Healthcare Industry News: Transdermal
News Release - August 9, 2006
Antares Submits 510(k) with a Branded Human Growth HormoneEWING, N.J.--(HSMN NewsFeed)--Aug. 9, 2006--Antares Pharma, Inc. (Amex:AIS ) has submitted a Premarket Notification 510(k) to the FDA announcing the Company's intent to market a needle-free injection system for use with a branded human growth hormone that is currently approved and marketed in the United States. Human growth hormone is an injectable protein that is commonly used to treat children of pathologically short stature. Pediatric patients and their parents, who sometimes assist with the injections, can benefit from the elimination of needles and disposal of contaminated sharps, ease of using alternative injection sites and the speed and quality of injections offered by needle-free devices. According to industry estimates the market for human growth hormone in the United States was approximately $900 million in 2005 and the U.S. market was the largest market segment for the distribution of human growth hormone globally. Antares currently markets its needle-free injection system for use in the treatment of growth hormone deficient children through its partners in Europe, Japan and Asia.
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, and its related TecTix(TM) system for topical and transmucosal delivery, its 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 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. 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' quarterly 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. Antares undertakes no obligation to update publicly any forward-looking statement.
Source: Antares Pharma
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