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Octapharma and Pfizer form an agreement for the future marketing and commercialization of human prothrombin complex concentrate.
Octapharma AG, a Swiss manufacturer of human protein products, has entered into an agreement with Pfizer 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 therapy in adult patients who require surgery or invasive procedures. Under the agreement, Octapharma AG has exclusive rights to commercialize this product globally, with the exception of the US, where Pfizer will exclusively be responsible for marketing and commercialization.
The biologics license application 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 US 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).