Three Additional Generic Manufacturing Partners Join Efforts to Increase Access to Generic Hepatitis C Treatment Glecaprevir/Pibrentasvir

Geneva, 4 October 2021 – The Medicines Patent Pool (MPP) today announced that it signed three new sublicence agreements with generic manufacturing companies, namely India-based Arene Life Sciences Private Limited and USV Private Limited, and Pakistan-based Remington Pharmaceuticals. Joining Mylan selected in February 2020, these three companies can now develop, manufacture and supply high-quality affordable versions of glecaprevir/pibrentasvir (G/P), a World Health Organization (WHO)-recommended treatment for people living with the hepatitis C virus (HCV).

G/P is an all-oral, once-daily, pan-genotypic combination regimen, originally approved in 2017. It is the only hepatitis C treatment recommended by WHO that is currently not yet available as a generic regimen. In November 2018, MPP signed a royalty-free licence agreement with AbbVie enabling quality-assured manufacturers to develop and sell generic medicines containing G/P in 96 LMICs at affordable prices.

“We are thrilled to count Arene Life Sciences Private Limited, Remington Pharmaceuticals and USV Private Limited as our partners for scaling up access to one of the most effective pan-genotypic regimens able to cure people living with hepatitis C in only eight weeks,” said Charles Gore, MPP Executive Director. “As with previous MPP licences, we look forward to facilitating access to high-quality affordable versions of this product as quickly as possible in as many countries as possible. This will mean that all the WHO-recommended hepatitis C treatments are available in generic form, potentially offering better supply security for countries and more choice for people living with hepatitis C.”

According to WHO, 58 million people live with HCV of whom 62% reside in LMICs. WHO’s goal is to eliminate viral hepatitis as a public health threat by 2030 but approximately 84% of the people infected with HCV are still not receiving treatment.

“At Arene, we think that access to safe, quality-assured treatments, affordable for all is key,” said K. Anuraag Reddy, Director, Arene Life Sciences Private Limited. “We look forward to taking our part in the global fight against hepatitis C and to strengthening our longstanding partnership with MPP.”

“Pakistan, where we are based, has the second highest global burden of HCV infection, with almost seven million people living with hepatitis C,” said Sehrish Aslam, Head of R&D Global Markets and Corporate Compliance (GxP), Remington Pharmaceuticals. “We are thrilled to have signed this sublicence agreement with MPP, becoming its first ever partner in Pakistan. This will benefit so many people affected by the disease around the world, including people from our own country.”

“After a rigorous selection process, we are very proud to have been selected by MPP as their partner for scaling up access to G/P for people in need in LMICs,” said Dr. Chetan Doshi, Chief Scientific Officer, USV Private Limited. “We are happy to start our collaboration with MPP and being able to supply soon this very important therapy for the treatment of HCV in LMICs.”

More information on the Abbvie-MPP licence agreement for G/P

Source: Medicines Patent Pool