctors never found the original surface tumor.

He may have gotten the disease because he was a landscaper during his teenage and college years and didn’t wear sunscreen, he said in a telephone interview.

By 2007, the melanoma had spread to his lungs, neck, and liver, and he had failed conventional treatment. After he received four doses of ipilimumab in the fall of 2007, the tumors started to shrink. “The scans right now are clean” other than a few enlarged lymph nodes, he said in March 22 telephone interview. “It cured me.”

Bristol-Myers is testing five other cancer drugs that, like ipilimumab, harness the immune system to fight cancer.

Roche Holding AG (ROG) of Basel, Switzerland, and closely held Plexxikon Inc., of Berkeley, California, plan to seek U.S. clearance this year for another new type of melanoma treatment, called vemurafenib. It targets a mutant gene found in about half of melanoma cases, and improved survival in a final-stage trial the companies reported in January.

Daiichi Sankyo, Japan’s third-largest drugmaker, agreed to buy Plexxikon for as much as $935 million on March 1.

To contact the reporter on this story: Robert Langreth in New York at rlangreth@bloomberg.net

To contact the editor responsible for this story: Reg Gale in New York rgale5@bloomberg.net

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