Spectrum Pharmaceuticals announced the closing of the transaction with Cell Therapeutics, Inc (CTI) to form a 50/50 owned joint venture, RIT Oncology, LLC, to commercialize and develop Zevalin ([90Y]-ibritumomab tiuxetan) in the United States. In connection with the closing, Spectrum Pharmaceuticals paid CTI an initial up-front payment of $7.5 million. An additional payment of $7.5 million will be paid to CTI in early January.
"We believe Zevalin is an outstanding addition to our portfolio and we are committed to making RIT a model joint venture as our highly motivated teams further develop and market Zevalin for patients in the United States," said Rajesh C Shrotriya, chairman, chief executive officer, and president of Spectrum Pharmaceuticals.
Zevalin, a radioimmunotherapeutic (RIT), was exclusively marketed by Cell Therapeutics in the United States prior to the close of the transaction and will now be marketed jointly by Spectrum Pharmaceuticals and CTI through RIT Oncology, LLC for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL), including patients who have rituximab-refractory follicular NHL. On November 28, 2008, the FDA accepted for filing and review, and granted priority review status for, the supplemental Biologics License Application for use of Zevalin as first line consolidation therapy for patients with B-cell follicular non-Hodgkin's lymphoma. Priority review is granted by the FDA for a treatment that addresses a significant unmet medical need. This does not represent any evaluation of the adequacy of the data submitted. A Prescription Drug User Fee Act (PDUFA) target date of April 2, 2009 has been established by the FDA for a decision regarding the Zevalin sBLA.
If approved, Zevalin would be the first radioimmunotherapy available to patients as first-line consolidation therapy. It is estimated that there would be approximately 18,000 patients that currently receive first-line treatment which would potentially be eligible to use Zevalin under the proposed expanded label. Together with Zevalin's current approval as treatment for patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL), including patients that are rituximab-refractory or rituximab-naive, approval of Zevalin as first-line consolidation therapy will allow Zevalin to be used in several lines of NHL therapy.
Spectrum Pharmaceuticals and Cell Therapeutics are the sole members of the LLC, whose sole purpose is to commercialize Zevalin in the United States. The LLC is governed by a Board of Managers comprised of an equal number of members from both companies. Both parties are to equally provide for the future capital requirements of the LLC and share equally in the profits and losses of the LLC.
Spectrum is a biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of drug products, with a focus mainly on oncology and urology.