Spectrum Pharmaceuticals has licensed an investigational multiple myeloma drug from Ligand Pharmaceuticals in a deal that could be worth over $50 million.
The treatment in question is an intravenous formulation of melphalan, which is in a Phase III trial for use as a conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma. Spectrum is assuming the responsibility for the trial and hopes to file Captisol-enabled melphalan in the first half of 2014.
The Captisol technology used to reformulate melphalan allows for longer administration durations and slower infusion rates. It has been used with six US Food and Frug Administration-approved products, including Onyx Pharmaceuticals’ multiple myeloma drug Kyprolis (carfilzomib )and Pfizer's antifungal Vfend (voriconazole).
Cashwise, Ligand is getting an upfront licence fee of $3 million and could receive more than $50 million in milestone payments, plus royalties. Spectrum chief executive Rajesh Shrotriya said that 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.
A Phase II study demonstrating that the Captisol-enabled melphalan formulation was safe and well-tolerated, and met the requirements for establishment of bioequivalence to the current commercial IV formulation of melphalan, which is sold by GlaxoSmithKline as Alkeran. The current IV melphalan market is valued at about $130 million annually, with predominant use in stem cell transplants.