Watson Pharmaceuticals, Inc. and Antares Pharma, Inc. announced an exclusive licensing agreement for Watson to commercialize Antares' topical oxybutynin gel product in the US 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 US 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 PhD, 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.”
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.
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.