6 Indian drug makers sign licensing deals for HIV, hepatitis C treatments

Hyderabad: A United Nations backed public health organisation on Thursday said it has signed a licencing agreement with six Indian drug makers to sell generic antiretrovirals (ARV) and the hepatitis C drug Daclatasvir in low and middle-income countries.

The Medicines Patent Pool (MPP) named the Indian manufacturers as: Aurobindo Pharma Ltd, Emcure Pharmaceuticals Ltd, Hetero Labs Ltd, Laurus Labs Ltd, Lupin Ltd and Zydus Cadila or Cadila Healthcare Ltd.

Anti-retroviral drugs are used in the treatment of patients with human immunodeficiency virus (HIV) infection, while Daclatasvir, in combination with sofosbuvir, is an effective treatment for patients with hepatitis-C.

MPP is a UN-backed public health organisation that works towards increasing access to drugs for HIV, hepatitis C and tuberculosis by negotiating for public-health driven licences with patent holders. Patent holders are compensated by royalties, saving millions of dollars for donors and developing country governments.

“These new sub-licences will secure greater volumes of low-cost medicines for people living with HIV and hepatitis C in low- and middle-income countries,” said Greg Perry, MPP’s executive director. “We look forward to working with the companies to speed delivery of these treatments to those most in need of better medical options.”

MPP’s long-time generic partner Hyderabad-based Aurobindo Pharma signed two sub-licences. The first allows the company to produce combination ARV drug lopinavir and ritonavir for Africa, following MPP’s agreement with US-based AbbVie Inc. in December 2015.

Aurobindo also joins six other companies in the development of Bristol-Myers Squibb Co.(BMS)’s Daclatasvir, the first hepatitis C medicine in MPP’s portfolio. Aurobindo sold ARV drugs worth of Rs.1200 crore or 11% of its total generic sales of Rs.11,166 crore in the year ended March, largely through participating in contracts brokered by multilateral agencies.

Pune-based Emcure said it has signed licences for lopinavir and ritonavir.

“LPV/r is a life-line for people living with HIV on the continent who have developed resistance to first-line treatments, additional, long-term supply is crucial,” said Vikas Thapar, head of corporate development and strategy of Emcure.

Hetero, an MPP generic partner since 2012, signed sub-licences for atazanavir, an important second-line antiretroviral licensed to the MPP by BMS in December 2013 and Raltegravir for paediatric use, a treatment MPP licensed from MSD (Merck & Co. in the United States and Canada) in February 2015.

Raltegravir was recently recommended by the UN World Health Organization as part of second-line treatment for children less than 10 years of age. Laurus and Lupin added to their portfolio of MPP-licensed drugs with agreements to produce Daclatasvir and paediatric Raltegravir, respectively.

Ahmedabad-based Zydus Cadila, joined MPP network for the first time to supply Daclatasvir. The MPP’s 13 generic manufacturing partners are currently working on more than 60 projects to develop crucial treatments for both children and adults in developing countries.

There are 37 million people eligible to receive HIV treatment, according to WHO. But only 15 million have access, and majority of them are living in low and middle-income countries. Moreover, of the 3.3 million children living with HIV today, only 32% receive antiretroviral therapy.

Hepatitis C is a major public health threat affecting up to 150 million people globally, with the vast majority living in low- and middle-income countries.

Disclaimer: This information has been collected through secondary research and IBEF is not responsible for any errors in the same.