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SYNTEX' TORADOL INJECTABLE NDA TO BE FILED THIS MONTH

Executive Summary

SYNTEX' TORADOL INJECTABLE NDA TO BE FILED THIS MONTH, Syntex President Paul Freiman reported May 7 at the Goldman Sachs annual health care seminar in New York. "We've already submitted the NDA for the tablet last December and this month we will be submitting our injectable NDA," the exec stated. The company views the two formulations of the non-narcotic analgesic as complementary and a potential marketing asset. Discussing the results of a recent market survey, Freiman said "the thing doctors really like about it is the fact that they can use one chemical entity in the hospital in an injectable form and in a tablet as a subsequent followup." Among Toradol's (ketorolac) other advantages, according to Freiman, are its potential for use in head injuries and respiratory depression. The chemical structure also lends itself to a wide variety of formulations including suppositories, patches, ophthalmic solutions and topical agents. "We think that in this cost-conscious world, a product like ours, which will not be cheap but will be cost effective, is going to be very widely accepted," Freiman predicted. The company estimates the current world analgesic market at over $3 bil., growing in the near term to $4-5 bil. Four other Syntex agents are currently under review at FDA: Cardene (nicardipine), a calcium channel blocker licensed from Yamanouchi; Gardrin (enprostil), a prostaglandin for treatment of duodenal and gastric ulcer; Cytovene (ganciclovir), an orphan product for treatment of cytomegalovirus in immunocompromised patients; and nafarelin, an LHRH analog for treatment of endometriosis and prostatic cancer. Freiman also mentioned a potential cardiovascular application for Gardrin that the company is pursuing. "One coincidental finding . . . is that in doing blood studies in people taking enprostil, we saw a cholesterol lowering take place in normal people with normal cholesterol," he said. "It was a reasonably significant drop and we've instituted some major studies now in people with hypercholesteremia to find out if this can be translated into a claim or a product." The Syntex exec also indicated that the company's fiscal 1987 (ended July 31) volume would be in excess of $1 bil. "We are estimating that our R&D will represent 15.5% of our total sales for fiscal year 1987, and our investment will be $175 mil.," he stated.
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