Antares Pharma, Inc. (AMEX:AIS) a specialty pharmaceutical company, today reported that the United States Patent & Trademark Office (USPTO) has issued a Notice of Allowance for U. S. patent application 11/120,306 entitled “Permeation Enhancing Compositions For Anticholinergic Agents” related to Antares’ Anturol™ product for the treatment of overactive bladder. The Notice of Allowance is the USPTO’s official communication that the Company’s application has successfully completed examination and that a patent will be issued.
Jack E. Stover, President and Chief Executive Officer, commented, “We are pleased to receive this notice of allowance which provides additional protection for our proprietary technology and products and most specifically for Anturol.”
Anturol is a novel treatment utilizing Antares’ proprietary ATD™ (Advanced Transdermal Delivery) gel system for treatment of overactive bladder (OAB) delivering the anticholinergic drug, oxybutynin in a sustained release basis. Anturol gel is an easy-to-use therapy which allows efficacious dosing of the drug which is systemically absorbed through the skin in a controlled manner. Our transdermal delivery of oxybutynin, using a metered dose pump, is potentially not only a convenient and effective method of dosing but may also significantly reduce the side effects commonly associated with oral mediations for overactive bladder such as dry mouth, dry eye and constipation. Antares is currently conducting a 12-week, multi-center, pivotal Phase 3 trial. The primary clinical endpoint is the reduction in the number of incontinence episodes.
Advanced Transdermal Delivery (ATD™) Gel Technology
Antares’ ATD gel technology is a patent-protected drug delivery system designed for the enhanced passive skin permeation of therapeutic entities. The technology is already validated in that it is the basis of an FDA approved product (transdermal estradiol gel for the treatment of menopausal symptoms) and two Phase III clinical stage products (transdermal oxybutynin gel for overactive bladder and transdermal testosterone for female sexual dysfunction). Based on hydroalcoholic solvent systems containing a combination of permeation enhancers, ATD gel formulations are not only easy to use but, also ensure drugs are absorbed rapidly through the skin after once-daily application on the upper arms, shoulders, abdomen or thighs. Clinical trials using different therapeutic actives have demonstrated efficacy and excellent skin tolerability.
About Antares Pharma
Antares Pharma is a specialized pharma product development company committed to improving pharmaceuticals through its patented drug delivery systems. Antares has three validated systems: the ATDTM Advanced Transdermal Gel Delivery system, subcutaneous injection technology platforms including both VibexTM disposable pressure assisted auto injectors and ValeoTM/Vision® reusable needle-free injectors; and Easy TecTM oral disintegrating tablets (ODT). Two of the systems have generated FDA approved products. Antares Pharma leverages its multiple drug delivery systems to add value to existing drugs and to create new products. The Company’s products are engineered to improve safety and efficacy profiles by minimizing dosing and reducing side effects while enabling improved patient compliance. Antares Pharma has corporate headquarters in Ewing, New Jersey, with subsidiaries performing research, development, manufacturing and product commercialization activities in Minneapolis, Minnesota and Basel, 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, that involve significant risks and uncertainties, including those discussed in this release and others that can be found in the “Risk Factors” section of Antares’ Annual Report on Form 10-K for the year ended December 31, 2007 and in Antares’ periodic reports on Form 10-Q and other filings made with the Securities and Exchange Commission. Antares is providing this information as of the date of this release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. No forward-looking statement can be guaranteed and actual events and results may differ materially from those projected. Forward-looking statements, including statements regarding the timing of product sales, market estimates and market potential 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 and general financial, economic, regulatory and political conditions affecting the pharmaceutical industry generally.