Antares Pharma, Inc. (AMEX:AIS) announced that data from two clinical trials for ANTUROL™, its transdermal oxybutynin ATD™ gel, will be presented at the 28th Annual Scientific Meeting of the American Urogynecologic Society (AUGS) on September 27-29, 2007, in Hollywood FL. Oxybutynin is considered the gold standard for Overactive Bladder treatment, and is currently available only in oral dose and adhesive patch formulations.
The first poster includes data from the Phase II Dose-Ranging Pharmacokinetic Study. In the Phase II study of 48 healthy subjects receiving 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. Results also showed clear evidence of dose proportionality and linear pharmacokinetics among the tested doses. At the intermediate dose, ANTUROL Gel provided oxybutynin average and peak plasma levels comparable to those previously published for the transdermal patch delivery system. The metabolic ratio of desethyloxybutynin to oxybutynin was significantly lower for all doses at steady-state compared to reported values for the market leading oral product DITROPAN®. A lower metabolic ratio of desethyloxybutynin to oxybutynin should result in reduced frequency and magnitude of adverse events, particularly dry mouth.
The second poster describes outcomes from the Application Site Pharmacokinetic Study that was completed in the Fall of 2006. The study was an open-label, comparative three-way crossover, application site pharmacokinetic study. The trial enrolled 25 healthy subjects (80% women), aged 18 to 42, who received one dose of ANTUROL applied topically on three skin sites: abdomen (reference), thighs and shoulders alternatively with 10 days washout between doses. The results of the study were that each of the three sites evaluated delivered bioequivalent amounts of ANTUROL.
The third poster shows results from the Enantiomers Ratios Pharmacokinetic Study, a subset of the Application Pharmacokinetic Site Study, from which ten subjects were submitted to analysis of the R- and S- enantiomers during treatment of the abdominal area. The ratio of plasma levels of R- to S- enantiomers of the active metabolite was lower following gel application (in comparison to the higher ratio of R- enantiomer levels known in oral products) indicating lower potential for adverse events from ANTUROL. Further, overall plasma levels of the combined R- and S- enantiomers of the active metabolite were also lower in ANTUROL in comparison to levels known in oral products.
“We are pleased to be invited to present and discuss ANTUROL at this important scientific meeting. The American Urogynecologic Society is a key professional organization for womens’ health and we look forward to sharing the positive clinical results we have had to date with such a knowledgeable audience," said Dario N. R. Carrara, Senior Vice President and Managing Director of the Pharmaceutical Group.
ANTUROL™ Gel is intended to treat symptoms of overactive bladder (OAB), a lower urinary tract disorder resulting in a symptom syndrome including urgency with (OAB wet) or without (OAB dry) urge incontinence, usually with frequency and/or nocturia. OAB is estimated to affect more than 22 million people in Europe, and more than 33 million in the United States. While OAB can affect a person at any age, it is most common among the elderly, with a prevalence of 33% to 61% in people over age 65. Despite its rising prevalence with age, OAB is treatable at every age. In a recent report from Scrip, "Urinary Incontinence Therapeutics: A Market Focus," the market is described as one of the fastest-growing sectors, growing at 40% per year, and projected to exceed $ 11 billion by 2008. ANTUROL utilizes Antares Pharma's proprietary ATD™ Gel technology designed to allow delivery of active substances across the skin. The oxybutynin formulation is a cosmetic quality, clear and odorless gel designed to be rapidly absorbed through the skin after once-a-day application on the abdomen, shoulders or thighs.
Advanced Transdermal Delivery Systems (ATD™)
The ATD drug delivery platform is dedicated to the development of gels that offer a cosmetically superior option to patches, while delivering medication efficiently with less potential for skin irritation, minimizing gastrointestinal impact, as well as, the first-pass liver metabolism effect of many orally ingested drugs. Antares’ ATD gels are hydro-alcoholic and contain a combination of permeation enhancers to promote rapid drug absorption through the skin following application typically to the arms, shoulders, abdomen or thighs. The Company’s transdermal ATD gel system provides the options for delivering both systemically (penetrating into and through the subcutaneous tissues and then into the circulatory system) as well as locally (e.g. topically for skin and soft tissue injury, infection and local inflammation). Typically, the gel is administered daily, and is effective on a sustained release basis over approximately a 24-hour period of time.
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 drug delivery platforms: the ATDTM Advanced Transdermal Delivery system, subcutaneous injection technology platforms including both VibexTM disposable mini-needle injection device and ValeoTM/Vision® reusable needle-free injection devices; and Easy TecTM oral fast-melt technology. Two of the platforms have generated FDA approved products. Antares Pharma leverages its multiple drug delivery platforms to add value to existing drugs and to create new pharmaceutical products and injectable devices. 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, 2006 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.