NEW YORK (AP) â€” Bristol-Myers said Tuesday that federal regulators will assist speed up development for one of its experimental HIV drugs.
The Food & Drug Administration designated the drug BMS-663068 as a breakthrough treatment, so Bristol-Myers Squibb Co. will obtain extra meetings with the FDA & 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, & 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, & if they develop resistance to several types of drugs, their doctors may not be able to assemble an effective treatment regimen.
p>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 & 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, & Evotaz, which was approved in January, & 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 & diabetes, so it could focus on HIV & hepatitis B, cancer, & immune system disorders, as well as its biggest-sellers, like the schizophrenia & bipolar disorder drug Abilify, rheumatoid arthritis treatment Orencia, Reyataz, & leukemia drug Sprycel.
The Princeton, New Jersey-based company is scheduled to report its second-quarter results Thursday morning.
Source: “Associated Press”