Bioniche Life Sciences Inc. Reorganizes One of Its Business Units

Published: Mar 08, 2013

BELLEVILLE, ON, March 7, 2013 /PRNewswire/ - Bioniche Life Sciences Inc. (TSX: BNC) (ASX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced that it is reorganizing one of its business units with a view to seeking to unlock the value of the Company's core Human Health technology.

The reorganization involves moving the Company's Human Health business into a new wholly-owned private subsidiary - Bioniche Therapeutics Corp. . The subsidiary will function as a standalone unit, and the new structure will allow direct external investment to support research and development activities, commercialization activities and acquisition opportunities, which may result in accretive value to the parent company.

"We realize that capital markets do not recognize the full value of the Company's underlying business units and technologies in their current configuration," said Mr. Graeme McRae, President & CEO of Bioniche Life Sciences Inc. "With global rights to Urocidin negotiated back from Endo Pharmaceuticals, we believe that this is the right time to reconfigure the organizational structure to better highlight the inherent value in the Human Health business unit with this late-stage therapeutic asset."

The Company will seek to source new investments in Bioniche Therapeutics Corp. to support the path to global commercialization for the Company's Phase III bladder cancer product - Urocidin. It should be noted that these investments could take the form of private equity or licensing income through the out-licensing of marketing rights to Urocidin in one or more global jurisdictions.

The Company is moving to hire a Chief Executive Officer for Bioniche Therapeutics Corp., and an executive search is underway.

About UrocidinTM

Urocidin is a formulation of MCC, a sterile mycobacterial cell wall-DNA complex composition that has a dual mode of action: immune stimulation and direct anticancer activity. UrocidinTMis formulated for the treatment of bladder cancer, where it is administered by trans-urethral catheter directly into the bladder. The agent is then able to directly interact with the cells of the immune system and bladder cancer cells. Industry Canada's Industrial Technologies Office (formerly Technology Partnerships Canada) has contributed to the development of Bioniche's mycobacterial cell wall technologies by means of a C$9.6 million loan to be repaid by Bioniche from sales.

About the First Phase III Clinical Trial with Urocidin

The Company's first Phase III trial was a 129-patient open label, single-arm trial, meaning there was no comparator therapy used in the trial. The trial was designed to assess the safety and efficacy of UrocidinTM as a treatment of non-muscle-invasive bladder cancer in patients whose cancer had not responded positively to prior treatment with BCG therapy. This trial enrolled its first patient in November, 2006 and the last patient was enrolled in April, 2009.

Preliminary results, reported at urology association meetings in March, May and June, 2011, showed that, after 12 months, there was a 25% overall disease-free survival rate and the product was well-tolerated by patients with most adverse events considered "mild to moderate".

About Bioniche Life Sciences Inc.

Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary and innovative products for human and animal health markets worldwide. The fully-integrated company employs more than 200 skilled personnel and has three operating divisions: Human Health, Animal Health, and One Health. The Company's primary goal is to develop and commercialize products that advance human or animal health and increase shareholder value.

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Except for historical information, this news release may contain forward-looking statements that reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process, and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.

SOURCE Bioniche Life Sciences Inc.

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