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XOMA PLANNING TWO THERAPEUTIC MONOCLONAL ANTIBODY PLAs

Executive Summary

XOMA PLANNING TWO THERAPEUTIC MONOCLONAL ANTIBODY PLAs by the end of the first quarter of 1989, Chairman Steven Mendell stated Nov. 30 at a medical conference for analysts in New York sponsored by the Robertson Colman & Stephens investment firm. Mendell said that the firm is planning to file a product license application (PLA) with FDA's Center for Biologics Evaluation & Research for XomaZyme-H65 for use in bone marrow transplantation to treat graft-versus-host disease before the end of the year. Mendell added that "based on the final analysis of the results of the Xomen-E5 septic shock program, we will be filing a PLA with FDA for this product in the first quarter of 1989." Mendell maintained that the two filings represent a "milestone" for both the company and the biotechnology industry. "We will be the first company to file not one but two therapeutic monoclonal antibody products with FDA," he said. Describing the clinical program for Xomen-E5 for septic shock, Mendell said that "we commenced trials in 1986, and over the summer we completed a 500-patient placebo controlled randomized study conducted in over 35 medical centers. This study was the largest prospective study ever conducted in gram negative sepsis." Mendell said that the pivotal Phase III trial for XomaZyme-H65 in graft-versushost disease has been completed recently, and that the company is now studying the product for other immunological disorders. The company is studying the drug for use against rheumatoid arthritis and aplastic anemia. Also, Mendell said, "based on the results of XomaZyme-H65 in bone marrow transplantation, we are expanding the indications and moving into mismatched patients, which is a very, very large market opportunity." In the future, the company also will evaluate the product for use in kidney transplantation, Type I diabetes, lupus, and inflammatory bowel disease.
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