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
Om Business Wire
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
CES Unveiled Amsterdam to Feature IoT, Smart Cities and Robotics17.10.2017 16:19 | Pressemelding
The Consumer Technology Association (CTA) announced today that more than 35 companies will showcase innovative products at the first-ever CES Unveiled Amsterdam, breaking the record for most exhibitors at an inaugural Unveiled event abroad. The event follows the fifth CES Unveiled Paris and serves as a preview of the innovative technology on display at CES 2018. CES Unveiled Amsterdam is scheduled to run from 1:30-5:30 PM on October 26, 2017 at the Beurs van Berlage. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171017006457/en/ “CES Unveiled Amsterdam is on track to break nearly all of our inaugural-year records for an Unveiled event abroad. From attendees to exhibitors, the tech community in the Netherlands and surrounding countries is showing unparalleled levels of interest in this event,” said Gary Shapiro, pre
Dropbox Brings Powerful Business-Grade Tools to Individuals with Dropbox Professional17.10.2017 16:00 | Pressemelding
Dropbox today launched Dropbox Professional, a new offering that introduces business-grade tools to help individual users store, share, and track work from a single, secure place. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171017006383/en/ Owners can add details on the materials in the Showcase at the top of the page. (Graphic: Dropbox) Dropbox Professional is designed to meet the needs of independent workers—a group that’s expected to rise to 47.6 million by 2022. The new offering brings together the most popular storage, sharing, and support solutions from Dropbox with new ways to present work to help individuals showcase their creativity in the best light. “Work is becoming more fluid as the scope of projects that individuals can take on expands,” said Todd Jackson, Head
The New Foldable Smartphone ZTE Axon M with Dual Screens Transforms the Mobile Experience for Consumers17.10.2017 14:40 | Pressemelding
ZTE Mobile Devices today announced the category defining ZTE Axon M, a foldable smartphone with dual screens that delivers a revolutionary smartphone experience to enable consumers to multitask and enjoy content in a better way. The ZTE Axon M provides the multitasking capabilities of two screens and a viewable screen size of a tablet, yet is the size of a traditional smartphone when folded, fitting easily into a pocket. Coming soon to consumers through leading partners in the US, Japan, China and Europe, the ZTE Axon M delivers new experiences never before seen in the smartphone market. “The ZTE Axon M is the beginning of true smartphone innovation, and ZTE is leading the way,” said Lixin Cheng, CEO of ZTE Mobile Devices. “The mobile technology ecosystem and consumer habits have evolved over the past several years, but the smartphone design has only slightly varied throughout that tim
Murex to Offer Cloud-Based Trading and Risk Management Solutions17.10.2017 14:00 | Pressemelding
Sibos - Murex, an industry leader in trading, risk management and processing solutions for capital markets, announces it has certified its MX.3 technology platform to run on Microsoft Azure. Since early 2016, Murex has collaborated with Microsoft to bring to market solutions enabling clients’ digital transformation. This collaboration has now come to fruition with the availability of support for the Murex MX.3 platform on Azure, as well as the planned integration of Microsoft SQL Server 2016 as a relational database for MX.3. Murex has certified Azure for its most demanding use cases including GPU-powered solutions for computationally intensive workloads. This enables Murex clients to leverage the flexibility and economies of scale of the cloud to meet new requirements. Those opting to adopt cloud as part of their infrastructure will continue to benefit from the full support
euNetworks Partners with Cloudwirx17.10.2017 14:00 | Pressemelding
euNetworks, a provider of bandwidth services in Europe, today announced it is working with Cloudwirx, enabling their West Coast client base with rapid access to euNetworks high bandwidth services. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171017006083/en/ Brady Rafuse, Chief Executive Officer of euNetworks (Photo: Business Wire) Cloudwirx is a leading procurement and systems integrator for data centre and bandwidth infrastructure services, helping companies source, build and optimise their IT systems and networks. Whether it’s for a start-up or Fortune 100 company, Cloudwirx matches enterprises with the right technologies, services, and suppliers, with the goal of decreasing costs while increasing the value add of their IT systems. They have a growing client base who, while predominantly U
Asseco SEE’s Enterprise Fraud Monitoring & Prevention Solution InACT® is in GarantiBank NV17.10.2017 13:59 | Pressemelding
Asseco SEE (ASEE), part of Asseco Group, 6th largest software vendor in Europe, announced today, that GarantiBank NV, member of BBVA Group, has deployed InACT® Enterprise Fraud Management to prevent and monitor fraud. Chosen by leading international banks and financial institutions to stop internal and external fraud activities since 2009, an additional tailor-made file management module has been developed for GarantiBank NV to manage SWIFT and SEPA transactions for the project. InACT® File Management Module checks and resolves SWIFT and SEPA message files regularly and filters through InACT® fraud scenarios. Also, InACT® produces alarms for managers to prevent fraudulent activities by identifying related files. With this infrastructure developed by ASEE, GarantiBank NV intends to enhance its fraud monitoring activities on a digital platform rather than manual controls. This change is
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom