Antares Pharma, Inc. (AMEX: AIS) announced that the Company received a milestone payment from Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) related to the filing of a Device Master File for a novel disposable pen injector. The pen injector is being developed under a license agreement signed in January 2008 between the companies where Antares will supply a custom proprietary pen for two self-administered drugs that ultimately will be marketed by Teva. The filing was a requisite part of the overall product development plan and Antares delivered this on schedule. This is the second Device Master File that Antares has submitted as part of its Teva collaborations and increases the number of product specific devices that have been the subject of Device Master File submissions with the U.S. Food and Drug Administration to three. Details of the financial terms were not disclosed.
“The true value of triggering this milestone payment is both the achievement of a regulatory filing in a short period of time and the important product design objectives that we have been able to reach since signing the agreement with Teva,” said Paul K. Wotton, President and Chief Executive Officer of Antares Pharma. “This progress could not have been possible without the hard work and depth of experience of the product team along with a close working relationship with Teva. Antares is becoming a demonstrated leader in the growing market segment of self injectable products with three distinct injection devices under advanced development or in already marketed products.”
The disposable pen injector represents Antares third injection platform and leverages the Company’s experience with re-usable precise dose needle-free injectors and disposable pressure assisted auto-injectors designed to optimize patient compliance and convenience. The pen injector has broad applications in the growing market for patient self administration of injectable drugs and was developed specifically with the intent of producing a highly competitive drug-device product for the market with Teva, a world leader in the development of injectable products.
About Antares Pharma (www.antarespharma.com)
Antares Pharma is a product development company committed to improving pharmaceuticals through its patented drug delivery systems. Antares has multiple development partnerships with leading pharmaceutical companies. The Company’s products are designed to improve safety and efficacy profiles by minimizing dosing and reducing side effects while enabling improved patient compliance. The Company’s lead product candidate, Anturol™, an oxybutynin ATD™ gel for the treatment of OAB (overactive bladder), is currently under evaluation in a pivotal Phase 3 trial. Antares has three validated drug delivery systems: the ATDTM Advanced Transdermal Gel Delivery system; subcutaneous injection technology platforms, including VibexTM disposable pressure-assisted auto injectors, ValeoTM/Vision® reusable needle-free injectors, and disposable multi-use pen injectors; and Easy TecTM oral disintegrating tablets (ODT). Two of the systems have generated FDA-approved products. Antares Pharma has corporate headquarters in Ewing, New Jersey, with subsidiaries performing research, development, manufacturing and product commercialization activities in Minneapolis, Minnesota and Basel, 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 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: that the Company may experience difficulties or delays in the initiation, progress, or completion of its clinical trials, including the phase 3 trial of Anturol, whether caused by competition, adverse events, investigative site initiation rates, patient enrollment rates, regulatory issues, or other factors; that clinical trials may not demonstrate that Anturol is both safe and effective for the treatment of patients with overactive bladder syndrome; that the safety and/or efficacy results of the phase 3 trial of Anturol may not support an application for marketing approval in the United States or any other country; that an application for marketing approval may not be accepted for priority 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 fund future clinical trials. 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, 2007, 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.