XARELTO® to be Studied with Factor Xa Inhibitor Antidote

           XARELTO® to be Studied with Factor Xa Inhibitor Antidote

Janssen and Bayer Announce Clinical Collaboration Agreement with Portola

PR Newswire

RARITAN, N.J., Feb. 5, 2013

RARITAN, N.J., Feb. 5, 2013 /PRNewswire/ -- Janssen Pharmaceuticals, Inc.
(Janssen) today announced a clinical collaboration agreement with Portola
Pharmaceuticals, Inc. and Bayer HealthCare to evaluate the safety of PRT4445 –
an investigational-stage antidote for Factor Xa inhibitors – in healthy
volunteers who have been administered the oral anticoagulant XARELTO^®
(rivaroxaban). The study will evaluate several dosage strengths of PRT4445 and
its ability to reverse the anticoagulant activity of XARELTO^® in emergency
situations.

XARELTO^® is approved by the U.S. Food and Drug Administration (FDA)for six
distinct uses. This proof-of-concept study is scheduled to complete in the
second half of 2013. ^A phase 3 trial will be required prior to submitting
PRT4445 to the FDA for approval in this setting. Standard clinical measures
are currently employed to manage these patients and events.

"XARELTO^® has the broadest indication profile of any of the new oral
anticoagulants in the U.S. market, and is being used by a wide array of
patients in many different settings," said Larry E. Fields, M.D., Senior
Director, Clinical Development, Medical Affairs at Janssen. "We are committed
to exploring ways to expedite reversal of the drug's effects when necessary,
which could provide physicians with an additional treatment option during
emergency situations."

As part of the agreement, Janssen and Bayer will make an upfront payment to
Portola and will provide development and regulatory guidance for the study.
Portola retains full global development and commercialization rights for
PRT4445.

To date, more than 2.5 million patients have received XARELTO^® worldwide and
more than one million prescriptions have been written in the U.S. XARELTO^® is
broadly reimbursed for more than 90% of commercial and Medicare health plan
members, with the majority covered at the lowest branded co-pay.

Janssen Pharmaceuticals, Inc. holds U.S. marketing rights for XARELTO^®, and
is supported by the Bayer HealthCare U.S. sales force in designated hospital
accounts.

About PRT4445
Portola Pharmaceutical's PRT4445 is a novel recombinant protein designed to
reverse the anticoagulant activity in patients treated with Factor Xa
inhibitors suffering from an uncontrolled bleeding episode or undergoing
emergency surgery. It is similar to native Factor Xa but has structural
modifications intended to restrict its biological activity to reverse the
effects of Factor Xa inhibitors. PRT4445 works by binding Factor Xa inhibitors
in the blood, thereby preventing them from inhibiting the activity of native
Factor Xa. As a result, the native Factor Xa is available to participate in
the coagulation process and restore normal clotting.

About XARELTO^® (rivaroxaban)
XARELTO^® 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.

There are two additional indications currently submitted and under review at
the FDA.

XARELTO^® works by blocking the blood clotting enzyme Factor Xa, and does not
require routine blood monitoring. The extensive program of clinical trials
evaluating XARELTO^® in more than 75,000 makes it the most studied oral,
Factor Xa inhibitor in the world today.

Janssen Research & Development, LLC, and Bayer HealthCare together are
developing rivaroxaban.

The XARELTO^® CarePath™ Support Program is a resource designed for health care
providers, patients and caregivers.Visit goxarelto.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 decide how long you should take XARELTO^®. Do not stop
    taking XARELTO^® without talking with your doctor first.
  oYour doctor may change your dose if needed,

For people who have:

     oAtrial Fibrillation: Take XARELTO^® 1 time a day with your evening
       meal. Stopping XARELTO^® may increase your risk of having a stroke or
       forming blood clots in other parts of your body.
     oBlood clots in the veins of your legs or lungs:

          oTo treat blood clots, take XARELTO^® once or twice a day according
            to your doctor's instructions. XARELTO^® is usually taken with
            food. Take XARELTO^® at the same time each day.

     oHip or knee replacement surgery: Take XARELTO^® 1 time a day with or
       without food.

  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 miss a dose of XARELTO^®, take it as soon as you remember on the
    same day and continue with your next regularly scheduled dose.
  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/medwatch or 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 Pharmaceuticals, Inc.
As a member of the Janssen Pharmaceutical Companies of Johnson & Johnson,
Janssen Pharmaceuticals, Inc. is dedicated to addressing and resolving the
major unmet medical needs of our time. Driven by our commitment to patients,
healthcare professionals, and caregivers, we strive to develop sustainable and
integrated healthcare solutions by working in partnership with all
stakeholders on the basis of trust and transparency. Our daily work is guided
by meeting goals of excellence in quality, innovation, safety, and efficacy in
order to advance patient care.

Our company provides medicines for an array of health concerns in several
therapeutic areas. Other innovative therapies that Janssen Pharmaceuticals,
Inc. offers include ACIPHEX^® (rabeprazole sodium), DORIBAX^® (doripenem for
injection), ELMIRON^® (pentosan polysulfate sodium), NUCYNTA^® (tapentadol)
and NUCYNTA^® ER (tapentadol extended-release tablets). The full prescribing
information for NUCYNTA^® and NUCYNTA^® ER, including boxed warnings, are
available here and here. 

For more information on Janssen Pharmaceuticals, Inc., visit us at
www.janssenpharmaceuticalsinc.comor follow us on Twitter at
www.twitter.com/JanssenUSand on YouTube at www.Youtube.com/JanssenUS.

(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
Pharmaceuticals, Inc., any of the other 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 healthcare 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 healthcare
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 January 1,
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 Pharmaceuticals, Inc. nor Johnson & Johnson undertakes to
update any forward-looking statements as a result of new information or future
events or developments.)

Media contacts:

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

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

Investor contacts:

Stan Panasewicz
Phone: 732.524.2524

Louise Mehrotra
Phone: 732.524.6491

SOURCE Janssen Pharmaceuticals, Inc.

Website: http://www.janssenpharmaceuticalsinc.com
 
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