Antares Pharma, Inc. (NYSE Amex: AIS) today announced plans to conduct a clinical trial of the Company’s proprietary VIBEX™ MTX product being developed for the treatment of rheumatoid arthritis following clearance of an Investigational New Drug application (IND) filed with the U.S. Food and Drug Administration (FDA) on December 8, 2010.
The clinical study will evaluate several dose strengths of VIBEX™ MTX delivered with Antares’ proprietary auto-injector versus conventional needle and syringe administered by a healthcare professional. "This IND is the result of a dedicated effort by the Antares team to develop a novel product based on our self injection technology that enables patients to administer drugs like methotrexate safely and effectively in a home setting, where there is a clearly defined market need for rheumatoid arthritis patients,” said Kaushik J. Dave R.Ph., Ph.D., MBA, Senior Vice President of Product Development.
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.
About VIBEX-MTX and Methotrexate
VIBEX™ MTX is Antares’ proprietary methotrexate injection system protected by several issued and pending patents. VIBEX™ MTX is designed to enable patients to self-inject, reliably, comfortably, and conveniently, while also enhancing safety with an integrated, shielded needle. Antares has conducted pre-clinical studies which demonstrated reproducible pharmacokinetics and good injection site tolerance when methotrexate was delivered using the VIBEX™ technology. VIBEX™ is a trademark of Antares Pharma.
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.