- Innovative pipeline products highlight Watson's commitment to urology - Embargoed Until 2:10 PM EDT
ORLANDO, Fla., May 21 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals,
Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced today
that investigators presented clinical data on two Phase 3 products at the
American Urological Association's annual meeting. The abstracts include a
cardiac safety trial involving silodosin, an investigational treatment for
benign prostatic hyperplasia (BPH, or prostate enlargement) and a
pharmacokinetic study of oxybutynin chloride topical gel (OTG), an
investigational product for overactive bladder.
"Watson is committed to helping urologists offer their patients the
highest standard of care through providing novel treatments that continually
address areas of urology with limited therapeutic options," said Edward
Heimers, Jr., Executive Vice President and President of Watson's Brand
Division. "We are extremely encouraged by the results demonstrated in these
two trials, as they support the safety of silodosin and the potential efficacy
of OTG as well as offer important patient benefits. A marketing application
for silodosin has been filed with the FDA, and one for OTG will be filed.
Both products represent potentially important additions to the expanding
Watson urology franchise."
In the first trial (abstract #2037), investigators conducted a
double-blind, randomized, parallel-group trial to assess whether or not
silodosin -- an investigational alpha blocker -- would prolong the QT interval
on an electrocardiogram (ECG). QT is a measure of the heart's electrical
activity. A prolongation of the QTc (corrected for heart rate) interval
favors the development of cardiac arrhythmias, which can lead to sudden death.
The investigators concluded that silodosin did not demonstrate any meaningful
effect on heart rate or QTc interval duration. The most common side effects
seen greater than 2% were retrograde ejaculation (reduced semen) and
dizziness. The abstract (Double-blind, Randomized, Parallel-Group Study to
Define Electrocardiographic Effects of Silodosin, a Uroselective
alpha-Adrenergic Antagonist) was presented by Herbert Lepor, M.D., Department
of Urology, New York University School of Medicine, NY, on Wednesday, May 21
at 2:10 pm.
"The effects of silodosin on the QTc interval were rigorously evaluated,"
said Dr. Lepor. "Our results found that silodosin does not affect the QT
interval. QTc prolongation has been observed with other alpha blockers.
Therefore, this is an important study for the development of any alpha
blocker."
The second trial (abstract #1508) found that OTG produces serum levels
similar to an already-approved oxybutynin transdermal patch (Oxytrol(R)), but
demonstrates improved skin tolerability that may lead to greater patient
acceptability and use. As expected, dry mouth and application site dermatitis
were the only treatment-related side effects reported in more than 2% of
participants. OTG is designed to provide the same advantages as the patch
over a pill formulation, in terms of convenience, ease of delivery, and a
lower risk of anticholinergic side effects such as dry mouth and constipation.
The abstract (Steady-State Pharmacokinetics of an Investigational Oxybutynin
Topical Gel in Comparison with Oxybutynin Transdermal System) was presented by
David R. Staskin, M.D., Department of Urology, Weill Medical College of
Cornell University, NY, on Tuesday, May 20 at 2:30 pm.
"I would expect that based on the comparative serum levels of oxybutynin
and desethyloxybutynin, the gel formulation will preserve many of the
advantages associated with the transdermal patch with the potential for a
significant improvement in skin-related side effects," Dr. Staskin said.
"Watson Urology is making a broader, more visible commitment to the
medical and patient communities," said Heimers. "Through our innovative
pipeline, we are focused on developing effective, safe and convenient
treatments that not only treat the symptoms of common urological conditions
but also offer patients quality of life advantages."
The two trials presented at AUA are part of Watson's comprehensive R&D
program, and represent the company's focus on providing products and services
that improve the quality of patients' lives. In addition, Watson recently
announced the approval of MIXJECT(R), a new delivery system for TRELSTAR(R)
DEPOT 3.75 mg and TRELSTAR(R) LA 11.25 mg (triptorelin pamoate for injectable
suspension), a palliative treatment for advanced prostate cancer. MIXJECT(R)
combines the proven efficacy of TRELSTAR(R) with new features that make
preparation, administration and disposal easier, including: a thinner 21-gauge
needle for improved patient comfort; reconstitution without the use of a
needle; and a shield covering the needle both before and after drug
administration. The system, developed and manufactured by West Pharmaceutical
Services, Inc., is specifically designed to encourage compliance with OSHA
(Occupational Safety and Health Administration) regulations within the medical
community.
About Silodosin
Silodosin is a novel, highly uroselective alpha (1A)-adrenoceptor
antagonist originally developed by Kissei Pharmaceutical Co., Ltd. in Japan
and licensed to Watson for the US, Canada and Mexico markets. Silodosin
preferentially binds to the alpha (1A) receptors in the prostate and bladder
neck relative to cardiovascular associated receptors, 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 US for the treatment of the signs
and symptoms of benign prostatic hyperplasia (BPH).
About Oxybutynin Chloride Topical Gel (OTG)
OTG is a clear, odorless, ethanolic gel that provides for delivery of
oxybutynin hydrochloride in a non-patch transdermal form. OTG is under
development for the treatment of overactive bladder with symptoms of urge
urinary incontinence, urgency and frequency.
About TRELSTAR(R)
TRELSTAR(R), developed by Debiopharm Group, a Swiss biopharmaceutical
specialist, 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(R) is available in a 4-week depot
formulation (TRELSTAR(R) DEPOT) and a 12-week long-acting formulation
(TRELSTAR(R) LA), offering an alternative treatment for advanced 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.
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 who are or may
become pregnant. For additional information, please discuss with your
physician or contact Watson Medical Communications at 866-75-J3315.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc., 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 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 OTG, 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 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.
MIXJECT(R) is manufactured by and is a registered trademark of Medimop
Medical Projects Ltd., a subsidiary of West Pharmaceutical Services, Inc., and
is manufactured by West Pharmaceutical Services, Inc.
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SOURCE Watson Pharmaceuticals, Inc.
