PARSIPPANY, N.J. and
EWING, N.J., April 26, 2012 /PRNewswire/ -- Watson
Pharmaceuticals, Inc. (NYSE: WPI) and Antares Pharma, Inc. (NYSE
Amex: AIS) today announced the launch of Gelnique 3%™ (oxybutynin)
gel 3%, for the treatment of overactive bladder (OAB) with symptoms
of urge urinary incontinence, urgency and frequency. Gelnique
3%™ is a clear, odorless topical gel that has been shown to be an
effective and safe treatment for OAB. The product is available
in a metered pump dispenser, offering patients convenient
dosing.
(Photo: http://photos.prnewswire.com/prnh/20120426/NY95340)
OAB is a condition that affects more than 33 million Americans,
and the treatment market in the U.S. currently exceeds $2.0 billion annually.[i] Gelnique 3%™, developed
by Antares and obtained through an exclusive licensing agreement by
Watson, was approved by the U.S.
Food & Drug Administration on December
8, 2011.
Because the active ingredient in Gelnique 3%™ is delivered
transdermally, in a clear, odorless gel, it is not metabolized by
the liver in the same way as orally administered oxybutynin
products. This is thought to result in a low level of side effects
such as dry mouth and constipation, common with orally administered
OAB medications.
"The launch of Gelnique 3%™ further demonstrates Watson's commitment to invest in building a
leadership position in urology, particularly in the overactive
bladder market," said Fred
Wilkinson, Watson's
Executive Vice President, Global Brands. "The clinical trial
demonstrated an early treatment effect versus placebo and improved
efficacy over time. In addition, Gelnique 3%™ provides OAB
patients with the convenience of once-daily dosing using a simple,
precise metered-dose pump.
"We are very excited about the launch of Gelnique 3%™," said
Paul K. Wotton Ph.D., President and Chief Executive Officer of
Antares Pharma. "Watson's
experience and commitment to urology coupled with their
well-established and knowledgeable commercial team makes them the
perfect partner to market this next generation gel product for the
treatment of overactive bladder."
About Gelnique 3%™ (oxybutynin) gel
3%
Gelnique 3%™ (oxybutynin) gel 3% is a topical, translucent
hydroalcoholic gel containing oxybutynin, an antispasmodic,
antimuscarinic agent. Applied once daily to the thigh, abdomen,
upper arm or shoulder, an 84 mg (approx. 3 mL) dose of Gelnique 3%™
delivers a consistent dose of oxybutynin through the skin over a
24-hour period, providing significant efficacy without sacrificing
tolerability.
In a Phase 3 study, 84 mg, once-daily Gelnique 3%™ was superior
to placebo at relieving OAB symptoms including a reduction in
incontinence episodes and urinary frequency, and an increase in
urine void volume. Gelnique 3%™ demonstrated a significant median
reduction in urinary incontinence episodes (67%) versus placebo
(50%) at week 12 of the clinical study supporting approval.
Notably, significant reductions in incontinence episodes were seen
in patients after just one week of therapy. Patients in the trial
experienced more than six urinary incontinence episodes a day on
average at baseline, or at the beginning of the trial.
Additional pharmacokinetic studies showed that showering one
hour or later, or the application of sunscreen 30 minutes before or
after gel application had no effect on the overall systemic
exposure of the drug.
Important Safety Information
The most commonly reported adverse events associated with the
use of Gelnique 3% included dry mouth (12.1%), application site
erythema (3.7%), and application site rash (3.3%). Gelnique 3% is
contraindicated in patients with urinary retention, gastric
retention, or uncontrolled narrow-angle glaucoma, and in patients
who are at risk for these conditions. Gelnique 3% should be used
with caution in patients with clinically significant bladder
outflow obstruction, myasthenia gravis, gastrointestinal
obstructive disorders, ulcerative colitis, intestinal atony,
gastroesophageal reflux and those concurrently taking drugs that
can cause or exacerbate esophagitis. Angioedema requiring
hospitalization and emergency medical treatment has occurred with
the first or subsequent doses of oxybutynin pills. If angioedema
occurs, Gelnique 3% should be discontinued and appropriate therapy
promptly provided. Transference of oxybutynin to another person can
occur when vigorous skin-to-skin contact is made with the
application site. Patients should be instructed to avoid open flame
or smoking until the gel has dried.
For full prescribing information, please visit
www.gelnique.com.
About Overactive Bladder (OAB)
OAB is characterized by a sudden, uncomfortable need to urinate
with or without urge incontinence (urine leakage), and usually
includes more frequent urination and nocturia (waking up at least
once during the night to urinate). It affects as many as 33
million adults in the U.S. – more than diabetes or asthma.
More than an "inconvenience," OAB is disabling and associated
with a marked decrease in health-related quality of life as well as
higher rates of depression. The disease affects both men and
women however, women experience more severe symptoms earlier in
life.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a leading integrated global
pharmaceutical company. Watson is
engaged in the development, manufacture and distribution of generic
pharmaceuticals and specialized branded pharmaceutical products
focused on Urology and Women's Health. The Company is also
developing biosimilar products in Women's Health and
Oncology. Additionally, we distribute generic and branded
pharmaceuticals through our Anda Distribution business.
In 2011, Watson was the third
largest generic pharmaceutical company in the United States.
We also have commercial operations in key international markets
including Canada, Western Europe, Asia/Pacific, South
Africa and Latin America.
Watson distributes approximately
8,500 stock-keeping units in the U.S. directly to more than 60,000
customers through our Anda Distribution Division.
For press release and other company information, visit Watson
Pharmaceuticals' Web site at http://www.watson.com.
About Antares Pharma, Inc.
Antares Pharma, Inc. focuses on self-injection pharmaceutical
products and topical gel-based medicines. The Company's
subcutaneous and intramuscular injection technology platforms
include Vibex™ disposable pressure-assisted auto injectors,
disposable multi-use pen injectors and Vision™ reusable needle-free
injectors marketed as Tjet® and Zomajet® by Teva Pharmaceutical
Industries, Ltd (Teva) and Ferring Pharmaceuticals (Ferring),
respectively. In the injector area, Antares Pharma, Inc. has
a multi-product deal with Teva that includes Tev-Tropin® human
growth hormone (hGH) and a partnership with Ferring that includes
Zomacton® hGH. In the gel-based area, the Company's FDA approved
product is Gelnique 3%™ for the treatment of OAB (overactive
bladder) which has been licensed to Watson Pharmaceuticals, Inc.
for marketing in the U.S. and Canada. Antares' portfolio includes Elestrin®
(estradiol gel) indicated for the treatment of moderate-to-severe
vasomotor symptoms associated with menopause, and marketed in the
U.S. by Jazz Pharmaceuticals. Antares Pharma has two
facilities in the U.S. The Parenteral Products Division located in
Minneapolis, Minnesota directs the
manufacturing and marketing of the Company's reusable needle-free
injection devices and related disposables, and develops its
disposable pressure-assisted auto injector and pen injector
systems. The Company's corporate offices and Pharma Division are
located in Ewing, New Jersey,
where pharmaceutical products are developed utilizing both the
Company's transdermal systems and drug/device combination
products.
Forward-Looking Statement
This communication contains forward-looking statements,
including statements regarding the timing of product launch.
These statements are indicated by the words "may," "will," "plans,"
" intends, " "believes," "expects," "anticipates," "potential,"
"could," "would," "should," and similar expressions. Such
forward-looking statements involve known and unknown risks,
uncertainties, and other factors that may cause actual results to
differ materially from those projected in the forward-looking
statements. Readers are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
on which they are made. Factors that might cause future results to
differ include, but are not limited to, the following: difficulties
or delays in manufacturing; the availability and pricing of third
party sourced products and materials; successful compliance with
FDA and/or other governmental regulations applicable to
manufacturing facilities, products and/or businesses; difficulty of
predicting the impact of competitive products and pricing; changes
in the laws and regulations, including Medicaid, and similar drug
reimbursement laws; competitive economic and regulatory factors in
the pharmaceutical and healthcare industry; the ability to obtain
and enforce patents and other intellectual property rights; general
economic conditions; and other risks and uncertainties that may be
detailed, from time-to-time, in Watson's and Antares' reports filed with the
SEC, including, but not limited to, their Annual Reports on Form
10-K for the year ended December 31,
2011. Watson and Antares do
not undertake any responsibility to revise or update any
forward-looking statements contained herein, except as expressly
required by law.
CONTACTS:
Watson
Investors:
Patty Eisenhaur
(862) 261-8141
Media:
Charlie Mayr
(862) 261-3020
Antares
Investors:
Jack Howarth
Vice President, Corporate Affairs
609-359-3020 x133
jhowarth@antarespharma.com
Westwicke Partners, LLC
John Woolford
(443) 213-0506
john.woolford@westwicke.com
[i] IMS Health Statistics.
SOURCE Watson Pharmaceuticals, Inc.