Unigene Successfully Completes Phase I/II Clinical Study For Oral Calcitonin

Main Category: Bones / Orthopedics
Article Date: 14 Mar 2008 - 1:00 PDT

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Unigene Laboratories, Inc. (OTCBB: UGNE) has successfully completed the Phase I/II oral calcitonin clinical study that it initiated last month. This study, which achieved all of its planned objectives, primarily measured the ability of Unigene's proprietary oral delivery technology to significantly reduce the levels of an established biochemical marker that correlates with bone loss. All of the twenty-two subjects who completed the study demonstrated a robust reduction in this marker. In addition, the study demonstrated a dose-dependent increase in calcitonin blood levels.

This is the second successful clinical study that the company has conducted using its improved oral calcitonin formulation. In October of last year, Unigene reported that all of the subjects in its first study achieved a biological response and that the goals for blood levels and variability were met. Those results will be reported next month at the Eighth European Congress on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis.

"The extremely significant findings of this study should enable us to select the optimal oral calcitonin dose that will be carried forward in the program," commented Dr. Ronald S. Levy, Executive Vice President of Unigene. "This achievement strongly advances our calcitonin development efforts and should facilitate the partnering activities that we are pursuing in parallel. It also confirms the importance of the delivery technology modifications that we have developed and optimized over the past year, which improve performance while simplifying the tablet manufacturing process. Finally, these improvements should provide the basis for additional intellectual property that will strengthen our patent portfolio and should improve the performance of our delivery platform for virtually any peptide that would be a suitable candidate."

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®, 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® 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 http://www.unigene.com. For information about Fortical, visit http://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.

http://www.unigene.com

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