16 March 2020
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2020 – Bristol-Myers Squibb (BMS) has announced that the marketing authorisations for Daklinza® (daclatasvir) will be withdrawn or will be allowed to lapse in countries where the product no longer is routinely prescribed or where there are other therapeutic options available.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.
Press and Media
The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to and facilitate the development of life-saving medicines for low- and middle-income countries. Through its innovative business model, MPP partners with civil society, governments, international organisations, industry, patient groups, and other stakeholders to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations.
To date, MPP has signed agreements with 22 patent holders for 13 HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals, a tuberculosis treatment, a cancer treatment, four long-acting technologies, a post-partum haemorrhage medicine, three oral antiviral treatments for COVID-19 and 16 COVID-19 technologies.
MPP was founded by Unitaid, which continues to be MPP’s main funder. MPP’s work on access to essential medicines is also funded by the Swiss Agency for Development and Cooperation (SDC), Government of Canada, the World Intellectual Property Organization (WIPO) and the Government of Flanders. MPP’s activities in COVID-19 are undertaken with the financial support of the Japanese Government, the French Ministry for Europe and Foreign Affairs, the German Agency for International Cooperation, and SDC.