EWING, N.J.--()--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.”
About Rheumatoid Arthritis
Rheumatoid Arthritis (RA) is a chronic autoimmune disorder characterized by painful inflammation of the synovial tissues lining the joints. RA generally starts between the ages of 25 and 55 years. Left untreated it often progresses to proliferation of tissues surrounding the joints and destruction of bones and cartilage, which restricts normal movement of the joint. According to the National Institutes of Health (NIH), RA affects about 1% of the population worldwide, including up to 2.1 million Americans, occurring in women at twice to three times the rate as that in men.
Methotrexate is a commonly prescribed disease-modifying anti-rheumatic drug (DMARD), used in an estimated 70% of rheumatoid arthritis patients either on its own or in combination with biological therapies. Methotrexate is started at a low dose, generally 7.5mg given orally, once-a-week, and titrated up for greater therapeutic effect, or until the patient incurs side effects. The maximum oral dose given is generally 20mg to 25mg per week. Published studies have reported as many as 30% to 60% of patients experience gastrointestinal side effects with oral methotrexate, preventing further dose escalation or requiring discontinuation in some patients. Also, the extent of oral absorption of methotrexate varies considerably between patients and has been shown to decline with increasing doses, which may also contribute to insufficient therapeutic response even after dose escalation. Switching patients from oral to parenteral methotrexate improves absorption and has been associated with improved therapeutic response. Additionally, some studies have shown a lower incidence of gastrointestinal side effects in patients that were switched from oral to parenteral methotrexate.
About Antares Pharma
Antares Pharma focuses on self-injection pharmaceutical products and topical gel-based medicines. The Company's subcutaneous and intramuscular injection technology platforms include VIBEXTM disposable pressure-assisted auto injectors, ValeoTM/VisionTM reusable needle-free injectors, and disposable multi-use pen injectors. In the injector area, Antares Pharma has a multi-product deal with Teva Pharmaceutical Industries, Ltd that includes Tev-Tropin® human growth hormone and a partnership with Ferring Pharmaceuticals. In the gel-based area, the Company's lead product candidate is Anturol®, an oxybutynin ATD™ gel that has completed Phase 3 studies for the treatment of OAB (overactive bladder). Antares also has a partnership with BioSante that includes LibiGel® (transdermal testosterone gel) in Phase 3 clinical development for the treatment of female sexual dysfunction (FSD), and Elestrin® (estradiol gel) indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, and currently marketed in the U.S. Antares Pharma has corporate headquarters in Ewing, New Jersey, with subsidiaries performing research, development and product commercialization activities in Minneapolis, Minnesota and Muttenz, Switzerland.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements related to the VIBEX MTX clinical trials and the potential market for VIBEX MTX. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties include, among others, difficulties or delays in the initiation, progress, or completion of product development, clinical trials, difficulties or delays in the progress or completion of Anturol’s product development or in the success of the NDA and whether or not the Company’s application for marketing approval is accepted for review or at all by the FDA or any other regulatory authority. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2009, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.