Spectrum Pharmaceuticals Divests Rights to ZEVALIN® (ibritumomab tiuxetan) in Japan and Select Other Ex-US Countries to Mundipharma

On November 18, 2015 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported the divestment of ZEVALIN rights in Japan and other countries in Asia Pacific (excluding China and India), Middle East, Africa and Latin America, to Mundipharma (Press release, Spectrum Pharmaceuticals, NOV 18, 2015, View Source [SID:1234508275]). Spectrum will receive an up-front payment of $15 million plus $5 million in profits on initial ZEVALIN supply. Spectrum will continue to own ZEVALIN rights for US, Canada, and Europe.

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"This divestiture is consistent with Spectrum’s strategy of focusing on our strong late state pipeline and increasing our operational effectiveness," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "While providing non-dilutive cash, this deal lets us concentrate our efforts on developing drugs like SPI-2012 and poziotinib that have the potential to compete in blockbuster markets. This deal also helps us lower our cost of operations related to territories that are not strategic for Spectrum’s growth. Mundipharma will be able to take over Spectrum’s operations in Japan, and with reinvigorated efforts be able to better serve non-Hodgkin lymphoma patients in select ex-US countries."

About ZEVALIN and the ZEVALIN Therapeutic Regimen

ZEVALIN (ibritumomab tiuxetan) injection for intravenous use, is indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s lymphoma (NHL). ZEVALIN is also indicated for the treatment of patients with previously untreated follicular non-Hodgkin’s Lymphoma who achieve a partial or complete response to first-line chemotherapy.

ZEVALIN is a CD20-directed radiotherapeutic antibody. The ZEVALIN therapeutic regimen consists of two components: rituximab, and Yttrium-90 (Y-90) radiolabeled ZEVALIN for therapy. ZEVALIN builds on the combined effect of a targeted biologic monoclonal antibody augmented with the therapeutic effects of a beta-emitting radioisotope.

Important ZEVALIN Safety Information

Deaths have occurred within 24 hours of rituximab infusion, an essential component of the ZEVALIN therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion. ZEVALIN administration can result in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the ZEVALIN therapeutic regimen.

Please see full Prescribing Information, including BOXED WARNINGS, for ZEVALIN and rituximab. Full prescribing information for ZEVALIN can be found at www.ZEVALIN.com.