Spectrum Pharmaceuticals Enters into Co-Development and Commercialization Agreement for Belinostat

Strategic Insights -

Spectrum Pharmaceuticals, a biotechnology company focused on oncology, has entered into a co-development and commercialization agreement with TopoTarget A/S for Belinostat, a novel histone deacetylase (HDAC) inhibitor. Belinostat is currently in a registrational trial for relapsed or refractory Peripheral T-Cell Lymphoma (PTCL) and has been granted Orphan Drug and Fast Track designation by the FDA. This agreement allows Spectrum to further develop and commercialize Belinostat in North America and India, with an option for China, in exchange for upfront cash payments, milestone payments, and royalties on net sales.

Key Takeaways:

  • Spectrum Pharmaceuticals has entered into a co-development and commercialization agreement with TopoTarget A/S for Belinostat, a novel HDAC inhibitor.
  • Belinostat is currently in a registrational trial for relapsed or refractory PTCL, with Orphan Drug and Fast Track designation from the FDA.
  • The agreement grants Spectrum exclusive rights to Belinostat in North America and India, with an option for China.
  • Spectrum will make upfront cash payments, milestone payments, and royalties on net sales of Belinostat, totaling up to $320 million.
  • The partnership aims to exploit synergies in the companies' combined capabilities, resulting in significant efficiencies in Belinostat's development.
  • Spectrum's Chairman, Rajesh C. Shrotriya, stated that Belinostat addresses the company's key strategic goal of in-licensing a late-stage anti-cancer compound.
  • The agreement also enables Spectrum to advance Belinostat in PTCL and other solid tumor indications, with the goal of providing cancer patients with more effective treatment options.

Statistics:

  • Belinostat has demonstrated unique attributes and has the potential to be a best-in-class HDAC inhibitor for hematological and solid tumors.
  • The company expects to file an NDA for Belinostat in PTCL in 2011.
  • The partnership will result in significant efficiencies in Belinostat's development, with Spectrum and TopoTarget jointly funding development activities.
  • Clinical trial costs will be 70% borne by Spectrum and 30% by TopoTarget for new trials to be initiated.

Sources:

  • Spectrum Pharmaceuticals press release
  • TopoTarget A/S press release
  • Blood Weekly editorial article
  • NewsRx.com press article