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Orbus Announces Health Canada Approval of Amitriptyline for Sale in Canada

Thu. May 14, 2009; Posted: 05:32 PM
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Markham, Ontario CANADA, May 14, 2009 (Filing Services Canada via COMTEX) -- OBSPF | Quote | Chart | News | PowerRating -- Orbus Pharma Inc. (ORB - TSX), announces that ratiopharm has received a Notice of Compliance (NOC) from Health Canada approving the sale of a generic form of Amitriptyline in Canada. The product was developed by Orbus Canada for sale in both Canada and Europe. According to Greg Muir, Vice President and CFO, "Orbus has an exclusive ten year agreement with ratiopharm to manufacture and supply product for the Canadian market that will generate both manufacturing revenue and royalty payments".

ratiopharm has been granted a drug identification number (DIN), along with the NOC, which will allow them under the terms of the agreement to market and distribute the product as "ratio-Amitriptyline" in the Canadian market. The process for launching the product is well along. Andrew Zaleski, Interim President and CEO of Orbus Pharma, stated; "The company is pleased with the success ratiopharm has had in filing the Abbreviated New Drug Submission (ANDS) with Health Canada. It marks the first collaboration between our two companies".

Ratiopharm inc. is a leading Canadian generic pharmaceutical company with the ability to develop, manufacture, market and distribute generic pharmaceutical products throughout Canada. The Canadian division is a subsidiary of ratiopharm GmbH, which is a large multinational generic pharmaceutical company headquartered in Germany.

Amitriptyline is an anti-depressant that is used to treat symptoms of endogenous depression. This particular depression state is more likely to be alleviated than are other depressive states. In addition to Canada, the Orbus developed product has been submitted for market authorization in selected European markets by Orbus licensees. Orbus will be manufacturing the product for both Canada and Europe at its production facility in Markham, Ontario.

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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