Watson Pharmaceuticals Inc. recently announced that it has entered into a licensing agreement with Antares Pharma Inc. for the commercialization of Antares Pharma's topical oxybutynin gel in the US and Canada. The oxybutynin gel is currently under regulatory review in the US as a treatment for overactive bladder (OAB). The US Food and Drug Administration (FDA) is expected to give its decision on the approval of the product by December 8, 2011.
According to the agreement, Watson will be responsible for certain manufacturing start-up activities and will make payments to Antares Pharma on the achievement of milestones like gaining regulatory approval and reaching certain sales levels. Following the launch of oxybutynin gel, Antares Pharma will also be entitled to receive escalating royalties on the US and Canadian sales of the drug.
The phase III study results of oxybutynin gel demonstrated that patients dosed 56 mg or 84 mg of oxybutynin gel daily, experienced a statistically significant decrease in OAB symptoms, including the number of urinary incontinence episodes per day, compared to patients who received placebo.
We believe this deal will enhance Watson Pharma’s proprietary drug portfolio, which recently was strengthened by the FDA accepting the company’s New Drug Application (NDA) for Prochieve (progesterone gel). Prochieve has been developed in partnership with Columbia Laboratories Inc. for the reduction of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy.
Watson Pharma had acquired the US rights to Prochieve from Columbia Labs in July last year. Along with Prochieve, Watson Pharma also acquired the US rights to Crinone. On Crinone, which is indicated for the treatment of infertility in women, Columbia Labs receives royalties on net sales made by Watson Pharma. Outside the US, Crinone is marketed by Merck KGaA (MKGAF).