Antares Pharma Announces Positive Study Results with VIBEX MTX in Rheumatoid Arthritis Patients
--New Patent Application Filed--
EWING, N.J.--(BUSINESS WIRE)--Aug 4, 2011 - Antares Pharma, Inc. (NYSE Amex: AIS) today announced the positive results of a clinical study evaluating VIBEX™ MTX, a proprietary auto injector product designed to give a rapid subcutaneous injection of methotrexate (MTX) for the treatment of rheumatoid arthritis (RA). The clinical pharmacokinetic study evaluated several dose strengths of MTX delivered by a healthcare professional to RA patients with VIBEX™ MTX versus subcutaneous or intramuscular injection using a conventional needle and syringe. The primary end points were met with all three methods of administration providing equivalent performance in the patients studied, together with comparable safety.
VIBEX™ MTX is designed for rapid injection of subcutaneous MTX in three simple steps and is engineered to enable RA patients to self-inject reliably, comfortably, and conveniently at home. Safety for patients is enhanced through the use of an integrated, shielded needle and lockout system which prevents accidental needle-sticks after use. The availability of VIBEX™ MTX could give physicians a new option to optimize both patient treatment and the use of biological agents in RA. VIBEX™ MTX is protected by several issued and pending patents.
Paul K. Wotton, President and CEO, commented, “I am pleased that we have completed this clinical pharmacokinetic study with positive results and that we remain on track to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in 2012. Patient interviews following the studies indicated that the VIBEX™ MTX product was comfortable and easy for patients to use and preferred over a conventional needle and syringe.” Dr Wotton added, “The filing of a new patent application based on findings from the study will potentially fortify our patent portfolio around this product. Moving forward we will continue to focus our efforts on commercializing innovative injectable products designed to improve patient care and provide therapeutic benefits cost effectively.”
Used in an estimated 70% 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 up, published studies have reported as many as 30% to 60% 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.
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 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 VIBEX™ disposable pressure-assisted auto injectors, disposable multi-use pen injectors and Vision™ reusable needle-free injectors distributed as Tjet® and Zomajet® by Teva Pharmaceutical Industries, Ltd (Teva) and Ferring Pharmaceuticals (Ferring), respectively. In the injector area, Antares Pharma has a multi-product deal with Teva that includes Tev-Tropin® human growth hormone (hGH) and a partnership with Ferring that includes Zomacton® hGH. In the gel-based area, the Company's lead product candidate is Anturol®, an oxybutynin ATD™ gel that is currently under review by the FDA for the treatment of OAB (overactive bladder) which has been licensed to Watson Pharmaceuticals, Inc. for the U.S. and Canada. 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 two facilities in the U.S. The Parenteral Products Division located in Minneapolis, Minnesota directs the manufacturing and marketing of the Company's reusable needle-free injection devices and related disposables, and develops its disposable pressure-assisted auto injector and pen injector systems. The Company's corporate offices and Pharma Division are located in Ewing, New Jersey, where pharmaceutical products are developed utilizing both the Company's transdermal systems and drug/device combination products.
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 study and the potential market for VIBEX MTX, and other statements which are other than statements of historical facts. 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, changes in revenue growth, difficulties or delays in the initiation, progress, or completion of product development, clinical trials, difficulties or delays in the progress or completion of VIBEX MTX or Anturol product development or in the success of the Anturol NDA or potential VIBEX MTX NDA. 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, 2010, 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.
Contact: Investor Contacts:
Antares Pharma, Inc.
Robert F. Apple
Chief Financial Officer
Westwicke Partners, LLC
Tiberend Strategic Advisors, Inc.
Posted: August 2011