Janssen Launches EXPLORER, Global Cardiovascular Research Program, Beginning with Five New Studies in Patients with Unmet

 Janssen Launches EXPLORER, Global Cardiovascular Research Program, Beginning
          with Five New Studies in Patients with Unmet Medical Needs

Program Further Extends XARELTO® as the Most Studied New Oral Anticoagulant in
the World Today

PR Newswire

RARITAN, N.J., March 8, 2013

RARITAN, N.J., March 8, 2013 /PRNewswire/ --Janssen Research & Development,
LLC (Janssen) today announced the launch of EXPLORER, a comprehensive, global
research program for XARELTO^® (rivaroxaban), an oral anticoagulant. The
program includes studies that will evaluate XARELTO^® for investigational use
in patients with chronic heart failure and in those with coronary artery
disease or peripheral artery disease.

XARELTO^® does not require routine blood monitoring, and with approvals for
six distinct uses, it has the broadest indication profile of any of the newer
oral anticoagulants in the market today. XARELTO^® is approved in the U.S. for
reducing the risk of strokes in patients with nonvalvular atrial fibrillation;
as a treatment for deep vein thrombosis and pulmonary embolism and to prevent
recurrence of these events; and for reducing the risk of blood clots in the
legs and lungs of people who have had hip or knee replacement surgery.

The extensive program of clinical trials evaluating XARELTO^® makes the
compound the most studied oral, Factor Xa inhibitor in the world today. By the
time of its completion, more than 100,000 patients will have participated in
the XARELTO^® clinical development program.

"Janssen is dedicated to improving patient outcomes in the cardiovascular
space and the EXPLORER program is one important way we are expressing our
commitment to patients with unmet medical needs," said Troy Sarich, Vice
President and Compound Development Team Leader at Janssen Research &
Development. "The EXPLORER program seeks to build upon the broad set of
approved indications, and further assess potential benefits of XARELTO^® in
additional patient populations who may benefit from oral anticoagulation
treatment."

As part of the EXPLORER program, Janssen and its development partner, Bayer
HealthCare, will enroll patients into five global clinical trials:

  oCOMMANDER-HF will evaluate XARELTO^® in patients with chronic heart
    failure and significant coronary artery disease who are receiving standard
    care.  The study will include 5,000 patients in 12 countries.
  oCOMPASS will evaluate XARELTO^® in patients with coronary artery disease
    or peripheral artery disease. This study includes 20,000 patients across
    25 countries and will be conducted in collaboration with the Population
    Health Research Institute (PHRI) at McMaster University in Hamilton,
    Canada.
  oPIONEER AF-PCI will evaluate XARELTO^® in 2,100 patients who have
    non-valvular atrial fibrillation and are undergoing percutaneous coronary
    intervention (PCI) with stent placement. The trial will assess XARELTO^®
    in combination with dual antiplatelet therapy and when aspirin is not
    used.
  oX-VeRT will evaluate patients with atrial fibrillation scheduled for
    cardioversion – a medical procedure to convert abnormally fast heart rate
    to a normal rhythm, using electricity or antiarrhythmic medications. The
    study includes 1,500 patients across 17 countries and will compare
    XARELTO^® to dose-adjusted vitamin K antagonist.
  oVENTURE-AF will evaluate the use of XARELTO^® in patients with
    non-valvular atrial fibrillation undergoing catheter ablation, a procedure
    that uses energy delivered through catheters to eliminate the abnormal
    tissue that is causing the arrhythmia. The study will include up to 250
    patients in four countries.

In addition, as part of our ongoing commitment to expanding therapeutic
choices for health care professionals, Janssen recently announced a clinical
collaboration agreement with Portola Pharmaceuticals, Inc. and Bayer
HealthCare to evaluate an investigational-stage antidote for Factor Xa
inhibitors. This proof-of-concept study is scheduled to complete in the second
half of 2013.

On March 4, 2012, Janssen announced the U.S. Food and Drug Administration
issued a second complete response letter regarding a supplemental New Drug
Application for XARELTO^® for the reduction of the risk of cardiovascular
events in patients with acute coronary syndrome. Janssen is evaluating the
letter and will respond to the agency's questions.

About XARELTO^® (rivaroxaban)
XARELTO^® works by blocking the blood clotting Factor Xa. It is approved for
six distinct uses:

1.To reduce the risk of blood clots in the legs and lungs of people who have
    just had knee replacement surgery.
2.To reduce the risk of blood clots in the legs and lungs of people who have
    just had hip replacement surgery.
3.To reduce the risk of both hemorrhagic and thrombotic strokes as well as
    other blood clots in people with atrial fibrillation not caused by a heart
    valve problem. There is limited information on how XARELTO^® compares to a
    medicine called warfarin in reducing the risk of stroke when the effects
    of warfarin are well controlled.
4.To treat people with pulmonary embolism (PE).
5.To treat people with deep vein thrombosis (DVT).
6.To reduce the risk of recurrence of DVT or PE following an initial six
    months of treatment for acute venous thromboembolism.

Janssen Research & Development, LLC, and Bayer HealthCare together are
developing rivaroxaban. Janssen Pharmaceuticals, Inc. holds U.S. marketing
rights for XARELTO^®, and is supported by the Bayer HealthCare U.S. sales
force.

For more information about XARELTO^®, ^ visit www.xarelto-us.com. The
XARELTO^® CarePath™ Support Program is a resource designed for health care
providers, patients and caregivers.Visit www.xareltocarepath.com or call
1-888-XARELTO to learn more about the XARELTO^® CarePath™ resources focused on
access, education and adherence.

Important Safety Information

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO^®?

  oFor people taking XARELTO^® for atrial fibrillation:
    People with atrial fibrillation (an irregular heart beat) are at an
    increased risk of forming a blood clot in the heart, which can travel to
    the brain, causing a stroke, or to other parts of the body. XARELTO^®
    lowers your chance of having a stroke by helping to prevent clots from
    forming. If you stop taking XARELTO^®, you may have increased risk of
    forming a clot in your blood.
    Do not stop taking XARELTO^® without talking to the doctor who prescribes
    it for you. Stopping XARELTO^® increases your risk of having a stroke.
    If you have to stop taking XARELTO^®, your doctor may prescribe another
    blood thinner medicine to prevent a blood clot from forming.
  oXARELTO^® can cause bleeding, which can be serious, and rarely may lead to
    death. This is because XARELTO^® is a blood thinner medicine that reduces
    blood clotting. While you take XARELTO^® you are likely to bruise more
    easily and it may take longer for bleeding to stop

You may have a higher risk of bleeding if you take XARELTO^® and take other
medicines that increase your risk of bleeding, including:

  oAspirin or aspirin-containing products
  oNon-steroidal anti-inflammatory drugs (NSAIDs)
  oWarfarin sodium (Coumadin^®, Jantoven^®)
  oAny medicine that contains heparin
  oClopidogrel (Plavix^®)
  oOther medicines to prevent or treat blood clots

Tell your doctor if you take any of these medicines. Ask your doctor or
pharmacist if you are not sure if your medicine is one listed above.

Call your doctor or get medical help right away if you develop any of these
signs or symptoms of bleeding:

  oUnexpected bleeding or bleeding that lasts a long time such as:

       oNosebleeds that happen often
       oUnusual bleeding from gums
       oMenstrual bleeding that is heavier than normal, or vaginal bleeding

  oBleeding that is severe or that you cannot control
  oRed, pink, or brown urine
  oBright red or black stools (looks like tar)
  oCough up blood or blood clots
  oVomit blood or your vomit looks like "coffee grounds"
  oHeadaches, feeling dizzy or weak
  oPain, swelling, or new drainage at wound sites

Spinal or epidural blood clots (hematoma): People who take a blood thinner
medicine (anticoagulant) like XARELTO^®, and have medicine injected into their
spinal and epidural area, or have a spinal puncture have a risk of forming a
blood clot than can cause long-term or permanent loss of the ability to move
(paralysis). Your risk of developing a spinal or epidural blood clot is higher
if:

  oA thin tube called an epidural catheter is placed in your back to give you
    certain medicine
  oYou take NSAIDs or a medicine to prevent blood from clotting
  oYou have a history of difficult or repeated epidural or spinal punctures
  oYou have a history of problems with your spine or have had surgery on your
    spine

If you take XARELTO^® and receive spinal anesthesia or have a spinal puncture,
your doctor should watch you closely for symptoms of spinal or epidural blood
clots. Tell your doctor right away if you have tingling, numbness, or muscles
weakness, especially in your legs and feet.

WHO SHOULD NOT TAKE XARELTO^®?

Do not take XARELTO^® if you:

  oCurrently have certain types of abnormal bleeding. Talk to your doctor
    before taking XARELTO^® if you currently have unusual bleeding.
  oAre allergic to rivaroxaban or any of the ingredients of XARELTO^®.

WHAT SHOULD I TELL MY DOCTOR BEFORE OR WHILE TAKING XARELTO^®?

Before taking XARELTO^®, tell your doctor if you:

  oHave ever had bleeding problems
  oHave liver or kidney problems
  oHave any other medical condition
  oAre pregnant or plan to become pregnant. It is not known if XARELTO^® will
    harm your unborn baby. Tell your doctor right away if you become pregnant
    while taking XARELTO^®. If you take XARELTO^® during pregnancy, tell your
    doctor right away if you have bleeding or symptoms of blood loss.
  oAre breastfeeding or plan to breastfeed. It is not known if XARELTO^®
    passes into your breast milk. You and your doctor should decide if you
    will take XARELTO^® or breastfeed.

Tell all of your doctors and dentists that you are taking XARELTO^®. They
should talk to the doctor who prescribed XARELTO^® for you before you have any
surgery, medical or dental procedure.

Tell your doctor about all the medicines you take, including prescription and
nonprescription medicines, vitamins, and herbal supplements. Some of your
other medicines may affect the way XARELTO^® works. Certain medicines may
increase your risk of bleeding.

Especially tell your doctor if you take:

  oKetoconazole (Nizoral^®)
  oItraconazole (Onmel™, Sporanox^®)
  oRitonavir (Norvir^®)
  oLopinavir/ritonavir (Kaletra^®)
  oIndinavir (Crixivan^®)
  oCarbamazepine (Carbatrol^®, Equetro^®, Tegretol^®, Tegretol^®-XR, Teril™,
    Epitol^®)
  oPhenytoin (Dilantin-125^®, Dilantin^®)
  oPhenobarbital (Solfoton™)
  oRifampin (Rifater^®, Rifamate^®, Rimactane^®, Rifadin^®)
  oSt. John's wort (Hypericum perforatum)

Ask your doctor if you are not sure if your medicine is one listed above. Know
the medicines you take. Keep a list of them to show your doctor and pharmacist
when you get a new medicine.

HOW SHOULD I TAKE XARELTO^®?

Take XARELTO^® exactly as prescribed by your doctor.

Do not change your dose or stop taking XARELTO^® unless your doctor tells you
to.

  oYour doctor will tell you how much XARELTO^® to take and when to take it.
  oYour doctor may change your dose if needed.

If you take XARELTO for:

  oAtrial Fibrillation: Take XARELTO^® 1 time a day with your evening meal.
    If you miss a dose of XARELTO^®, take it as soon as you remember on the
    same day. Take your next dose at your regularly scheduled time.
  oBlood clots in the veins of your legs or lungs:

       oTake XARELTO^® once or twice a day as prescribed by your doctor.
       oTake XARELTO^® with food at the same time each day.
       oIf you miss a dose of XARELTO^®:

            +and take XARELTO 2 times a day: Take XARELTO^® as soon as you
              remember on the same day. You may take 2 doses at the same time
              to make up for the missed dose. Take your next dose at your
              regularly scheduled time.
            +and take XARELTO^® 1 time a day: Take XARELTO^® as soon as you
              remember on the same day. Take your next dose at your regularly
              scheduled time.

  oHip or knee replacement surgery: Take XARELTO^® 1 time a day with or
    without food. If you miss a dose of XARELTO^®, take it as soon as you
    remember on the same day. Take your next dose at your regularly scheduled
    time.

  oIf you have difficulty swallowing the tablet whole, talk to your doctor
    about other ways to take XARELTO.
  oYour doctor will decide how long you should take XARELTO^®. Do not stop
    taking XARELTO^® without talking to your doctor first.
  oYour doctor may stop XARELTO^® for a short time before any surgery,
    medical or dental procedure. Your doctor will tell you when to start
    taking XARELTO^® again after your surgery or procedure.
  oDo not run out of XARELTO^®. Refill your prescription for XARELTO^® before
    you run out. When leaving the hospital following a hip or knee
    replacement, be sure that you have XARELTO^® available to avoid missing
    any doses.
  oIf you take too much XARELTO^®, go to the nearest hospital emergency room
    or call your doctor right away.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO^®?

XARELTO^® can cause bleeding, which can be serious, and rarely may lead to
death. Please see "What is the most important information I should know about
XARELTO^®?"

Tell your doctor if you have any side effect that bothers you or that does not
go away.

Call your doctor for medical advice about side effects. You are also
encouraged to report side effects to the FDA: visit
http://www.fda.gov/medwatchor call 1-800-FDA-1088. You may also report side
effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).

Please click here for full prescribing information, including Boxed Warnings
and the Medication Guide.

Trademarks are those of their respective owners.

About Janssen Research & Development, LLC

At Janssen, we are dedicated to addressing and solving some of the most
important unmet medical needs of our time 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. Janssen Research & Development, LLC and Janssen
Pharmaceuticals, Inc., are part of the Janssen Pharmaceutical Companies of
Johnson & Johnson. Please visit http://www.janssenrnd.com for more
information.

This press release contains "forward-looking statements" as defined in the
Private Securities Litigation Reform Act of 1995. 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 unknown risks or uncertainties materialize, actual results could
vary materially from the expectations and projections of Janssen Research &
Development, any of the Janssen Pharmaceutical Companies and/or Johnson &
Johnson. Risks and uncertainties include, but are not limited to, general
industry conditions and competition; economic factors, such as interest rate
and currency exchange rate fluctuations; technological advances, new products
and patents attained by competitors; challenges inherent in new product
development, including obtaining regulatory approvals; challenges to patents;
changes in behavior and spending patterns or financial distress of purchasers
of health care products and services; changes to governmental laws and
regulations and domestic and foreign health care reforms; trends toward health
care cost containment; and increased scrutiny of the health care industry by
government agencies. A further list and description of these risks,
uncertainties and other factors can be found in Exhibit 99 of Johnson &
Johnson's Annual Report on Form 10-K for the fiscal year ended December 30,
2012. Copies of this Form 10-K, as well as subsequent filings, are available
online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson.
Neither Janssen Research & Development nor Johnson & Johnson undertake to
update any forward-looking statements as a result of new information or future
events or developments.

Media contacts:
Ernie Knewitz
Phone: 908.927.2953
Mobile: 917.697.2318
eknewitz@its.jnj.com

Bill Foster
Phone: 908.704.4404
Mobile: 908.392.6057
wfoster@its.jnj.com

Investor contacts:
Stan Panasewicz
Phone: 732.524.2524

Louise Mehrotra
Phone: 732.524.6491

SOURCE Janssen

Website: http://www.janssenrnd.com
 
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