Corixa and GlaxoSmithKline Respond to FDA; Complete Review Letter for BEXXAR.Business Editors & Health/Medical Writers BIOWIRE2K SEATTLE & PHILADELPHIA--(BW HealthWire)--March 25, 2002 Corixa Corporation (Nasdaq:CRXA) and GlaxoSmithKline (NYSE NYSE See: New York Stock Exchange :GSK GSK GlaxoSmithKline plc (pharmaceutical company) GSK Glycogen Synthase Kinase GSK Gruppentraining Sozialer Kompetenzen (Germany) GSK Greenland Shark (FAO fish species code) ), today announced that Corixa has notified the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) that it intends to amend its Biological License Application (BLA BLA abbr. Bachelor of Liberal Arts ) for BEXXAR(R) (tositumomab, iodine I-131 tositumomab), an investigational radioimmunotherapy for the treatment of low-grade or transformed low-grade non-Hodgkin's lymphoma non-Hodg·kin's lymphoma n. Any of various malignant lymphomas characterized by the absence of Reed-Sternberg cells. Non-Hodgkin's lymphoma . The companies also announced that they have formally requested a meeting with the FDA to discuss the complete review letter and potential next steps regarding this application. A meeting is expected to occur within the next 45 days. BEXXAR is being co-developed by Corixa and GlaxoSmithKline in the United States. As previously announced, Corixa received a complete review letter regarding the BEXXAR BLA on March 12, 2002. In the letter, the FDA stated that it believed additional data would be required to approve BEXXAR and gave Corixa the options of amending its application, notifying the Agency of its intent to file an amendment, withdrawing the application, or requesting an opportunity for a hearing on whether there are grounds for denying approval of the application. About Corixa Corixa is a developer of immunotherapeutics with a commitment to treating and preventing autoimmune diseases Autoimmune diseases A group of diseases, like rheumatoid arthritis and systemic lupus erythematosus, in which immune cells turn on the body, attacking various tissues and organs. Mentioned in: Complement Deficiencies, Premature Menopause , cancer and infectious diseases by understanding and directing the immune system. Corixa is focused on immunotherapeutic products and has a broad technology platform enabling both fully integrated vaccine design and the use of its separate, proprietary product components on a stand-alone basis. Corixa currently has 18 programs in clinical development and 22 programs in preclinical development. The company partners with numerous developers and marketers of pharmaceuticals, targeting products that are Powered by Corixa(TM) technology with the goal of making its potential products available to patients around the world. Corixa was founded in 1994 and is headquartered in Seattle, Washington, with additional operations in Hamilton, Montana and South San Francisco, California South San Francisco is a city in San Mateo County, California, United States, located on the San Francisco Peninsula in the San Francisco Bay Area. The population was 60,552 at the 2000 census. . For more information, please visit Corixa's Website at www.corixa.com or call the company's investor relations information line at 1.877.4CORIXA or 877.426.7492. About GlaxoSmithKline GlaxoSmithKline -- one of the world's leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer. GlaxoSmithKline is committed to the research, development, manufacturing and marketing of therapeutic and supportive care products for hematology and oncology patients. Currently, GlaxoSmithKline Oncology markets Zofran(R) (ondansetron), Hycamtin(R) (topotecan HCl), Navelbine(R) (vinorelbine tartrate) Injection, Argatroban Injection, Alkeran(R) (melphalan), Leukeran(R) (chlorambucil chlorambucil /chlor·am·bu·cil/ (klor-am´bu-sil) an alkylating agent from the nitrogen mustard group, used as an antineoplastic. chlor·am·bu·cil n. ), Compazine(R) (prochlorperazine prochlorperazine /pro·chlor·per·a·zine/ (pro?klor-per´ah-zen) a phenothiazine derivative, used as the base or the edisylate or maleate salts as an antiemetic and antipsychotic. pro·chlor·per·a·zine n. ), Purinethol(R) (mercaptopurine mercaptopurine: see metabolite. ), Myleran(R) (busulfan busulfan /bu·sul·fan/ (bu-sul´fan) an antineoplastic used in treating chronic granulocytic leukemia, polycythemia vera, myeloid metaplasia, and myeloproliferative syndrome; also used in lieu of whole body irradiation in bone marrow ), and Thioguanine. GlaxoSmithKline Oncology has novel agents in late-stage development, including a radioimmunotherapy BEXXAR. Forward Looking Statements Except for the historical information presented, certain statements in this press release relating to the FDA's approval of Bexxar are forward-looking statements. Forward-looking statements are based on the opinions and estimates of management at the time the statements are made. They are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Factors that could affect Corixa's actual results include, but are not limited to, the failure of FDA to approve the commercial sale of Bexxar, as well as the "Factors Affecting Our Operating Results, Our Business and Our Stock Price," described in Corixa's Annual Report on Form 10-K for the year ended December 31, 2001, copies of which are available from Corixa's investor relations department. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. |
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