PR61049

ViiV Healthcare and Desano Pharmaceuticals' Manufacturing Agreement Will Allow Competitive Supply of Dolutegravir in China and Several Developing Countries

LONDON, Jul. 2 /PRN=KYODO JBN/ --

    - 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(R)) 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(R) (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(R) (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 (greater than or equal to2%)

adverse reactions of moderate to severe intensity in treatment naive 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:

    1) 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

    2) 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