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IDEC's SPECIFID "PANEL" OF 14 ANTI-IDIOTYPE ANTIBODIES

Executive Summary

IDEC's SPECIFID "PANEL" OF 14 ANTI-IDIOTYPE ANTIBODIES is estimated to react with tumors in approximately 25% of patients with B-cell lymphomas, the biotech firm said in a recent preliminary prospectus for an initial public offering. IDEC Pharmaceuticals has selected 14 antibodies for commercial development from among the most cross-reactive of the anti- idiotype antibodies it previously custom manufactured for individual patients; the 14 "anti-ids" compose the Specifid panel. For patients whose tumors are cross-reactive with a Specifid antibody, IDEC believes "the ability to inventory the panel permits expedited and less costly treatment." The "immediate availability" of the panel anti-ids, in contrast to the customized versions, also has "made possible the application of Specifid antibodies in more diverse clinical situations and in a broader variety of tumor types," the prospectus notes. IDEC describes the panel as a "managable size" but anticipates that newly-created antibodies may be added to the panel or used as replacements if they demonstrate higher levels of cross-reactivity. A "pivotal" Phase III trial in patients with low-grade lymphoma is scheduled for late 1991. The multi-center study in the U.S. and Canada will test Specifid manufactured by Boehringer Ingelheim under terms of an agreement signed in May. BI will be the exclusive manufacturer and supplier of Specifid for a five-year period in exchange for European rights to the product. In addition, the agreement calls for BI to pay royalties and make payments upon FDA and European regulatory approval. IDEC, based in La Jolla, Calif., has previously manufactured the antibodies used in all of its clinical trials. Preliminary results from an IDEC initial Phase III trial involving 13 patients who have completed a full course of Specifid therapy showed that nine experienced tumor shrinkage, IDEC said. In two of the patients, tumors shrank to less than 50% of the pre- treatment volume. Three patients are continuing to experience tumor shrinkage. IDEC anticipates that the rate and extent of tumor remission will increase when Specifid is used in "earlier stage, less aggressive and less bulky disease." Of the 13 patients in the initial trial, seven had intermediate-grade lymphoma and 12 had failed multiple courses of conventional therapy, the firm said. Specifid efficacy will be measured by comparing results with conventional treatments used in case matched controls. A second IDEC licensing agreement signed in May gives the Japanese firm Zenyaku Kogyo rights to certain anti-ids to be used for "therapeutic treatment of B-cell malignancies and autoimmune diseases." Zenyaku will pay $ 2 mil. plus royalties and has acquired a $ 7.5 mil. equity stake in IDEC. The deal represents a reassignment of rights previously held by the Institute of Immunology ("The Pink Sheet" March 5, 1990, T&G-8). The Institute's rights are now limited to diagnostic and monitoring applications of IDEC anti-ids. As a complement to the Specifid panel, IDEC has developed a group of radio-immunoconjugates for use in more aggressive or advanced cases of lymphoma or leukemia. In an ongoing Phase I/II trial, five patients with recurrent lymphomas are receiving IDEC anti-ids conjugated to low doses of yttrium. IDEC is also developing two antibodies -- I Mel- 1 and I Mel-2 -- for treatment of malignant melanoma. The antibodies are intended to prevent or delay relapse following surgical resection of the disease. Phase I trials have been completed for I Mel-1 and are now underway for I Mel-2, the prospectus said. IDEC's proposed 2.5 mil. share offering will supplement the $ 40 mil. the firm has raised since its inception in 1986 through the private placement of preferred stock ($ 20.4 mil.) and R&D agreements with Merrill Lynch/Morgan Stanley and New York Life Insurance worth $ 11.4 mil. and $ 8.5 mil., respectively ("The Pink Sheet" May 2, 1988, T&G-12). The underwriters for the proposed initial public offering are Montgomery Securities, Alex Brown & Sons, and Lehman Brothers. The "majority" of the proceeds from a successful offering will be used to fund pre-clinical and clinical trials and R&D efforts, including associated manufacturing costs, the prospectus said. The remainder will be used for general corporate purposes and "possibly certain capital expenditures." IDEC had an accumulated deficit of approximately $ 17.3 mil. as of March 31.

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