Antares Pharma, Inc. announced that US Patent number 8,021,335 has been granted by United States Patent and Trademark Office (USPTO), covering technology used in the Company’s Vibex platform of needle-assisted jet injection devices. The patent provides protection for the Vibex technology until 2027. Antares’ Vibex platform is the basis for several products in development by Antares including Vibex MTX, the first auto-injector in development to potentially enable rheumatoid arthritis patients to comfortably and safely self-inject methotrexate at home. Antares is a leading US developer of novel and advanced self-injection products including needle-free injectors and pen devices in addition to Vibex.

Paul K Wotton, PhD, president and chief executive officer of Antares Pharma, stated, “The strength and breadth of Antares’ patent portfolio continues to build. The issuance of this important, broad patent to enhance the intellectual property protecting products developed using our Vibex platform will strengthen the potential commercial value of Vibex MTX, as well as the products we are currently developing in collaboration with Teva Pharmaceuticals. Importantly, as we look at the emerging biosimilars market, Vibex addresses the growing need for product differentiation among similar therapeutic agents, as our delivery technology provides patients with easy-to-administer, safe and effective self-injection options.”

The Vibex system is designed to economically provide highly reliable subcutaneous injections comfortably and conveniently in conjunction with the enhanced safety of an integrated shielded needle. Vibex employs a proprietary coil-spring power source to rapidly deliver the prescribed medication. This spring is combined with a tiny hidden needle in a disposable, single-use injection system compatible with conventional syringes. After use, the device can be disposed of without the typical “sharps” disposal concerns. Antares and its development partners have successfully tested the device in patient preference and clinical bioavailability studies. Antares continues to explore product extensions including multiple dose and variable dose applications as well as integrated reconstitution systems for lyophilized drugs.

Methotrexate used in an estimated 70 per cent of patients alone and in combination with biological therapies, MTX is a foundational Disease-Modifying Anti-Rheumatic Drug (DMARD) for RA. Generally initiated orally at lower doses and titrated 2 of 3 up, published studies have reported as many as 30 per cent to 60 per cent of patients experience gastrointestinal side effects with oral MTX. This can prevent further dose escalation or require discontinuation in some patients which can be avoided by subcutaneous administration.

The extent of oral absorption of MTX varies considerably between patients and has been shown to decline with increasing doses. Studies have also reported that switching patients from oral to parenteral MTX improves absorption providing superior therapeutic response resulting in longer duration of use. 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 MTX, potentially providing improved absorption, reduced side effects, and a better therapeutic response.

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.

Antares Pharma focuses on self-injection pharmaceutical products and topical gel-based medicines.