Octapharma AG Enters into Agreement with Pfizer for the Future Commercialization and Marketing in the U.S. of an Investigational Intravenous Therapy for the Urgent Reversal of an Oral Anticoagulant

Biologics License Application (BLA) Currently Under Review by U.S. Food and Drug Administration (FDA)

LACHEN, Switzerland--()--Octapharma AG today announced it has entered into an agreement with Pfizer Inc. for the future marketing and commercialization of human prothrombin complex concentrate (PCC), an investigational agent currently under FDA review for the urgent reversal of Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients who require urgent surgery or invasive procedures. Under the terms of the agreement, Octapharma AG has exclusive rights to commercialize this product globally, with the exception of the U.S. where Pfizer will exclusively be responsible for marketing and commercialization.

“This collaboration will add value to the overall potential of the compound,” said Octapharma AG Board Member Flemming Nielsen. “Subject to FDA approval of our BLA, the relationship enables the two companies to effectively build on each other’s core capabilities to help meet a need in emergency medicine.”

The BLA for the product was submitted by Octapharma AG in April 2013 and is currently under FDA review. Octapharma AG’s PCC is approved for use in 75 countries outside the U.S. under the brand name Octaplex® and was first approved for use in Germany in 2003 (it is branded as Ocplex® in Sweden and Pronativ® in Australia).

“If the FDA approves this submission, we will combine the expertise of Pfizer’s surgical field force and Octapharma AG’s clinical development program to be able to offer this new treatment in the U.S.,” added William Kennally, Pfizer Established Products North America Regional President.

About the Octapharma Group

Headquartered in Lachen, Switzerland, Octapharma AG is one of the world’s largest human protein products manufacturers and has been committed to patient care and medical innovation for 30 years. With a broad and expanding pipeline, Octapharma AG’s core business is the development, production, and sale of high quality human protein therapies from both human plasma and human cell-lines, including intravenous immune globulin and von Willebrand Factor/Coagulation Factor VIII Complex. Octapharma AG employs over 5,000 people and has biopharmaceutical experience in 100 countries worldwide. Octapharma AG operates two state-of-the-art production sites licensed by the U.S. Food and Drug Administration (FDA), providing a high level of production flexibility.

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.

Contacts

Octapharma Contact:
Fred Feiner (Media)
Yankee Public Relations
908-425-4878

Release Summary

Octapharma AG has entered into an agreement with Pfizer Inc. for the future marketing and commercialization of human prothrombin complex concentrate (PCC), which is currently under FDA review.

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Contacts

Octapharma Contact:
Fred Feiner (Media)
Yankee Public Relations
908-425-4878