-Bioniche identifies potential for early access to the Canadian market-
BELLEVILLE, ON, Dec. 21, 2012 /PRNewswire/ - Bioniche Life Sciences Inc. (TSX: BNC) (ASX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced that global rights to Urocidin™ are being returned to the Company from Endo Pharmaceuticals (Endo), a subsidiary of Endo Health Solutions.
On November 5th, it was announced that a second Phase III clinical trial with Urocidin™ in non-muscle-invasive bladder cancer being run by Endo was being discontinued. The trial, a randomized, active-controlled, open-label, multi-center study, was designed to compare UrocidinTM with mitomycin C in the intravesical treatment of patients with BCG recurrent or refractory non-muscle-invasive bladder cancer. The trial was not recruiting at the expected rate and, after discussions with the U.S. Food and Drug Administration (FDA) regarding the clinical trial design, Endo decided to end the trial before its scheduled completion.
As a result of this decision, the two companies came to an agreement that a mutually favourable path forward for the product is to return global rights to Bioniche. In exchange for this agreement, Endo will receive a royalty on future revenue.
"This is a tremendous opportunity for us," said Mr. Graeme McRae, President & CEO of Bioniche Life Sciences Inc. "With control of the development program in our hands, we can build on the results of our first Phase III clinical trial with Urocidin™ by working with regulators to assess the best path forward, including exploring a 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."
The Company also now has the opportunity to seek alternate partnership arrangements, which would be expected to generate income to offset the costs of any additional clinical trial work required.
"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.