Business Wire

European CHMP Adopts Positive Opinion for Gilead’s Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide)

Del

Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Biktarvy® (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg; BIC/FTC/TAF), 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.

BIC/FTC/TAF combines the potency of the novel integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of the Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg; FTC/TAF) dual nucleoside reverse transcriptase inhibitor (NRTI) backbone.

“Triple therapy has been the standard of HIV treatment for more than 20 years and has allowed people living with HIV to achieve durable undetectability. At Gilead, we have continued to explore ways to improve and provide more HIV treatment options, with the goal of going beyond reducing viral load and helping to address some of the wider challenges faced by people living with HIV,” said Andrew Cheng, MD, PhD, Chief Medical Officer, Gilead Sciences. “If approved, Biktarvy would be the fifth TAF-based product for HIV in the European Union in the past three years, and because of its drug interaction profile, minimal monitoring requirements and ease of administration we believe it could represent a meaningful advance in HIV treatment for appropriate patients in Europe.”

The MAA for BIC/FTC/TAF is supported by data from four ongoing Phase 3 studies: Studies 1489 and 1490 in treatment-naïve HIV-1 infected adults, and Studies 1844 and 1878 in virologically suppressed adults. The trials are comprised of a population of 2,415 participants. BIC/FTC/TAF met its primary objective of non-inferiority at 48 weeks in all four studies.

The CHMP’s recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union, Norway, Iceland and Liechtenstein. A European Commission decision is expected in mid-2018.

BIC/FTC/TAF was approved by the U.S. Food and Drug Administration (FDA) on February 7, 2018.

In the European Union, BIC/FTC/TAF is an investigational product and its efficacy and safety have not yet been established.

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 35 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 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 generic 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 the risk that the European Commission may not approve BIC/FTC/TAF in the currently anticipated timelines or at all, and any marketing approval, if granted, may have significant limitations on its use. 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 Annual Report on Form 10-K for the year ended December 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.

Biktarvy, Descovy, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc. or its related companies.

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.
Investors
Sung Lee, 650-524-7792
or
Media
Ryan McKeel, 650-377-3548
or
Media (EU)
Stephen Head, +44 (0)7768 705945

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

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

(c) 2018 Business Wire, Inc., All rights reserved.

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

Rimini Street Delivers Premium SAP Support to Solar Frontier23.5.2018 23:02Pressemelding

Rimini Street, Inc., (Nasdaq: RMNI), a global provider of enterprise software products and services, and the leading third-party support provider for Oracle and SAP software products, today announced that Solar Frontier K.K., a leading developer and distributor of residential and industrial CIS (copper, indium and selenium) solar panels based in Japan, has adopted Rimini Street for support of its SAP ERP applications. Solar Frontier moved to Rimini Street third-party support to reduce annual SAP vendor maintenance costs, achieve business efficiencies and help drive investments in other critical areas of the business, including data analysis and supply chain management. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180523006351/en/ Solar Frontier K.K., a leading developer and distributor of residential and industrial solar panels based in Japan, has adopted Rimini Street for support of its SAP ERP applications. (Photo: Busin

Corsearch Announces Strategic Partnerships with Key-Systems GmbH and INCOPRO23.5.2018 22:11Pressemelding

Corsearch, a premier provider of clearance and protection solutions for trademark and brand professionals, is pleased to announce strategic partnerships with Key-Systems, a global player in the internet and domain industry, and INCOPRO, a leading online IP and brand protection company. The agreements solidify Corsearch’s full service domain management and brand protection offerings for law firms . “We are thrilled to be moving forward in a new partnership with Key Systems to complement our existing partnership with COM LAUDE, and to be expanding the partnership we have with INCOPRO,” said Corsearch President and CEO Tobi Hartmann. “These relationships will allow Corsearch to expand its domain name management and brand protection solutions for law firms and their end clients.” Corsearch & Key-Systems Partnership Working with the corporate domain management solution “BrandShelter", Corsearch will provide law firms an easy way to manage the domain portfolios of their clients. This collabo

CORRECTING and REPLACING Zebra Medical Vision Announces CE Approval of its Seventh AI Imaging Algorithm - Mammography Lesion Detection23.5.2018 21:30Pressemelding

Fourth paragraph, first sentence of release should read: Zebra-Med’s Mammography algorithm aims to change that dynamic, by providing a state of the art clinical decision support product at a previously unprecedented price point (instead of Zebra-Med’s Mammography algorithm aims to change that dynamic, by providing a state of the art malignancy detection product at a previously unprecedented price point). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180523005843/en/ Credit: Zebra Medical Vision The corrected release reads: ZEBRA MEDICAL VISION ANNOUNCES CE APPROVAL OF ITS SEVENTH AI IMAGING ALGORITHM - MAMMOGRAPHY LESION DETECTION The new algorithm expands Zebra-Med’s footprint into Oncology, with the most affordable Mammo lesion detection package in the market. Zebra Medical Vision (http://zebra-med.com/) announces today the CE regulatory approval of its newest algorithm to be included in its growing Deep Learning Imaging

Seoul Semiconductor AC LED Modules Pass 4kV Surge Testing23.5.2018 18:40Pressemelding

Seoul Semiconductor, a global innovator of LED products and technology, has demonstrated a 277V AC lighting module using its NanoDriver Series LED driver that complies with the industry standard 4kV surge testing. Prior to this, AC LED modules have been mainly used only in residential lighting applications due to the technology’s limited capability to meet the surge requirements for industrial and commercial applications. This demonstration module proves that it is possible to achieve a 277VAC module with high surge capability using Seoul Semiconductor’s NanoDriver Series LED driver. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180523006267/en/ Seoul Semiconductor AC LED modules with Acrich technology demonstrate compliance at 4kV surge test. (Photo: Business Wire) Prior to Seoul Semiconductor’s recent product introduction, many LED fixture designers perceived AC LED technology as a low performance, low cost solution, assu

GCEL Releases G20 Nations Case Study Involving 90 Ministries, NGOs & IGOs Defining the Guidelines for the Digital Economy Era23.5.2018 18:34Pressemelding

GCEL, INSME, BVMW and CONFAPI executed a strategic agreement at the European Union Parliament to deploy the Digital Economy Platform (DEP) through GCEL’s HumaWealth Program that digitizes the USD 140 trillion B2B marketplace. These agreements will implement the newly released G20 Nations Case Study recommendations providing the roadmap to reduce annual domestic and international trade costs by USD 3.7 trillion, increase trade by USD 7.7 trillion, create a USD 1 trillion SME fund and generate 300 million manufacturing, agricultural and service industry jobs by 2030. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180523006259/en/ GCEL, INSME, BVMW and CONFAPI executed a strategic agreement at the European Union Parliament to deploy the Digital Economy Platform in collaboration with the world's leading technology firms to digitize the USD 140 trillion B2B marketplace (Photo: Business Wire) The agreement was signed by Captain Sa

LTI Q4 USD Revenue Growth up 5.3% QoQ and 21.6% YoY; FY18 Revenues of USD1.13bn, up 16.7%; Digital Revenues Grow 42% in FY1823.5.2018 15:04Pressemelding

Larsen & Toubro Infotech (BSE: 540005, NSE: LTI), a global technology consulting and digital solutions company, announced its Q4 FY18 and full year FY18 results today. Q4 FY 18 In US Dollars: Revenue at USD 309.0 million; growth of 5.3% QoQ and 21.6% YoY Constant Currency Revenue growth of 4.5% QoQ and 18.7% YoY In Indian Rupees: Revenue at Rs 20,012 million; growth at 6.2% QoQ and 19.3% YoY Net Income at Rs 2,894 million; Net Income growth at 2.3% QoQ and 13.7% YoY Full year FY18 In US Dollars: Revenue at USD 1,132.3 million; growth of 16.7% YoY Constant Currency Revenue growth of 14.7% YoY In Indian Rupees: Revenue at Rs 73,065 million; growth at 12.4% YoY Net Income at Rs 11,124 million; Net Income growth at 14.6% YoY “Our outstanding growth of 5.3% QoQ in Q4 is a result of a broad-based performance across all verticals. We have delivered an industry leading growth of 16.7% for the full financial year with digital revenues up 42% YoY. Our sustained investments in exponential technol