Bristol-Myers' Sprycel Works for First-Line Leukemia (Update1)

By Lisa Rapaport

June 2 (Bloomberg) -- Bristol-Myers Squibb Co.'s Sprycel stalls tumor growth in previously untreated patients with rare, hard-to-defeat blood cancers, a study found.

Sprycel restored white blood cells and platelets to a normal level in 81 percent of untreated patients with chronic myelogenous leukemia after three months, researchers said today at the American Society for Clinical Oncology meeting in Chicago. It also reduced a tumor-causing protein to undetectable levels in 73 percent of patients.

Sprycel was approved in 2006 for use when treatment fails with Novartis AG's Gleevec. Sprycel had sales of $21 million in the first quarter of 2007. Bristol-Myers said it will now conduct comparison studies with Gleevec, which generated $674 million in first quarter 2007 revenue, and may seek U.S. approval to sell Sprycel as a first-line therapy.

``We are much more comfortable now doing a direct comparison of Sprycel against Gleevec,'' said Renzo Canetta, vice president for oncology global clinical research at Bristol- Myers, in a telephone interview. ``The level of response is something not normally seen in so many patients with Gleevec.''

The most common side effects included muscle pain and fatigue, researchers said.

Cannetta said the head-to-head studies would be used to seek approval to market Sprycel as a first-choice treatment. Sprycel costs $3,900 a month wholesale, according to a February 2007 article in the Journal of the National Cancer Institute.

4,500 diagnosed

About 4,500 people will be diagnosed with chronic myelogenous leukemia in the U.S. this year, and about 200 will be told they have leukemia in which the so-called Philadelphia chromosome is active, according to the American Cancer Society. Both blood cancers usually strike in middle age.

``These results show Sprycel elicits a potent response when used as a first-line therapy, and that the side effects are very manageable,'' said Ehab Atallah, lead study author and a leukemia fellow at the University of Texas M.D. Anderson Cancer Center in Houston.

``This adds a weapon for patients with newly diagnosed'' leukemia, he said at a news conference today..

The Sprycel study compared outcomes for 31 patients who were randomly given either 50 milligrams twice a day or a single 100-milligram daily dose. There was no difference in effectiveness at the different doses and, after six months, 95 percent of 21 patients on the drug reduced the Philadelphia chromosome to undetectable levels in bone marrow.

Earlier Study

In an earlier study conducted at M.D. Anderson, 54 percent of patients taking the standard lower dose of Gleevec, 400 milligrams, and 85 percent of those on twice that dose had undetectable levels of Philadelphia chromosome after six months.

Bristol-Myers is also testing Sprycel to treat breast, prostate and pancreatic cancer, as well as tumors in the gastrointestinal tract.

The shares of Bristol-Myers, based in New York, rose 17 cents to $30.48 at 4:01 p.m. yesterday in New York Stock Exchange composite trading. The stock climbed 16 percent in the previous 12 months.

To contact the reporter on this story: Lisa Rapaport in New York at Lrapaport1@bloomberg.net

Last Updated: June 2, 2007 15:41 EDT

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