Antares Pharma, Inc. (NASDAQ: ATRS) (the “Company”), a specialty pharmaceutical company, today announced that an abstract on XYOSTED®, a subcutaneous testosterone enanthate injection, was accepted as on oral presentation at the 22nd Annual Fall Scientific Meeting of SMSNA in Scottsdale, AZ on October 21-24, 2021.

The abstract entitled “Subcutaneous Testosterone Enanthate and the Effect of Body Mass Index on Serum Testosterone in Men with Testosterone Deficiency” was presented by Martin M. Miner, MD, Men’s Health Center, Miriam Hospital, Providence, RI. The post-hoc analysis evaluated the association between body mass index (“BMI”) and serum total testosterone to assess the pharmacokinetics parameters of XYOSTED®, a weekly subcutaneous testosterone enanthate treatment, in men with testosterone deficiency and varying BMIs. Dr. Miner concluded that patients with higher BMI may require higher testosterone doses to return serum testosterone to physiological levels.

Dr. Peter Richardson, EVP, Research and Development and Chief Medical Officer of Antares Pharma, commented, “We appreciated the opportunity to highlight analysis of our clinical trial data on XYOSTED at this year’s congress. We believe the multiple dosage strengths (50 mg, 75 mg, 100mg) of XYOSTED can allow patients to be titrated to their optimal dose. As always, we value our engagement with healthcare providers who are committed to patient care.”

About SMSNA

The Sexual Medicine Society of North America’s objective is to promote, encourage, and support the highest standards of practice, research, education, and ethics in the study of human sexual function and dysfunction. Members of SMSNA are all committed to sexual health and are comprised of Physicians (MD/DO), Clinician/Research Scientists (PhD), Advance Practice Providers (APN/PA), Allied Health Professionals (LPN/LVN/RN, Technician, Medical Assistant), Social Workers (MSW), and other healthcare or research professionals focused on sexual health across North America.

The SMSNA seeks to identify existing and emerging issues in the field of human sexual function and dysfunction, provide a forum for the free exchange and discussion of new ideas, thoughts, and concepts in sexual medicine, develop standards and guidelines for sexual medicine research and practice, and bring leading-edge concepts of research, clinical practice, ethics, and politics to health care professionals interested in sexual medicine and sexual health.

About Antares Pharma

Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma’s FDA-approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® (desmopressin acetate) in the U.S. and expects to commercially launch TLANDO® (testosterone undecanoate) in the U.S. pending final FDA approval.

IMPORTANT SAFETY INFORMATION

 WARNING: BLOOD PRESSURE INCREASES
  • XYOSTED® can cause blood pressure (BP) increases that can increase the risk for major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death, with greater risk for MACE in patients with cardiovascular risk factors or established cardiovascular disease.
  • Before initiating XYOSTED®, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled.
  • Starting approximately 6 weeks after initiating therapy, periodically monitor for and treat new onset hypertension or exacerbations of pre-existing hypertension in patients on XYOSTED®.
  • Re-evaluate whether the benefits of XYOSTED® outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease while on treatment.
  • Due to this risk, use XYOSTED® only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.
 

XYOSTED® INDICATIONS AND USAGE

XYOSTED® (testosterone enanthate) injection is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

Limitations of Use:

  • Safety and efficacy of XYOSTED® in males less than 18 years old have not been established.

XYOSTED® CONTRAINDICATIONS

  • Men with carcinoma of the breast or known or suspected carcinoma of the prostate.
  • Women who are pregnant. Testosterone may cause fetal harm.
  • Known hypersensitivity to XYOSTED® or its ingredients.
  • Men with hypogonadal conditions not associated with structural or genetic etiologies.

XYOSTED® WARNINGS AND PRECAUTIONS

  • Monitor hematocrit approximately every 3 months to detect increased red blood cell mass and polycythemia.
  • Monitor patients with benign prostatic hyperplasia (BPH) for worsening signs and symptoms of BPH.
  • Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone products. Evaluate patients with signs or symptoms consistent with DVT or PE.
  • Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids.
  • Exogenous administration of androgens may lead to azoospermia.
  • Edema with or without congestive heart failure may be a complication in patients with preexisting cardiac, renal, or hepatic disease.
  • Sleep apnea may occur in those with risk factors.
  • Monitor prostatic specific antigen (PSA) and lipid concentrations periodically.
  • Depression and suicidal ideation and behavior, including completed suicide, have occurred during clinical trials in patients treated with XYOSTED®.

ADVERSE REACTIONS

The most commonly reported adverse reactions (>5%) were: hematocrit increased, hypertension, PSA increased, injection site bruising, and headache.

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. 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: the Company’s ability to achieve the 2021 full-year revenue guidance; the uncertainty regarding the findings in the above referenced abstract presentation at SMSNA and the post-hoc analysis evaluating the association between body mass index (“BMI”) and serum total testosterone to assess the pharmacokinetics parameters of XYOSTED®, the ongoing COVID-19 pandemic, including new strains of the virus, and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, clinical trials, and our overall business, operating results and financial condition; commercial success of XYOSTED® and future revenue from the same; market acceptance of Teva’s generic epinephrine auto-injector product and future revenue from the same; future prescriptions and sales of OTREXUP®; successful commercialization of NOCDURNA® in the U.S. and market acceptance and future revenue from the same; uncertainties regarding future FDA approval of TLANDO®, market acceptance and future revenue from the same, whether Antares will exercise the option for LPCN 1111 (TLANDO XR) and if exercised, future timing and success of the clinical development program for TLANDO XR and future FDA approval, market acceptance and revenue from the same; whether the FDA will withdraw marketing approval for AMAG Pharmaceuticals’ Makena® subcutaneous auto injector following the FDA letter seeking withdrawal, the outcome of the FDA hearing and whether Makena® will be successful and future prescriptions, market acceptance and revenue from the same; Teva’s ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; Teva’s ability to successfully commercialize generic teriparatide in Europe, Canada and Israel and future revenue from the same, successful development including the timing and results of the Phase 3 trial of the drug device combination product for selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; the timing and results of the clinical development program for ATRS-1902 adrenal crisis rescue auto-injector, future NDA submission and FDA approval of the same, and if approved, future market acceptance and revenue for the same; FDA approval of Teva’s ANDAs for both generic Forteo® and Byetta® and future revenue from the same; the timing and results of the Company’s or its partners’ research projects or clinical trials of product candidates in development including the Company’s urology assets in development as well as Pfizer’s undisclosed development product; actions by the FDA or other regulatory agencies with 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 repay the debt obligation to Hercules Capital; 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, 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:

Tram BuiVice President, Corporate Communications and Investor Relations609-359-3016tbui@antarespharma.com

 

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