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Octapharma Launches Clinical Trial to Evaluate Efficacy & Safety of wilate® In Preventing Surgical Bleeding in Type 3 von Willebrand Disease Patients
Date:9/26/2011

HOBOKEN, N.J. and LACHEN, Switzerland, Sept. 26, 2011 /PRNewswire/ -- Octapharma, one of the largest human protein products manufacturers in the world, has launched an international multi-center clinical study to investigate the efficacy and safety of wilate® (von Willebrand Factor/Factor VIII Concentrate, Human) in preventing excessive intra- and post-operative bleeding in pediatric and adult patients with Type 3 von Willebrand Disease (VWD) who undergo major surgical procedures.

The prospective, open-label, Phase 3 trial is being conducted at study centers in the U.S., Europe, Asia, and South Africa and recently enrolled its first patient. As the most common inherited bleeding disorder in humans, VWD affects one to two percent of the general population or approximately 3 million people in the United States. VWD is a complex congenital bleeding disorder that is divided into subtypes with Type 3 being the most severe form.

"The study will collect valuable information on this rare VWD patient subset," said Coordinating Investigator Craig Kessler, M.D., Georgetown University Hospital, Professor of Medicine and Pathology and Director of the Division of Coagulation. "Sufficient data is not currently available for Type 3 VWD patients. The research will be invaluable in determining the adequacy of dosing and duration of treatment in this group of patients."

Originally approved in Germany in 2005, wilate® is available in 46 countries worldwide. In December 2009, the U.S. Food and Drug Administration (FDA) granted Octapharma orphan drug exclusivity for wilate®, the first replacement therapy developed specifically for VWD.


SOURCE Octapharma
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1. Octapharma USA Sponsors International Advisory Board for Evaluating Treatment of Patients with von Willebrand Disease
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3. Octapharma Clinical Trial Begins in the U.S. and Germany Treating Hemophilia A Patients with First Recombinant Factor VIII Derived from a Human Cell-Line
4. Octapharma Accepting Applications for Research Grants Focused on Human Protein Therapies
5. Octapharma USA Launches Web Resource for von Willebrand Disease Healthcare Professionals and Patients
6. FDA Confirms Orphan Drug Exclusivity Approval for wilate®, Octapharma USAs New Therapy for Common Inherited Bleeding Disorder
7. Octapharma USA Announces Availability and Distributors for wilate®, the First Replacement Therapy Developed Specifically for von Willebrand Disease
8. Octapharma Receives Orphan Drug Exclusivity Approval for wilate(R) - A Replacement Therapy Developed Specifically for von Willebrand Disease
9. Octapharma USA Announces FDA Approval of wilate(R) - the First Replacement Therapy Developed Specifically for von Willebrand Disease
10. Octapharma Group and Fresenius Kabi Enter Into an Exclusive License, Development and Supply Agreement for a HESylated Recombinant Protein
11. Octapharma Targeting the Major Risk of Hemophilia Treatment - FVIII Antibodies
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