EWING, N.J. -- (BUSINESS WIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) today announced that the first patients have been dosed in a clinical study evaluating testosterone enanthate administered weekly by subcutaneous injection at doses of 50 mg and 100 mg via the VIBEX™ QuickShot™ auto injector device in testosterone deficient adult males. Up to 45 patients will be enrolled at approximately eight investigative sites in the United States.
Paul K. Wotton, Ph.D., President and Chief Executive Officer, stated, “We are very excited about the QuickShot™ testosterone (QS T) opportunity because we believe it will fill a real need in the growing testosterone replacement market for a convenient self-administered injectable product.” Dr. Wotton continued, “Our proprietary QuickShot™ device is designed to discreetly administer a fixed dose of testosterone subcutaneously in a matter of seconds. We believe the self-contained QuickShot™ technology could potentially eliminate transference issues currently seen in the market leading topical testosterone products. The QS T is another example of continued execution of our combination product strategy where we expect to create added value for physicians, patients and shareholders alike.”
The proprietary VIBEX™ QS device offers a dose capacity of up to 1 ml and the design can be scaled for larger volumes. The device design emphasizes enhanced performance on the attributes most critical to patient success – speed, comfort and discretion. The State-of–the Art engineering accommodates fast injection of highly-viscous drug products such as testosterone that stall less-powerful conventional auto injectors.
About Testosterone Deficiency
Testosterone deficiency, also known as male hypogonadism or Low T, is a condition in which the body doesn’t produce enough testosterone – the hormone that plays a key role in masculine growth and development during puberty. Some types of male hypogonadism can be treated with testosterone replacement therapy. According to published data, 2012 U.S. sales of testosterone replacement therapies exceeded $2.5 billion dollars with prescriptions on average growing more than 20% annually.
About Antares Pharma
Antares Pharma focuses on self-administered parenteral pharmaceutical products and topical gel-based medicines. The Company is developing OTREXUP™ (methotrexate) injection, a combination product for the delivery of methotrexate using Medi-Jet™ technology for the treatment of rheumatoid arthritis, poly-articular-course juvenile rheumatoid arthritis and psoriasis, as well as 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. 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 initiation, progress, or completion of product development. In addition, the QuickShot™ testosterone product referred to in this press release has not yet been approved by the FDA, and the commercialization of QuickShot™ testosterone is dependent on the Company receiving FDA approval of this product. 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.