Spectrum Pharma licenses lymphoma drug belinostat from TopoTarget for up to $350 million

US biotechnology firm Spectrum Pharmaceuticals has entered into a co-development and commercialization agreement with Denmark's TopoTarget A/S for belinostat, a novel histone deacetylase (HDAC) inhibitor.

Under terms of the deal, Spectrum licensed the rights to belinostat for North America and India, and an option for China, in exchange for an upfront cash payment of $30 million, potential milestone payments of up to $320 million, and one million shares of Spectrum common stock based upon the successful achievement of certain development, regulatory and commercial milestones, as well as double-digit royalties on net sales of the drug. The two companies will jointly fund development activities, whereby clinical trial costs will be 70% borne by Spectrum, and 30% by TopoTarget for new trials to be initiated.

Belinostat is currently in a registrational trial, under a Special Protocol Assessment (SPA), as a monotherapy for relapsed or refractory peripheral T-cell lymphoma (PTCL), an indication in which it has been granted Orphan Drug and Fast Track designation by the US Food and Drug Administration. Belinostat is also under investigation in a randomized Phase II trial, as a combination therapy with carboplatin and paclitaxel, for cancer of unknown primary (CUP). Additionally, the NCI is currently conducting several clinical trials of belinostat in a variety of hematological and solid tumors, both as monotherapy as well as combination therapy.