said they will once again seek government approval for a once-a-day, fixed-dose HIV/AIDS drug using compounds from two existing treatments.
The companies failed twice last year to develop a combination product, but they said Monday that new data has encouraged them to seek approval from the Food and Drug Administration. The combination pill contains Sustiva from Bristol-Myers and Truvada from Gilead. Truvada is a once-a-day combination of Emtriva and Viread from Gilead.
The stumbling block is bioequivalence, or the combination pill's ability to deliver the same amount of medication into the bloodstream that is available from the two separate pills given simultaneously. The combination pill hadn't achieved bioequivalence in the past, thwarting the companies' efforts to produce a more convenient treatment.
"The advancement of our fixed-dose regimen represents an important step forward in the further simplification of HIV treatment," said John C. Martin, president and chief executive of Gilead Sciences, in a prepared statement.
The announcement helped raise his company's stock $1.47, or 2.6%, to $58.50 in late morning trading. Shares of Bristol-Myers slipped 19 cents, or 0.8%, to $22.59.
The companies established a joint venture 13 months ago to develop the fixed-dose pill. But
in April and then again
in August, they failed to achieve bioequivalence with the combination pill.
In a related matter, Gilead says it completed an early stage clinical trial of GS-9137, an experimental HIV/AIDS drug licensed from
. Gilead has the rights to develop and sell the drug in all markets except Japan.
The company says it will present the results at an upcoming scientific conference. Gilead anticipates starting a phase II clinical trial -- the second of three rounds of testing before a drug is submitted for FDA approval -- during the first half of the year.