Release issued 7th November 2004

THE EFFICACY AND SAFETY OF NIMESULID GEL (SULIDIN®) IN GONARTHROSIS: A PILOT STUDY Fahri Erdogan(1), N. Selim Gökay(1), S. Ezgi Gulmez(2), F. Cankat Tulunay(2) (1-Istanbul University Cerrahpasa School of Medicine, Department of Orthopedics and Traumatology, Istanbul, Turkey), (2-Ankara University School of Medicine, Department of Pharmacology & Clinical Pharmacology, Ankara, Turkey).

Osteoarthritis is a progressive and painful disease, which mainly effects elderly patients. In common practice it is treated with simple analgesics and NSAIDs. However, since the clinical usages of those NSAIDs are for a long time of period and the elder patients are more sensitive to those agents, side effects occur more frequently. There is increasing evidence that topically applied analgesic may be effective and safe alternatives to oral treatment. The aim of this pilot study was to evaluate the efficacy and safety of a new topical gel formulation of nimesulide (Sulidin gel®, %1 nimesulide) in patients with gonarthrosis. Patients were asked to complete the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) before and 1 week after the usage of Sulidin gel® applied three times a day on knee at a doses of 0,4 mg/10 cm2 in an open study design. Main outcomes were pain, joint stiffness and physical functioning. The results of this study indicate that, even for a short period of time, topical application of nimesulide gel produces mild but beneficial changes in the parameters measured. Our randomized, double-blind, placebo controlled study is under way. Please see http://www.cpt2004.com/ and www.embil.com for further information.

(17th November 2004) Sulidin® 1% Nimesulide LPS® gel receives European and US Patents

(29th December 2003) Two papers on Neo-Penotran® Forte and Neo-Penotran® Forte-L have been accepted for presentation at the 4'th World Conference on Vaginitis, Costa Rica, 10-13 Jan 2004

(6th June 2003) Australian Patent Approval announced for SULIDIN LPS (Topical Nimesulide Gel) formulation.

(10th October 2002) Recent Patent Approvals for SULIDIN® LPS® (Topical Nimesulide Gel)

(9th October 2002) Two New Clinical study reports released for Kortos® HC Cream used in the treatment of benign anorectal diseases.