ViiV Healthcare and CHAI Collaboration Delivers Second Milestone With First Filing With the FDA of Generic Dolutegravir by Aurobindo Pharma for the Treatment of HIV

London (ots/PRNewswire) - ViiV Healthcare, Aurobindo Pharma, and the
Clinton Health Access Initiative, Inc. (CHAI) announced today that
Aurobindo Pharma has submitted an Abbreviated New Drug Application
(ANDA) for dolutegravir 50mg, for Tentative Approval, to the Food and
Drug Administration (FDA), for the treatment of HIV. This is the
first ANDA for a generic version of dolutegravir, less than two years
after FDA approval of Tivicay(R) (dolutegravir) for sale in the
United States.

Upon receiving Tentative Approval from the FDA, Aurobindo Pharma will
be able to supply dolutegravir 50mg via the President's Emergency
Plan for AIDS Relief (PEPFAR) programme, following completion of
required local regulatory approval process, in the licensed countries
outside of the United States, as per the agreement signed between
Aurobindo Pharma and ViiV Healthcare in 2014.

This submission comes less than five years after ViiV Healthcare and
CHAI signed an agreement to collaborate with the goal of bringing
innovative formulations of medicines for the treatment and prevention
of HIV/AIDS to people living with HIV in developing countries, on an
affordable yet sustainable basis.

CHAI and ViiV Healthcare worked together to identify a generic
partner after conducting feasibility research. Following this initial
joint work, ViiV Healthcare submitted necessary documentation to the
FDA providing a selective waiver letter for the five-year period of
New Chemical Entity (NCE) exclusivity that would have otherwise
prevented FDA review and Tentative Approval of Aurobindo Pharma's
ANDA at this time.

Dr. Dominique Limet, CEO, ViiV Healthcare, said: "This first ANDA for
a generic dolutegravir confirms that our strong commitment to
thinking and acting differently to pursue new ways to expand access
to our medicines, for people living with HIV in countries where the
need is most pressing, is working."

David Ripin, PhD, Executive Vice President, and Chief Scientific
Officer, CHAI, said: "UNAIDS has set global public health goals
calling for 90 percent of those who are HIV-positive to know their
status, 90 percent of those identified to be linked to treatment
programs, and 90 percent of those in treatment to achieve
undetectable viral load. To tackle these complex challenges, targeted
efforts to facilitate access to HIV treatment medicines, such as
dolutegravir, are needed."

Mr. N. Govindarajan, Managing Director, Aurobindo Pharma, said: "We
are pleased to be part of this innovative partnership designed to
accelerate access to medicines for treating HIV. Aurobindo Pharma is
committed to HIV care and aims to achieve the goals of wider access
to HIV treatment, care, and support; seeking to address the spread of
HIV through development of this newer class of drugs and fixed-dose
combinations for low- and middle-income countries."

The filing by Aurobindo Pharma is the second result of the agreement
between CHAI and ViiV Healthcare and comes less than six months after
another generic manufacturer announced that it had received Tentative
Approval from the FDA for paediatric formulations of another ViiV
Healthcare antiretroviral (also under PEPFAR for sale in licensed
countries outside of the United States), through innovative
collaboration with ViiV Healthcare and CHAI.

About Clinton Health Access Initiative

The Clinton Health Access Initiative, Inc. (CHAI) was founded in 2002
with a transformational goal: help save the lives of millions of
people living with HIV/AIDS in the developing world by dramatically
scaling up antiretroviral treatment. When CHAI was founded, many
viewed this goal as unreasonable because health systems in poor
countries were too weak and prices of relevant drugs and diagnostic
tests were too high. CHAI played a leadership role, working alongside
governments and other partners, to lower the costs of treatment and
help build the in-country systems necessary to provide lifesaving
treatment to millions of people. Since then, CHAI has pursued several
similarly ambitious goals, from scaling up pediatric AIDS treatment
in order to achieve equity with adults in a timeframe few thought
possible, to rapidly accelerating the rollout of new vaccines. CHAI
has achieved many of its most important successes when seeking to
fundamentally change the way the world approaches an issue and
pushing the boundaries of what is considered feasible in global
health. For more information, please visit:
http://www.clintonhealthaccess.org

About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in
November 2009 by GlaxoSmithKline and Pfizer dedicated to delivering
advances in treatment and care for people living with HIV. Shionogi
joined as a 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 visit http://www.viivhealthcare.com.

About Aurobindo Pharma

Aurobindo Pharma Ltd. is a vertically integrated pharmaceutical
company that delivers innovative solutions. Aurobindo Pharma
leverages India's globally competitive cost base and talented team of
scientists to discover, develop, and commercialize a range of
affordable medicines for markets across the globe. For more
information, please visit http://www.aurobindo.com.

About President's Emergency Plan for AIDS Relief (PEPFAR)

PEPFAR is the US government initiative to help save the lives of
those suffering from HIV/AIDS around the world. This historic
commitment is the largest by any nation to combat a single disease
internationally. In May 2004, in support of the President's Emergency
Plan, the FDA announced a new initiative to help ensure that those
being served by the President's Plan would receive safe, effective,
and quality manufactured antiretroviral drugs. This new initiative
included an expedited review process. Through guidance and an active
outreach program to the pharmaceutical industry, the FDA actively
encouraged any sponsors worldwide to submit US marketing applications
for single entity, fixed dose combination (FDC), and co-packaged
versions of previously approved antiretroviral therapies-even if
there was still patent or exclusivity market protection for the
product in the US.

Important Information about Tivicay(R) (dolutegravir) in the US

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 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.

How Tivicay Works Tivicay belongs to a class of HIV medicines called
integrase inhibitors. 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 a registered trademark of the ViiV Healthcare group of
companies.

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