Janssen Expands the EXPLORER Global Cardiovascular Research Program with Three
New Studies Evaluating XARELTO® in Patients at Risk for Venous Thromboembolism
RARITAN, N.J., March 31, 2014
RARITAN, N.J., March 31, 2014 /PRNewswire/ -- Janssen Research & Development,
LLC (Janssen) announced today it is adding three new clinical trials to its
EXPLORER global cardiovascular research program for XARELTO^® (rivaroxaban),
the most studied and broadly indicated oral Factor Xa inhibitor in the world
today. The additional trials will evaluate rivaroxaban for the treatment or
prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in
pediatric and other patient populations, including those at risk for DVT or PE
due to a concurrent medical illness. The new studies will include more than
11,000 patients in over 30 countries.
With the addition of these studies, the EXPLORER global cardiovascular
research program now encompasses eight clinical trials assessing the safety
and efficacy of rivaroxaban in high-risk patient populations, including those
with chronic heart failure, coronary artery disease and peripheral artery
disease. EXPLORER is an integral part of the extensive clinical development
program for rivaroxaban, evaluating its use in a broad range of cardiovascular
"Each year in the U.S., more people die from DVT and PE than from motor
vehicle accidents, breast cancer and HIV combined," said Anne Hermanowski
Vosatka, M.D., Ph.D., FACC, vice president and compound development team
leader for XARELTO^® at Janssen. "New trials added to the EXPLORER global
cardiovascular research program will broaden our understanding of how
rivaroxaban might help patients at risk for developing blood clots such as DVT
or PE, addressing an urgent unmet need."
Specifically, Janssen and its development partner, Bayer HealthCare, will add
the following new trials under the EXPLORER global cardiovascular research
oMARINER is a Phase 3 study designed to evaluate the efficacy and safety
of rivaroxaban once-daily compared with placebo to reduce the risk of
symptomatic DVT and/or PE due to a concurrent medical illness for up to 45
days after hospital discharge. This study will include approximately 8,000
patients in more than 15 countries.
oEINSTEIN JUNIOR, including Phase 1, 2a, 2b and 3 clinical trials, will
evaluate rivaroxaban according to an age- and body weight-adjusted dosing
schedule for the treatment and secondary prevention of DVT and/or PE in
pediatric populations. The study program will include at least 150
patients in 20 countries, and is currently enrolling participants for
Phase 2 trials. The Phase 3 study is expected to start in September 2014.
Please click here for more information.
oEINSTEIN CHOICE is a Phase 3 study designed to evaluate whether once-daily
rivaroxaban in doses of 10mg or 20mg is superior to aspirin for the
prevention of symptomatic recurrent DVT and/or PE in patients who have
completed between six and 12 months of anticoagulant therapy. The study
will include approximately 2,850 patients in 31 countries and is currently
enrolling participants. Please click here for more information.
In total, the global clinical development program for rivaroxaban will include
15 Phase 3 clinical trials, 10 of which are completed. By the time of its
completion in 2018, more than 136,000 patientsare expected to
haveparticipated in the global clinical development program, including those
patients assessed in EXPLORER.
In addition, Janssen and Bayer recently entered into an agreement with Portola
Pharmaceuticals, Inc. to initiate Phase 3 studies evaluating Portola's
investigational Factor Xa inhibitor reversal agent, andexanet alpha, for use
with XARELTO^® in emergency situations, such as for patients with major
bleeding or those requiring emergency surgery. The clinical collaboration will
be in effect through completion of Phase 3 studies with XARELTO^® and any
potential U.S. and EU regulatory approval of andexanet alfa. Phase 3 studies
are expected to start in the first half of 2014.
DVT is a condition in which blood clots form in one of the large, deep veins,
usually in the legs. PE is a serious condition that most commonly occurs when
part or all of a DVT dislodges and travels to the lung, via the heart, where
it can partially or completely block a branch of the pulmonary artery. When PE
occurs with large clots, multiple clots or when the patient already has
pre-existing heart or lung disease, the event may be fatal. Each year up to
900,000 Americans experience a DVT or PE, resulting in up to 300,000 deaths.
About EXPLORER Global Cardiovascular Research Program
The EXPLORER global cardiovascular research program is an integral part of the
extensive clinical development program for rivaroxaban, evaluating its use in
a broad range of cardiovascular conditions, making it the most studied and
broadly indicated oral Factor Xa inhibitor in the world today. Additional
studies within the EXPLORER program include:
oCOMMANDER-HF is evaluating rivaroxaban 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. Please click
here for more information.
oCOMPASS is evaluating rivaroxaban 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,
Ontario, Canada. Please click here for more information.
oPIONEER AF-PCI is evaluating rivaroxaban in 2,100 patients who have
non-valvular atrial fibrillation (NVAF) and are undergoing percutaneous
coronary intervention (PCI) with stent placement. The trial is assessing
rivaroxaban in combination with dual antiplatelet therapy and when aspirin
is not used. Please click here for more information.
oVENTURE-AF is evaluating the use of rivaroxaban in patients with NVAF
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.
Please click here for more information.
oX-VeRT is evaluating 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
rivaroxaban to dose-adjusted vitamin K antagonist. Please click here for
About XARELTO^® (rivaroxaban)
XARELTO^® works by blocking the blood clotting Factor Xa and does not require
routine blood monitoring. XARELTO^® has the broadest indication profile of any
novel oral anticoagulant and is approved for six indications that include:
1.To reduce the risk of strokes and blood clots in patients with atrial
fibrillation not caused by a heart valve problem. For patients currently
well managed on warfarin, there is limited information on how XARELTO^®
and warfarin compare in reducing the risk of stroke.
2.To treat patients with deep vein thrombosis (DVT).
3.To treat patients with pulmonary embolism (PE).
4.To reduce the risk of recurrence of DVT or PE following an initial
six-month treatment for acute venous thromboembolism.
5.To reduce the risk of blood clots in the legs and lungs of patients who
have just had knee replacement surgery.
6.To reduce the risk of blood clots in the legs and lungs of patients who
have just had hip replacement surgery.
Eight million patients have received XARELTO^® worldwide, and more than five
million prescriptions have been written for XARELTO^® in the U.S. XARELTO^®
has earned a strong reimbursement profile among oral anticoagulants, with 90
percent of patients on Medicare Part D and 90 percent of commercial patients
covered at the lowest branded co-pay.
Janssen Research & Development, LLC and Bayer HealthCare together are
For more information about XARELTO^®, ^ visit www.xarelto-us.com. The
XARELTO^® CarePath™ Support Program is a resource designed for healthcare
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.
WHAT IS XARELTO^®?
XARELTO^® is a prescription medicine used to reduce the risk of stroke and
blood clots in people with atrial fibrillation, not caused by a heart valve
problem. For patients currently well managed on warfarin, there is limited
information on how XARELTO^® and warfarin compare in reducing the risk of
XARELTO^® is also a prescription medicine used to treat deep vein thrombosis
and pulmonary embolism, and to help reduce the risk of these conditions
XARELTO^® is also a prescription medicine used to reduce the risk of forming a
blood clot in the legs and lungs of people who have just had knee or hip
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
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
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 that 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
oA thin tube called an epidural catheter is placed in your back to give you
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
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 back pain, tingling, numbness,
muscle weakness (especially in your legs and feet), or loss of control of the
bowels or bladder (incontinence).
XARELTO^® is not for patients with artificial heart valves.
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. See "What is the most important information I
should know about XARELTO^®?"
Especially tell your doctor if you take:
oItraconazole (Onmel^™, Sporanox^®)
oCarbamazepine (Carbatrol^®, Equetro^®, Tegretol^®, Tegretol^®-XR, Teril^™,
oPhenytoin (Dilantin-125^®, Dilantin^®)
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
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
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^®:
oand 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.
oand 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
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
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^®?
Please see "What is the most important information I should know about
Tell your doctor if you have any side effect that bothers you or that does not
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 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
(This press release contains "forward-looking statements" as defined in the
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Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any
forward-looking statement as a result of new information or future events or
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