EMEA, the European Medicines Agency, recommends that the EU Commission should grant TopoTarget European marketing authorisation for Savene™

TopoTarget announce that EMEA (the European Medicines Agency) has issued a positive opinion recommending that the European Commission should grant marketing authorisation in Europe for Savene™ for the treatment of extravasation accidents. TopoTarget therefore maintains its expectation of a launch of Savene™ in Europe by the end of 2006.

The recommendation follows TopoTarget’s filing of an application for marketing authorisation for Savene™ with EMEA in August 2005. EMEA has informed the Commission of its recommendation, and the Commission will under normal circumstances consider the recommendation within 67 days after which TopoTarget can commence sales of Savene™.

There is currently no satisfactory treatment or prevention of the serious tissue damage that may result from extravasation of anthracyclines (anti-cancer agents) where the treatment accidentally has leaked into the tissue. Despite the utmost caution when using anthracyclines, these accidents occur in about 0.1-1.0% of all treatments. Accordingly, Savene™ addresses an unmet clinical need.

Peter Buhl Jensen, CEO of TopoTarget A/S, commented:

”We are proud to have identified a good solution to a much-feared accident and are pleased that Savene™ has been recommended for marketing authorisation in Europe. We expect to hear from the Commission in August concerning the final approval and are currently building our European specialist sales force with a view to launching Savene™.”

In the USA, Savene™ is expected to be marketed under the Totect™ brand. TopoTarget filed an application for marketing authorisation for Totect™ with the FDA (US health authorities) on 31 January 2006. On 12 April 2006, TopoTarget announced that the FDA had granted priority review status to Totect™. Against this background, TopoTarget expects to obtain marketing authorisation in the United States in the second half of 2006. Savene™/Totect™ has obtained Orphan Drug status in both Europe and the United States, providing marketing exclusivity for periods of ten and seven years, respectively.