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

Cork, Ireland (ots/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/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 [http://www.prezista.com/sites/default/files/pdf/us_pack
age_insert.pdf ]

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.

###

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/. [http://www.who.int/gho/hiv/en/.%20 ] 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

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