Octapharma AG has announced that 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.