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UPJOHN FILES DERACYN NDA IN NOVEMBER: FIRST OF TWO PRODUCTS AIMED AT ANTIDEPRESSANT USE; XANAX ALSO BEING REVIEWED FOR ADDED INDICATION

Executive Summary

Upjohn's Deracyn (adinazolam mesylate) NDA was submitted to FDA on Nov. 19 initiating the company's two-pronged approach to the antidepressant market. The 441-volume NDA filing is aimed at showing the products's effectiveness against a wide range of depression states, from mild to severe. Upjohn has been testing the triazolobenzodiazepine in humans since 1982 and is highlighting an improved side effect profile, particularly less sedative effects, compared to other antidepressants. Upjohn Senior VP Mark Novitch reported on the Deracyn NDA filing during a discussion of Upjohn human drug research projects at a Dec. 10 meeting with securities analysts in New York. Comparing Deracyn to Upjohn's major anti-anxiolytic product Xanax (alprazolam), Novitch pointed out that Deracyn is a more potent antidepressant. Novitch said that Upjohn hopes to begin participating in the $750 mil. worldwide market for antidepressants within two years. In the U.S., the approval process for antidepressants can be lengthy. Lilly's recently approved Prozac antidepressant is indicative of the type of review period for products in that class. On Dec. 28, FDA approved the Lilly drug after a 4 1/2 year review. Xanax, which has become the leading brand product in the U.S. minor tranquilizer market, is being studied for an additional indication in mild depression. An NDA for that added indication will be filed during 1988. Upjohn is relying on the two products Deracyn and Xanax to be complementary entries into the antidepressant field. Upjohn President Lawrence Hoff noted that the market share for Xanax in the anxiolytic/tranquilizer class was up to 28% in October 1987 compared to 24% in 1986. "Xanax also had 28% of the U.S. market's new Rxs, up from 24% a year ago," Hoff said. While Upjohn is hoping to expand the Xanax market into the antidepressant area, the major new area targeted for growth of that product in is the treatment of panic disorders -- an indication being developed and pioneered by Upjohn. The company submitted an NDA for that indication late last summer ("The Pink Sheet" Nov. 9, p. 11). Novitch told the analysts that Xanax dosing for panic disorders will be more intensive and for longer periods of time than that currently used for anxiety. The starting does for the anxiety use is .25 to .75 mg three times a day. The central nervous system category has become Upjohn's lead business with Xanax and the hypnotic Halcion, which has an even more commanding position in its market segment. Hoff reported a 45% market share, up from 38% in 1986. Halcion has substantial market potential in the nursing home market, Hoff told the analysts. He noted that the over-60 population is a primary use group for hypnotics (with 40% of all prescriptions to that group). However, he pointed out that hypnotic sales to nursing homes represented only about 1.5% of the total $416 mil. sales to that market. Hoff stressed the importance of the growing managed care market to pharmaceutical marketing. His comments on the potential of the nursing home market taken in conjunction with the company's developing stable of CNS products indicate a marketing strategy similar to an approach recently described by Sandoz to blanket the elderly care category ("The Pink Sheet" Dec. 14, p. 5). Both marketing approaches are indicative of the changing market strategies by major drug companies to what Hoff called the "industrialization" of health care and its shift away from a cottage industry. The anti-inflammatory category has dropped to third in importance among Upjohn's Rx business segments, behind metabolic disease (diabetes) and CNS agents. Motrin sales through October were down 17%, Hoff reported. However, he indicated that the company is planning promotional campaigns and "purchasing incentives" to combat further generic inroads. Upjohn is also awaiting NDA approval for a sustained release version of Motrin 800 mg. With a handful of other companies, Upjohn is also anticipating potential FDA action on a pending new chemical entity in the NSAID class. Upjohn's application for flurbiprofen (Ansaid) has been pending for over five years. At least one company is ready to enter the U.S. market with a new NSAID approval: Roche's Rimadyl (carprofen) was approved by FDA on Dec. 31. While waiting for the analgesic/anti-inflammatory application for Ansaid, Upjohn has been developing the product for a separate dental indication. Novitch told the analysts that the company has finished Phase II trials with Ansaid for periodontal disease and has "initiated a multi-center Phase III study in several hundred patients with the disorder." He noted that the only current treatment for that condition is surgery. Chart omitted.
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