First Sub-Licences Signed for Hepatitis C Drug Daclatasvir

The first round of sub-licenses for a hepatitis C virus (HCV) drug was recently announced by the Medicines Patent Pool (MPP).

Daclastavir (Daklinza) is a first-in-class NS5A inhibitor used in combination with sofosbuvir for the treatment of chronic HCV genotype 3.

A phase 3 study found the combination therapy increases the cure rate after 12 weeks, which showed the treatment it could cure up to 100% of patients depending on genotype and the stage of liver disease. The drug also shows improvement for HCV patients proven to be difficult-to-treat.

It’s estimated that approximately 130 to 150 million people have hepatitis globally. Those who live in developing countries are estimated to make up the majority of that number.

MPP first signed a licensing agreement for HCV with Bristol-Myers Squibb in November 2015. This was the first time that generic manufacturers worked with a non-profit, public health organization in order to boost access to HCV medicines for developing countries.

Companies such as Cipla, Emcure, Hetero, and Natco signed non-exclusive, royalty free agreements in order to manufacture and sell daclastavir.

"Given the burden of hepatitis C, MPP worked quickly to forge agreements with generic companies," said MPP Executive Director Greg Perry. "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."

Of the generic pharmaceutical companies MPP is working with, Natco is an India-based company that is 1 of the first to have India’s Drug Controller General’s approval in order to market the HCV drug. Ciplo is a global company that has more than 1500 products across different areas with a strong HIV presence. They also have several other MPP sub-licenses for antiretrovirals, like dolutegravir and tenofovir alafenamide.

Emcure is one of the first companies to sign a lease in 2012 with MPP for HIV antiretroviral, while Hetero is one of India’s leading generic pharmaceutical companies.

"It has been a pleasure working with the Medicines Patent Pool that has recently included hepatitis C into its focus areas,” said Emcure Head of Strategy Vik Thapar. “This license will help us distribute daclatasvir to low and middle-income countries at affordable prices."