BELLEVILLE, ON, April 1, 2013 /CNW/ - 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
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.
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. UrocidinTM 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
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. 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
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.
For further information:
Jennifer Shea, Vice-President, Communications, Investor & Government Relations
Bioniche Life Sciences Inc.
Telephone: (613) 966-8058; from Australia: 0011 1 613-966-8058
Cell: (613) 391-2097; from Australia: 0011 1 613-391-2097