Antares initiates dosing in VIBEX MTX clinical study for rheumatoid arthritis

Antares Pharma, Inc. (NYSE Amex: AIS) today announced that the first patient has been dosed in a clinical study evaluating the VIBEX™ MTX product which is being developed for the treatment of rheumatoid arthritis. The clinical study will evaluate several dose strengths of VIBEX MTX delivered with a proprietary autoinjector versus conventional needle and syringe administration by a healthcare professional.

VIBEX MTX is Antares' proprietary, wholly owned methotrexate injection system designed for rapid self-administration in three simple steps by patients. VIBEX MTX is engineered to enable patients to self-inject reliably, comfortably, and conveniently at home. It is designed to enhance safe use with an integrated, shielded needle and lockout system which prevents accidental needlesticks after use. Antares has conducted in vivo pre-clinical studies which demonstrated reproducible pharmacokinetics and good injection site tolerance when methotrexate was delivered using the VIBEX technology. VIBEX MTX is protected by several issued and pending patents. Uman Pharma (Montreal, Canada) will supply methotrexate for the U.S. market and will also market the product in Canada.

Paul K. Wotton, President and CEO commented, "According to published studies, methotrexate is the most commonly used disease modifying anti-rheumatic drug (DMARD) but a significant number of patients are unable to tolerate it when given orally. Independent market research commissioned by Antares with 200 rheumatologists has confirmed that physicians, if offered a reliable and patient-friendly method for self-injection, would like to switch many patients to an injectable form of methotrexate, potentially providing reproducible absorption, reduced side effects and a better therapeutic response. Since rheumatoid arthritis patients are often already prescribed methotrexate in combination with injectable biological products, VIBEX MTX may represent a significant revenue opportunity for Antares, potentially as early as in 2013, as we continue to focus on our product based strategy."