New data at American Society of Hematology (ASH) Annuaul Meeting will offer important insights into safe and efficacious use of XARELTO®

Janssen Research & Development, LLC (Janssen) announced today that new data involving its novel oral anticoagulant XARELTO® (rivaroxaban) will be presented at the 55th American Society of Hematology (ASH) Annual Meeting and Exposition held in New Orleans, LA, USA, from December 7-10, 2013.

Notable presentations at ASH’s Annual Meeting and Exposition include:

Statin Use Was Associated With a Non-Significant Reduction In The Observed Incidence Of Recurrent VTE In Einstein-DVT and Einstein-PE

• Poster Presentation: Session 332; Antithrombotic Therapy: Poster I
• Saturday, December 7, 2013, 5:30 PM-7:30 PM CST; Hall E (Ernest N. Morial Convention Center)

Performance Of The Simplified PESI Score In Patients With Pulmonary Embolism Treated With Rivaroxaban Or Standard Therapy

• Poster Presentation: Session: 332. Antithrombotic Therapy: Poster I
• Saturday, December 7, 2013, 5:30 PM-7:30 PM CST; Hall E (Ernest N. Morial Convention Center)

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial Demonstrating Reversal Of Rivaroxaban-Induced Anticoagulation In Healthy Subjects By Andexanet Alfa (PRT064445), An Antidote For FXa Inhibitors

• Poster Presentation: Session 332; Antithrombotic Therapy: Poster III
• Monday, December 9, 2013, 6:00 PM-8:00 PM CST; Hall E (Ernest N. Morial Convention Center)

“As the most widely studied and prescribed novel oral anticoagulant, XARELTO® is an important medication for reducing the risk of or treating blood clots,” said Larry E. Fields, M.D., Senior Director, Clinical Development, Medical Affairs at Janssen. “The presentation of this research will provide important information regarding the performance of XARELTO® when it is used concomitantly with statin therapy and insight on a potential antidote to reverse the blood thinning effects of the treatment in emergency situations.”

XARELTO® is the most prescribed novel oral anticoagulant in the U.S. market today and is approved for six clinical uses in the U.S. It has earned the strongest reimbursement profile among novel anticoagulants, with 90 percent of patients on Medicare Part D and 85 percent of commercial patients covered at the lowest branded co-pay. To date, more than 5 million patients have received XARELTO® worldwide and more than 3 million prescriptions have been written for XARELTO® in the U.S.

About XARELTO® (rivaroxaban)

XARELTO® works by blocking the blood clotting Factor Xa. XARELTO® does not require routine blood monitoring. XARELTO® is the only Factor Xa inhibitor 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.

The extensive program of clinical trials evaluating rivaroxaban 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 rivaroxaban clinical development program.

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.