Orbus Pharma Inc.

Orbus Pharma Inc.

November 07, 2005 16:54 ET

Orbus Receives Notification of Regulatory Approval in Denmark for Cefuroxime Axetil Tablets

TORONTO, ONTARIO--(CCNMatthews - Nov. 7, 2005) -

- Danish approval clears the road to commercial launch across Europe -

Orbus Pharma Inc. (TSX:ORB) today announced that it has received notification of regulatory approval for cefuroxime axetil from the Danish Medicines Authority. The product has been approved for use in dosages of 250 and 500 mg tablets. Approval in Denmark allows Orbus to initiate the Mutual Recognition Procedure ("MRP") in pursuit of regulatory approval for the remainder of the European Union countries.

"Regulatory approval of this first major product is our most significant milestone to date," said Jeff Renwick, President and Chief Executive Officer of Orbus. "This product will be made at our Cambridge antibiotic manufacturing plant and we are looking forward to generate our first commercial revenue from this facility."

Together with our regulatory consultants, Orbus has been preparing its submission to initiate the MRP process for its cefuroxime axetil product. Orbus is also working closely with each of its European licenses to finalize preparations for commercial launch of its product which is expected in six to nine months.

The European market for cefuroxime axetil is large with annual sales exceeding US$150 million.

As previously announced, Orbus has licensing and distribution partners for its cefuroxime axetil product in the countries of Luxemburg, Belgium, Spain and Italy. The Company is in active discussions with potential licenses for the remaining European markets, the United Kingdom, Canada and the USA.

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

Contact Information

  • Orbus Pharma Inc.
    Jeffrey W. Renwick
    President & Chief Executive Officer
    (905) 943-9444
    Website: www.orbus.ca