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.
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.
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.
Vice President, Corporate Affairs
Westwicke Partners, LLC
[i] IMS Health Statistics.
SOURCE Watson Pharmaceuticals, Inc.