Microsoft word - antares oxybutynin gel approval final clean
Antares’ Oxybutynin Gel Product Approved by FDA
for the Treatment of Overactive Bladder
-- Novel Formulation Provides Convenience, Efficacy and Excellent Tolerability
-- Watson to Launch Product in Spring 2012 --
PARSIPPANY, NJ and EWING, NJ – December 8, 2011 -- Watson Pharmaceuticals, Inc.
(NYSE: WPI) and Antares Pharma, Inc. (NYSE Amex: AIS) today announced that the U.S.
Food and Drug Administration (FDA) has approved Antares’ topical oxybutynin gel 3% product
for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence,
urgency, and frequency. OAB is a condition that affects more than 33 million Americans, and
the market currently exceeds $2.0 billion annually.
Antares’ oxybutynin product is a clear, odorless topical gel available in a convenient, metered-
dose pump that has demonstrated to be an effective and safe treatment for overactive bladder
(OAB). Because the active ingredient is delivered transdermally, it is not metabolized by the
liver in the same way as orally administered oxybutynin. This results in a low level of side
effects, such as dry mouth and constipation. Under an exclusive licensing agreement, Watson
anticipates launching the product in 2012.
“This significant achievement represents Antares’ first NDA approval and is the culmination of a
development program managed successfully by our clinical and regulatory team,” said Paul K.
Wotton, Ph.D., Antares’ President and CEO. “Watson Pharmaceuticals’ proven track record of
commercializing transdermal products to urologists and other significant prescribers of OAB
treatments makes them an ideal partner to execute a successful product launch.”
“The addition of Antares’ oxybutynin gel product will strategically enhance our overactive
bladder product portfolio which currently includes GELNIQUE® (oxybutynin chloride) Gel 10%,
and OXYTROL® oxybutynin transdermal system,” said Fred Wilkinson, Watson’s Executive
Vice President, Global Brands. “With the addition of Antares’ new gel formulation, we look
forward to offering patients the added convenience of a novel pump delivery system beginning
About Antares’ Oxybutynin Gel 3%
Antares 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 delivers a consistent dose of oxybutynin through the
skin over a 24-hour period, providing significant efficacy without sacrificing tolerability.
The approval of Antares’ oxybutynin gel 3% is based on a 12-week, multi-center placebo
controlled Phase 3 clinical study conducted by Antares. Patients were randomized to either an
84 mg or 56 mg dose application of oxybutynin gel 3% versus placebo. The FDA approved the
84 mg dose application. Patients treated with 84 mg oxybutynin gel daily achieved steady
state drug concentrations within three days and experienced a statistically significant decrease
in OAB symptoms versus placebo, including the number of urinary incontinence episodes per
week. Statistically significant improvements in daily urinary frequency and urinary void volume
The product was well tolerated in the study. The most frequently reported treatment-related
adverse events (>3%) were dry mouth (12.1% versus 5% in placebo), application site erythema
(3.7% versus 1.0% in placebo) and application site rash (3.3% versus 0.5% in placebo).
Additional pharmacokinetic studies showed that showering one hour or later, or the application
of sunscreen 30 minutes before or after gel application had no affect on the overall systemic
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 Antares Pharma
Antares Pharma 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 distributed as Tjet® and Zomajet® by Teva
Pharmaceutical Industries, Ltd (Teva) and Ferring Pharmaceuticals (Ferring), respectively. In
the injector area, Antares Pharma 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 lead product candidate is Anturol®, an oxybutynin ATD™
gel for the treatment of OAB (overactive bladder) which has been licensed to Watson
Pharmaceuticals, Inc. for the U.S. and Canada. Antares’ partnership with BioSante includes
LibiGel® (transdermal testosterone gel) which is now in Phase 3 clinical development for the
treatment of female sexual dysfunction (FSD), and Elestrin® (estradiol gel) indicated for the
treatment of moderate-to-severe vasomotor symptoms associated with menopause, and
currently marketed in the U.S. 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
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a leading integrated global pharmaceutical company. The
Company is engaged in the development and distribution of generic pharmaceuticals and
specialized branded pharmaceutical products focused on Urology and Women's Health.
Watson has operations in many of the world's established and growing international markets.
For press release and other company information, visit Watson Pharmaceuticals' Web site at
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, 2010 and Form 10-Q for the quarter ended September 30, 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.
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