Antares Pharma Announces Update to QuickShot Testosterone Program

Antares Pharma, Inc. (NASDAQ:ATRS) today announced that a meeting was held with the U.S. Food and Drug Administration (FDA) to discuss a registration study for the VIBEX QuickShot auto injector in testosterone deficient adult males. The study will include approximately 150 adult males with testosterone blood levels less than 300 ng/dL, and will begin recruitment in the third quarter of 2014. The study is designed to show that once-weekly self-administration of testosterone with the VIBEX QuickShot auto injector can safely achieve normal blood levels of testosterone in hypogonadal men.

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 discussions we had with the FDA.” Dr. Wotton continued, “We are committed to working closely with the FDA on all aspects of the study and believe that we will be able to provide a novel product for self-administration of testosterone at home that offers a new and potentially safer route of administration than currently available options for treating hypogonadism or Low T.”

About QuickShot Auto Injector

The 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 and children with active polyarticular juvenile idiopathic arthritis. LEO Pharma markets OTREXUP to dermatologists for 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. 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, 2013, 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.