ViiV Healthcare announces new initiatives to improve access to dolutegravir:
licence to the Medicines Patent Pool
- Timely collaborations underscore ViiV Healthcare's commitment to increase
access to life-saving HIV medicines for children and adults in the developing
- Agreement with MPP supports access in developing world countries where 99%
of children and 93.4% of adults with HIV live
LONDON, April 1, 2014
LONDON, April 1, 2014 /PRNewswire/ -- ViiV Healthcare today announced new
collaborations with the goal of increasing access to its HIV medicine,
dolutegravir (marketed under the name Tivicay®), just two months after its
approval by the European Medicines Agency (EMA) and eight months after
approval by the US Food and Drug Administration (FDA). Through an agreement
with the Medicines Patent Pool (MPP), ViiV Healthcare will accelerate access
to dolutegravir where the need is the greatest, in the countries where 99% of
children and 93.4% of adults with HIV in the developing world live.
"Our new collaborations prioritise dolutegravir access for millions of
children and adults with HIV, and represent another step in our ongoing
commitment to improving access and delivering innovation in the areas of
highest unmet need," said Dr Dominique Limet, Chief Executive Officer, ViiV
Healthcare."We recognise that important new agents have the potential to make
a real difference in resource poor settings.In fact, the World Health
Organization has recently cited dolutegravir as a development priority for
future anti-retroviral treatments for children–it is currently approved for
children 12 years and older.^i Therefore, accelerating access to medicines
like dolutegravir is of the utmost importance."
Licence to the Medicines Patent Pool
In adults: The collaboration with MPP includes two distinct approaches to
improve access for adults living with HIV in the developing world: first, a
royalty-free voluntary licence in all least-developed, all low-income and all
sub-Saharan African countries; second, for specific middle-income countries
including India, ViiV Healthcare has established the first-ever MPP licence
with a tiered royalty structure, where a small percentage of the sale price is
paid based on the gross domestic product (GDP) of the specific country.The
licences will also allow for the possible development, manufacture and supply
of dolutegravir-based fixed-dose combinations, including those with abacavir,
if and when approved by local regulatory agencies.
Supporting children living with HIV: ViiV Healthcare will grant MPP a
voluntary licence for generic manufacturers to develop paediatric formulations
of dolutegravir without paying a royalty in 121 countries where most (99%)
children with HIV live.Dolutegravir is currently approved for patients 12
years and older. However, this licence also includes a commitment for future
lower dose tablets and age-appropriate formulations developed by ViiV
Healthcare to meet the needs of younger children with HIV, if and when
approved by a major regulatory authority.
Today's announcement complements an earlier voluntary licence for dolutegravir
signed in 2013 with Aurobindo Pharma for adults and children for our standard
voluntary licence territories.
Our Approach to Improving Access: ViiV Healthcare is committed to improving
access to medicines for people living with HIV through a variety of
approaches, based on the differing needs of people living with HIV in
different parts of the world.
oRoyalty-free voluntary licences in those countries with the lowest incomes
and/or hardest hit by the global epidemic: In 2010 ViiV Healthcare
extended its royalty-free voluntary licensing policy, which includes the
company's existing portfolio in all least-developed, all low-income and
all sub-Saharan countries; home to 25 million people living with HIV
(i.e., 75% of people living with HIV worldwide). These licences facilitate
the manufacture and sale of low-cost versions of the company's medicines
in those countries most affected by HIV and least able to pay for
treatment and care.
oFlexible pricing and local partnerships with generics manufacturers in
middle-income countries (i.e., emerging and newly industrialised
economies): In countries where incomes are higher and infrastructure is
more developed, the flexible pricing policy factors in the GDP and the
impact of the epidemic in each country to improve affordability. Local
partnerships are approached on a case-by-case basis, taking into account
the local needs and situation. One key approach is creating partnerships
with in-country pharmaceutical companies to manufacture medicines locally
in order to bring costs down, while simultaneously investing resources and
expertise to build skills in the local economy.
Our Commitment to Children Living with HIV: Approximately 3.3 million children
are living with HIV worldwide, but 66% of those needing treatment do not have
access to appropriate care and medicines. Among several barriers preventing
further scale up of the numbers of children on treatment is the lack of
low-cost medicines that are palatable and acceptable for use by children^ii.
ViiV Healthcare is committed to improving scientific understanding and
treatment options for infants and children living with HIV. This includes a
broad range of initiatives supported through our Paediatric Innovation Seed
Fund, which aims to improve paediatric HIV research, care and treatment in
resource-limited settings. Additionally, the Positive Action for Children Fund
supports 150 organisations across 30 countries to deliver programmes designed
to prevent mother-to-child transmission of HIV.
Important Information about Tivicay® (dolutegravir)
FDA Indication and Usage in the US: 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 in adults and children aged 12 years and older and weighing at least
40 kg. The following should be considered prior to initiating TIVICAY: poor
virologic response was observed in subjects treated with TIVICAY 50 mg twice
daily with an INSTI-resistance Q148 substitution plus 2 or more additional
INSTI-resistance substitutions including L74I/M, E138A/D/K/T, G140A/S,
Y143H/R, E157Q, G163E/K/Q/R/S, or G193E/R.
Important Safety Information for Tivicay® (dolutegravir)
Contraindication: Co-administration of TIVICAY with dofetilide
(anti-arrhythmic) is contraindicated due to the potential for increased
dofetilide plasma concentrations and the risk for serious and/or
Hypersensitivity Reactions: Hypersensitivity reactions have been reported and
were characterised 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. Immediately discontinue
TIVICAY and other suspect agents 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 should not be used in patients who have experienced a
hypersensitivity reaction to TIVICAY.
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 naive adult subjects in any one
trial receiving TIVICAY in a combination regimen were insomnia (3%) and
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
Please visit the following link for the full US prescribing and patient
Tivicay (dolutegravir) is an integrase inhibitor indicated for use in
combination with other antiretroviral agents for the treatment of HIV-1 in
adults and children aged 12 years and older weighing at least 40 kg. 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.
It is available as a small, yellow, 50 mg tablet. Importantly, it can be taken
with or without food and at any time of the day.
Today's announcement follows the US Food and Drug Administration (FDA)
approval of dolutegravir (Tivicay®) on 12 August 2013 and the European
Medicines Agency (EMA) approval on 20 January 2014. Dolutegravir is indicated
for use in combination with other antiretroviral agents for the treatment of
HIV-1 in adults and children aged 12 years and older.
Tivicay is the first new treatment delivered by ViiV Healthcare.
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 as a 10% shareholder 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
ViiV UK/US Media enquiries: Rebecca Hunt +44 (0) 20 8380 6275
Marc Meachem +1 919 483 8756
GSK Global Media enquiries: David Mawdsley +44 (0) 20 8047 5502
Catherine Hartley +44 (0) 20 8047 5502
Analyst/Investor enquiries: Ziba Shamsi +44 (0) 20 8047 5543
Kirsty Collins (SRI & CG) +44 (0) 20 8047 5534
Tom Curry + 1 215 751 5419
Gary Davies +44 (0) 20 8047 5503
James Dodwell +44 (0) 20 8047 2406
Jeff McLaughlin +1 215 751 7002
Lucy Singah +44 (0) 20 8047 2248
^i "MARCH 2014 SUPPLEMENT TO THE 2013 CONSOLIDATED GUIDELINES ON THE USE OF
ANTIRETROVIRAL DRUGS FOR TREATING AND PREVENTING HIV INFECTION.
Recommendations for a public health approach." WHO. Web. 28 February 2014.
^ii "Global Report: UNAIDS report on the global AIDS epidemic 2013." UNAIDS.
Web. 11 February 2014.
SOURCE ViiV Healthcare
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