Business Wire

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

Del

Gilead Sciences, Inc. (NASDAQ: GILD) today 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-naïve adult patients and among virologically suppressed adult patients who switched regimens.

“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-naïve 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.

For nearly 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention, testing and linkage to care, and cure research. Today, it’s estimated that more than 10 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company’s manufacturing partners.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including FDA and other regulatory agencies may not approve BIC/FTC/TAF, and any marketing approvals, if granted, may have significant limitations on its use. In addition, there are risks associated with Gilead’s ability to submit its regulatory application for BIC/FTC/TAF in the European Union in the currently anticipated timeline. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com , follow Gilead on Twitter ( @GileadSciences ) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Contact information

Gilead Sciences, Inc.
Sung Lee, 650-524-7792 (Investors)
Ryan McKeel, 650-377-3548 (Media)

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Sparkol Launches VideoScribe 318.10.2017 13:24Pressemelding

Introducing VideoScribe Version 3 by Sparkol. Already used by over two million people across the world to create engaging explainer videos, Version 3 of the highly intuitive software comes packed full of new features, including: An improved user experience and slick UI - animate easier than ever before Enhanced search - find exactly the image you need in record time Intelligent image recommendations - focus your creativity on your video instead Smoother performance - maximum productivity when using the software VideoScribe customers include the world’s largest brands (HP, BBC, Sky and the University of British Columbia), businesses across every sector, leading education providers, award-winning teachers, charities, campaigners, and coun

Piraeus Bank: Agreement for the Sale of Serbian Operations18.10.2017 13:06Pressemelding

Piraeus Bank announces that it has entered into an agreement to sell its Serbian banking and leasing operations to Direktna Banka A.D., a local Serbian banking group that has been strongly growing its presence in the market, for a total cash consideration between €58mn up to €61mn, depending on the financial performance of the divested assets until completion of the transaction, through a combination of direct sale price and simultaneous reduction of capital in Piraeus Bank Beograd AD. The transaction is conditional upon the usual corporate and regulatory approvals, including those of the National Bank of Serbia and the Hellenic Financial Stability Fund. The transaction represents another step towards the implementation of Piraeus Bank’s Restructuring Plan commitments, as those were agreed with the Directorate General of Competition of the European Commission. The transactio

Introducing InVision Studio, The World’s Most Powerful Screen Design Tool18.10.2017 13:01Pressemelding

InVision, the product design platform powering the world’s best digital experiences, today introduced Studio, a powerful new tool that will change the way screen design is done. InVision Studio was created by working closely with the world’s best design teams and finding inspiration in how they create beloved digital products. The launch of Studio comes at a time when modern organizations are shaping and redefining entire markets through their focus on digital customer experience. InVision already powers the product design process of more than 3 million people at tens of thousands of companies, including eighty percent of the Fortune 100 and brands like Airbnb, Uber, HBO, Amazon, IBM, Nike, and Slack. This new product reflects a major evolution of the digital product design workflow. With Studio, InVision has developed an end-to-end platform for designing digit

SmartStream and Credit Suisse Expand their Agreement from the Processing of Invoices and Reconciliations to Now Include Listed Derivatives Brokerage Fees18.10.2017 12:00Pressemelding

SmartStream Technologies, the financial Transaction Lifecycle Management (TLM®) solutions provider, today announced that its original agreement with Credit Suisse was recently expanded to include the processing of Listed Derivatives Brokerage fees which began in February of this year. This expansion in SmartStream’s partnership with Credit Suisse complements its existing managed service solution for the processing of invoices and reconciliations within Credit Suisse’s OTC Fixed Income Derivatives, US Listed Equity Options and Cash Equities businesses across brokerage, clearing and exchange fees operations, which began in June of 2016. The managed service enables the bank to advance the operational efficiencies created through the use of the utility-based solutions offered by SmartStream, utilizing their proprietary execution fees and expense management software. By centralizing the ent

Biogen Confirms Commitment to Tackle Multiple Sclerosis Through Comprehensive Approach18.10.2017 11:30Pressemelding

Biogen (NASDAQ: BIIB) confirms its comprehensive approach to tackle multiple sclerosis (MS) at the seventh Joint Meeting of the European Committee for Treatment and Research in MS and Americas Committee for Treatment and Research in MS (ECTRIMS-ACTRIMS; 25 – 28 October). “With more than 25 years of scientific leadership in MS, Biogen’s commitment is unwavering,” said Michael Ehlers, executive vice president, Research & Development at Biogen. “Our expertise puts Biogen in a unique position with a comprehensive approach including active research and clinical development on how to repair the damage to the central nervous system from relapsing forms of MS, a portfolio of new drug candidates that we are advancing to the clinic, our collaboration to identify a digital biomarker, our focus to advance understanding of the disease through global data collection with MS PATHS, active pursuit

Scientist.com Collaborates With UKCRC Tissue Directory and Coordination Centre to Ensure Quality of Human Biosample Acquisition Globally18.10.2017 11:01Pressemelding

Scientist.com, the world’s leading marketplace for outsourced scientific services, today announced that it is entering into a collaboration with the UKCRC Tissue Directory and Coordination Centre (UKCRC TDCC) to support the work of biobanks throughout the United Kingdom. The partnership will enable drug R&D to move forward more quickly by making large collections of prescreened human biological samples available for scientific research. Through the new COMPLI™ feature, Scientist.com provides a simple, efficient and effective way of increasing the visibility and accessibility of biobanks’ human biological samples collections, which support new medical research. COMPLI™ introduces a common, comprehensive process and supply agreement supporting access to human biosamples. The goal is to enable biobanks to more easily connect with researchers in the pharmaceutical and biotech indust

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom