Urologists Should Recognize the Cardiac Safety of Prescribed Medications, Article...

Urologists Should Recognize the Cardiac Safety of Prescribed Medications,
Article Concludes
- QTc profile particularly important among BPH patients with cardiovascular
risk factors -

CORONA, Calif., Aug. 5 /PRNewswire-FirstCall/ -- A paper published in the
current issue of Reviews in Urology (2008; 10(2):85-91) concludes that
urologists and other physicians treating benign prostatic hyperplasia (BPH)
should prescribe medications that do not affect the heart's electrical
activity (heart repolarization), especially since most men with BPH are older
and often take other medications that also may impact the heart.
"In the complex and fast-paced world of medicine, where patient safety is
a primary concern, physicians need to be assured that they are using agents
and the best possible safety profile. This is particularly important with
agents that affect heart rhythm and may predispose patients to
life-threatening arrhythmias that can occur without warning," said Herbert
Lepor, M.D., Professor of Urology and Martin Spatz, Chairman of the Department
of Urology, New York University School of Medicine, NY, and lead author of the
review article.
Alpha-blockers are an easy-to-use, well-tolerated class of drugs for BPH.
However, some current agents may prolong the QT interval (a measure of heart
repolarization on an electrocardiogram, or ECG), thereby predisposing patients
to potentially life-threatening ventricular arrhythmias. In October 2005, the
U.S. Food and Drug Administration (FDA) suggested that new drugs under
development, particularly agents with systemic bioavailability (i.e., drug
that enter the circulatory system), should undergo critical assessment of
their effect on QTc interval.*
Watson's investigational alpha-blocker, silodosin, was highlighted in the
review article. The FDA is currently reviewing a New Drug Application for
silodosin, for the treatment of BPH. If approved, silodosin will provide an
important option for men with BPH.
"Many urologists and other physicians who treat BPH don't often have
access to ECG to monitor the cardiac safety of the agents they prescribe,"
said Norman Lepor, M.D., a cardiologist and associate clinical professor of
medicine, University of California, Los Angeles (UCLA) Cedars-Sinai Medical
Center, and co-author of the new review article. "Therefore, it's important
that physicians recognize which agents affect the QTc interval and to avoid
those agents if an alternative is available."
For a copy of Dr. Lepor's review article ("Treatment Update -- The QT
Interval and Selection of Alpha-Blockers for Benign Prostatic Hyperplasia"),
please contact Watson Medical Communications at (800) 272-5525.
About Silodosin
Silodosin is a novel, uniquely selective alpha (1A)-adrenoceptor
antagonist originally developed by Kissei Pharmaceutical Co., Ltd. in Japan
and licensed to Watson for the U.S., Canada and Mexico. Silodosin
preferentially binds to the alpha (1A) receptors in the prostate, bladder
neck, urethra, and vas deferens relative to cardiovascular associated
adrenoreceptors, thereby maximizing target organ activity while minimizing the
potential for blood pressure effects. Urief(R) (silodosin) 4mg, dosed twice
daily, was launched in Japan in May 2006 and is marketed by Kissei in
cooperation with Daiichi Sankyo Co., Ltd. Silodosin is under development in
the U.S. for the treatment of the signs and symptoms of BPH.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc., (NYSE: WPI) headquartered in Corona, CA, is
a leading specialty pharmaceutical company that develops, manufactures,
markets, sells and distributes brand and generic pharmaceutical products.
Watson pursues a growth strategy combining internal product development,
strategic alliances and collaborations and synergistic acquisitions of
products and businesses.
The mission of Watson Urology is 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: Oxytrol(R);
TRELSTAR(R) LA; TRELSTAR(R) Depot; Androderm(R); ProQuin(R) XR, under a
co-promotion agreement with Depomed, Inc.; and AndroGel(R), under a
co-promotion agreement with Solvay Pharmaceuticals, Inc. The Watson portfolio
also includes a number of products under development including: silodosin, a
product under development for the treatment of benign prostatic hyperplasia; a
six-month formulation of TRELSTAR(R) (triptorelin pamoate for injectable
suspension), under development for the treatment of advanced prostate cancer;
and oxybutynin topical gel, under development for overactive bladder.
For press releases and other company information, visit Watson
Pharmaceuticals' Web site at http://www.watson.com.
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 difficulty of predicting the timing or outcome of product
development efforts and FDA or other regulatory agency approvals or actions,
if any; whether the results of clinical trials for silodosin and other
information will be sufficient to support approval by FDA or other regulatory
authorities; impact of competitive products and pricing; market acceptance of
and continued demand for Watson's products; difficulties or delays in
manufacturing; 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.
* US FDA. Guidance for Industry E14 Clinical Evaluation of QT/QTc
Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic
Drugs. October 2005. Available at:
http://www.fda.gov/cber/gdlins/iche14qtc.htm#v

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SOURCE Watson Pharmaceuticals, Inc.

Patty Eisenhaur of Watson Pharmaceuticals, Inc., +1-951-493-5611; or Trina
Chiara, +1-646-420-3365, or Rashelle Isip, +1-212-880-5354, both of Ogilvy
Public Relations, for Watson Pharmaceuticals, Inc.