BELLEVILLE, ON, July 8, 2013 /PRNewswire/ - Bioniche Life Sciences Inc. (TSX:
BNC) (ASX: BNC), a research-based, technology-driven Canadian
biopharmaceutical company, today announced the outcome of a meeting in
late June with Health Canada, at which time the Company discussed the
filing of a regulatory submission for its Phase III bladder cancer
product - Urocidin - under Health Canada's Notice of Compliance with Conditions (NOC/c)
Health Canada advised the Company that the data from the first Phase III
clinical trial with Urocidin may be sufficient to qualify for filing under the NOC/c policy. The
regulator asked the Company to submit a clinical assessment package
addressing some clinical questions as part of the request to file a New
Drug Submission (NDS) under the NOC/c policy. It is anticipated that
all materials may be submitted to Health Canada before the end of
calendar 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 will also be seeking a meeting with the U.S. Food and Drug
Administration (FDA) to discuss a clinical development plan to achieve
The Company recently announced its first new licensing deal for Urocidin - with Paladin Labs Inc. The Company has granted Paladin an exclusive
license to market and distribute Urocidin for bladder cancer in Canada, South Africa and Mexico. The companies
have agreed to a net revenue sharing arrangement. Bioniche will be
responsible for all product development and manufacturing costs and
Paladin will be responsible for all sales and marketing costs in the
said territories. The agreement provides that Paladin will pay a series
of potential sales performance milestones that can total up to $16
million during the term of the agreement.
Treatment of non-muscle-invasive bladder cancer in patients who failed
BCG therapy is the first target indication for Urocidin. The Company estimates that, in Canada alone, a minimum of 3,100
patients per year will qualify for treatment with Urocidin according to this label claim. At up to 21 doses per patient and at a
pricing per dose that is competitive relative to other treatments, the
Company believes that the market for UrocidinTM could be considerable.
Several other companies remain interested and actively engaged in
discussing licensing opportunities for Urocidin in other global jurisdictions.
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. 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 386,300 new 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 7,900 (5,900 men; 2,000 women) new
bladder cancer cases are expected in 2013, 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.