Antares Pharma, Inc. (NYSE Amex: AIS), a leader in self-injection drug delivery technology, today announced it was awarded two Qualifying Therapeutic Discovery Project (QTDP) Grants totalling approximately $500,000. Antares applied for grants related to investments made in the Company’s ongoing development programs for Anturol(R) and VIBEX™ MTX. The QTDP provides companies engaged in pharmaceutical product development grants or tax credits for up to 50% of their qualified investments in qualifying therapeutic discovery projects for 2009 and 2010. Final grant amounts authorized reflect a reduction applied to all applicants, as the QTDP program was significantly oversubscribed.
Anturol(R) is oxybutynin gel for the treatment of overactive bladder, a condition characterized by one or more symptoms that include urinary frequency, urgency (a sudden need to urinate that can happen at any time whether or not the bladder is full) incontinence and nocturia (waking up one or more times during the night to urinate). In a Phase 3 trial, two doses of Anturol(R) demonstrated a statistically significant reduction in the primary endpoint of urinary incontinence events as well as a low incidence of reported side effects. Market research with physicians showed that offering the first titratable oxybutynin gel to achieve efficacy with low interference from side effects is highly appealing and would significantly expand their anticipated use of transdermal oxybutynin. The Company plans to file a new drug application (NDA) with the FDA in 2010.
VIBEX™ MTX is Antares’ proprietary methotrexate injection system for the treatment of rheumatoid arthritis, a chronic autoimmune disorder characterized by painful inflammation of the synovial tissues lining the joints. Methotrexate is the most commonly prescribed disease-modifying anti-rheumatic drug (DMARD), used in an estimated 70% of rheumatoid arthritis patients. Switching patients from oral to parenteral methotrexate improves absorption and has been associated with improved therapeutic response. Market research with physicians has shown that most would use methotrexate by the parenteral route more frequently, thereby accelerating market growth, if provided with a simple-to-use and secure system that enabled patients to reliably and comfortably self-inject the drug. VIBEX™ MTX is protected by several issued and pending patents.
“We are pleased that the reviewers at the Department of Human Heath and Services recognize the merit of our product development programs on the basis of each one’s potential to meaningfully address unmet medical needs and reduce medical costs,” stated Paul K. Wotton, Ph.D., President and Chief Executive Officer.
The grants are targeted to therapeutic discovery projects that show a reasonable potential to result in new therapies to treat areas of unmet medical need or prevent, detect or treat chronic or acute diseases and conditions, reduce the long-term growth of health care costs in the United States, or significantly advance the goal of curing cancer within 30 years. Projects with the greatest potential to create and sustain high-quality, high-paying U.S. jobs and to advance U.S. competitiveness in life, biological and medical sciences were considered in allocating the grants.
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(R) human growth hormone and a partnership with Ferring Pharmaceuticals. In the gel-based area, the Company's lead product candidate is Anturol(R) 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(R) (transdermal testosterone gel) in Phase 3 clinical development for the treatment of female sexual dysfunction (FSD), and Elestrin(R) (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 Harbour 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 Company’s future financial performance, and other statements which are other than statements of historical facts. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "potential," "continue," and other similar terminology or the negative of these terms, but their absence does not mean that a particular statement is not forward-looking. 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, statements about future product revenue growth, difficulties or delays in the initiation, progress, or completion of its product development, clinical trials, difficulties or delays in the progress or completion of Anturol’s product development or in the preparation of the NDA, whether caused by competition, adverse events, investigative site initiation rates, patient enrollment rates, regulatory issues, or other factors; that an application for marketing approval may not be accepted for review or at all by the FDA or any other regulatory authority; and that the Company may lack the financial resources and access to capital to continue to fund the development of Anturol®. 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.