ATRS Antares Pharma Inc

Antares Pharma, Inc. (NASDAQ:ATRS) today announced that data from the 52-week pharmacokinetics and safety phase 3 study of subcutaneous testosterone enanthate delivered through the QuickShot® auto injector was selected for a moderated poster presentation at the Endocrine Society Annual Meeting (ENDO 2017).  The poster will be presented today, April 3, 2017.

The poster, entitled “Safety, Efficacy, and Metabolic Parameters in the STEADY™ Trial of a Novel, Pre-Filled Subcutaneous Testosterone Enanthate Auto-Injector (SCTE-AI),” was authored by Christina Wang, MD, co-principle investigator for the study at Los Angeles Biomedical Research Institute and Harbor-UCLA Medical Center, Los Angeles, CA, et al.  The submission was among a select group of key abstracts awarded the distinction of a moderated poster presentation.

The dose-blind, multicenter Subcutaneous Testosterone Efficacy and Safety in Adult Men Diagnosed with Hypogonadism (STEADY™) trial of a proprietary, pre-filled auto injector enrolled 150 hypogonadal adult men with baseline testosterone (T) levels of <300 ng/dL.  Patients received 75 mg of testosterone enanthate administered via auto injector once-weekly for six weeks. At week seven blinded dose adjustments were based upon the week six blood concentration levels at end of the dosing interval (Ctrough) in the patients.  The primary endpoint was the percentage of patients achieving a Cavg of 300 to 1,100 ng/dL and a key secondary endpoint was percentage of patients with week 12 Cmax testosterone values of <1500 ng/dL.  Markers of glucose metabolism (M) and insulin resistance risk (IR) were assessed via the Quantose™ insulin resistance (IR) panel.  Quantose™ IR and M scores and cholesterol panel assessments were performed from blood samples at weeks 1, 13, 26, 38 and 52.

Of the 150 patients enrolled, 139 patients met the primary endpoint at week 12.  Overall, the study found that QuickShot® testosterone (QST) administered to hypogonadal men achieved serum testosterone levels within a clinically desirable and physiologically normal range.  Quantose™ IR and M scores suggested a large portion of the patient population exhibited a prediabetic/diabetic phenotype at baseline, and insulin resistance scores were decreased from baseline throughout the treatment period.  Total cholesterol, triglycerides, LDL and HDL levels decreased with treatment. According to the investigators, QST was found to be safe, well tolerated and virtually pain free. 

“We are pleased that data from our phase 3 QuickShot testosterone study has been accepted for presentation at the annual ENDO 2017 meeting,” said Robert F. Apple, CEO of Antares Pharma.  Mr. Apple continued, “We believe data compiled to date from our QST clinical program have shown that adult men diagnosed with hypogonadism can achieve a steady pharmacokinetic profile for testosterone well within the physiologically normal range over the course of therapy.  We also believe QST has been shown to be well tolerated and virtually painless. We will continue to work closely with the FDA during the regulatory review process toward a potential approval.”

The details for Dr. Wang’s poster presentation are as follows:

Date: Monday, April 3, 2017Session: Male Reproductive Endocrinology IISession Time: 1:00 p.m. – 3:00 p.m. ETLocation: Orange County Convention Center, Orlando, Florida – West Hall B

About Quantose™ IRQuantose™ IR is a validated commercial laboratory test that detects and measures insulin resistance, a risk factor for Type 2 diabetes mellitus.  

About The Endocrine SocietyThe 100-year-old Endocrine Society is the largest global membership organization representing professionals from the intriguing field of endocrinology.  Medical doctors, scientists, researchers, and educators comprise the majority of the Society’s membership.  Endocrinologists conduct research on – and treat patients with – a host of conditions and diseases related to the human body’s complex system of glands and hormones. Hormonal disruptions cause conditions that affect millions of people, including diabetes, thyroid disorders, obesity, infertility, growth disorders, sleep disorders, and endocrine cancers. Endocrine Society members come from 122 countries, with 40 percent of them located outside the United States.

About QuickShot® TestosteroneThe investigational subcutaneous testosterone enanthate auto injector is a proprietary self-administered testosterone replacement option for men with hypogonadism that is designed to be injected at home, on a weekly basis. Results from the previously reported Phase 3 pharmacokinetic study showed that testosterone delivered subcutaneously using the QuickShot® testosterone auto injector provided rapid, steady, and reliable restoration of testosterone to pre-defined physiologic levels.

The most common adverse reactions (incidence ≥5%) in the phase 3 study referenced in these presentations were increased hematocrit, hypertension, increased PsA, Upper Respiratory Tract Infection, sinusitis, injection site bruising and headache.   Serious adverse events reported included one case each of worsening depression, vertigo and suicide.  All of the SAE’s were not considered to be related to study drug by the investigators, however the Company determined that the case of suicide could not be ruled out as potentially being related to study drug.  There have been no reported adverse events consistent with urticaria (hives), POME, anaphylaxis or major adverse cardiovascular events in this study. The safety data collected included an assessment of pain.  When pain was reported its intensity was recorded using a 10-point pain scale, with a score of 1 described as barely noticeable and 10 as the worst pain experienced.  Of 1519 injections assessed, pain was reported 9 times.  In these 9 instances, the pain intensity was reported as either a 1 or a 2, with an average score of 1.3.   The QuickShot® testosterone auto injector has not been approved by the United States Food and Drug Administration.

About Antares PharmaAntares Pharma focuses on self-administered parenteral pharmaceutical products. The Company’s product, OTREXUP® (methotrexate) injection for subcutaneous use, is approved in the U.S. for the treatment of adults with severe active rheumatoid arthritis, children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis. The Company’s product Sumatriptan Injection USP, is approved in the U.S. for the acute treatment of migraine and cluster headache and is distributed by Teva Pharmaceutical Industries, Ltd. (Teva).    Antares Pharma is also developing QuickShot® Testosterone for the treatment of hypogonadal men and has filed a New Drug Application with the Food and Drug Administration. The Company's technology platforms include VIBEX® disposable auto injectors, disposable multi-use pen injectors and reusable needle-free injectors. Antares Pharma has license, development and supply agreements with Teva that include VIBEX® epinephrine, exenatide multi-dose pen, and teriparatide multi-dose pen.  Our reusable needle-free injector for use with human growth hormone (hGH) is sold worldwide by Ferring B.V.  The Company is also working with AMAG Pharmaceuticals on a subcutaneous method for administering Makena, a progesterone product indicated for use in lowering the risk of pre-term birth.  For more information, visit www.antarespharma.com.

SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described.  Factors that may cause such differences include, but are not limited to: FDA acceptance of the phase 3 data to support our NDA for QST; U.S. Food and Drug Administration (“FDA”) approval of the QST NDA and future market acceptance and revenue for QST; the outcome of the pending patent litigation between Teva Pharmaceutical Industries, Ltd. (Teva) and Eli Lilly and Company regarding the Teriparatide multi-dose pen; FDA action with respect to Teva’s Abbreviated New Drug Application (“ANDA”) for the Teriparatide multi-dose pen and the timing and approval, if any, by the FDA of the same; Teva’s ability to adequately and timely respond to the Complete Response Letter received from the FDA for the VIBEX® epinephrine pen ANDA and approval by the FDA of the same, the timing and therapeutic equivalence rating thereof, and any future purchase orders and revenue pre or post FDA approval; Teva’s ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; FDA action with respect to Teva’s ANDA filed for the Exenatide pen and future revenue from the same; continued growth of prescriptions and sales of OTREXUP®;  the timing and results of the development project with AMAG Pharmaceuticals for an auto injector for Makena; the timing and results of research projects, clinical trials,  and product candidates in development; actions by the FDA or other regulatory agencies with the respect to the Company’s products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company’s ability to obtain financial and other resources for its research, development, clinical, and commercial activities 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. 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, 2016, 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.

Contact:
Jack Howarth
Vice President, Corporate Affairs
609-359-3016
jhowarth@antarespharma.com