LONDON, July 2, 2015 /PRNewswire/ --
Agreement reinforces ViiV
Healthcare commitment to improving access to HIV treatments
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.[1] 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).[2] 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 http://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
http://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 taken 2 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/documents/CHN_narrative_report_2014.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 ViiV Healthcare