Orbus Pleased With Metoprolol Bioequivalence Results
June 20, 2007
Mr. Jeffrey Renwick reports
ORBUS PHARMA INC. ANNOUNCES SUCCESFUL BIOEQUIVALENCE RESULTS THE 95 MG METOPROLOL SUCCINATE EXTENDED RELEASE TABLET
Orbus Pharma Inc. has released successful results for the fasted-state bioequivalence study in its European drug development of the 95-milligram metoprolol succinate extended-release (XR) tablet. 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.
The Orbus metoprolol succinate XR formulation is a generic version of Astra Zeneca's Beloc-ZOK in Europe and Toprol XL in the United States, which had reported 2006 annual sales of $1.95-billion (U.S.). Orbus will be completing bioequivalence studies for the remaining two dosage strengths to demonstrate therapeutic equivalence for all dosage strengths of the European brand product Beloc-ZOK (metoprolol CR/XL). These results are expected early in the third quarter of 2007 with anticipated approval of the product for sale in Europe by the end of the second quarter 2008.
Orbus is currently pursuing licensing opportunities with European companies based on earlier completion of all three of the bioequivalence studies (fed, fasted and steady states) on the 190-milligram metoprolol succinate XR product. Orbus recently signed a letter of intent with Breckenridge Pharmaceutical Inc. that covers the development, supply and marketing of metoprolol succinate XR tablets in the United States. Additionally, Orbus has a U.S. patent pending that covers the in-house-developed delivery system for the product. All batches of the Orbus metoprolol succinate XR product used for the clinical trials were manufactured in Orbus's Markham, Ont., plant.
