Fantastic News boooyaahhh
Bioniche Life Sciences Inc. and Endo Pharmaceuticals Inc. Sign Licensing Agreement for Urocidin(TM)
7/10/2009 8:00 AM - Canada NewsWire
BELLEVILLE, ON and CHADDS FORD, PA, Jul 10, 2009 (Canada NewsWire via COMTEX News Network) --
Bioniche Life Sciences Inc. (TSX: BNC) and Endo Pharmaceuticals Inc. (Nasdaq: ENDP) jointly announced today that Endo has licensed from Bioniche the exclusive rights to develop and market Urocidin(TM) in the U.S. with an option for global rights. Urocidin is a patented formulation of Mycobacterial Cell Wall-DNA Complex (MCC) developed by Bioniche for the treatment of non-muscle-invasive bladder cancer that is currently undergoing Phase III clinical testing.
Under the agreement signed by both companies, Endo will pay Bioniche an up-front cash payment of $20M USD and the potential for up to $110M USD in additional payments linked to the achievement of future clinical, regulatory, and commercial milestones. In addition, Bioniche will manufacture the product and receive a transfer price for supply.
"We are excited about the opportunity to expand our portfolio in bladder cancer treatment and enhance our late stage development pipeline," said David Holveck, president and chief executive officer of Endo Pharmaceuticals. "In August, Endo plans to launch Valstar(TM), for the treatment of BCG-refractory bladder cancer. If successful in clinical development, Urocidin has the potential to extend and enhance our recent therapeutic expansion and strengthen the Valstar franchise."
Graeme McRae, Chairman, President & CEO of Bioniche, added, "Endo Pharmaceuticals represents the optimal development and commercialization partner for Bioniche, given its understanding of the bladder cancer market and breadth of pharmaceutical industry experience. We look forward to advancing the Urocidin development and commercialization program in collaboration with the Endo team. Equally, we are very excited about the potential returns to Bioniche and its shareholders following commercialization of Urocidin."
<< Bladder Cancer and the Ongoing Phase III Clinical Program for Urocidin(TM) >>
In North America, bladder cancer is the fourth most common cancer in men and in the top ten for women. In the United States, approximately 70,000 patients are newly diagnosed with bladder cancer each year. In addition, the cancers of many 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 at diagnosis and, on appropriate regulatory approvals, might be eligible for multiple treatments with Urocidin.
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 is an intravesical infusion therapy, administered via trans-urethral catheter into the bladder.
The first of two Phase III U.S. Food and Drug Administration (FDA)-approved and Fast Track designated registration trials with Urocidin is nearing complete enrolment. In this trial, patients with non-muscle-invasive bladder cancer whose cancer is specifically refractory (unresponsive) to current therapy are receiving Urocidin in an open label trial. Thirty-one urology centres in North America are participating in this trial and recruitment of 105 evaluable patients was completed in March, 2009.
Data from the full cohort of evaluable patients from this trial, coupled with additional safety information to be collected from a second registration trial, will be used to support regulatory submissions under the FDA's Accelerated Approval program.
Bioniche plans to conduct a second registration trial that will directly compare the efficacy and safety of Urocidin with current therapy in the first-line treatment of non-muscle-invasive bladder cancer. In September, 2007, Bioniche announced that an agreement had been reached with the FDA under the Special Protocol Assessment (SPA) procedure on the design of the trial, including its endpoints, data analysis and conduct. It provides assurance that, if the trial endpoints are met, they will serve as the basis for product approval under a Biologics Licensing Application (BLA). An SPA gives a clear pathway to registration of MCC when the trial endpoints are achieved. This trial received Fast Track designation by the FDA last year. With Endo's support, Bioniche will commence this multi-centre trial, setting up clinical trial centres immediately.
