Orbus Pharma Inc.

Orbus Pharma Inc.

May 23, 2006 15:46 ET

Orbus Pharma Inc. Announces Succesful Bioequivalence Results in Its Metoprolol Succinate Extended Release Drug Development

TORONTO, ONTARIO--(CCNMatthews - May 23, 2006) - Orbus Pharma Inc.,(TSX:ORB) ("Orbus") today announces the successful results of the most demanding phase of the bioequivalence studies in its European drug development of a once per day formulation for metoprolol succinate extended release ("XR") tablets. 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 XR formulation is a generic version of Astra Zeneca's Beloc-ZOK® (metoprolol CR/XL) which has reported 2005 annual sales of US$1.735 billion.

Bioequivalence studies are required to demonstrate that a generic formulated product results in the same level of medication in the blood as the innovator brand product. The most demanding of these studies is the "Fed" study, which the Orbus formulation has now successfully fulfilled. Orbus will be completing the remaining two bioequivalence studies to demonstrate therapeutic equivalence to the brand product Beloc-ZOK® (metoprolol CR/XL) and results are expected near the end of the third quarter of 2006.

All batches of the XR product used for regulatory submissions are manufactured in Orbus's Markham, Ontario plant. Orbus is currently in licensing negotiations with North American and European companies for the marketing and manufacturing of the once-a-day metoprolol succinate product. Additionally, Orbus has a U.S. patent pending covering the in house developed delivery system for this product. "Our once-a-day formulation of metoprolol, using our proprietary in house developed controlled release technology, is a major milestone for Orbus and we are very confident that our product will gain regulatory approval in Europe" says Jeff Renwick, President and CEO of Orbus Pharma Inc.

Forward-looking statements

Certain statements in this disclosure are "forward-looking statements", which reflect management's expectations regarding the Company's future growth, results of operations, performance and business prospects and opportunities. Such forward-looking statements reflect management's current beliefs and are based on information currently available to management. Many factors could cause results to differ materially from the results discussed in the forward-looking statements, including risks related to dependence on key suppliers, economic conditions, competition, regulatory change, foreign exchange rates, and interest rates, among others. Although the forward-looking statements are based on what management believes to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with these forward-looking statements.

Orbus Pharma Inc. is listed on The Toronto Stock Exchange under the symbol ORB and pursues a strategy of generating revenue through the licensing of its generic drug developments as well as the manufacturing and selling of pharmaceutical products.

Contact Information

  • Orbus Pharma Inc.
    Jeffrey W. Renwick
    President and C.E.O.
    (905) 943-9444
    Website: www.orbus.ca