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KODAK/STERLING IN VIVO DIAGNOSTIC R&D PIPELINE HAS 15 PRODUCTS

Executive Summary

KODAK/STERLING IN VIVO DIAGNOSTIC R&D PIPELINE HAS 15 PRODUCTS in clinical trials, with two in the NDA pending stage. According to a chart of the combined Kodak and Sterling drug pipelines prepared for a Nov. 22 presentation to security analysts, the company has collected a broad stable of imaging product candidates from four research sources. One indicator of the range of the Sterling imaging projects is the wide variety of cancers being investigated: the firm currently has imaging agents under study for eight different forms of cancer (see box below). The pending NDA projects are supplemental, new indication NDAs for Omnipaque (iohexol) and an NDA for a NeoRx Tc-99m scanning agent for melanoma screening. The next Sterling radiopharmaceutical NDA filing is likely in the third quarter of 1989 for an Omnipaque followup agent from Nycomed, the nonionic contrast agent iopentol. The indications for iopentol will be angiocardiography and I.V. CT use. Sterling says that Phase III work is almost complete in Europe. The company hopes that "most or all of that data will support" the U.S. NDA. The European sponsor of the product made the first filing for licensing approval of iopentol on Nov. 7 in Norway. To protect its substantial franchise in nonionic contrast media, Sterling is in a heated race against a series of competitors led by Squibb, Medi-Physics, Amersham, DuPont and Berlex. Squibb, for example, is planning an NDA filing for a cardiovascular radiopharmaceutical, Cardiotec, at about the same time as the iopentol filing (see related T&G, above). Omnipaque sales are continuing at a rapid pace: the product appears to have doubled again in 1988 from 1987 levels. Although Sterling did not provide an exact figure for analysts, Winthrop Pharmaceuticals President Henry Shoff reported 1988 sales would exceed $200 mil. after crossing the $100 mil. sales mark in 1987. The primary source of Sterling's R&D pipeline is the Norwegian firm, Nycomed. As per a mid-1987 licensing agreement, Sterling has a 10-year option agreement for Nycomed diagnostic imaging agents. That Nycomed agreement has assumed additional importance with Nycomed's recent acquisition offer for Salutar. Sterling already lists one Salutar project, the development of an organ imaging agent, S-095, in its pipeline. Sterling licensed that compound directly from Salutar ("The Pink Sheet" Nov. 23, 1987, T&G-10). Sterling told analysts that the Salutar compound "should be ready for initiation of clinical trials soon." Through Nycomed, Sterling should have access to another Salutar project, a nonionic contrast media agent for MRI use. That product, S-041, began clinical trials on Nov. 10. Nycomed calls it the first agent of its type. Through previous Kodak agreements, Sterling is also plugged into extensive imaging agent research from NeoRx and Cytogen. Those two start-up firms together have 11 imaging agents in Phase I trials. Table or Chart Omitted
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