- Company to Address Agency Requests in a Timely Manner -
MORRISTOWN, N.J., July 14 /PRNewswire-FirstCall/ -- Watson
Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company,
announced today that it received a Complete Response Letter from the U.S. Food
and Drug Administration (FDA) on its New Drug Application (NDA) for TRELSTAR
22.5 mg (triptorelin pamoate for injectable suspension), a 24-week formulation
of TRELSTAR for the palliative treatment of advanced prostate cancer. The
TRELSTAR 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
TRELSTAR 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 is designed to be conveniently administered and to
continuously suppress the production of testosterone in men with advanced
prostate cancer for 24 weeks. TRELSTAR is an already proven therapy with
established efficacy and safety in two formulations - a four-week formulation
(TRELSTAR DEPOT) and a 12-week formulation (TRELSTAR LA).
TRELSTAR , 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 is currently available in a four-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 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.
For press release and other company information, visit Watson
Pharmaceuticals' Web site at http://www.watson.com.
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.
For more information on Debiopharm Group, please visit:
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.
SOURCE Watson Pharmaceuticals, Inc.
of Watson Pharmaceuticals, Inc.,
of Ogilvy Public Relations,
for Watson Pharmaceuticals, Inc.
Web Site: http://www.watson.com