First Complete Single-Dose Regimen

If approved, the new product would be the first complete
Highly Active Antiretroviral Therapy (HAART) treatment regimen for HIV
available in a fixed-dose combination taken once daily.  Fixed-dose
combinations contain multiple medicines formulated together and may help
simplify HIV therapy for patients and providers.

The work necessary to co-formulate Sustiva and Truvada into a once-daily
combination product has been ongoing throughout most of 2004 and will continue into 2005, the companies said.  Through their joint venture, they companies will work to complete development and U.S. regulatory filings for this fixed-dose regimen. 

The companies expect to share responsibility for commercializing the product in the United States. Both companies will provide funding and field-based sales representatives in support of promotional efforts for the combination product. 

Bristol-Myers Squibb and Gilead will receive revenues from future net sales at percentages relative to the contribution represented by their individual products that comprise the fixed-dose combination.

Goal to Simplify Treatment

Guidelines issued by the U.S. Department of Health and Human Services
(DHHS) list the combination of emtricitabine, tenofovir disoproxil fumarate
and efavirenz as one of the preferred non-nucleoside reverse transcriptase
inhibitor (NNRTI)-based treatments for use in appropriate patients that have never taken anti-HIV medicines before.

It is important that patients be aware that individual HIV medications must be taken as part of combination regimens, and that they do not cure HIV infection or prevent passing HIV to others.

Earlier in 2004, U.S. Secretary of Health and Human Services Tommy
Thompson addressed the need for new products to help advance and simplify treatment for people with HIV/AIDS, encouraging members of industry to work together to create fixed-dose combinations that would help achieve these goals. 

Additionally, earlier this year the U.S. Food and Drug Administration
issued new guidelines to expedite the approval of new combination products for HIV.

"The availability of simplified treatment regimens for HIV/AIDS is
important to our ability to make progress in the fight against the disease,"
Secretary Thompson said. "I am pleased to see the collaboration and efforts of Bristol-Myers Squibb and Gilead. This partnership to create a fixed-dose combination of three HIV medications represents an important advance in our collective effort to deliver simplified therapy for people living with HIV."