Janssen R&D Ireland and Gilead Sciences have expanded two existing HIV drug collaborations through agreements to develop new once-daily HIV tablets, the companies said today in separate announcements. The value of both collaborations was not disclosed.
The companies agreed to expand a 2009 collaboration by developing a Phase III-ready HIV treatment that will combine Gilead’s tenofovir alafenamide (TAF) and emtricitabine, and Janssen’s rilpivirine. Gilead said it plans to launch Phase III studies of emtricitabine/rilpivirine/TAF “in the coming months.”
Pending approval of the new combination, Gilead agreed to oversee the manufacturing, registration, distribution, and commercialization of the regimen in most countries, while Janssen agreed to distribute the new combo treatment in approximately 17 unspecified markets.
That new collaboration builds upon the companies’ 2009 agreement to develop and commercialize Complera®, marketed as Eviplera® in the European Union. Complera combines emtricitabine and rilpivirine in a once-daily tablet with Gilead’s Viread® (tenofovir disoproxil fumarate or TDF).
Gilead seeks to replace TDF with TAF, an investigational nucleotide reverse transcriptase inhibitor that has demonstrated high antiviral efficacy at a dose 10 times lower than Viread, as well as an improved renal and bone safety profile: “We believe that TAF’s efficacy and safety advantages may make it a strong backbone of new fixed-dose combinations and single tablet regimens,” Norbert Bischofberger, Ph.D., Gilead evp, research and development and CSO, said in a company statement.
Gilead’s commitment to TAF extends into a second separate collaboration with Janssen. The companies agreed to amend a 2011 collaboration for a once daily, darunavir-based single-tablet HIV treatment regimen based on Janssen’s darunavir, marketed as Prezista®.
Under the amendment, Gilead and Janssen agreed to develop and commercialize a once-daily single tablet regimen for HIV that combines darunavir with TAF, emtricitabine and a third Gilead compound, cobicistat (marketed as TYBOST®). Janssen agreed to take responsibility for further development of the regimen and, subject to regulatory approval, for worldwide manufacturing, registration, distribution, and commercialization of the product.
According to Janssen, the new darunavir-based combo would represent the first protease inhibitor-based single-treatment regimen (STR) if approved by regulators: “If approved, this STR has the potential to provide additional choice in the form of another one pill, once a day, as a new and simplified regimen,” Paul Stoffels, Johnson & Johnson CSO and worldwide chairman, pharmaceuticals, said in a company statement.
Gilead earlier showed its commitment to TAF on November 6, when the company filed for FDA approval of its own single tablet regimen that combined 10 mg of tenofovir alafenamide (TAF) with elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg, and is indicated for treatment of HIV in adults. The combo, abbreviated as E/C/F/TAF, has a PDUFA target decision date of July 6, 2015.
The NDA for E/C/F/TAF was supported by 48-week data from two pivotal Phase 3 studies (Studies 104 and 111) in which the regimen met its primary objective of noninferiority compared to another already-marketed Gilead combination HIV treatment Stribild® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) among treatment-naïve patients.
