PARSIPPANY and EWING, N.J. — Watson Pharmaceuticals Inc. and Antares Pharma Inc. have entered into an exclusive licensing agreement for Watson to commercialize Antares’ topical oxybutynin gel product in the United States and Canada.

The pharmaceutical companies said Monday that a New Drug Application (NDA) for the product — a clear, odorless oxybutynin topical gel, indicated for the treatment of overactive bladder — is now under review by the Food and Drug Administration, which has assigned a Prescription Drug User Fee Act (PDUFA) date of Dec. 8.

Overactive bladder (OAB) affects more than 30 million Americans, Watson and Antares reported.

"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," stated Fred Wilkinson, executive vice president of global brands at Watson. "Additionally, this product will expand our product offerings to the urology and ob/gyn audiences."

Under the agreement, Watson will make milestone payments based on the achievement of regulatory approval and certain sales levels, and it will be responsible for certain manufacturing start-up activities, the companies said. And with the launch of the product, Antares will receive escalating royalties based on U.S. and Canadian product sales.

"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," commented Paul Wotton, president and chief executive officer of Antares. "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."