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Antares Pharma, Inc. (NASDAQ: ATRS) today announced that it has received a Notice of Allowance from the U.S. Patent Office for application 13/584,317. This application, along with U.S. Patent 8,251,947 granted in August of 2012, relate to Antares’ injector technology for wet-dry injectable drugs such as lyophilized biologicals or peptide drugs that require dry storage to assure stability. The designs described in the application result in the injector performing the reconstitution of the dry drugs into an injectable liquid form and then perform the injection similar to the Antares VIBEX
® and QuickShot
™ devices. Adding the reconstitution mechanism to the base of the VIBEX
® and QuickShot
™ injection platform allows the Company to build on its comprehensive technology platform upon which OTREXUP
™ was developed. The expiry date for the patent issued in August of 2012 is 2028.
Paul K. Wotton Ph.D., President and CEO commented, “This new patent application confirms our position as a leading developer of drug device combination products and enhances our ability to apply proprietary technology to the new biological generation of drugs which is extremely important for our long term business goals and creation of shareholder value. We are developing a pipeline of injectable products, designed for use in a home care setting and we have extended our intellectual property to reconstitutable drugs, including those biological agents where high viscosity may be a challenge for device technologies less innovative than our VIBEX
® or QuickShot
About Antares Pharma
Antares Pharma focuses on self-administered parenteral pharmaceutical products and topical gel-based medicines. The Company has received marketing approval from the U.S. Food and Drug Administration for OTREXUP™ (methotrexate) injection for the treatment of adults with severe active rheumatoid arthritis, children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis. Antares Pharma is also developing VIBEX
® QS T for testosterone replacement therapy. The Company's technology platforms include VIBEX
® disposable Medi-Jet, disposable multi-use pen injectors and Vision™ reusable needle-free injectors marketed as Tjet
® and Zomajet
® by Teva Pharmaceutical Industries, Ltd (Teva) and Ferring Pharmaceuticals (Ferring), respectively. Antares Pharma has a multi-product deal with Teva that includes Tev-Tropin
® [somatropin (rDNA origin) for injection] human growth hormone (hGH), VIBEX
® epinephrine and several other products. Antares Pharma’s partnership with Ferring includes Zomacton
® hGH (somatropin) injection. In the U.S. Antares has received FDA approval for Gelnique 3%™ (oxybutynin) gel, a treatment for overactive bladder that is marketed by Actavis. Elestrin
® (estradiol gel) is FDA approved for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, and is marketed in the U.S. by Meda Pharma. Antares Pharma has two facilities in the U.S. The Parenteral Products Group located in Minneapolis, Minnesota directs the manufacturing and marketing of the Company’s reusable needle-free injection devices and related disposables, and develops its disposable pressure-assisted Medi-Jet and pen injector systems. The Company’s corporate office and Product Development and Commercial Groups are located in Ewing, New Jersey.
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. These statements are indicated by the words “may,” “will,” “plans,” “intends,” “believes,” “expects,” “anticipates,” “potential,” “could,” “would,” “should,” and similar expressions, and includes statements regarding the ability of additional patents on current and future proprietary programs deriving maximum commercial value. 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, changes in revenue growth and difficulties or delays in the commercial launch of OTREXUP™ for rheumatoid arthritis and psoriasis, market acceptance by physicians and patients of new products, delays in product development and changes or delays in the regulatory process for existing or new product candidates. 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, 2012, 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.