BELLEVILLE, ON and CHADDS FORD, PA, July 10 /CNW/ - 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.
