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THERATECH TRANSDERMAL NITROGLYCERIN ANDA PREPARED

Executive Summary

THERATECH TRANSDERMAL NITROGLYCERIN ANDA PREPARED as of Dec. 29 and is ready for submission to FDA by early January. In a Nov. 30 prospectus for TheraTech's recently completed secondary offering, the firm said it has granted worldwide marketing rights for the angina treatment to "a privately held European company with sales of less than $100 mil." If approved, the nitroglycerin patch could be the Salt Lake City drug delivery start-up's first product in the U.S. TheraTech completed the secondary offering on Dec. 18, netting a total of $18.9 mil. from the sale of 1.4 mil. shares at $14 per share. The firm plans to devote $5-$7 mil. of the proceeds to R&D and $3-$5 mil. for new research and manufacturing facilities. With the completion of the secondary offering, TheraTech ends 1992 having raised more than $27 mil. during the year. The company went public on May 13, netting $8.3 mil. through the sale of 1.3 mil. shares at $7.50 per share. On Nov. 11, the firm received another $1 mil. via the sale of 93,024 shares to SmithKline Beecham's S.R. One venture capital arm. Prior to 1992, TheraTech had raised about $8 mil. through private financings since its founding in January 1985. The company's first corporate investor was Pfizer, which purchased a 600,000 share stake (now 6% of the company) in February 1987. Solvay purchased 683,000 shares in November 1988. Except for S.R. One, TheraTech has no venture capital investors. TheraTech's first full NDA is expected to be for a testosterone transdermal patch for treatment of hypogonadism in males 20 to 65 years old. The condition affects up to 5% of that population, Theratech said. The patch is currently in Phase III trials that are forecast to conclude in 1993. An NDA "is expected to be filed by mid-1994," the prospectus states. TheraTech began additional Phase I studies for the testosterone patch in men over the age of 65 in 1992. Long-term studies in that population for possible indications including osteoporosis and muscle wasting will begin in 1993 with funding support from the National Institutes of Health, the prospectus states. The prospectus asserts that TheraTech's patch will have an advantage over Alza's Testoderm, for which an NDA is pending at FDA, because it can be applied to "normal skin sites" rather than the scrotum. TheraTech was granted a patent for transdermal administration of testosterone through non-scrotal skin in October 1992, the prospectus states. TheraTech has partners for the testosterone patch in Spain, Portugal and Scandinavia and is "currently negotiating marketing rights for the remainder of the world with several multinational companies," the prospectus notes. Other compounds under development by TheraTech include a Phase II transdermal estradiol patch licensed to Solvay. "The company expects to submit an NDA in the U.S. for its estradiol matrix patch in late 1994," the prospectus says. A transdermal system for pain management is in Phase I. The patch delivers an undisclosed proprietary Syntex drug, under development pursuant to a September 1991 deal ("The Pink Sheet" Sept. 9, 1991, T&G-5). Earlier-stage candidates include cardiovascular drugs under development in collaboration with Pfizer and Procter & Gamble Pharmaceuticals. Theratech also is developing a polymer matrix oral drug delivery system, an oral mucosal system for delivery of large molecules, an orally delivered colonic targeting technology and a long-acting injectable delivery system, the prospectus states.
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