National Cancer Institute, Research Contracts Branch, PSAS, 6120 Executive Blvd, EPS/Room 638, Bethesda, MD 20892-7227

66 -- MIFEPRISTONE & MATCHING PLACEBO TABLETS SOL RFQ-NCI-90170-NR DUE 090299 POC Marsha Gorham, Purchasing Agent & Todd Cole, Contracting Officer The National Cancer Institute (NCI), Division of Cancer Treatment and Diagnosis (DCTD), Cancer Therapy Evaluation Program (CTEP), Pharmaceutical Management Branch (PMB) plans to procure a batch of 6,000 mifepristone 200 mg tablets and a batch of 4,500 matching placebos for mifepristone 200 mg tablets from Exelgyn Laboratories, 6 Rue Christophe Colomb, Paris, France 75008. The Pharmaceutical Management Branch requires mifepristone and matching placebo tablets for an ongoing clinical trial, "SWOG-9005: Double Blind Randomized Trial of the Anti-Progestational Agent Mifepristone in the Treatment of Unresectable Meningioma." Patients enrolled in this clinical trial have failed standard therapy and are enrolled in this clinical trial to determine the efficacy of mifepristone in stabilizing or curing meningioma. Because the DCTD study is ongoing and has previously utilized Exelgyn tablets, the integrity of the available data (due to varying absorption rates between products) may be affected if the tablets are not purchased through Exelgyn. Additional variables, such as differing absorption rates between mifepristone tablets, cannot be introduce into the study. Since Exelgyn mifepristone and matching placebo tablets have been utilized from the outset of the aforementioned study, Exelgyn is only source known to NCI that can meet all of the above requirements, particularly the same absorption rate. This is not a request for competitive quotation. However, if any interested party believes it can perform the above requirement, it may submit a statement of capabilities. The statement of capabilities and any other furnished information must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform this requirement. Capability statements must be received in the contracting office by 3:00 p.m. EST, on September 2, 1999. If you have any questions, please contact Marsha Gorham, Purchasing Agent (301)402-4509. A determination by the Government not to compere this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Posted 08/16/99 (W-SN368069). (0228)

Loren Data Corp. http://www.ld.com (SYN# 0326 19990818\66-0005.SOL)