ViiV HEALTHCARE AND DESANO PHARMACEUTICALS’ MANUFACTURING AGREEMENT WILL ALLOW COMPETITIVE SUPPLY OF DOLUTEGRAVIR IN CHINA AND SEVERAL DEVELOPING COUNTRIES
London, UK, 2 July 2015 – ViiV Healthcare and Desano Pharmaceuticals (Desano) today announced a strategic manufacturing agreement to enable production in China of
“This manufacturing agreement with Desano for
Based in Shanghai, Desano is a
Healthcare. Under the agreement, Desano will manufacture the API of
“As one of the leading Chinese pharmaceutical companies dedicated to developing, manufacturing and supplying antiretroviral (ARV) APIs for HIV and finished pharmaceutical products, Desano is honoured to cooperate with ViiV Healthcare to manufacture
Dolutegravir is an integrase strand transfer inhibitor (INSTI) for use in combination with other antiretroviral agents for the treatment of HIV. Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection.
Tivicay is approved in over 70 countries across North America, Europe, Asia, Australia, Africa
UNAIDS estimates that approximately 780,000 (620,000 to 940,000) people are infected with HIV/AIDS in China. With more than 40,000 new HIV infections and over 25,000 deaths reported in 2011. People living with HIV/ AIDS in China who meet the national treatment criteria are referred to receive care through the China National Free Antiretroviral Treatment Programme (CNFATP). Still, only an estimated 126,000 people with HIV were receiving antiretroviral treatment, with an estimated 76% of adults and children who met the criteria receiving antiretroviral treatment.
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV. Shionogi joined in October 2012. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and new HIV medicines, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com
About Desano Pharmaceuticals
Founded in 1996, Desano Pharmaceutical is a leading vertically integrated pharmaceuticals company
Important Information about Tivicay® (
FDA Indication and Usage: TIVICAY is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Use of TIVICAY in INSTI-experienced patients should be guided by the number and type of baseline INSTI substitutions. The efficacy of TIVICAY 50 mg twice daily is reduced in patients with an INSTI-resistance Q148 substitution plus 2 or more additional INSTI-resistance substitutions including T66A, L74I/M, E138A/K/T, G140S/A/C, Y143R/C/H, E157Q, G163S/E/K/Q, or G193E/R.
Important Safety Information for Tivicay® (
Contraindication: TIVICAY is contraindicated (1) in patients with
Hypersensitivity Reactions: Hypersensitivity reactions have been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury. The events were reported in 1% or fewer subjects receiving TIVICAY in Phase 3 clinical trials. Discontinue TIVICAY and other suspect agents immediately if signs or symptoms of hypersensitivity reaction develop, (including but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters or peeling of the skin, oral blisters or lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema, difficulty breathing.) Monitor clinical status, including liver aminotransferases, and initiate appropriate therapy. Delay in stopping treatment with TIVICAY or other suspect agents after the onset of hypersensitivity may result in a life-threatening reaction. TIVICAY is contraindicated in patients who have experienced a hypersensitivity reaction to
Effects on Serum Liver Biochemistries in Patients with Hepatitis B or C Coinfection: Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with use of TIVICAY. In some
Fat Redistribution: Redistribution/accumulation of body fat has been observed in patients receiving antiretroviral therapy.
Immune Reconstitution Syndrome: During the initial phase of treatment, immune reconstitution syndrome can occur, which may necessitate further evaluation and treatment. Autoimmune disorders have been reported to occur in the setting of immune reconstitution; the time to onset is more variable and can occur many months after initiation of treatment.
Adverse Reactions: The most commonly reported (≥2%) adverse reactions of moderate to severe intensity in treatment naïve adult subjects in any one trial receiving TIVICAY in a combination regimen were insomnia (3%), fatigue (2%), and headache (2%).
Drug Interactions: Co-administration of TIVICAY with drugs that are strong inducers of UGT1A1 and/or CYP3A4 may result in reduced plasma concentrations of
- TIVICAY should be taken2 hours before or 6 hours after taking cation-containing antacids or laxatives, sucralfate, oral iron supplements, oral calcium supplements, or buffered medications.
- Consult the full Prescribing Information for TIVICAY for more information on potentially significant drug interactions, including clinical comments.
Pregnancy: Pregnancy category B. TIVICAY should be used during pregnancy only if the potential benefit justifies the potential risk. An Antiretroviral Pregnancy Registry has been established.
Breastfeeding: Breastfeeding is NOT recommended due to the potential for HIV transmission and the potential for adverse reactions in nursing infants.
Please visit the following link for the full US prescribing and patient information: https://www.viivhealthcare.com/media/58599/us_tivicay.pdf.
Tivicay is a registered trademark of the ViiV Healthcare group of companies.
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 UNAIDS China. 2012 China AIDS Progress Report. Retrieved on 31 December 2014 from: http://www.unaids.org/sites/default/files/en/dataanalysis/knowyourresponse/countryprogressreports/2012countries/ce_CN_Narrative_Report.pdf
 Zhang et al. Effect of earlier initiation of antiretroviral treatment and increased treatment coverage on HIV-related mortality in China: a national observational cohort study. The Lancet Infectious Diseases, Vol. 11, No. 7, p516–524