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Health Canada Provides Direction to Bioniche Life Sciences Inc. (BNC) Regarding New Drug Submission Filing


7/9/2013 9:21:05 AM

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BELLEVILLE, ON, July 8, 2013 /PRNewswire/ - Bioniche Life Sciences Inc. (TSX: BNC) (ASX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced the outcome of a meeting in late June with Health Canada, at which time the Company discussed the filing of a regulatory submission for its Phase III bladder cancer product - Urocidin - under Health Canada's Notice of Compliance with Conditions (NOC/c) policy.

Health Canada advised the Company that the data from the first Phase III clinical trial with Urocidin may be sufficient to qualify for filing under the NOC/c policy. The regulator asked the Company to submit a clinical assessment package addressing some clinical questions as part of the request to file a New Drug Submission (NDS) under the NOC/c policy. It is anticipated that all materials may be submitted to Health Canada before the end of calendar 2013. Approximately one year of review would follow and, if Health Canada is satisfied with the submission, an approval under NOC/c could follow before the end of 2014.

An early registration in Canada would generate revenues from commercial sales to offset the cost of additional clinical trial work that may be required for the U.S. and other jurisdictions.

The Company will also be seeking a meeting with the U.S. Food and Drug Administration (FDA) to discuss a clinical development plan to achieve U.S. registration.

The Company recently announced its first new licensing deal for Urocidin - with Paladin Labs Inc. The Company has granted Paladin an exclusive license to market and distribute Urocidin for bladder cancer in Canada, South Africa and Mexico. The companies have agreed to a net revenue sharing arrangement. Bioniche will be responsible for all product development and manufacturing costs and Paladin will be responsible for all sales and marketing costs in the said territories. The agreement provides that Paladin will pay a series of potential sales performance milestones that can total up to $16 million during the term of the agreement.

Treatment of non-muscle-invasive bladder cancer in patients who failed BCG therapy is the first target indication for Urocidin. The Company estimates that, in Canada alone, a minimum of 3,100 patients per year will qualify for treatment with Urocidin according to this label claim. At up to 21 doses per patient and at a pricing per dose that is competitive relative to other treatments, the Company believes that the market for UrocidinTM could be considerable.

Several other companies remain interested and actively engaged in discussing licensing opportunities for Urocidin in other global jurisdictions.

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. The last patient's last dose was administered in April, 2011 and the last patient's last visit occurred in December, 2011.

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 Bladder Cancer

Bladder cancer is one of the leading causes of death among men and women and an estimated 386,300 new bladder cancer cases occur worldwide each year. It is estimated that 72,570 new cases of bladder cancer and 15,210 deaths from bladder cancer will occur in the United States in 2013. In Canada, an estimated 7,900 (5,900 men; 2,000 women) new bladder cancer cases are expected in 2013, with 2,100 expected deaths. Bladder cancer is the 4th most common cancer in men and the 12th most common cancer in women in North America. The prevalence of non-muscle-invasive bladder cancer is ten times its incidence and creates a major economic burden on healthcare systems. As measured on the basis of cumulative per patient cost from the time of diagnosis until death, bladder cancer is the most expensive cancer to treat.

Non-muscle-invasive bladder cancer is a form of bladder cancer localized in the surface layers of the bladder that has not yet spread into the deeper muscle layer. This form of bladder cancer is treated predominantly by urologists using surgical resection and intravesical infusion therapy. Urocidin is an intravesical infusion therapy, administered via trans-urethral catheter into the bladder.

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.

For more information, please visit www.Bioniche.com.

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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