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Janssen Launches EXPLORER, Global Cardiovascular Research Program, Beginning with Five New Studies in Patients with Unmet Medical Needs
Date:3/8/2013

/a> 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.
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