A new collaboration between pharmaceutical companies and non-profit organizations will manufacture and supply a new, more affordable, hepatitis C treatment regimen in Latin America. An estimated 3.5 million people live with this viral disease in Latin America including around 325,000 in Argentina, with high treatment prices one of the many barriers to access for life-saving care.
Under the terms of the collaboration announced at the 18th International Congress on Infectious Diseases (ICID), Buenos Aires, Egyptian pharmaceutical company Pharco Pharmaceuticals (Pharco) will supply the active pharmaceutical ingredients for sofosbuvir and drug candidate ravidasvir. Pharmaceutical company Insud Pharma and Argentinian research and development company Laboratorio Elea Phoenix (Elea) will register, manufacture, and distribute ravidasvir and sofosbuvir in Latin America. Non-profit research and development organization Drugs for Neglected Diseases initiative (DNDi) will collaborate with clinical trials data and jointly with non-profit foundation Mundo Sano will collaborate on advocacy activities to boost access to easy diagnosis and affordable treatment of hepatitis C virus (HCV).
"Our ambition is to help develop a new safe, effective, and affordable treatment regimen which will allow countries to take a public health approach to hepatitis C," said Dr Bernard Pécoul, DNDi Executive Director.
Currently a 12-week course of HCV treatment is available in Argentina for at least US$7,000, in Chile for $12,000 and in Brazil for over $6,000. Although the cost of manufacturing ravidasvir is potentially higher than some direct-acting antivirals (DAAs), the commitment from all partners to a reasonable profit margin means that the target price of the new ravidasvir/sofosbuvir combination will be under $500 in Latin America.
"We are proud to have Insud Pharma, Elea, and Pharco as reliable industrial partners capable of registering and manufacturing what will be a quality new drug that could transform the dynamic of access to HCV treatment in Latin America," said Silvia Gold, President of Mundo Sano.
Ravidasvir is an NS5A inhibitor produced by Pharco, one of a new generation of DAAs that are revolutionizing the treatment of hepatitis C. DNDi clinical trials are testing its potential use as a treatment in combination with sofosbuvir, an existing DAA, to prove its pan genotypic profile in treatment-naïve and treatment-experienced patients, in cirrhotic and non-cirrhotic patients, in people co-infected with both HCV and HIV, and in people who inject drugs. The full safety and efficacy results of a Phase II/III clinical trial in 301 patients in Malaysia and Thailand, covering the same genotypes as are prevalent in Latin America, will be published in April 2018. In an earlier Phase III clinical trial in 300 patients in Egypt, conducted by Pharco, ravidasvir showed an overall cure rate of 98% in patients with genotype 4 when used in combination with sofosbuvir.
"We hope that our collaboration will lead to widespread access to safe, effective, and affordable treatment for patients in Argentina and around the region," said Dr Sherine Helmy, CEO of Pharco Pharmaceuticals.
"As a leading Argentine pharmaceutical company, one of Elea's principles is the development of new effective, safe, and affordable therapies for people. This new treatment will be fully produced in our manufacturing facilities in Argentina and will be available for all those living with this disease in Argentina and Latin America," said Eduardo Spitzer, Scientific Director, Elea Phoenix.
Countries in the region are adopting different strategies to face the high price of HCV treatment. However, a number of patent applications that could prevent affordable access to sofosbuvir are pending in Argentina and in other Latin American countries, all of which are middle-income countries (MIC) as per the World Bank's classification. In September 2017, Malaysia, also an MIC, issued a "government use" licence enabling access to more affordable versions of the expensive medicine. This landmark decision will help the more than 400,000 people living with hepatitis C in Malaysia access sofosbuvir, and could have important repercussions in the global effort to secure access to treatments for this viral disease.
Insud Pharma/Elea/Mundo Sano: Lorena Sueiro, firstname.lastname@example.org
Pharco: Yaser Fayed, email@example.com
About Elea Phoenix
With more than 75 years of experience, Elea Phoenix researches and develops reliable medicines for a range of medicinal specialties. It is one of the top pharmaceutical companies of Argentina in terms of revenues. It has leading brands, innovative R&D projects, and licenses from major international companies. With its own production plants and a wide distribution network, it is oriented to the development of new products, mainly in the areas of Women's Health, Cardiology, Neurosciences, Oncology and OTC drugs. http://www.elea.com
About Mundo Sano
Mundo Sano is a private foundation dedicated to developing research, prevention, diagnosis and treatment programs to reduce the impact of neglected diseases. http://www.mundosano.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 650M 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://www.pharco.org
The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit R&D organization working to deliver new treatments for neglected patients, in particular sleeping sickness, Chagas disease, leishmaniasis, filaria, paediatric HIV/AIDS, and hepatitis C. http://www.dndi.org