Antares Pharma, Inc. (AMEX:AIS) announced the commercial launch of Elestrin by the Kenwood Therapeutics Division of Bradley Pharmaceuticals, Inc.(NYSE:BDY). Elestrin is an effective ultra low dose transdermal estrogen therapy for the treatment of hot flashes in menopausal women which is delivered in Antares’ proprietary Advanced Transdermal Delivery (ATD™) gel system. Elestrin was approved by the Food and Drug Administration (FDA) in December, 2006. Bradley has exclusive marketing rights for Elestrin in the U.S. while Antares maintains the sole rights in Europe and elsewhere. Bradley in-licensed the product from Antares’ licensee BioSante Pharmaceuticals (AMEX:BPA).
There are approximately 14,000 OB/GYN physicians in the U.S. who account for the majority of prescriptions in the estimated $1.3 billion estrogen therapy market. The transdermal market alone is estimated to be approximately $300 million. Bradley is expected to increase its Kenwood sales force to 60 representatives in order to support the launch.
Antares is slated to receive an additional $875,000 in the fourth quarter for a total of $2.6 million in milestones in 2007. Additionally Antares will also receive an important portion of the royalties on third party sales. Further sales based payments could bring the total of such payments to $13 million.
“The commercial launch of Elestrin is a major milestone for Antares,” said Jack E. Stover, President & CEO. “Not only is it our first ATD gel based pharmaceutical product launched, but it also highlights one of our key areas of therapeutic focus, womens’ health / urology . (Our ANTUROL™ product for the treatment of overactive bladder is progressing toward initiation of Phase III). Benefits of our ATD system typically include minimizing first-pass liver metabolism as well as gastro intestinal effects while managing dose proportionality. There has been a significant need for a low dose, effective and easy to use product like Elestrin for the indication of moderate-to-severe vasomotor symptoms. Elestrin provides physicians and female patients a very low dose alternative which is delivered in an elegant manner.”
About Antares Pharma
Antares Pharma is a specialized pharma product development company focused on developing patented drug delivery systems and injectable device engineering capabilities. Antares’ current technology platforms include its ATD™ Advanced Transdermal Delivery system, and its related TecTix™ system for topical and transmucosal delivery, its Easy Tec™ oral fast-melt technology, and subcutaneous injection technology platforms including both Vibex™ disposable mini-needle injection device and Valeo™/Vision® reusable needle-free injection devices. Antares Pharma is committed to leveraging its multiple drug delivery platforms to add value to existing drugs and to create new pharmaceutical products and injectable devices. Overall, Antares’ product pipeline, if approved, will address unmet medical needs by reducing side effect profiles, improving safety, increasing effectiveness, and improving patient compliance and convenience. Antares Pharma has corporate headquarters at Princeton Crossroads Corporate Center in Ewing, NJ, with subsidiaries performing research, development, manufacturing and product commercialization activities in Minneapolis, Minnesota and Basel, Switzerland.
Safe Harbor Statement
In addition to historical facts or statements or current conditions, this press release contains forward-looking statements within the meaning of the “Safe Harbor” provisions of The Private Securities Litigation Reform Act of 1995, including statements regarding the timing of product sales, market estimates, market potential and potential benefits of our ATD system and Elestrin. Forward-looking statements provide Antares’ current expectation or forecasts of future events. Antares’ results could differ materially from those reflected in these forward-looking statements due to decisions of regulatory authorities, Antares’ ability to execute on its development plans and general financial, economic, regulatory and political conditions affecting the pharmaceutical industry generally.For a discussion of these and other risks and uncertainties that may effect the forward-looking statements, please see the risk factors in Antares’ 10Q’s, 10K’s and other filings made with the Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Antares undertakes no obligation to update publicly any forward-looking statement.