Gilead Sciences, Inc. GILD announced that its investigational fixed-dose combination of Emtriva and tenofovir alafenamide has been accepted for review by the European Medicines Agency (EMA) for the treatment of HIV-1 infection in combination with other HIV antiretroviral agents.
The company is seeking approval for two doses of the Emtriva/tenofovir alafenamide combination (200/10 mg and 200/25 mg).
Apart from the Emtriva/tenofovir alafenamide combination, an investigational once-daily single tablet regimen comprising Vitekta (150 mg), Tybost (150 mg), Emtriva (200 mg) and tenofovir alafenamide (10 mg) is also under review by the EMA. Additionally, Gilead filed the above investigational combinations for approval in the U.S. on Nov 5, 2014, and Apr 7, 2015, respectively.
We note that HIV is one of the primary areas of focus for Gilead. The company already has a strong HIV portfolio comprising Stribild, Complera, Atripla, Truvada, Viread, Emtriva, Tybost and Vitekta. Gilead generates a substantial portion of its revenues from sales of HIV products especially, Atripla, Complera and Stribild. In 2014, HIV product sales accounted for more than 40% of Gilead’s total sales.
However, competition in the HIV landscape is gradually intensifying with other companies launching new treatment options such as ViiV Healthcare’s Tivicay and Triumeq (launched in 2013 and in the third quarter of 2014, respectively). Meanwhile, Tybost is facing competition from AbbVie Inc.’s ABBV Norvir.
Gilead carries a Zacks Rank #1 (Strong Buy). Other well-ranked stocks in the health care sector include Actelion Ltd. ALIOF and Valeant Pharmaceuticals International, Inc. VRX. Both carry the same Zacks Rank as Gilead.
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