BELLEVILLE, ON, Oct. 7, 2013 /CNW/ - Bioniche Life Sciences Inc. (TSX:
BNC) (ASX: BNC), a research-based, technology-driven Canadian
biopharmaceutical company, today provided an update on its plans for a
New Drug Submission filing in Canada for Urocidin™, the Company's Phase III bladder cancer product.
As announced in July, the Company had a meeting in late June with Health
Canada, at which time the Company discussed the filing of a regulatory
submission for Urocidin™ under Health Canada's Notice of Compliance with Conditions (NOC/c)
policy. At that time, 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, but 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.
The Company initially anticipated that all of the requested materials
could be submitted to Health Canada before the end of calendar 2013.
However, based on subsequent discussions with Health Canada, additional
information will be required to finalize the submission, which will
result in a delay. The Company now believes that it will have these
materials ready for submission by June 30, 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
U.S. registration. Such meeting is being sought at the earliest
As indicated in its year-end financials news release of September 27,
2013, the Company is focused on licensing Urocidin™ rights for major markets such as the U.S. and Europe, as well as preparations
for its launch in Canada. In June, 2013, the Company announced a
license agreement with Paladin Labs Inc. for the Canadian, Mexican and
South African markets. For the U.S. and other market licenses, the
Company began receiving unsolicited requests for information on
possible regional licenses for Urocidin™ early in 2013. To date, the Company has a list of 9 companies in the
U.S. and 18 companies in Europe that have requested to be considered as
license partners for Urocidin™, and a list of 9 companies for smaller markets.
Treatment of non-muscle-invasive bladder cancer in patients who failed
BCG therapy is the first target indication for Urocidin™.
Urocidin™ is a formulation of MCNA, a sterile mycobacterial cell wall-nucleic acid
composition that has anticancer activity. Previously known as MCC
suspension, this name has been changed to reflect the detailed characterization of MCC suspension following receipt of
regulatory feedback. It was discovered that the current method of
manufacture resulted in conservation of RNA, in addition to the previously conserved DNA, hence
the name MCNA. UrocidinTM 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.
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