In November 2012, a second Phase III clinical trial with Urocidin in non-muscle-invasive bladder cancer being run by Endo was discontinued. The trial, a randomized, active-controlled, open-label, multi-center study, was designed to compare Urocidin 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 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 favorable 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. Industry Canada's Industrial Technologies Office has contributed to the development of Bioniche's mycobacterial cell wall technologies by means of a $9.6 million loan to be repaid by Bioniche from sales.
"This is a tremendous opportunity for us," said Graeme McRae, president and chief executive officer of Bioniche Life Sciences. "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 Urocidin."