BMS, Gilead Zero in on Complete Fixed-Dose HIV Pill

01/20/2005

Bristol-Myers Squibb (New York, N.Y.) and Gilead Sciences (Foster City, Calif.) have forged a partnership aimed at bringing to market the first complete fixed-dose combination (i.e., single pill) regimen for HIV/AIDS patients. If approved, the drug would, for some patients, eliminate the need for the “cocktail” regimen that many HIV/AIDS patients must consume daily.

While other fixed-dose forms have gained FDA approval, they have still needed supplementation by at least one other antiretroviral—typically BMS’s Sustiva (efavirenz), a leader in the non-nucleoside reverse transcriptase inhibitor (NNRTI) class.

The new pill would combine Sustiva and Gilead’s Truvada (which consists of two drugs from the nucleotide/nucleoside class, emtricitabine and tenofovir disoproxil fumarate). While HIV/AIDS treatments are extremely patient-specific, meaning no one magic pill will ever suit all, the new drug would satisfy the requirements of one of FDA’s preferred regimens.

The pill would be a major advance toward something HIV patients have long coveted, convenience and simplicity in their treatment. “For the first time, individuals living with HIV will have a solution that will come from one container,” says Ronald Cooper, senior VP of Virology at BMS. Cooper says the two firms plan to file for approval late this year, with anticipation of approval in the second half of 2006. Clinical trials have shown positive responses from patients with limited side effects.

Cooper says the greatest manufacturing challenge will be unifying the efforts of the two firms. “The biggest hurdle was just bringing the two companies to the table,” he notes. “One thing that binds us is the single purpose of doing the right thing.”

The broader significance of the fixed-dose is what it would mean to the developing world, if it were readily available. The once-daily, single pill would make it much easier for governments and NGOs to deliver much-needed treatment to patients in developing countries. Last summer President Bush, in his Emergency Plan for AIDS Relief, pledged funds for the purchase of fixed-dose combinations for the global community, as long as they were FDA approved.

If this particular fixed-dose is to make an impact in the developing world, another drug giant will have to get on board. Merck owns the rights to efavirenz outside the U.S. and the five largest E.U. nations. Cooper says the BMS and Gilead are in “continuing discussion” to this end.