Category: Uncategorized
December 13, 2002

News Release: Bioniche Receives FDA Approval For Urology Product

Bioniche Life Sciences Inc. (TSX:BNC) today announced that the Company's specialty pharmaceutical business unit, Bioniche Pharma, received approval from the U.S. Food & Drug Administration (FDA) to market Dimethyl Sulfoxide USP (DMSO). This product is indicated for the symptomatic relief of interstitial cystitis, a painful bladder disorder. Bioniche believes it is the first manufacturer with an equivalent product to the innovator, which markets the product under the brand name Rimso-50(R). "This FDA approval is of key importance to our urology strategy. This product will establish a presence in the U.S. urology arena that complements our existing European and Canadian urology franchise," said Graeme McRae, President and CEO of Bioniche Life Sciences.

Cystistat(R), the company's proprietary product for the treatment of interstitial cystitis is currently marketed successfully in Canada and Europe using an expanded distribution network. Cystistat(R) is currently undergoing a pivotal trial for registration in the U.S.

"We look to DMSO to establish a marketing presence amongst U.S. urologists for Bioniche, and to support the eventual U.S. marketing of the Company's proprietary urology products, Cystistat(R) and MCC," said Albert Beraldo, President of Bioniche Pharma and Vice-President of Business Development for Bioniche Life Sciences. The Company's proprietary technology, Mycobacterial Cell Wall DNA Complex (MCC) is being developed for the treatment of bladder cancer (Urocidin(TM)) and for the treatment of prostate cancer (Prostacidin(TM)).

DMSO will be manufactured in the company's 45,000 square foot Galway, Ireland facility which is USA FDA, Irish Medicines Board, Health Canada, and cGMP compliant. The facility is ISO 9001 registered and manufactures sterile vials, and pre-filled syringes.

About Bioniche Pharma Group

The Bioniche Life Sciences pharmaceutical division is a specialty pharmaceutical company involved in the development, manufacturing and marketing of injectable pharmaceutical products and has an aggressive product development program. Bioniche Pharma also manufactures several proprietary products for Bioniche Life Sciences Inc. and other unrelated companies.

About Bioniche Life Sciences Inc.

Bioniche Life Sciences Inc. is a leading Canadian biopharmaceutical company that develops, manufactures, and markets proprietary products for human and animal health markets worldwide. The company is developing a pipeline of anti-cancer therapies based on its proprietary mycobacterial cell wall technologies. The Company has 230 employees worldwide in four business units: Bioniche Pharma, Bioniche Therapeutics, Bioniche Animal Health, and Bioniche Food Safety. For more information visit www.bioniche.com.

Bioniche Life Sciences Inc. trades on the Toronto Stock Exchange (TSX) under the symbol "BNC" and currently has 27,818,445 shares outstanding.

For further information: Lynn Nielsen, Corporate Communications Manager,
Bioniche Life Sciences Inc., Tel: (613) 966.8058 x 254,
Lynn.Nielsen(at)bioniche.com; Mary S. Dellar, MBA, Investor Relations, The
Equicom Group, Tel: (514) 939.3900 x236, mdellar(at)equicomgroup.com

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