Antares Pharma, Inc. (AMEX:AIS) a specialty pharmaceutical company focused on improving pharmaceuticals through advanced drug delivery systems, today announced that they have entered into a development agreement with Dr. Reddy’s Laboratories, Inc. for the development of an innovative, topically applied product, using Antares’ ATD Gel platform, targeting specific receptor sites within the skin.
As part of the overall understanding between the parties, Antares will be responsible for development and commercial manufacturing of the product and Dr. Reddy’s will be responsible for clinical development and marketing. Dr. Reddy’s will market the product through Promius Pharma, its US based speciality dermatology business, upon final approval. Under the terms of this agreement, Antares will receive fees for all its development activities. Upon successful completion of this development, a license and supply agreement will be executed by the parties. The license and supply agreement would include mutually agreed upon upfront and milestone payments, product sales and royalties.
“We look forward to developing another novel product utilizing our FDA approved ATD gel with our partner Dr. Reddy’s. In addition, this project signifies the initiation of utilizing our ATD system to deliver active ingredients topically, and not systemically, demonstrating the flexibility of our platform in the therapeutic field of dermatology,” said Jack E. Stover, Chief Executive Officer.
Advanced Transdermal Delivery (ATD™) Gel Technology
Antares’ ATD gel technology is a patent-protected drug delivery system designed for the enhanced skin permeation of therapeutic entities. The technology is already validated in that it is the basis of an FDA approved product (transdermal estradiol gel for the treatment of menopausal symptoms) and two Phase III clinical stage products (transdermal oxybutynin gel for overactive bladder and transdermal testosterone for female sexual dysfunction). Based on hydroalcoholic solvent systems containing a combination of permeation enhancers, ATD gel formulations are not only easy to use but, also ensure drugs are absorbed rapidly through the skin after once-daily application on the upper arms, shoulders, abdomen or thighs. Clinical trials using different therapeutic actives have demonstrated efficacy and excellent skin tolerability.
About Antares Pharma
Antares Pharma is a specialized pharma product development company committed to improving pharmaceuticals through its patented drug delivery systems. Antares has three validated 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. The Company’s products are engineered 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. The Anturol™ trial is being conducted under an agreement reached with the U.S. Food and Drug Administration under its special protocol assessment, or SPA process.
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 relating to the Company’s projected timeline for potential formulation and development of an unnamed enhanced dermatology product including execution of an agreement containing upfront, milestone, product sales and royalties, 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. 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.
Stephanie M. Baldwin
Senior Manager, Investor Relations