Indian drug firms dip into patent pool for Hep C drug

Indian drugmakers Cipla, 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, an 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.

Between 130 and 150 million people worldwide are estimated to have hepatitis C, largely in low and middle-income countries.

Greg Perry, MPP Executive Director, said: “Cipla, Hetero and Emcure are long-term partners working with us to develop generic HIV anti-retrovirals.” 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 per cent 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 middle-income countries. It was founded and remains fully funded by UNITAID.

COMMENT NOW