Corixa and GlaxoSmithKline Provide BEXXAR Regulatory Update.Business Editors, Health & Medical Writers BIOWIRE2K SEATTLE & PHILADELPHIA--(BUSINESS WIRE)--Dec. 2, 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) ): -- FDA Confirms That Receipt of Additional BEXXAR Data Constitutes a Complete Response to March 12, 2002 Complete Review Letter -- ODAC Appearance and Return to Active Review Status Prompts Corixa's Withdrawal of Dispute Resolution Corixa Corp. (Nasdaq:CRXA) and GlaxoSmithKline (NYSE:GSK) today announced that 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. ) has determined that additional BEXXAR(R) (tositumomab, iodine I-131 tositumomab) safety data submitted in March 2002 and submission of a response in October 2002 to the agency's complete review letter from March 2002 constitute a complete response to the questions and issues raised by the FDA in its most recent complete review letter. The FDA has further confirmed that the data submitted constitute substantial new information addressing prior concerns and now the agency chooses to take the data on BEXXAR to 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 ) for advice regarding approval. The FDA also confirmed that the BEXXAR BLA BLA abbr. Bachelor of Liberal Arts has been returned to active review status. The new Prescription Drug User Fee Act The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. (PDUFA PDUFA Prescription Drug User Fee Act of 1992 (USA) ) goal date for the FDA to complete its review of all materials regarding BEXXAR is May 2, 2003. Corixa and GlaxoSmithKline announced earlier this month that BEXXAR safety and efficacy data will be presented to ODAC on December 17, 2002. Corixa is seeking approval of BEXXAR therapy for the treatment of relapsed or refractory 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 . In addition, Corixa is seeking registration for use of BEXXAR in low-grade non-Hodgkin's lymphoma patients who do not respond or progress following rituximab therapy. On May 31, 2002, Corixa filed a request for formal dispute resolution, appealing the position articulated by the FDA on the approval status of BEXXAR in its complete review letter dated March 12, 2002. On June 26, 2002 the FDA granted Corixa's appeal, paving the way for presentation of safety and efficacy data before ODAC. Since that time Corixa has provided the agency with additional safety and efficacy analyses in response to questions in the complete review letter as well as questions that arose during further analysis by FDA review staff. As a result of the scheduling of the ODAC meeting, the return of the BEXXAR BLA to active review status and the FDA's stance regarding the suitability of the BEXXAR safety and efficacy data for presentation to ODAC, Corixa has chosen to withdraw its prior request for formal dispute resolution. "We are pleased to have received notification from FDA of the return of the BEXXAR BLA to active review status. We have worked closely with FDA review staff for the past several months and have provided prompt responses to multiple inquiries arising as a result of FDA's continuing review. We are looking forward to presentation of safety and efficacy data for BEXXAR at the December 17 meeting of ODAC," stated Steven Gillis, Ph.D., chairman and chief executive officer at Corixa. "We continue to believe that BEXXAR can be approved on the basis of safety and efficacy data submitted in our BLA including our replies to FDA complete review letters. These data now include the durability of response seen in a significant percentage of treated patients." 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 infectious diseases: see communicable 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 multiple 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 www.corixa.com. 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, including statements regarding the potential 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 on a timely basis, if at all, and 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, 2002, copies of which are available from Corixa's investor relations Investor relations The process by which the corporation communicates with its investors. 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 Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. 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 |
|
||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion