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Antares Pharma Announces FDA Approval of Generic EpiPen Utilizing VIBEX Auto Injector
Teva’s Epinephrine Auto Injector Product Deemed AP Rated and Fully Substitutable at the Pharmacy
EWING, N.J., Aug. 16, 2018 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (“Antares”) today announced that the U.S. Food and Drug Administration (FDA) has approved Teva Pharmaceutical Industries, Ltd.’s (“Teva”) epinephrine auto injector drug-device combination product indicated for emergency treatment of severe allergic reactions including those that are life threatening (anaphylaxis) in adults and certain pediatric patients. Our partner Teva filed an Abbreviated New Drug Application (ANDA) seeking FDA approval of the product as a generic substitute of Mylan’s branded product EpiPen®. Teva’s drug-device combination product utilizes the Antares Pharma VIBEX® device and has been approved with an AP rating, defined as a therapeutically equivalent injectable aqueous solution and therefore fully substitutable to the EpiPen at the pharmacy.
“We are extremely pleased with the FDA’s decision to approve Teva’s ANDA for the first and only fully substitutable generic version of Mylan’s branded EpiPen, the most widely used epinephrine auto injector on the market,” said Robert F. Apple, President and Chief Executive Officer of Antares Pharma. “This approval means patients living with severe, sometimes life-threatening allergic reactions, (anaphylaxis), who require immediate access to life-sparing epinephrine should have access to a generic alternative. We and our partner Teva worked diligently together to obtain the approval of this very complex drug/device rescue pen combination product utilizing our VIBEX auto injector platform and we look forward to Teva making it commercially available to patients.”
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 injection 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) and AMAG Pharmaceuticals, Inc. Antares Pharma’s proprietary products include OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company has developed an investigational new drug for testosterone replacement therapy called XYOSTED™, currently under active review at the FDA with a PDUFA date of September 29, 2018.
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 of Teva’s generic epinephrine auto-injector product and future revenue from the same; timing and successful development of the rescue pen with Pfizer and FDA approval and future revenue from the same; successful completion of the transaction with Ferring International Center, S.A.; the Company’s ability to resolve the deficiencies identified by the FDA in the Complete Response Letter for XYOSTED™, FDA approval of the Company’s NDA for XYOSTED™ and future market acceptance and revenue for XYOSTED™; future 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 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 of Antares