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SCHERING's FIRST CEPHALOSPORIN IS LICENSED FROM SHIONOGI; ORAL PRODUCT SCHEDULED TO BEGIN PHASE IIs "SOON," WITH 1989 NDA FILING PROJECTED

Executive Summary

Schering-Plough is licensing its first cephalosporin antibiotic, designated SCH 39720, from the Japanese firm Shionogi under an agreement announced July 13. "The new, orally active cephalosporin has broad spectrum antibacterial activity, extended safety and excellent bioavailability," the company said. "It is expected to become an important new antibiotic for the treatment of upper and lower respiratory tract infections and urinary tract infections, and to be particularly useful in treating otitis media." An IND for the drug was filed June 30 and Phase II trials are expected to begin "soon," the firm reported. An NDA filing is projected for sometime in 1989. The agreement gives Schering exclusive worldwide marketing rights except in Japan and certain Far East countries. Shionogi will manufacture the drug and has retained comarketing rights in those countries exclusive to Schering, the release notes. Schering becomes the second research-based U.S. firm to announce the licensing of a Japanese cephalosporin product during 1987. In February, Upjohn acquired the U.S. rights to a wide-spectrum antibiotic, CS-807, from Sankyo. Currently, Schering's antibiotic line is dominated by aminoglycosides -- Garamycin, now off patent, and Netromycin. At a recent security analyst presentation, the company also noted the development of a third aminoglycoside, isepamicin. "We expect to introduce it next year in Japan, which is the world's second largest market for antibiotics," Chairman Robert Luciano observed. Sales of anti-infectives, which are grouped with anticancer products in Schering's product organization scheme, were up 21% in the first six months of 1987 to $130 mil., the company reported. Anticancer products include Eulexin (flutamide), for treatment of prostatic cancer, and Intron A (alpha interferon). The NDA for Eulexin is still pending in the U.S. The product is available outside the U.S. in more than 20 countries. Luciano noted improved prospects for Eulexin, pointing out that Schering scientists recently met with FDA to review a 617-patient clinical study with flutamide in combination with the LHRH agonist leuprolide (TAP's Lupron) conducted by the National Cancer Institute. "The combination therapy resulted in a lessening of the 'disease flare,' which usually occurs after the start of LHRH monotherapy, and an extension of the time to progression of the disease," he reported. Schering has said in the past that the concomitant study is likely to be key to FDA approval. By year end, the company expects to receive FDA approval for Intron A as a treatment for venereal warts, a disease affecting over 1 mil. people in the U.S. Recombinant alpha interferon is currently approved in the U.S. for hairy cell leukemia, and internationally for additional cancer indications including malignant melanoma, non-Hodgkin's lymphoma, multiple myeloma and Kaposi's sarcoma. At the same time it is studying additional anticancer and antiviral applications for Intron A, Schering is continuing to spend aggressively in the biotech area. Luciano noted that of the company's budgeted $240 mil. for R&D in 1987, about 20%, or close to $50 mil. has been earmarked for biotechnology. From the biotechnology effort, Schering has two products about to enter the clinic. Granulocyte macrophage colony stimulating factor, scheduled for Phase I in September, "has shown promise in the treatment of infectious diseases, immunodeficiencies, and the side effects of radiation in cancer therapy," Luciano said. Interleukin-4, slated for clinicals in the spring of 1988, "has the potential for the treatment of infectious diseases, a variety of immunodeficiencies and, possibly, several cancers," he added.
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