XML 29 R7.htm IDEA: XBRL DOCUMENT v2.4.0.8
Description of Business
9 Months Ended
Sep. 30, 2014
Accounting Policies [Abstract]  
Description of Business
1. Description of Business

Antares Pharma, Inc. (the “Company” or “Antares”) is an emerging specialty pharmaceutical company that focuses on developing and commercializing self-administered, parenteral, pharmaceutical products and technologies. The Company has numerous partnerships with pharmaceutical companies as well as multiple internal product development programs. The Company has developed both subcutaneous and intramuscular injection technology systems which include Vibex® disposable, pressure-assisted auto injectors, reusable needle-free injectors, and disposable multi-use pen injectors.

On October 14, 2013, the Company announced the approval of OTREXUP™ (methotrexate) injection by the U.S. Food and Drug Administration (“FDA”), in January 2014 announced the launch of OTREXUP™ and in February began detailing the product to health care professionals. OTREXUP™ is the first FDA-approved, subcutaneous methotrexate for once weekly self-administration with an easy-to-use, single dose, disposable auto injector. OTREXUP™ is indicated for adults with severe active rheumatoid arthritis (“RA”) or children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis. The Company has worldwide marketing rights for OTREXUP™. The Company commercializes OTREXUP™ in the U.S. for the treatment of RA and has provided LEO Pharma Inc. (“LEO”) the exclusive right to commercialize OTREXUP™ in the U.S. for the treatment of psoriasis.

The Company is also developing Vibex® QuickShot® Testosterone (“QS T”) for testosterone replacement therapy for men suffering from symptomatic testosterone deficiency. In February 2014, the Company announced positive, top-line results from a clinical study evaluating the pharmacokinetics of testosterone enanthate administered weekly by subcutaneous injection at doses of 50 mg and 100 mg via the Vibex® QS T auto injector device in adult males with testosterone deficiency. The study results were considered positive in that most of the 39 patients enrolled achieved average levels of testosterone within the normal range from the first dose onward. Vibex® QS T was also safe and well tolerated by all dosed patients. On July 22, 2014, the Company announced that the first patient was dosed in a Phase 3 double-blind, multiple-dose study to evaluate the efficacy and safety of Vibex® QS T administered subcutaneously once each week to adult males with testosterone deficiency. In October 2014, the Company announced the last patient was enrolled in the study. It is anticipated that patients will continue to be dosed in the study until the second half of 2015.

The Company has licensed its reusable needle-free injection device for use with human growth hormone (“hGH”) to Teva Pharmaceutical Industries, Ltd. (“Teva”), Ferring Pharmaceuticals BV (“Ferring”) and JCR Pharmaceuticals Co., Ltd. (“JCR”), with Teva and Ferring being two of the Company’s primary customers. The Company’s needle-free injection device is marketed by Teva as the Tjet® injector system to administer their 5mg Tev-Tropin® brand hGH marketed in the U.S. The Company’s needle-free injection device is marketed by Ferring with their 4mg and 10mg hGH formulations as Zomajet® 2 Vision and Zomajet® Vision X, respectively, in Europe and Asia. The Company has also licensed both disposable auto and pen injection devices to Teva for use in certain fields and territories and is engaged in product development activities for Teva utilizing these devices.

The Company also has a portfolio of gel-based products. Gelnique 3%®, the Company’s topical oxybutynin gel product for the treatment of overactive bladder (“OAB”), is currently being marketed by Actavis plc (“Actavis”) in the U.S. The Company’s gel portfolio also includes Elestrin® (estradiol gel) currently marketed by Meda Pharmaceuticals Inc. in the U.S. for the treatment of moderate-to-severe vasomotor symptoms associated with menopause.