ATRS Antares Pharma Inc

Antares Pharma, Inc. (NASDAQ: ATRS) (“Antares”) (“the Company”), a pharmaceutical technology company, announced the first commercialization of the Company’s multi-dose pen platform launched in Europe. Antares development partner Teva, launched Teriparatide Injection (“teriparatide”), the generic version of Eli Lilly’s brand product Forsteo®  featuring the Antares multi-dose pen platform in Austria, Croatia, Hungary, The Netherlands, Portugal, Sweden, Switzerland and The United Kingdom and is expected to launch in other European countries later this year.

Teriparatide injection is a drug-device combination product indicated for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men, and in postmenopausal women and in men at increased risk of fracture.   

“The European launch of this product represents the achievement of another milestone in our development collaboration with Teva.  This is the third successful approval and launch of a drug device combination product which follows the previous launches of the generic epinephrine auto injector and the generic sumatriptan auto injector,” said Robert F. Apple, President and Chief Executive Officer of Antares Pharma. 

Antares previously entered into an exclusive Development, License and Supply Agreement with Teva Pharmaceutical Industries, Ltd. (“Teva”), a global leader in generic and specialty medicines, for a teriparatide injection product to be marketed globally, once approved by the respective regulatory authorities.  Antares is responsible for the manufacturing and supply of the multi-dose pen utilized in Teva’s generic teriparatide product.  The scope of the teriparatide license and supply agreement with Teva is worldwide.

About Teriparatide Injection

Teriparatide injection is used for the treatment of osteoporosis as the active substance, teriparatide, reduces the risk of bone fracture by stimulating bone formation.  Osteoporosis is a disease that is especially common in women after menopause, but it can also occur in both men and women as a side effect of glucocorticoid treatment. 

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 FDA approved 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: Teva’s successful commercialization of teriparatide injection in Europe and future 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.

Contact:

Jack HowarthVice President, Corporate Affairs 609-359-3016 - jhowarth@antarespharma.com