Date: 2017-04-25
Type of information: Licensing agreement
Compound: Pixuvri® (pixantrone)
Company: CTI BioPharma - previously known as Cell Therapeutics (USA - WA) - Servier (France)
Therapeutic area: Cancer - Oncology
Type agreement: licensing, collaboration
Action mechanism: topoisomerase II inhibitor. Pixuvri® is a novel aza-anthracenedione with distinct structural and physio-chemical properties. Similar to anthracyclines, Pixuvri® inhibits Topo-isomerase II but unlike anthracyclines -- rather than intercalation with DNA – Pixuvri® alkylates DNA -- forming stable DNA adducts with particular specificity for CpG-rich, hyper-methylated sites. Pixuvri® is conditionally approved in the EU as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell NHL .
Disease: aggressive B-cell non-Hodgkin lymphoma (NHL) who failed two or three prior lines of therapy
Details: • On September 17, 2014, CTI BioPharma and Servier jointly announced 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. 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. 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.
Financial terms: 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.
Latest news: • On April 25, 2017, CTI BioPharma and Servier jointly announced that they agreed to expand their existing license and development collaboration agreement for Pixuvri® (pixantrone). Under this expanded agreement, Servier will have rights to Pixuvri® in all markets except the US, where CTI BioPharma will retain the commercialization rights. Servier will pay CTI BioPharma €12 million with the potential for CTI BioPharma to receive €76 million in additional sales and regulatory milestone payments as well as royalties on net product sales. In 2014, CTI granted Servier rights to commercialize the drug globally except in Austria , Denmark , Finland , Germany , Israel , Norway , Sweden , Turkey , UK and the US. With this expanded agreement, which provides Servier's rights to all markets except the US, the companies will continue to work closely together to build the efficacy and safety evidence for Pixuvri® and to ensure that as many eligible patients as possible are benefitting from it.
