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Corixa Outlines Operational Strategy Following Receipt of FDA Complete Review Letter for Bexxar.


Business Editors, Health/Medical Writers

SEATTLE--(BW HealthWire)--March 19, 2001

Corixa Corporation (Nasdaq:CRXA), a developer of immunotherapeutics, today provided an update on a modified operating plan it has adopted after receiving 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.
) following FDA's six-month review of the Bexxar Biologics License Application (BLA BLA
abbr.
Bachelor of Liberal Arts
).

In a separate press release issued today (3-19-01, Corixa and GlaxoSmithKline Receive Complete Review Letter Following FDA Evaluation of Bexxar BLA), Corixa summarized additional clinical and manufacturing information that the company will submit as a result of the review.

Corixa has modified its operating plan as a result of Bexxar's delayed market introduction and the recognition of additional synergies that have been identified between Corixa and former Coulter workforces. Corixa will initiate immediate expense reductions, including a 10-15 percent reduction in total headcount that includes the elimination of unfilled open positions, as well as existing positions. The majority of these reductions will take place at Corixa's California operations.

These reductions in research and development and administrative support staff will result in the postponement of further internal development of certain programs. These programs will become the focus of potential territory-specific, out-licensing activities as they represent either clinical stage, or near-clinical stage partnership opportunities.

Additionally, in an effort to minimize expenses during the Bexxar delay, Corixa is currently pursuing several new opportunities in which Corixa would contract out the services of its sales personnel to promote and sell a potential partner's products. Under such an agreement, Corixa's sales and marketing personnel would be partnered until these resources were required to support Bexxar commercialization. If Corixa is unable to establish such an agreement, the company may be required to make additional headcount reductions within the direct sales and marketing groups.

The headcount reductions announced today will result in a first quarter restructuring charge restructuring charge

The expense of reorganizing a company's operations. A restructuring charge is an infrequent expense that generally results from asset writedowns or facility closings.
 of approximately $1.5 million, and could result in annual cost savings of approximately $6 million. Following today's reductions, the company will have approximately 512 employees employed at three different locations.

"The actions taken today will provide us with additional financial flexibility to help deliver on the promise of Bexxar and to continue the advancement of the high priority programs in our product pipeline," stated Steven Gillis, Ph.D., chairman and chief executive officer of Corixa. "We remain dedicated to the future success and commercialization of Bexxar and are committed to providing the FDA with answers to the questions raised in its complete review letter as completely and expeditiously ex·pe·di·tious  
adj.
Acting or done with speed and efficiency. See Synonyms at fast1.



ex
 as possible."

The FDA requested updated and/or final safety and efficacy data from ongoing, recently completed and other additional trials to establish safety and effectiveness. Corixa and GlaxoSmithKline believe that safety and efficacy data from recently completed trials, beyond those contained in the Bexxar BLA, may fulfill FDA's requests. Recently completed trials, have:
-- Examined comparative safety and efficacy in NHL patients treated either with
Bexxar or the unlabeled antibody in Bexxar;

-- Assessed clinical safety and efficacy of Bexxar treatment of relapsed,
refractory NHL patients who did not respond to Rituxan(R) (rituximab)(a); and

-- Assessed Bexxar safety and efficacy as front-line therapy in low-grade NHL
patients.


The FDA also requested:

-- Further documentation and analysis of patient diagnosis and

confirmation of response from pivotal and non-pivotal trials

that involved treatment of low-grade lymphoma low-grade lymphoma Indolent lymphoma Any relatively indolent lymphoma classified by the Working Formulation, with a prolonged survival of 5 to 7.5 yrs, often with minimal therapy Examples Small lymphocytic–plasmacytoid lymphoma, follicular small cleaved cell  patients,

including those patients with transformed low-grade lymphoma;

-- Additional information or source documentation regarding:

-- Certain adverse events,

-- Long-term follow-up on patient thyroid thyroid /thy·roid/ (thi´roid)
1. the thyroid gland; see under gland.

2. pertaining to the thyroid gland.

3. scutiform.

4.
 function and HAMA

response,

-- White blood cell counts white blood cell count,
n a diagnostic clinical laboratory test to determine the number and types of leukocytes present in a measured sample of blood. Overall the normal number of leukocytes ranges from 5000 to 10,000/mm3.
 following Bexxar administration,

and

-- Dosimetry dosimetry /do·sim·e·try/ (do-sim´e-tre) scientific determination of amount, rate, and distribution of radiation emitted from a source of ionizing radiation, in biological d.  calculations on certain patients whose response

data was submitted in the BLA;

-- Further documentation and analysis supporting comparability of

tositumomab manufactured by different suppliers during the

course of Bexxar clinical development; and

-- Additional documentation and test results related to

validation of various production processes and release tests

as well as additional information concerning processes and

procedures used in drug shipment.

Conference Call

Corixa will hold a conference call on March 19, 2001 at 8:30 a.m. EST EST electroshock therapy.

EST
abbr.
electroshock therapy
 to discuss today's announcement. Those who would like to participate in the conference call should dial 800/289-0529 (passcode 410501). A replay of the conference call will be available from Monday, March 19 through 12 a.m. EST, Wednesday, March 21. To access the replay, please dial 888/203-1112 (passcode 410501) or visit the "events" section of Corixa's website (http://www.shareholder.com/corixa/medialist.cfm).

About Corixa

Corixa is a developer of immunotherapeutics with a commitment to treating and preventing autoimmune disease autoimmune disease, any of a number of abnormal conditions caused when the body produces antibodies to its own substances. In rheumatoid arthritis, a group of antibody molecules called collectively RF, or rheumatoid factor, is complexed to the individual's own gamma , cancer and infectious disease Infectious disease

A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions.
 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 16 programs in clinical development and 22 programs in preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable.

pre·clin·i·cal
adj.
1.
 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, Wash., with additional operations in Hamilton, Mont. and Redwood City Redwood City, city (1990 pop. 66,072), seat of San Mateo co., W Calif., on San Francisco Bay; inc. 1868. Manufactures include commmunications, electrical, electronic, and medical equipment. , Calif. 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 forward-looking statement

A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections.


Except for the historical information presented, certain matters discussed in this press release 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, failure to receive Bexxar market clearance from the FDA, and the "Factors Affecting Our Operating Results, Our Business and Our Stock Price," described in our Quarterly Report on Form 10-Q/A filed on November 7, 2000 and our Registration Statement on Form S-4/A filed on November 17, 2000, copies of which are available on our Web site, www.corixa.com. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release.

(a) Rituxan is a registered trademark of IDEC IDEC Instituto Brasileiro de Defesa do Consumidor (Portugese: Brazilian Consumer Protection Agency)
IDEC Information Design & End-User Computing
IDEC Interior Design Educators Council, Inc.
 Pharmaceuticals Corporation.
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:Mar 19, 2001
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