Orbus announces successful results from bioequivalence study of generic Beloc-ZOK

New York, May 23 - Orbus Pharma Inc. unveiled what it called successful results of the most demanding phase of the bioequivalence studies for its once per day formulation for metoprolol succinate extended release tablets.

The drug is a generic version of AstraZeneca's Beloc-ZOK, which has reported 2005 annual sales of $1.735 billion. Metoprolol succinate is the world's leading cardioselective beta-blocker for hypertension, angina pectoris, heart failure, disturbances of cardiac rhythm including especially supraventricular tachycardia, maintenance treatment after myocardial infarction and functional heart disorders with palpitations and for migraine prophylaxis.

Bioequivalence studies are required to demonstrate that a generic formulated product results in the same level of medication in the blood as the brand product. The most demanding of the studies is the "Fed" study, which Orbus said its formulation has now successfully fulfilled.

The study is aimed at obtaining regulatory approval in Europe.

Orbus said it will be completing the remaining two bioequivalence studies and results are expected near the end of the third quarter.

Orbus is a Toronto-based company that aims to license its generic drug developments and manufactures and sells pharmaceutical products.

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