On September 17, 2014 CTI BioPharma Corp. (CTI) (NASDAQ and MTA: CTIC) and Servier reported that they have entered into an exclusive license and collaboration agreement to develop and commercialize PIXUVRI (pixantrone) in a transaction valued at up to €103.0 million (approximately $133.5 million) if all milestones are achieved (Press release, CTI BioPharma, SEP 17, 2014, View Source;p=irol-newsArticle&ID=1968777 [SID1234529057]). Under the agreement, CTI retains full commercialization rights for PIXUVRI in Austria, Denmark, Finland, Germany, Israel, Norway, Sweden, Turkey, the United Kingdom and the U.S., with Servier having exclusive rights to commercialize PIXUVRI in all other countries.
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PIXUVRI is conditionally approved in the European Union for patients with aggressive B-cell non-Hodgkin lymphoma (NHL) who failed two or three prior lines of therapy. PIXUVRI is the first monotherapy treatment option for this patient group and the only therapy licensed for third and fourth line use in aggressive B-cell NHL patients, which includes diffuse large B-cell lymphoma (DLBCL). As of this announcement, PIXUVRI was available in 11 countries and has achieved reimbursement decisions under varying conditions in England/Wales, Italy, France, Germany and the Netherlands. Under the terms of the agreement, CTI will receive an upfront payment of €14 million (approximately $18.1 million) and is eligible to receive additional sales, clinical and regulatory milestone payments, as well as royalties on sales, such royalty payments being subject to certain reductions.
"We believe Servier represents the ideal strategic partner to achieve the full potential of PIXUVRI, particularly in those regions of the world where CTI does not currently have, or plan to have a presence," said James A. Bianco, M.D., President and CEO of CTI. "Our two companies share a vision for bringing PIXUVRI to patients and believe this collaboration will not only maximize the development, commercialization and market potential of PIXUVRI, but will also help accelerate potential development expansion into new indications. We believe Servier’s development expense contributions could help us achieve a net positive contribution margin for PIXUVRI this year and profitability in 2015 and beyond."
"Servier is conducting a comprehensive chemistry and biology research program in the field of oncology with the aim to develop and bring novel effective therapies to patients with cancer," said Jean Pierre Abastado, Head of the Oncology Therapeutic Innovation Center at Servier. "In addition, Servier has entered into several scientific collaborations with Academic Institutions as well as a number of other partnerships in the field of oncology and hematology. This new partnership will nicely fit within Servier’s portfolio by bringing an immediate therapeutic solution for patients suffering from aggressive B-cell non-Hodgkin lymphoma (NHL) who failed two or three prior lines of therapy."
"This partnership around PIXUVRI will also enable Servier to build its hemato-oncology capabilities for market access and medical information in many countries, thereby preparing for the arrival of an extensive portfolio of innovative treatments that are currently in clinical development," said Pascal Touchon, Vice President Scientific Collaboration and Business development at Servier.