Friday, April 21, 2017

The Medicines Patent Pool and Pharco Pharmaceuticals Sign Licence for Promising Hepatitis C Drug Candidate Ravidasvir

Agreement seeks to improve health options for hepatitis C patients in low- and middle-income countries  

Amsterdam, Netherlands, 21 April 2017 —The Medicines Patent Pool (MPP) announced a new licence and technology transfer agreement with Egyptian company Pharco Pharmaceuticals for ravidasvir (RAV), an investigational direct-acting antiviral (DAA) with the potential of working across all six major hepatitis C genotypes. The agreement, signed on the sidelines of the International Liver Congress in Amsterdam, will enable competitive supply of RAV in low- and middle-income countries (LMICs) including high prevalence nations Russia, Ukraine, Egypt and Iran.

“If successfully developed, ravidasvir could help treat millions of hepatitis C patients and we are pleased to work with Pharco to ensure the availability of affordable versions,” said Greg Perry, Executive Director of the Medicines Patent Pool.

“Chronic hepatitis C affects approximately 71 million people globally, with Egypt suffering from one of the highest burdens,” said Dr. Sherine Helmy, CEO of Pharco Pharmaceuticals. “RAV, in combination with other hepatitis C treatments, could support new national as well as global goals to eliminate the virus.”

MPP’s agreement expands the geographic scope of a licence signed by Presidio, the original developer of RAV, and the Drugs for Neglected Diseases initiative (DNDi) in March 2016, extending coverage to several LMICs that were not included in the DNDi licence. Combined, the MPP and DNDi agreements could potentially benefit countries where 85.3% of people live with hepatitis C in the 139 block of economies classified by the World Bank as low- and middle-income.

“DNDi is currently sponsoring trials of ravidasvir in combination with sofosbuvir with the objective of providing a pan-genotypic and affordable treatment for eventual distribution in developing countries,” said Dr. Bernard P├ęcoul, Executive Director of DNDi. “DNDi welcomes the opportunity to work with all partners to ensure that safe, effective and affordable drugs are made available to all those in need.”

“The combined efforts of MPP, DNDi and private sector partners show how R&D and licensing can be leveraged to deliver successful health solutions,” said Lelio Marmora, Executive Director of UNITAID, MPP’s funder.

RAV is an NS5A inhibitor that, in a Phase III trial in Egypt conducted by Pharco, demonstrated cure rates of up to 100% in patients with genotype 4 when used in combination with other treatments. The MPP also has a licence for Bristol-Myers Squibb’s daclatasvir, one of several approved DAAs with pan-genotypic potential that is revolutionising the hepatitis C field. Ten generic manufacturing companies are now licensed to produce and sell daclatasvir in 112 countries.

The MPP-Pharco licence for RAV is royalty-bearing over net sales in the licensed territory (four percent in low-income nations and seven percent for middle-income countries). Pharco Pharmaceuticals is waiving royalties for paediatric formulations. The licence includes a technology transfer to MPP’s sub-licensees.

About the Medicines Patent Pool
The Medicines Patent Pool is a United Nations-backed public health organisation working to increase access to HIV, hepatitis C and tuberculosis treatments in low- and middle-income countries. Through its innovative business model, the MPP partners with industry, civil society, international organisations, patient groups and other stakeholders to prioritise, forecast and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, the MPP has signed agreements with eight patent holders for twelve HIV antiretrovirals, one HIV technology platform, a tuberculosis treatment and two hepatitis C direct-acting antivirals. The MPP was founded and is funded by UNITAID.
Licence and list of countries in the MPP-Pharco agreement
Access DNDi April 2016 press release
Katherine Moore
Head of Communications
Medicines Patent Pool
Tel: +41 22 533 5054 | Mobile: +41 79 825 4786

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