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Corixa Announces Health Canada's Acceptance of BEXXAR Submission for Priority Review.


Business Editors/Health/Medical Writers

BIOWIRE2K

SEATTLE--(BUSINESS WIRE)--Aug. 25, 2003

Corixa Corporation (Nasdaq:CRXA) today announced that the Biologics and Genetic Therapies Directorate (BGTD BGTD Biologics and Genetic Therapies Directorate
BGTD Bangalore Telecom District (India)
BGTD Boom Goes the Dynamite (band) 
) of Health Canada Health Canada (French: Santé Canada) is the department of the government of Canada with responsibility for national public health.

Health Canada's goal is to improve Canadian life by improving Canadian longevity, lifestyle and use of public healthcare.
 has accepted Corixa's New Drug Submission for BEXXAR(TM) under a Priority Review. The U.S. Food and Drug Administration approved BEXXAR in June 2003 for the treatment of 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 
.

Health Canada's Priority Review is a status granted to eligible new drug submissions for human use with a shortened review target of 180 days, in comparison to 300 days for non-priority. Priority Review status may be granted to drug submissions intended for the treatment, prevention or diagnosis of serious, life-threatening or severely debilitating illnesses severely debilitating illness Any condition in which there is major irreversible morbidity–eg, AIDS, Alzheimer's disease, blindness, diabetic nephropathy, neurologic degeneration, Parkinson's disease, terminal CA, etc.  or conditions where a) there is no existing drug on the Canadian market with the same profile or b) where the new product represents a significant improvement in the benefit/risk profile over existing products.

"We are very pleased that BEXXAR has been granted a priority review by Health Canada," said Steven Gillis, Ph.D., chairman and chief executive officer at Corixa. "This milestone is further demonstration of Corixa's commitment to delivering the promise of radioimmunotherapy and, in collaboration with GlaxoSmithKline, we are excited about the potential opportunity to bring BEXXAR to patients in Canada as quickly as possible."

Corixa and GlaxoSmithKline Inc. (GSK GSK GlaxoSmithKline plc (pharmaceutical company)
GSK Glycogen Synthase Kinase
GSK Gruppentraining Sozialer Kompetenzen (Germany)
GSK Greenland Shark (FAO fish species code) 
) in Canada entered into an agreement in May 2003 whereby in the event of product approval GSK will market BEXXAR in Canada. Under the terms of the agreement, GSK is responsible for registration, marketing and sales of the product in Canada. Corixa is responsible for the manufacture and supply of BEXXAR therapy to GSK for the Canadian market.

About BEXXAR

On July 31, 2003, Corixa and GSK announced that they have begun sales and marketing of BEXXAR to cancer treatment centers, oncologists and nuclear medicine professionals 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. . The BEXXAR therapeutic regimen, which is given in four office visits over one to two weeks, culminating in the administration of a patient-specific therapeutic dose, is indicated in the United States for the treatment of patients with CD20 positive, follicular fol·lic·u·lar
adj.
1. Relating to, having, or resembling a follicle or follicles.

2. Affecting or growing out of a follicle or follicles.
, non-Hodgkin's lymphoma (NHL NHL Non-Hodgkin's lymphoma, see there ), with and without transformation, whose disease is refractory to Rituximab and has relapsed following chemotherapy.

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 multiple programs in clinical development, including several product candidates that have advanced to and through late stage clinical trials.

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, Montana, 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, visit Corixa's Web site at www.corixa.com.

Corixa Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the prospects for approval of our product, BEXXAR(TM) therapy by Health Canada, statements about our potential future royalties from the marketing agreement with GSK and other statements about our plans, objectives, intentions and expectations. 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 risk that we do not obtain approval for the sale of BEXXAR(TM) therapy in Canada, the risk that we do not receive the expected royalties from our agreement with GSK and the "Factors Affecting Our Operating Results, Our Business and Our Stock Price," described in our Quarterly Report on Form 10-Q Form 10-Q

See 10-Q.
 for the quarter ended June 30, 2003, copies of which are available from our 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.

BEXXAR(TM) is a trademark of Corixa Corporation, used under license by GlaxoSmithKline Inc.

(BEXXAR(R) is a registered trademark in the United States.)
COPYRIGHT 2003 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2003, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Aug 25, 2003
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