Ligand Pharmaceuticals confirms FDA accelerated approval of Kyprolis

Ligand Pharmaceuticals (LGND) announced that its licensee, Onyx Pharmaceuticals (ONXX), received accelerated approval from the U.S. FDA for Kyprolis for Injection, a proteasome inhibitor indicated for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy. The indication for Kyprolis is based on response rate. Currently, no data are available for Kyprolis that demonstrate an improvement in progression-free survival or overall survival. Kyprolis is formulated with Ligand's Captisol(R), which improves drug solubility and enables a reduced drug load. Ligand is entitled to receive a $600,000 milestone payment from Onyx Pharmaceuticals; Ligand also is required to make a payment of $3.5M toward the former stockholders of CyDex Pharmaceuticals, which Ligand acquired in 2011.