ViiV Healthcare and Desano Pharmaceuticals’ manufacturing agreement will allow competitive supply of dolutegravir in China and several developing countries
Agreement reinforces ViiV Healthcare commitment to improving access to HIV treatments
London, UK, 2 July 2015 - ViiV Healthcare and Desano
Pharmaceuticals (Desano) today announced a strategic manufacturing agreement to enable production
in China of dolutegravir. The agreement will offer an additional source of the dolutegravir
active pharmaceutical ingredient (API), and will allow ViiV Healthcare to offer a
competitive supply of the finished product (dolutegravir 50mg, marketed under
the name Tivicay®) for China and a number of developing countries, subject
to national approvals. This strengthens ViiV Healthcare’s commitment to
improve access to its treatments for people living with HIV,
especially in countries hardest hit by the disease.
“This manufacturing agreement with Desano for dolutegravir is a significant achievement to facilitate
access to our medicines. With our recent agreement with the Medicines Patent Pool and our other access
initiatives this deal is aligned with our ongoing commitment to improve access to our medicines in
countries where the need is greatest.” said Dr Dominique Limet, Chief Executive Officer,
ViiV Healthcare.
Based in Shanghai, Desano is a high quality manufacturer, therefore well suited to partner with ViiV
Healthcare. Under the agreement, Desano will manufacture the API of dolutegravir to feed in to the
GSK/ViiV Healthcare supply chain for onward sale in China and developing countries covered by the
agreement. ViiV Healthcare and Desano are also exploring further options for future manufacture
of finished drug product and fixed dose combinations of dolutegravir with APIs.
“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 honored
to cooperate with ViiV Healthcare to manufacture a high quality, competitive supply of
dolutegravir and its combinations,” said Ying Kan, President of Desano Pharmaceuticals.
“We believe that working together with ViiV Healthcare we can better contribute to
the global goal of making treatment options available to patients across the globe.”
About dolutegravir (Tivicay)
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 and
Latin America. A regulatory application for dolutegravir is currently being evaluated by the China
Food and Drug Administration (CFDA).
About Human Immunodeficiency Virus (HIV) in China
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. 1
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
specialising in developing and manufacturing of generic ARV APIs and formulations with 4
manufacturing sites located in China approved by the agencies of CFDA, USFDA and WHO.
Desano Pharmaceutical is one of the key ARV APIs suppliers for low to middle income
countries, supporting over 4 million AIDS patients treatment. For more
information, please visit www.desano.com
Important Information about Tivicay® (dolutegravir)
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® (dolutegravir)
Contraindication: TIVICAY is contraindicated (1) in patients with previous hypersensitivity reaction
to dolutegravir, and (2) in patients receiving dofetilide (antiarrhythmic) due to the potential for
increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events.
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 dolutegravir.
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 cases the elevations in transaminases were consistent
with immune reconstitution syndrome or hepatitis B reactivation particularly in the setting
where anti-hepatitis therapy was withdrawn. Appropriate laboratory testing prior to
initiating therapy and monitoring for hepatotoxicity during therapy with TIVICAY
are recommended in patients with underlying hepatic disease such as hepatitis B or C.
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 dolutegravir and require dose adjustments of
TIVICAY.
- 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.
Paediatric Patients: Safety and efficacy of TIVICAY has not been established in children younger
than 12 years old, or weighing <40 kg, or in INSTI-experienced paediatric patients with
documented or clinically suspected INSTI resistance.
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.
References:
- 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[1].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
Source: https://www.viivhealthcare.com/media/press-releases/2015/july/viiv-healthcare-and-desano-pharmaceuticals-manufacturing-agreement-will-allow-competitive-supply-of-dolutegravir-in-china-and-several-developing-countries.aspx
Reproduced with permission - "ViiV Healthcare"
ViiV Healthcare
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