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

London (ots/PRNewswire) -

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®) and
Janssen's non-nucleoside reverse transcriptase inhibitor (NNRTI)
rilpivirine (EDURANT®). 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®). 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®) is a once daily non-nucleoside reverse
transcriptase inhibitor (NNRTI) used for the treatment of human
immunodeficiency virus (HIV-1) infection in combination with other
antiretroviral agents in antiretroviral treatment-naïve adult
patients with a viral load <= 100,000 HIV RNA copies/mL.

Rilpivirine was developed by Janssen. Rilpivirine is approved in
US and EU as EDURANT® 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® (US) or
EVIPLERA®. The most common side effects of EDURANT® 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® (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® (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 naïve 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.

ots Originaltext: ViiV Healthcare
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Sébastien Desprez (UK)
Global Communications
ViiV Healthcare
+44 7920 567 707

Marc Meachem (US)
US Communications
ViiV Healthcare
+1 919 483 8756

GSK enquiries: UK Media enquiries: Simon Steel +44 (0) 20 8047 5502
(London)
David Daley +44 (0) 20 8047 5502 (London)

US Media enquiries: Sarah Alspach +1 202 715 1048 (Washington
DC)
Sarah Spencer +1 215 751 3335 (Philadelphia)

Analyst/Investor enquiries: Ziba Shamsi +44 (0) 20 8047 5543 (London)
Tom Curry + 1 215 751 5419 (Philadelphia)
Gary Davies +44 (0) 20 8047 5503 (London)
James Dodwell +44 (0) 20 8047 2406 (London) Jeff McLaughlin +1 215 751
7002 (Philadelphia)