Antares Pharma, Inc. (AMEX:AIS) today announced that it’s license partner, Ferring Pharmaceuticals has received additional regulatory approvals in Europe and Australia for use of Antares’ needle-free injection devices with it’s human growth hormone (hGH), Zomacton.
Ferring has been notified recently that the mutual recognition process for European member states has been positively concluded for the Zomacton 10 mg formulation and the Antares’ needle-free injection device (Zomajet Vision X) and consumables. Following an initial product launch in France, Ferring expects to launch in the other key European markets in 2009. The Zomacton 4 mg formulation with the Zomajet 2 Vision needle-free device and consumables was previously approved in Europe and is currently being marketed.
In addition, the Therapeutic Goods Administration, Australia’s regulatory agency for drugs and devices, has recently approved applications filed by Ferring for the Antares Zomajet 2 Vision and Vision X needle-free injection devices, and their associated consumables, to be used with Zomacton in both the 4 mg and 10 mg formulations.
Paul Wotton, Ph.D., President and Chief Executive Officer of Antares, commented, “We are pleased that Ferring continues to expand into new markets and is introducing the Vision X device for use with their Zomacton 10 mg product. The combination of the higher strength formulation with Antares’ proprietary needle-free system will continue the focus for both companies of enhancing patient compliance and convenience with self administration of hGH.”
About Antares Pharma
Antares Pharma is a product development company committed to improving pharmaceuticals through its patented drug delivery systems. Antares has multiple development partnerships with leading pharmaceutical companies. The Company’s products are designed 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. Antares has three validated drug delivery 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. 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. Such forward-looking statements include statements relating to Ferring's expectations regarding launch of the product in other key European markets in 2009 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. 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, 2007, 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.