|By PR Newswire||
|April 1, 2013 06:55 PM EDT||
BELLEVILLE, Ontario, April 1, 2013 /PRNewswire/ --
Bioniche Life Sciences Inc. (TSX: BNC) (ASX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced that sponsorship of its Phase III bladder cancer product - Urocidin™ - has been returned to the Company from former development/marketing partner, Endo Pharmaceuticals (Endo).
It was announced in December, 2012 that Bioniche and Endo had come to an agreement whereby Endo would return global rights to Urocidin™. Since that time, Bioniche and Endo have been working together to ensure a smooth transition. Endo has completed all termination activities related to the original license agreement between the two companies and sponsorship has now been officially returned to Bioniche.
"This is an important milestone for Urocidin™," said Mr. Graeme McRae, President & CEO of Bioniche Life Sciences Inc. "With sponsorship back in our hands, we will endeavor to schedule meetings with North American regulatory agencies. With Health Canada, we will discuss the potential for approval of a regulatory submission under its Notice of Compliance with Conditions policy. With the U.S. Food and Drug Administration (FDA), we will propose a revised clinical development plan to achieve U.S. registration."
"The urology community recognizes the urgent need for complementary and/or alternative treatments for non-muscle-invasive bladder cancer that fails to respond to BCG," said Dr. Alvaro Morales, Professor Emeritus, Department of Urology, Queen's University (Kingston, Ontario). "A number of research teams around the world are actively studying a variety of agents, some of which are showing significant promise. Currently, Urocidin™ is the only one that has completed a Phase III trial." Dr. Morales was the Principal Investigator in the Phase I and II clinical trials, as well as the Phase III clinical trial with Urocidin™.
If the Company is successful in obtaining access to the Canadian market under the Notice of Compliance with Conditions (NOC/c) policy, a new drug submission could be made to Health Canada before the end of 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 is also actively in discussions with potential new development/partners who are interested in obtaining rights to Urocidin™ in certain jurisdictions. Such partnerships are expected to generate up-front payments, milestones, development support, and licensing revenues.
The Company recently announced the establishment of a new wholly-owned private Human Health subsidiary - Bioniche Therapeutics Corp. The subsidiary is 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. A search is ongoing for a Chief Executive Officer for the new subsidiary.
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. Urocidin[TM] is 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 Urocidin[TM] 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 357,000 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 7,800 (5,800 men; 2,000 women) new bladder cancer cases were expected in 2012, 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 http://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.
For further information:
Jennifer Shea, Vice-President, Communications, Investor & Government Relations
Bioniche Life Sciences Inc.
Telephone: +1(613)966-8058; from Australia: 0011-1-613-966-8058
Cell: +1(613)391-2097; from Australia: 0011-1-613-391-2097
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