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Gilead (GILD) Application for HIV Drug Validated in EU

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Gilead Sciences, Inc. (GILD - Free Report) announced that the company’s Marketing Authorization Application (MAA) for a once-daily single tablet regimen containing bictegravir (50 mg; BIC) and emtricitabine/tenofovir alafenamide (200/25mg; FTC/TAF) for the treatment of HIV-1 infection in adults has been fully validated by the European Medicines Agency (EMA). Currently, the application is under review by the EMA.

The regimen is novel experimental integrase strand transfer inhibitor which is being evaluated for the treatment of HIV-1 infection in adults.

Shares of Gilead have underperformed the Zacks classified Medical-Biomedical and Genetics industry in the last year, with the stock losing 1.5% during this period, against the industry’s gain of 8.6%.

The MAA for BIC/FTC/TAF is based on data from four phase III studies in which the regimen met its primary objective of non-inferiority at 48 weeks. Out of these, three ongoing studies are designed to explore the efficacy and safety of BIC/FTC/TAF compared to triple-therapy regimens containing GlaxoSmithKline’s (GSK - Free Report) Tivicay (dolutegravir) (50mg) (DTG) among treatment-naïve patients and virologically suppressed patients switching from an existing antiretroviral regimen. The data from these studies showed that BIC/FTC/TAF demonstrated high rates of virologic suppression and no treatment-emergent resistance through 48 weeks.

The fourth study is being conducted among virologically suppressed patients and compares switching to BIC/FTC/TAF versus on a suppressive regimen of two nucleoside/nucleotide reverse transcriptase inhibitors and a boosted protease inhibitor.

Additionally, Gilead submitted a new drug application (NDA) for BIC/FTC/TAF in the U.S. on Jun 12, 2017. The company will present the48-week data from two phase III studies evaluating BIC/FTC/TAF compared to regimens containing Tivicay (50mg) (DTG) in treatment-naïve adult patients at the International AIDS Society Conference on HIV Science (IAS 2017),July 23-26, 2017, in Paris.

We note that Gilead is a dominant player in the HIV market, with an impressive portfolio. The newly launched TAF-based products Genvoya, Odefsey and Descovy are performing well, with strong adoption in both the U.S. and EU. Genvoya has already become the most-prescribed regimen for both treatment-naïve and switch patients since its launch in Nov 2015.
The uptake in HIV franchise should help the company combat the persistent decline in HCV franchise due to competitive pressure.

Competition as well as pricing pressure has intensified further with the launch of Merck’s (MRK - Free Report) Zepatier.

Zacks Rank & Key Pick

Gilead currently carries a Zacks Rank #3 (Hold). Another better-ranked health care stock in the same space is Enzo Biochem, Inc. (ENZ - Free Report) which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Enzo Biochem’s loss per share estimates narrowed from 12 cents to 7 cents for 2017 and from 11 cents to 3 cents for 2018, over the last 30 days. The company delivered positive earnings surprises in all the trailing four quarters, with an average beat of 55.83%. The share price of the company has increased 66.8% year to date.

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