Antares Pharma Announces Poster Presentation at the Pediatric Endocrine Society 2021 Virtual Annual Meeting
Antares Pharma (NASDAQ: ATRS) presented new data on testosterone enanthate for adolescent hypogonadal males at the Pediatric Endocrine Society 2021 Virtual Annual Meeting. The study, led by Dr. Maria Vogiatzi, utilized pharmacokinetic modeling from a Phase 2 trial of XYOSTED to demonstrate that a reduced frequency of subcutaneous testosterone administration could match testosterone exposure in normal adolescents. This suggests a potential new treatment avenue for a currently underserved population, though further clinical studies are needed for FDA approval.
- Potential expansion of XYOSTED's label to include adolescent hypogonadal males, addressing an unmet medical need.
- Data presented at a prestigious pediatric endocrinology conference, enhancing reputation and visibility.
- XYOSTED is currently only FDA-approved for adult males, limiting immediate market potential.
- FDA approval for adolescent use is uncertain and contingent on future clinical studies.
EWING, N.J., May 03, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (“the Company”), a specialty pharmaceutical company, today announced 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 on 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 of Pediatrics and Director, Adrenal and Puberty Center, Division of Endocrinology and Diabetes, Children’s Hospital of Philadelphia, Philadelphia, PA. Pharmacokinetic modelling of datasets from the Company’s Phase 2 trial for XYOSTED® for the treatment of hypogonadism in adult males was performed to permit the extrapolation of testosterone exposure to patients with body weights typical of preadolescent males. The PK modelling showed that subcutaneous testosterone enanthate dosed at a reduced frequency predicted testosterone exposure similar to normal adolescents and could represent a viable treatment option for permanently hypogonadal adolescent males, who require lifelong hormonal support.
Dr. Vogiatzi commented, “We were pleased to be able to share this novel data extrapolation with our colleagues and peers. Although XYOSTED has been FDA-approved for the treatment of testosterone deficiency only in adult males, our analysis of the PK data suggests that it could also potentially be confirmed for use in adolescent hypogonadal males with additional clinical studies. There are currently no approved autoinjectors to deliver subcutaneous testosterone in this medically underserved population. We appreciate the recognition of the Pediatric Endocrine Society that allowed us to present these important findings.”
The poster presentation can be accessed at PES Annual Meeting | Pediatric Endocrine Society (pedsendo.org).
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. Safety and efficacy of XYOSTED® in males less than 18 years old have not been established. Please see Prescribing Information including important safety information and boxed warning at www.xyosted.com.
* Dr. Maria Vogiatzi is a consultant of Antares Pharma, Inc.
About Antares Pharma
Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address unmet needs in targeted therapeutic areas such as urology and endocrinology. 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., which was licensed from Ferring Pharmaceuticals.
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 successful outcome of any future clinical trials to treat hypogonadal adolescent males and FDA approval of an indication for this patient population; the Company’s ability to achieve the 2021 full-year revenue guidance; the uncertainty regarding 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; whether the FDA will withdraw marketing approval for AMAG Pharmaceuticals’ Makena® subcutaneous auto injector following the FDA letter seeking withdrawal, whether AMAG will be granted an appeal hearing and if granted, 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 in Europe, Canada and Israel and future revenue from the same, successful development including the timing and results of the Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; FDA approval of Teva’s pending ANDAs for both generic Forteo® and Exenatide 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 endocrinology and 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 meet loan extension and interest only payment milestones 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 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 Bui
Vice President, Corporate Communications and Investor Relations
609-359-3016
tbui@antarespharma.com
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