Gilead Sciences, Inc. GILD announced that its once-daily single tablet regimen (STR) Odefsey gained approval in the EU for the treatment of HIV-1 infection in certain patients. Odefsey comprises Gilead’s Descovy (Emtriva;v 200 mg and tenofovir alafenamide/TAF; 25 mg) and Johnson & Johnson's JNJ Edurant (25 mg).
Odefsey is approved for the treatment of adults and adolescents (aged 12 years and older with body weight of at least 35 kg) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor class, tenofovir or Emtriva, and with a viral load less than 100,000 HIV-1 RNA copies/ml.
Following the approval of Genvoya in Nov 2015, Odefsey is the company’s second STR containing Descovy and the third product to be added to Gilead’s new TAF portfolio to receive approval in the EU. Moreover, Odefsey is the smallest STR pill for the treatment of HIV.
Earlier this year, Odefsey gained approval in the U.S. for the treatment of HIV-1 infection.
We note that Odefsey approval is part of the ongoing development and commercialization agreement between Gilead and Johnson & Johnson’s Janssen, which was struck in 2009. While Gilead is responsible for the manufacturing, registration, distribution and commercialization of Odefsey in most countries, Janssen will distribute it in about 18 markets and have co-detailing rights in several key markets including the U.S.
The original agreement was signed for the development and commercialization of Complera/Eviplera and was expanded in 2014 to include Odefsey.
HIV is Gilead’s one of the primary areas of focus and the company is working to bring new HIV treatments to market to boost sales of the franchise. Currently, an STR of bictegravir is being evaluated in phase III studies in combination with TAF and Emtriva for the treatment of HIV-1 infection.
Gilead is a Zacks Rank #5 (Strong Sell) stock. A couple of better-ranked stocks in the health care sector are ANI Pharmaceuticals, Inc. ANIP and Retrophin, Inc. RTRX, each sporting a Zacks Rank #1 (Strong Buy).
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