Bristol-Myers Squibb e Gilead Sciences hanno annunciato che tenteranno di sviluppare e commercializzare una pillola unica contenente emtricitabina, tenofovir disoproxil fumarato ed efavirenz.Sarebbe il primo regime triplice a somministrazione “una volta al giorno” in una sola compressa. Da un punto di vista tecnico è corretto parlare dell’evoluzione tecnologica della HAART: in una pillola sarebbero contenuti tutti i farmaci necessari per la persona HIV+.
Di seguito I dettagli in inglese:
On Monday Dec 13 2004 Bristol Myers Squibb & Gilead jointly released a press release announcing an agreement between them to develop and seek approve for the first HAART regimen in a one pill once daily regimen, so-called Fixed Dose Regimen.
Bristol-Myers Squibb Company and Gilead Sciences, Inc. announced details of a joint venture to develop and commercialize the fixed-dose combination of Bristol-Myers Squibb’s Sustiva (efavirenz) and Gilead’s Truvada™ (emtricitabine and tenofovir disoproxil fumarate) in the United States. 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 joint venture established by the two companies is the first of its kind in the field of HIV therapy.
The work necessary to co-formulate Sustiva (efavirenz) and Truvada (TDF+3TC) into a once-daily combination product has been ongoing throughout most of 2004 and will continue into 2005. Through the joint venture Bristol-Myers Squibb & Gilead Sciences will work in partnership to complete development and U.S. 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 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.
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.”