Cell Therapeutics, Inc. (CTI) 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.
"We are pleased that Novartis and CTI were able to reach a mutually beneficial agreement regarding rights to Pixuvri and Opaxio," stated James A Bianco, MD, CTI's president and CEO. "Regaining full rights to these two anti-cancer agents -- one currently marketed in Europe and the other completing late-stage development -- provides us with the flexibility to manage these assets within the context of our overall product portfolio strategy. 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. Opaxio is completing phase III development as maintenance therapy in patients with ovarian cancer and is also being studied in phase II trials for patients with malignant brain cancer. We believe these drugs could have an important impact in the treatment of patients with cancer."
Pixuvri (pixantrone) is a novel aza-anthracenedione with unique structural and physiochemical properties. Unlike related compounds, Pixuvri forms stable DNA adducts and in preclinical models has superior anti-lymphoma activity compared to related compounds. Pixuvri was structurally designed so that it cannot bind iron and perpetuate oxygen radical production or form a long-lived hydroxyl metabolite -- both of which are the putative mechanisms for anthracycline induced acute and chronic cardiotoxicity. These novel pharmacologic properties allow Pixuvri to be administered to patients with near maximal lifetime exposure to anthracyclines without unacceptable rates of cardiotoxicity.
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. The benefit of Pixuvri treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy. The Summary of Product Characteristics (SmPC) has the full prescribing information, including the safety and efficacy profile of Pixuvri in the approved indication.
CTI is currently accruing patients into a phase III trial comparing Pixuvri and rituximab with gemcitabine and rituximab in the setting of aggressive B-cell NHL. Pixuvri does not have marketing approval in the United States.
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 tumour 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 tumours due to their leaky blood vessels and trapped in the tumour bed, thereby allowing significantly more of the dose of chemotherapy to localize in the tumour than with standard paclitaxel. Once inside the tumour 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.
CTI is a biopharmaceutical company committed to the development and commercialization of an integrated portfolio of oncology products aimed at making cancer more treatable.