NDA for 6-Month Formulation of Trelstar Accepted for Filing
Watson Announces the NDA for a 6-Month Formulation of Trelstar Accepted for Filing by FDA for the Treatment of Advanced Prostate Cancer
CORONA, Calif., November 13, 2008 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, today announced that its New Drug Application (NDA) for a 6-month formulation of Trelstar (triptorelin pamoate), a luteinizing hormone releasing hormone (LHRH) agonist, has been accepted for filing by the U.S. Food and Drug Administration (FDA). Watson is seeking marketing approval of this Trelstar formulation for the palliative treatment of advanced prostate cancer. Watson anticipates that FDA will take action on its application in the third quarter 2009.
The sustained-release formulation of Trelstar is designed to suppress the production of testosterone in men with advanced prostate cancer over 6 months. Prostate cancer growth is regulated in part by the level and activity of testosterone.
"This filing reflects Watson's commitment to urology and to making a difference in the lives of men living with prostate cancer," said Paul Bisaro, Watson's President and Chief Executive Officer. "This new longer duration Trelstar formulation requires only one injection every 24 weeks, and showed comparable efficacy and safety with our marketed Trelstar 1 and 3-month formulations. The Trelstar 6-month formulation should be a welcome alternative for men and their physicians and will be a significant addition to our expanding urology portfolio."
Trelstar, developed by Debiopharm Group, a Swiss biopharmaceutical development specialist, and marketed by Watson Pharma, Inc., is a synthetic hormone known as a luteinizing hormone releasing hormone (LHRH) agonist, which suppresses the production of testosterone in the testicles. The growth of the prostate is regulated in part by the level and activity of testosterone. Trelstar is currently available in a 4-week depot formulation (Trelstar Depot) and a 12-week long-acting formulation (Trelstar LA), offering an alternative treatment for prostate cancer when orchiectomy (removal of the testicles) or estrogen administration are either not indicated or unacceptable to the patient. Trelstar does not require refrigeration and should be stored at controlled room temperature.
Important Safety Information
In clinical trials, the most common adverse events occurring in patients were hot flushes, skeletal pain, impotence and headache. As with all LHRH agonists, triptorelin causes an initial transient increase in testosterone levels and may initiate or worsen symptoms during this transient period. Rare post-marketing reports of anaphylactic shock and angioedema have been reported. Trelstar is contraindicated for use in women.
About Prostate Cancer
Prostate cancer is the most common cancer in men in the U.S., excluding skin cancer, and is estimated to account for 25 percent of all new cancers diagnosed in men. According to the American Cancer Society, approximately 186,320 new cases of prostate cancer are expected to be diagnosed in 2008 in the U.S.; 28,660 men with prostate cancer are expected to die this year(1). The majority of cases diagnosed are in men over the age of 65. Prostate cancer can be detected early through regular digital rectal examinations and PSA testing. Low PSA levels typically are found in the blood of healthy men; the amount of PSA in the blood normally increases in the presence of prostate cancer.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes generic and specialty brand pharmaceutical products. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses.
The Watson urology franchise is pleased to offer products and services that improve the quality of patients' lives, and satisfy the needs of physicians who specialize in the diagnosis, management, and treatment of urological disorders. By advancing education and support for urological diseases, we are creating the differences that make life more livable.
In the U.S., the Watson urology portfolio includes: RAPAFLO; Oxytrol; Trelstar LA; Trelstar Depot; Androderm; ProQuin XR, under a co-promotion agreement with Depomed, Inc.; and AndroGel, under a co-promotion agreement with Solvay Pharmaceuticals, Inc. The Watson portfolio also includes a number of products under development including oxybutynin topical gel for overactive bladder and Uracyst(TM), for cystitis.
For press releases and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.
Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Watson's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Watson's current expectations depending upon a number of factors affecting Watson's business. These factors include, among others, the impact of competitive products and pricing; market acceptance of and continued demand for Watson's products, including Trelstar; difficulties or delays in manufacturing; the difficulty of predicting the timing or outcome of FDA or other regulatory agency approvals or actions, if any; patents and other intellectual property rights held by the Company and the ability to successfully enforce such rights against third parties; and other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's Annual Report on Form 10-K for the year ended December 31, 2007.
(1) American Cancer Society. Cancer Facts & Figures 2008. Atlanta: American Cancer Society; 2008. Page 10.
CONTACT: Patty Eisenhaur of Watson Pharmaceuticals, Inc., +1-951-493-5611;or Lori Schachtman, +1-847-975-2330, or Maggie Hoffman, +1-330-653-3196,both of Ogilvy Public Relations, for Watson Pharmaceuticals, Inc.
Ticker Symbol: (NYSE:WPI)
Terms and conditions of use apply
Copyright © 2008 PR Newswire Association LLC. All rights reserved.
A United Business Media Company
Posted: November 2008