CHADDS FORD, Pa. and
BELLEVILLE, Ontario, Feb. 16, 2011 /PRNewswire/ -- Endo
Pharmaceuticals (Nasdaq: ENDP) and Bioniche Life Sciences Inc. (TSX
and ASX: BNC), today announced enrollment of the first patient in
the second Phase III clinical trial of Urocidin™. The trial
is a randomized, active-controlled, open-label, multi-center study
with a blinded endpoint assessment designed to compare
Urocidin™ with mitomycin C in the intravesical treatment of
patients with BCG recurrent or refractory non-muscle-invasive
bladder cancer.
It is estimated that 450 patients will be enrolled for this new
trial at approximately 120 clinical sites worldwide. Summary
details of the study protocol are now publicly available via the
U.S. National Institutes of Health (NIH) clinical trial
registration service at http://www.clinicaltrials.gov.
About Bladder Cancer
In North America, bladder
cancer is the fourth most common cancer in men and the fifth
overall between both men and women. In the United States, approximately 70,000
patients are newly diagnosed with bladder cancer each year and
500,000 living patients have been affected. In Europe, more than 100,000 patients are newly
diagnosed each year. Bladder cancer is frequently a recurrent
disease, with some cases becoming refractory to available
chemotherapeutic or immunotherapeutic agents and leading to
cystectomy (bladder removal) or death. Approximately 70 percent of
bladder cancer patients have the non-muscle-invasive form of
bladder cancer. Collectively across the U.S., Europe and Japan, approximately 350,000
non-muscle-invasive bladder cancer patients are newly diagnosed or
have a recurrence each year.
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 Urocidin™
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™
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 Endo-Bioniche Partnership
Endo holds exclusive global rights to develop and market
Bioniche's patented formulation of Mycobacterial Cell Wall-DNA
Complex (MCC), Urocidin™, being developed for the
intravesical treatment of non-muscle-invasive bladder cancer. Under
the licensing agreement, Bioniche received an up-front payment of
US$20 million in July 2009, and became eligible to receive an
additional US$110 million in
milestone payments. Milestones are announced as they are achieved
and, with its exclusive manufacturing supply contract, Bioniche
provides clinical trial material and will also receive a
net-sales-based revenue stream upon product approval.
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
products for human and animal health markets worldwide. The
fully-integrated company employs over 200 skilled personnel and has
three operating divisions: Human Health, Animal Health, and Food
Safety. For more information, please visit www.Bioniche.com.
About Endo
Endo Pharmaceuticals is a U.S.-based, specialty healthcare
solutions company, focused on high-value branded products and
specialty generics. Endo is redefining its position in the
healthcare marketplace by anticipating and embracing the evolution
of health decisions based on the need for high-quality and
cost-effective care. We aim to be the premier partner to healthcare
professionals and payment providers, delivering an innovative suite
of complementary diagnostics, drugs, devices and clinical data to
meet the needs of patients in areas such as pain, urology, oncology
and endocrinology. For more information about Endo Pharmaceuticals,
and its wholly owned subsidiaries HealthTronics, Inc. and Qualitest
Pharmaceuticals, please visit www.endo.com.
Bioniche Forward-Looking Statements
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.
Endo Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding, among other things, the company's financial position,
results of operations, market position, product development and
business strategy, as well as estimates of future net sales, future
expenses, future net income and future earnings per share.
Statements including words such as "believes," "expects,"
"anticipates," "intends," "estimates," "plan," "will," "may," "look
forward," "intend," "guidance" or similar expressions are
forward-looking statements. Because these statements reflect
our current views, expectations and beliefs concerning future
events, these forward-looking statements involve risks and
uncertainties. Investors should note that many factors, as more
fully described under the caption "Risk Factors" in our Form 10-K,
Form 10-Q and Form 8-K filings with the Securities and Exchange
Commission and as otherwise enumerated herein or therein, could
affect our future financial results and could cause our actual
results to differ materially from those expressed in
forward-looking statements contained in our Annual Report on Form
10-K. Important factors that could cause our actual results
to differ materially from the expectations reflected in the
forward-looking statements in our Annual Report on Form 10-K
include those factors described herein under the caption "Risk
Factors" and in documents incorporated by reference, including,
among others: our ability to successfully develop, commercialize
and market new products; timing and results of pre-clinical or
clinical trials on new products; our ability to obtain regulatory
approval of any of our pipeline products; competition for the
business of our branded and generic products, and in connection
with our acquisition of rights to intellectual property assets;
market acceptance of our future products; government regulation of
the pharmaceutical industry; our dependence on a small number of
products; our dependence on outside manufacturers for the
manufacture of most of our products; our dependence on third
parties to supply raw materials and to provide services for certain
core aspects of our business; new regulatory action or lawsuits
relating to our use of narcotics in most of our core products; our
exposure to product liability claims and product recalls and the
possibility that we may not be able to adequately insure ourselves;
our ability to protect our proprietary technology; the successful
efforts of manufacturers of branded pharmaceuticals to use
litigation and legislative and regulatory efforts to limit the use
of generics and certain other products; our ability to successfully
implement our acquisition and in-licensing strategy; regulatory or
other limits on the availability of controlled substances that
constitute the active ingredients of some of our products and
products in development; the availability of third-party
reimbursement for our products; the outcome of any pending or
future litigation or claims by third parties or the government, and
the performance of indemnitors with respect to claims for which we
have the right to be indemnified; our dependence on sales to a
limited number of large pharmacy chains and wholesale drug
distributors for a large portion of our total revenues; significant
litigation expenses to defend or assert patent infringement claims;
any interruption or failure by our suppliers, distributors and
collaboration partners to meet their obligations pursuant to
various agreements with us; a determination by a regulatory agency
that we are engaging or have engaged in inappropriate sales or
marketing activities, including promoting the "off-label" use of
our products; existing suppliers become unavailable or lose their
regulatory status as an approved source, causing an inability to
obtain required components, raw materials or products on a timely
basis or at commercially reasonable prices; the loss of branded
product exclusivity periods and related intellectual property.
SOURCE Endo Pharmaceuticals