EndocrinologyWatson Pharmaceuticals Receives A Complete Response Letter For Its 24-Week Formulation Of TRELSTAR(R) (triptorelin Pamoate) NDA From US FDA
Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced that it received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) on its New Drug Application (NDA) for TRELSTAR(R) 22.5 mg (triptorelin pamoate for injectable suspension), a 24-week formulation of TRELSTAR(R) for the palliative treatment of advanced prostate cancer. The TRELSTAR(R) NDA was prepared in cooperation with Debiopharm Group, a Swiss-based global biopharmaceutical group of companies.
According to the letter, the FDA has requested clarifications related to the clinical testing of the product, additional information regarding the chemistry, manufacturing and controls (CMC) of the product and other components, and information related to third party manufacturing. Watson is working to ensure the requested information is provided to the FDA expeditiously.
TRELSTAR(R) 22.5 mg builds on Watson"s long-standing track record in prostate cancer and expanding urology franchise. The new, longer-acting formulation of TRELSTAR(R) is designed to be conveniently administered and to continuously suppress the production of testosterone in men with advanced prostate cancer for 24 weeks. TRELSTAR(R) is an already proven therapy with established efficacy and safety in two formulations - a four-week formulation (TRELSTAR(R) DEPOT) and a 12-week formulation (TRELSTAR(R) LA).
About TRELSTAR(R)
TRELSTAR(R), developed by Debiopharm Group and marketed by Watson, administers a synthetic luteinizing hormone releasing hormone (LHRH) agonist, triptorelin, which suppresses the production of testosterone in the testicles. Prostatic cancer proliferation is regulated in part by the level and activity of testosterone. TRELSTAR(R) is currently available in a four-week depot formulation (TRELSTAR(R) DEPOT) and a 12-week long-acting formulation (TRELSTAR(R) 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(R) 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(R) is contraindicated for use in women.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc., is a global leader in the development and distribution of pharmaceuticals with a broad portfolio of generic products and a specialized portfolio of brand pharmaceuticals focused on Urology, Women"s Health and Nephrology/Medical.
About Debiopharm Group
Debiopharm Group is a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs. The group in-licenses promising biological and small molecule drug candidates. It develops its products for global registration and maximum commercial potential. Once registered, the products are out-licensed to pharmaceutical partners for sales and marketing.
Debiopharm independently funds the worldwide development of all of its products while providing expertise in pre-clinical and clinical trials, manufacturing, drug delivery and formulation, and regulatory affairs.
Founded in 1979 and headquartered in Lausanne, Switzerland, Debiopharm has developed four products with global combined sales of $2.6 billion in 2008.
Forward-Looking Statement
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; difficulties or delays in manufacturing; the difficulty of predicting the timing or outcome of FDA or other regulatory agency approvals or actions, if any; 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, 2008.
Watson Pharmaceuticals, Inc.