Medicines Patent Pool expands access to HIV, hepatitis C drugs with new deals
- The Medicines Patent Pool has signed sub-licensing deals with seven generic drugmakers in India and China to make copycat versions of four HIV treatments and a hepatitis C drug made by Bristol-Myers Squibb.
- Bristol-Myers agreed to license its hepatitis C drug Daklinza to the MPP in November 2015, giving the organization the ability to sign deals with generic drugmakers to produce generic versions of the drug in 112 low- and middle-income countries. Daklinza is the first hepatitis C drug in the MPP.
- The generic manufacturers involved in last week's agreements include the Indian manufacturers Aurobindo, Emcure, Hetero Labs, Laurus and Lupin, as well as Shanghai, China-based Desano.
The MPP allows for the generic manufacturing of drugs covered by licensing agreements. The licenses are typically either royalty-free or tiered, depending on the economic status of the country.
Aurobindo, Desano and Emcure have all signed on to manufacture lopinavir and ritonavir, two antiretroviral drugs for treatment of HIV, for use in Africa. The drugs are "a life-line for people living with HIV on the continent who have developed resistance to first-line treatments," said Vik Thapar, head of strategy at Emcure.
Two other antiretrovirals—pedatric raltegravir and atazanavir—are also covered by the agreements.
The inclusion of Daklinza in November was a major addition to the MPP's portfolio of licensed drugs. "“This agreement could change the lives of millions of people with hepatitis C,” said Dr. Margaret Chan, WHO Director-General, at the time.
When combined with Sovaldi, Daklinza is effective in harder-to-treat patients, including those with advanced liver disease, and rarer genotypes of the liver disease. Similar to other drugs from GIlead, Daklinza requires a shorter treatment regimen of 12 weeks and does not require the use of interferon or ribavirin. These factors make it an ideal therapy for patients in low-income countries, where adherence is particularly challenging.
Although Gilead's hepatitis C drugs are not included in the MPP's portfolio, the Foster City, CA-based company has licensed its newly-approved hepatitis C drug Epclusa to 11 Indian manufacturing partners, who can begin production and distribution of a generic version of the drug for 101 developing countries.