Unigene Initiates Phase I Clinical Study For Oral PTH

Main Category: Bones / Orthopaedics
Also Included In: Menopause
Article Date: 07 Oct 2008 - 9:00 PDT

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Unigene Laboratories, Inc. (OTCBB: UGNE http://www.unigene.com) has initiated a Phase I clinical study in the U.S. with its proprietary formulation of oral PTH for the treatment of osteoporosis. Twenty-four healthy postmenopausal women have been enrolled in the study, which is designed to assess product safety and measure PTH blood levels at varying doses. The dosing is scheduled to be completed this month and the data analysis is expected to be completed before year end.

The tablets being tested in the study utilize the improved Enteripep® oral delivery technology. This same solid dosage form was previously used in the Phase I/II oral calcitonin clinical study conducted by Unigene earlier this year. In that study, the improved version of the tablet demonstrated a more consistent biological response and reduced blood level variability when compared with earlier studies that utilized Unigene's original oral delivery technology.

"We are looking forward to the evaluation of the tablet's performance with our PTH molecule," commented Dr. Ronald S. Levy, Executive Vice President of Unigene. "We have previously shown that it improved PTH delivery performance in animal models, so it is appropriate to now move the program into the clinic. We gain valuable information about our delivery technology from each study that we conduct, and we hope to leverage that knowledge into additional enhancements that can further strengthen our broad intellectual property portfolio."

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) 265-1100 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.

Unigene Laboratories, Inc.