Janssen Announces Collaboration with Gilead to Develop PREZISTA(R)-based Single-tablet Regimen for the Treatment of People Living with HIV

PR59061

CORK, Ireland, Dec. 30 /PRN=KYODO JBN/ --

-- 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/20140324/NY88746LOGO )

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)?

- Do not take PREZISTA(R) if you are taking the following medicines: alfuzosin

(Uroxatral(R)), dihydroergotamine (D.H.E.45(R), Embolex(R), Migranal(R)),

ergonovine, ergotamine (Cafergot(R), Ergomar(R)), methylergonovine, cisapride

(Propulsid(R)), pimozide (Orap(R)), oral midazolam, triazolam (Halcion(R)), the

herbal supplement St. John's wort (Hypericum perforatum), lovastatin

(Mevacor(R), Altoprev(R), Advicor(R)), simvastatin (Zocor(R), Simcor(R),

Vytorin(R)), rifampin (Rifadin(R), Rifater(R), Rifamate(R), Rimactane(R)),

sildenafil (Revatio(R)) when used to treat pulmonary arterial hypertension,

indinavir (Crixivan(R), lopinavir/ritonavir (Kaletra(R)), saquinavir

(Invirase(R)), boceprevir (Victrelis(TM)), or telaprevir (Incivek(TM))

- Before taking PREZISTA(R), tell your healthcare professional if you are

taking sildenafil (Viagra(R), Revatio(R)), vardenafil (Levitra(R), Staxyn(R)),

tadalafil (Cialis(R), Adcirca(R)), atorvastatin (Lipitor(R)), rosuvastatin

(Crestor(R)), pravastatin (Pravachol(R)), or colchicine (Colcrys(R),

Col-Probenecid(R)). Tell your healthcare professional if you are taking

estrogen-based contraceptives (birth control). PREZISTA(R) might reduce the

effectiveness of estrogen-based contraceptives. You must take additional

precautions for birth control, such as condoms

This is not a complete list of medicines. Be sure to tell your healthcare

professional about all the medicines you are taking or plan to take, including

prescription and nonprescription medicines, vitamins, and herbal supplements.

What should I tell my doctor before I take PREZISTA(R)?

- Before taking PREZISTA(R), tell your healthcare professional if you have any

medical conditions, including liver problems (including hepatitis B or C),

allergy to sulfa medicines, diabetes, or hemophilia

- Tell your healthcare professional if you are pregnant or planning to become

pregnant, or are breastfeeding

- The effects of PREZISTA(R) on pregnant women or their unborn babies are not

known. You and your healthcare professional will need to decide if taking

PREZISTA(R) is right for you

- Do not breastfeed. It is not known if PREZISTA(R) can be passed to your baby

in your breast milk and whether it could harm your baby. Also, mothers with HIV

should not breastfeed because HIV can be passed to your baby in the breast milk

What are the possible side effects of PREZISTA(R)?

- High blood sugar, diabetes or worsening of diabetes, and increased bleeding

in people with hemophilia have been reported in patients taking protease

inhibitor medicines, including PREZISTA(R)

- Changes in body fat have been seen in some patients taking HIV medicines,

including PREZISTA(R). The cause and long-term health effects of these

conditions are not known at this time

- Changes in your immune system can happen when you start taking HIV medicines.

Your immune system may get stronger and begin to fight infections that have

been hidden

- The most common side effects related to taking PREZISTA(R) include diarrhea,

nausea, rash, headache, stomach pain, and vomiting. This is not a complete list

of all possible side effects. If you experience these or other side effects,

talk to your healthcare professional. Do not stop taking PREZISTA(R) or any

other medicines without first talking to your healthcare professional

You are encouraged to report negative side effects of prescription drugs to the

FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please refer to the ritonavir (Norvir(R)) Product Information (PI and PPI) for

additional information on precautionary measures.

Please see full Product Information for more details:

http://www.prezista.com/sites/default/files/pdf/us_package_insert.pdf#zoom=100

About Janssen Pharmaceutical Companies of Johnson & Johnson

The Janssen Pharmaceutical Companies of Johnson & Johnson 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.  

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

Private Securities Litigation Reform Act of 1995 including 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 R&D Ireland and/or Johnson & Johnson.  

Risks and uncertainties include, but are not limited to: challenges inherent in

new product development, including obtaining regulatory approvals;  

competition, including technological advances, new products and patents

attained by competitors; changes to regulations and domestic and foreign health

care reforms; and general industry conditions, including 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 Annual

Report on Form 10-K for the fiscal year ended December 29, 2013, 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 undertake to

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

events or developments.  

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1. Sax P, Brar I, Elion R, et al. 48 Week study of tenofovir alafenamide (TAF)

versus tenofovir disoproxil fumarate (TDF), each in a single tablet regimen

with elvitegravir, cobicistat, and emtricitabine for initial HIV treatment.

53rd ICAAC. September 10-13, 2013. Denver. Abstract H1464d.

2. World Health Organization. Global summary of the AIDS epidemic. Available

at: http://www.who.int/gho/hiv/en/. Last accessed July 2014.

3. Hui Dy. Effects of HIV protease inhibitor therapy on lipid metabolism. Prog

Lipid Res 2003; 42(2):81-92.

4. World Health Organization. Global summary of the AIDS epidemic. Available

at: http://www.who.int/hiv/data/2012_epi_core_en.png . Last accessed July 2014.

MEDIA CONTACT:

Daniel De Schryver

+49-173-768-9149

ddschryv@its.jnj.com

Ronan Collins

+47-488-425-00

rcollin5@its.jnj.com

INVESTOR RELATIONS:

Stan Panasewicz

+1-732-524-2524

Louise Mehrotra

+1-732-524-6491

SOURCE: Janssen R&D Ireland Ltd