Nordic Group gets ex-US right to Trasylol from Bayer

Privately-held Netherlands-based Nordic Group has reached an agreement with Germany’s Bayer (BAYN: DE) to acquire worldwide rights excluding the USA for the surgical blood clotting agent Trasylol (aprotinin injection), marketing of which was suspended in 2008.

Under this accord, Nordic will become the Marketing Authorization Holder for aprotinin in the relevant territories. Ahead of the safety problems causing the suspension of Trasylol, it was one of Bayer Healthcare’s best selling drugs, generating annual sales of 230 billion euros. Financial terms of the deal with Nordic were not disclosed.

This follows the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, recommending that the marketing authorization for aprotinin should be reinstated in the European Union (The Pharma Letter February 20). The recommendation took into account a full review of the benefits and risks of all antifibrinolytic medicines, which found that the results of the study on which the suspension of aprotinin was based were unreliable. This positive opinion is expected to be ratified by the European Commission later this year. Nordic will be managing global supplies of aprotinin in the relevant Territories.