On February 2, 2010 TopoTarget and Spectrum Pharmaceuticals reported an agreement to co-develop and commercialise belinostat, TopoTarget’s lead anticancer drug for cancer in North America and India (Press release TopoTarget, FEB 2, 2010, View Source;messageId=459613 [SID:1234500428]). Belinostat, an HDAC inhibitor, is in registrational clinical trial in Peripheral T-Cell Lymphoma (PTCL) as monotherapy and in a randomized phase 2 clinical trial for cancer of unknown primary site (CUP) in combination with carboplatinum and paclitaxel (BelCaP). Belinostat is currently being investigated in 20 clinical trials in aematological and solid cancers in monotherapy as well as in combination therapies.
Under the terms of the agreement, TopoTarget will receive an upfront payment of USD 30 million in cash. The total potential value of up-front and milestones (for both development and sales) of the agreement, in the event of full commercial success could exceed USD 350. In addition, TopoTarget will receive a double digit royalty on sales of belinostat as well as one million Spectrum shares. Spectrum commits to fund 100% of the costs for the ongoing PTCL study; TopoTarget will fund 100% of the ongoing CUP study. Spectrum and TopoTarget will split the development costs in a 70 to 30 ratio for future development of belinostat.
Under the agreement it is now expected that the BELIEF trial will be finalised and NDA filed with the FDA in 2011 the previous timeline announced by TopoTarget was December 2010. The CUP trial will be fully recruited in 2010 – the previous timeline announced by TopoTarget was H1 2010. In addition other randomised clinical trials in indications such as in lungcancer (NSCLC) are expected to be initiated.
Taking into account the 70:30 cost sharing arrangement under the collaboration, the sign on fee and existing cash resources excluding any other partnerships TopoTarget will, as a result of entering into the Agreement with Spectrum, have sufficient cash resources for at least two to three years. The agreement also includes diligence provisions on development and commercialisation as well as an option to co-promote under certain conditions.
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