Bioniche Life Sciences Inc. and Endo Pharmaceuticals Sign Licensing Agreement for Urocidin(TM) |
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| Friday, 10 July 2009 09:45 |
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Under the agreement signed by both companies, Endo will pay Bioniche an up-front cash payment of "We are excited about the opportunity to expand our portfolio in bladder cancer treatment and enhance our late stage development pipeline," said
Bladder Cancer and the Ongoing Phase III Clinical Program for Urocidin(TM) In 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. The first of two Phase III U.S. Food and Drug Administration (FDA)-approved and Fast Track designated registration trials with Urocidin is nearing complete enrolment. In this trial, patients with non-muscle-invasive bladder cancer whose cancer is specifically refractory (unresponsive) to current therapy are receiving Urocidin in an open label trial. Thirty-one urology centres in Data from the full cohort of evaluable patients from this trial, coupled with additional safety information to be collected from a second registration trial, will be used to support regulatory submissions under the FDA's Accelerated Approval program. Bioniche plans to conduct a second registration trial that will directly compare the efficacy and safety of Urocidin with current therapy in the first-line treatment of non-muscle-invasive bladder cancer. In September, 2007, Bioniche announced that an agreement had been reached with the FDA under the Special Protocol Assessment (SPA) procedure on the design of the trial, including its endpoints, data analysis and conduct. It provides assurance that, if the trial endpoints are met, they will serve as the basis for product approval under a Biologics Licensing Application (BLA). An SPA gives a clear pathway to registration of MCC when the trial endpoints are achieved. This trial received Fast Track designation by the FDA last year. With Endo's support, Bioniche will commence this multi-centre trial, setting up clinical trial centres immediately. About Urocidin(TM) 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, coming into contact with immune system cells 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 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 approximately 200 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 About Endo Pharmaceuticals Inc. Endo Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development, sale and marketing of branded and generic prescription pharmaceuticals used to treat and manage pain, overactive bladder, prostate cancer and the early onset of puberty in children, or central precocious puberty (CPP). Its products include LIDODERM(R), a topical patch to relieve the pain of postherpetic neuralgia; PERCOCET(R) and PERCODAN(R) tablets for the relief of moderate-to-moderately severe pain; FROVA(R) tablets for the acute treatment of migraine attacks with or without aura in adults; OPANA(R) tablets for the relief of moderate-to-severe acute pain where the use of an opioid is appropriate; OPANA(R) ER tablets for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time; and VOLTAREN(R) Gel, a nonsteroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment such as those of the hands and the knees. Voltaren(R) Gel is owned and licensed by Novartis AG; SANCTURA(R) and its XR version for treatment of overactive bladder, VANTAS(R) for the palliative treatment of advanced prostate cancer, and SUPPRELIN(R) LA for the treatment of early onset puberty in children. The company markets its branded pharmaceutical products to physicians in pain management, neurology, surgery, oncology, endocrinology and primary care. More information, including this and past press releases of Endo Pharmaceuticals, is available at www.endo.com. BiomedReports is not paid or compensated to report news and developments about publicly traded companies. Full disclosure can be read in the About Us Section Add this page to your favorite Social Bookmarking websites            |
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