Business Wire

Gilead Presents Results From Phase 3 Study Evaluating Patients Who Switched to Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide From Boosted Protease Inhibitor-Based Regimens

Jaa

Gilead Sciences, Inc. (NASDAQ: GILD) today announced detailed 48-week results from a Phase 3 study (Study 1878) evaluating the efficacy and safety of switching virologically suppressed HIV-1 infected adult patients from a multi-tablet regimen containing a boosted protease inhibitor (bPI) to a fixed-dose combination of bictegravir (50 mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF), a dual-NRTI backbone. In the ongoing study, BIC/FTC/TAF was found to be statistically non-inferior to regimens containing bPIs and demonstrated no treatment-emergent resistance at 48 weeks. The data are being presented at IDWeek 2017 in San Diego (Session 228).

“These data demonstrate the potential of BIC/FTC/TAF to match the efficacy of a boosted protease inhibitor regimen while also offering a high barrier to resistance and fewer interactions with other drugs,” said Eric Daar, MD, Chief of the Division of HIV Medicine at Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and lead author of Study 1878. “The findings, along with data from three other Phase 3 studies in both treatment-experienced and treatment-naïve patients, suggest that the investigational regimen of BIC/FTC/TAF may be appropriate for a broad range of people living with HIV.”

In Study 1878, a total of 577 virologically suppressed adults with HIV taking regimens of boosted atazanavir (ATV) or darunavir (DRV) + abacavir/lamivudine (ABC/3TC) or FTC/tenofovir disoproxil fumarate (TDF) were randomized 1:1 to continue their bPI regimen or to switch to open-label coformulated BIC/FTC/TAF once daily. At the primary endpoint of Week 48, switching to BIC/FTC/TAF was non-inferior to continuing on a bPI regimen with 1.7 percent of patients in each group having HIV-1 RNA ≥50 c/mL (difference: 0.0 percent, 95 percent CI: -2.5 percent to 2.5 percent, p=1.00); the proportion of patients with HIV-1 RNA <50 c/mL was 92.1 percent in the BIC/FTC/TAF arm and 88.9 percent in the bPI arm, according to FDA snapshot algorithm.

No patients in the BIC/FTC/TAF arm developed treatment-emergent resistance, and one participant on DRV/ritonavir + ABC/3TC developed a treatment-emergent NRTI mutation associated with abacavir. No renal adverse events leading to discontinuations or cases of proximal renal tubulopathy occurred with BIC/FTC/TAF. The incidence of grade 3 or 4 adverse events was 4 percent (n=13) for the BIC/FTC/TAF arm versus 6 percent (n=18) for the bPI arm; the incidence of grade 3 or 4 laboratory abnormalities was 16 percent (n=45) for the BIC/FTC/TAF arm versus 29 percent (n=83) for the bPI arm. The most commonly reported adverse events (all grades) in both arms included headache, diarrhea, nasopharyngitis and upper respiratory tract infection.

“The combination of the unboosted integrase inhibitor bictegravir with the FTC/TAF backbone has the potential to further evolve HIV triple therapy with convenient dosing in a single-tablet regimen,” said Norbert W. Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. “We look forward to the opportunity to offer patients this next-generation therapy as part of our TAF-based portfolio of treatments for HIV.”

Gilead filed a New Drug Application for BIC/FTC/TAF with a Priority Review voucher on June 12, 2017, and the U.S. Food and Drug Administration (FDA) set a target action date of February 12, 2018, under the Prescription Drug User Fee Act. A marketing application for BIC/FTC/TAF is also under review in the European Union and was validated by the European Medicines Agency (EMA) on July 13.

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.

Further information about the clinical trials can be found at www.clinicaltrials.gov.

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 the possibility that regulatory authorities, including the FDA and EMA, may not approve BIC/FTC/TAF in the currently anticipated timelines or at all, and any marketing approvals, if granted, may have significant limitations on their use. As a result, BIC/FTC/TAF may never be successfully commercialized. 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 June 30, 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.
Investors
Sung Lee, 650-524-7792
or
Media
Ryan McKeel, 650-377-3548

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 jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

First Westinghouse AP1000® Nuclear Plant Sanmen 1 Completes Initial Criticality21.6.2018 23:24Tiedote

Westinghouse Electric Company, China State Nuclear Power Technology Corporation (SNPTC) announced today that the world’s first AP1000 nuclear power plant located in Sanmen, Zhejiang Province, China has successfully completed initial criticality. “Today we completed the final major milestone before commercial operation for Westinghouse’s AP1000 nuclear power plant technology,” said José Emeterio Gutiérrez, Westinghouse president and chief executive officer. “We are one step closer to delivering the world’s first AP1000 plant to our customer and the world – with our customers, we will provide our customers in China with safe, reliable and clean energy from Sanmen 1.” Following initial criticality will be connection to the electrical grid. Once plant operations begin at Sanmen 1, it will be the first AP1000 nuclear power plant in operation, offering innovative passive safety system technology, multiple layers of defense and advanced controls for unequaled reliability and safety. Commentin

Westinghouse Loads Fuel in Second AP1000® Nuclear Power Plant21.6.2018 23:07Tiedote

Westinghouse Electric Company and its customers, China State Nuclear Power Technology Corporation (SNPTC) and Shangdong Nuclear Power Company Limited (SDNPC) announced today that Haiyang Unit 1, the AP1000 nuclear power plant located in Haiyang, Shandong Province, China, has begun to load fuel. “This is a great day for Westinghouse, our China partners and the nuclear industry. Haiyang Unit 1 continues to demonstrate our ability to deliver safe, innovative solutions for power generation,” said José Emeterio Gutiérrez, Westinghouse president and chief executive officer. He added, “Westinghouse will continue to deploy AP1000 technology throughout the world and demonstrate our technical leadership in the nuclear energy industry.” Fuel load at Haiyang Unit 1 commenced at 7:36 p.m. (GMT+8) today. Earlier this summer, in preparation for fuel load, Haiyang Unit 1 successfully completed the necessary testing and regulatory reviews conducted by China’s National Nuclear Safety Administration (NNS

Pharnext to Announce Top-Line Results from the Pivotal Phase 3 Trial of PXT3003 for the Treatment of Charcot-Marie-Tooth Type 1A Disease by October 201821.6.2018 21:23Tiedote

Regulatory News: Pharnext SA (Paris:ALPHA) (FR0011191287 - ALPHA), a biopharmaceutical company pioneering a new approach to the development of innovative drug combinations based on big data genomics and artificial intelligence, today announced an update from its ongoing Phase 3 clinical program (PLEO-CMT and PLEO-CMT-FU studies) evaluating PXT3003 for the treatment of Charcot-Marie-Tooth type 1A disease (CMT1A) in adults. Top-line results from the pivotal PLEO-CMT study are now expected by October 2018. Prof. Daniel Cohen, M.D., Ph.D., Pharnext’s Co-Founder and Chief Executive Officer said: “We are thrilled to bring this Phase 3 clinical trial to completion and we now expect to disclose top-line results by October of this year. Our PLEODRUG™ PXT3003 has already shown initial signals of efficacy in our Phase 2 trial in CMT1A. We are hopeful we can bring this much-needed therapy to patients suffering from this debilitating condition, as they currently have limited therapeutic options, mo

Philip Morris International Makes Call to Creative, Media and Communications Communities21.6.2018 21:13Tiedote

Philip Morris International Inc. (“PMI”) (NYSE: PM), today announced a bold call to action for the creative, media and communications communities to embrace its ongoing commitment to creating a smoke-free world. As part of this initiative, PMI will offer smoke-free alternatives wherever we can, including heated tobacco products and e-cigarettes, to current smokers in the industry who would otherwise continue to smoke. During a keynote at the PMI Science Lounge at The Cannes Festival of Creativity, SVP of Communications Marian Salzman said, “We are asking the creative community to join us in raising awareness of the potential of science, technology and innovation for those who smoke and the people around them.” The move is part of PMI’s vision to lead the charge towards greater innovation and technology in the tobacco industry, all of which is backed by science. Agencies interested in joining the movement can contact Marian Salzman at marian.salzman@pmi.com. “People who smoke deserve in

IBC2018 Announces Cyber Security Forum to Help Media Tackle Cyber Threats21.6.2018 19:30Tiedote

IBC2018, the world’s most influential media, entertainment and technology show, today announces a Cyber Security Forum to expand its position as the preeminent cyber security destination for broadcasters and media. The event will form part of the prestigious annual IBC show at the RAI in Amsterdam from Thursday 13 to Tuesday 18 September 2018, which last year attracted more than 57,000 attendees from 170 countries. The Cyber Security Forum is one-day, invitation-only event that will convene Chief Technology Officers, Chief Information Officers, Chief Information Security Officers and Chief Digital Officers within media and broadcasting for a conversation on the challenges and opportunities presented by cyber security for broadcasters. Attendees will discuss how to anticipate the next cyber threat, how to manage a breach and how to prepare for the future of cyber security. The Cyber Security Forum sits alongside the Telco & Media Innovation Forum and Leaders’ Forum as part of IBC’s Exec

Mensia Technologies Raises 1,3 Million Euro to Introduce Koala Neurofeedback as a Revolutionary Medical Device in Europe21.6.2018 19:23Tiedote

Mensia Technologies, french MedTech start up, leads the new booming category of Digital therapeutics with its revolutionary « at home « neurofeedback, to train the brain and cure neuropsy disorders without drugs. Co-founder INRIA-IT2, existing shareholders and now HARA, which are business angels experts in medical device category, joined this fund raise. BPI de Rennes is also part of this tour. Mensia Technologies, borned out of INRIA in 2012. The IT expert labs in Rennes are computing real time signaling softwares. The neurofeedback technique is non invasive, at home and without drugs. MENSIA KOALA treats ADHD, Attention Deficit Disorders with or without Hyperactivity, children and adolescents. This unique medical device is a therapeutic video game on an interactive tablet connected to the brain activity. Children learn to control their attention by exercising 3 times a week during 4 months of treatment. Visual feedback given during the game, allows the children to learn, control and

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