FDA Confirms Orphan Drug Exclusivity Approval for wilate(R), Octapharma USA's New Therapy for Common Inherited Bleeding Disorder

By Octapharma Usa, PRNE
Sunday, August 1, 2010

Approval Provides Seven Years of FDA Marketing Exclusivity

HOBOKEN, New Jersey, August 2, 2010 - Octapharma USA has received confirmation of orphan drug exclusivity from
the U.S. Food and Drug Administration (FDA) for wilate(R) (von Willebrand
Factor/Factor VIII Concentrate, Human), the replacement therapy developed
specifically for von Willebrand Disease (VWD). The approval comes from the
FDA Office of Orphan Products Development, which helps to advance the
development of products that demonstrate promise for the treatment of rare
diseases.

"In awarding orphan drug exclusivity, the FDA Office determined that
wilate(R) offers greater viral safety than Humate-P," said 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(R) has received seven years of marketing exclusivity as a result of
the evidence suggesting wilate(R) is as efficacious and safer than Humate P."

The FDA has approved wilate(R) 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(R) 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 normal
plasma. No albumin is added as a stabilizer. wilate(R) is exclusively derived
from large pools of human plasma collected in U.S. FDA approved plasma
donation centers. wilate(R) contains a VWF triplet structure and VWF
mulitmeric distribution similar to normal human plasma.

According to the National Institutes of Health, VWD is the most common
inherited bleeding disorder and occurs in about 1 out of every 100 to 1,000
people. "The FDA orphan drug exclusivity approval for wilate(R) confirms
Octapharma's decision to focus exclusively on the treatment of von Willebrand
patients and further demonstrates Octapharma's commitment to the continued
advancement of human protein therapies," said Nielsen.

For more information on wilate(R), please visit www.wilateusa.com.

About the Octapharma Group

Headquartered in Lachen, Switzerland, Octapharma 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(R) (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(R) 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.

Fred Feiner, Yankee Public Relations, +1-908-894-3930, fred at yankeepr.com

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