Antares Pharma, Inc. Submits 510(k) With A Branded Human Growth Hormone

EWING, N.J.--(BUSINESS WIRE)--Aug. 9, 2006--Antares Pharma, Inc. (Amex:AIS - News) 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.

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