BELLEVILLE, ON, Jan. 3, 2013 /CNW/ - Bioniche Life Sciences Inc. (TSX:
BNC) (ASX: BNC), a research-based, technology-driven Canadian
biopharmaceutical company, today provided an update on the return of
global rights to Urocidin™ from Endo Pharmaceuticals (Endo), a subsidiary of Endo Health
Solutions. It was announced on December 21, 2012 that the two companies
came to an agreement that a mutually favourable path forward for the
product is to return its global rights to Bioniche.
As detailed in the Termination Agreement posted on www.SEDAR.com and www.ASX.com.au, in exchange for this agreement, Endo will receive a 5% royalty on
future net sales revenue for a term of 10 years from the first
commercial sale of the product or, on a country by country basis, until
the last of the valid patent claims covering the product has expired or
The two companies are currently focused on ensuring a smooth transition
from Endo to Bioniche, which includes the completion of a number of
activities related to terminating the original license agreement that
was signed in July, 2009. The termination activities include closing
clinical trial sites from the most recent Phase III clinical trial that
was discontinued by Endo in November, 2012. It is expected that all
such activities will be concluded by March 31, 2013, at which time,
clinical trial sponsorship will officially return to Bioniche.
"With sponsorship in our hands, we can work with regulators to assess
the best path forward, including a potential 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," said Mr. Graeme McRae, President & CEO of Bioniche Life Sciences Inc.
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. The Company is also seeking new partners in selected
jurisdictions. "The Company has identified potential new 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," added Mr. McRae. "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. 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.
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.
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