Bayer Schering Pharma withdraws its MAA for Recothrom in Europe

German drug major Bayer Schering Pharma has withdrawn its application for a centralized marketing authorization for the medicine Recothrom (thrombin alfa) 1,000 IU/ml, which was submitted to the European Medicines Agency (EMEA) in August 2008.

Seattle, USA-based ZymoGenetics licensed all rights to Recothrom outside the USA to Bayer in 2007. The drug won US Food and Drug Administration approval in January 2008, but the drug has failed to achieve strong sales in that market, where it is estimated to generate $28 million to $30 million this year. Recothrom was expected to be used as supportive treatment in surgery to improve hemostasis where standard surgical techniques are insufficient.

In its official letter, the company stated that the withdrawal of the application was based on the concerns raised by the Committee regarding the choice of study population for the label in general surgery as well as the choice of comparator relative to the CHMP fibrin sealant guideline.

Specifically, according to a US Securities and Exchange Commission Form 8-K filing by ZymoGenetics, it is the view of the Committee for Medicinal Products for Human Use (CHMP) that the data provided were not sufficient for approval because Bayer's submission did not meet CHMP's fibrin sealant guideline.

The MAA was filed by the German firm based on data from ZymoGenetics' Phase III clinical trial, which was conducted in the USA prior to the Bayer license transaction and which used a comparator, bovine thrombin, that is not available in Europe. Bayer proceeded with the approval application based on data from the US trial after consulting with regulatory authorities in certain key member countries. Although Recothrom is not a fibrin sealant, it now appears that an additional clinical trial complying with the CHMP fibrin sealant guideline will be required to support approval in Europe.

Withdrawal of an application does not prejudice the possibility of a company making a new application at a later stage.