Phase 2 studies of Antares' Anturol gel for overactive bladder nearing completion; phase 3 studies begin early 2006

By E. Janene Geiss

Philadelphia, Dec. 13 - Antares Pharma, Inc. said Tuesday that because of important progress made in the development of Anturol, the company's lead proprietary oxybutynin ATD gel to treat overactive bladder syndrome, the company now expects to complete phase 2 trials by the end of this year.

Phase 3 trials are expected to begin in early 2006, according to a company news release.

Oxybutynin is used for adults with symptoms of overactive bladders that include sudden urges to urinate, urinary incontinence and frequent urination.

Annual sales of the leading products in this category were in excess of $500 million in 2004, officials said.

The most common side effects of oxybutynin are dry mouth, constipation, tiredness and headache.

Antares said it believes its gel formulation, if approved by the Food and Drug Administration, would mitigate many of these side effects.

The company also announced Tuesday that it signed an agreement with Toronto-based Patheon Inc. to provide manufacturing and scale-up support for the product's phase 3 program. Patheon is a global provider of drug development and manufacturing services to the international pharmaceutical industry, operating a network of 14 facilities in the United States, Canada and Europe, officials said.

"Patheon has a successful track record with specialized manufacturing capabilities. We believe our relationship with Patheon will result in reliable, cost-effective, and high quality development services that we, and our partners, can depend on to support the commercialization of Anturol," James Hattersley, vice president of corporate business development at Antares, said in the release.

Antares is an Exton, Pa., specialty pharmaceutical product development company with patented drug delivery systems and injectable device engineering capabilities. Antares has active partnering programs with several pharmaceutical and distribution companies for a number of indications and applications, including diabetes, growth disorders, obesity, female sexual dysfunction and other hormone therapy.

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