Gilead Negotiates Worldwide License to BI’s Early Clinical Stage HIV Program
While Gilead takes over noncatalytic site integrase inhibitor candidates, BI says it will focus on HCV.
Gilead Sciences negotiated exclusive worldwide rights to Boehringer Ingelheim’s (BI) noncatalytic site integrase inhibitor (NCINI) program for HIV. Under terms of the deal BI will receive an up-front fee, along with development, regulatory, and commercial milestones, plus royalties on future net sales.
The acquired NCINI program includes lead compound, BI 224436, which has been evaluated in a Phase Ia dose escalation study in healthy volunteers. BI says outlicensing the program to Gilead will enable it to focus development efforts on other candidates in its virology pipeline, including its hepatitis C program.
Gilead’s existing HIV/AIDS pipeline includes the Phase III-stage integrase inhibitor elvitegravir, the PK enhancer cobicistat (formerly GS 9350), which is also in Phase III development, and a Phase I-stage NRTI, GS 7340.
Elvitegravir and cobicistat are also being evaluated in combination with emtricitabine and tenofovir disoproxil fumarate as a fixed-dose, single-tablet combination product. In September Gilead reported positive data from a second Phase III clinical trial (Study 103), which demonstrated noninferiority of the Quad regimen in comparison with ritonavir-boosted atazanavir plus Truvada™ (emtricitabine/tenofovir disoproxil fumarate) in treatment-naïve HIV patients. Positive data from the first Phase III study (102) were released In August. When the 103 study data was released the following month, the firm indicated that it planned to file for approval of the Quad by the end of 2011.
Also in September the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion on Gilead’s once-daily single-tablet regimen, Eviplera®, which combines the firm’s Truvada (emtricitabine and tenofovir disoproxil fumarate) with Tibotec Pharmaceuticals' non-nucleoside reverse transcriptase inhibitor Edurant™ (rilpivirine hydrochloride) for the treatment of HIV-1 infection in antiretroviral-naïve adults. The combination therapy was granted FDA approval in August under the trade name Complera™.