Topotarget A/S and Spectrum Pharmaceuticals Inc Announce Belinostat Pivotal BELIEF Trial Meets Primary Endpoint

Topotarget A/S announced that the pivotal BELIEF trial (PXD101-CLN-19) evaluating the efficacy and safety of belinostat for the treatment of patients with relapsed/refractory PTCL met its primary endpoint. A Special Protocol Assessment (SPA) agreement with the United States Food and Drug Administration (FDA) requires the BELIEF trial to reach an objective response rate (ORR) of at least 20% and this objective was met. Data from the trial is being further analyzed and is expected to be communicated during the fourth quarter of 2012. Under the terms of a 2010 license and collaboration agreement, belinostat is currently being developed jointly by Spectrum Pharmaceuticals Inc (Spectrum) and the Company. Spectrum possesses the commercial rights to market belinostat in North America and India. A New Drug Application (NDA) for belinostat in PTCL is expected to be filed with the FDA by Spectrum in the first half of 2013. Should Spectrum receive FDA’s acceptance to file the belinostat NDA, Topotarget A/S is entitled to receive one million shares of common stock in Spectrum and a double-digit million USD cash payment. If belinostat is approved by the FDA, Topotarget A/S will further receive a double-digit million USD cash payment. BELIEF is a pivotal, open-label, multi-center, single-arm efficacy and safety trial of i.v. belinostat in patients with relapsed or refractory PTCL. FDA has granted belinostat Orphan Drug and Fast Track designation for the treatment of PTCL.