Spectrum Pharmaceuticals announced the closing of the transaction whereby Spectrum Pharmaceuticals acquired 100 per cent control of RIT Oncology, LLC, to commercialize Zevalin ([90Y]-ibritumomab tiuxetan) in the United States.
In connection with the closing, Spectrum Pharmaceuticals will pay its former partner a total of $16.5 million, which is subject to further adjustments based on outstanding liabilities and obligations. Additionally, there will be no further payments or milestones to the former partner. Spectrum Pharmaceuticals now has 100 per cent ownership of RIT Oncology, LLC, and will be responsible for all activities relating to Zevalin. Spectrum Pharmaceuticals will now book 100 per cent of Zevalin revenues.
Zevalin is currently approved 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. Zevalin is under review by the FDA for use as a first line consolidation therapy for patients with NHL. The FDA recently established July 2, 2009 as a target date for a decision regarding the Zevalin sBLA.
"We are excited to have 100 per cent ownership of Zevalin," said Rajesh C Shrotriya, MD, chairman, chief executive officer, and president of Spectrum Pharmaceuticals. "Recent clinical data have dramatically underscored the clinical benefits of Zevalin in NHL. We believe that approval of the supplemental Biologics License Application (sBLA) for first-line consolidation therapy, which is based on the Phase 3 FIT data, anticipated regulatory and reimbursement changes, combined with our marketing efforts, will substantially improve patient access to Zevalin."
"The anticipated FDA approval of the sBLA for Zevalin on or before the July 2, 2009 PDUFA action date will allow for the label to address a substantially larger patient population," added Dr. Shrotriya. "We expect our commercial launch program to be fully in place by the anticipated approval of the additional indication for Zevalin in July. This asset, along with Fusilev, creates added synergies across multiple cost centres, thereby maximizing the return on our investments."
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 a first line consolidation therapy for patients with NHL. 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 July 2, 2009 has been established by the FDA for a decision regarding the Zevalin sBLA.
If approved, Zevalin would be the first therapeutic available to patients as first-line consolidation therapy to treat NHL. Following the anticipated approval, the addressable patient population would increase by approximately 18,000. Together with Zevalin's current approval as treatment for patients with relapsed or refractory, low-grade or follicular B-cell NHL, including patients that are rituximab-refractory or rituximab-naive, approval of Zevalin as first-line consolidation therapy may allow Zevalin to be used in several lines of NHL therapy.
Spectrum Pharmaceuticals is the sole member of the LLC, whose sole purpose is to commercialize Zevalin in the United States.
Zevalin (Ibritumomab Tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated as part of the Zevalin therapeutic regimen for treatment of relapsed or refractory, low-grade or follicular B-cell NHL, including patients with rituximab-refractory follicular NHL. Zevalin is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naïve, low-grade and follicular NHL based on studies using a surrogate endpoint of overall response rate. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL.
Spectrum is a biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of drug products, with a focus mainly on oncology and urology.