Gilead Sciences, Inc. (GILD) announced that it has expanded its agreement with Janssen R&D Ireland, a subsidiary of Johnson & Johnson (JNJ), for the development and commercialization of a new once-daily single tablet regimen containing Gilead’s tenofovir alafenamide (TAF) and Emtriva and Johnson & Johnson’s Edurant. Gilead plans to initiate a phase III study on the combination single tablet regimen in the coming months.
If approved, Gilead will undertake the responsibility of manufacturing, registration, distribution and commercialization of the TAF, Emtriva and Edurant combination regimen in most countries, while Johnson & Johnson will distribute it in approximately 17 markets.
In 2009, Gilead and Johnson & Johnson had entered into an agreement for the development and commercialization of the HIV drug Complera (EU trade name: Eviplera), which is a fixed-dose combination of Truvada and Edurant.
Meanwhile, Gilead and Johnson & Johnson have amended a licensing agreement for the development and commercialization of a once-daily single tablet regimen for HIV containing Gilead’s TAF, Emtriva and Tybost, and Johnson & Johnson’s Prezista. Per the amended agreement, Johnson & Johnson will be responsible for further development, manufacturing, registration, distribution and commercialization of the combination regimen worldwide.
We note that Gilead is advancing its TAF-based single tablet regimen containing TAF, Vitekta, Tybost and Emtriva. Last month, the company announced the filing of regulatory application for the combination regimen to the FDA (read more: Gilead Submits HIV Combination Drug for FDA Review).
Gilead holds a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Allergan (AGN) and Actavis (ACT), both carrying a Zacks Rank #2 (Buy).
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