Nice:
Thursday September 23, 7:30 am Eastern Time
Company Press Release
CollaGenex Signs Agreement with Merck to Co-Promote Vioxx to
the Dental Market
NEWTOWN, Pa.--(BUSINESS WIRE)--Sept. 23, 1999--CollaGenex Pharmaceuticals, Inc. (Nasdaq: CGPI - news) today announced the signing of a co-promotion agreement with Merck & Co., Inc. of Whitehouse Station, NJ for the co-promotion of Vioxx® (rofecoxib) to the dental market.
Vioxx® is a new prescription strength non-steroidal anti-inflammatory drug (NSAID) that was approved by the U.S. Food and Drug Administration on May 20, 1999. Vioxx® is one of the fastest growing prescription pharmaceuticals in the United States.
Under the terms of the agreement, CollaGenex will use its 125 person dental pharmaceutical sales force to promote Vioxx® to the professional dental market. The sales force has already undergone extensive product training and will begin promoting Vioxx® to the dental community on September 23, 1999.
''We are absolutely delighted to have been chosen by Merck to represent this important new product to the professional dental market,'' said Brian M. Gallagher, PhD, president and chief executive officer of CollaGenex. ''Vioxx® is an exciting product for CollaGenex to market along with Periostat®, our lead product for the treatment of adult periodontitis. We expect Vioxx® to contribute significantly to our revenue and earnings growth over the next few years. It also marks a significant next step toward completing our goal of becoming a premier, specialty pharmaceutical company.''
Vioxx® was approved by the FDA for the treatment of osteoarthritis, the management of acute pain in adults, including dental pain, and the treatment of primary dysmenorrhea (moderate to severe menstrual pain). Vioxx® is contraindicated in patients with hypersensitivity to any component of Vioxx® and in people who have had a severe allergic reaction to other NSAIDS.
In clinical studies, common adverse events included upper-respiratory infection, diarrhea, nausea and high blood pressure. Serious stomach problems can occur with or without warning symptoms with NSAIDS.
Scientists believe that Vioxx® works by inhibiting the COX-2 enzyme, which plays a role in pain and inflammation. Vioxx® spares a related enzyme (COX-1) that helps maintain the normal stomach lining. In general, certain NSAIDS block both enzymes. These medications treat pain and inflammation, but may damage the stomach lining, potentially leading to ulcers in some patients.
Periostat®, CollaGenex's lead product for treating adult periodontitis, was approved by the FDA in September 1998 and is rapidly gaining widespread acceptance by dental professionals. Since January 1999, approximately 230,000 Periostat prescriptions were filled through August.
In addition, the CollaGenex sales force promotes Denavir® (pencyclovir), a prescription drug for treating cold sores, under an agreement with Smithkline Beecham Consumer Healthcare.
CollaGenex is a specialty pharmaceutical company focused on providing innovative medical therapies to the dental market. The company's lead product, Periostat®, is the first and only pharmaceutical to treat periodontal disease by inhibiting the enzymes that destroy periodontal support tissues.
Research has shown that the enzyme suppression technology underlying Periostat® may also be applicable to other diseases involving destruction of the body's connective tissues, including cancer metastasis, osteoporosis, osteoarthritis and wounds. CollaGenex intends to pursue the research and development of these other applications primarily through partnerships with third parties.
To receive additional information on CollaGenex, please visit the Company's web site at www.collagenex.com, which is not part of this press release.
This news release may contain certain 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®, risks inherent in research and development activities, risks associated with conducting business in a highly regulated environment, 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.
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