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U.S. and Swiss Company Sign Agreement For Once-daily Transdermal Version Of Ketoprofen
Prescription Non-Steroidal Anti-Inflammatory Patch Promises to Prevent Gastro Discomfort
Montgomery, Alabama, April 7, 2003 - The $7.3 billion market for non-steroidal anti-inflammatory drugs (NSAIDs) - dominated by two of the most widely prescribed medicines in the United States - may soon include an upstart competitor whose breakthrough product holds the promise of allaying joint pain but without the gastro-intestinal discomfort often caused by current medications.
ProEthic Pharmaceuticals, Inc., a Montgomery, Alabama-based distributor of prescription drugs, and Applied Pharma Research, a Balerna, Switzerland-based developer of innovative drug delivery systems, announced today that they have signed a licensing agreement for a once-daily transdermal version of ketoprofen, a member of the NSAID class of drugs that also includes the popular Celebrex and Vioxx brands.
The still unnamed ketoprofen patch, which resembles a small piece of bandaging tape, provides a steady, continuous influx of the active drug directly to the inflamed area. By delivering therapeutic dosages of the drug directly to the site of the injury - as opposed to being taken orally and absorbed into the bloodstream through the stomach - the ketoprofen patch reduces the likelihood of potentially dangerous gastro-intestinal side effects that commonly occur with oral NSAIDS.*
The agreement with Applied Pharma Research gives ProEthic exclusive U.S. marketing rights to the product. The company will oversee its clinical development in the United States, with a NDA submission scheduled for late next year.
In 2001, Applied Pharma Research licensed worldwide rights (excluding the United States, Canada and Japan) to the Zambon Group S.p.A., a privately held multinational company based in Milan, Italy. In one of two phase III clinical trials recently completed in France and Belgium, the effectiveness of the product in patients with periarticular soft tissue pain, such as tendonitis and bursitis, was confirmed. Results of the second trial, aimed at assessing the drug's efficacy on ankle sprains, are expected next month. Upon completion of these trials, the Zambon Group S.p.A. will submit the drug for EC approval.
The European market for anti-inflammatory (IMS ATC M2A) drugs accounts for 160 million units annually with a market value of more than 500 million (equivalent to approximately $540 million) for topical, locally acting anti- inflammatory drugs. New innovations and formulations of existing products have quickly gained acceptance in Europe, and the U.S market is expected to do the same. While no topical or transdermal NSAID has received FDA approval, industry estimates project the potential U.S. market at $200-$300 million. According to IMS Health, the total market for NSAIDs in 2002 was $7.3 billion for topical, locally acting anti-inflammatory drugs (Retail and Provider Perspective™ 3/2002).
"We believe the ketoprofen patch has tremendous domestic potential," said Carl Whatley, Chief Executive Officer, ProEthic. "There is already strong clinical evidence of its effectiveness in relieving pain, but perhaps even more impressive is its capacity to effectively eliminate stomach distress, which often prohibits many patients from taking NSAIDS. We are excited over our agreement with Applied Pharma Research, a company respected around the world for its research and product innovations."
"Transdermals are becoming increasingly popular in Europe, and we believe the momentum for this type of drug delivery will only accelerate in the United States," said Paolo Galfetti, Director of Licensing, Applied Pharma Research. "We are elated to have ProEthic as our U.S. partner and look forward to working together toward a successful launch in the United States in the years ahead."
*In a recent clinical trial, 10 patients undergoing arthroscopic knee surgery had the 100mg ketoprofen patch applied once daily for six days prior to surgery. Upon analysis of tissue samples conducted post-operatively, ketoprofen was found in the tendon sheath area at levels 300 times higher than the level found in plasma. The drug levels in the synovial fluid were six times higher than the drug levels found in plasma. [Arznaimittel forschung,m 2002, 52 (11), p 822]
About ProEthic Pharmaceuticals, Inc.
ProEthic is an emerging specialty pharmaceutical company enhancing treatment strategies initially in the areas of pain and migraine. Founded in 2001, the privately held company focuses its efforts on the acquisition, development, licensing, and marketing of pharmaceutical products. ProEthic also markets niche generic prescription pharmaceutical products through Midlothian Laboratories LLC, a wholly owned subsidiary. For more information, please visit the ProEthic website at: www.proethic.com.
APR Applied Pharma Research s.a. is a privately owned, pure R&D company with registered offices in Switzerland. It is focused in the research & development of innovative and patented drug delivery systems as well as innovative pharmaceutical products primarily for oral and topical administration. The APR products and technologies are licensed to third parties for distribution and marketing activities. R&D activities are carried out directly or under contract. APR has signed licensing agreements with pharmaceutical companies in about 35 countries worldwide and its sales are almost totally achieved abroad. Interview Contact: Paolo Galfetti, Director of Licensing Telephone: +41.91.6957020 Email: paolo.galfetti@apr.ch Website: www.apr.ch
Labtec GmbH is an innovative and internationally oriented pharmaceutical company, located in Germany. It is focused on research and development of drug delivery systems (transdermal delivery systems, buccal/gingival delivery systems, liposomes/nanosomes, fast dissolving dosage forms) and contract analytics & stability testing, according to the ICH standards. Labtec was founded in 1990 by Dr. Cordes, who was responsible for the development of the first nitroglycerine matrix patch (Deponit™). It has Research and Development partnership agreements with several large pharmaceutical companies throughout the world. Labtec has developed one of the first matrix type estradiol patches, which is marketed worldwide under the trade names Dermestril®, Tradelia® and Epiestrol®. Interview Contact: Peter Klaffenbach, Director of Contract Analytics Telephone: +49.2173.97350 Email: info@labtec-pharma.com Website: www.labtec-pharma.com
Zambon Group is a pharmaceutical and chemical company founded in Vicenza in 1906. It has grown to become a leading multinational with 2,500 employees in 15 countries operating on three continents, Europe, South America and Asia. It has developed a reputation for inventive and innovative thinking, flexibility and customer focus. Zambon has also worked to foster a multicultural environment with close links to its local markets and the international research community alike. These strengths, combined with diversified research, product and distribution channel strategies, ensure that the Zambon Group consistently outperforms its competitors and the market. Interview Contact: Corporate Communication Dept. Telephone +390266524906 E-mail info.communication@zambongroup.com
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