Printer Friendly
The Free Library
19,604,530 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Corixa announces results of BEXXAR Discussions with the FDA; Corixa to Appeal Recent Complete Review Letter and Will Request Appearance at ODAC Meeting.


Business Editors and Pharmaceutical/Biotechnology Writers

SEATTLE--(BW HealthWire)--May 15, 2002

Corixa Corp. (Nasdaq:CRXA), today announced the results of its recent meeting with 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 potential commercialization of BEXXAR(R).

In advance of the meeting, the company submitted to the FDA as a part of the BEXXAR Biologics License Application (BLA BLA
abbr.
Bachelor of Liberal Arts
) detailed responses to the clinical issues raised in the Agency's complete review letter dated March 12, 2002. At the meeting, Corixa and GlaxoSmithKline further articulated their belief that BEXXAR merits approval for the treatment of relapsed, refractory refractory

Material that is not deformed or damaged by high temperatures, used to make crucibles, incinerators, insulation, and furnaces, particularly metallurgical furnaces.
 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 
 patients based on the high level of durable responses observed across multiple clinical studies. The companies contended that this level of persistent, independently confirmed, disease-free survival disease-free survival Oncology The time that a person with a disease lives without known recurrence; DFS is major clinical parameter used to evaluate the efficacy of a particular therapy, which is usually measured in 'units' of 1 or 5 yrs. See Cure, Remission.  has not been demonstrated in clinical trials of other products. As a result, the companies believe that BEXXAR does address a medical need that cannot be met via administration of previously approved products in this patient population. Following these discussions, the FDA continued to question the clinical benefit of BEXXAR and suggested that such benefit should be shown in additional, prospective clinical studies.

Following the presentation, and given that a second complete review letter has already been issued, Corixa and the FDA discussed an appropriate process for resolution of the existing differences in opinion. This approach involves a formal request for dispute resolution under the Food and Drug Administration Modernization Act (FDAMA FDAMA Food and Drug Administration Modernization Act ).

As a result of the discussion with the FDA, Corixa will submit a written request to appeal the FDA's position as articulated in the complete review letter dated March 12, 2002 and will further request a presentation of BEXXAR data to the FDA's scientific advisors, 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
).

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 information in support of its contention that BEXXAR meets an unmet medical need over and above that manifested by existing products. With respect to Corixa's assertion that BEXXAR provides a level of durable response, the FDA has further provided guidance as to what additional information must be submitted if an appeal is granted. 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. However, a presentation before ODAC this year remains a possibility, subject to approval of the appeal.

Although the FDA continues to request additional studies to more carefully assess the true incidence of adverse events and assess for factors that may correlate with an increased incidence of adverse events, following the meeting the FDA also confirmed that based on data submitted to the BLA prior to receipt of the March 12, 2002 complete review letter, the Agency was now able to sufficiently characterize the safety of BEXXAR in order to permit an assessment of net clinical benefit.

"Our meeting with the FDA was productive and we look forward to continuing our work with the Agency in an effort to secure a BEXXAR presentation before an ODAC panel," stated Steven Gillis, Ph.D., chairman and chief executive officer at Corixa. "We intend to provide further updates regarding the formal filing of a request for dispute resolution and the regulatory status of BEXXAR as further developments warrant."

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.

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 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 18 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, 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.

Corixa Forward Looking Statements

Except for the historical information presented, certain matters discussed in this press release are 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.
 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 Annual Report on Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 for the year ended Dec. 31, 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.
COPYRIGHT 2002 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Date:May 15, 2002
Words:993
Previous Article:Brilliant Digital Entertainment Reports First Quarter 2002 Results; Successfully Completes Financing Round of $1.25 Million.
Next Article:Meadow Valley Reports First Quarter Results.
Topics:



Related Articles
Corixa Outlines Operational Strategy Following Receipt of FDA Complete Review Letter for Bexxar.
Corixa and GlaxoSmithKline Receive Complete Review Letter Following FDA Evaluation of Bexxar BLA.
ORGANON GETS FIRST EUROPEAN MARKETING APPROVAL FOR REMERON.
Corixa Reports Strong Third Quarter Results; Revenue for the Third Quarter Up 76 Percent.
Corixa Provides Bexxar Regulatory Update.
CORIXA/BEAUFOUR IPSEN TO DEVELOP ANERGIX.MG TECHNOLOGY.
Oncologic Drugs Advisory Committee Endorses Corixa's Phase III Trial Design for Melacine Melanoma Vaccine.
Corixa Receives Complete Review Letter On BEXXAR.
Corixa and GlaxoSmithKline Respond to FDA; Complete Review Letter for BEXXAR.
Corixa Files Request for Formal Dispute Resolution With FDA on BEXXAR; In its Appeal, Company Requests Appearance at ODAC Meeting.

Terms of use | Copyright © 2012 Farlex, Inc. | Feedback | For webmasters | Submit articles