[The International Liver Congress 2016, Barcelona, Spain, 13 April 2016] The Drugs for Neglected Diseases initiative (DNDi) and the Egyptian drug manufacturer Pharco Pharmaceuticals have signed agreements covering the clinical testing and scale-up of a hepatitis C treatment regimen at a price of just under $300.
"If our clinical trials are successful, this regimen could become part of a public health approach to treating hepatitis C that will be an alternative to today's high drug prices and treatment rationing," said Dr Bernard Pécoul, Executive Director of DNDi. "An affordable cure for this deadly disease that treats all strains, or 'genotypes,' of the disease, is essential to tackling the worldwide hepatitis C epidemic."
DNDi will be launching clinical trials to test a combination treatment of the drug candidate ravidasvir and the registered hepatitis C drug sofosbuvir in pan-genotypic patient populations in Malaysia and Thailand, as soon as the necessary approvals are received. Ravidasvir is an NS5A inhibitor, one of a new generation of direct-acting antivirals (DAAs) that are revolutionizing the treatment of hepatitis C. In a Phase III clinical trial in Egypt, conducted by Pharco, ravidasvir showed cure rates of up to 100% in patients with genotype 4 when used in combination with sofosbuvir, which also is a DAA.
DNDi has licensed rights for ravidasvir in low- and middle-income countries from Presidio Pharmaceuticals.
Pharco has agreed to supply DNDi with the combination sofosbuvir plus ravidasvir for its clinical studies for $300 per course of treatment. For the scale-up of this regimen, once approved, Pharco has agreed to set the commercial price at $294 or less per treatment course.
"Because of the high prices of new hepatitis C medicines, it has been almost impossible for governments to provide access to treatment at the necessary scale," said YB Datuk Seri Dr. S. Subramaniam, the Minister of Health in Malaysia. "We are pleased to support this project and hope data from these studies will support our efforts to introduce this combination as soon as possible and scale up to reach all patients in need."
DNDi's Phase II/III studies in Malaysia and Thailand will be conducted with the full cooperation of both governments and will compare sofosbuvir plus ravidasvir with a current standard of care, sofosbuvir plus daclatasvir. These studies will enroll approximately 1,000 participants and will evaluate the efficacy, safety, and pharmacokinetics of the sofosbuvir plus ravidasvir combination in patients with various levels of liver fibrosis, various genotypes, and with/without HIV co-infection.
"We are encouraged by the signing of these agreements as they will help millions of people who are affected by chronic hepatitis C infection around the world," said Dr. Amnuay Gajeena, Director General of the Department of Disease Control in Thailand. "Accessibility to affordable DAAs is key and participation in this research will facilitate the process of scaling up effective treatment of hepatitis C infection, and foster the prevention and control of the disease."
Malaysia and Thailand are among the many middle-income countries that are excluded from the voluntary licensing agreements that Gilead and Bristol-Myers Squibb, the intellectual property holders of the hepatitis C drugs sofosbuvir and daclatasvir, respectively, have concluded with generic companies. Of the up to 150 million people infected with chronic hepatitis C globally, approximately 75% live in middle-income countries.
"Once these trials have been successfully completed and the safety and efficacy data of this combination assessed, we will encourage governments to design their national health strategies to use all options at their disposal to gain access to life-saving DAAs, including price negotiation, voluntary licensing, or the use of TRIPS flexibilities such as patent oppositions and compulsory licensing," added Dr. Pécoul.
Before DAAs became available, hepatitis C treatment consisted of multiple injections over a period of up to one year and frequently caused severe side effects. Treatment was only successful 40-80% of the time. DAAs have transformed treatment options for patients and clinicians, but multiple barriers to access for patients exist, in particular, price. As with the introduction and scale-up of antiretroviral therapy for HIV/AIDS over the past 15 years, new and innovative public health approaches to HCV treatment will require affordable access to DAAs.
"Egypt has the world's highest hepatitis C prevalence, yet thanks to an Egyptian Presidential program that aims to treat one million patients a year, economies of scale have helped make DAAs affordable and are helping to reach our goal of a world free from hepatitis C," said Dr. Sherine Helmy, CEO of Pharco Pharmaceuticals. "We hope that our collaboration with DNDi to develop a combination treatment that costs $3.50 per day or less - as opposed to $1000 per day for only one pill - will lead to widespread access to safe, effective, and affordable treatment for hepatitis C patients around the world."
Note to editors:
- Today, DNDi released a paper outlining its R&D strategy for hepatitis C, 'An alternative Research and Development Strategy to Deliver Affordable Treatments for Hepatitis C Patients' (http://www.dndi.org/wp-content/uploads/2016/04/AlternativeRDStrategyHepC.pdf). DNDi's paper describes how the race to approve blockbuster DAAs in the US and the European Union has led to exorbitant drug prices and also has neglected certain patient populations. Under the current R&D model, research has prioritized genotypes which are predominant in high-income markets, and has promoted competition rather than collaboration for the development of optimal combinations for public health use.
- Further details of the terms of the non-exclusive license agreement between DNDi and Presidio, including the lists of countries covered, are provided in DNDi's R&D strategy paper (see above).
- The Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization (WTO) sets forth minimum standards for intellectual property protection. "TRIPS flexibilities" refers to fully legal steps governments can take to overcome intellectual property barriers to access to medicines, including compulsory licensing, parallel importation, etc. and were reaffirmed in the November 2001 Declaration on the TRIPS Agreement and Public Health.
Ilan Moss (on site at the International Liver Congress), DNDi North America: +1 646 266 5216, email@example.com
Manisha Sharma, DNDi India: +91 9711 009 088, firstname.lastname@example.org
Violaine Dällenbach, DNDi Europe: +41 22 906 92 47, +41 79 424 14 74, email@example.com
A not-for-profit research and development organization, DNDi works to deliver new treatments for neglected diseases, in particular leishmaniasis, human African trypanosomiasis, Chagas disease, specific filarial infections, paediatric HIV, mycetoma, and hepatitis C. Since its inception in 2003, DNDi has delivered six treatments: two fixed-dose antimalarials (ASAQ and ASMQ), nifurtimox-eflornithine combination therapy (NECT) for late-stage sleeping sickness, sodium stibogluconate and paromomycin (SSG&PM) combination therapy for visceral leishmaniasis in Africa, a set of combination therapies for visceral leishmaniasis in Asia, and a paediatric dosage form of benznidazole for Chagas disease. DNDi has established regional disease-specific platforms, which bring together partners in disease-endemic countries to strengthen existing clinical research capacity, as well as to build new capacity where necessary. http://www.dndi.org
Pharco Pharmaceuticals, Inc. is the largest manufacturer of pharmaceuticals in Egypt, focused on research, formulation, manufacturing and commercialization of pharmaceutical products in the MENA region. Today, Pharco employs over 8,000 employees, and has over 500M product sales units--ranking as the leader in the Egyptian pharmaceutical market. Pharco also exports to 47 countries around the world. Pharco works towards one goal...to provide highly effective and safe pharmaceutical products to patients at an affordable price. Pharco licensed ravidasvir hydrochloride, formerly known as (PPI-668), from Presidio Pharmaceuticals, a San Francisco-based clinical stage, specialty pharmaceutical company. http://pharco.org