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news.Bristol-Myers Squibb and Gilead Sciences have established a joint venture to develop and commercialize the fixed-dose combination of Bristol-Myers Squibb's Sustiva and Gilead's Truvada for the treatment of HIV in the US.
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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.
The work necessary to co-formulate Sustiva (efavirenz) and Truvada (emtricitabine and tenofovir disoproxil fumarate) into a once-daily combination product has been ongoing throughout most of 2004 and will continue into 2005. Through the joint venture the companies will work in partnership to complete development and US regulatory filings for this fixed-dose regimen.
Subject to receiving marketing approval of the fixed-dose regimen, the companies would share responsibility for commercializing the product in the US. Both companies will provide funding and promotional support for the combination product and both companies will receive revenues from future net sales at percentages relative to the contribution represented by their individual products.
Guidelines issued by the US 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.
Earlier in 2004, US 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 FDA 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.”