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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

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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.

References

  1. Wilate® Approved Complete Prescribing Information, December 2009.
  2. Ibid.
  3. Note for guidance on virus validation studies: The design, contribution and interpretation of studies validating the inactivation and removal of viruses CPMP/BWP/268/95 February 1996.
  4. Note for guidance on plasma-derived products CPMP/BWP/269/95, rev.2. July 1998.
  5. Farrugia A . Guide for the assessment of clotting factor concentrates for the treatment of Hemophilia. 2003, WFH.
  6. Centers for Disease Control and Prevention. Bleeding disorders. Available at www.cdc.gov/ncbddd/hbd/hemophilia.htm. Accessed on November 22, 2009.

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