Geneva, 16 March 2020 – Bristol-Myers Squibb (BMS) has announced that the marketing authorisations for Daklinza® (daclatasvir) will be withdrawn or will be allowed to lapse in countries where the product no longer is routinely prescribed or where there are other therapeutic options available. These actions will affect some additional countries outside the licensed territory to the Medicines Patent Pool (MPP). Following the withdrawal / lapse of the marketing authorisation in each country, the patents in that country will be allowed to lapse. In the interim period between the withdrawal / lapse of a marketing authorisation and the patent expiry, BMS will not enforce its patents for Daklinza in that country. This policy is specific for and limited to Daklinza moving forward.
This means that patients diagnosed with hepatitis C in additional countries will soon have access to generic versions of daclatasvir. This list, with or without existing patents, includes Albania, Armenia, Belarus, Bosnia, Bulgaria, Chile, Colombia, Egypt, Jordan, Kazakhstan, Kosovo, Kyrgyz Republic, Lebanon, Macedonia, Malaysia, Mexico, Moldova, Montenegro, Peru, Romania, Serbia, Thailand, Tajikistan, Ukraine, Uruguay, and Venezuela.
In 2015, MPP and BMS signed a licensing agreement for the direct-acting antiviral daclatasvir, which was included in the World Health Organization (WHO) Model List of the Essential Medicines. The licence enables the sales of daclatasvir and daclatasvir-based regimens such as daclatasvir/sofosbuvir, in 112 low- and middle-income countries (LMICs). MPP signed sublicence agreements with 10 generic manufacturers, of which three already have supplied more than 64 million doses of affordable quality-assured versions of daclatasvir and/or daclatasvir-based regimens in 23 developing countries.
As more countries will soon be able to procure from generic companies, MPP can confirm that its generic manufacturing partners stand ready to supply quality-assured medicine that can be used in a pan-genotypic regimen, crucial in resource-limited settings where access to genotype testing might not be possible.
According to WHO, an estimated 71 million people have chronic HCV infection worldwide and over 400 000 people die each year from hepatitis C, mostly from cirrhosis and liver cancer. Direct-acting antiviral medicines can cure more than 95% of patients but access to diagnosis and treatment is low especially in LMICs, where the vast majority of people with the virus live.