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02/20/14 - $4.96
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antares pharma inc (ATRS) Details

Antares Pharma, Inc. operates as a specialty pharmaceutical company that focuses on developing and commercializing self-administered parenteral pharmaceutical products and technologies worldwide. The company’s injection products include OTREXUP, a pre-filled methotrexate syringe with Medi-Jet technology to enable rheumatoid arthritis (RA) and psoriasis patients to self-inject methotrexate at home; and Tjet/Zomajet, the needle-free auto injectors to deliver human growth hormone treatment to children without the use of a needle. Its transdermal products comprise Gelnique3%, an oxybutynin gel product for the treatment of overactive bladder; and Elestrin, a transdermal estradiol gel for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. The company is also developing OTREXUP for the treatment poly-articular-course juvenile RA and psoriasis; Vibex QS T for testosterone replacement therapy for men suffering from symptomatic testosterone deficiency; Vibex auto injectors; and disposable pen injectors. Antares Pharma, Inc. has collaborative and license agreements with Ferring Pharmaceuticals BV; Teva Pharmaceutical Industries, Ltd.; JCR Pharmaceuticals Co., Ltd.; Actavis, Inc.; Daewoong Pharmaceuticals; Meda Pharmaceuticals; Pfizer Inc; Population Council; and LEO Pharma. The company was founded in 1979 and is headquartered in Ewing, New Jersey.

60 Employees
Last Reported Date: 03/13/14
Founded in 1979

antares pharma inc (ATRS) Top Compensated Officers

Chief Operating Officer and Executive Vice Pr...
Total Annual Compensation: $360.0K
Compensation as of Fiscal Year 2013.

antares pharma inc (ATRS) Key Developments

Antares Pharma Provides Regulatory Update on Sumatriptan Injection USP

Antares Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the Abbreviated New Drug Application (ANDA) for Sumatriptan Injection USP for the acute treatment of migraine. The complete response letter from the FDA provided revisions to labelling and cited minor deficiencies. If approved, Sumatriptan Injection USP would represent the Companys first ANDA approval and second device approved from the VIBEX® auto injector platform. As previously disclosed, Teva Pharmaceutical Industries Ltd. would distribute the product and share the profits equally with Antares Pharma.

Antares Pharma Announces Update to QuickShot Testosterone Program

Antares Pharma Inc. announced that it has received written recommendations from the U.S. Food and Drug Administration (FDA) related to its clinical development program for QuickShot Testosterone. The recommendations received were in response to various clinical, CMC (Chemistry, Manufacturing and Controls) and user study submissions made by the company through November 2014. The company believes that it has already factored many of the recommendations cited in the advice letter into the protocol of the ongoing phase 3 study and into the protocols for planned human use studies as a result of guidance provided by FDA at the May 2014 Type C meeting. Based on a single reported occurrence of hives in the Company’s phase 2 study, which the FDA characterized as an apparent allergic reaction, as well as the known safety experience with other parenteral testosterone products, the FDA is recommending that the company create a larger safety database, including approximately 350 subjects exposed to QS T with 200 subjects exposed for six months and 100 subjects exposed for a year. The company does not believe that the adverse event of hives reported in the phase 2 study was related to study drug. Based on the number of subjects in previous studies and in the current phase 3 study, the Company anticipates that it may need approximately 70 additional subjects exposed to QS T for six months. The company is assessing the FDA’s comments in the advice letter and their impact on the timing of the filing of a New Drug Application for QS T with the FDA. The timing, cost and design of the study to obtain the additional 70 subjects and data required will be determined based on further discussion with the FDA. The company continues to expect to release top-line pharmacokinetic data from the current phase 3 study in the second quarter of 2015. As previously announced, the Company is conducting a double-blind, multiple-dose, phase 3 study to evaluate the efficacy and safety of QS T administered subcutaneously once each week to testosterone-deficient adult males. Patients enrolled in this study had a documented diagnosis of hypogonadism or testosterone deficiency defined as having repeated testosterone levels below 300 ng/dL. The study includes a screening phase, a treatment titration and efficacy phase and an extended treatment phase. Approximately 150 patients are enrolled in this study. Patients meeting all eligibility criteria were assigned to receive a starting dose of 75 mg QS T once weekly for six weeks. Blinded adjustments to dose are made at week 7 based upon the week 6 pre-dose blood level. The efficacy of QS T and dose adjustment to regulate testosterone levels will be evaluated after 12 weeks of treatment. Upon completion of this phase, patients may remain on their optimized QS T dose and will be followed for an additional 40 weeks.

Antares Pharma Inc. Presents at 33rd Annual J.P. Morgan Healthcare Conference, Jan-15-2015 09:00 AM

Antares Pharma Inc. Presents at 33rd Annual J.P. Morgan Healthcare Conference, Jan-15-2015 09:00 AM. Venue: Westin St. Francis Hotel, San Francisco, California, United States. Speakers: Eamonn P. Hobbs, Chief Executive Officer, President, Director, Member of Audit Committee and Member of Governance & Nominating Committee.


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