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Executive Summary

SIBIA TO WORK WITH UCB ON DEVELOPMENT OF ANTI-EPILEPSY DRUG in the U.S. and Canada under an agreement announced Jan. 4. Under the agreement, La Jolla, Calif.-based SIBIA and the Belgian firm UCB would copromote the agent in North America and would split profits in the countries, given equal promotional effort by SIBIA and UCB. No milestone payments, fees or equity purchases are included in the agreement. The compound, referred to by SIBIA (the Salk Institute Biotechnology/Industrial Associates) as SIB-S1 and by UCB as L-059, will be manufactured by UCB and promoted under a single brand name. Based on UCB's European Phase I and Phase II data, SIBIA expects to file an IND for the compound by 1993 and to begin pivotal Phase II studies before the end of the year, the company said. In Europe, UCB's pharmaceutical division currently is conducting Phase II studies of L-059 for epilepsy and for anxiety. SIBIA is pursuing only the epilepsy indication at this time, although the U.S./Canada agreement covers all potential indications, the U.S. firm said. In Phase I and early Phase II trials, "the drug was extensively tested in normal individuals and patients and shown to be very safe," SIBIA said. In addition, according to SIBIA, the drug "showed significant therapeutic benefit" in Phase II studies of "epileptic patients non-responsive to other anti-convulsant drugs" conducted in Belgium, France and the U.K. SIBIA's brain receptor-specific in vitro assays will be used to investigate whether SIB-S1 has a novel mechanism of action, the company noted. The firm's assays use cloned human receptor genes expressed in mammalian cell lines to gather information on candidate drugs' binding and functional characteristics. SIBIA focuses its research on excitatory amino acid (EAA) receptors, neuronal voltage-dependent calcium channels (VDCCs) and neuronal nicotinic acetylcholine (ACh) receptors. This is the third collaboration this year for SIBIA. The privately held firm signed a three-year research agreement with Ciba-Geigy this fall for the use of its cloned human EAA receptor technology in the development of central nervous system treatments ("The Pink Sheet" Sept. 21, 1992, In Brief). In May, Lilly and SIBIA announced a three-year calcium channel CNS research collaboration ("The Pink Sheet" May 18, 1992, T&G-6).

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