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Generic Sovaldi/ledipasvir Licensed by Gilead
  Gilead Press Release-
Gilead Announces Generic Licensing Agreements to Increase Access to Hepatitis C Treatments in Developing Countries -
-- Indian companies granted license to produce generic sofosbuvir and investigational single tablet regimen of ledipasvir/sofosbuvir for treatment of chronic hepatitis C --
NEW DELHI--(BUSINESS WIRE)--Sep. 15, 2014-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company has signed non-exclusive licensing agreements with seven India-based generic pharmaceutical manufacturers to expand access to its chronic hepatitis C medicines in developing countries. The agreements allow the companies - Cadila Healthcare Ltd., Cipla Ltd., Hetero Labs Ltd., Mylan Laboratories Ltd., Ranbaxy Laboratories Ltd., Sequent Scientific Ltd. and Strides Arcolab Ltd. - to manufacture sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir for distribution in 91 developing countries.
The countries within the agreement account for more than 100 million people living with hepatitis C, representing 54% of the total global infected population.
"Hepatitis C is a significant public health issue worldwide, and Gilead is working to make its chronic hepatitis C medicines accessible to as many patients, in as many places, as quickly as possible. In developing countries, large-volume generic manufacturing and distribution is widely regarded as a key component in expanding access to medicines. These agreements are essential to advancing the goals of our humanitarian program in these countries," commented Gregg H. Alton, Executive Vice President, Corporate and Medical Affairs, Gilead Sciences.
Under the licensing agreements, the Indian companies receive a complete technology transfer of the Gilead manufacturing process to enable them to scale up production as quickly as possible. The licensees also set their own prices for the generic product they produce, paying a royalty on sales to Gilead to support product registrations, medical education and training, safety monitoring and other essential business activities. The licenses also permit the manufacture of sofosbuvir or ledipasvir in combination with other chronic hepatitis C medicines.
Sofosbuvir was approved under the trade name Sovaldi® by the U.S. Food and Drug Administration (FDA) in December 2013 and by the European Commission in January 2014. The FDA and the European Medicines Agency are currently reviewing the company's applications for a single tablet regimen of ledipasvir/sofosbuvir; it is an investigational agent and its safety and efficacy have not been established.
For a fact sheet on the agreement, visit www.gilead.com........ http://www.gilead.com/~/media/Files/pdfs/other/HCVGenericAgreementFactSheet.pdf
Gilead's Approach to Treatment Access in Developing Countries
Gilead makes it a priority to increase access to its medicines for people who can benefit from them, regardless of where they live or their economic means. In developing countries, Gilead's treatment access strategies include tiered pricing, voluntary generic licensing (often in advance of U.S./EU regulatory approval), negotiation with national governments, regional business partnerships, product registration, medical education and partnerships with non-profit organizations. This approach has been successfully applied to Gilead's humanitarian program in HIV over the past ten years, with six million patients now receiving Gilead-based HIV medicines in developing countries.
NY Times - Maker of Costly Hepatitis C Drug Sovaldi Strikes Deal on Generics for Poor Countries - ".....struck deals with seven generic drug makers in India to sell lower-cost versions of the medicine - a $1,000-a-pill hepatitis C treatment - in poorer countries"......."Gilead plans to introduce the drug in India for about $10 a pill - 1 percent of the price in the United States.......That is likely to force the seven Indian generics companies to price their pills even lower".........The generic drugs will be available in India the second or third quarter of 2015 at the earliest.......The seven Indian generic drug makers will pay royalties to Gilead to manufacture the drug for 91 developing countries, where there are more than 100 million people infected with hepatitis C, more than half of the world's infected population........All companies will be allowed to set their own prices......allowing for a competitive market......."Our view is that the competition and the capabilities of our partners will bring down the price for both the Indian system and for health-care systems around the world,"
..........."Pricing for Thailand, Mexico or Brazil will be very different than the U.S. price."......Campaigners, however, were critical of the licensing deals, saying they would not ensure access to several middle-income countries where health authorities would still struggle to provide treatment to patients. http://www.nytimes.com/2014/09/16/business/international/maker-of-hepatitis-c-drug-strikes-deal-on-generics-for-poor-countries.html?_r=0
Reuters - Gilead licenses hepatitis C drug to Cipla, Ranbaxy, five others
By Aditya Kalra and Zeba Siddiqui, NEW DELHI/MUMBAI Mon Sep 15, 2014........http://in.reuters.com/article/2014/09/15/gilead-sciences-india-idINKBN0HA0TI20140915
Hepatitis C drug in India to cost Rs 49 lakh less than in US.......Gilead, announced on Monday that it would be selling the drug at this price in India and also giving voluntary licences to seven Indian pharma companies to produce it. TNN | Sep 16, 2014
Gilead to Allow Cheaper Hepatitis C Drug in Developing Countries Biotech Signed Licensing Deals to Produce Generic Versions of Its $1,000-a-Day Drug Sovaldi http://online.wsj.com/news/article_email/gilead-to-allow-cheaper-hepatitis-c-drug-1410779963-lMyQjAxMTE0ODEyNjgxMzY4Wj?tesla=y
Health Gap -
Gilead's Proposed Hepatitis C Medicines License -
How Badly Will it Miss the Target?

"Gilead has announced tiered pricing plans - where the company offers lower prices in different markets - for its branded HCV medicines in LMICs, and differential pricing between the public/voluntary sector and the private sector in specific countries. Using common drug company metrics, it plans to offer different price bands for the public sector and select NGOs in low-income countries, lower-middle-income countries, and upper-middle-income countries. It is uncertain at this point whether the public/NGO sector tiered pricing will be uniform within each tier or whether Gilead plans to negotiate country-by-county, particularly in the upper- middle-income country tier." Download the PDF here
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