Gilead and Janssen Announce Deal to Develop New TAF Single-Tablet Regimens

Gilead Sciences and Janssen R&D announced an agreement in late December to develop antiretroviral coformulations containing Gilead's novel tenofovir alafenamide (TAF) formulation and emtricitabine plus Janssen's HIV protease inhibitor darunavir (Prezista) or NNRTI rilpivirine (Edurant).

TAF is designed to produce higher levels of the active drug in HIV-infected cells than the original tenofovir disoproxil fumarate formulation (TDF, marketed as Viread), which allows for lower dosing. Studies have shown that TAF works as well as TDF in combination antiretroviral regimens, but has less effect on bone and kidney biomarkers. 

The latest agreement extends the companies' previous partnership to develop the Complera single-tablet regimen (Eviplera in Europe), which contains TDF, emtricitabine, and rilpivirine. In November Gilead requested U.S. FDA approval for another new coformulation containing TAF, emtricitabine, the boosting agent cobicistat, and its integrase inhibitor elvitegravir (Vitekta) -- a replacement for the Stribild single-tablet regimen. Gilead and Janssen are also working on a once-daily coformulation containing TAF, emtricitabine, cobicistat, and darunavir, which has no current equivalent and would be the first protease inhibitor-based single-tablet regimen.

Below is an edited excerpt from Gilead's press release announcing the deal. Janssen's release is available online.

Gilead Announces Amended Agreements With Janssen to Develop and Commercialize Tenofovir Alafenamide-Based Single Tablet Regimens for HIV Treatment

Foster City, Calif. -- December 29, 2014 -- Gilead Sciences, Inc. (Nasdaq:GILD) today announced an expansion to its agreement with Janssen R&D Ireland for the development and commercialization of a new once-daily single tablet regimen containing Gilead’s tenofovir alafenamide (TAF) and emtricitabine, and Janssen’s rilpivirine. The original agreement was established in 2009 for the development and commercialization of Complera, marketed as Eviplera in the European Union, which combines tenofovir disoproxil fumarate, emtricitabine and rilpivirine in a once-daily tablet. Gilead will initiate Phase 3 studies of emtricitabine/rilpivirine/TAF in the coming months. Pending the product’s approval, Gilead will be responsible for the manufacturing, registration, distribution and commercialization of the regimen in most countries, while Janssen will distribute in approximately 17 markets.

TAF is a novel nucleotide reverse transcriptase inhibitor that has demonstrated high antiviral efficacy at a dose 10 times lower than Gilead’s Viread (tenofovir disoproxil fumarate), 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," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "Gilead is pleased to continue its collaboration with Janssen to bring improved treatment options to patients living with HIV."

Gilead and Janssen also have amended a licensing agreement for the development and commercialization of a once-daily single tablet regimen for HIV containing Gilead’s TAF, emtricitabine and cobicistat, and Janssen’s darunavir. Under the amended agreement, Janssen will be responsible for further development of the regimen and, subject to regulatory approval, the manufacturing, registration, distribution and commercialization of the product worldwide.

Separate to the Janssen agreements, Gilead is advancing its own TAF-based single tablet regimen containing elvitegravir, cobicistat, emtricitabine and TAF. The company announced on November 6, 2014, it filed for regulatory approval in the United States.

TAF and TAF-based regimens are investigational products in the United States and have not yet been determined safe or efficacious in humans.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.

U.S. full prescribing information for Complera and Viread is available at www.gilead.com.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

1/12/15

Sources

Gilead Sciences. Gilead Announces Amended Agreements With Janssen to Develop and Commercialize Tenofovir Alafenamide-Based Single Tablet Regimens for HIV Treatment. Press release. December 29, 2014.

Janssen R&D. Janssen Announces Collaboration with Gilead to Develop Prezista-Based Single-Tablet Regimen for the Treatment of People Living with HIV. Press release. December 29, 2014.