Rapid Restoration and Consistent Maintenance of Steady Blood Levels Achieved with Once-Weekly Subcutaneous Administration of Testosterone Delivered with a Novel Auto Injector
Antares Pharma Announces The Presentation of a Scientific Poster At The 16TH International Congress Of Endocrinology And The Endocrine Society’s 96TH Annual Meeting & Expo
EWING, N.J.--(BUSINESS WIRE)--Antares Pharma, Inc. (NASDAQ: ATRS) today announced the presentation of a scientific poster at the 16th International Congress of Endocrinology and the Endocrine Society’s 96th Annual Meeting & Expo held in Chicago, Illinois. The poster presents the final pharmacokinetic and safety results from 29 randomized patients treated with a once-weekly injection of testosterone administered subcutaneously with the Company’s VIBEX® QuickShot® auto injector. The Company’s previously reported interim results from this multi-center phase 2 clinical study were also presented as a scientific abstract at the same meeting.
“We believe this study suggests that weekly subcutaneous administration of testosterone using the Company’s VIBEX QuickShot auto injector achieves consistent testosterone levels within the normal physiologic range, reduces the peak-and-trough variation and prevents transfer by contact.”
Results from 29 adult males ages 31 to 69 with hypogonadism symptoms and screening testosterone blood levels less than 300 ng/dl were reported. These patients were randomized into two groups and followed for 10 weeks. The first group received weekly 50 mg testosterone administered subcutaneously with a novel auto injector, and the second group received 100 mg of testosterone using the same device and time sequence.
The mean testosterone baseline was 244 ng/dL in the 50 mg group and 243.7ng/dL in the 100 mg group. Testosterone levels normalized within hours of the first dose. At week six of the study when patients were at steady state pharmacokinetic conditions, the 50 mg and 100 mg groups had average plasma testosterone values within the normal range at 422ng/dL and 896 ng/dL, respectively. Rapid restoration, consistent maintenance of normal testosterone levels and dose proportionality of the 50 mg and 100 mg strengths were thereby demonstrated. The once-weekly, virtually pain-free administration took three to four seconds and consistently provided a precise dose of 0.5 ml.
“Current topical treatments for hypogonadal men require daily administration and risk transfer to women and children. Intramuscular injections do not carry this risk but may be painful, difficult to administer, and can be associated with wide variation between testosterone level peaks and troughs potentially leading to side effects, including mood swings,” said Antares Pharma President and Chief Executive Officer, Eamonn P. Hobbs. “We believe this study suggests that weekly subcutaneous administration of testosterone using the Company’s VIBEX QuickShot auto injector achieves consistent testosterone levels within the normal physiologic range, reduces the peak-and-trough variation and prevents transfer by contact.”
Antares Pharma plans to initiate a Phase 3 study in 150 testosterone-deficient adult males during the third quarter of 2014.
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 in 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. The Company markets 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 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 UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements made with respect to the data to be presented from research sponsored by the Company at the 16th International Congress of Endocrinology & the Endocrine Society’s 96th Annual Meeting & Expo, the timing of initiation of the Company’s phase 3 study in 150 testosterone-deficient males, the approval of the VIBEX® QuickShot® testosterone product by the U.S. Food and Drug Administration and the timing thereof; the efficacy of the QuickShot® device; and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. 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, 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.