Healthcare Industry News: oxybutynin gel
News Release - June 26, 2006
Antares Reports On End of Phase II Meeting with FDA for Anturol(TM)
Anturol to Proceed to Phase III Pivotal Study for Overactive BladderEXTON, Pa.--(HSMN NewsFeed)--June 26, 2006--Antares Pharma, Inc. (Amex:AIS ) announced that an end of Phase II meeting was held with the U.S. Food and Drug Administration (FDA), based on the positive Phase II clinical study results for Anturol(TM), its oxybutynin gel product for the treatment of overactive bladder (OAB). Antares plans to initiate a Phase III clinical program in patients with urge and mixed urinary incontinence pending finalization of protocol specific details. The Phase III protocol is currently defined as a randomized, double-blinded, placebo-controlled multi-center study evaluating the effect of 12 weeks of Anturol treatment in patients. It is expected to support an optimized regulatory strategy with submission of an NDA anticipated before the end of 2007.
"We are pleased with the outcome of the end of Phase II meeting with the FDA and we believe our final protocol will provide Antares with an efficient pathway for approval of Anturol," commented Dario N. Carrara, PhD, Managing Director of Antares Pharma's Pharmaceutical operations in Basel, Switzerland.
In February 2006, Antares announced the results of its Anturol Phase II program in 48 healthy subjects. Each subject received three different doses (parallel three-treatment design) over 20 consecutive days. Anturol was found to be well tolerated at all doses with a reduced adverse event profile in comparison to those reported in both oral and adhesive patch formulations, the only treatments currently available.
Jack E. Stover, Antares' President and Chief Executive Officer, said "We are pleased to be able to continue the development program for Anturol as we explore opportunities with potential marketing partners. Anturol is an important new formulation and method of treatment for OAB which we believe will be well positioned to compete in the growing urinary incontinence market."
Anturol, the Company's transdermal gel product, is targeted for the treatment of OAB a common urological condition. Anturol is a clear, odorless and cosmetically appealing gel formulation of oxybutynin that is designed for optimized absorption through the skin following once-a-day application to the abdomen. The formulation utilizes Antares' proprietary Advanced Transdermal Delivery (ATD(TM)) platform.
According to SG Cowen & Co.'s Therapeutic Categories Outlook (March 2006), OAB affects an estimated 17 million Americans and is one of the fastest growing segments in the urology market. It is characterized by involuntary muscle contractions leading to loss of urine. Symptoms include urinary frequency, urgency, and urge incontinence.
About Antares Pharma
Antares Pharma is a specialized pharma product development company focused on developing patented drug delivery systems and injectable device engineering capabilities. Antares' current technology platforms include its ATD(TM) Advanced Transdermal Delivery system, and its related TecTix(TM) system for topical and transmucosal delivery, its Easy Tec(TM) oral fast-melt technology, and subcutaneous injection technology platforms including both Vibex(TM) disposable mini-needle injection device and Valeo(TM)/Vision® reusable needle-free injection devices. Antares Pharma is committed to leveraging its multiple drug delivery platforms to add value to existing drugs and to create new pharmaceutical products and injectable devices. Overall, Antares' product pipeline, if approved, will address unmet medical needs by reducing side effect profiles, improving safety, increasing effectiveness, and improving patient compliance and convenience. Antares Pharma has corporate headquarters in Exton, Pennsylvania, with subsidiaries performing research, development, manufacturing and product commercialization activities in Minneapolis, Minnesota and Basel, Switzerland.
Safe Harbor Statement
In addition to historical facts or statements or current conditions, this press release contains forward-looking statements within the meaning of the "Safe Harbor" provisions of The Private Securities Litigation Reform Act of 1995, including statements regarding the timing of Antares Phase III clinical trial for Anturol and NDA filing and Antares' expectations for the product candidate. Forward-looking statements provide Antares' current expectation or forecasts of future events. Antares' results could differ materially from those reflected in these forward-looking statements due to decisions of regulatory authorities, Antares' ability to execute on its development plans, patient and market acceptance of Anturol and general financial, economic, regulatory and political conditions affecting the pharmaceutical industry generally. For a discussion of these and other risks and uncertainties that may effect the forward-looking statements, please see the risk factors in Antares' quarterly reports filed with the Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Antares undertakes no obligation to update publicly any forward-looking statement.
Source: Antares Pharma
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