Urocidin™ Phase III Clinical Trial Results Presented at AUA Conference in Washington, D.C.
podium presentation by Dr. Alvaro Morales, Global Principal Investigator
CHADDS FORD, PA, and BELLEVILLE, ON, May 17 - Endo Pharmaceuticals and Bioniche Life Sciences today presented Phase III trial results for the intravesical formulation of Mycobacterial cell wall-DNA complex (MCC), known as Urocidin™, during a podium presentation at the 2011 American Urological Association annual meeting in Washington, D.C. The preliminary results from the interim analysis of this prospective trial indicate that Urocidin™ may provide an alternative to cystectomy for patients with bacillus Calmette-Guérin (BCG) refractory non-muscle invasive bladder cancer (NMIBC).
The preliminary results were generated from an interim analysis in an ongoing Phase III trial with Urocidin in the treatment of NMIBC that is refractory to BCG and at high risk of progression.
A total of 129 patients were enrolled from 25 centers in the U.S. and Canada, with high grade papillary tumors and/or carcinoma in situ (CIS) and having failed to respond to one or more courses of BCG. According to the preliminary results the overall one-year disease-free survival (DFS) rate was 25 percent. DFS is defined as lack of recurrence or progression to muscle-invasive disease, as confirmed by biopsy. The one-year DFS rate was 35 percent for patients with only papillary tumors and 21 percent for patients with carcinoma in situ (CIS) with or without papillary tumors. The preliminary results indicate that intravesical administration of Urocidin™ was well tolerated.
Ongoing Phase III Clinical Program with Urocidin™
Summary details of a Phase III clinical trial protocol with Urocidin™ being conducted by Endo are publicly available via the U.S. National Institutes of Health (NIH) clinical trial registration service at http://www.clinicaltrials.gov. This trial is actively enrolling eligible NMIBC patients.
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.
Urocidin™ is a formulation of MCC, a sterile mycobacterial cell wall-DNA complex composition that appears to have a dual mode of action: immune stimulation and direct anticancer activity. Urocidin™ is being investigated for the treatment of non-muscle invasive 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 214 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety. The Company’s primary goal is to develop proprietary cancer therapies supported by revenues from marketed products in human and animal health. Bioniche has been named one of the Top 50 Best Small and Medium-Sized Employers in Canada for 2010. For more information, please visit www.Bioniche.com.
About Endo Pharmaceuticals Inc.
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.
For further information, please contact:
Jennifer Shea, Vice-President, Communications, Investor & Government Relations
Bioniche Life Sciences Inc.
Telephone: (613) 966-8058
Cell: (613) 391-2097