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 -
- 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
. 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
," said Mr.
, 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.
, Professor Emeritus, Department of Urology, Queen's University (
). "A number of research teams around the world are actively studying a variety of agents, some of which are showing significant promise. Currently,
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
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.