Octapharma AG, a Swiss maker of protein-based medicines with U.S. operations in Hoboken, has entered into an agreement with Pfizer Inc. for future marketing and commercialization of an intravenous therapy that would alleviate bleeding in adults who require urgent surgery or invasive procedures.
The product called Octaplex, currently under review by the Food and Drug Administration, would reverse the effects of warfarin — an oral drug that reduces blood clotting — in cases of major bleeding.
Under terms of the agreement, Octapharma has exclusive rights to commercialize this product globally except the United States, where Pfizer will be exclusively responsible for marketing and commercialization.
Octapharma AG board member Flemming Nielsen said FDA approval of the product will enable both companies to "effectively build on each other's core capabilities to help meet a need in emergency medicine."
About 3.8 million Americans take warfarin, an oral drug generally prescribed to prevent thrombosis, or blood clotting. The drug has major bleed rate of 1.7 to 3.4 percent, according to the FDA.
Octapharma AG in April submitted an application for Octaplex to the FDA. The drug is approved in 75 countries outside the under the brand name Octaplex, 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.," William Kennally, the North America regional president for Pfizer's Established Products division in Peapack-Gladstone, said in a statement.
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