Corixa Receives Complete Review Letter On BEXXAR.Business Editors & Health/Medical Writers BIOWIRE2K SEATTLE--(BW HealthWire)--March 13, 2002 Corixa Corporation (Nasdaq:CRXA), a developer of immunotherapeutics, today announced the receipt of a complete review letter from 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. ) regarding the 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 . Bexxar is being co-developed by Corixa and GlaxoSmithKline in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . In the Complete Review letter received in the evening of March 12, 2002, the FDA stated that in its opinion, Corixa's September 10, 2001 response to the Agency's March 16, 2001 Complete Review letter did not provide sufficient evidence of the safety and net clinical benefit of BEXXAR and further stated that additional clinical studies will be required to provide such evidence. Regarding Corixa's prior request for Accelerated Approval, the letter stated that the data reviewed by the Agency do not provide sufficient evidence that BEXXAR addresses an unmet medical need. Additionally, the letter stated that within 10 days from its receipt, Corixa must either amend its application, notify the Agency of its intent to file an amendment, withdraw the application or request an opportunity for a hearing on whether there are grounds for denying approval of the application. Corixa will formally request a meeting with representatives of the Agency for further discussion of a regulatory path for BEXXAR. It is expected that this meeting will occur within the next 45 days. "We are extremely disappointed with the FDA's decision and intend to promptly pursue resolution with our partner, GlaxoSmithKline and the Agency," stated Steven Gillis, Ph.D., Corixa chairman and chief executive officer. "We are formally requesting a meeting with the FDA and hope to reach mutual agreement on the specific steps still necessary for approval. We will provide additional guidance as to the regulatory pathway for BEXXAR after further discussions with GlaxoSmithKline and the FDA." 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 immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. . 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 16 programs in clinical development and 22 programs in preclinical development, including its most advanced product candidate, Bexxar(R), a monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing conjugated conjugated adj. Conjugate. estrogens, conjugated Warning - Hazardous drug! C.E.S. to a radioisotope radioisotope: see radioactive isotope. Radioisotope (biology) A radioactive isotope used in studying living systems, such as in the investigation of metabolic processes. . 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, Wash., with additional operations in Hamilton, Mont. and South San Francisco South San Francisco, city (1990 pop. 54,312), San Mateo co., W Calif.; inc. 1908. South San Francisco has several industrial parks; its manufactures include medical supplies and equipment, foods, paint, paper products, consumer goods, and clothing. , Calif. For more information, please visit Corixa's Website at www.corixa.com or call the company's investor relations Investor relations The process by which the corporation communicates with its investors. information line at 877/4CORIXA or 877/426-7492. 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 Quarterly Report on Form 10-Q Form 10-Q See 10-Q. for the quarter ended September 30, 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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