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Mylan to make generic hepatitis drug under MPP sublicence Posted 02/12/2016

Generics giant Mylan Pharmaceuticals (Mylan) announced on 28 November 2016 that the company had signed a sublicence with the Medicines Patent Pool (MPP) to make a generic of Bristol-Myers Squibb’s hepatitis C medicine Daklinza (daclatasvir).

The agreement licences Mylan to produce and market generic daclatasvir tablets at dosages of 30 and 60 mg, for distribution in 112 low- and middle-income countries. It is estimated that 130−150 million people worldwide have hepatitis C. The vast majority of these are in low- and middle-income countries.

This latest agreement follows those for generics companies Cipla, Emcure, Hetero and Natco, who also signed non-exclusive, royalty free agreements with Bristol-Myers Squibb and the MPP to produce and sell generic daclatasvir [1].

Daclatasvir is indicated for use with sofosbuvir, with or without ribavirin, for the treatment of patients with chronic hepatitis C virus genotype 1 or genotype 3 infection in the US and genotype 1, 3 and 4 in Europe. The MPP licence allows generics makers to develop fixed-dose combinations that offer the potential to treat all of the six major genotypes of the hepatitis C virus. Earlier in 2016, the World Health Organization (WHO) added several new hepatitis C treatments, including daclatasvir, to its essential medicines list, highlighting the urgent need to promote equitable access to innovative medicines.

WHO estimates that about 3% of the world’s population has been infected with the hepatitis C virus and that more than 170 million chronic carriers are at risk of developing liver cirrhosis, liver cancer or both. Around 350,000 people are thought to die from the virus each year [2].

The announcement comes as welcome relief for poorer countries, who would, without such agreements, have had to wait many years to gain access to this treatment at prices affordable for the general population. Bristol-Myers Squibb only received approval for Daklinza in Europe on 22 August 2014 and in the US on 24 July 2015.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Medicines Patent Pool signs first sub-licences for HCV med daclatasvir [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 1]. Available from: www.gabionline.net/Generics/General/Medicines-Patent-Pool-signs-first-sub-licences-for-HCV-med-daclatasvir
2. GaBI Online - Generics and Biosimilars Initiative. Improving access to HCV treatment in developing countries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 1]. Available from: www.gabionline.net/Biosimilars/Research/Improving-access-to-HCV-treatment-in-developing-countries

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Source: Mylan

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