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Gilead Sciences : Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir...

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06/22/2017 | 09:12pm CEST

Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for HIV Treatment

By a News Reporter-Staff News Editor at AIDS Weekly -- Gilead Sciences, Inc. (NASDAQ: GILD) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily single tablet regimen containing bictegravir (50 mg) (BIC), a novel investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) for the treatment of HIV-1 infection in adults. BIC/FTC/TAF has demonstrated high rates of virologic suppression and no treatment-emergent resistance through 48 weeks in Phase 3 clinical trials among treatment-naive adult patients and among virologically suppressed adult patients who switched regimens (see also Drugs and Therapies - Antiretrovirals).

"We aim to simplify the management of HIV for a broad range of patients with this single tablet regimen that combines the potency of an integrase inhibitor, bictegravir, and the demonstrated long-term safety profile of the FTC/TAF backbone," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "This regulatory filing is a demonstration of Gilead's ongoing commitment to bringing forward treatment innovations that have the potential to address the needs of patients and physicians."

The NDA for BIC/FTC/TAF is supported by data from four Phase 3 studies in which the regimen met its primary objective of non-inferiority. Three of the ongoing studies are designed to explore the efficacy and safety of BIC/FTC/TAF compared to triple-therapy regimens containing dolutegravir (50mg) among treatment-naive patients and among virologically suppressed patients (HIV-1 RNA levels <50 copies/mL) switching from an existing antiretroviral regimen with dolutegravir. A fourth ongoing study in virologically suppressed patients compares switching to BIC/FTC/TAF versus remaining on a suppressive regimen of two nucleoside/nucleotide reverse transcriptase inhibitors and a boosted protease inhibitor.

Gilead plans to submit a marketing authorization application for BIC/FTC/TAF in the European Union in the third quarter of 2017.

Bictegravir in combination with FTC/TAF as a single tablet regimen is an investigational treatment that has not been determined to be safe or efficacious and is not approved anywhere globally. About Gilead Sciences Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.

Keywords for this news article include: Antiinfectives, Antivirals, Pharmaceutical Companies, Genetics, HIV/AIDS, Tenofovir, RNA Viruses, Retroviridae, Emtricitabine, Vertebrate Viruses, Regulatory Agencies, Gilead Sciences Inc., Primate Lentiviruses, Drugs and Therapies - Antiretrovirals, Immune System Diseases and Conditions.

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2017, NewsRx LLC

(c) 2017 NewsRx LLC, source Health Newsletters

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Financials ($)
Sales 2017 24 660 M
EBIT 2017 15 036 M
Net income 2017 9 722 M
Debt 2017 4 528 M
Yield 2017 3,12%
P/E ratio 2017 9,11
P/E ratio 2018 10,05
EV / Sales 2017 3,76x
EV / Sales 2018 4,20x
Capitalization 88 204 M
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Number of Analysts 27
Average target price 77,6 $
Spread / Average Target 15%
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NameTitle
John F. Milligan President, Chief Executive Officer & Director
John C. Martin Executive Chairman
Kevin B. Young Chief Operating Officer
Robin L. Washington Chief Financial Officer & Executive Vice President
Norbert W. Bischofberger Chief Scientific Officer & Executive VP-Research
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