Spectrum Pharmaceuticals, Inc. and Cell Therapeutics, Inc. (CTI) have entered into an agreement to form a 50/50 owned joint venture, RIT Oncology LLC, to commercialize and develop Zevalin ([90Y]-ibritumomab tiuxetan) in the United States.
Zevalin, a radioimmunotherapeutic (RIT), is currently marketed in the United States by Cell Therapeutics, Inc. (CTI) 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. CTI submitted a supplemental Biologics License Application (sBLA) in September 2008 to expand the label for use in first-line consolidation therapy in previously untreated patients with follicular NHL.
Non-Hodgkin's lymphoma (NHL) is caused by the abnormal proliferation of white blood cells and normally spreads through the lymphatic system, a system of vessels that drains fluid from the body. NHL can be broadly classified into two main forms -- aggressive NHL, a rapidly spreading acute form of the disease, and indolent NHL, which progresses more slowly. The American Cancer Society estimates that in the United States 66,120 people are expected to be diagnosed with, and approximately 19,160 are expected to die from, this disease in 2008. According to the National Cancer Institute's SEER database, there were approximately 400,000 people in the US with NHL in 2004.
"Zevalin represents a powerful addition to our marketed oncology drug portfolio," said Rajesh C Shrotriya, MD, chairman, chief executive officer, and president of Spectrum Pharmaceuticals. "Zevalin is safe and effective in treating indolent NHL. Although approved by the FDA in 2002, its potential has not been fully realized. We are proud to partner with Cell Therapeutics, which over the past year has made great headway toward removing many of the obstacles that have kept this important drug from patients that could benefit from it. There are approximately one thousand patients currently receiving Zevalin treatments for refractory indolent NHL, generating approximately $15 million in annual sales. If approved for first line consolidation therapy in indolent NHL, we estimate that an additional 18,000 patients per year would be eligible to receive Zevalin in this setting. We assembled an experienced sales force, comprised of individuals with established track records of success, to launch our recently approved drug Fusilev. Zevalin represents a complementary product that our sales force can provide to their accounts."
"This partnership is especially important as we hope to move toward use of Zevalin in first-line consolidation treatment of indolent NHL patients, which would significantly expand the available patient population," said James A. Bianco, M.D., CEO of Cell Therapeutics. "This partnership will enable CTI to deploy a larger combined sales and marketing team to accelerate top-line product revenues in the near-term and reduce our costs to develop Zevalin for new growth opportunities, resulting in an increase in CTI's bottom-line overall. Spectrum has a wealth of experience in the field of oncology, including the sales and marketing leadership that oversaw the successful launch of Abraxane and Xeloda. We believe the Spectrum partnership allows us to better serve patients and capitalize on the growing recognition of Zevalin's effectiveness in patients with indolent NHL, while at the same time provide a significant return on investment for our shareholders."
Under terms of the agreement, upon the closing of the transaction the companies will become the sole members of a limited liability company (LLC) whose sole purpose would be to commercialize Zevalin in the United States. A Board of Managers comprised of an equal number of members from both companies would be established to govern the LLC. Both parties will equally provide for the future capital requirements of the LLC and share equally in the profits and losses of the LLC. Cell Therapeutics will receive an initial payment of $7.5 million at closing and $7.5 million in early January, in addition up to $15 million product sales milestone payments upon achievement of certain revenue targets. The closing of the joint venture transaction is subject to the satisfaction of certain customary closing conditions, including the consent of Biogen Idec, Inc. to convey the Zevalin-related assets to the LLC. CTI and Spectrum currently expect the transaction to close in December 2008.
Rodman & Renshaw, LLC, a subsidiary of Rodman & Renshaw Capital Group, Inc. (Nasdaq: RODM), acted as the exclusive strategic advisor in connection with the transaction.
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 non- Hodgkin's lymphoma, including patients with rituximab refractory follicular NHL. Zevalin is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naive, 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.
Rare deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab (Rituxan(R)) infusions. Yttrium-90 Zevalin administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions have been reported. The most serious adverse reactions of the Zevalin therapeutic regimen were primarily haematologic, including neutropenia, thrombocytopenia and anaemia. Infusion-related toxicities were associated with pre-administration of rituximab. The risk of haematologic toxicity correlated with the degree of bone marrow involvement prior to ZEVALIN therapy. Myelodysplasia or acute myelogenous leukaemia was observed in 2 per cent of patients (8 to 34 months after treatment). Zevalin should only be used by health care professionals qualified by training and experience in the safe use of radionuclides.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable.
Spectrum is a biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of drug products, with a focus mainly on oncology and urology.