HDAC inhibitor is in multiple clinical trials against solid and hematologic cancers.
Spectrum Pharmaceuticals is paying TopoTarget $30 million up front for rights to the latter’s Phase III lymphoma drug, Belinostat. TopoTarget could receive another $320 million and 1 million Spectrum shares on the achievement of development, regulatory, and commercial milestones.
The co-development and commercialization deal gives Spectrum licensing rights to Belinostat in North America and India as well as an option for China. Topotarget will receive double-digit royalties from sales in these territories.
Spectrum confirmed that it hopes to file an NDA for Belinostat, a histone deacetylase inhibitor, as a treatment against peripheral T-cell lymphoma during 2011. “The addition of Belinostat addresses our key strategic goal of in-licensing a late-stage anticancer compound,” states Rajesh C. Shrotriya, M.D., chairman, CEO, and president at Spectrum. “With this collaboration we have now completed our strategic initiatives relating to in-licensing of compounds with near-term commercialization.”
Spectrum’s recent expansion of its commercial infrastructure has also prepared the company for the drug’s launch, comments Amar Singh, Spectrum’s chief commercial officer. “So far, Belinostat has demonstrated some unique and differentiating attributes.
“If approved, it would give Spectrum access to potentially large markets while allowing for enhanced coordination with our marketed drugs, Zevalin and Fusilev.” Zevalin is approved as a treatment for non-Hodgkin lymphoma, and Fusilev for osteosarcoma.
The deal with TopoTarget comes less than a week after Spectrum announced axing further development of its LHRH antagonist, Ozarelix, for the treatment of benign prostatic hyperplasia. The drug was poised for Phase III trials. At the time the company said part of the potential $40 million that had been budgeted for Ozarelix clinical trials would go toward padding commercialization efforts for its approved drugs.
TopoTarget’s Belinostat is currently undergoing a registrational trial as intravenous monotherapy for relapsed or refractory peripheral T-cell lymphoma under an FDA special protocol assessment. A Phase II trial evaluating the drug combined with pacliaxel was recently initiated in patients with cancer of unknown primary.
In January the Gynecologic Oncology Group started a Phase II study evaluating the efficacy and safety of Belinostat plus carboplatin in the treatment of recurrent or persistent platinum-resistant ovarian, fallopian tube, or peritoneal cancer.
TopoTarget points out that the NCI is also carrying out a number of trials evaluating the drug both as monotherapy and as a combination therapy for a range of hematological and solid tumors. Ongoing trials include those evaluating Belinostat given as continuous intravenous administration for the treatment of solid tumors and acute myeloid leukemia. An oral formulation of the drug is separately being evaluated in a Phase I trial in patients with advanced solid tumors.
Several trials in the belinostat program are conducted under a clinical trials agreement with the NCI. TopoTarget also has a CRADA with the NCI to conduct preclinical and nonclinical studies on Belinostat to help further understand its antitumor activity and provide supporting information for clinical trials.