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Onset Therapeutics Announces FDA Submission for Novel Product for Topical Treatment of Genital Warts

Posted on: Thursday, 6 December 2007, 09:01 CST

Onset Therapeutics, a specialty pharmaceutical company that focuses on the development and commercialization of innovative treatments for skin and skin related disorders, announced that it has submitted an application to the Food and Drug Administration (FDA) requesting approval for a product for the topical treatment of external genital warts. The Company has chosen not to disclose the active ingredient at this time.

Onset intends to market this product to dermatologists and select women's health specialists through its field sales force as well as its telesales team. The company currently has 17 sales representatives calling on dermatologists and intends to expand its sales force upon the approval and launch of this and other products in its pipeline.

Genital warts are one of the most common and fastest spreading venereal diseases worldwide. Genital warts are benign but disfiguring and contagious skin tumors in the genital and anal area, which can be difficult to treat. It is estimated that approximately 20 million people in the United States and 15 million people in Europe are infected with human papilloma virus (HPV), and that approximately 80% of females in the United States will have acquired HPV by the age of 50. Certain strains of HPV can cause genital warts. This results in over 1 million cases of genital warts in the US and 32 million cases worldwide each year.

"We believe that this product has the potential to provide some significant advantages to patients with this difficult to treat condition," states Michael Heffernan, President of Onset Therapeutics. "This submission represents a significant milestone for the Company and our efforts to become a leader in topical drug delivery. We look forward to receiving market approval and launching the product."

About Onset Therapeutics

Onset Therapeutics, a wholly owned subsidiary of Collegium Pharmaceutical (www.collegiumpharma.com), is a specialty pharmaceutical company focusing on the development and commercialization of novel, patent protected topical products for the treatment of skin and skin related disorders. The Company's currently marketed products include: Kerafoam® (Urea Foam), Clarifoam™ EF (Sulfacetamide/Sulfur Foam), Optase® (Balsam Peru, Castor Oil, Trypsin Gel) and Paptase™ (Papain/Urea Foam). In addition, Onset has an extensive pipeline of products in development utilizing its proprietary drug delivery formulations. For more information, please visit the company's website at www.onsettx.com.

Source: Business Wire

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