Healthcare Industry News: transdermal estradiol gel
News Release - April 21, 2006
Antares Announces FDA Acceptance of Licensee's NDAtransdermal estradiol gel is Antares' First ATD(TM) Gel Product Potentially Approvable By FDA
EXTON, Pa.--(HSMN NewsFeed)--April 21, 2006--Antares Pharma, Inc. (Amex:AIS ) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and review its licensee's (BioSante Pharmaceuticals, Inc.), New Drug Application (NDA) for transdermal estradiol gel (Bio-E-Gel®). The NDA includes data from a Phase III clinical trial as well as data from a sunscreen study, a pharmacokinetic study and a transfer study.
Bio-E-Gel is a low dose estradiol product candidate based on Antares' proprietary Advanced Transdermal Delivery (ATD(TM)) gel system and, if approved, will be used to treat moderate-to-severe hot flashes in menopausal women. Antares' ATD system is designed to deliver hormones and other active ingredients across the skin and be quickly absorbed in the bloodstream evenly, over time, with minimal dosage.
Our transdermal estradiol gel offers an important additional advantage over oral estrogen products by providing bio identical estrogen that is not subject to first-pass liver metabolism, thus avoiding further potential side effects associated with oral administration of conjugated estrogens. Our transdermal estradiol gel is also less conspicuous than wearing a patch and there is less potential for irritation.
The current U.S. market for estrogen products is estimated to be approximately $1.4 billion in annual sales and the European market is estimated to be equally substantial. Antares retains the rights to utilize the data developed from the FDA trial and potentially market its own estradiol ATD gel products in Europe, Japan, and other important markets.
"We are pleased that the NDA for Bio-E-Gel has been accepted for filing and review by the FDA and we believe that our transdermal estradiol gel may become a significant advance in women's health," said Jack E. Stover, President and CEO of Antares Pharma, Inc. "This is an important validation for Antares. Bio-E-Gel is the first ATD product that has been accepted for filing and review by the FDA, and we are now able to evaluate the types of potential European partners in markets that we control. Further, this event should also trigger a financial milestone payment for us," Stover continued.
In the April 12, 2006 issue of the Journal of the American Medical Association (JAMA) new data from the Women's Health Initiative (WHI) study demonstrates that estrogen-alone therapy did not increase breast cancer incidence in postmenopausal women after an average of 7.1 years as had been previously suggested. This article also discussed a possible protective effect of estrogen-alone therapy against breast cancer incidence in certain categories: women with no first-degree relatives with breast cancer, women with no prior history or breast benign breast disease and women with a low, five- year risk as measured by the Gail Risk Score.
"We appear to be entering a period of enlightenment for women as to the improved options they now have for treating menopausal symptoms," added Mr. Stover. "We are proud to potentially play an important role in women's health with products being developed in this category from our pipeline."
The filing of an NDA with the FDA is an important step in the approval process in the United States. Acceptance for filing by the FDA does not mean that the NDA has been or will be approved, nor does it represent an evaluation of the adequacy of the data submitted.
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(TM) Advanced Transdermal Delivery system, Easy Tec(TM) oral fast-melt technology, and subcutaneous injection technology platforms including both Vibex(TM) disposable mini-needle injection device and Valeo(TM)/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 in Exton, Pennsylvania, with subsidiaries performing research, development, manufacturing and product commercialization activities in Minneapolis, Minnesota and Basel, Switzerland.
In addition to historical facts or statements of current condition, 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 our beliefs for transdermal estradiol gel and our expectations for other potential filings with the FDA.. Forward-looking statements relate to our current expectations or forecasts of future events. Our performance could be materially different from that reflected in these forward-looking statements due to decisions of regulatory authorities and the other risks and uncertainties set forth in our reports filed with the Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. We undertake no obligation to update publicly any forward-looking statements.
Source: Antares Pharma
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