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Executive Summary

ZAMBON SpA WILL COMMIT $ 100 MIL. THROUGH 1999 TO BUILD a U.S. brandname pharmaceutical subsidiary. Zambon Corp. USA was established in October 1988 and officially opened offices in the Meadowlands complex in East Rutherford, N.J. on Sept. 21. The company's goal by the year 2000 is to become an integrated pharmaceutical operation with 1,200 employees and annual sales of $ 250 mil. The U.S. operation has an interim target of $ 20 mil. sales by 1993. The start-up is headed by Herb Grossman, ex-USV exec and formerly president of Physicians World Communications. The company has recruited two ICI researchers for its early development efforts: Joseph Franciosa, VP-R&D, and Robin McGarry, director of cardio-renal clinical research. The official opening of the N.J. facilities coincided with a preliminary in vitro report from a Swiss conference on AIDS treatment strategies which indicates a potential role for an existing active ingredient provided by Zambon, N-acetycysteine. Stanford University scientists reported at the Swiss conference that raising the glutathione level in cells may have a dual effect on AIDS: through an immunomodulating activity and by blocking the replication of the AIDS virus. Zambon's N-acetycysteine (NAC) promotes the formation of the intercellular glutathione. Zambon said it plans "to pursue further investigations into NAC's activity and use in immuno-compromised and related conditions." The company submitted a pre-IND package of information to FDA about two weeks ago. Zambon Group has been assigned patents for the use of NAC in AIDS treatments. NAC is currently available in the U.S. in an aerosol form, marketed by Bristol under the brand Mucomyst. Available overseas in a tablet formulation, it is used as adjuvant therapy for chronic bronchial congestion and for acetaminophen overdose. The preliminary AIDS findings were reported at an AIDS research strategy conference in Geneva by Stanford genetics professor Leonard Herzenberg, PhD. The research by Herzenberg, et al, was conducted with support from Zambon at the Stanford University Hospital Zambon Cellular Diagnosis Research Lab. The Herzenberg lab is also supported by the National Institutes of Health. "Our studies show we can block the TNF [Tumor Necrosis Factor] activation of HIV with increased thiol levels in models of HIV-infected cells," Herzenberg stated in a press release. "We proposed that by administering NAC we can augment thiol levels, and neutralize TNF activity and production which will slow or stop the virus from going into an active stage." Herzenberg cited the current AIDS research theory that the activation of TNF sets off the cycle which activates the dormant AIDS virus. Zambon Corp. USA expects to place eight compounds in clinical development by 1993. In 1990, Zambon plans to file four INDs, including the AIDS use for NAC. By the year 2000, the U.S. operations project 16 INDs and 14 NDAs will be ready for submission to FDA. The firm's lead compounds are ibopamine, an intropic agent for congestive heart failure; Monuril (fosfomycin trometamol), a single dose antibiotic for uncomplicated urinary tract infections; and broxaterol, a beta agonist for asthma. Zambon is analyzing ibopamine data received from SmithKline, from which the company regained rights last year. The drug was in Phase III studies at SmithKline. The company is beginning neurohormonal and hemodynamic studies in preparation for their own Phase III trials, a spokesperson said. In conjunction with its ibopamine research effort, the Zambon Cardiorenal Physiology and Pharmacology Research Lab is being established at Mt. Sinai. An IND filing for Monuril is scheduled for the fourth quarter, the company said. Zambon is in early stage development of a transdermal patch for broxaterol using Hercon's patch technology. An IND for the patch form is slated for the first quarter of 1990. For asthma, the company is working on two mast cell inhibitors, and hopes to file an NDA on one of them "by mid-1991." Z-1819 is in Phase I in Europe. The firm's "next stage technologies" for asthma include a Platelet Activating Factor (PAF) inhibitor and a leukotriene inhibitor, for which the company is looking for licensing interest.

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