On March 14, 2014 Spectrum Pharmaceuticals reported that the company has gained global development and commercialization rights to Ligand Pharmaceuticals’ Captisol-enabled, propylene glycol-free (PG-free) melphalan. Captisol-enabled melphalan is currently in a pivotal trial for use as a conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma (Press release, Spectrum Pharmaceuticals, MAR 14, 2013, View Source [SID:1234502924]).
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Spectrum is assuming the responsibility for the ongoing pivotal clinical trial and will be responsible for filing an NDA, which is anticipated in the first half of 2014. Under the license agreement, Ligand will receive a license fee and is eligible to receive milestone payments, as well as royalties following potential commercialization.
"We are pleased to add this late-stage program to our portfolio, which includes belinostat, for which we anticipate an NDA filing mid-year, and apaziquone, for which we expect to file an NDA in 2014," stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. "Captisol-enabled melphalan is designed to meet the need for a formulation of melphalan that is free of propylene glycol, which has been associated with renal and cardiac side effects. The Captisol technology may allow longer duration of administration and slower infusion rates, potentially enabling a higher dose intensity of pre-transplant chemotherapy to optimize efficacy. We look forward to rapid progress of the program."
"We are pleased to have forged this agreement," commented John Higgins, President and Chief Executive Officer of Ligand Pharmaceuticals. "Spectrum has an established oncology and hematology business, and this melphalan product is an ideal complement to their two commercial hematology products, ZEVALIN and FOLOTYN, including an expected high degree of commercial call overlap. Spectrum’s highly experienced, oncology-focused R&D team is committed to the efficient development of Captisol-enabled melphalan, and has established relationships with key investigators."