Date: 2014-01-13
Type of information: Licensing agreement
Compound: Opaxio™ (paclitaxel poliglumex), Pixuvri® (pixantrone)
Company: Cell Therapeutics (USA) Novartis (Switzerland)
Therapeutic area: Cancer - Oncology
Type agreement: licensing
sale
Action mechanism:
Disease: multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma
Details: * On January 13, 2014, Cell Therapeutics has announced that it has reached an agreement with Novartis to reacquire rights to two anti-cancer compounds -- pixantrone (Pixuvri®) and paclitaxel poliglumex (Opaxio™). Under the terms of the previous agreement, CTI has been responsible for development and commercialization activities and expenses for both compounds to date. Upon the effective date of termination, CTI will regain all rights that had been granted to Novartis. In exchange for Novartis\' agreement to return such rights to CTI, CTI has agreed to make certain potential payments to Novartis based on sales of Opaxio™ and Pixuvri® and on any sublicense and certain other amounts payable to CTI.
Pixuvri® is a first-in-class aza-anthracenedione with unique structural and physiochemical properties and the first approved therapy in the European Union for the treatment of patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma. In May 2012, the European Commission (EC) granted conditional marketing authorization for PIXUVRI as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL.
Opaxio™ (paclitaxel poliglumex) is an investigational, biologically-enhanced chemotherapeutic that links paclitaxel, the active ingredient in Taxol®, to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, paclitaxel is inactive, potentially sparing normal tissue\'s exposure to high levels of paclitaxel and its associated toxicities. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to macromolecules such as Opaxio™. Based on preclinical studies, it appears that Opaxio™ is preferentially distributed to tumors due to their leaky blood vessels and trapped in the tumor bed, thereby allowing significantly more of the dose of chemotherapy to localize in the tumor than with standard paclitaxel. Once inside the tumor cell, enzymes metabolize the protein polymer, releasing active paclitaxel. Unlike standard radiosensitizing agents, Opaxio™ appears tumor selective and does not appear to enhance radiation toxicity to normal tissues.
Financial terms:
Latest news:
