ViiV Healthcare to Progress Collaboration with Janssen to Develop the First Long-acting, Two Drug Injectable Regimen for Treatment of HIV-1 Infection

PR63024

LONDON, Jan. 8, 2016 /PRNewswire=KYODO JBN/ --

     ViiV Healthcare, a global specialist HIV company with GSK, Pfizer Inc. and

Shionogi Limited as shareholders, today formalised its collaboration with

Janssen Sciences Ireland UC (Janssen) for the phase III investigation and

commercialisation of the long-acting, injectable formulations of cabotegravir

(ViiV Healthcare) and rilpivirine (Janssen) for the treatment of HIV-1

infection. The long-acting formulations of cabotegravir (CAB LA) and

rilpivirine (RPV LA) are being investigated as an injectable maintenance

treatment for patients who have achieved viral suppression.

    "As a company committed to innovation in the field of HIV, this agreement

with Janssen will enable us to progress the development of the first

long-acting, injectable two drug regimen," said Dominique Limet, CEO, ViiV

Healthcare. "If successful, this regimen would offer people living with HIV who

have achieved viral suppression an alternative option to the standard oral

daily, three drug therapy."

    While HIV is now considered a chronic manageable condition for most

individuals, there are remaining treatment challenges that continue to impact

the lives of people living with HIV; which may include tolerability, safety,

dosing schedules, drug interactions and adherence.  ViiV Healthcare is

committed to investigating new treatment options that may help to address some

of these challenges with the aim of providing healthcare professionals with

alternative treatment options for appropriate patients.

    As part of this agreement and as announced at the GSK R&D day (3 November

2015), the two companies expect to start a phase III programme to evaluate the

efficacy, safety and tolerability of the long-acting, two drug injectable

regimen in mid-2016.

    This is the second development agreement with Janssen. In June 2014 both

companies entered into an agreement to develop and commercialise a

single-tablet combining ViiV Healthcare's integrase strand transfer inhibitor

(INSTI), dolutegravir (Tivicay(R)) and Janssen's non-nucleoside reverse

transcriptase inhibitor (NNRTI) rilpivirine (EDURANT(R)). A phase III clinical

trial programme to evaluate the safety and efficacy of both medicines as

maintenance treatment of HIV-1 infection began in May 2015. These agreements

build on ViiV Healthcare's strategy to collaborate with other companies,

institutions and not-for-profit organisations to contribute to the

understanding and management of HIV.

    About HIV

    HIV stands for the Human Immunodeficiency Virus. Unlike some other viruses,

the human body cannot get rid of HIV, so once someone has HIV they have it for

life. There is no cure for HIV, but effective treatment can control the virus

so that people with HIV can enjoy healthy and productive lives. The current

standard of care in HIV involves a combination of at least three oral

antiretroviral (ARV) drugs taken daily: two non-nucleoside reverse

transcriptase inhibitors (NRTIs), plus either a non-nucleoside reverse

transcriptase inhibitor, protease inhibitor (PI) or integrase strand transfer

inhibitor (INSTI).

    About cabotegravir

    Cabotegravir is an investigational integrase strand transfer inhibitor

(INSTI) and analogue of dolutegravir (Tivicay(R)). Cabotegravir is being

developed by ViiV Healthcare for the treatment and prevention of HIV and is

currently being evaluated as a once-daily oral tablet formulation and as a

long-acting nanosuspension formulation for intramuscular (IM) injection.

    About rilpivirine

    Rilpivirine (EDURANT(R)) is a once daily non-nucleoside reverse

transcriptase inhibitor (NNRTI) used for the treatment of human

immunodeficiency virus (HIV1) infection in combination with other

antiretroviral agents in antiretroviral treatment-naive adult patients with a

viral load less than or equal to 100,000 HIV RNA copies/mL.

    Rilpivirine was developed by Janssen. Rilpivirine is approved in US and EU

as EDURANT (R) as a single agent tablet dosed at 25mg taken once a day and is

always taken with a meal. The overall safety profile of rilpivirine is based on

phase III clinical studies. Rilpivirine is also available in the United States

(US) and the European Union as part of a once daily fixed dose antiretroviral

combination with Gilead Sciences Inc's tenofovir disoproxil fumarate and

emtricitabine. This combination, is known as COMPLERA(R) (US) or EVIPLERA(R).

The most common side effects of EDURANT(R) include: depression, headache,

trouble sleeping (insomnia) and rash.

    About dolutegravir

    Dolutegravir (Tivicay) 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 90 countries across

North America, Europe, Asia, Australia, Africa and Latin America.

    Tivicay is a registered trademark of the ViiV Healthcare group of companies.

    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.

    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

(TYO: 4507) 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 the Janssen Pharmaceutical Companies of Johnson & Johnson

    At Janssen, we are dedicated to addressing and solving some of the most

important unmet medical needs of our time in infectious diseases and vaccines,

oncology, immunology, neuroscience, and cardiovascular and metabolic diseases.

Driven by our commitment to patients, we develop innovative products, services

and healthcare solutions to help people throughout the world.

Source: ViiV Healthcare