Watson Receives US FDA Approval for RAPAFLO(TM) (silodosin) for the Treatment of Benign Prostatic Hyperplasia (BPH)

CORONA, Calif., Oct. 8 — Watson
Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical
company, announced today that the U.S. Food and Drug Administration (FDA)
has approved RAPAFLO(TM) (silodosin), the company’s new alpha blocker for
the treatment of the signs and symptoms of BPH.

BPH is the number one reason patients visit urologists and is
characterized by urination problems, including decreased urine flow, more
frequent urination and nocturia. The U.S. BPH market is growing and
currently exceeds $2 billion annually, of which $1.7 billion is attributed
to alpha blockers.

“RAPAFLO’s approval is the most important milestone for the Company’s
Brand division thus far,” said Paul Bisaro, Chief Executive Officer of
Watson. “RAPAFLO is a novel product that provides strong efficacy and an
exceptional safety profile for patients managing their BPH. RAPAFLO
provides an excellent long term opportunity for Watson and will be the
foundation for future growth of our urology franchise.”

Today’s approval is based on data from two Phase 3, 12-week,
randomized, double-blind, placebo-controlled, multi-center studies as well
as a 40 week open label study. In the two Phase 3 studies, 923 patients
(mean age 64.6 years) were randomized to receive either RAPAFLO 8 mg
once-daily or placebo. In the two trials, 8 mg once-daily RAPAFLO for 12
weeks resulted in significant and rapid relief of BPH symptoms, compared
with placebo, as measured by the International Prostate Symptom Score
(IPSS). IPSS includes irritative (frequency, urgency, and nocturia), and
obstructive (hesitancy, incomplete emptying, intermittency, and weak
stream) symptoms. RAPAFLO also has been proven to significantly improve
Qmax scores (maximum urine flow rates) as early as two hours following
first dose and at 12 weeks of treatment.

“We are pleased we received approval for RAPAFLO so quickly which
demonstrates, among other things, the high quality of our clinical and
regulatory groups,” said Mr. Bisaro. “With our oxybutynin gel NDA under
consideration with the FDA and plans to file our Trelstar(R) 6 month
application later this year, Watson is in a unique position to introduce
products within the next 12 to 18 months that treat the top three
conditions in urology.”

About RAPAFLO

RAPAFLO is an effective, selective alpha-1 adrenergic receptor
antagonist. RAPAFLO binds with high affinity to the alpha (1A) receptors
concentrated in the prostate, causing the smooth muscles in these tissues
to relax and resulting in improved urine flow and a reduction in BPH
symptoms. The binding affinity for the alpha (1B) receptors that cause
smooth muscle relaxation and blood pressure effects is significantly lower,
thereby maximizing target organ activity for treating BPH and minimizing
the potential for side effects and interactions with other therapies.

In clinical trials, RAPAFLO demonstrated strong efficacy with minimal
effects on the cardiovascular system, and clinical studies have shown that
RAPAFLO does not cause any meaningful prolongation of the QT interval. The
most common drug-related side effect was retrograde ejaculation (orgasm
with reduced semen), a direct reflection of the product’s selective binding
properties. In targeting the 1A receptors, organ-specific activity is
maximized, and cardiovascular effects are minimized. Rates of discontinuing
therapy due to retrograde ejaculation were low. The second most
commonly-reported adverse event was dizziness. The incidence of
treatment-related dizziness was low and only slightly higher among RAPAFLO
than placebo-treated patients.

Recently presented data demonstrate that RAPAFLO can also be
administrated in combination with medications for erectile dysfunction with
no symptomatic effects on blood pressure or heart rate.

RAPAFLO was originally developed by Kissei Pharmaceutical Co., Ltd. in
Japan and licensed to Watson for the US, Canada and Mexico markets.

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 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: RAPAFLO(TM);
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: a
six-month formulation of TRELSTAR(R) (triptorelin pamoate for injectable
suspension), for the treatment of advanced prostate cancer; 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.

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, including RAPAFLO; 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.

SOURCE Watson Pharmaceuticals, Inc.