ANTARES PHARMA, INC. 
By
EWING, N.J., January 15, 2014 - Antares Pharma, Inc. (NASDAQ: ATRS) today announced the availability of OTREXUP™, the first U.S. Food and Drug Administration (FDA) approved subcutaneous (SC) methotrexate (MTX) product for once weekly self-administration with an easy-to-use, single dose, disposable auto injector. OTREXUP was approved by the FDA in October 2013. OTREXUP is available at distribution centers throughout the USA.
Approximately 1.3 million Americans are diagnosed with RA and about 7.5 million with psoriasis. Initial treatment of these conditions with oral MTX usually provides a good response for many patients. However, some patients find it difficult to tolerate the oral formulation and/or receive limited benefit, especially when higher doses are required for a satisfactory response. Absorption following oral dosing showed a plateau effect at doses of 15 mg and greater.
"OTREXUP provides an attractive new option that may benefit patients who have had an inadequate response to or are intolerant of oral MTX," said Paul K. Wotton, Ph.D., President and Chief Executive Officer, Antares. "OTREXUP is an easy-to-use auto injector that delivers greater blood levels of medication than oral MTX. OTREXUP could extend the use and benefits of MTX and potentially delay or avoid the use of other more expensive treatment options in some patients."
OTREXUP is indicated for adults with severe active rheumatoid arthritis (RA) who have had an insufficient therapeutic response to or are intolerant of an adequate trial of first line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs), and children with active polyarticular juvenile idiopathic arthritis (pJIA). OTREXUP also is indicated for use in adults who need symptomatic control of severe recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy.
"CreakyJoints welcomes new treatment options for patients with RA," said Seth Ginsberg, president and co- founder of CreakyJoints, one of the nation's largest rheumatic disease patient advocacy groups. "Because so many RA patients have limited manual dexterity, conventional syringes for injection of methotrexate are often difficult to use. An easy delivery system that combines subcutaneous methotrexate with a pre-filled auto-injector is an important addition to treatment options available because it expands RA patients' access to care."
The injectable use of MTX after an inadequate response to oral MTX is quite common in Europe and elsewhere in the world. In the United States, however, use of injectable MTX is often overlooked primarily due to the challenges of self-injection. The fear of needles, poor manual dexterity, especially in people living with RA, and a lack of confidence in accurately and safely self-injecting with a vial, needle and syringe may be some of the challenges people have to face.
"OTREXUP is a useful new treatment option that physicians can consider for their patients who could continue to benefit from MTX when their tablets provide an inadequate response," said Alvin F. Wells, MD, PhD, Director, Rheumatology & Immunotherapy Center, located in Franklin, Wisconsin. "An easy-to-use and almost pain-free injection can provide the higher blood levels of medication that may be necessary for these patients."
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"Antares is committed to the consistent availability of OTREXUP and the support that patients and healthcare providers need," said LeRoux Jooste, SVP and General Manager, Antares Pharmaceuticals. "We have shipped OTREXUP to distribution centers throughout the US and have ample inventory of OTREXUP available to supply the market. As a research and development company, we plan ahead to ensure that OTREXUP remains an available treatment option for the patients who need it."
For full prescribing information please visit WWW.OTREXUP.COM
Important Safety Information
Otrexup is a single-dose auto-injector containing a prescription medicine, methotrexate. Methotrexate is used to:
