Antares Pharma, Inc. (AMEX:AIS), a specialty pharmaceutical company focused on improving pharmaceuticals through advanced drug delivery systems, and its partner, Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) today announced the filing of a Supplemental New Drug Application (sNDA) in order to add “needle-free injection” to the product drug label. This submission is the result of clinical testing and drug-device interaction studies performed over the past 18 months. The sNDA filing also references the 510(k) previously filed by Antares in 2006. The FDA has required this supplemental filing since needle-free injection is a new route of administration for this product; a needle and syringe is the current route of administration. The FDA review cycle generally takes four to six months to complete with potential FDA approval in the fourth quarter of 2008.
“Our experience and proven track record in needle-free administration of this important biologic product underscores our strategy of focusing on the emerging biologic market place as well as our continuing commitment to the patient and the caregiver,” said Jack E. Stover, CEO and Vice Chairman of Antares. “We look forward to progressing with our partners to approval, whereupon we expect to recognize important revenues based on sales of our devices and royalties on the product.”
Human growth hormone is an injectable protein that is commonly used to treat children of pathologically short stature. Pediatric patients and their parents, who sometimes assist with the injections, can benefit from the elimination of needles and disposal of contaminated sharps, ease of using alternative injection sites and the speed and quality of injections offered by needle-free devices. According to industry estimates, the market for human growth hormone in the United States is approximately $1 billion and the U.S. market is the largest market segment for the distribution of human growth hormone globally. Antares currently markets its needle-free injection system for use in the treatment of growth hormone deficient children through its partners in Europe, Japan and Asia.
About Antares Pharma, Inc.
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 VibexTM disposable pressure assisted auto injectors, ValeoTM/Vision® reusable needle-free injectors and disposable multi-use pen injectors and Easy TecTM oral disintegrating tablets (ODT). Two of the systems have generated FDA approved 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. The Company’s lead product candidate, Anturol™, an oxybutynin ATD™ gel for the treatment of OAB (overactive bladder), is currently under evaluation in a pivotal Phase 3 trial. The Anturol™ trial is being conducted under an agreement reached with the U.S. Food and Drug Administration under its special protocol assessment, or SPA process.
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, which 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 FDA reviews and potential approvals, future product revenues and royalties, 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.