Bioniche's achievement of fourth milestone in Urocidin Phase III trial triggers $4.0M payment from Endo

Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology driven Canadian biopharmaceutical company, today announced achievement of a US$4.0 million milestone payment from its development partner, Endo Pharmaceuticals Inc. This milestone is the fourth achieved by Bioniche subsequent to the parties executing their agreement in July, 2009.

The current milestone payment was triggered by Urocidin™ attaining a contractual efficacy goal from an ongoing U.S. Food and Drug Administration (FDA) Phase III registration trial. Urocidin™ is a product for non-muscle-invasive bladder cancer that is refractory to current first-line therapy. The clinical trial providing results was initiated in late 2006, prior to the execution of the agreement between the parties.

This clinical trial involves the use of an intravesical formulation of a patented mycobacterial cell wall composition: Mycobacterial Cell Wall-DNA Complex (MCC), known as Urocidin^TM (or as "EN3348") for treatment-refractory non-muscle-invasive bladder cancer. The trial completed recruitment of patients in March, 2009, with the last patient reaching his/her one-year assessment this spring. Data compilation has been ongoing since that time, with the database lock undertaken in November.

In North America, bladder cancer is the fourth most common cancer in men and the fifth overall between both men and women. In the United States, approximately 70,000 patients are newly diagnosed with bladder cancer each year and 500,000 living patients have been affected. The cancers of many of the previously-diagnosed patients remain unresolved, sometimes leading to cystectomy (bladder removal) or death. Approximately 70 percent of bladder cancer patients have the non-muscle-invasive form of bladder cancer and, on appropriate regulatory approvals, might be eligible for multiple treatments with Urocidin^TM.

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^TM is an intravesical infusion therapy, administered via trans-urethral catheter into the bladder. 

Under the licensing agreement, Bioniche received an up-front payment of US$20 million in July, 2009, and has the potential to receive a total of US$110 million in payments associated with the achievement of certain clinical, regulatory and commercial milestones. Four development milestones have been achieved by the Company since November, 2009, resulting in total payments of US$18 million. Future milestones will be announced as they are achieved and, with its exclusive manufacturing supply contract, Bioniche will also receive a net-sales-based revenue stream upon product approval.

It was announced on August 19, 2010 that Bioniche and Endo are finalizing a protocol for an additional clinical trial - targeted to begin enrolling patients around year-end, 2010. Summary details of this new protocol are now publicly available via the U.S. National Institutes of Health (NIH) clinical trial registration service at http://www.clinicaltrials.gov. This new trial will be a Phase III, randomized, active-controlled, open-label, multi-centre trial to evaluate Urocidin^TM (EN3348) versus mitomycin C in the intravesical treatment of patients with recurrent or refractory non-muscle-invasive bladder cancer. It is intended that 450 patients will be enrolled at 120 clinical sites. The trial will form part of a regulatory submission to the U.S. Food and Drug Administration (FDA).