PARSIPPANY, N.J. and EWING, N.J., July 11, 2011 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) and Antares Pharma, Inc. (NYSE Amex: AIS) today announced an exclusive licensing agreement for Watson to commercialize Antares' topical oxybutynin gel product in the U.S. and Canada. A New Drug Application for the oxybutynin gel product is currently under review by the Food and Drug Administration (FDA). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of December 8, 2011.
Under terms of the agreement, Watson will make milestone payments based on the achievement of regulatory approval and certain sales levels, and will also be responsible for certain manufacturing start-up activities. Upon launch of the product, Antares will receive escalating royalties based on product sales in the U.S. and Canada. Additional details on the agreement have not been disclosed.
Antares' oxybutynin product is a clear, odorless topical gel that has demonstrated to be an effective and safe treatment for overactive bladder (OAB), a condition that affects more than 30 million Americans. Based on a 12-week, multi-center placebo controlled Phase 3 clinical study conducted by Antares, patients treated with 56 mg daily or 84 mg daily experienced a statistically significant decrease in OAB symptoms versus placebo, including the number of urinary incontinence episodes per day. The product was well tolerated in the study with no reported serious treatment-related side effects. Anticholinergic side effects such as dry mouth and constipation were low and no increase in CNS side effects was seen compared to placebo.
"The addition of Antares' oxybutynin gel product will strategically enhance our overactive bladder product portfolio, potentially providing patients with the dosing flexibility of two strengths, allowing for dose titration, together with a convenient novel pump delivery system," said Fred Wilkinson, Watson's Executive Vice President, Global Brands. "Additionally, this product will expand our product offerings to the Urology and OB/GYN audiences."
"We are extremely pleased to partner Anturol® with Watson, a company with a growing strategic position in urology with a well established commercialization infrastructure and a dedicated experienced sales force," said Paul K. Wotton Ph.D., President and Chief Executive Officer. "We are confident Watson will successfully market the positive attributes of this next generation OAB gel product to physicians and patients. We look forward to working with Watson and developing a strong strategic relationship between our two companies."
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 http://www.watson.com.
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 that is currently under review by the FDA for the treatment of OAB (overactive bladder). Antares also has a partnership with BioSante that includes LibiGel® (transdermal testosterone gel) 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 corporate headquarters in Ewing, New Jersey, with subsidiaries performing research, development and product commercialization activities in Minneapolis, Minnesota and Muttenz, Switzerland.
This communication contains forward-looking statements, which 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: difficulty of predicting the timing and outcome of FDA and/or Health Canada approvals or actions, if any; the impact of competitive products and pricing; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA, Health Canada and/or other governmental regulations applicable to manufacturing facilities, products and/or businesses; 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 Report on Form 10-K for the year ended December 31, 2010 and Form 10-Q for the quarter ended March 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.
Antares Pharma, Inc.
Robert F. Apple
Chief Financial Officer
Westwicke Partners, LLC
Tiberend Strategic Advisors, Inc.
SOURCE Watson Pharmaceuticals, Inc.; Antares Pharma, Inc.