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ViiV Healthcare announces new strategic alliance to enable greater access to antiretroviral medicines in Brazil - PRESS RELEASE
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Strategic alliance will enable local development and manufacture of a fixed dose combination of dolutegravir 50mg and lamivudine 300mg, with the aim of making this HIV treatment regimen more widely available to people living with HIV in Brazil.
London, 15 July 2020 - ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced a new partnership in Brazil with GSK, a science-led global healthcare company and the Institute of Technology in Pharmaceuticals (Farmaguinhos / Fiocruz), aiming to enable increased access to antiretroviral treatments in Brazil.
The agreement includes the transfer of technology and "know-how" for the local manufacture of dolutegravir 50mg, which was registered in Brazil by ViiV Healthcare in 2014 and was introduced in the National Health System (SUS) in Brazil in 2016[i]. GSK, ViiV Healthcare's distributor to Brazil, currently supplies sufficient dolutegravir to the Brazilian Ministry of Health, enabling approximately 300,000 Brazilian people living with HIV to access this treatment.
In the agreement, ViiV Healthcare will provide technical assistance for the development of lamivudine 300mg tablet, a drug that is already produced by Farmanguinhos in a 150mg dosage formulation.
ViiV Healthcare will also support Farmanguinhos to locally develop its own fixed dose combination of dolutegravir 50mg and lamivudine 300mg. The fixed dose combination of dolutegravir 50mg and lamivudine 300mg developed by ViiV Healthcare is currently under review by the Brazilian Healthcare Regulatory Agency (ANVISA). This is the first time that an antiretroviral treatment, not yet registered in Brazil, will be part of a strategic alliance between a global healthcare company and a Brazilian public laboratory.
Deborah Waterhouse, CEO of ViiV Healthcare, said: "For the last 10 years we have worked closely with the Brazilian Ministry of Health to enable access to dolutegravir. Our hope is that this alliance will continue to build on that important work, supporting continued access to HIV medicines like dolutegravir 50mg and potentially enabling the fixed-dose combination of dolutegravir 50mg and lamivudine 300mg to be made available to more people living with HIV in Brazil. As part of our commitment to leave no person living with HIV behind, we are proud to join forces with one of Latin America's most prominent science and health technology institutions to secure access to our innovative medicines, support the scientific community and boost local manufacturing capability in Brazil."
The president of Fiocruz, Nísia Trindade, highlights the importance of this alliance to strengthen the National Health System (SUS). "This strategic alliance reaffirms Fiocruz's commitment to public health and to improving quality of life for people living in Brazil. Through this partnership, we will aim to modernize HIV treatment in Brazil and hopefully provide treatment options for thousands of people living with HIV in Brazil. At the same time, we will boost national science and production capability that is so important for the strengthening of our Public Health System", she points out.
In 2018, approximately 900,000 people in Brazil were living with HIV, 66% of whom were on treatment[ii] and over the past year, there were around 40,000 new HIV diagnoses in Brazil.[iii]
As the only company 100% focused on people affected by HIV/AIDS, this partnership further reinforces our commitment to leaving no person living with HIV behind.
Notes to editors:
Please see the full US Prescribing Information, including Boxed Warning, for DOVATO
DOVATO (dolutegravir and lamivudine) tablets
DOVATO is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known substitutions associated with resistance to the individual components of DOVATO.
IMPORTANT SAFETY INFORMATION
See the attached pdf for full discussion of adverse affects and contraindications etc.
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