Six Indian firms ink pact to supply HIV, Hepatitis C drugs to WHO

Six Indian pharmaceutical firms, including Aurobindo, Emcure, Hetero Labs, Laurus Labs, Lupin and Zydus Cadila, are among seven drug makers that have signed licensing pact with UN-backed Medicines Patent Pool (MPP) for producing HIV and Hepatitis C drugs.

A total of nine new sub-licensing agreements to produce generic versions of key World Health Organisation-priority HIV and Hepatitis C treatments have been signed by MPP with these pharmaceuticals firms and Shanghai-based Desano.

Zydus Cadila has inked a generic manufacturing pact with the MPP for manufacturing global pharma major Bristol-Myers Squibb's daclatasvir tablets used in the treatment of Hepatitis C.

The company ''has signed a non-exclusive, royalty-free agreement with the MPP for generic production of Bristol-Myers Squibb's daclatasvir, a novel direct-acting antiviral that is proven to help cure multiple genotypes of the Hepatitis C Virus,'' Zydus Cadila said in a statement.

The agreement sub licenses Zydus to produce and sell daclatasvir in 112 low and middle-income countries, it added.

The agreement sub-licences Zydus to produce and sell daclatasvir in 112 low and middle income countries, it added.

"We are happy to work together with the Medicines Patent Pool and Bristol-Myers Squibb to serve the cause of healthcare by providing access to new and affordable therapies to the economically disadvantaged communities across the developing countries," Zydus group Chairman and MD Pankaj R Patel said.

The MPP licence allows generic manufacturers to develop fixed-dose combinations that offer the potential to treat all of the six major genotypes of Hepatitis C Virus (HCV), the statement said.

Between 130 and 150 million people worldwide are estimated to have HCV. The vast majority lives in low and middle income countries, it added.

''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 Aurobindo signed two new sub-licences. The first allows the company to produce lopinavir and ritonavir for Africa, following MPP's agreement with AbbVie in December 2015. Aurobindo will also develop and sypply Bristol-Myers Squibb's daclatasvir, the first hepatitis C medicine in MPP's portfolio.

''We are very pleased to support product development of these key medicines for both HIV and hepatitis C and to continue our work with the MPP to bring formulations and fixed-dose combinations to market very soon,'' said Aurobindo's Managing Director N. Govindarajan.

Desano, a Chinese manufacturer based in Shanghai, and Emcure also signed licences for lopinavir and ritonavir.

Vik Thapar, head of strategy, Emcure said: ''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.''

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 WHO as part of second-line treatment for children less than 10 years of age. ''Hetero, through its partnership with MPP, has demonstrated success in creating larger access for HIV and hepatitis C treatment and now looks forward to supporting efforts to distribute low-cost versions of atazanavir and raltegravir,'' said Bhavesh Shah, Director- Hetero Drugs Limited.

Laurus and Lupin added to their portfolio of MPP-licensed drugs with agreements to produce daclatasvir and paediatric raltegravir, respectively. ''Laurus has been working with the MPP for more than four years on HIV and we are happy to support efforts to successfully treat hepatitis C with this promising medicine,'' stated Raju Kalidindi Executive Director.

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 world settings.