Release date- 05102017 - FOSTER CITY, Calif. - 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.
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 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.