Antares Pharma, Inc. (AMEX:AIS) announced that the company received a milestone payment of $450,000 from BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) related to an agreement with AZUR Pharma for the marketing of Elestrin (estradiol gel) to treat moderate to severe hot flashes in menopausal women in the United States. BioSante received $3.325 million on signing with AZUR, of which approximately $1.5 million was purchased inventory. Antares is entitled to 25 percent of any upfront and milestone payments as well as a percentage of product royalties. AZUR has agreed to market Elestrin using its women’s health and urology sales force of approximately 50 sales people that target estrogen prescribing physicians in the U.S. comprised mostly of gynecologists.
Elestrin is a low-dose transdermal estradiol therapy delivered in our proprietary Advanced Transdermal Delivery (ATDTM) gel system, which is licensed to BioSante. Additionally, Antares is currently conducting a Phase III study of Anturol™, an oxybutynin gel for over-active bladder which incorporates the same ATD gel system and was approved in Elestrin by the FDA.
In other news, Antares announced that a new patent has been issued covering Elestrin. U.S. Patent 7,470,433 issued on December 30, 2008, and is expected to expire on June 25, 2022. The named inventors of this patent are both Antares Pharma and BioSante. This new patent is the second issued patent that covers Elestrin potentially providing further protection against generic competition.
“We are pleased that Elestrin will be commercialized by a focused and committed organization like AZUR,” said Paul K. Wotton, President and CEO of Antares Pharma. “Our ATD system is an effective technology used to deliver drugs in a reproducible and patient friendly manner which we believe will provide AZUR with a competitive advantage over existing estradiol therapies and may result in additional milestone and royalty revenues in the future.”
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 Elestrin’s competitive advantage resulting in additional milestone and royalty revenue, 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.