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Octapharma Receives Orphan Drug Exclusivity Approval for wilate(R) - A Replacement Therapy Developed Specifically for von Willebrand Disease
Date:1/13/2010

y growing U.S. division of Octapharma AG

"The FDA orphan drug exclusivity approval for wilate® is an important aspect in Octapharma`s development of this drug," said Kim Bjornstrup, Vice Chairman Octapharma Group. "Orphan drug exclusivity confirms Octapharma's decision to focus exclusively on the treatment of von Willebrand patients. Wilate has a combination of two viral attenuation steps, high purity and a physiological 1:1 ratio of VWF and FVIII activity and is approved for treating all VWD patients including those with the most severe, type 3, disease."

About wilate®:

Wilate® is a newly developed, high-purity, double virus inactivated von Willebrand Factor/Coagulation Factor VIII Concentrate (Human) that demonstrated efficacy for all types of VWD including pediatric patients in four prospective clinical trials utilizing both objective and subjective criteria.

On December 4, 2009, wilate® received FDA approval for the treatment of spontaneous and trauma-induced bleeding episodes in patients with severe VWD as well as patients with mild or moderate VWD in whom the use of desmopressin is known or suspected to be ineffective or contraindicated.(1) Wilate® is the first double virus inactivated VWF/FVIII (von Willebrand Factor/Factor FVIII), high-purity concentrate, utilizing the solvent/detergent (S/D) process and a special terminal dry-heating (TDH) system. The selected purification processes isolate the VWF/FVIII complex under highly protein-protecting conditions, resulting in a 1:1 ratio of VWF:RCo (ristocetin cofactor) and FVIII activities that is similar to normal plasma. Wilate® is exclusively derived from large pools of human pl
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