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Batch Yields Expected To Increase Threefold
FAIRFIELD, NJ, USA | April 29, 2008 | The U.S. Food and Drug Administration (FDA) has approved the use of a new clone for the manufacture of calcitonin, the active ingredient in Fortical(R), Unigene Laboratories, Inc.'s (OTCBB: UGNE, http://www.unigene.com) nasal spray product for the treatment of osteoporosis. This is the second improvement to the production process approved by the FDA this year. The combination of these improvements is expected to increase batch yields of the product by a factor of three.
"We believe that these improvements to our manufacturing process will reduce our future costs and allow us to increase capacity for Fortical," said Dr. Warren Levy, President and CEO of Unigene. "Given the safety concerns reported for certain other osteoporosis products, we believe that the availability of alternative products may become important for osteoporosis sufferers. The global history of calcitonin products has shown that these products are effective with no significant side effects. Also, FDA approval of our improved manufacturing process should provide additional capacity for other peptide products."
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 Statement
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. |
