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Document Preview Corixa and GlaxoSmithKline Announce FDA Approval of Bexxar |
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Title: |
Corixa and GlaxoSmithKline Announce FDA Approval of Bexxar |
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Entities: |
Corixa Corp.; GlaxoSmithKline plc; University of Michigan, Ann Arbor |
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Date: |
2003 |
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$34 |
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#289032 |
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FOR IMMEDIATE RELEASE
| For more information: | ||||
| Jim DeNike | Jill Dolgin | Laura Liotta | ||
| Corixa Corporation | GlaxoSmithKline | Sam Brown Inc. | ||
| 206-754-5716 | 919-483-2839 | 610-353-4545 | ||
| denike@corixa.com | jill.g.dolgin@gsk.com | laura@sambrown.com |
CORIXA AND GLAXOSMITHKLINE ANNOUNCE FDA APPROVAL
OF BEXXAR
The BEXXAR Therapeutic Regimen Produced Durable Responses
in Patients with Follicular Non-Hodgkins Lymphoma (NHL) Whose Disease Had
Relapsed After Chemotherapy and was Refractory to Rituximab
SEATTLE and PHILADELPHIA, June 30, 2003 Corixa Corporation (Nasdaq: CRXA) and GlaxoSmithKline (NYSE: GSK) today announced that the U.S. Food and Drug Administration (FDA) has approved BEXXAR (Tositumomab and Iodine I 131 Tositumomab) for the treatment of patients with CD20 positive, follicular, non-Hodgkins lymphoma (NHL), with and without transformation, whose disease is refractory to Rituximab and has relapsed following chemotherapy. BEXXAR will be co-marketed in the United States by Corixa and GlaxoSmithKline.
The approval of BEXXAR is the culmination of a decade of collaboration between our scientists and many outside investigators and is a victory for patients with NHL who have been waiting for new options, said Steven Gillis, Ph.D., chairman and chief executive officer of Corixa Corporation. This is also a key milestone for Corixa. We are focused on ensuring the efficient introduction and commercial success of our first product. With the support of our partner GlaxoSmithKline, we will be ready to start filling orders for BEXXAR from cancer treatment centers in approximately 30 days.
BEXXAR represents our vision of a new direction in cancer therapy. It is a targeted treatment that is also specifically dosed based on individual patient characteristics, it is given in a single short course of therapy, and it can provide durable responses in patients whose disease does not respond to other treatments, said Kevin Lokay, vice president of Oncology at GlaxoSmithKline. We have dedicated significant resources to training and supporting the treatment teams who will be administering the BEXXAR therapeutic regimen to ensure this important new therapy is available as soon as possible for the patients who will benefit from it.
BEXXAR is a dual-action therapy that pairs the tumor-targeting ability of a cytotoxic (cancer killing) monoclonal antibody (Tositumomab) and the therapeutic potential of radiation (Iodine-131) with patient-specific dosing. Combined, these agents form a radiolabeled monoclonal antibody (Iodine I 131 Tositumomab) that is able to bind to the target antigen CD20 found on NHL cells, thereby initiating an immune response against the cancer and delivering a dose of radiation directly to tumor cells.
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