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Executive Summary

Newport Pharmaceuticals' is preparing three new Isoprinosine (inosiplex) clinical studies involving 2,000 patients worldwide with AIDS-related complex to supplement clinical data compiled for an NDA rejected earlier by FDA. In its recently released 1986 annual report, Newport said it plans "to conduct three major clinical studies, one in the U.S. and two in conjunction with our licensees in Australia and Scandinavia." The studies will include 1,400 patients who are currently asymptomatic but HTLV-III seropositive (700 in Australia and 700 in Scandinavia) and 600 patients who present the signs and symptoms of AIDS-related complex or pre-AIDS (200 in the U.S., 200 in Australia and 200 in Scandanavia). "This large patient population," Newport predicted, "should prove to be definitive in evaluating the effect of Isoprinosine versus placebo at various stages of the disease." The company had filed an NDA in September 1985 for the use of Isoprinosine in the Treatment of persistent generalized lymphadenopathy and AIDS-related complex, conditions prodromal to AIDS. Last February, however, FDA told the firm the NDA was not approvable as submitted and that certain deficiencies needed to be corrected ("The Pink Sheet" Feb. 24, T&G-6). The firm has marketing arrangements covering the sale of inosoplex in 133 countries. Newport said the drug is marketed in only 80 of these countries for treatment of viral infections and immunodeficient conditions. Isoprinosine is approved in New Zealand for treatment of AIDS and pre-AIDS conditions, and in the Philippines for treatment of diseases etiologically correlated to AIDS. In addition to research on Isoprinosine and its analogs, Newport is also investigating a series of new pharmaceutical compounds. In a recent 10-K filing with the Securities and Exchange Commission, Newport reported that under an agreement with the Sloan-Kettering Institute for Cancer Research, the company co-owns compounds designated as the "NPT-1500 Series" and the "NPT-1600 Series." Newport said the compounds have "demonstrated immunopharmacological and antiviral activity in preliminary testing." Under the 1978 agreement, Newport will have exclusive worldwide rights to develop any commercial products from the compounds, "subject to Sloan-Kettering's right to receive 4% of net sales of the products, 25% of license fees and 50% of royalties received by the company from third party licensees." Preliminary data on the immunomodulating agent, NPT-16416, indicate that the compound "may be used to enhance the effectiveness of vaccines," Newport stated. The company said the compound is in preclinicals in the U.S. and an IND has not yet been submitted. Newport also has agreements with the Chinese Academy of Medical Sciences Cancer Institute in Beijing, China, and the University of Texas M. D. Anderson Hospital for research and licensing rights to two Chinese herbs, Astragalus Membranaceus and Ligustrum Lucidum. The company said the herbs "appear to have immunoenhancing properties" according to current work being done at the institute in China. The herbs are in the preclinical phase in the U.S.

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