BELLEVILLE, Ontario,
April 1, 2013 /PRNewswire/ --
Bioniche Life Sciences Inc. (TSX: BNC) (ASX: BNC), a
research-based, technology-driven Canadian biopharmaceutical
company, today announced that sponsorship of its Phase III bladder
cancer product - Urocidin™ - has been returned to the
Company from former development/marketing partner, Endo
Pharmaceuticals (Endo).
It was announced in December, 2012 that Bioniche and Endo had
come to an agreement whereby Endo would return global rights to
Urocidin™. Since that time, Bioniche and Endo have been
working together to ensure a smooth transition. Endo has completed
all termination activities related to the original license
agreement between the two companies and sponsorship has now been
officially returned to Bioniche.
"This is an important milestone for Urocidin™," said Mr.
Graeme McRae, President & CEO of
Bioniche Life Sciences Inc. "With sponsorship back in our hands, we
will endeavor to schedule meetings with North American regulatory
agencies. With Health Canada, we will discuss the potential for
approval of a regulatory submission under its Notice of Compliance
with Conditions policy. With the U.S. Food and Drug Administration
(FDA), we will propose a revised clinical development plan to
achieve U.S. registration."
"The urology community recognizes the urgent need for
complementary and/or alternative treatments for non-muscle-invasive
bladder cancer that fails to respond to BCG," said Dr. Alvaro Morales, Professor Emeritus, Department
of Urology, Queen's University (Kingston,
Ontario). "A number of research teams around the world are
actively studying a variety of agents, some of which are showing
significant promise. Currently, Urocidin™ is the only one
that has completed a Phase III trial." Dr. Morales was the
Principal Investigator in the Phase I and II clinical trials, as
well as the Phase III clinical trial with Urocidin™.
If the Company is successful in obtaining access to the Canadian
market under the Notice of Compliance with Conditions (NOC/c)
policy, a new drug submission could be made to Health Canada before
the end of 2013. Approximately one year of review would follow and,
if Health Canada is satisfied with the submission, an approval
under NOC/c could follow before the end of 2014.
An early registration in Canada
would generate revenues from commercial sales to offset the cost of
additional clinical trial work that may be required for the U.S.
and other jurisdictions.
The Company is also actively in discussions with potential new
development/partners who are interested in obtaining rights to
Urocidin™ in certain jurisdictions. Such partnerships are
expected to generate up-front payments, milestones, development
support, and licensing revenues.
The Company recently announced the establishment of a new
wholly-owned private Human Health subsidiary - Bioniche
Therapeutics Corp. The subsidiary is a standalone unit, and the new
structure will allow direct external investment to support research
and development activities, commercialization activities and
acquisition opportunities, which may result in accretive value to
the parent company. A search is ongoing for a Chief Executive
Officer for the new subsidiary.
About Urocidin[TM]
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.
Urocidin[TM] is
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 from sales.
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
Urocidin[TM] 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. The last
patient's last dose was administered in April, 2011 and the last
patient's last visit occurred in December, 2011.
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 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 72,570 new cases of
bladder cancer and 15,210 deaths from bladder cancer will occur in
the United States in 2013. In
Canada, an estimated 7,800 (5,800
men; 2,000 women) new bladder cancer cases were expected in 2012,
with 2,100 expected deaths. 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.
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 One Health. The Company's primary goal is to
develop and commercialize products that advance human or animal
health and increase shareholder value.
For more information, please visit http://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 annual reporting.
For further information:
Jennifer Shea, Vice-President,
Communications, Investor & Government Relations
Bioniche Life Sciences Inc.
Telephone: +1(613)966-8058; from Australia: 0011-1-613-966-8058
Cell: +1(613)391-2097; from Australia: 0011-1-613-391-2097
Jennifer.Shea@Bioniche.com
