Bayer has filed the clotting agent Recothrom, which is licensed from ZymoGenetics, with regulators in Europe.

The Leverkusen-based firm has submitted a marketing authorisation application to the European Medicines Agency for Recothrom (recombinant human thrombin) as a topical aid to control surgical bleeding. Bayer acquired the global rights for all markets outside the USA in June last year.

Recothrom is not made from animal or human blood, but from genetically-modified Chinese hamster ovary cells. This means that it does not carry the risk of infections which is generally associated with plasma products, Bayer noted, and as the production of recombinant proteins is not dependent on the availability of blood from animals or humans, it can be scaled up to meet market demand.

The plasma-free thrombin was approved by the US Food and Drug Administration in January this year and while ZymoGenetics retains marketing rights there, Bayer’s sales force is providing support for the
first three years of the US market launch. The European filing has triggered a $5 million milestone payment to ZymoGenetics and the latter’s chief executive, Bruce Carter, said that Bayer has been a valued partner in selling Recothrom across the Atlantic “and in driving the ex-US programme forward”.

Currently, stand-alone thrombin products are not widely available in the European Union, but in five of the largest member states of the EU there are in excess of 4 million surgical procedures performed annually where a haemostatic product is generally used. At present, surgeons currently have
to rely on either sponges or tissue sealants.