Antares Pharma, Inc. (NASDAQ: ATRS) today announced positive results from a multi-center phase 2 clinical study evaluating the pharmacokinetic profile of testosterone enanthate administered once-weekly by subcutaneous injection at doses of 50 mg and 100 mg using the VIBEX QuickShot auto injector in testosterone deficient adult males. Twenty nine adult males with hypogonadism (low testosterone) and testosterone blood levels less than 300 ng/dL were randomized into two groups. The first group received 50 mg testosterone enanthate administered subcutaneously with the QuickShot auto injector once weekly for six weeks and the second group received 100 mg of testosterone enanthate using the same device and time sequence. The clinical study followed patients for four weeks after the last dose. The mean testosterone baseline for the 50 mg group was 214.6 ng/dL and 201.5 ng/dL in the 100 mg group. At week one, both doses produced normal mean total testosterone concentrations at 24 hours post-dose, 434 ng/dL in the 50 mg group and 572 ng/dL in the 100 mg group. During week six of the study when patients were already at steady state pharmacokinetic conditions, the 50 mg and 100 mg groups had average plasma testosterone values within the normal range at 422.4 ng/dL and 895.5 ng/dL, respectively. The study demonstrated rapid restoration, consistent maintenance of normal testosterone levels and dose proportionality of the 50 mg and 100 mg strengths. The once-weekly injection was generally well tolerated. No injection site pain was reported by 28 of 29 patients and seventeen patients reported mild to moderate adverse events which according to the investigators were unrelated to the drug or device. There were no deaths, serious adverse events or discontinuations due to adverse events in the study. Paul K. Wotton, Ph.D., President and Chief Executive Officer, stated, “We are very optimistic about the potential for a self-administered, once weekly subcutaneous dose of testosterone based on the outcome of this study.” Dr. Wotton continued, “The administration of testosterone using our proprietary QuickShot device showed that normal testosterone levels can be rapidly restored and then reliably maintained with reduced peak to trough fluctuations relative to those associated with intramuscular injections. Unlike topical treatments for males with hypogonadism, currently approved injectable forms of testosterone do not carry a black box warning for risk of transference, which has been reported to lead to abnormal development of male sexual characteristics in women and children.”
About QuickShot Auto InjectorThe proprietary VIBEX QuickShot auto injector emphasizes enhanced performance on the attributes contributing most to patients successfully controlling their testosterone deficiency – reliable and consistent blood levels, ease and speed of self-administration, comfort and discretion. The State-of-the-Art precision engineering of the QuickShot device allows rapid subcutaneous self-administration of highly viscous drugs such as testosterone and biologics using high spring pressure through a fine gauge needle. Conventional auto injectors or even a vial, needle and syringe could not inject these drugs efficiently or as fast and easy as the QuickShot device. 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, and maintenance of musculoskeletal and mental health in maturity. Symptoms of male hypogonadism can be treated with testosterone replacement therapy. According to published data, 2013 U.S. sales of testosterone replacement therapies were approximately $2.8 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 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 StatementThis 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.