Navigation Links
Octapharma Launches Clinical Trial to Evaluate Efficacy & Safety of wilate® In Preventing Surgical Bleeding in Type 3 von Willebrand Disease Patients

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.

wilate® is a plasma-derived, stable, highly purified concentrate of freeze-dried human von Willebrand factor (VWF) and coagulation factor VIII (FVIII). Two well-established virus inactivation steps are incorporated into the manufacturing process of wilate®, specifically a solvent/detergent (S/D) and terminal dry heat treatment.

For more information on the research, entitled "Clinical Study to Investigate the Efficacy and Safety of Human Factor VWF/VIII Concentrate (wilate®) in Subject with Inherited Type 3 Von Willebrand Disease (VWD) who Undergo Major Surgical Procedures (WONDERS)," please visit U.S. researchers interested in participating in the study should contact Sylvia Werner, Octapharma Associate Director Clinical Operations – Coagulation, at (201) 604-1149 or

About the Octapharma Group

Headquartered in Lachen, Switzerland, Octapharma AG is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation for over 27 years. Octapharma's core business is the development, production and sale of high quality human protein therapies from both human plasma and human cell-lines, including immune globulin intravenous (IGIV). In the U.S., Octapharma's IGIV product, octagam®  (immune globulin intravenous [human] 5%), is used to treat disorders of the immune system, and Octapharma's Albumin (human)® is indicated for the restoration and maintenance of circulating blood volume. Octapharma's wilate® received orphan drug exclusivity from the U.S. Food and Drug Administration (FDA) for the treatment of von Willebrand disease (VWD). Octapharma employs over 4,000 people and has biopharmaceutical experience in 80 countries worldwide, including the United States, where Octapharma USA is located in Hoboken, N.J.  Octapharma operates two state-of-the-art production sites licensed by the FDA, providing a high level of production flexibility. For more information, please visit or

Forward-looking statements

This news release contains forward-looking statements, which include known and unknown risks, uncertainties and other factors not under the company's control. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. These factors include results of current or pending research and development activities and actions by the FDA or other regulatory authorities.

SOURCE Octapharma
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Octapharma USA Sponsors International Advisory Board for Evaluating Treatment of Patients with von Willebrand Disease
2. Octapharma Targets Primary Immune Deficiency Research With Grant for The Mount Sinai Medical Center
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
Post Your Comments:
(Date:11/25/2015)... Nov. 25, 2015 Allergan plc (NYSE: ... and Rugen Therapeutics, a start-up  biotechnology company focused ... CNS disorders and funded by the F-Prime Biomedical ... entered into an exclusive collaboration to support the ... Spectrum Disorders (ASD) and Obsessive Compulsive disorders (OCD). ...
(Date:11/25/2015)... 25, 2015 USP 800 applies to ... (e.g. pharmacists, pharmacy technicians, nurses, physicians, physician assistants, ... chapter also covers all entities which store, prepare, ... other healthcare institutions, patient treatment clinics, physicians, practice ... --> What is the purpose ...
(Date:11/25/2015)... Asia -based venture ... and the New Investors will make a direct equity ... private placement. The financing will help IOPtima to continue ... in the treatment of glaucoma, as well as to ... system with the U.S. Food and Drug Administration, commencing ...
Breaking Medicine Technology:
(Date:11/25/2015)... BROOK, Ill. (PRWEB) , ... November 25, 2015 ... ... larger and potentially more aggressive than those found on mammography, according to a ... MRI findings of additional cancers not seen on mammography may necessitate a change ...
(Date:11/25/2015)... ... 2015 , ... As part of a global movement to ... together who want to combine talents and resources to help create sustainable communities ... The non-profit launched its first major fundraiser on November 6, 2015 at Bent ...
(Date:11/25/2015)... ... November 25, 2015 , ... The holiday season ... and pleasing the palates of attendees is of the utmost importance. Whether you ... seasonal get-together, give these recipes a try this holiday season. , Turkey Croquettes ...
(Date:11/25/2015)... ... November 25, 2015 , ... Finnleo, a leader in ... on several models of traditional and far-infrared saunas. , For traditional saunas, ... the most traditional Finnish sauna wood, and Finnleo uses only European Grade A Nordic ...
(Date:11/25/2015)... , ... November 25, 2015 , ... ... has been recognized once again for its stellar workplace culture with the company’s ... , Medical Solutions’ Cincinnati office was named a finalist in Cincinnati ...
Breaking Medicine News(10 mins):