FSC / Press Release
Orbus Announces Health Canada Approval of Cefuroxime Axetil for Sale in Canada
Markham, Ontario CANADA, April 02, 2009 /FSC/ - Orbus Pharma Inc. (ORB - TSX), (Orbus) announces the receipt of a Notice of Compliance (NOC) from Health Canada approving the sale of Cefuroxime Axetile in Canada. Andrew Zaleski, Interim President and CEO of Orbus Pharma, stated; "The company is excited about this achievement as it marks the first Orbus developed product to be approved in Canada". To date, the product is being sold in selected European countries and the Philippines.
A process variation to the approved file is being submitted mid April 2009 and is expected to be approved within 90 days. Concurrently, a licensing agreement for the product in Canada is being pursued with several interested.
Orbus manufactures the product, embodying the patent filed in Canada (www.patents1.ic.gc.ca), at its production facility in Cambridge, Ontario, and exports to Europe and the Philippines under both specific country regulations and European wide mutual recognition regulations.
Cefuroxime Axetile is a broad spectrum antibiotic for the treatment of certain respiratory tract infections caused by bacteria, such as bronchitis; gonorrhea; Lyme disease; and infections of the ears, throat, sinuses, urinary tract, and skin.
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:
Andrew B. Zaleski
Chairman and Interim President and C.E.O.
905-943-9444 ext. 229
Greg W. Muir
Vice President Finance and C.F.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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