Bristol-Myers Diabetes Drug Produces Positive Test Results
By BARBARA MARTINEZ
Staff Reporter of THE WALL STREET JOURNAL
November 18, 2004; Page A6
Bristol-Myers Squibb Co. announced positive results of final-stage human trials of its experimental diabetes drug, muraglitazar. The drug could boost the fortunes of both Bristol-Myers and Merck & Co., which will co-market the drug.
Bristol-Myers announced the results during the company's first research and development meeting for Wall Street analysts in more than three years.
At the meeting, the company outlined the drugs it has under development, including medicines to treat rheumatoid arthritis, hepatitis B and cancer, among others.
The New York company has been dealing with the challenges of patent losses on major drugs and is in the midst of shifting its research and development focus to drugs marketed to specialist physicians rather than primary-care doctors. In addition, Bristol-Myers has been working to put behind it an accounting scandal that erupted two years ago. It announced a settlement with the Securities and Exchange Commission over the accounting issues two months ago, though there is still a Justice Department probe that could result in criminal indictments.
Investors bid up Bristol-Myers shares slightly yesterday. In 4 p.m. composite trading on the New York Stock Exchange, the stock was at $24.29, up 11 cents.
Muraglitazar presents one of Bristol-Myers's most promising near-term prospects. The company plans to submit it for approval from the Food and Drug Administration next month. If approved, the drug could have sales approaching $1.7 billion by 2009, according to John Boris, an analyst at Harris Nesbitt.
In April, Bristol-Myers announced it would share development and marketing for the drug with Merck, Whitehouse Station, N.J. Merck had been developing a similar diabetes drug, but halted work on it after it caused tumors in mice. Bristol-Myers said that incidences of tumors found in rodents given muraglitazar were found to be "either species-specific" or occurred at drug levels greater than 48 times human exposure, and that the FDA has reviewed the data.
Bristol-Myers said yesterday that in trials involving 4,500 patients, muraglitazar showed a significant lowering of blood sugar as well as triglycerides, or fats in the blood. It also increased HDL, or "good," cholesterol levels in patients with Type 2 diabetes. The company said that in the studies, muraglitazar controlled blood-sugar levels as well as or better than other blood-sugar-lowering drugs called thiazolidinediones. Also, patients who stayed on muraglitazar in clinical trials were able to control their glucose levels for as many as two years -- an accomplishment other diabetic drugs thus far have found elusive, the company said.
Muraglitazar hits two targets in the body: one to sensitize cells to insulin, and the other to reduce triglycerides. It is designed to compete with two existing billion-dollar-plus drugs -- Avandia from GlaxoSmithKline PLC and Actos from Takeda Pharmaceutical Co. and Eli Lilly & Co. Those drugs hit only the first target and tend to cause weight gain.
--Hollister H. Hovey contributed to this article.
Write to Barbara Martinez at barbara.martinez@wsj.com
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