Gilead Announces New License Agreement With the Medicines Patent Pool for Access to Bictegravir
Gilead Sciences, Inc. (NASDAQ:GILD) announced today a new licensing agreement with the Medicines Patent Pool (MPP), a United Nations-backed public health organization, to expand access to bictegravir (BIC) upon regulatory approval in the United States. BIC is a novel investigational integrase strand transfer inhibitor for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. Through this agreement, MPP can sub-license rights to BIC to generic drug companies in India, China and South Africa to manufacture therapies containing BIC for distribution in 116 low- and middle-income countries.
Gilead has also expanded its licensing agreements with Sun Pharmaceutical Industries Limited, Strides Shasun Limited, Mylan Laboratories Limited and SeQuent Scientific Limited to include BIC, and products incorporating the compound, for distribution in 116 developing countries.
Under these voluntary licensing agreements, the manufacturers may produce BIC as a single agent or in fixed-dose combinations with other HIV medicines. BIC is the fifth HIV agent to be licensed in Gilead’s agreements with the MPP and generic manufacturers. Gilead and the MPP recently expanded the geographic scope of the licensing agreements for Gilead’s other HIV therapies to include Malaysia, Philippines, Ukraine and Belarus.
“These agreements allow for our licensees to provide generic versions of our latest therapies to people living with HIV in the developing world,” said Gregg H. Alton, Executive Vice President for Corporate and Medical Affairs at Gilead Sciences. “Today, more than 10 million people in resource-limited countries are on Gilead-based HIV therapies, which would not be possible without these strong alliances.”
Voluntary licensing agreements are a key component of Gilead's efforts to increase access to the company's therapies in the developing world. Competition among manufacturers has reduced the lowest price of a Gilead HIV generic therapy by 80 percent since 2006, to as low as $3.50 per patient per month. Ninety-nine percent of people taking Gilead’s HIV therapies in developing countries receive generic medicine.
Gilead has filed a New Drug Application to the U.S. Food and Drug Administration for an investigational, once-daily single tablet regimen containing BIC (50mg) and emtricitabine/tenofovir alafenamide (200mg/25mg) (BIC/FTC/TAF). In the European Union, the company’s Marketing Authorization Application for BIC/FTC/TAF has been fully validated and is now under evaluation by the European Medicines Agency.
BIC 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.
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 may not approve BIC/FTC/TAF in the currently anticipated timelines, and 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.
Gilead Sciences, Inc.
Sung Lee, 650-524-7792
Michele Rest, 650-577-6935
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 23:24 | Tiedote
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 23:07 | Tiedote
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 21:23 | Tiedote
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 21:13 | Tiedote
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 firstname.lastname@example.org. “People who smoke deserve in
IBC2018 Announces Cyber Security Forum to Help Media Tackle Cyber Threats21.6.2018 19:30 | Tiedote
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 19:23 | Tiedote
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