Bioniche provides update on Urocidin clinical development program for non-muscle-invasive bladder cancer

Aug 20 2010

- analysis of data from first Phase III clinical trial nearing completion -

Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology driven Canadian biopharmaceutical company, today provided an update on the clinical development program for its proprietary product for non-muscle-invasive bladder cancer - Urocidin(TM).

Bioniche and its development partner, Endo Pharmaceuticals Inc. (NASDAQ: ENDP), are in the process of finalizing a protocol for an additional clinical trial - expected to begin enrolling patients in 2010. Details of this new protocol, when finalized, will be made publicly available via the U.S. National Institutes of Health clinical trial registration service at http://www.clinicaltrials.gov.

"We're preparing to initiate a large study with Urocidin in the second half of this year that could become the pivotal study of this very interesting product to treat bladder cancer," said Dr. Ivan Gergel, Executive Vice President, Research and Development at Endo Pharmaceuticals Inc. "Urocidin is a novel treatment for refractory bladder cancer, which represents the type of innovative solutions we want to offer urologists and their patients."

Concurrently, 12-month data from the ongoing U.S. Food and Drug Administration (FDA) Phase III registration trial with Urocidin(TM) for non-muscle-invasive bladder cancer refractory to current therapy are undergoing thorough analysis. Endo expects to complete this process by the end of September, 2010.

In North America, bladder cancer is the fourth most common cancer in men and is in the top ten for 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. Three milestones have been achieved by the Company since November, 2009, for total proceeds of US$14 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.