FDA Grants Priority Review Status to TopoTarget’s Application for Approval of Totect™ (Savene™)

TopoTarget announces that the US Food and Drug Administration (FDA) has accepted TopoTarget’s application for marketing approval of Totect™ (Savene™) for the treatment of extravasation (accidents involving anthracyclines (anti-cancer agents) in chemotherapy) for review and has granted priority review status to Totect™.

TopoTarget’s application for marketing approval of Totect™ for the treatment of extravasation (accidents involving anthracyclines in chemotherapy), has been accepted for review by the FDA. In addition, the FDA has granted Totect™ priority review status.Totect™ will be marketed in Europe under the Savene™ brand.

Priority review status means that the FDA, having considered the therapeutic potential of Totect™, has recommended a fast track review of TopoTarget’s marketing application, which should be completed in six months compared with the standard processing time of around 10 - 12 months. However, priority review status does not guarantee that the results of the review will be available within this timeframe or that the compound will be approved.

Peter Buhl Jensen, CEO of TopoTarget A/S, said: “We are very pleased that the FDA has granted an expedited review of Totect™. Currently, there’s no satisfactory treatment of extravasation, the term used for accidents involving anthracyclines in chemotherapy, which occurs in about 0.1-1.0 % of all chemotherapy treatments. In this context, an early approval of Totect™ would be welcomed by both patients and physicians. From a business standpoint Totect™/Savene™ is strategically important for TopoTarget as it will be our first product to market”.

The US application for Totect™ was filed with the FDA on 31 January 2006 and in light of the expedited FDA review, TopoTarget may receive US marketing approval later this year. TopoTarget filed a registration application for Savene™ with the European Medicines Agency (EMEA) in August 2005 and in this territory Totect™ will be marketed under the Savene™ brand.