Antares Pharma, Inc. (NYSE Amex: AIS) announced today that it has completed enrollment in the double-blind portion of the Company’s Phase 3 clinical trial of Anturol™, its transdermal oxybutynin ATD™ gel for the treatment of overactive bladder (OAB). Top line data from this pivotal trial, which is being conducted under a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA), is expected in the third quarter of this year.
Dr. Paul Wotton, President and Chief Executive Officer of Antares, said, “We are delighted to announce the completion of enrollment for this pivotal trial of Anturol, and we remain on track to file a New Drug Application, or NDA, with the U.S. FDA in 2010. We continue to believe that Anturol offers many unique advantages over currently marketed products for the treatment of OAB. As Anturol is dispensed in a pump and applied directly to the skin once daily, potential advantages include a more reproducible and convenient dosing formulation, the ability to titrate the dosage, and potential for fewer side effects or adverse events.”
About the Anturol Phase 3 Trial
The randomized, double-blind, parallel, placebo controlled, multi-center trial was designed to evaluate the efficacy and safety of Anturol when administered topically, once daily for 12 weeks in patients predominantly with urge incontinence episodes for at least three months. The study enrolled 600 patients (approximately 200 per arm) using two doses (56 mg QD or 84 mg QD) versus placebo. The primary end point of the trial is efficacy versus placebo, defined as the reduction in the number of urinary incontinence episodes experienced per week. Secondary end points include changes from baseline in urinary urgency, average daily urinary frequency, patient perceptions, as well as safety and tolerability including skin irritation.
“The Phase 3 program has progressed with a high degree of commitment shown by our study participants and clinical investigators. Patients and physicians continue to express satisfaction and confidence in the treatment as evidenced by their continued participation in our Open Label Extension protocol. We would like to thank our clinical investigators and their patients for the interest and support of the Anturol program," said Dr. Kaushik J. Dave, Senior Vice President of Product Development.
About Overactive Bladder
Overactive bladder (OAB), also called urge incontinence, is a condition marked by sudden need to urinate that can happen at any time whether or not the bladder is full. OAB is typically caused when smooth muscle of the bladder undergoes involuntary contractions and may result in uncontrolled leakage and have a significant, negative impact on an individual’s health and quality of life. It is estimated that more than 30 million Americans have OAB, and while it can happen at any age, it is more common among older individuals.
About Antares Pharma
Antares Pharma is an emerging pharma that focuses on self-injection pharmaceutical products and technologies and topical gel-based products. The Company's subcutaneous injection technology platforms include VibexTM disposable pressure-assisted auto injectors, ValeoTM/Vision® reusable needle-free injectors, and disposable multi-use pen injectors. In the injector area, Antares Pharma has a multi-product deal with Teva Pharmaceuticals Industries, Ltd that includes Tev-Tropin® human growth hormone and a partnership with Ferring Pharmaceuticals. In the gel-based area, the Company's lead product candidate, AnturolTM an oxybutynin ATD™ gel for the treatment of OAB (overactive bladder), is currently under evaluation in a pivotal Phase 3 trial. Antares also has a partnership with BioSante that includes LibiGel® (transdermal testosterone gel) in Phase 3 clinical development for the treatment of female sexual dysfunction (FSD), and Elestrin (estradiol gel) for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, and currently marketed in the U.S. Antares Pharma has corporate headquarters in Ewing, New Jersey, with subsidiaries performing research, development and product commercialization activities in Minneapolis, Minnesota and Muttenz, Switzerland.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements related to the Company's future financial performance, and other statements which are other than statements of historical facts. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "potential," "continue," and other similar terminology or the negative of these terms, but their absence does not mean that a particular statement is not forward-looking. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties include, among others the expected timing of top line data as well as the timing of filing the NDA for Anturol, difficulties or delays in the initiation, progress, or completion of its clinical trials, including the phase 3 trial of Anturol(TM), whether caused by competition, adverse events, investigative site initiation rates, patient enrolment rates, regulatory issues, or other factors; that clinical trials may not demonstrate that Anturol(TM) is both safe and effective for the treatment of patients with overactive bladder syndrome; that the safety and/or efficacy results of the phase 3 trial of Anturol(TM) may not support an application for marketing approval in the United States or any other country; that an application for marketing approval may not be accepted for review or at all by the FDA or any other regulatory authority; and that the Company may lack the financial resources and access to capital to fund clinical trials. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2008, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.