The Medicines Patent Pool (MPP) inked a license and technology transfer agreement with Egyptian drug manufacturer Pharco Pharmaceuticals covering affordable supply of the late-clinical-stage pan-genotypic hepatitis C virus (HCV) drug ravidasvir (PPI-668) in certain low- and middle-income countries (LMICs) with high hepatitis prevalence, including Russia, Ukraine, Egypt, and Iran.
Ravidasvir is a direct-acting antiviral (DAA) NS5A inhibitor that has been evaluated successfully as combination therapy with the registered HCV drug sofosbuvir, in a Phase III study in Egypt, carried out by Pharco. The license granted to the United Nations-backed public health organization MPP extends the geographic coverage of a license signed last year between Presidio, which originally developed ravidasvir, and the Drugs for Neglected Diseases initiative (DNDi). MPP says the two deals mean that ravidasvir could in future be accessible to the 85% of hepatitis patients who live in LMIC regions.
The MPP license includes a technology transfer to MPP's sublicensees.” 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, MPP executive director.
DNDi and Pharco signed an agreement in March 2016 covering the clinical testing and scaleup of a HCV therapy regimen combining ravidasvir with sofosbuvir, in pan-genotypic patients in Malaysia and Thailand, at a cost per treatment course of under $300. Pharco had also agreed to set a commercial price for the treatment course, once the therapeutic regimen achieved regulatory approval, of $294.
“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,” stated Dr. Bernard Pécoul, M.D., MPH,executive director of DNDi, in response to the latest deal between MPP and Pharco. “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 license deal between MPP and Pharco includes future royalties set at 4% for low-income nations, and 7% in middle-income countries, although Pharco is waiving royalties for pediatric formulations.
In 2015, MPP negotiated a royalty-free license for the generic manufacture of Bristol-Myers Squibb's FDA- and EC-approved NS5A replication complex inhibitor daclatasvir for sale in 112 LMICs.