Bristol-Myers says HIV drug gets FDA incentives
NEW YORK (AP) — Bristol-Myers said Tuesday that federal regulators will help speed up development for one of its experimental HIV drugs.
The Food and Drug Administration designated the drug BMS-663068 as a breakthrough treatment, so Bristol-Myers Squibb Co. will get extra meetings with the FDA and earlier communication with scientists as it studies the drug. BMS-663068 is intended to be used with other antiretroviral drugs in adults who have already developed resistance to several other types of HIV treatments. Bristol-Myers is running late-stage clinical tests of the drug.
There are six classes of HIV drugs, according to the National Institutes of Health, and patients are typically treated with drugs from at least two different classes at any given time. After years of treatment patients sometimes develop resistance to those drugs, and if they develop resistance to several types of drugs, their doctors may not be able to assemble an effective treatment regimen.
Bristol-Myers is studying BMS-663068 in patients who have two or fewer drug classes left available to them. The drug is designed to stick to HIV cells and stop them from binding to a type of white blood cell. The company says BMS-663068 doesn't fit into the six current classes of HIV therapy.
The company's shares dipped 80 cents to $69.17 in afternoon trading.
Bristol-Myers sells the HIV drugs Reyataz, one of its top products by revenue, and Evotaz, which was approved in January, and it is studying several other treatments for the disease. However it announced in June that it will end early-stage research in HIV as well as hepatitis B so it could focus on other fields, including drugs that stimulate the immune system to fight cancer.
That announcement came less than two years after Bristol-Myers said it would end broad-based drug discovery work in several other areas, including hepatitis C and diabetes, so it could focus on HIV and hepatitis B, cancer, and immune system disorders, as well as its biggest-sellers, like the schizophrenia and bipolar disorder drug Abilify, rheumatoid arthritis treatment Orencia, Reyataz, and leukemia drug Sprycel.
The Princeton, New Jersey-based company is scheduled to report its second-quarter results Thursday morning.