Potential for early access.. Part 1 more to come Endo Pharmaceuticals Returns Urocidin(TM) Global Rights to Bioniche Life Sciences Inc.1 hour ago by CNW Group
-Bioniche identifies potential for early access to the Canadian market-
Bioniche Life Sciences Inc. (TSX: BNC) (ASX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced that global rights to UrocidinTM are being returned to the Company from Endo Pharmaceuticals (Endo), a subsidiary of Endo Health Solutions.
On November 5(th), it was announced that a second Phase III clinical trial with UrocidinTM 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 Urocidin(TM) 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 UrocidinTM 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 Urocidin(TM)."
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 UrocidinTM, 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)
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