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Gilead's (GILD) Biktarvy Gets EC Nod for HIV- 1 Infection

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Gilead Sciences, Inc. (GILD - Free Report) announced that the European Commission has granted Marketing Authorization to HIV combination therapy Biktarvy (bictegravir 50mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg; BIC/FTC/TAF).

Biktarvy is approved as a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to the integrase class, emtricitabine or tenofovir.

The approval was supported by positive data from four ongoing phase III studies, namely Studies 1489 and 1490 in treatment-naïve HIV-1 infected adults, and Studies 1844 and 1878 in virologically suppressed adults.

With this approval, BIC/FTC/TAF becomes Gilead’s third FTC/TAF-based STR approved in the European Union in the past three years. BIC/FTC/TAF met its primary objective at 48 weeks in all four studies.

The regimen was earlier approved by the FDA in February 2018. The approval in Europe will further strengthen the company’s HIV franchise.

Gilead is a dominant player in the HIV market with an impressive portfolio for the same. HIV is one of the primary areas of focus for Gilead and the company is working to bring new HIV treatments to market to further boost sales of the franchise. The company was the first to bring to market a single-tablet regimen (STR) for the treatment of HIV — Atripla. The TAF-based products, Genvoya, Odefsey and Descovy, are performing well with strong adoption in both the United States and Europe.

Biktarvy combines the novel, unboosted integrase strand transfer inhibitor (“INSTI”) bictegravir, with the demonstrated safety and efficacy profile of the Descovy, (FTC/TAF) dual nucleoside reverse transcriptase inhibitor (“NRTI”) backbone, and the smallest INSTI-based triple-therapy STR is produced. The approval of this new HIV therapy will pose stiff competition to GlaxoSmith’s (GSK - Free Report) existing therapies, Tivicay and Triumeq.

Meanwhile, Gilead is banking on its HIV franchise to drive growth in future, given the persistent decline in HCV sales. Gilead’s stock has gained 0.8% in the last six months as against the industry's decline of 6.8%.

Gilead’s HCV franchise is experiencing slowdown across key markets, including the United States and Europe, reflecting lower sales of Harvoni and Sovaldi as a result of competitive and pricing pressure. The franchise saw a significant plunge in sales, due to new competition and fewer patient starts.

Pricing has largely stabilized and market share will stabilize by mid-2018, while patient starts are expected to decline further. We note that Harvoni, Sovaldi and Epclusa face competition from AbbVie’s (ABBV - Free Report) Viekira Pak and Mayret, and Merck’s (MRK - Free Report) Zepatier among others.

Meanwhile, Gilead is looking at newer avenues to help its top line, by solidifying its presence in the gene therapy space. The initial uptake of Yescarta is also encouraging. Gilead is also intending to foray into the NASH market with pipeline candidates — selonsertib and filgotinib.

Zacks Rank

Gilead currently carries a Zacks Rank #3 (Hold).

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

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