EWING, N.J., Dec. 19, 2016 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS ) today announced that Teva Pharmaceutical Industries, Ltd. (Teva) has successfully concluded a decentralized procedure registration process in Europe for its teriparatide injection product, a treatment for osteoporosis in postmenopausal women and men at increased risk of fracture and for glucocorticoid induced osteoporosis in men and women. Applications for marketing authorizations in Europe are ongoing in each of the countries of application.
“We are extremely pleased with the outcome of Teva’s teriparatide decentralized procedure in Europe and look forward to the issuance of the marketing authorizations in each country of application,” said Robert F. Apple, President and Chief Executive Officer of Antares Pharma. He continued, “While our collaboration partner Teva awaits final marketing authorizations and the clearance of the intellectual property of the original product, we will continue to monitor progress on their Abbreviated New Drug Application for a U.S. generic equivalent of Forteo ®[1] , which is currently under active review at the Food and Drug Administration.”
Antares is responsible for manufacturing and the supply of the multi-dose pen that Teva will use for teriparatide. The scope of the teriparatide license and supply agreement with Teva is worldwide and provides for a margin on device sales and a royalty on end sales of the product.
About Teriparatide
Teriparatide is used for the treatment of osteoporosis as it reduces the risk of bone fracture in various patient groups. Osteoporosis is more common in women after menopause, and it can also occur in both men and women as a side effect of glucocorticoid treatment.
About Antares Pharma Antares Pharma focuses on self-administered parenteral pharmaceutical products. The Company’s product, OTREXUP® (methotrexate) injection for subcutaneous use, is approved in the U.S. for the treatment of adults with severe active rheumatoid arthritis, children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis. The Company and Teva Pharmaceutical Industries, Ltd. (Teva) recently announced the third quarter 2016 U.S. commercial launch of VIBEX ® Sumatriptan Injection USP for the acute treatment of migraine and cluster headache. Antares Pharma is also developing QuickShot ® Testosterone for testosterone replacement therapy. The Company's technology platforms include VIBEX ® disposable auto injectors, disposable multi-use pen injectors and reusable needle-free injectors. Antares Pharma has a multi-product deal with Teva that includes VIBEX ® epinephrine, exenatide multi-dose pen, and teriparatide multi-dose pen. Our reusable needle-free injector for use with human growth hormone (hGH) is sold worldwide by Ferring B.V. The Company is also working with AMAG Pharmaceuticals on a subcutaneous method of administering Makena, a progesterone product indicated for use in lowering the risk of pre-term birth. For more information, visit www.antarespharma.com .
[1] FORTEO ® is a registered trademark of Eli Lilly and Company.
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 timing and issuance of the marketing authorizations for Teriparatide multi-dose pen in the various European Member States of application, the timing and clearance of patents related to Forteo or the expiration of patents related to Forteo, whichever is longer, and Teva Pharmaceutical Industries, Ltd. (Teva) ability to successfully commercialize the Teriparatide multi-dose pen in Europe and any future revenue therefrom; the outcome of the pending patent litigation between Teva and Eli Lilly and Company regarding the Teriparatide multi-dose pen; U.S. Food and Drug Administration (“FDA”) action with respect to Teva’s Abbreviated New Drug Application (“ANDA”) for the Teriparatide multi-dose pen and the timing and approval, if any, by the FDA of the same; the results of the phase 3 studies for QuickShot ® Testosterone (QST) and acceptance of the data by the FDA; the timing and Company’s ability to successfully complete a New Drug Application (“NDA”) for QST, acceptance of the NDA for QST by the FDA and approval of the same by the FDA; Teva’s ability to adequately and timely respond to the Complete Response Letter received from the FDA for the VIBEX ® epinephrine pen ANDA and approval by the FDA of the same, the timing and therapeutic equivalence rating thereof, and any future purchase orders and revenue pre or post FDA approval; Teva’s ability to successfully commercialize VIBEX ® Sumatriptan Injection USP and the amount of revenue from the same; FDA action with respect to Teva’s ANDA filed for the Exenatide pen and future revenue from the same; continued growth of prescriptions and sales of OTREXUP ® ; the timing and results of the development project with AMAG Pharmaceuticals for an auto injector for Makena; the timing and results of research projects, clinical trials, and product candidates in development; actions by the FDA or other regulatory agencies with the 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 for the year ended December 31, 2015, 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 Howarth Vice President, Corporate Affairs 609-359-3016 jhowarth@antarespharma.com
