Octapharma AG has entered into a marketing and commercialization agreement with Pfizer for human prothrombin complex concentrate (PCC), an investigational agent 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. Octapharma has exclusive rights to commercialize the product globally, except the U.S., where Pfizer will be responsible for marketing and commercialization.
Octapharma’s PCC is approved for use in 75 countries outside the U.S. under the brand name Octaplex. It was first approved in Germany in 2003.
“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.”
“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.,” said William Kennally, Pfizer Established Products North America regional president.