-Bioniche identifies potential for early access to the Canadian market-
BELLEVILLE, ON, Dec. 21, 2012 /PRNewswire/ - Bioniche Life Sciences Inc. (TSX:
BNC) (ASX: BNC), a research-based, technology-driven Canadian
biopharmaceutical company, today announced that global rights to Urocidin are being returned to the Company from Endo Pharmaceuticals (Endo), a
subsidiary of Endo Health Solutions.
On November 5th, it was announced that a second Phase III clinical trial with Urocidin in non-muscle-invasive bladder cancer being run by Endo was being
discontinued. The trial, a randomized, active-controlled, open-label,
multi-center study, was designed to compare UrocidinTM 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
U.S. Food and Drug Administration (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 favourable 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.
"This is a tremendous opportunity for us," said Mr. Graeme McRae,
President & CEO of Bioniche Life Sciences Inc. "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 UrocidinTM."
The Company also now has the opportunity to seek alternate partnership
arrangements, which would be expected to generate income to offset the
costs of any additional clinical trial work required.
"We remain committed to the successful commercialization of Urocidin, which we believe is an important and much-needed therapy for those
suffering from non-muscle-invasive bladder cancer," added Mr. McRae.
Company representatives will be available to discuss this development
further during a:
Conference Call & Audio Webcast
Thursday, January 10, 2013
5:00 p.m. (Eastern)
To participate in the conference call from North America, call (888)
231-8191 (conference ID: 83659012).
To participate in the conference call from Australia, call 1-800-287-011
(conference ID: 83659012).
A listen-only audio webcast will be available at:
A replay of the conference call will be available until January 17, 2013
at midnight by calling 1-855-859-2056 (passcode: 83659012).
The webcast will be available for replay using the above link until
January 10, 2014.
About Bladder Cancer
Bladder cancer is one of the leading causes of death among men and women
and an estimated 357,000 bladder cancer cases occur worldwide each
year. It is estimated that 73,510 new cases of bladder cancer and
14,880 deaths from bladder cancer will occur in the United States in
2012. In Canada, an estimated 7,800 (5,800 men; 2,000 women) new
bladder cancer cases are expected in 2012. Bladder cancer is the 4th most common cancer in men and the 12th most common cancer in women in North America. The prevalence of
non-muscle-invasive bladder cancer is ten times its incidence and
creates a major economic burden on healthcare systems. As measured on
the basis of cumulative per patient cost from the time of diagnosis
until death, bladder cancer is the most expensive cancer to treat.
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.
Urocidin is a formulation of MCC, a sterile mycobacterial cell wall-DNA complex
composition that has a dual mode of action: immune stimulation and
direct anticancer activity. UrocidinTMis formulated for the treatment of bladder cancer, where it is
administered by trans-urethral catheter directly into the bladder. The
agent is then able to directly interact with the cells of the immune
system and bladder cancer cells. Industry Canada's Industrial
Technologies Office (formerly Technology Partnerships Canada) has
contributed to the development of Bioniche's mycobacterial cell wall
technologies by means of a C$9.6 million loan to be repaid by Bioniche
About the First Phase III Clinical Trial with Urocidin
The Company's first Phase III trial was a 129-patient open label,
single-arm trial, meaning there was no comparator therapy used in the
trial. The trial was designed to assess the safety and efficacy of UrocidinTM as a treatment of non-muscle-invasive bladder cancer in patients whose
cancer had not responded positively to prior treatment with BCG
therapy. This trial enrolled its first patient in November, 2006 and
the last patient was enrolled in April, 2009.
Preliminary results, reported at urology association meetings in March,
May and June, 2011, showed that, after 12 months, there was a 25%
overall disease-free survival rate and the product was well-tolerated
by patients with most adverse events considered "mild to moderate".
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a research-based, technology-driven
Canadian biopharmaceutical company focused on the discovery,
development, manufacturing, and marketing of proprietary and innovative
products for human and animal health markets worldwide. The
fully-integrated company employs more than 200 skilled personnel and
has three operating divisions: Human Health, Animal Health, and Food
Safety. The Company's primary goal is to develop and commercialize
products that advance human or animal health and increase shareholder
For more information, please visit www.Bioniche.com.
Except for historical information, this news release may contain
forward-looking statements that reflect the Company's current
expectation regarding future events. These forward-looking statements
involve risk and uncertainties, which may cause, but are not limited
to, changing market conditions, the successful and timely completion of
clinical studies, the establishment of corporate alliances, the impact
of competitive products and pricing, new product development,
uncertainties related to the regulatory approval process, and other
risks detailed from time to time in the Company's ongoing quarterly and
SOURCE Bioniche Life Sciences Inc.