Janssen to Progress Collaboration with ViiV Healthcare to Develop the First Long Acting Two Drug Injectable Regimen for

CORK, Ireland, January 7, 2016 /PRNewswire/ --

Results from ongoing phase IIb Week 32 study show that if successfully developed and approved, people living with HIV could potentially maintain viral suppression  

Janssen Sciences Ireland UC (Janssen), today formalized its collaboration with ViiV Healthcare on phase III development and commercialization of a two drug regimen of two long acting, all-injectable formulations of rilpivirine (a non-nucleoside reverse transcriptase inhibitor by Janssen) and cabotegravir (ViiV Healthcare).

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Janssen and ViiV Healthcare have been working together on this regimen, through a number of clinical trial agreements, for several years. Under this new agreement, the phase III development, to evaluate the efficacy, safety and tolerability of the regimen, will be led by ViiV Healthcare with support from Janssen. Each company will manufacture and supply their individual drug formulations following successful phase III completion and regulatory outcomes.

"Despite great progress in developing HIV treatments, the day-to-day burden of managing HIV remains high and poses challenges to ensure people living with HIV maintain an undetectable viral load," says Paul Stoffels, Chief Scientific Officer, Johnson & Johnson and Worldwide Chairman, Janssen Pharmaceutical Companies. "We are committed to making a real difference for those affected by HIV. The prospect of developing new therapies, such as long acting formulations which are broadly accessible, may offer hope to the many millions affected by HIV around the world."

At week 32, in an ongoing phase IIb study (LATTE 2, NCT02120352), the investigational long acting, all-injectable combination regimen, given every 4 or 8 weeks, showed comparable efficacy to a daily oral regimen of three HIV medicines (investigational cabotegravir and two nucleoside reverse transcriptase inhibitors (NRTIs)). If successfully developed and approved by regulatory authorities, people living with HIV who are virologically suppressed could be offered an alternative option to the standard oral daily regimen* of three drug therapy.

"While we work toward our long-term goal of developing a preventative HIV vaccine, we are excited to be able to continue to support people living with HIV through innovative improvements," said Wim Parys, Head of R&D, Global Public Health, Janssen. "Through this collaboration, we have the potential to develop the first long acting, all-injectable two drug regimen as an innovative option for HIV maintenance therapy."

Since the beginning of the HIV epidemic, almost 75 million people have been infected with the virus. It is estimated that 35 million people are currently living with HIV globally, with 2.5 million people becoming newly infected each year.

*Standard three drug oral therapy contains three active components taken daily: a backbone of two NRTIs, plus either a non-nucleoside reverse transcriptase inhibitor, a protease inhibitor (PI) or an integrase inhibitor (INI).

More information on the Phase IIb LATTE 2 study  

LATTE 2 was initiated as a phase IIb, multicentre, open label, 96 week study investigating the safety and efficacy of this first all-injectable long acting combination regimen of rilpivirine and cabotegravir to maintain suppression of viral load. LATTE 2 included adults (n=309) who, after reaching virologic suppression on oral therapy with once-daily investigational oral cabotegravir 30mg + 2 NRTIs (n=286, 93%), were subsequently randomized to one of three study arms to receive either CAB LA + RPV LA injections every 4 weeks (n=115, Q4W), 8 weeks (n=115 Q8W) or continued on oral CAB + NRTIs (n=56).

Viral suppression rates (plasma HIV-1 RNA <50 c/ml by FDA snapshot analysis) for 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 rate 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 who continued on oral CAB + NRTIs (2%, n=1). The most common AE reported by patients was injection site pain (93% of injection recipients). Two patients in the Q8W arm (none in the Q4W arm) withdrew due to injection intolerance. Two patients met protocol-defined virologic failure criteria, Q8W (n=1), oral (n=1); neither patient had evidence of resistance at failure.

Results of the LATTE 2 study, co-funded by Janssen and ViiV Healthcare, will be presented at a forthcoming scientific conference. 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 below, and talk to your healthcare professional to learn if EDURANT(R) is right for you.  

Important Safety Information  

Can EDURANT(R) be taken with other medicines?  

EDURANT(R) may affect the way other medicines work and other medicines may affect how EDURANT(R) works and may cause serious side effects. If you take certain medicines with EDURANT(R), the amount of EDURANT(R) in your body may be too low and it may not work to help control your HIV infection, and the HIV virus in your body may become resistant to EDURANT(R) or other HIV medicines that are like it. To help get the right amount of medicine in your body, you should always take EDURANT(R) with a meal. A protein drink alone does not replace a meal.

Do not take EDURANT(R) if:  

(CONTINUA)