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ASCENT ANTIBACTERIAL UTI AGENT ANDA FOR PEDIATRIC USE

Executive Summary

ASCENT ANTIBACTERIAL UTI AGENT ANDA FOR PEDIATRIC USE, filed June 16, is the company's first product approval application. Ascent Pharmaceuticals claims to use patented and proprietary technologies to "significantly improve products commonly prescribed for the pediatric patient." The company's focus is the reformulation of off-patent drugs to address problems associated with their pediatric use, such as frequent dosing, side effects and toxicity. The unnamed antibacterial for urinary tract infections is one of Ascent's four lead products. A controlled-release analgesic/antipyretic is in early Phase III trials, a transdermal patch is entering Phase II clinicals and a nonsedating antihistamine is in preclinicals, the company said. Other indications for the UTI therapy are also being investigated. Ascent was founded in March 1989 by CEO and President Emmett Clemente, who previously was a regulatory affairs exec at Fisons. Ascent has raised $9.1 mil. in private funding. Initial backing came from Harvard Medical School's venture capital spin-off Medical Science Partners, as well as from Nordic Health Partners and Europa. Burr, Egan and Deleage, Union Carbide and New York Life provided additional funding in a subsequent round of financing. Ascent named Robert Baldini to its board of directors June 7. Baldini is senior VP and general manager of marketing and sales for Schering-Plough's Key Pharmaceuticals. He previously spent 21 years in Ciba-Geigy's Pharmaceutical Division and played a management role in Key's 1986 merger with Schering. Based in Billerica, Mass., Ascent currently employs 12 people. The company intends to market its own products.
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