Indications -- cardiovascular Message Board

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Biotech / Medical : Indications -- cardiovascular

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To: scaram(o)uche who started this subject	4/19/2002 4:12:21 AM
From: mopgcw	of 214

MediGene’s Etomoxir project delayed Martinsried – San Diego, April 19, 2002. Today, the German-American biopharmaceutical company MediGene (Neuer Markt: MDG) announced a delay for one of its seven drug development projects. The company has prematurely terminated the phase 2 clinical trial for the therapeutic drug candidate Etomoxir for the treatment of congestive heart failure and is now preparing for the development of a lower dosage. During the clinical trial side effects occurred in a small number of patients, which seem to be associated with treatment. In addition recent preclinical results indicate that Etomoxir may be efficacious at a lower dosage than that administered so far. Therefore, significantly lower dosages should be tested during further development. Administration of a lower dosage might improve the tolerability for the patient and reduce the production costs of the drug candidate. It is expected that due to additional clinical trials the total development period for Etomoxir will be prolonged by approximately one year. The further development will be financed within the current business plan. According to the current business plan, the delay in MediGene’s Etomoxir project will have no implications on the planned break-even point of MediGene. The final design of further clinical trials will be developed on the basis of the results obtained from the study that has now been terminated. These results are based on the data of 155 patients who received two different dosages (40 or 80 mg/day) of Etomoxir or placebo for a period of 12 weeks. More than 380 patients have already been screened for this trial. Screening, in other words selection of the appropriate patient population, has therefore been completed on time. In addition to Etomoxir, MediGene AG has five more drug candidates in different stages of clinical development. The application for marketing authorization has been submitted for another drug candidate.

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