The royalty-free agreement allows manufacturers to develop daclatasvir for 112 low- and middle-income countries.

The Medicines Patent Pool (MPP) today announced its first licence for a hepatitis C medicine, signing an agreement with Bristol-Myers Squibb for daclatasvir, a novel direct-acting antiviral that is proven to help cure multiple genotypes of the HCV virus. The royalty-free licence will enable generic manufacture of daclatasvir for sale in 112 low- and middle-income countries (LMICs), 76 of which are World Bank classified middle-income nations. Nearly two-thirds of all patients living with hepatitis C in the LMICs reside in the territory covered by this agreement.

Hepatitis C is a major public health threat affecting up to 150 million people globally, with the vast majority living in low- and middle-income countries. Earlier this year the World Health Organization added several new hepatitis C treatments, including daclatasvir, to its Essential Medicines List, underscoring the urgent need to promote equitable access to innovative medicines.

“This agreement could change the lives of millions of people with hepatitis C,” said Dr. Margaret Chan, WHO Director-General. “It’s a vital step towards ensuring essential treatments are available to all who need them, both rich and poor.”

“The licence comes shortly after the MPP announced its mandate expansion into the area of hepatitis C and on the heels of a six-month dialogue with patient groups, civil society and other stakeholders on best approaches to improving access to new curative HCV solutions,” said Greg Perry, Executive Director of the MPP. “Thus, we believe the licence takes into consideration the concerns of patient advocates who have been campaigning for some time for new life-saving innovations such as daclatasvir to reach more people quickly.”

“We are very pleased to see that the recent decision of the UNITAID board to support the work of MPP in the HCV space has made possible the conclusion of an agreement opening the way to wider access to effective medicines against HCV among those in need,” said UNITAID’s Deputy Executive Director, Philippe Duneton.

MPP and Bristol-Myers Squibb have joined together previously, having negotiated an agreement in December 2013 for the Bristol-Myers Squibb HIV medication atazanavir. The daclatasvir agreement allows for manufacturers to be based anywhere in the world; generic daclatasvir can be made in any country as long as it is for sale in the 112 countries covered by the agreement. Importantly, the licence allows generic manufacturers to develop fixed-dose combinations with other direct-acting antivirals to create powerful pan-genotypic regimens that offer the potential to treat all of the six major genotypes of HCV. Pan-genotypic regimens are crucial in resource-limited countries where access to genotype testing is limited. Bristol-Myers Squibb will provide a technology transfer package and information needed for the manufacture and registration of the product.

“This agreement with the MPP is an important component of Bristol-Myers Squibb’s overall global efforts to make daclatasvir broadly available to patients around the world to help eliminate HCV,” said Amadou Diarra, Head of Global Policy, Advocacy & Government Affairs, Bristol-Myers Squibb. “We are pleased to work with the MPP in this collaborative effort.”

Daclatasvir, a once-daily, all oral treatment, inhibits HCV by targeting a key protein, NS5A, involved in the replication of the virus. Daclatasvir, in combination with sofosbuvir, produces high cure rates after 12 weeks of treatment, even among HIV/HCV co-infected patients. Recent Phase III studies demonstrated that the daclatasvir regimen could cure up to 100% of HCV patients depending on genotype and stage of liver disease.

“BMS should be congratulated for their strong commitment to patient access and for sharing their IP and technology so widely. We will continue to work with the company to review access needs for daclatasvir,” concluded Perry.

The full MPP licensing agreement is available here.

About the Medicines Patent Pool

The Medicines Patent Pool is a United Nations-back public health organisation working to increase access to HIV, viral hepatitis C and tuberculosis treatments in low- and middle-income countries. Through its innovative business model, the MPP partners with industry, civil society, international organisations, patient groups and other stakeholders to prioritise, forecast and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, the MPP has signed agreements with six patent holders for twelve HIV antiretrovirals and for one hepatitis C direct-acting antiviral. Its generic partners have distributed more than three billion doses of low-cost medicines to 117 countries. The MPP was founded and remains fully funded by UNITAID.