FSC / Press Release
Orbus Announces Outcome of Metoprolol Succinate Pilot Bioequivalence Studies
Markham, Ontario CANADA, October 26, 2009 /FSC/ - Orbus Pharma Inc. (ORB - TSX), announces that the outcome of the small scale Metoprolol Succinate pilot bioequivalence studies generated mixed results. The company conducted a 25 subject pilot bioequivalence study under "Fed" conditions on each of three strengths of Metoprolol Succinate. The highest strength demonstrated bioequivalence with the reference product, but the two lower strengths did not. Orbus has undertaken further reformulation work on the two lower strengths.
Metoprolol Succinate extended release tablets are a once a day beta blocker that can be used alone or in combination with other medications to treat high blood pressure. It is also used to prevent angina (chest pain) and, in combination with other medications, to treat heart failure.
The need to reformulate the lower strengths extends the time line to potential market authorization for the drug as well as increases the cost of development. The company has limited financial resources and thus it is re-evaluating its immediate business plans including moving to finalize its strategic alternatives review announced in the January 26, 2009 press release.
Orbus Pharma Inc., headquartered in Markham, Ontario and listed on the Toronto Stock Exchange under the symbol ORB, is pursuing an integrated strategy of: (1) generic drug development, using proprietary delivery systems for certain products; (2) product out-licensing; and (3) pharmaceutical manufacturing. For more information, please visit www.orbus.ca.
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.
For more information contact:
Greg W. Muir
Interim President and C.E.O.
905-943-9444 ext. 222
Email gmuir@orbus.ca
20 Konrad Crescent, Markham, Ontario, L3R 8T4
Telephone 905-943-9444, Fax 905-943-9878, Web: www.orbus.ca
Source: Orbus Pharma Inc. (TSX: ORB) http://www.orbus.ca
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