Paladin Labs and Hydro Med Sciences Sign License Agreement for a Once Yearly Implant for Prostate Cancer.Business Editors & Health/Medical Writers BIOWIRE2K MONTREAL & CRANBURY, N.J.--(BUSINESS WIRE)--Oct. 4, 2002 Paladin Paladin archetypal gunman who leaves a calling card. [TV: Have Gun, Will Travel in Terrace, I, 341] See : Wild West Labs Inc. (TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension :PLB (Picture Level Benchmark) A benchmark for measuring graphics performance on workstations. The Benchmark Interface Format (BIF) defines the format, the Benchmark Timing Methodology (BTM) performs the test, and the Benchmark Reporting Format (BRF) generates results in ), a Canadian specialty pharmaceutical company focused on marketing and selling urology urology Medical specialty dealing with the urinary system and male reproductive organs. It traces its origin to medieval lithologists, itinerant healers who specialized in surgical removal of bladder stones. , endocrinology and women's health Women's Health Definition Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues. products, and Hydro Med Sciences, Inc. announce that they have entered into a licensing agreement regarding the Canadian rights to a unique, once-yearly implant (Histrelin Hydrogel hy·dro·gel n. A colloidal gel in which the particles are dispersed in water. hydrogel a gel that contains water. hydrogel Wound care A polymer absorptive wound dressing. See Dressing. Implant) for the palliative treatment palliative treatment n. Treatment to alleviate symptoms without curing the disease. Palliative treatment A type treatment that does not provide a cure, but eases the symptoms. Mentioned in: Laparoscopy of advanced prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. . Under this agreement, Paladin receives exclusive rights for the sale and marketing of the product in Canada while Hydro Med will assume responsibility for manufacturing and completing the development of this novel implant. The Histrelin Implant is a drug-filled, miniature hydrogel implant that utilizes Hydro Med's patented and proprietary Hydron(TM) Implant technology. It is surgically placed under the skin in the inner aspect of a patient's upper arm during an in-office procedure. This product provides 12 months of continuous, steady-state drug delivery with a single treatment. This once-yearly implant represents an alternative to leuprolide, goserelin goserelin /go·se·rel·in/ (go´se-rel?in) a synthetic gonadotropin-releasing hormone; on prolonged administration it suppresses release of gonadotropins and is used as the acetate salt to treat breast and prostate carcinomas and and buserelin injections, which are currently administered once every one, three or four months. The implant is currently being investigated in a multi-center, pivotal Phase III trial in Canada and the U.S. Based on encouraging interim data from this trial, it is anticipated that a regulatory submission will be filed in the United States by Q3 2003 and in Canada by Q1 2004. The implant active ingredient, Histrelin, is part of a class of drugs known as luteinizing hormone-releasing hormone luteinizing hormone-releasing hormone n. Abbr. LHRH, LRH See gonadotropin-releasing hormone. (LHRH LHRH abbr. luteinizing hormone-releasing hormone LHRH Luteinizing hormone-releasing hormone, GnRH, gonadotropin-releasing hormone, LRH, LRF Endocrinology A decapeptide synthesized by hypothalamic neurons which ) agonists. Sustained levels of LHRH agonists decrease testosterone levels to suppress tumor growth in patients with hormone-responsive prostate cancer. Research shows that suppression of testosterone production can lead to the cancer shrinking or the prevention of further growth. A standard treatment regimen for advanced prostate cancer often includes a urologist Urologist A physician who deals with the study and treatment of disorders of the urinary tract in women and the urogenital system in men. Mentioned in: Congenital Bladder Anomalies, Lithotripsy, Men's Health, Overactive Bladder urologist starting a patient on one-month LHRH therapy and then moving to a longer release product (3-4 months) if the patient responds to therapy. Chronic administration of an LHRH agonist is needed to provide continuous suppression of testosterone levels. The National Cancer Institute of Canada estimates that, with the exception of skin cancers, prostate cancer is the most common cancer afflicting Canadian men. Each year approximately 16,000 new cases of prostate cancer are diagnosed in Canada and an estimated 4,000 men will die of the disease. According to IMS (1) See IP Multimedia Subsystem. (2) (Information Management System) An early IBM hierarchical DBMS for IBM mainframes. IMS was widely implemented throughout the 1970s under MVS and continues to be used under z/OS. Canada Inc., in 2001 the total LHRH agonist market in Canada for the treatment of prostate cancer was $69 million. This market has grown at a compounded annual growth rate of 8% since 1998 on a prescription basis. "This is a terrific opportunity for Paladin," said Jonathan Goodman, President and Chief Executive Officer of Paladin Labs Inc. "There are over 2000 physicians in Canada who prescribed approximately $69 million of LHRH agonists for prostate cancer last year. However, about 320 urologists wrote 63% of the business. This urologist driven market represents an excellent strategic fit for us, given that our national sales force is currently calling on Canadian urologists to promote Androderm(R), the only testosterone patch approved for sale in Canada." David Tierney, M.D., President and Chief Executive Officer of Hydro Med Sciences said, "We are pleased to be partnering with Paladin, a company with established relationships with Canadian urologists and a proven ability to successfully launch innovative pharmaceuticals in Canada. Our Histrelin Hydrogel Implant is a highly compact and flexible implant that is simple to administer in-office and it offers patients an alternative to monthly or quarterly injections. We are presently advancing this unique LHRH implant through Phase III clinical trials and we look forward to its commercialization." About Hydro Med Sciences, Inc. Hydro Med Sciences, with executive offices in Cranbury, N.J., is led by a highly experienced management team committed to extending the possibilities of pharmaceutical healthcare. The Company focuses on developing, acquiring and commercializing specialty pharmaceuticals and, through internal R&D and strategic partnerships, is advancing the state-of-art of drug delivery with its innovative Hydron(TM) Implant technology. Additional information is available on the internet at: http://www.hydromed.com/ About Paladin Labs Inc. Paladin Labs, headquartered in Montreal, Quebec, is a rapidly growing pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian market. With this strategy, a focused national sales team and proven marketing expertise, Paladin has evolved into one of Canada's most profitable publicly-traded pharmaceutical companies. Paladin's shares trade on the Toronto Stock Exchange Toronto Stock Exchange (TSE) Canada's largest stock exchange, trading approximately 1,200 company stocks and 33 options. under the symbol PLB. For more information about Paladin, please visit the Paladin Web Site at www.paladin-labs.com. This news release may contain forward-looking statements or predictions. These statements represent our judgement as of this date and are subject to risks and uncertainties that could cause actual results or events to differ materially from those expressed in such forward-looking statements. Potential risks and uncertainties include, without limitation, those associated with product development, clinical trials, future revenues and profitability, and obtaining marketing approval. |
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