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Executive Summary

INTRON (INTERFERON) USE AS GENITAL WART TREATMENT could eventually be one of the product's major applications, Schering-Plough Senior Director Infectious Diseases & Immunology Jonathan Spicehandler, MD, indicated Dec. 4 at a presentation to security analysts. Noting Intron is currently in clinicals for use of genital warts, he pointed out that "there were over one million patient visits to physicians for this condition last year, twice the frequency of visits for genital herpes." Schering-Plough's studies "involve patients with persistent warts, refractory to available therapies, who receive intralesional Intron over a three-week course" of treatment, Spicehandler explained. He referred to one study where "a majority of the Intron-treated patients either completely cleared or markedly reduced the size of their warts, in contrast to the placebo group which demonstrated either no change or exacerbation of their warts." In his presentation, Spicehandler gave an overview of the breadth of Schering-Plough's interferon research. In separate remarks Schering-Plough Chairman and President Robert Luciano defended his firm's commitment to interferon and to biotechnology. "Some people think we've put too many of our eggs in the interferon basket, in spite of the fact that our entire biotechnology effort represents less than a third of our overall research program," Luciano observed. "Be that as it may, I still believe that, to the surprise of some doubters, the interferon basket may turn out to be of pretty good size." However, Luciano declared: "The main point is that we're not aiming at just an interferon basket. It's a recombinant DNA and immunology basket, and it is going to revolutionize medical treatment in the decades ahead, and we expect to be an active participant in the field." In anti-cancer trials to date Intron has proven "highly active" against hairy cell leukemia, Kaposi's sarcoma, non-Hodgkin's lymphoma, and bladder cancer, Spicehandler explained. The drug is "active" against another five cancers, he said, multiple myeloma, malignant melanoma, renal cell carcinoma, Hodgkins disease and ovarian cancer. The three anti-cancer NDAs the firm has filed thus far are for Kaposi's sarcoma, multiple myeloma, and malignant melanoma. A fourth NDA is pending for an intra nasal dosage form for prophylaxis of the common cold. Spicehandler also pointed out that Intron has not demonstrated activity against breast cancer, colon cancer, non-small cell lung cancer and prostate cancer. Of the over 70 hairy cell leukemia patients treated with Intron thus far, Spicehandler reported, "almost all" had increases in homoglobin, white cell, and platelet counts. The Schering exec declared: "This has translated into clinical benefit for over 80% of the patients, as the transfusion requirements of these patients have dropped significantly. We anticipate infections and bleeding complications will also diminish as we continue to follow these patients." Commenting on the common cold prophylaxis studies, Spicehandler presented results from a recent study of 400 patients given either placebo or intranasal Intron daily for a month. The Intron group had a "four fold reduction of the incidence of positive viral cultures" compared to the placebo group, he said. "The most frequent side effects, seen more often with the Intron than the placebo-treated group, were signs and symptoms of nasal irritation consisting of nasal dryness, blood tinged mucus or small nasal erosions, Spicehandler noted. "These side effects were generally mild, transient and often unnoticed by the patient. They frequently resolved with continued therapy." The research exec explained that 3% of Intron patients discontinued treatment v. 1% of placebo patients. He added: "We continue to explore a variety of dosage regimens that will further minimize these side effects."

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