Executive Summary

DURA PHARMACEUTICALS ABANDONING ITS DEVELOPMENT OF PICUMAST, the company announced Nov. 19. Dura licensed the antihistamine from Boehringer Mannheim in April and hoped then to file an NDA as early as the end of 1992, but the company has decided "not to proceed with the development" of the drug now that its market potential seems less immediate. Boehringer Mannheim filed an NDA for picumast in Germany in 1989, and Dura had planned to file its U.S. NDA based on European data. "Despite the drug's efficacy," Dura explained, "picumast no longer [meets our] development criteria in light of new information from Boehringer Mannheim indicating a potentially longer and more expensive approval process than originally anticipated." Picumast is a once-a-day, nonsedating anti-allergic compound that Dura had planned to promote to respiratory physician specialists as a "unique therapeutic alternative to other antihistamine compounds." Dura's sales force focuses on respiratory physician specialists, who "often prefer to prescribe drugs not widely used by the generalist physicians," and who are more likely to consider prescribing new drugs in the allergy/asthma area that is Dura's niche. The specialty sales force has grown to more than 100 reps. Dura expects to submit a statistical reanalysis of the data from its clinical trials for Pentyde Nasal Spray to FDA by the end of the year. FDA's Pulmonary-Allergy Drugs Advisory Committee voted against approval of Pentyde (pentigetide .5%) for the treatment of seasonal allergic rhinitis at its March 23 meeting amid questions regarding the design and analysis of Dura's two pivotal trials ("The Pink Sheet" March 30, p. 7). Dura is conducting the reanalysis pursuant to discussions with FDA that followed the advisory committee meeting.