Antares Pharma Announces Poster Presentation at the Pediatric Endocrine Society 2021 Virtual Annual Meeting
EWING, NJ, May 3, 2021 (GLOBE NEWSWIRE) – Antares Pharma, Inc. (NASDAQ: ATRS) (“the Company”), a specialty pharmaceutical company, announced today that data highlighting the therapeutic potential of subcutaneous testosterone enanthate in younger hypogonadal populations was presented in a poster presentation at the Pediatric Endocrine Society (PES) 2021 Virtual Annual Meeting from April 30 – May 3, 2021.
The poster presentation entitled ‘Allometric scaling of testosterone enanthate pharmacokinetics from adult males to adolescent hypogonadal males (30-60 kg) after IM and SC administration using population PK modeling’ was presented by Maria Vogiatzi, MD *, professor Pediatrics and Director, Adrenal and Puberty Center, Department of Endocrinology and Diabetes, Children’s Hospital of Philadelphia, Philadelphia, PA. Pharmacokinetic modeling of datasets from the company’s Phase 2 study for XYOSTED® for the treatment of hypogonadism in adult men was performed to allow the extrapolation of testosterone exposure to patients with body weights typical of preadolescent men. The PK modeling showed that subcutaneous testosterone enanthate dosed at a lower frequency predicted testosterone exposure comparable to that of normal adolescents and that it could be a viable treatment option for permanently hypogonadal adolescent males, who require lifelong hormone support.
Dr. Vogiatzi said, “We were delighted to be able to share this new extrapolation of data with our colleagues and colleagues. Although XYOSTED is only approved by the FDA for the treatment of testosterone deficiency in adult men, our analysis of the pharmacokinetic data suggests that it could potentially be confirmed for use in adolescent hypogonadal men as well with additional clinical studies. There are currently no approved autoinjectors to deliver subcutaneous testosterone to this medically disadvantaged population. We appreciate the recognition from the Pediatric Endocrine Society for enabling us to present these important findings. “
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The poster presentation is accessible at PES Annual Meeting | Pediatric Endocrine Society (pedsendo.org).
XYOSTED® (testosterone enanthate) injection is an androgen indicated for testosterone replacement therapy in adult men for conditions related to a deficiency or absence of endogenous testosterone. Safety and efficacy of XYOSTED® in men younger than 18 years have not been determined. See prescribing information including important safety information and warning in a box www.xyosted.com.
* Dr. Maria Vogiatzi is a consultant to Antares Pharma, Inc.
About Antares Pharma
Antares Pharma, Inc. is a specialty pharmaceutical company primarily focused on the development and commercialization of pharmaceutical products and technologies addressing unmet needs in targeted therapeutic areas such as urology and endocrinology. The company has a portfolio of proprietary commercial products and partners with various product candidates at various stages of development, as well as important strategic alliances with 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 US, which is licensed by Ferring Pharmaceuticals.
PORT SAFE DECLARATION UNDER THE PRIVATE SECURITIES REFORM LAW IN 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 could cause actual results to differ materially from those described. Factors that could cause such differences include, but are not limited to: the successful outcome of future clinical trials in the treatment of hypogonadal adolescent males and FDA approval of an indication for this patient population; the company’s ability to meet its full-year 2021 revenue forecast; the uncertainty about the ongoing COVID-19 pandemic, including new virus strains, and the mitigations and other restrictions implemented in response and the impact on the demand for our products, new patients and prescriptions, future revenues, product offerings, clinical studies and our general operations, results of operations and financial condition; commercial success of XYOSTED®and future income from it; market acceptance of Teva’s generic epinephrine auto-injector product and future revenues therefrom; future regulations and sale of OTREXUP®; successful commercialization of NOCDURNA® in the US and market adoption and future earnings thereof; whether the FDA will withdraw marketing approval for AMAG Pharmaceuticals’ Makena® subcutaneous auto-injector following the FDA letter requesting revocation, whether AMAG will have an appeal hearing and whether Makena®will be successful and future regulations, market acceptance and income from them; Teva’s ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of its income ;; Teva’s ability to successfully market generic teriparatide in Europe, Canada and Israel and future revenues from the same successful development, including the timing and results of the Phase 3 clinical trial of the Selatogrel drug combination product with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future income from them; FDA approval of Tevas pending ANDAs for both generic Forteo® and Exenatide and future earnings thereof; the timing and results of the Company’s or its partners’ research projects or clinical trials of product candidates under development, including those of the Company endocrinology and urology assets in development as well as Pfizer’s undisclosed development product; actions by the FDA or other regulatory authorities regarding the Company’s products or its partners’ product candidates; continued growth in product, development, license and royalty income; the Company’s ability to meet the milestones for the loan renewal and payment of interest only and the 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 on matters that are not historical facts and that include predictions. These statements involve known and unknown risks, uncertainties and other factors that could cause actual results, performance, performance or prospects to differ materially 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 using terminology such as ” could ”, ” will ”, ” would ”, ” would ”, ” expect ”, ” intend ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” ” “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 about these and other factors that could cause actual results to differ materially from those expected in the forward-looking statements can be found in the “ Risk Factors ” section of the company’s annual report on Form 10-K, and in the company’s other periodic report. reports and filings with the Securities and Exchange Commission. The company cautions investors not to place undue reliance on the forward-looking statements in this press release. All forward-looking statements are based on information currently available to the company as of the date hereof, and the company assumes no obligation to revise or update these forward-looking statements to reflect events or conditions after the date of this press release except as required by law.
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