You are here
Antares Pharma Partner Teva Announces Commercial Availability of Generic Epipen®
Teva’s Epinephrine Auto Injector Product FDA Approved as Therapeutically Equivalent and Fully Substitutable at the Pharmacy
EWING, N.J., Nov. 27, 2018 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (“Antares”) today announced that Teva Pharmaceutical Industries, Ltd.’s (“Teva”) generic EpiPen® is now commercially available in limited quantities. Teva’s generic EpiPen® was approved by the U.S. Food and Drug Administration (“FDA”) on August 16, 2018 and is indicated for emergency treatment of severe allergic reactions including those that are life threatening (anaphylaxis) in adults and certain pediatric patients. The product, which utilizes the Antares Pharma VIBEX® auto injector, has been approved as therapeutically equivalent and fully substitutable to the EpiPen® at the pharmacy.
“Today’s announcement of the commercial availability of the only fully substitutable generic version of the EpiPen is important for patients who have struggled to fill prescriptions due to various epinephrine product shortages.” said Robert F. Apple, President and Chief Executive Officer of Antares Pharma. “The availability of a therapeutically equivalent generic means patients living with severe, sometimes life-threatening allergic reactions including anaphylaxis, will now potentially have access to an FDA approved alternative.”
Antares previously entered into an exclusive License, Development and Supply Agreement with Teva for an epinephrine auto injector product to be marketed in the U.S. Pursuant to the agreement, Antares is responsible for supply of the device which will be sold to Teva at cost plus margin. Teva is responsible for commercialization and distribution of the final product for which Antares will receive royalties on net sales.
About Antares Pharma
Antares Pharma, Inc. is a specialty pharmaceutical company focused on the development and commercialization of self-administered parenteral 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 advanced stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals, Inc. and Pfizer Inc. (Pfizer). 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: market acceptance, adequate reimbursement coverage and commercial success of XYOSTED™ and future revenue from the same; market acceptance, adequate reimbursement coverage and commercial success of Teva’s generic epinephrine auto-injector product and future revenue from the same; future market acceptance and revenue from AMAG’s 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®; successful completion of the asset sale transaction with Ferring International Center, S.A.; the timing and results of the Company’s or its partners’ research projects or clinical trials of product candidates in development including projects with Teva and Pfizer; 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 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.
Vice President, Corporate Affairs