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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
Date:11/1/2010

HOBOKEN, N.J., Nov. 1, 2010 /PRNewswire/ -- Octapharma AG, one of the largest human protein products manufacturers in the world, and Octapharma USA today announced that patients diagnosed with severe hemophilia A have started treatment in a multi-center study that is researching the use of the first recombinant Factor VIII (rFVIII) derived from a human cell line (Human-cl rhFVIII). Researchers are investigating Human-cl rhFVIII, to assess pharmacokinetics, efficacy, safety and immunogenicity for previously treated patients with severe hemophilia A.

The National Institutes of Health estimate that 90 percent of all hemophilia patients have hemophilia A, also known as Factor VIII deficiency, and 70 percent of those have the severe form of the illness.

The prospective, randomized, actively controlled, open label Phase 2 trial is being held at research centers in the US and Germany under the title "Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of human-cl rhFVIII, a Newly Developed Human Cell-Line Derived Recombinant FVIII Concentrate in Previously Treated Patients with Severe Hemophilia A." The study started in spring 2010 and patient enrollment is well underway. Please visit www.clinicaltrials.gov for details.

Human-cl rhFVIII is a fourth-generation recombinant factor VIII (rFVIII) concentrate developed by Octapharma for the control and prevention of bleeding episodes and for surgical prophylaxis in patients with hemophilia A.  Human-cl rhFVIII is produced in genetically modified Human Embryonic Kidney (HEK) 293F cells. Human-cl rhFVIII is currently the only rFVIII, which has a human glycosylation pattern. Today, the development of antibodies against infused FVIII represents the most devastating complication in modern hemophilia A replacement therapy. The human glycosylation pattern in Human-cl rhFVIII might make it possible to avoid potentially immunogenic epitopes as expressed by hamster cells. Although clinical data have not yet been reviewed and verified by the U.S. Food and Drug Administration, the study aims to show an improved safety and long-term reduced immunogenicity of Human-cl  rhFVIII.

Human-cl rhFVIII is concentrated and purified for virus inactivation/removal although the cell bank and end of production cells have been extensively tested to ensure they are free of any endogenous or infectious viruses. The process ensures that any theoretical virus contamination is safely inactivated and/or removed. The manufacturing of Human-cl rhFVIII is completely free of animal or human derived added materials. The clinical development plan for Human-cl rhFVIII follows the requirements of the U.S. Food and Drug Administration and European guidelines.

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 www.octapharma.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.


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