HIV is one of the primary areas of focus for Gilead Sciences Inc. GILD. The company has submitted a marketing application for yet another tenofovir alafenamide (TAF)-based regimen for the treatment of HIV.
The company has submitted a new drug application (NDA) to the FDA for a once-daily single tablet regimen that combines Gilead’s Emtriva (emtricitabine) and TAF along with Johnson & Johnson’s JNJ Edurant (rilpivirine) for the treatment of HIV-1 infection in adults and pediatric patients above 12 years.
We note that Gilead submitted a priority review voucher along with the NDA to the FDA. Gilead had acquired the priority review voucher from Canada-based Knight Therapeutics Inc. A priority review would shorten the review period of the candidate to six months. Gilead plans to submit a regulatory application for the Emtriva, TAF and Edurant combination regimen in the EU in the third quarter of 2015.
Last year Gilead and Johnson & Johnson had expanded their agreement for the development and commercialization of the TAF, Emtriva and Edurant combination. If approved, Gilead will undertake the responsibility of manufacturing, registration, distribution and commercialization of the cocktail therapy in most countries, while Johnson & Johnson will distribute it in approximately 17 markets.
Other TAF-based Regimens at Gilead
We remind investors that this is the third TAF-based regulatory application that Gilead has submitted to the FDA. Last November, the company had submitted an NDA to the FDA for another TAF-based single tablet regimen comprising TAF, Vitekta (elvitegravir), Tybost (cobicistat) and Emtriva, for the treatment of adults suffering from HIV-1 infection.
The FDA is expected to render a final decision on the regulatory application for the TAF, Vitekta, Tybost and Emtriva combination by Nov 5, 2015.
In Apr 2015, Gilead filed another NDA for two doses of a fixed-dose combination of Emtriva and TAF for HIV-1 infection in combination with other HIV antiretroviral drugs. A final decision from the FDA is expected by Apr 7, 2016.
The company is also looking to get both the TAF-based combination approved in the EU and has submitted regulatory applications for the same.
Gilead’s pipeline includes a fourth TAF-based regimen comprising TAF, Emtriva, Tybost and Johnson & Johnson’s Prezista (darunavir).
Our Take
We are pleased with the pipeline progress at Gilead. If approved, we believe that the TAF-based regimens would complement the company’s current portfolio. Gilead’s portfolio includes several drugs targeting HIV among which Tybost and Vitekta were approved last year.
Gilead carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Achillion Pharmaceuticals, Inc. ACHN and Avalanche Biotechnologies, Inc. AAVL. While Achillion Pharmaceuticals holds a Zacks Rank #1 (Strong Buy), Avalanche Biotechnologies carries a Zacks Rank #2 (Buy).
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