In July 2000 the Swiss R&D company APR and the German R&D company Labtec partnered together to co-develop and co-license out the Ketoprofen TDS Patch to pharmaceutical companies interested to market this product under their own brand name. APR owns a 70% stake in the project and Labtec owns the remaining 30%.
Ketoprofen TDS Patch is a matrix patch consisting of 3 dinstinct layers: the first layer is a textile polyester material longwise and crosswise elastic assuring perfect adhesion also when applied on joints like knee or elbow; the second layer is the adhesive layer containing and delivering the active ingredient through the skin and the third layer is the protective release liner to be removed prior application.
The ketoprofen TDS Patch has the following advantages compared with the existing topical gels: a) Once a Day Posology b) Longer and more constant drug flux through the skin c) No clothes contamination during treatment d) Fixed dressing especially for joints
The product has been developed according to the "Note for Guidance on the Clinical requirements for locally applied, locally acting products containing known ingredients" (CPMP/EWP/293/95 dated June 96). Preclinical studies have been all successfully completed to assess safety and tolerability of the product; bioavailability studies in humans have been successfully completed. 2 Pivotal Efficacy and Tolerability studies on about 180 patients each have been successfully completed in May 2003.
In addition the product has been officially and favorable evaluated by the FDA in a Pre-IND meeting held in late 2003 and received official IND in the US in late 2004. Phase III clinica trials (placebo controlled) in the US are on-going and expected to eb completed by Q3/2007.
PCT Patent Application worldwide; priority date July 5th 2001.
Countries in which the patent application will be extended will be selected according to the marketing partners and the licensing agreements signed.
The product has been licensed exclusively for USA and Canada to the privately owned pharmaceutical company ProEthic Pharmaceuticals Inc. located in Montgomery (Alabama): ProEthic undertook the further development of the Product in view of a submission to the FDA. In March 2005 ProEthic transferred the US and Canadian rights on the product to Endo Pharmaceuticals, Inc. (www.endo.com) which is now running Phase III trials in the US. NDA submission is expected in late 2007.
The product is available for licensing in all the other countries worldwide except US and Canada.
Mr Paolo Galfetti
APR is a private, independent, integrated Healhcare Company focused on Delivering, Funding and Supporting Innovation in Healthcare.View profile
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