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Octapharma USA, Inc. Release: First Clinical Study Comparing Pharmacokinetic Profiles of VWF/FVIII Products Published in Medical Journal


11/7/2011 2:26:32 PM

HOBOKEN, N.J., Nov. 7, 2011 /PRNewswire/ -- The Journal of Thrombosis and Haemostasis has published the results of the first prospective, head-to-head, randomized crossover clinical study to compare the pharmacokinetic (PK) profiles of two VWF/FVIII containing Von Willebrand Disease (VWD) products. The study compared the PK profiles of wilate® (Von Willebrand Factor/Factor VIII Concentrate, Human) and Humate-P® Human Plasma-derived Von Willebrand Factor (HP-VWF/FVIII) Concentrate.

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. 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® for treating certain types of VWD.

The study entitled, "The pharmacokinetic diversity of two Von Willebrand Factor (VWF)/Factor VIII (FVIII) concentrates in subjects with congenital Von Willebrand Disease," is available online through National Center for Biotechnology Information. PK profiles of VWF/FVIII "concentrates can be important for evaluation of treatment efficacy and safety" in VWD patients, the journal article reported.

"This PK comparison of wilate® and Humate-P® showed that the pharmacokinetic parameters of VWF component in these two concentrates are similar, while the pharmacokinetic profile of the FVIII:C components were significantly different. wilate® exhibited an exponential decay curve for FVIII:C within the first 12-24 hours post injection whereas Humate-P® FVIII:C PK showed a plateau in the same time period. Both products showed similar multimer profiles and a multimeric decay pattern that paralleled that of the VWF:RCo concentration curves over time, with a minimal reduction in multimers of high molecular weight relative to control plasma. The authors concluded that an approximate a 1:1 ratio of VWF:RCo to FVIII:C and the parallel PK profile of both coagulation factors may simplify dosing and monitoring of VWD product and may help avoid the clinical complications of over- or under-dosing of these key coagulation parameters in clinical scenarios requiring multiple dosing."

The study's investigators were: Craig M. Kessler, M.D. (Hemophilia and Thrombophilia Comprehensive Treatment Center, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, D.C.); Jerry S. Powell, M.D. (Hemophilia Treatment Center, University of California, Davis, Sacramento, Calif.); Jorge DiPaola, M.D. (Mountain State Regional Hemophilia and Thrombosis Center, University of Colorado at Denver and Health Sciences Center, Aurora, Colo.); Ken D. Friedman, M.D. (Comprehensive Center for Bleeding Disorders, Children's Hospital of Wisconsin, Milwaukee, Wis.); Joan Cox Gill, M.D. (Comprehensive Center for Bleeding Disorders, Children's Hospital of Wisconsin, Milwaukee, Wis.); Arthur R. Thompson, M.D., Ph.D. (Hemophilia Care and Coagulation Labs, University of Washington, Seattle, Wash.); and Christopher E. Walsh, M.D., Ph.D. (Comprehensive Hemophilia Center, Mount Sinai School of Medicine, New York).

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.

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 28 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 primary immune deficiencies, and Octapharma's Albumin (human)® is indicated for the restoration and maintenance of circulating blood volume. Octapharma's wilate® (Von Willebrand Factor/Coagulation Factor VIII Concentrate) received orphan drug exclusivity from the U.S. Food and Drug Administration (FDA) for the treatment of certain types ofVon 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 www.octapharma.com or www.wilateusa.com.

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 USA



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