Antares Pharma, Inc. (NASDAQ: ATRS), a pharmaceutical technology company, today announced they have entered into an exclusive distribution agreement with Lunatus Global Medical Supplies (“Lunatus”) to distribute and promote the sale of  XYOSTED® in Saudi Arabia and the United Arab Emirates (“UAE”). 

Under the agreement, Antares will be responsible for the supply of fully packaged product to Lunatus and Lunatus will be responsible for submitting and obtaining regulatory approval for XYOSTED® in Saudi Arabia and the UAE as well as marketing, promotion and distribution of XYOSTED® in these two countries.

“We believe today’s announcement represents the first step in creating increased brand awareness for XYOSTED in the rest of the world, and look forward to working with our partner Lunatus in that endeavour.  XYOSTED is currently the fastest growing branded testosterone replacement therapy in the U.S.,” said Robert F. Apple, President and Chief Executive Officer of the Company.”  He continued, “Current treatment options in these two countries include a painful hospital administered testosterone injection given every three months or a topical gel.  Alternatively, XYOSTED would be an attractive new treatment option for physicians and patients given its unique product profile featuring a virtually painless, once-weekly, at-home subcutaneous self-injection.  Lunatus, a Dubai based company, has a proven track record of introducing, building and maintaining profitable brands in the Arabian Gulf and Middle East regions.  We believe this agreement will help lay the groundwork for expanding our global footprint for XYOSTED and represents the first of potentially multiple international distribution agreements.”

“We are excited to bring XYOSTED to Saudi Arabia and the UAE.  XYOSTED is a U.S. FDA approved treatment option for adult men diagnosed with testosterone deficiency,” said Dr. Lina Kouatly, President and Chief Executive Officer of Lunatus.  “Assuming regulatory approval in these two countries, we believe our partnership can achieve significant share and expand the market using this novel treatment approach.”  

About Antares Pharma

Antares Pharma, Inc. is a pharmaceutical technology 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, Inc. (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia).  Antares Pharma’s proprietary products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva.

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: Lunatus’ ability to obtain regulatory approval and successfully commercialize XYOSTED in Saudi Arabia and the United Arab Emirates and the amount of revenue from the same, the uncertainty regarding the duration, scope and severity of the COVID-19 pandemic 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, and our overall business, operating results and financial condition; market acceptance, adequate reimbursement coverage and commercial success of XYOSTED® and future revenue from the same; successful development including the timing and results of the clinical bridging and 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; market acceptance of Teva’s generic epinephrine auto-injector product and future revenue from the same; our expectations regarding whether the FDA will pursue withdrawal of approval for AMAG Pharmaceuticals Inc.’s Makena® subcutaneous auto injector following the recent FDA advisory committee meeting and future prescriptions, market acceptance and revenue from Makena® subcutaneous auto injector; Teva’s ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; continued growth of prescriptions and sales of OTREXUP®;  the timing and results of the Company’s or its partners’ research projects or clinical trials of product candidates in development;  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.

Contacts:

Jack HowarthVice President, Corporate Affairs609-359-3016jhowarth@antarespharma.com

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