Antares Pharma, Inc. Announces FDA Acceptance of Anturol(R) NDA for Filing
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of December 8, 2011, ten months from the official NDA filing. The PDUFA date is the target date for the FDA to complete its review of the NDA.
"The FDA's acceptance of the NDA filing is an important milestone in the review process to secure approval from the FDA for commercial distribution of Anturol. We look forward to working with the FDA in their ongoing review of Anturol," said Kaushik J. Dave R.Ph., Ph. D., MBA, Senior VP Product Development of Antares Pharma.
The Anturol NDA submission is supported by data from a Phase 3 randomized, double-blind, placebo-controlled clinical trial involving 600 patients with OAB. In the 12-week study, patients treated with Anturol 56 mg daily or 84 mg daily experienced a significant decrease in OAB symptoms versus placebo, including the number of urinary incontinence episodes per day. Anturol was well tolerated in the study with no reported serious treatment-related adverse events. Anticholinergic side effects such as dry mouth and constipation were low and no increase in CNS side effects was seen compared to placebo. The study was conducted under a Special Protocol Assessment (SPA) by the FDA.
"The FDA's acceptance for filing of the NDA for Anturol, Antares Pharma's first NDA, is another notable achievement for the Company resulting from the dedicated efforts of the entire Antares team. This is an important accomplishment in the continued execution of our product focused strategy," said Paul K. Wotton Ph.D., President and Chief Executive Officer.
About Anturol®
Anturol is an oxybutynin gel based on the ATD Gel technology platform which is a clear, odorless, hydroalcoholic gel that provides for delivery of oxybutynin in a non-patch transdermal form. The ATD technology is also used in Elestrin®, an FDA approved product for hormone replacement therapy in postmenopausal women. It has been well recognized that transdermal delivery of drugs including oxybutynin is a safe and effective way of delivering certain drugs that undergo first pass metabolism. By delivering oxybutynin transdermally, first-pass gastric and hepatic metabolism is avoided, which is believed to result in lower anticholinergic side effects such as dry mouth and constipation compared to orally administered treatments. These side effects are believed to account for a significant level of patient non-compliance among existing oral OAB treatments.
About Overactive Bladder
OAB, also called urge incontinence, is a condition marked by a sudden need to urinate that can happen at any time whether or not the bladder is full. OAB is typically caused when the smooth muscle of the bladder undergoes involuntary contractions and may result in uncontrolled leakage. OAB is defined as urgency, with or without urge incontinence and usually includes frequency and nocturia (waking up one or more times during the night to urinate). According to published reports it is estimated that more than 30 million Americans have OAB, and while it can happen at any age is more prevalent among older individuals. It is more common than both diabetes and asthma. According to IMS the annual OAB prescription market in the United States is valued at approximately $2.0 billion.
About Antares Pharma
Antares Pharma focuses on self-injection pharmaceutical products and topical gel-based medicines. The Company's subcutaneous and intramuscular injection technology platforms include VibexTM disposable pressure-assisted auto injectors, ValeoTM/VisionTM reusable needle-free injectors, and disposable multi-use pen injectors. In the injector area, Antares Pharma has a multi-product deal with Teva Pharmaceutical 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 is Anturol®, an oxybutynin ATD™gel that is currently under review by FDA for the treatment of OAB (overactive bladder). 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) indicated 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 potential success or failure of the Anturol NDA. 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, difficulties or delays in the initiation, progress, or completion of product development, clinical trials, and whether or not the Company's NDA for Anturol is approved by the FDA or any other regulatory authority, including whether the FDA will complete its review of the NDA by December 8, 2011. 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, 2010, 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.
Investor Contacts:
Antares Pharma, Inc.
Robert F. Apple
Chief Financial Officer
(609) 359-3020
or
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John Woolford
(443) 213-0506
john.woolford@westwicke.com
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