First Regimen Combining Long Acting Injectable Antiretrovirals; 32-Week LATTE 2 Study Results Presented at CROI

PR63542

CORK, Ireland, Feb. 24, 2016 /PRNewswire=KYODO JBN/--

     Intramuscular 2-drug maintenance therapy demonstrates comparable antiviral

activity to daily oral 3-drug combination

    Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of

Johnson & Johnson, (Janssen) announced 32-week data from an ongoing phase IIb

study. A regimen of two investigational long acting, intramuscular (IM)

formulations of HIV medicines-Janssen's rilpivirine and ViiV Healthcare's

cabotegravir-given together every 4 or 8 weeks-show comparable antiviral

activity to 3-drug oral antiretroviral therapy (ART) (investigational

cabotegravir and two nucleoside reverse transcriptase inhibitors (NRTIs). The

full results of the study, named LATTE-2, co-funded by Janssen and ViiV

Healthcare were presented at this year's Conference on Retroviruses and

Opportunistic Infections (CROI) in Boston, Massachusetts today.

         Logo: http://photos.prnewswire.com/prnh/20160223/336306LOGO

    The LATTE-2 study is investigating the safety and efficacy of 2-drug IM

ART, relative to 3-drug oral ART when used to maintain viral suppression in

HIV-1 infected adults.[1]

    Virologic responses (plasma HIV-1 RNA ＜50 c/ml by FDA snapshot analysis)

for 309 patients at 32 weeks receiving two drug maintenance therapy with

investigational long acting cabotegravir (CAB LA) and long acting rilpivirine

(RPV LA) whether dosed every 8 weeks (Q8W, 95%) or every 4 weeks (Q4W, 94%)

were comparable to the response observed in patients continuing with a

three-drug oral regimen of investigational CAB + NRTIs (91%). Patients

switching to CAB LA and RPV LA administered Q4W reported more adverse events

(AEs)  leading to withdrawal (5%; n=6) compared with those receiving an

injection Q8W (2%; n=2) or those who continued on oral CAB + NRTIs (2%, n=1).

The most common AE reported by patients was injection site pain (92% of

injection recipients).[1]

    LATTE-2 (31LB) is a phase IIb, multicentre, parallel group, and open-label

study which recruited ART-naive HIV-infected adults. Enrolled patients who had

a plasma HIV-1 RNA, ＜50 c/ml during 20-week Induction Period (IP) with daily

oral CAB 30 mg + ABC/3TC were randomised 2:2:1 to IM CAB LA + RPV LA every four

weeks, every 8 weeks, or remained on oral CAB + ABC/3TC (PO) in the Maintenance

Period (MP). The primary endpoints evaluated antiviral activity by FDA snapshot

algorithm, protocol defined virologic failure, and safety at 32 weeks in the

MP.[1]

    If successfully developed and approved by regulatory authorities, this

regimen could offer adult patients living with and treated for HIV an option to

maintain viral suppression with 6 or 12 long acting injections of each drug per

year.

    "Through scientific advances, over the past two decades, HIV has moved from

a death sentence to a manageable chronic disease," says Wim Parys, M.D., Vice

President and Head of Research and Development Global Public Health, Janssen.

"Results of the LATTE-2 study show that long acting injectable drug

formulations may offer an important option for HIV maintenance therapy and we

remain committed to developing such combinations as we enter phase 3 studies."

    Driven by a purpose of caring, and remaining committed to the prevention,

detection, education and treatment of HIV, Janssen has a long history in the

global battle against HIV/AIDS. It is estimated that around 37 million people

are currently living with HIV globally, with 2 million people becoming newly

infected each year[2]. As a company, Janssen has a deep commitment to HIV and

the company's ultimate goal is to help all those living with the virus to

achieve an undetectable viral load and have an improved quality of life with

the aim of making HIV history.

    About EDURANT(R) (Rilpivirine)

    EDURANT(R) (rilpivirine) is a prescription HIV medicine that is used with

other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1)

in patients:

    - Who have never taken HIV medicines before, and     

    - Who have an amount of HIV in their blood (called "viral load") that is no

more than 100,000 copies/mL. Your healthcare professional will measure your

viral load

    EDURANT(R) should be taken in combination with other HIV medicines. Your

healthcare professional will work with you to find the right combination of HIV

medicines.

    It is important that you remain under the care of your healthcare

professional during treatment with EDURANT(R).

    EDURANT(R) is not recommended for patients less than 12 years of age

    EDURANT(R) does not cure HIV infection or AIDS. You should remain on your

HIV medications without stopping to ensure that you control your HIV infection

and decrease the risk of HIV-related illnesses. Ask your healthcare

professional about how to prevent passing HIV to other people.

    Please read Important Safety Information

[http://www.edurant.com/patients/important-safety-information ], and talk to

your healthcare professional to learn if EDURANT(R) is right for you.

    About cabotegravir

    Cabotegravir is an investigational integrase strand 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 LA nanosuspension

formulation for intramuscular (IM) injection.

    About the Janssen Pharmaceutical Companies of Johnson & Johnson

    Janssen Sciences Ireland UC is one of the Janssen Pharmaceutical Companies

of Johnson & Johnson. At Janssen, we are dedicated to addressing some of the

most important unmet medical needs in oncology, immunology, neuroscience,

infectious diseases and vaccines, 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. More information

about Janssen can be found at: http://www.janssen.com.

    Delivering Sustainable Impact in Global Public Health

    Combatting HIV is an important component of Johnson & Johnson's

long-standing legacy of commitment and partnership to improve global public

health for individuals, families and communities worldwide. Janssen supports

this commitment with groundbreaking science and innovative strategies to

improve access to medicines, foster collaborations, and support public health

solutions to sustainably advance health care worldwide.

    Through Johnson & Johnson's global public health organization, the company

aims to deliver integrated evidence-based solutions to address comprehensive

health needs and deliver meaningful and enduring impact in three core focus

areas: HIV, maternal and child health, and extensively drug-resistant (XDR)-

and Multidrug-resistant (MDR)- tuberculosis (TB).

    References

    1) Margolis DA, Gonzalez-Garcia J, Stellbrink HJ, et al.

Cabotegravir+rilpivirine as long-acting maintenance therapy: LATTE-2 week 32

results. Presentation at Conference on Retroviruses and Opportunistic

Infections (CROI), Boston, MA, USA; 22-25 February 2016: abstract 31LB.

    2) World Health Organization. HIV/AIDS Fact sheet Ndegree(s)360, updated

November 2015. Available at:

http://www.who.int/mediacentre/factsheets/fs360/en. Last accessed February 2016.

    Cautions Concerning Forward-Looking Statements

    This press release contains "forward-looking statements" as defined in the

Private Securities Litigation Reform Act of 1995 regarding product development.

The reader is cautioned not to rely on these forward-looking statements. These

statements are based on current expectations of future events. If underlying

assumptions prove inaccurate or known or unknown risks or uncertainties

materialize, actual results could vary materially from the expectations and

projections of Janssen Sciences Ireland UC and/or Johnson & Johnson. Risks and

uncertainties include, but are not limited to: challenges and uncertainties

inherent in new product development, including uncertainty of clinical success

and obtaining regulatory approvals; competition, including technological

advances, new products and patents attained by competitors; challenges to

patents; changes to applicable laws and regulations, including global health

care reforms; and trends toward health care cost containment. A further list

and description of these risks, uncertainties and other factors can be found in

Johnson & Johnson's most recent Annual Report on Form 10-K, including in

Exhibit 99 thereto, and the company's subsequent filings with the Securities

and Exchange Commission. Copies of these filings are available online at

http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson.

None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to

update any forward-looking statement as a result of new information or future

events or developments.

Source: Janssen Sciences Ireland UC