EWING, NJ, USA I December 19, 2016 I Antares Pharma, Inc. (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.
SOURCE: Antares Pharma
Post Views: 118
EWING, NJ, USA I December 19, 2016 I Antares Pharma, Inc. (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.
SOURCE: Antares Pharma
Post Views: 118
