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Gilead's (GILD) Harvoni and Descovy Get Approval in China

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Gilead Sciences, Inc. (GILD - Free Report) announced that the National Medical Products Administration (NMPA) has approved its hepatitis C virus (HCV) drug, Harvoni, in China.

The drug has been approved for the treatment of HCV infection genotype 1-6 infection in adults and adolescents aged 12-18 years.

The approval should boost sales of the dwindling HCV franchise due to competitive pressure from the likes of AbbVie (ABBV - Free Report) .

Concurrently, Gilead announced that the NMPA has also approved Descovy (emtricitabine 200 mg/tenofovir alafenamide 10 mg and emtricitabine 200 mg/tenofovir alafenamide 25 mg, F/TAF), a fixed-dose combination for the treatment of HIV. Descovy is approved in combination with other antiretroviral agents for the treatment of HIV-1 in adults and adolescents (aged 12 years or older with at least 35 kg body weight). The therapy is already approved in the United States.

Gilead is a dominant player in the HIV market with an impressive product portfolio. The company was the first to bring to market a single-tablet regimen (STR) — Atripla — for the treatment of HIV. Additional STRs for HIV in the market include Complera/Eviplera and Stribild, among others. TAF-based products like Genvoya, Odefsey and Descovy are performing well with strong adoption both in the United States and Europe.

The company received a major boost when the FDA approved its once-daily STR, Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF) for HIV-1 infection. The approval, which comes ahead of the PDUFA date of Feb 12, 2018, significantly boosts Gilead’s HIV franchise. Biktarvy combines the novel, unboosted integrase strand transfer inhibitor (“INSTI”) bictegravir, with the demonstrated safety and efficacy profile of Descovy (FTC/TAF). The approval of this new HIV therapy will pose stiff competition to GlaxoSmith’s (GSK - Free Report) existing therapies, Tivicay and Triumeq.

Gilead’s stock has gained 0.9% in the past six months, worse than the industry's decline of 9.2%.

 

Given the persistent decline in HCV sales, the company is looking to HIV and newer avenues to help the top line. The initial uptake of Yescarta (from the Kite Pharma acquisition) is slow but encouraging.

Moreover, Gilead has promising late-stage candidates — selonsertib and filgotinib — in the NASH and inflammation markets, respectively. The company also has a collaboration agreement with Sangamo Therapeutics, Inc. (SGMO - Free Report) to use Sangamo’s zinc finger nuclease technology platform for the development of next-generation ex vivo cell therapies in oncology.

Zacks Rank

Gilead currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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