To simplify the daily drug regimen for HIV patients, Gilead Sciences Inc. has partnered with Bristol-Myers Squibb Co. to create a three-antiretroviral combination that can be taken in one daily dose.
Earlier this year, Gilead received FDA approval for Truvada, which combined two of the company's other drugs, Emtriva (emtricitabine) and Viread (tenofovir disoproxil), and can be used with other antiretroviral agents for treating HIV-1 infection in adults. In May, the Foster City, Calif.-based company announced it was exploring the possibility of combining those drugs with Bristol-Myers' Sustiva to create a combination product.
To do that, the companies are forming a joint venture - called Bristol-Myers Squibb & Gilead Sciences LLC - to develop and commercialize a single, fixed-dose regimen for HIV patients, who currently might take three or more drugs every day to combat the resistant virus.
"If approved, it will be the first triple-drug regimen for HIV available in a fixed dose that [patients] take once daily, potentially in one pill," Gilead spokeswoman Amy Flood told BioWorld Today.
Gilead said having a simplified drug regimen will increase compliance and "increase the potential success of the drugs," she added.
Financial arrangements for the collaboration were not disclosed, though Flood said both companies will fund development work and will receive revenues based on the percentages of each product's contribution to the final drug formulation.
Work on the co-formulation likely will continue into 2005, with a new drug application expected to be filed during the last half of the year. Assuming the three-drug combination moves through the standard 10-month review process, Flood said the companies could receive possible approval by the latter half of 2006.
Although Gilead and New York-based Bristol-Myers will begin by seeking approval only in the U.S., Flood said, "It is our intent to make this product available to other geographic areas."
Truvada, Emtriva and Viread all are marketed in the U.S. Bristol-Myers' Sustiva (efavirenz) is marketed in the U.S., Canada and certain European countries. In other areas of the world, efavirenz is sold by Merck & Co. Inc. under the brand name Stocrin.
"This is really the necessary first step," Flood said of Gilead's collaboration with BMS, adding that it is the first time the companies have worked together. "We're very pleased to establish this joint venture."
With seven marketed products, Gilead primarily focuses its research on HIV therapeutics, though the company recently announced collaborations with two other companies to develop treatments for hepatitis C.
Gilead is working with Achillion Pharmaceuticals Inc., of New Haven, Conn., on it hepatitis C virus program in a deal that gives Gilead exclusive worldwide rights for the research, development and commercialization of the HCV compounds. The lead product is slated for an investigational new drug application filing in the middle of 2005. (See BioWorld Today, Nov. 30, 2004.)
Several months ago, Gilead announced a partnership with Genelabs Technologies Inc., of Redwood City, Calif., in a research deal for novel nucleoside inhibitors of HCV polymerase. The deal could be worth up to $46 million for Genelabs if one compound emerges. (See BioWorld Today, Oct. 1, 2004.)