Unigene Reports Positive PTH Clinical Study Results
Formulation Delivers Therapeutic Blood Levels with Reduced Variability
BOONTON, N.J.--(BUSINESS WIRE)--Mar 16, 2009 - Unigene Laboratories, Inc. (OTCBB: UGNE http://www.unigene.com) reported that its improved Enteripep® PTH tablets were able to consistently deliver therapeutic blood levels of the drug with significantly reduced variability in a Phase I study involving twenty-four postmenopausal women. The resulting average blood levels exceeded those that have been shown in third party studies using injectable PTH to stimulate bone growth in osteoporotic women. No serious or unexpected adverse events were reported.
The same improved solid dosage form used in this PTH study was successfully tested by Unigene in clinical studies with oral calcitonin conducted last year, and in those trials it also demonstrated superior performance when compared with earlier calcitonin studies that utilized Unigene's original oral delivery technology.
“We have learned a tremendous amount about our delivery system and the PTH molecule over the past two years, and the performance of these tablets has justified our diligence in building that database,” said Dr. Ronald S. Levy, Executive Vice President of Unigene. “Currently PTH is the only FDA-approved bone anabolic therapy and it is sold as an injectable product. These results are a major step forward in the development of an oral PTH product and we believe that this valuable know-how will make it easier for us to adapt our technology to orally deliver other peptides as well.”
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 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 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.
Contact: Unigene Investors:
The Investor Relations Group
Erika Moran/Dian Griesel, Ph.D., 212-825-3210
Janet Vazquez, 212-825-3210
Posted: March 2009