Business Wire

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

Jaa

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

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Ipsen Receives Positive CHMP Opinion for Cabometyx® (Cabozantinib) for the Second-line Treatment of Patients with Hepatocellular Carcinoma (HCC)21.9.2018 08:30Tiedote

Regulatory News: Ipsen (Euronext:IPN; ADR:IPSEY) announced today that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), provided a positive opinion for Cabometyx® (cabozantinib) as a monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have been previously treated with sorafenib. The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). Alexandre Lebeaut, MD, Executive Vice President, R&D and Chief Scientific Officer, Ipsen, said: “The global burden of liver cancer is increasing and despite the recent introduction of new agents, it remains the second leading cause of cancer mortality worldwide. Following today’s positive CHMP opinion and if approved by the European Commission, Cabometyx ® as monotherapy will give patients with HCC a much-needed new oral therapeutic option.” Dr Lorenza Rimassa,

Quanergy Selected as Exclusive LiDAR Partner for VRCO21.9.2018 08:00Tiedote

Quanergy Systems, Inc., a global leader in the design and development of solid state LiDAR sensors and smart sensing solutions, and VRCO, designer and manufacturer of the luxury high-end e-VTOL (electric Vertical Take-Off and Landing) craft, the NeoXcraft XP2, today announced that VRCO will exclusively use Quanergy’s S3 solid state LiDAR sensors in the testing and market release versions of the aircraft. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180920006036/en/ VRCO NeoXcraft XP2 with Quanergy S3 LiDAR Sensor (Graphic: Business Wire) The NeoXcraft XP2, which VRCO and the University of Derby unveiled in late 2017 and intend to launch in 2020, is a two-passenger e-VTOL high-speed land, air, and water capable craft. The craft can scan and memorize take-off locations and store the data for use on the next approach to the same location. Quanergy’s innovative S3 solid state LiDAR sensor will be used for downward and forward

Overseas Roadshow for the IAPH Guangzhou 2019 World Ports Conference Was Held in London21.9.2018 06:08Tiedote

Overseas roadshow for the IAPH Guangzhou 2019 World Ports Conference was successfully held in Armourer's Hall, London, UK on September 20th. Ms. Yuan Yue, Deputy Director General of Guangzhou Port Authority, met with over 100 senior representatives from British ports, ship-owners, commodity traders, shipping & service companies, shipping public policy research institutes, and other representatives from the port and shipping industry. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180920006031/en/ Speech made by Lord Jeffrey Evans, Chairman of Maritime London (Photo: Business Wire) In her keynote speech, Ms. Yuan Yue said, “Guangzhou is the gateway city of South China and is known as the “Millennium Business Capital” and a popular destination for business and investment. At present, Guangzhou has attracted investors from over 130 countries. Nearly 300 of the world's top 500 companies have businesses and investment in Guangzho

AbuDhabi Dubai STOB Series 22 Investment Enters into Favorable Tender Offer Agreement with MINDOL HOLDINGS21.9.2018 04:00Tiedote

AbuDhabi Dubai STOB Series 22 Investment Limited Partnership, hereafter AbuDhabi22, and MINDOL HOLDINGS LIMITED, hereafter MINDOL, listed on the Hong Kong-based Coinsuper exchange (https://www.coinsuper.com) have reached an agreement where AbuDhabi22 will acquire the minimum 33.3 percent holding for the MINDOL cryptocurrency (MIN, https://mindol.net) to be issued by MINDOL, via a tender offer (TOB). Implementation of the TOB will serve to strengthen the strategic partnership with MINDOL. Both companies expect that the AbuDhabi22 bid will greatly exceed any bids made via ordinary exchange channels. With a bid offering at a stable price, the TOB method was chosen for its strategic worth. The MINDOL business vision for 2019 sets a target for its cryptocurrency, from among the more than 2,000 types of cryptocurrencies currently available, to have a top-30 market capitalization. As a business that focuses on "the fusion of subculture and blockchain," they will develop an online game that ta

Afton Chemical’s S$380 Million Phase II Expansion of Its Jurong Island Plant is Now Complete20.9.2018 23:30Tiedote

Afton Chemical Corporation, a global leader in the lubricant and fuel additive market, today announced the completion of the Phase II expansion of its Chemical Additive Manufacturing Facility in Jurong Island, Singapore. This milestone was marked by a special visit from Singapore’s Minister for Trade & Industry Mr. Chan Chun Sing, who also made a speech and toured the facility. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180920005903/en/ Afton Chemical Corporation – Singapore Chemical Additive Manufacturing Facility Phase II Expansion (Photo: Business Wire) As a wholly owned subsidiary of NewMarket Corporation (NYSE: NEU), Afton has been a leading player in the lubricant and fuel additive marketplace for over 90 years. The company was founded on a Passion for Solutions® and has maintained a focus on customizing commercial and industrial solutions that meet customer needs. Afton begun its Singapore manufacturing operations

IFF Announces Pricing of €1,100,000,000 Senior Notes Offering20.9.2018 23:15Tiedote

Regulatory News: International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris: IFF), a leading innovator of sensorial experiences that move the world, today announced that it has priced its public offering of €300,000,000 aggregate principal amount of its 0.500% senior notes due 2021 and €800,000,000 aggregate principal amount of its 1.800% senior notes due 2026. IFF intends to use the net proceeds from the offering to pay a portion of the consideration for the previously announced merger with Frutarom Industries Ltd. and to pay related fees and expenses. IFF anticipates that the offering will close on September 25, 2018, subject to customary closing conditions. The offering is not contingent upon the consummation of the merger. If the closing of the merger has not occurred on or prior to February 7, 2019, or, if prior to such date, the merger agreement with Frutarom is terminated, IFF will be required to redeem all of the notes on the special mandatory redemption date at a redem

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme