Business Wire - Corixa and GlaxoSmithKline Respond to FDA; Complete Review Letter for BEXXAR
Business Editors & Health/Medical Writers
BIOWIRE2K
SEATTLE & PHILADELPHIA–(BW HealthWire)–March 25, 2002
Corixa Corporation (Nasdaq:CRXA) and GlaxoSmithKline (NYSE:GSK), today announced that Corixa has notified the U.S. Food and Drug Administration (FDA) that it intends to amend its Biological License Application (BLA) for BEXXAR(R) (tositumomab, iodine I-131 tositumomab), an investigational radioimmunotherapy for the treatment of low-grade or transformed low-grade non-Hodgkin’s lymphoma.
The companies also announced that they have formally requested a meeting with the FDA to discuss the complete review letter and potential next steps regarding this application. A meeting is expected to occur within the next 45 days.
Most Popular
10 Jobs That Pay $30 An Hour
13 Job Interview Mistakes To Avoid
3 Questions No Job Seeker Ever Wants To Be Asked?
Public Speaking: 7 Secrets Of Great Public Speakers
5 Regular Mistakes In Public Speaking
BEXXAR is being co-developed by Corixa and GlaxoSmithKline in the United States.
As previously announced, Corixa received a complete review letter regarding the BEXXAR BLA on March 12, 2002. In the letter, the FDA stated that it believed additional data would be required to approve BEXXAR and gave Corixa the options of amending its application, notifying the Agency of its intent to file an amendment, withdrawing the application, or requesting an opportunity for a hearing on whether there are grounds for denying approval of the application.
About Corixa
Corixa is a developer of immunotherapeutics with a commitment to treating and preventing autoimmune diseases, cancer and infectious diseases by understanding and directing the immune system. 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 stand-alone basis. Corixa currently has 18 programs in clinical development and 22 programs in preclinical 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, Washington, with additional operations in Hamilton, Montana and South San Francisco, California. For more information, please visit Corixa’s Website at www.corixa.com or call the company’s investor relations information line at 1.877.4CORIXA or 877.426.7492.
About GlaxoSmithKline
GlaxoSmithKline — 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. GlaxoSmithKline is committed to the research, development, manufacturing and marketing of therapeutic and supportive care products for hematology and oncology patients. Currently, GlaxoSmithKline Oncology markets Zofran(R) (ondansetron), Hycamtin(R) (topotecan HCl), Navelbine(R) (vinorelbine tartrate) Injection, Argatroban Injection, Alkeran(R) (melphalan), Leukeran(R) (chlorambucil), Compazine(R) (prochlorperazine), Purinethol(R) (mercaptopurine), Myleran(R) (busulfan), and Thioguanine. GlaxoSmithKline Oncology has novel agents in late-stage development, including a radioimmunotherapy BEXXAR.
Forward Looking Statements
Except for the historical information presented, certain statements in this press release relating to the FDA’s approval of Bexxar 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, the failure of FDA to approve the commercial sale of Bexxar, as well as the “Factors Affecting Our Operating Results, Our Business and Our Stock Price,” described in Corixa’s Annual Report on Form 10-K for the year ended December 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
COPYRIGHT 2008 Gale, Cengage Learning
