Mumbai, January 20:
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.
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