AsiaNet 60632

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, May 26, 2015 / PRN=KYODO JBN / --

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 (LSE: GSK) and Pfizer (NYSE: PFE) 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 (＞＝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%), 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.

Source: ViiV Healthcare