PHILADELPHIA, Dec. 13 /PRNewswire-FirstCall/ -- GlaxoSmithKline today announced that it has reached an agreement with Corixa Corporation to acquire worldwide rights and responsibilities related to the manufacturing, development and commercialization of the BEXXAR(R) therapeutic regimen.
Under the terms of the agreement, on December 31, 2004, GSK assumes rights and responsibilities for the commercial and clinical development of BEXXAR on a worldwide basis. As a result, Corixa will assign or otherwise transfer all of its BEXXAR-related assets to GSK, including the rights to commercialize BEXXAR in Canada. In addition, GSK will assume Corixa's relationship with the Australian Nuclear Science and Technology Organization for the commercialization of BEXXAR in Australasia.
According to the agreement, GSK will provide development and sales milestones and royalties to Corixa based on sales of BEXXAR in the United States, Canada and Australasia. GSK and Corixa will continue to equally share royalties on Zevalin sales according to the terms of the previous patent litigation settlement with Biogen Idec.
"GlaxoSmithKline and Corixa have enjoyed a strong partnership as we introduced BEXXAR, a targeted therapy for relapsed or refractory non-Hodgkin's lymphoma," said Kevin Lokay, vice president of Oncology and Acute Care at GlaxoSmithKline. "Together, we have worked with healthcare providers and payers to increase awareness and access to this promising and novel therapy for patients with non-Hodgkin's lymphoma. GSK remains committed to BEXXAR and the patients who may benefit from it."
About the BEXXAR Therapeutic Regimen
BEXXAR pairs the targeting ability of a monoclonal antibody (Tositumomab) and the therapeutic potential of radiation (Iodine-131). Combined, these agents form a radiolabeled monoclonal antibody regimen that is able to bind to the target antigen CD20 found on B-cells, including normal cells and those that become cancerous in non-Hodgkin's lymphoma, thereby delivering the dose of radiation. BEXXAR, which is given in four visits over one to two weeks, is specifically dosed based on an individual's drug clearance rate, allowing the delivery of a pre-determined amount of radiation to each patient.
The BEXXAR therapeutic regimen has been studied for over 13 years. In a multi-center, single-arm, clinical trial in patients who had received an average of four prior chemotherapies and who had Rituximab-refractory disease (N=35), 63 percent (22 of 35) responded to BEXXAR. The median duration of response was 25 months. The results of this study were supported by demonstration of durable objective responses in four single-arm studies enrolling 190 patients evaluable for efficacy with Rituximab-naive, follicular non-Hodgkin's lymphoma with or without transformation, who had relapsed following or were refractory to chemotherapy. Determination of clinical benefit of the BEXXAR therapeutic regimen was based on evidence of durable responses without evidence of an effect on survival.
The BEXXAR therapeutic regimen is not indicated for the initial treatment of patients with CD20 positive non-Hodgkin's lymphoma. The BEXXAR therapeutic regimen is intended as a single course of treatment. The safety of multiple courses of the BEXXAR therapeutic regimen, or combination of this regimen with other forms of irradiation or chemotherapy, has not been evaluated.
BEXXAR may not be for everyone. Patients who are pregnant or allergic to any components of the regimen should not receive BEXXAR. Treatment with BEXXAR resulted in very low blood counts in the majority of patients, which could be serious, for an extended period of time (about a month). Infections occurred in almost half the patients, bleeding in one of eight patients, and treatment with supportive care in about one of four patients. Allergic reactions, including anaphylaxis, which may be severe, have occurred in patients receiving BEXXAR. Other less severe reactions during or following the infusion have included fever, chills, sweating, nausea, low blood pressure, shortness of breath and trouble breathing. Patients may also experience weakness, fever, nausea, increased cough, infection, pain, chills, rash, or headache. There is a risk of hypothyroidism following the administration of BEXXAR. Administration of BEXXAR resulted in the development of antibodies to the mouse antibody (called HAMA). Certain cancer therapies including BEXXAR have been associated with the development of a second type of blood cancer and solid tumors. Thirty-two cases (3.2 percent) of myelodysplastic syndrome (a type of pre-leukemia) and/or leukemia and 52 cases of secondary tumors were reported in 995 patients enrolled in BEXXAR studies. After being treated with BEXXAR, less than five percent of patients suffered hair loss or developed severe nausea, vomiting or mucositis (sores in the mouth or gastrointestinal tract). Healthcare providers must be specifically trained to administer BEXXAR.
BEXXAR was developed by Corixa Corporation and is co-marketed in the United States by Corixa Corporation and GlaxoSmithKline. Additional information about the BEXXAR therapeutic regimen, including complete prescribing information, may be obtained by calling 1-877-4BEXXAR or visiting http://www.bexxar.com/.
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