Date: 2013-03-14
Type of information: Establishment of a new subsidiary in the EU
Compound: Captisol-Enabled Melphalan (CE-Melphalan) HCl for injection (propylene glycol-free)
Company: Spectrum Pharmaceuticals (USA - NV) Ligand Pharmaceuticals (USA - CA)
Therapeutic area: Cancer - Oncology
Type agreement:
Action mechanism: alkylating agent. Captisol© is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella at the University of Kansas’ Higuchi Biosciences Center for specific use in drug development and formulation. Captisol-Enabled, Propylene Glycol-free Melphalan is a novel intravenous formulation of melphalan being investigated for the multiple myeloma transplant setting, for which it has been granted an Orphan Drug Designation by the FDA . This formulation eliminates the use of propylene glycol, which has been reported to cause renal and cardiac side effects that limit the ability to deliver higher doses of therapeutic compounds. The use of the Captisol® technology to reformulate melphalan also improves its stability and is anticipated to allow for slower infusion rates and longer administration durations, potentially enabling clinicians to safely achieve a higher dose intensity for pre-transplant chemotherapy.
Disease: multiple myeloma
Details: * On March 14, 2013, Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, announced 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. In December 2012 Ligand announced the initiation of a pivotal trial of Captisol-enabled melphalan. This multi-center trial is evaluating safety and efficacy in 60 patients, and is intended to confirm the results from an earlier Phase 2 study demonstrating that the Captisol-enabled melphalan formulation showed acceptable safety findings, and met the requirements for establishment of bioequivalence to the current commercial intravenous formulation of melphalan (sold by GlaxoSmithKline as Alkeran® for Injection). 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.
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