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FIVE ALPHA INTERFERON NDAs NOW PENDING AT FDA INCLUDE FOUR FROM SCHERING, ONE FROM ROCHE; SCHERING EXPECTS FURTHER SUBMISSIONS IN NEXT FEW MONTHS

Executive Summary

There are at least five separate NDAs for alpha interferon pending at FDA following recent submissions by Roche and Schering-Plough. At an Oct. 29 analysts' meeting in London, Schering-Plough announced its most recent NDA submission was for use of alpha interferon in the treatment of malignant melonoma. The company previously submitted two alpha interferon NDA applications at the end of 1983, for the treatment of Kaposi's sarcoma and multiple melonoma. Last May, the firm filed an alpha interferon NDA in the antiviral area for the prophylaxis of the common cold. Roche, which began clinical trials in January 1981, approximately one year before Schering, has also reached the NDA stage with its alpha interferon for cancer indications. Like Schering, Roche has tested its interferon in the treatment of Kaposi's sarcoma. The May 5, 1983 issue of the New England Journal of Medicine published a study conducted by Memorial Sloan-Kettering Cancer Center researchers in collaboration with Roche which found that of 12 Acquired Immune Deficiency Syndrome (AIDS) patients completing alpha interferon treatment, three were free of sarcoma symptoms 10 months later, two had tumors that shrank at least 50%, two had tumors that temporarily shrank at least 25% and four showed some tumor regression, Post-Patent Expiration Sales Of Garamycin Have Declined By Almost Half, Schering Says Schering-Plough Chairman, President and CEO Robert Luciano told the London analysts that "a variety of new alpha-2 studies -- moving toward combination therapies, earlier-stage uses, and uses for different indications -- are either underway or in the offing." He said Schering anticipates "filing for approval of several other indications in the months to come." Production of alpha interferon is one of Schering's primary projects. Luciano noted that the company is projecting capital spending of $165 mil., "concentrated in two major pharmaceutical projects -- a new development facility in Kenilworth, N.J., in the U.S., and a new interferon production plant in Ireland, which would be on-stream by mid-1985." Schering Exec VP-Administration Hugh D'Andrade added that company scientists in Union, N.J. "came through with a 40-fold improvement in interferon yields last year, enabling us to reduce our planned outlay for constructing our interferon production facility in Ireland by approximately one-half -- from $106 mil. to $50 mil." With respect to Schering's gamma interferon program with Suntory, D'Andrade said "early evidence suggests that gamma might provide superior activity against solid tumors, as compared to alpha-2 interferon." He noted that Schering is considering studying the compound in combination with alpha-2 in addition to exploring it as a separate entity. He said Schering is now conducting toxicology, formulation and stability studies and expects to begin clinicals in the first quarter of 1985. D'Andrade also noted biotechnology and immunology efforts underway at Schering's DNAX subsidiary. He said DNAX researchers have cloned and expressed a variety of proteins, including interleukin-3. In the allergy field, the firm has produced a binding factor "that regulates the production of the immunoglobulin IgE." He explained that the company's objective is to "identify and characterize substances that will regulate the amount of IgE produced, and thereby prevent the initiation of the allergic response." Among other compounds in development, Luciano mentioned Quazepam, a benzodiazepine sedative hypnotic for the treatment of insomina, which Schering expects to be approved in the U.S. in 1985. FDA's Drug Abuse Advisory Cmte. recommended Quazepam be placed in Schedule IV under the Controlled Substances Act when it reviewed the drug in April 1983. The cmte. concluded that the drug did not show lower abuse potential than other benzodiazepines. Luciano noted that clinical studies of Eulexin, an anti-androgen for the orally administered treatment of prostate cancer, are underway. Studies to evaluate the efficacy of Eulexin alone and in combination with other agents as an alternative to surgery or estrogen therapy include a combination study underway in Canada. Cooperative studies directed by the Natl. Cancer Institute are also scheduled to begin in the U.S. next month, Luciano said. In March, 1983, FDA's Oncologic Drugs Advisory Cmte. reviewed Eulexin data and recommended that an additional study in advanced prostatic cancer should be conducted. Schering-Plough VP-Investor Relations Ralph Golby gave analysts an overview of the company's sales performance by product line. The allergy, asthma, cough/cold products accounted for the largest portion of drug sales, $313 mil. Golby noted that for the first nine months of the year, sals for those products were up 6%. "If foreign exchange rates had been the same this year as they were last, sales would have been up 9%," Golby said. He explained that "as with many internatl. companies in the U.S., the reported results of Schering-Plough have been severely impacted by the unprecedented strength of the U.S. dollar." Golby reported that sales of dermatologics and antibiotics each accounted for $194 mil. in sales. Post-patent expiration sales of Garamycin have declined by almost half, Golby noted. The drug had "sales of over $250 mil. before the U.S. patent expiration" and now "accounts for just over $130 mil." He noted that although Netromycin is selling "very well in overseas markets," the company has been unsuccessful in achieving significant sales in the U.S. Netromycin was introduced in the U.S. in March 1983.

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