Janssen Announces Collaboration with Gilead to Develop PREZISTA®-based Single-tablet Regimen for the Treatment of People

CORK, Ireland, December 29, 2014 /PRNewswire/ --

-- Two Companies to also Collaborate on the Further Development of

Complera(R), Marketed as Eviplera(R) in the European Union --

Janssen R&D Ireland (Janssen) announced today an amendment to its existing agreement with Gilead Sciences, Inc. (Gilead), initially established in 2011, for the development of a once daily, darunavir-based, single-tablet regimen (STR) for the treatment of people living with HIV. This new STR contains a combination of darunavir (PREZISTA(R)), cobicistat (TYBOST(R)), emtricitabine and tenofovir alafenamide (TAF). A number of Phase 1 and 2 studies of the new STR have been completed. Under this amended agreement, Janssen will conduct all further clinical development of the regimen and, subject to regulatory approval, will be responsible for all manufacturing, registration, distribution and commercialization of the product worldwide.

(Logo: http://photos.prnewswire.com/prnh/201403... )

If successfully developed and approved by regulatory authorities, this treatment would represent the first protease inhibitor-based STR and thereby continue Janssen's commitment to providing its HIV products in more simplified dosing presentations.

"Janssen has vast experience in developing and making innovative HIV treatments available to patients and we have engaged in several successful collaborations with Gilead. We are proud to be extending our collaboration and leading the development of this darunavir-based single-tablet regimen," says Paul Stoffels, Chief Scientific Officer and Worldwide Chairman, Pharmaceuticals, Johnson & Johnson. "Our ultimate goal is to offer new treatment options for people living with HIV. If approved, this STR has the potential to provide additional choice in the form of another one pill, once a day, as a new and simplified regimen."

In addition to this collaboration, Janssen and Gilead have also expanded a separate agreement initiated in 2009 regarding the approved single-tablet regimen, COMPLERA(R), marketed as EVIPLERA(R) in the European Union (EU) (rilpivirine, tenofovir disoproxil fumarate (TDF) and emtricitabine). This expanded agreement will allow for Gilead's investigational tenofovir alafenamide (TAF), a novel nucleotide reverse transcriptase inhibitor, to replace TDF within COMPLERA(R)/ EVIPLERA(R). TAF has been shown in clinical trials to have a better renal and bone safety profile than TDF.[1] Gilead will be responsible for the development and commercialization in most countries, while Janssen will lead the commercialization in select markets.

Since the beginning of the HIV epidemic, almost 75 million people have been infected with the HIV virus.[2] It is estimated that 35 million people are currently living with HIV globally, with 2.5 million people becoming newly infected each year.[2],[3],[4]

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PREZISTA(R)

Indication

PREZISTA(R) (darunavir), coadministered with ritonavir (PREZISTA(R)/r), and with other antiretroviral agents (ARVs), is indicated for the treatment of human immunodeficiency virus (HIV-1) infection.

This indication is based on analyses of plasma HIV-1 RNA levels and CD4+ cell counts from 2 controlled Phase 3 trials of 48 weeks duration in ARV treatment-naive and treatment-experienced patients and 2 controlled Phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients.

In treatment-experienced adult patients, the following points should be considered when initiating therapy with PREZISTA(R)/r:

- Treatment history and, when available, genotypic or phenotypic testing
should guide the use of PREZISTA(R)/r
- The use of other active agents with PREZISTA(R)/r is associated with a greater
likelihood of treatment response

Important Safety Information

PREZISTA(R) (darunavir) is a prescription medicine. It is one treatment option in the class of HIV (human immunodeficiency virus) medicines known as protease inhibitors.

PREZISTA(R) is always taken with and at the same time as ritonavir (Norvir(R)), in combination with other HIV medicines for the treatment of HIV infection in adults. PREZISTA(R) should also be taken with food.

- The use of other medicines active against HIV in combination with
PREZISTA(R)/ritonavir (Norvir(R)) may increase your ability to fight HIV. 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 PREZISTA(R)

PREZISTA(R) does not cure HIV infection or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using PREZISTA(R).

Please read Important Safety Information below, and talk to your healthcare professional to learn if PREZISTA(R) is right for you.

Important Safety Information

What is the most important information I should know about PREZISTA(R)?

- PREZISTA(R) can interact with other medicines and cause serious side
effects. See "Who should not take PREZISTA(R)?"
- PREZISTA(R) may cause liver problems. Some people taking PREZISTA(R),
together with Norvir(R) (ritonavir), have developed liver problems which may be
life-threatening. Your healthcare professional should do blood tests before and during
your combination treatment with PREZISTA(R). If you have chronic hepatitis B or C
infection, your healthcare professional should check your blood tests more often
because you have an increased chance of developing liver problems
- Tell your healthcare professional if you have any of these signs and symptoms
of liver problems: dark (tea-colored) urine, yellowing of your skin or whites of your
eyes, pale colored stools (bowel movements), nausea, vomiting, pain or tenderness on
your right side below your ribs, or loss of appetite
- PREZISTA(R) may cause a severe or life-threatening skin reaction or rash.
Sometimes these skin reactions and skin rashes can become severe and require treatment
in a hospital. You should call your healthcare professional immediately if you develop
a rash. However, stop taking PREZISTA(R) and ritonavir combination treatment and call
your healthcare professional immediately if you develop any skin changes with these
symptoms: fever, tiredness, muscle or joint pain, blisters or skin lesions, mouth
sores or ulcers, red or inflamed eyes, like "pink eye." Rash occurred more often in
patients taking PREZISTA(R) and raltegravir together than with either drug separately,
but was generally mild

Who should not take PREZISTA(R)?

(CONTINUA)