BELLEVILLE, ON, Jan. 3, 2013 /PRNewswire/ - Bioniche Life Sciences Inc. (TSX: BNC) BNC, a research-based, technology-driven Canadian biopharmaceutical company, today provided an update on the return of global rights to Urocidin™ from Endo Pharmaceuticals (Endo), a subsidiary of Endo Health Solutions. It was announced on December 21, 2012 that the two companies came to an agreement that a mutually favourable path forward for the product is to return its global rights to Bioniche.
As detailed in the Termination Agreement posted on www.SEDAR.com and www.ASX.com.au, in exchange for this agreement, Endo will receive a 5% royalty on future net sales revenue for a term of 10 years from the first commercial sale of the product or, on a country by country basis, until the last of the valid patent claims covering the product has expired or been invalidated.
The two companies are currently focused on ensuring a smooth transition from Endo to Bioniche, which includes the completion of a number of activities related to terminating the original license agreement that was signed in July, 2009. The termination activities include closing clinical trial sites from the most recent Phase III clinical trial that was discontinued by Endo in November, 2012. It is expected that all such activities will be concluded by March 31, 2013, at which time, clinical trial sponsorship will officially return to Bioniche.
"With sponsorship in our hands, we can work with regulators to assess the best path forward, including a potential Canadian regulatory submission under Health Canada's Notice of Compliance with Conditions policy, which could result in early access to the Canadian market for UrocidinTM," said Mr. Graeme McRae, President & CEO of Bioniche Life Sciences Inc.
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. The Company is also seeking new partners in selected jurisdictions. "The Company has identified potential new 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," added Mr. McRae. "We remain committed to the successful commercialization of Urocidin™, which we believe is an important and much-needed therapy for those suffering from non-muscle-invasive bladder cancer," added Mr. McRae.
Company representatives will be available to discuss this development further during a:
Conference Call & Audio Webcast
Thursday, January 10, 2013
5:00 p.m. (Eastern)
To participate in the conference call from North America, call (888) 231-8191 (conference ID: 83659012).
To participate in the conference call from Australia, call 1-800-287-011 (conference ID: 83659012).
A listen-only audio webcast will be available at:
A replay of the conference call will be available until January 17, 2013 at midnight by calling 1-855-859-2056 (passcode: 83659012).
The webcast will be available for replay using the above link until January 10, 2014.
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 73,510 new cases of bladder cancer and 14,880 deaths from bladder cancer will occur in the United States in 2012. In Canada, an estimated 7,800 (5,800 men; 2,000 women) new bladder cancer cases are expected in 2012. 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.
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. UrocidinTM 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 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 Food Safety. 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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