CollaGenex Pharmaceuticals Settles West-ward Patent Infringement Case.Business Editors/Health/Medical Writers NEWTOWN, Pa.--(BUSINESS WIRE)--Nov. 10, 2003 CollaGenex Pharmaceuticals, Inc. (Nasdaq:CGPI CGPI Corporate Goods Price Index (Japan) CGPI Capital Goods Price Index (New Zealand) ) today announced that it has settled all pending litigations between CollaGenex and West-ward Pharmaceutical Corporation. CollaGenex sued West-ward and other defendants ("West-ward") in the United States District Court for the Eastern District of New York EDNY redirects here, for other uses see EDNY (disambiguation). The United States District Court for the Eastern District of New York is the federal district court whose jurisdiction comprises the entirety of Long Island (including the portion in New York City) and Staten , alleging that West-ward infringes CollaGenex's patents for Periostat(R) for the treatment of adult periodontitis periodontitis Inflammation of soft tissues around the teeth (see tooth). Poor dental hygiene leads to deposition of bacterial plaque on the teeth below the gum line, irritating and eroding nearby tissues. . CollaGenex's complaint also alleged that West-ward infringed CollaGenex's patent rights under the Hatch-Waxman act by submitting an Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar ("ANDA ANDA abbr. abbreviated new drug application ") with the Food and Drug Administration, seeking FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval to market a generic capsule version of Periostat(R). In a separate action in the United States District Court for the District of Columbia The United States District Court for the District of Columbia is the United States District Court that hears cases originating in the District of Columbia over which federal courts have original jurisdiction. , CollaGenex sought and, on July 23, 2003, was granted a preliminary injunction preventing the FDA from approving generic versions of Periostat(R), including West-ward's version. West-ward intervened in that case. "We are pleased to resolve these disputes with West-ward," said Brian M. Gallagher, Ph.D., chairman, president, and chief executive officer of CollaGenex. "The settlement, which followed extensive pre-trial activities, eliminates the need to devote substantial financial resources and management time to completing discovery and preparing for the trial of the West-ward case." In the settlement, West-ward agreed and confessed to judgment that CollaGenex's Periostat(R) patents are valid and infringed by the filing of West-ward's ANDA. West-ward also agreed and confessed to judgment that CollaGenex's Periostat(R) patents would be infringed by the manufacture and sale of a generic version of Periostat(R). West-ward consented to a Judgment enjoining en·join tr.v. en·joined, en·join·ing, en·joins 1. To direct or impose with authority and emphasis. 2. To prohibit or forbid. See Synonyms at forbid. West-ward and any party acting in concert with West-ward from making and selling a generic version of Periostat(R) until CollaGenex's patents expire or are declared invalid or unenforceable by a court of competent jurisdiction. Finally, West-ward agreed to withdraw from the FDA case in the District of Columbia District of Columbia, federal district (2000 pop. 572,059, a 5.7% decrease in population since the 1990 census), 69 sq mi (179 sq km), on the east bank of the Potomac River, coextensive with the city of Washington, D.C. (the capital of the United States). . CollaGenex agreed to pay a portion of West-ward's actual legal expenses in the amount of $700,000. In keeping with generally accepted accounting principles The standard accounting rules, regulations, and procedures used by companies in maintaining their financial records. Generally accepted accounting principles (GAAP) provide companies and accountants with a consistent set of guidelines that cover both broad accounting , a charge of approximately $0.06 per basic and diluted share will be recorded in the third quarter of 2003. Accordingly, net income allocable to common stockholders during the third quarter of 2003, previously announced in the Company's October 28, 2003 earnings release, will be adjusted to reflect this charge, and earnings per share will be adjusted to $0.07 per basic share and $0.06 per diluted share. The Company's financial statements for the third quarter of 2003 will be filed on Form 10-Q with the United States Securities and Exchange Commission on or about November 14, 2003. Paul Lubetkin, senior vice president and general counsel of CollaGenex, noted that, "West-ward's recognition of CollaGenex's intellectual property rights and agreement to be enjoined from marketing a generic version of Periostat(R) is a 'significant acquiescence of CollaGenex's rights in the industry,' which is a factor weighing in favor of CollaGenex if, for example, the Company seeks an injunction against other generic drug companies attempting to manufacture and sell Periostat(R)." CollaGenex has separately sued United Research Laboratories/Mutual Pharmaceuticals Company (Mutual) in the United States District Court for the Eastern District of New York, claiming that Mutual infringes the claims of CollaGenex's Periostat(R) patents. Mutual has sued CollaGenex in the United States District Court for the Eastern District of Pennsylvania The United States District Court for the Eastern District of Pennsylvania is one of the original 13 federal judiciary districts created by the Judiciary Act of 1789. It originally sat in Independence Hall in Philadelphia as the United States District Court for the District of , alleging that CollaGenex engaged in tortuous and anticompetitive an·ti·com·pet·i·tive adj. That discourages competition among businesses: anticompetitive foreign trade restrictions. behavior to prevent Mutual from commercializing a generic version of Periostat(R). Mutual has also intervened the FDA action in the United States District Court for the District of Columbia. In addition, CollaGenex on July 14, 2003 submitted a Citizen Petition to the FDA requesting that it refuse to approve any generic version of Periostat(R), submitted by Mutual on the ground that the bioequivalence bioequivalence /bio·equiv·a·lence/ (-e-kwiv´ah-lens) the relationship between two preparations of the same drug in the same dosage form that have a similar bioavailability. studies Mutual submitted are insufficient to show that the Mutual product is bioequivalent bi·o·e·quiv·a·lent n. A value indicating the rate at which a substance enters the bloodstream and becomes available to the body. to Periostat(R). The FDA has not reached a decision on CollaGenex's Citizen Petition. The resolution of the West-ward cases does not resolve any of the pending Mutual litigations or administrative proceedings. "CollaGenex will vigorously enforce its patent rights against all those who infringe or state their intention to infringe those rights. We will continue to pursue any unauthorized use of our intellectual property, seek the enforcement of our rights, and protect the Company against any infringing party's tactics. In addition, we remain committed to the development of our once-daily formulation of Periostat(R) and are working towards expanding the Periostat(R) franchise for applications in dermatology," concluded Dr. Gallagher. CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical company currently focused on providing innovative medical therapies to the dental and dermatology markets. Currently, the Company's 115-person professional dental pharmaceutical sales force markets Periostat(R), which is indicated as an adjunct to scaling and root planing The objective of scaling and root planing, otherwise known as conventional periodontal therapy, is to remove or eliminate the etiologic agents which cause inflammation: dental plaque, its products and calculus,[1] for the treatment of adult periodontitis. Periostat(R) 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 sales force also promotes Vioxx(R), a Merck & Co. drug that CollaGenex co-promotes for the treatment of acute dental pain; Pandel, a prescription, topical corticosteroid corticosteroid /cor·ti·co·ster·oid/ (-ster´oid) any of the steroids elaborated by the adrenal cortex (excluding the sex hormones) or any synthetic equivalents; divided into two major groups, the glucocorticoids and licensed from Altana, Inc.; Sirius Laboratories' AVAR(TM) product line for the topical control of acne vulgaris, rosacea and seborrheic dermatitis; and Atridox(R), Atrisorb(R) FreeFlow(TM) and Atrisorb-D FreeFlow, Atrix Laboratories Inc.'s products for the treatment of adult periodontitis. Research has shown that certain unique properties of the tetracyclines Tetracyclines Definition Tetracyclines are medicines that kill certain infection-causing microorganisms. Purpose Tetracyclines are called "broad-spectrum" antibiotics, because they can be used to treat a wide variety of discovered during the development of Periostat(R) may be applicable to other diseases involving inflammation and/or destruction of the body's connective tissues, including acne, rosacea, meibomianitis and cancer metastasis, among others. CollaGenex is further evaluating Periostat(R), as well as the new IMPACS IMPACS Institute for Media, Policy and Civil Society IMPACS Integrated Manufacturing Planning and Control System IMPACS International Message and Packet Switching Service (R) compounds, to assess whether they are safe and effective in these applications. In addition, CollaGenex has licensed the Restoraderm(TM) technology, a unique, proprietary dermal dermal /der·mal/ (der´mal) pertaining to the dermis or to the skin. der·mal or der·mic adj. Of or relating to the skin or dermis. 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. This press release contains forward-looking statements within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended. Investors are cautioned that forward-looking statements involve risks and uncertainties, which may affect the Company's business and prospects. The Company's business of selling, marketing and developing pharmaceutical products is subject to a number of significant risks, including risks relating to the implementation of the Company's sales and marketing plans for Periostat(R) and other products that the Company markets, the outcome and consequences of the patent litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. against Mutual and the outcome of litigation initiated by Mutual, risks that the FDA will approve generic products, such as Mutual's products, that will compete with and limit the market for Periostat(R), risks inherent in research and development activities, risks associated with conducting business in a highly regulated environment and uncertainty relating to clinical trials of products under development, all as discussed in the Company's periodic filings with the U.S. Securities and Exchange Commission. Periostat(R), IMPACS(R) and Metastat(R) are registered trademarks, and Restoraderm(TM) is a trademark, of CollaGenex Pharmaceuticals, Inc. All other trade names, trademarks or service marks are the property of their respective owners and are not the property of CollaGenex Pharmaceuticals, Inc. or any of our subsidiaries. Pandel(R) is a trademark of Taisho Pharmaceuticals. VIOXX(R) is a trademark of Merck & Co., Inc. AVAR(TM) is a trademark of Sirius Laboratories, Inc. Atridox(R) and Atrisorb(R) are registered trademarks, and FreeFlow(TM) is a trademark, of Atrix Laboratories, Inc. |
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