Janssen Expands the EXPLORER Global Cardiovascular Research Program with Three New Studies Evaluating XARELTO® in Patients at

Janssen Expands the EXPLORER Global Cardiovascular Research Program with Three New Studies Evaluating XARELTO® in Patients at Risk for Venous Thromboembolism  PR Newswire  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 conditions.  "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 program:    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     more information.  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 developing rivaroxaban.  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 stroke.  XARELTO^® is also a prescription medicine used to treat deep vein thrombosis and pulmonary embolism, and to help reduce the risk of these conditions occurring again.  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 replacement surgery.  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 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 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 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:    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^®:                 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        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^®?  Please see "What is the most important information I should know about XARELTO^®?" above.  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 Medication Guide.  Trademarks are those of their respective owners.  011417-140307  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 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 unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies 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; 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; general industry conditions including 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 Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2013, including in Exhibit 99 thereto, and our subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.)  Media Contacts: Kristina Chang Tel: (908) 927-2416 Mobile: (201) 213-4115 kchang12@its.jnj.com   Christina Chan Tel: (908) 927-5769 Mobile: (908) 635-2406 cchan20@its.jnj.com   Investor Relations Contacts: Johnson & Johnson Louise Mehrotra Tel: (732) 524-6491  Johnson & Johnson Stan Panasewicz Tel: (732) 524-2524  SOURCE Janssen Research & Development, LLC  Website: http://www.janssenrnd.com