UN-backed Medicines Patent Pool licences hepatitis C drug to four Indian companies

The Medicines Patent Pool (MPP), a United Nations-backed public health organisation, has granted sub-licences for the generic production of Bristol-Myers Squibb’s daclatasvir, an antiviral drug used for curing hepatitis C, to Cipla, Emcure, Hetero and Natco. These companies have signed non-exclusive, royalty free agreements with Bristol-Myers Squibb and the MPP to produce and sell daclatasvir in 112 low- and middle-income countries.
 
The sub-licences follow MPP’s announcement of its first hepatitis C licensing agreement, signed with Bristol-Myers Squibb in November 2015, and mark the first time that generic manufacturers have worked through a non-profit, public health organisation to increase access to new hepatitis C medicines for developing world patients. Between 130 and 150 million people worldwide are estimated to have hepatitis C. The vast majority lives in low- and middle-income countries.
   
“Given the burden of hepatitis C, MPP worked quickly to forge agreements with generic companies. Cipla, Hetero and Emcure are long-term partners working with us to develop generic HIV antiretrovirals. We welcome Natco, a new collaborator, to the MPP and hope to have other companies on board as well,” said Greg Perry, executive director of the Medicines Patent Pool, in a press statement.
 
MPP is 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 virus (HCV). Daclatasvir, discovered and developed by Bristol-Myer Squibb, is the first-in-class NS5A inhibitor used in combination with sofosbuvir for the treatment of patients with chronic HCV genotype 3 infection. Compared to other treatment options, this combination not only increases the cure rate, but is also regarded as a valuable treatment option in some of the difficult-to-treat HCV patient subsets.
 
Natco is one of the first generic companies to have Drug Controller General of India’s approval to market the hepatitis C drug in the country. “Daclatasvir combinations offer valuable treatment choices, including a potential pan-genotypic option. We look forward to collaborating with MPP to improve access to these medicines in India and elsewhere,” said Rajeev Nannapaneni, vice chairman & CEO, Natco.
 
“It has been a pleasure working with the Medicines Patent Pool that has recently included hepatitis C into its focus areas. This licence will help us distribute daclatasvir to low- and middle-income countries at affordable prices,” informed Vik Thapar, head of strategy, Emcure, one of the first generic companies to sign a licence with MPP for HIV antiretrovirals in 2012.
 
According to Dr Jaideep Gogtay, chief medical officer of Cipla, which holds several MPP sub-licences for key antiretrovirals, including dolutegravir and tenofovir alafenamide, pan-genotypic daclatasvir regimens are crucial in resource-limited countries where access to genotype testing is limited.