Unigene Announces Promising Preclinical Results in Its Obesity Peptide Program
BOONTON, N.J.--(BUSINESS WIRE)--Dec 17, 2009 - Unigene Laboratories, Inc. (OTCBB: UGNE, http://www.unigene.com) announced today that it has selected a lead peptide compound, designated UGP281, from its obesity program for development. In a short-term study reported at the Keystone Symposium Conference on “Obesity: Novel Aspects of the Regulation of Body Weight” last January, a previously developed compound, orally-administered UGL269, reduced food intake in dogs by up to 50% and correspondingly reduced body weight. Subsequent studies by Unigene have led to the development of UGP281, a peptide modeled after naturally-occurring hormones which is significantly more potent than UGL269 and achieves the same reduction in food consumption at a lower dose. Importantly, in comparative animal studies at the same dose, UGP281 was at least 3-fold more effective in reducing food consumption than certain other peptide compounds that are currently in later-stage clinical development by third parties for accelerated weight loss. In addition, there were no overt signs of toxicity. The pronounced reductions in feeding behavior, as well as the weight of the animals after daily administration of this peptide, persisted over several weeks of dosing. The peptide has the additional advantages that it can be delivered orally using Unigene's Enteripep® technology and manufactured using Unigene's Secrapep® technology.
“Obesity is one of the fastest-growing public health issues in the United States, as well as in several other countries,” said Dr. Warren Levy, President and CEO of Unigene. “The treatment of obesity is still largely an unmet medical need, and we believe that Unigene's obesity program offers the potential to identify peptides that may significantly alter food intake in obese individuals and thus reduce the health care cost and the burdens associated with it.”
It has been estimated by the NIH that almost one third of the adult US population is obese, and if current trends continue, 103 million American adults will be considered obese by 2018. Obesity is a known risk factor for a variety of diseases and conditions such as diabetes, coronary heart disease, stroke, hypertension, osteoarthritis, gall bladder disease, sleep apnea and some forms of cancer. Several calculations have estimated that at least $75 billion in health care costs are directly attributable to obesity.
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, worldwide rights for its calcitonin manufacturing technology to Novartis and worldwide rights (except for China) for its oral calcitonin program to Tarsa Therapeutics, Inc. Unigene's patented oral delivery technology has successfully delivered, in preclinical and/or clinical trials, various peptides including calcitonin and PTH analogs. 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 regarding us and our business, financial condition, results of operations and prospects. Such forward-looking statements include those which express plans, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact. We have based these forward-looking statements on our current expectations and projections about future events and they are subject to risks and uncertainties known and unknown which could cause actual results and developments to differ materially from those expressed or implied in such statements. These forward-looking statements include statements about the following: general economic and business conditions, our financial condition, competition, our dependence on other companies to commercialize, manufacture and sell products using our technologies, the ability of our products to gain market acceptance and increase market share, the uncertainty of results of animal and human testing, the risk of product liability and liability for human trials, our dependence on patents and other proprietary rights, dependence on key management officials, the availability and cost of capital, the availability of qualified personnel, changes in, or the failure to comply with, governmental regulations, the failure to obtain regulatory approvals for our products and other risk factors discussed in our Securities and Exchange Commission filings. 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.
Contact: The Investor Relations Group
Erika Moran, 212-825-3210
Janet Vasquez, 212-825-3210
Posted: December 2009