Corixa Files Request for Formal Dispute Resolution With FDA on BEXXAR; In its Appeal, Company Requests Appearance at ODAC Meeting.Business Editors & Health/Medical Writers BIOWIRE2K SEATTLE & PHILADELPHIA--(BW HealthWire)--May 31, 2002 Corixa Corp. (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 filed a request for formal dispute resolution, appealing the position articulated by 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. ) on the approval status of BEXXAR(R) in its complete review letter dated March 12, 2002. Corixa also requested the opportunity to present data on the safety and efficacy of BEXXAR in the treatment of relapsed or refractory low-grade and 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 (NHL NHL Non-Hodgkin's lymphoma, see there ) to a meeting of the Oncologic Drugs Advisory Committee (ODAC ODAC Old Dominion Athletic Conference ODAC Oracle Data Access Components ODAC Oil Depletion Analysis Centre ODAC Oncologic Drugs Advisory Committee ODAC Open Democracy Advice Centre ODAC Open Document Architecture Consortium ODAC Old Dominion Aquatic Club ). "This request initiates the dispute resolution process provided under the Food and Drug Administration Act (FDAMA FDAMA Food and Drug Administration Modernization Act )," stated Steven Gillis, Ph.D., chairman and chief executive officer at Corixa. "The filing also summarizes our strong belief that BEXXAR should be approved on the basis of the number of durable responses demonstrated across multiple clinical trials." Under FDA procedures, requests for formal dispute resolution are sent to the appropriate dispute resolution project manager at the Agency. Appeals are then reviewed by the appropriate Center for Biologics Evaluation and Research The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the Food and Drug Administration, which is in the United States Department of Health and Human Services. official as established under the Center's chain of command. A written response from the Agency should be provided within 45 days of receipt of the request for dispute resolution. If additional information is required for the official to make a decision, that time period may be extended. Although no new information may be submitted as a part of a request for dispute resolution, if an appeal is granted, Corixa could then provide the FDA with additional data in support of the contention that BEXXAR meets an unmet medical need that has not been observed with currently approved therapies. If an appeal is granted, the timing of an ODAC meeting would be dependent upon the receipt and review of additional information submitted in connection with the BLA BLA abbr. Bachelor of Liberal Arts . However, a presentation before ODAC this year remains a possibility, subject to approval of the appeal. Further information regarding the procedures for dispute resolution is available in the February 2000 FDA Guidance for Industry document, "Formal Dispute Resolution - Appeals Above the Division Level" and can be accessed at http://www.fda.gov/cber/gdlns/dispute.pdf 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 standalone basis. Corixa currently has 18 programs in clinical 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, 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. . For more information, please visit Corixa's Web site at http://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 (426-7492) or 877/426-7492. About GlaxoSmithKline GlaxoSmithKline (NYSE: GSK), 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. For more information, visit www.gsk.com. Corixa Forward Looking Statements Except for the historical information presented, certain matters discussed in this press release are forward-looking statements regarding the regulatory approval of our product candidate, BEXXAR. 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, and the "Factors Affecting Our Operating Results, Our Business and Our Stock Price," described in Corixa's Quarterly Report on Form 10-Q for the quarter ended March 31, 2002, 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. GlaxoSmithKline Forward-Looking Statement Under the safe harbor provisions of the US Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995, the Company cautions investors that any forward-looking statements or projections made by the Company, including those made in this Announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are described under Risk Factors in the Operating and Financial Review and Prospects in the Company's Annual Report on Form 20-F for 2001, filed with the US Securities and Exchange Commission. |
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