Coulter Pharmaceutical and SmithKline Beecham Announce FDA Notification On License Application for Bexxar.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. and PHILADELPHIA, Penn.--(BW HealthWire)--August 30, 1999--Coulter Pharmaceutical, Inc. (Nasdaq:CLTR CLTR China Liver Transplant Registry CLTR CPPU (Constant Pressure Power Uprate) Licensing Topical Report (nuclear) ) and SmithKline Beecham (NYSE NYSE See: New York Stock Exchange :SBH SBH State Bank of Hyderabad (India) SBH Small Business Hawaii (non-profit business advocacy organization) SBH Sequencing By Hybridization SBH St Barthelemy, Guadeloupe (Airport Code) ) 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 requested modifications to the Biologics License Application (BLA BLA abbr. Bachelor of Liberal Arts ) for Bexxar(TM) (tositumomab, iodine I 131 tositumomab) submitted for marketing approval for the treatment of relapsed or refractory low-grade or transpartners and the FDA towards an expeditious acc exciting new product." Coulter Pharmaceus based upon two drug development programs: therapeutic antibodies and targeted oncologics. The company's most advanced product candidate is Bexxar(TM), a monoclonal antibody conjugated to a radioisotope radioisotope: see radioactive isotope. Radioisotope (biology) A radioactive isotope used in studying living systems, such as in the investigation of metabolic processes. . Initial efforts in the targeted oncologics program are focused on the development of a tumor-activated peptide pro-drug version of doxorubicin to potentially treat certain solid tumor cancers. The company's therapeutic antibody program includes an antibody-based approach to block the Type I interferon receptor for the treatment of autoimmune diseases and transplanham -- one of the world's leading healthcare companies -- discovers, develops, manufactures and markets pharmaceuticals, vaccines, over-the-counter medicines and health-related consumer products. For company information, visit SmithKline Beecham on the World Wide Web at http://www.sb.arkets Hycamtin(R) (topotecan hydrochloride), Kd in this news release are forward-looking statements for Coulter Pharmaceutical, Inc. that involve risks and uncertainties, including uncertainties related to product development, uncertainties related to the need for regulatory and othes and Exchange Commission (SEC). In particular, see "Risk Factors" in the company's filed Form 10-K for the year ended December 31, 1998. Under the safe harbor provrially from those projected. Factors that may affect the company's operations are discussed in Exhibit 99 to the company's Annual Report on Form 20-F for 1998, filed with the U.S. Securities and Exchange Commission. |
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