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Executive Summary

FIDIA PHARMACEUTICAL HAS AT LEAST TWO DRUGS IN PHASE II CLINICALS, Cronassial for the treatment of peripheral neuropathies, and monosialoganglioside GM[1] to enhance recovery of central nervous system damage due to stroke and for potential use in spinal cord injuries. The Phase II Cronassial trials are expected to be completed by the end of 1985. Six studies are currently ongoing. The firm asserts that Cronassial, "an injectable form of highly purified gangliosides, is among the world's top 200 products and is the leading peripheral neuropathy product in Italy." Established in July, Fidia Pharmaceutical, based in Washington, D.C., is a whollyowned subsidiary of the Italian firm Fidia, S.p.A. In a Nov. 22 press release, the Italian company explained that formation of the U.S. unit is part of its effort "to establish reference points on important foreign markets." Fidia S.p.A. explained in the press release that the objectives of the affiliate are to "encourage clinical research and coordinate clinical investigations" and to "provide for regulatory development of Fidia's original drugs; in particular to proceed to submission of NDAs for the products in development." The U.S. affiliate is headed by the parent's former clinical data center director Danilo Casadei Massari. As president of the U.S. unit, Massari heads a staff of nine, including two VPs. The staff will expand to 12 during 1985. The 35-year old parent, Fidia S.p.A., is primarily involved in neurologic drugs for use in cardiology, wound healing and arthritis. The company noted that other products in the pipeline for IND submissions in the U.S. are phosphatidylserine for the treatment of "brain organic syndrome" and hyaluronic acid. The firm added it is developing a "specific fraction of hyaluronic acid, obtained by an innovative process, for the intra-articular treatment of human degenerative joint disease." Fidia S.p.A. stated that "the considerable research interest in the U.S.A. in these new leads warranted the direct involvement and investment represented" by the new affiliate.

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