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Unigene Reports Successful Completion of Oral Calcitonin Human Study Print E-mail
26 Oct 2007
Unigene Laboratories, Inc. (OTCBB: UGNE) reports that the clinical study that was initiated in August with its proprietary formulation of oral calcitonin has now been successfully completed

FAIRFIELD, NJ, USA | October 25, 2007 |
Unigene Laboratories, Inc. (OTCBB: UGNE) reports that the clinical study that was initiated in August with its proprietary formulation of oral calcitonin has now been successfully completed. All of the subjects achieved a biological response and the study met the desired goals for blood levels and variability.

The tablets used in the study utilized an improved solid dosage form of Unigene's Enteripep(R) oral delivery technology for which a patent application has been filed. The study measured the blood levels of an established marker of bone resorption in eighteen post-menopausal women.

"These results suggest that the solid dosage form development effort conducted by Unigene over the last year may result in a significant improvement in formulation performance," stated Dr. Warren Levy, President and CEO of Unigene. "The study confirms that the calcitonin measured in the blood of the subjects is intact and biologically active. This novel formulation will also simplify the tablet manufacturing process. Unigene intends to utilize this improved formulation for the development of its oral calcitonin product and for the development of other oral peptide products. We believe that these results have the potential to broaden the range of products that may be commercialized using our technology."

About Unigene


Unigene Laboratories, Inc. is a biopharmaceutical company focusing on the oral and nasal delivery of large-market peptide drugs. Due to the size of the worldwide osteoporosis market, Unigene is targeting its initial efforts on developing calcitonin and PTH-based therapies. Fortical(R), Unigene's nasal calcitonin product for the treatment of postmenopausal osteoporosis, received FDA approval and was launched in August 2005. Unigene has licensed the U.S. rights for Fortical(R) to Upsher-Smith Laboratories, worldwide rights for its oral PTH technology to GlaxoSmithKline and worldwide rights for its calcitonin manufacturing technology to Novartis. Unigene's patented oral delivery technology has successfully delivered, in preclinical and/or clinical trials, various peptides including calcitonin, PTH and insulin. Unigene's patented manufacturing technology is designed to cost-effectively produce peptides in quantities sufficient to support their worldwide commercialization as oral or nasal therapeutics. For more information about Unigene, call (973) 882-0860 or visit www.unigene.com. For information about Fortical, visit www.fortical.com.

Safe Harbor statements under the Private Securities Litigation Reform Act of 1995: This press release contains forward-looking statements as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements are based upon Unigene Laboratories, Inc.'s management's current expectations, estimates, beliefs, assumptions, and projections about Unigene's business and industry. Words such as "anticipates," "expects," "intends," "plans," "predicts," "believes," "seeks," "estimates," "may," "will," "should," "would," "potential," "continue," and variations of these words (or negatives of these words) or similar expressions, are intended to identify forward-looking statements. In addition, any statements that refer to expectations, projections, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to certain risks, uncertainties, and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various risk factors. These risks and uncertainties include the risks associated with the effect of changing economic conditions, trends in the products markets, variations in Unigene's cash flow, market acceptance risks, technical development risks and other risk factors detailed in Unigene's Securities and Exchange Commission filings.

SOURCE: Unigene Laboratories, Inc.




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