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Nitec Pharma Reports Positive and Highly Significant Phase III Results From Capra-2 Study of Lodotra(TM) in RA
Date:9/1/2009

BASEL and REINACH, Switzerland, September 2 /PRNewswire/ --

- CAPRA-2-Data Will be Used to File for US Marketing Approval

Nitec Pharma AG ("Nitec" or "Nitec Pharma"), a Switzerland-based specialty pharma company focused on the development and commercialization of medicines to treat chronic inflammation and pain-related diseases, today announced positive results from the second pivotal phase III trial for its lead product, Lodotra(TM).

The CAPRA-2 study (Circadian Administration of Prednisone in Rheumatoid Arthritis-2) was a 12-week, multicentre, double-blind phase III trial evaluating the safety and efficacy of Lodotra(TM) for the treatment of rheumatoid arthritis ("RA"), a chronic, progressive and disabling autoimmune disorder. In total 350 patients, all inadequate responders to DMARD therapy, were randomised in one of two arms to receive either Lodotra(TM) (5mg once daily), or placebo in addition to their existing therapy. The primary efficacy endpoint was the ACR-20 response rate, which is defined as at least a 20% improvement in a number of disease-specific criteria. The key secondary endpoint was the change in the duration of morning stiffness of the joints. CAPRA-2-data will be used to file for US marketing approval with the FDA together with the data already available from the CAPRA-1 pivotal phase III trial which has shown the superiority of Lodotra(TM) over standard prednisone treatment.

Lodotra(TM)-treated patients showed an ACR-20 response of 49% compared to 29% in the placebo group. The difference was highly significant (p=0.0002; LOCF). The reduction of morning stiffness was 44% in the Lodotra(TM) group (21 % in the placebo group). This difference was also highly significant (p=0.0008). Lodotra(TM) was safe and well tolerated. The number of adverse events was low and comparable in both groups.

Dr. Anders Harfstrand, CEO of Nitec commented: "We are deli
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SOURCE Nitec Pharma AG
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