Cipla, Emcure, Hetero and Natco join patent pool for new Hepatitis C drug

Indian drugmakersCipla, Emcure, Hetero and Natco have received the first round of sub-licences from the Medicines Patent Pool (MPP) to make generic versions of Bristol-Myers Squibb’s hepatitis C drug, Daclatasvir. The development marks a first for generic drug companies working through a non-profit, public health organisation to increase access to new hepatitis C medicines for developing world patients, and MPP note said.

The companies have signed non-exclusive, royalty-free agreements with Bristol-Myers Squibb (BMS) and the United Nations-backed MPP to produce and sell the anti-viral Daclatasvir in 112 low and middle-income countries.

The sub-licences follow MPP’s announcement of its first hepatitis C licensing agreement, signed with BMS in November 2015. Around 150-mn people worldwide are estimated to have hepatitis C, largely in low and middle income countries.

MPP is also assessing applications from several other companies and expects to grant further sub-licences soon.

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 (HCV). Daclatasvir, in combination with Sofosbuvir, for example, produces high cure rates after 12 weeks of treatment, with recent phase III studies demonstrating that the regimen could cure up to 100% of HCV patients, depending on genotype and stage of liver disease.

The MPP works to increase access to HIV, viral hepatitis C and tuberculosis treatments in low- and meddle-income countries. It was founded and remains fully funded by UNITAID.

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