Based upon a written response the company received from the FDA related to its clinical development program for XYOSTEDTM, the company conducted an additional supplemental safety study QST-15-005. Teva also filed an ANDA for a generic version of Forteo® (teriparatide [rDNA origin] injection), which was accepted by the FDA in February 2016 and is currently under review. Antares Vision performs in-line inspection to prevent cross-contamination and detect product defects during the phase of bottles filling with tablets and capsules. Teva has advised it that they submitted a response to the CRL and are targeting a launch in early 2018. Antares Pharma is collaborating with Teva on a VIBEX® auto injector pen containing epinephrine used for the treatment of severe allergic reactions (anaphylaxis). Antares' partnered product sales to Teva Pharmaceutical Industries, AMAG Pharmaceuticals, and Ferring Pharmaceuticals also increased year over year. You can change your choices at any time by visiting Your Privacy Controls. 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. Yahoo is part of Verizon Media. The company develop, manufacture and commercialize, for itself or with partners, novel therapeutic products using its advanced drug delivery systems that are designed to help improve safety and efficacy, reduce side effects, and enhance patient comfort and adherence. Teva also successfully concluded a decentralized procedure registration process in Europe. PCI Pharma Services is an integrated full-service provider and a trusted partner to leading companies in the global healthcare industry. Antares Pharma's other combination product development projects in collaboration with Teva include a multi-dose pen for a generic form of BYETTA® (exenatide injection) for the treatment of diabetes, and another multi-dose pen for a generic form of Forteo® (teriparatide [rDNA origin] injection) for the treatment of osteoporosis. : +39-030-7283500 / Fax. Antares now offers three grades of TPGS: Food Grade, NF Grade and SF (non-GMO) Grade. Its strategy is to identify new or existing approved drug formulations and apply its drug delivery technology to enhance the drug compounds and delivery methods. The stay will expire in August 2018 unless the litigation is resolved sooner. To enable Verizon Media and our partners to process your personal data select 'I agree', or select 'Manage settings' for more information and to manage your choices. Antares Pharma has strategic alliances and partnership arrangements with several pharmaceutic companies. EWING - Antares Pharma, Inc. (NASDAQ: ATRS) ('the Company'), a pharmaceutical technology company, today announced that Robert F. Apple, President and Chief Executive Officer has participated in a fireside chat presentation and will host investor meetings at the Piper Sandler 32nd Annual Virtual Healthcare Conference being held on December 1-3, 2020. It has the added benefit of being a clean label ingredient. Antares Pharma, Inc. (ATRS) is an emerging, specialty pharmaceutical company that focuses on the development and commercialization of self-administered parenteral pharmaceutical products and technologies. Our wide selection of fully customizable Inspection solutions for pharma can guarantee the consistent quality of your product. With its commercialization partner Teva, the company launched Sumatriptan Injection USP, indicated in the U.S. for the acute treatment of migraine and cluster headache in adults, in June 2016. Antares Pharma has formed significant strategic alliances and partnership arrangements with industry leading pharmaceutical companies including Teva, AMAG, and Ferring Pharmaceuticals Inc. and Ferring B.V. (together “Ferring”). The NDA submission was accepted for standard review by the FDA and assigned a Prescription Drug User Fee Act (“PDUFA”) target date for completion of its review by October 20, 2017. Antares Pharma has a portfolio of proprietary and partnered products, including approved commercial products and several product candidates in advanced stages of development and under active FDA review. Sumatriptan Injection USP represents the Company’s first ANDA approval of a complex generic and second product approved using the VIBEX® auto injector platform and is commercialized and distributed by Teva under the terms of a license, supply and distribution arrangement. Under a license, development and supply agreement, AMAG is responsible for the clinical development and preparation, submission and maintenance of all regulatory applications, the manufacture and supply of the drug, and the marketing, sale and distribution of the product. We and our partners will store and/or access information on your device through the use of cookies and similar technologies, to display personalised ads and content, for ad and content measurement, audience insights and product development. Antares Pharma, Inc. is a pharmaceutical technology company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products … Antares Pharma to Present at the H.C. Wainwright 22nd Annual Global Virtual Investment Conference. Antares Pharma is developing XYOSTEDTM (testosterone enanthate) injection for testosterone replacement therapy, and submitted a 505 (b) (2) New Drug Application (“NDA”) to the FDA in December 2016. The study included a screening phase, a treatment titration phase and a treatment phase for evaluation of safety and tolerability assessments, including laboratory assessments, adverse events and injection site assessments. Antares Pharma, Inc. is a pharmaceutical technology company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products … To date, Antares Pharma has received FDA approval for dosage strengths of 7.5 mg, 10 mg, 12.5 mg, 15 mg, 17.5 mg, 20 mg, 22.5 mg and 25 mg of OTREXUP®. Antares Pharma Inc. has a market valuation of $540.61 million and last released its earnings reports on 11/05/2020, for the quarterly period ended on Sep 2020. EWING, N.J., July 21, 2020 -- Antares Pharma, Inc. , a pharmaceutical technology company, announced the first commercialization of the Company’s multi-dose pen platform launched in... | December 15, 2020 Teva submitted an amendment to the VIBEX® epinephrine pen ANDA in December 2014 and received a Complete Response Letter (“CRL”) from the FDA in February 2016 in which, according to Teva, the FDA identified certain major deficiencies. To date, Antares Pharma has received FDA approval for dosage strengths of 7.5 mg, 10 mg, 12.5 mg, 15 mg, 17.5 mg, 20 mg, 22.5 mg and 25 mg of OTREXUP®. POSITION SUMMARY . ATRS. The pages created by the user or by XWiki extensions on behalf of the user. Our accurate detection technologies optimize efficiency by ensuring genuine reliability of all packaging and production processes, for guaranteed end user safety within the pharmaceutical industry. Information about your device and internet connection, including your IP address, Browsing and search activity while using Verizon Media websites and apps. Antares Pharma, Inc. develops pharmaceutical delivery systems, including needle-free and mini-needle injector systems and transdermal gel technologies. The following table provides an overview and brief description of products and product opportunities: This site is funded and maintained by Fintel.io. Its subcutaneous injection technology platforms include the VIBEX® pressure-assisted auto injector system suitable for branded and generic injectable drugs in unit dose containers, reusable needle-free spring-action injector devices, and disposable multi-dose pen injectors for use with standard cartridges. Antares Vision leads the complete process of protecting products throughout their life-cycle by delivering the most comprehensive solutions in Track & Trace, Inspection and Smart Data Management. 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. In 2016, the company announced that Teva had settled the patent litigation with AstraZeneca Pharmaceuticals, LP, AstraZeneca AB, and Amylin Pharmaceuticals, LLC (collectively “AstraZeneca”) relating to certain AstraZeneca U.S. patents and their drug, BYETTA® (exenatide). Manufacturing Engineer II. EWING, N.J., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (“the Company”), a pharmaceutical technology company, today announced that Robert F. Apple, President and Chief Executive Officer, is scheduled to present at the H.C. … In response to Teva’s paragraph IV certification contained in Teva’s ANDA for teriparatide, Eli Lilly & Co (“Lilly”) filed a lawsuit against Teva alleging infringement of six U.S. patents related to Forteo® (teriparatide [rDNA origin] injection) resulting in a 30-month stay in FDA approval of the ANDA. Antares Pharma continues to build its commercial portfolio, with four products approved by the FDA in less than 5 years, focusing on innovative, patient-focused therapeutic options. Our Culture and Our People; Antares Benefits; Open Positions; Contact Us The company generates its revenue in three ways: product sales, development activities, and royalties. Our marketed products include Otrexup™, Sumatriptan autoinjector, Zoma-Jet and Gelnique, and are built on our proven auto injector and pen device platforms. © 2020 ANTARES VISION S.p.A. - Via Del Ferro, 16 - 25039 Travagliato - Brescia - ITALY Tel. The company's testosterone injection Xyosted and chemotherapy Otrexup both delivered strong sales growth. Sumatriptan Injection USP (generic equivalent to Imitrex® STATdose Pen®). Antares' product sales in Q4 of $28.5 million set an all-time high, and more than doubled the $14.2 million in the prior-year period. Antares Pharma, Inc. is a pharmaceutical technology company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products … Includes modified extension pages (usually configuration pages). In September 2016, the company announced the successful completion of the QST-15-005 study. With a strong reputation for providing secure and reliable advice on the importation and distribution of clinical trial products, PCI’s primary goal is customer safety. The Company also markets NOCDURNA® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals. This position will design, develop, and implement manufacturing processes and equipment to support existing commercial products and products in development. AMAG initiated a pharmacokinetic (“PK”) study in October 2016 and disclosed positive top line results of the study in February 2017. As the natural choice for the most demanding industries , Antares Vision is more than a technology provider. 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. 10 Nov 2020 Antares Pharma to Present at the Jefferies Virtual London Healthcare Conference Read More. The company received FDA approval of its Abbreviated New Drug Application (“ANDA”) for 4 mg/0.5 mL and 6 mg/0.5 mL single-dose prefilled syringe auto-injectors, a generic equivalent to Imitrex® STATdose Pen®, in December 2015. Antares Pharma’s FDA-approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Inject… With its commercialization partner Teva, the company launched Sumatriptan Injection USP, indicated in the U.S. for the acute treatment of migraine and cluster headache in adults, in June 2016. TPGS has utility and a proven record of safety and efficacy in pharmaceutical, dietary supplement, food & beverage, personal care, animal nutrition and CBD and other botanical oil products. In 2001 Dr. Sadowski became Vice President of the Company’s Devices Group where he led the conceptualization and development of the VIBEX mini-needle injection technology platform. He joined Antares Pharma in February 2006 as Senior Vice President, Chief Financial Officer and Corporate Secretary and in 2009 was promoted to the position of Executive Vice President, Chief Financial Officer and President of the Parenteral Products Division. Teva filed an ANDA for exenatide, which was accepted by the FDA in October 2014 and is currently under FDA review. Dr. Sadowski joined Medi-Ject Corporation, a predecessor company to Antares Pharma, in March 1994 as Vice President, Product Development. OTREXUP® is the first FDA-approved subcutaneous methotrexate for once weekly self-administration with an easy-to-use, single dose, disposable auto injector, indicated for adults with severe active rheumatoid arthritis, children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis. Antares Pharma’s FDA-approved products include XYOSTED ® (testosterone enanthate) injection, OTREXUP ® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP… Partnering with Antares; Devices; For Investors. The Company's injection products include syringes and self-injection systems for patients with rheumatoid arthritis, psoriasis, migraine and cluster headache, needle-free and disposable pressure-assisted auto injectors for various purposes. Antares Pharma, Inc. focuses on developing and commercializing self-administered parenteral pharmaceutical products and technologies in the United States, Europe, and internationally. Open Position at Antares Pharma. The settlement allows Teva to commercialize their exenatide product in the U.S. beginning October 15, 2017 or earlier under certain circumstances. Find out more about how we use your information in our Privacy Policy and Cookie Policy. 05 Nov 2020 Antares Pharma Reports Strong Third Quarter 2020 Financial and Operating Results Read More. The company market and sell its proprietary product OTREXUP® (methotrexate) injection, which was launched in the U.S. in February 2014. Antares development partner Teva, launched Teriparatide … According to Teva, the Public Assessment Report for the decentralized procedure has been published and the product was filed in 17 countries, which addresses the majority of the market value in Europe. Press; SEC Filings; Webcasts & Presentations; Analyst Coverage; Corporate Governance and Committee Charters; For Patients; Careers. Antares Pharma’s FDA approved products include XYOSTED ® (testosterone enanthate) injection, OTREXUP ® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP… Antares Pharma to Participate in the Piper Sandler 32nd Annual Virtual Healthcare Conference Read More. In partnership with AMAG, Antares Pharma is currently developing a variation of its VIBEX® QuickShot® subcutaneous auto injector for use with AMAG’s Makena® (hydroxyprogesterone caproate injection) for the treatment of pre-term birth. According to AMAG, the study successfully demonstrated comparable bioavailability between subcutaneous injection of Makena® compared to intra muscular injection. Antares Pharma is responsible for the design and development of the auto-injection device, the manufacturing and supply of the device, and assembly and packaging of the final product. 877-870-0159 info@tpgs.com The company also make reusable, needle-free injection devices that administer injectable drugs, which are currently marketed primarily through its partner Ferring, for use with human growth hormone, and have two gel-based products that are commercialized through its partners pursuant to licensing arrangements. Customer service, documentation, purchase orders, general office, accounting, and the R&D facility. Overview of Clinical, Regulatory and Product Development Activities. Contact us at Antares Health Products Vitamin E TPGS. The company conducted a multi-center, phase 3 clinical study (“QST-13-003”) evaluating the efficacy and safety of testosterone enanthate administered once-weekly by subcutaneous injection using the QuickShot® auto injector in adult males diagnosed with testosterone deficiency, and the company previously announced positive top-line pharmacokinetic results that showed that the primary endpoint for this study was achieved. The company’s revenue for the quarter stood at $40.0 billion. Antares Pharma’s FDA-approved products include XYOSTED ® (testosterone enanthate) injection, OTREXUP ® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP… AMAG submitted its sNDA for the Makena® subcutaneous auto injector in April 2017, which was accepted by the FDA and given a PDUFA target action date of February 14, 2018. AstraZeneca and Teva entered into a settlement and license agreement pursuant to which AstraZeneca granted Teva a license to manufacture and commercialize the generic version of BYETTA® described in Teva’s ANDA. FIRST COMMERCIAL PRODUCT USING ANTARES PHARMA'S MULTI-DOSE PEN PLATFORM LAUNCHES IN EUROPE EWING, NJ, July 21, 2020--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. About Antares Pharma. The results of these two studies formed the clinical basis of its NDA submission for XYOSTEDTM and are further discussed in the “Research and Development Programs” section below. 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