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FDA Confirms Orphan Drug Exclusivity Approval for wilate®, Octapharma USA's New Therapy for Common Inherited Bleeding Disorder
Date:8/2/2010

ar3,prop15';s.prop5='External Link';s.eVar3=s.prop5;s.prop15='99751994';s.tl(this,'o','ExternalLink');" target='_blank' href="http://www.octapharma.com/corporate/02_the_company/02_people/01_management_board/01_management_board.php">Flemming Nielsen, President of Octapharma USA, the rapidly growing U.S. division of Octapharma AG, one of the world's largest human protein products manufacturers. "wilate® has received seven years of marketing exclusivity as a result of the evidence suggesting wilate® is as efficacious and safer than Humate P."

The FDA has approved wilate® for the treatment of spontaneous or trauma-induced bleeding episodes in patients with severe VWD as well as in patients with mild or moderate forms of the illness in whom the use of desmopressin is known or suspected to be ineffective or contraindicated.

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) step. The selected purification processes isolates the VWF/FVIII complex under highly protein-protecting conditions, resulting in a 1:1 ratio of VWF:RCo (ristocetin cofactor) to FVIII activity that is similar to
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SOURCE Octapharma USA
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