MSD (tradename Merck & Co., Inc., Kenilworth, N.J.,USA) has entered into non-exclusive voluntary licensing agreements with two leading generic manufacturers for doravirine (100 mg) – the company’s oral non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of HIV-1 infection in adults.
Under the agreement, MSD will provide licenses for the registration, commercialization, and
distribution of generic doravirine (100 mg) for use in a single entity tablet and in a fixed-dose combination tablet with lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg) in 86 countries. These countries include all countries of Sub-Saharan Africa, other low- and lower middle-income countries outside of Sub-Saharan Africa (as classified by the World Bank), and all Least Developed countries (as defined by the United Nations). Nearly 80% of people living with HIV globally reside in these 86 countries.
At MSD we recognise that more progress is needed to address health inequalities and improve
access to healthcare, particularly for underserved populations. These agreements are part of
our long-term commitment to work together with others in partnerships that will increase access
to our breakthrough medicines for those people who need them most,” said Dr Priya Agrawal,
Managing Director of MSD in South Africa & Sub-Saharan Africa. “We have a long history of
research and discovery in HIV and we remain committed to making sure people living with HIV
benefit from our inventions.”
According to UNAIDS, 38 million people were estimated to be living with HIV worldwide at the
end of 2019, with a vast majority of those people residing in low- and middle-income countries,
but only an estimated 25.4million people were accessing antiretroviral therapy as of 2019. There
are also 1.7 million additional HIV infections occurring each year. Under the terms of the
non-exclusive agreements, the licensee companies can manufacture and supply generic
doravirine (100 mg) and the fixed-dose combination of doravirine (100 mg)/lamivudine (300
mg)/tenofovir disoproxil fumarate (300 mg) in designated countries.
“In many African nations, we are challenged by the provision of limited treatment options and
will benefit from the availability of newer medicines that can be more suitable for some patients due to various factors, such as tolerability and safety,” said Prof. Francois Venter, Divisional
Director: Ezintsha. “By increasing access to Doravirine in these resource-limited settings, we
are one step closer to getting treatment into the hands of patients in need of new options.”