said Wednesday that it expects to file applications with the Food and Drug Administration by year-end for three experimental drugs designed to treat diabetes, hepatitis B and rheumatoid arthritis.
"Bristol-Myers Squibb is executing a strategy to transform our pharmaceutical business to be much more focused on areas of serious unmet medical need, where the company can build leadership positions," said Peter R. Dolan, the company's chairman and CEO. "We believe that doing so will afford us the greatest potential for future growth, and the greatest ability to impact the lives of people through the development of innovative medicines."
The company recently submitted applications to the FDA and to the European Medicines Evaluation Agency, the drug regulatory agency for the European Union, for the hepatitis B treatment entecavir. At a meeting Wednesday with financial analysts, the company said the entecavir application has been accepted for a priority review by the FDA.
Bristol-Myers Squibb also plans to submit an application for muraglitazar for diabetes and an application for abatacept, for rheumatoid arthritis, to the FDA by the end of 2004. The FDA has granted fast-track status for abatacept. All three drugs scheduled to hit the FDA are home-grown compounds.
Bristol-Myers Squibb is collaborating with
to develop and market the diabetes drug.
Muraglitazar belongs to a class of drugs nicknamed PPAR, which present intriguing therapeutic possibilities but also significant challenges.
Last year, Merck cancelled late-stage clinical tests on a PPAR drug when a safety review program discovered rare, malignant tumors in mice. Merck, which was working with Japan's Kyorin Pharmaceutical, said that the "clinical relevance of these findings in humans is unknown."
And in early October,
said it was moving back by one year to 2007 its plans for seeking regulatory approval of its PPAR drug Galida. The company said it found no problems for the drug, which is entering the final stage of clinical testing.. However, it said it was extending long-term follow-up clinical studies due to "worldwide regulatory authority review of the safety and toxicology" of PPAR drugs.
On Wednesday, Bristol-Myers Squibb said clinical trials involving more than 4,500 patients showed muraglitazar demonstrated "significant glucose lowering," "significant reductions" in triglycerides and increases in so-called good cholesterol in patients with Type 2 diabetes, the most common form of the disease.
Bristol-Myers Squibb said it will present or publish more detailed clinical trial data next year. The company said the drug, like two similar medications on the market, "resulted in dose-related increases in the incidence of edema
swelling caused by fluid accumulation in body tissues and heart failure."
The company also highlighted several experimental drugs in early stage testing including a compound that shows "promising activity" in thwarting organ transplant rejection; a drug being examined for preventing vein graft failure in heart bypass surgery; and several compounds being tested on several types of cancer.
Shares of Bristol-Myers Squibb rose 7 cents to $24.25.