CollaGenex Pharmaceuticals Identifies Application for Generic Form of Periostat on Illinois Drug Formulary
Monday May 10, 4:28 pm ET
NEWTOWN, Pa.--(BUSINESS WIRE)--May 10, 2004--CollaGenex Pharmaceuticals, Inc. (Nasdaq:CGPI - News) today announced that it had identified an application by IVAX Corporation to list a generic form of Periostat® (doxycycline hyclate) 20mg tablets on the Illinois Drug Formulary. The application was filed on April 8, 2004 and was listed on the Illinois Drug Formulary on May 7, 2004.
IVAX's generic form of Periostat has not been approved by the United States Food and Drug Administration (FDA). A preliminary injunction was entered in July 2003 that prevents FDA from approving Abbreviated New Drug Applications (ANDAs) for generic versions of Periostat until the Court has finally resolved the issue of whether FDA should have classified Periostat as an antibiotic. The Court's ruling on this issue is not expected to occur until early 2005.
"We have an issued and valid patent covering Periostat until 2007, and we intend to vigorously assert our patent and other legal rights to protect our Periostat franchise," said Colin Stewart, president and chief executive officer of CollaGenex. "The preliminary injunction against the FDA prevents approval of any ANDA for a generic form of Periostat until the Court resolves our case on the merits. Meanwhile, we will pursue all other legal remedies available to us."
CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on providing innovative medical therapies to the dental and dermatology markets. Currently, the Company's professional dental pharmaceutical sales force markets Periostat, which is indicated as an adjunct to scaling and root planing for the treatment of adult periodontitis. Periostat is the first and only pharmaceutical to treat periodontal disease by inhibiting the enzymes that destroy periodontal support tissues, and by enhancing bone protein synthesis. The dental sales force also promotes Atridox®, Atrisorb FreeFlow® and Atrisorb-D FreeFlow®, Atrix Laboratories, Inc.'s products for the treatment of adult periodontitis, to the dental market. The Company's professional dermatology sales force markets Pandel®, a prescription topical corticosteriod licensed from Altana, Inc.
Research has shown that certain unique properties of the tetracyclines discovered during the development of Periostat® may be applicable to other diseases involving inflammation and/or destruction of the body's connective tissues, including acne, rosacea, meibomianitis and cancer metastases, among others. CollaGenex is further evaluating Periostat®, as well as the new IMPACS® compounds, to assess whether they are safe and effective in these applications. In addition, CollaGenex has licensed the Restoraderm® technology, a unique, proprietary dermal drug delivery system, in order to develop a range of topical dermatological products with enhanced pharmacologic and cosmetic properties.
To receive additional information on the Company, please visit our Web site at www.collagenex.com, which does not form part of this press release. |
