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CollaGenex Pharmaceuticals Announces USPTO Schedules Date for Issuance of Additional Oracea Patent
Monday, June 04, 2007
Newtown, PA -- CollaGenex Pharmaceuticals, Inc. (Nasdaq: CGPI) today announced that the U.S. Patent and Trademark Office (USPTO) has informed the Company that its patent application No. 11/061,866, covering Oracea®, will issue on June 19, 2007 as Patent No. 7,232,572 (the "572 Patent"). This patent covers the use of tetracyclines in a sub-antibiotic amount, including Oracea, specifically for the treatment of papules and pustules associated with rosacea. The USPTO issued a notice of allowance of this application in February 2007. CollaGenex received FDA approval for Oracea in May 2006 and is currently marketing Oracea to the U.S. dermatology community.
Colin W. Stewart, president and chief executive officer of CollaGenex, stated, "We are very pleased that an issue date for the ‘572 Patent has been scheduled by the USPTO. This patent considerably strengthens the intellectual property around Oracea and complements the recently issued patent No. 7,211,267, which covers the use of sub-antimicrobial amounts of tetracyclines to treat various forms of acne and acne rosacea. The primary additive value of the ‘572 Patent is that the claims of this patent reflect the language of the FDA-approved Oracea indication, which is the treatment of ‘inflammatory lesions (papules and pustules) of rosacea.’ Both the ‘267 and the ‘572 patents are not due to expire until April 2022."
CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical company currently focused on developing and marketing proprietary, innovative medical therapies to the dermatology market. In July 2006, CollaGenex launched Oracea®, the first FDA-approved systemic product for the treatment of rosacea. CollaGenex’s professional dermatology sales force also markets Pandel, a prescription topical corticosteroid licensed from Altana, Inc., Alcortin® (1% iodoquinol and 2% hydrocortisone), a prescription topical antifungal steroid combination, and Novacort® (2% hydrocortisone acetate and 1% pramoxine HCl), a prescription topical steroid and anesthetic. Alcortin and Novacort are marketed by the Company under a Promotion and Cooperation agreement with Primus Pharmaceuticals, Inc. CollaGenex is conducting two Phase II dose-finding studies to evaluate its second dermatology candidate, incyclinide, for the treatment of acne and rosacea, respectively. CollaGenex is also conducting Phase II clinical trials to evaluate COL-118, a topical compound based on the SansRosa technology, for the treatment of redness associated with rosacea and other skin disorders. CollaGenex recently acquired the rights to develop and commercialize becocalcidiol, a patented Vitamin D analogue developed by QuatRx Pharmaceuticals Company that is currently in Phase II clinical trials for the topical treatment of mild to moderate psoriasis.
Research has shown that compounds can be created by chemically modifying certain tetracyclines and that these new compounds have properties that may make them effective in treating diseases involving inflammation and/or destruction of the body's connective tissues. CollaGenex is evaluating various chemically modified tetracyclines (so called "IMPACS" compounds because they are Inhibitors of Multiple Proteases And CytokineS) to assess whether they are safe and effective in these applications. The Company has a pipeline of innovative product candidates with possible applications in dermatology and other disease states. In addition, CollaGenex has acquired the SansRosa technology, which consists of a class of compounds that have shown promise in reducing the redness associated with rosacea, and the Restoraderm® technology, a unique, proprietary dermal drug delivery system. CollaGenex plans to leverage these platforms to develop a range of topical dermatological products with enhanced pharmacologic and cosmetic properties.
To receive additional information on the Company, please visit our Website at www.collagenex.com, which does not form part of this press release.
Statements in this press release regarding management’s future expectations, beliefs, intentions, goals, strategies, plans or prospects, including statements relating to the Company’s plans to develop becocalcidiol and its future research and development efforts relating to Oracea, incyclinide and COL-118 and its dermatology franchise, product pipeline and intellectual, property, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by terminology such as "anticipate," "believe," "could," "could increase the likelihood," "estimate," "expect," "intend," "is planned," "may," "should," "will," "will enable," "would be expected," "look forward," "may provide," "would" or similar terms, variations of such terms or the negative of those terms. Such forward-looking statements involve known and unknown risks, uncertainties and other factors including those risks, uncertainties and factors referred to in the Company’s Annual Report on Form 10-Q for the quarter ended March 31, 2007 filed with the Securities and Exchange Commission under the section "Risk Factors," as well as other documents that may be filed by CollaGenex from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company’s actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. CollaGenex is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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