Topiglan MacroChem.

Abstract

MacroChem is developing Topiglan, a topical gel containing prostaglandin E1 (PGE1 or alprostadil) and its patented through-the-skin absorption enhancer excipient (SEPA), for the potential treatment of erectile dysfunction. By September 2000, it was in phase III clinical trials [382682]. By October 2000, MacroChem expected to file an NDA for Topiglan in late 2002 [387433]. In January 2002, at the JP Morgan Hambrecht & Quist 20th Annual Healthcare Conference in San Francisco, CA, MacroChem stated that further phase III studies were planned, including a reformulation that could reduce initation and increase dosage, as well as providing new packaging that improves dose consistency These studies should be underway by the third quarter of 2002, with a potential launch in late 2003 or early 2004 [436390]. The company's patented SEPA technology used in Topiglan is an absorption enhancer for transdermal delivery that has the potential to effectively increase the passage of therapeutic agents through the skin. The application of SEPA alone to the skin of carcinogenic-sensitive rats did not cause the development of tumors attributable to the SEPA [357621]. The company received a US notice of allowance of all patent claims covering Topiglan in February 1999. The patent (US-05942545) was issued in August 1999 [316028], [337720]. Further patent applications are pending in Canada, Europe and Japan [337720]. In February 2000, MacroChem filed further patent applications in 13 countries in Europe, Asia and Latin America and with the EPO [355947].