Antares Pharma, Inc. (AMEX:AIS) reports that its low-dose testosterone ATD™ gel for the treatment of FSD (female sexual dysfunction) has had the regulatory pathway for approval clarified by the U.S. Food and Drug Administration (FDA).
“Clarification of a regulatory pathway from the FDA for testosterone ATD™ gel is very important news that reopens the prospects for approval in the U.S. as well as in Europe, each large potential markets, after several years of little regulatory progress. It also demonstrates the approvability of our core gel platform while emphasizing the flexibility of our technology in the key therapeutic area of women’s health,” commented Jack E. Stover, President & CEO.
Our development licensee for this product, BioSante Pharmaceuticals Inc., recently announced they had met with FDA representatives from the Division of Reproductive and Urologic Products, the Division of Cardio-Renal Products and the Office of Biometrics III (statistics) earlier this summer. The primary focus of the meeting was the safety study protocol to evaluate the cardiovascular risk of using testosterone in women, a key pre-approval concern of the FDA. It was reported that in addition to two Phase III efficacy trials, a separate Phase III cardiovascular safety study will also need to be conducted. The safety study will be a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events driven study of between 2,400 and 3,100 women exposed to the low-dose testosterone or placebo for 12 months. A new drug application (NDA) can be filed and reviewed by the FDA, possibly leading to approval at that time. After NDA submission and potential approval the women enrolled in the study will be followed for an additional four years.
The Antares portfolio currently includes three women’s health/urology products in clinical trials and one FDA approved product. Anturol™ ATD™ gel is for the treatment of overactive bladder (OAB) is in Phase III, a nestorone/estradiol low-dose ATD™ gel contraceptive is in Phase I and the low-dose testosterone ATD™ gel for Female Sexual Dysfunction (FSD) (mentioned above) is now in Phase III. The fourth product in this important therapeutic class is Elestrin™ which was approved by the FDA late last year and launched this past June.
Currently there is no FDA approved pharmaceutical product to treat FSD, and if approved, this product may help address the unmet medical need. It should be noted further that Intrinsa®, a testosterone patch developed and marketed by Procter & Gamble was approved for FSD in Europe and has been launched to date in the United Kingdom, France and Germany. According to a study published in the Journal of the American Medical Association, 43 percent of American women (about 40 million) experience some degree of impaired sexual function and it is anticipated that the size of the European market is approximately the same as the US. The overall market potential for low-dose testosterone products for FSD has been estimated to range from between $2 billion to $5 billion.
Advanced Transdermal Delivery Systems (ATD™)
The ATD drug delivery platform is dedicated to the development of gels that offer a cosmetically superior option to patches, while delivering medication efficiently with less potential for skin irritation, minimizing gastrointestinal impact, as well as, the first-pass liver metabolism effect of many orally ingested drugs. Antares’ ATD gels are hydro-alcoholic and contain a combination of permeation enhancers to promote rapid drug absorption through the skin following application typically to the arms, shoulders, abdomen or thighs. The Company’s transdermal ATD gel system provides the options for delivering both systemically (penetrating into and through the subcutaneous tissues and then into the circulatory system) as well as locally (e.g. topically for skin and soft tissue injury, infection and local inflammation). Typically, the gel is administered daily, and is effective on a sustained release basis over approximately a 24-hour period of time.
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 drug delivery platforms: the ATDTM Advanced Transdermal Delivery system, subcutaneous injection technology platforms including both VibexTM disposable mini-needle injection device and ValeoTM/Vision® reusable needle-free injection devices; and Easy TecTM oral fast-melt technology. Two of the platforms have generated FDA approved products. Antares Pharma leverages its multiple drug delivery platforms to add value to existing drugs and to create new pharmaceutical products and injectable devices. The Company’s products are engineered to improve safety and efficacy profiles by minimizing dosing and reducing side effects while enabling improved patient compliance. 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, that involve significant risks and uncertainties, including those discussed in this release and others that can be found in the “Risk Factors” section of Antares’ Annual Report on Form 10-K for the year ended December 31, 2006 and in Antares’ periodic reports on Form 10-Q and other filings made with the Securities and Exchange Commission. Antares is providing this information as of the date of this release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. No forward-looking statement can be guaranteed and actual events and results may differ materially from those projected. Forward-looking statements, including statements regarding the timing of product sales, market estimates and market potential 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.