FOSTER CITY, Calif.—Biopharmaceutical company Gilead Sciences, Inc. has announced that it has expanded its agreement with Janssen R&D Ireland for the development and commercialization of a new once-daily single tablet regimen that combines Gilead's tenofovir alafenamide (TAF) and emtricitabine with Janssen's rilpivirine. The companies established the original agreement in 2009 to develop and commercialize Complera, which is marketed as Eviplera in the European Union, which combines tenofovir disoproxil fumarate, emtricitabine and rilpivirine in a once-daily tablet. Per the expanded agreement, Gilead will soon begin Phase 3 studies of emtricitabine/rilpivirine/TAF, and, should the product gain regulatory approval, Gilead will be responsible for manufacturing, registration, distribution and commercialization of the regimen in most countries. For its part, Janssen will handle distribution in approximately 17 markets.
“We believe that TAF’s efficacy and safety advantages may make it a strong backbone of new fixed-dose combinations and single tablet regimens,” Dr. Norbert Bischofberger, executive vice president of Research and Development and chief scientific officer at Gilead Sciences, commented in a statement. “Gilead is pleased to continue its collaboration with Janssen to bring improved treatment options to patients living with HIV.”
TAF is a novel nucleotide reverse transcriptase inhibitor. So far, the compound has demonstrated high antiviral efficacy at a dose 10 times lower than Viread, in addition to an improved renal and bone safety profile.
Janssen and Gilead have also made amendments to a licensing agreement concerning the development and commercialization of a once-daily single-tablet regimen for HIV that features Gilead’s TAF, emtricitabine and cobicistat, and Janssen’s darunavir. Per that amended deal, Janssen will assume responsibility for additional development of the regimen and, should it secure approval from the appropriate regulatory officials, the worldwide manufacturing, registration, distribution and commercialization of the product.
This follows another deal Gilead announced earlier in the month. On Dec. 19, the company shared that it had struck an exclusive license agreement with Ono Pharmaceutical Co. Ltd. to develop and commercialize ONO-4059, an oral Bruton's tyrosine kinase inhibitor for the treatment of B-cell malignancies and other diseases. Per the deal's terms, Ono will receive an upfront payment as well as additional payments should certain development, regulatory and commercial milestones be met. Ono and Gilead will jointly collaborate on the global development of ONO-4059, with Gilead holding exclusive rights to develop and commercialize the compound in all countries outside of Japan, South Korea, Taiwan, China and the Association of Southeast Asian Nations (ASEAN) countries, where Ono will retain development and commercialization rights.
