Unigene Achieves $5.5 Million Milestone in Calcitonin Collaboration for Phase III InitiationFAIRFIELD, N.J.--(BUSINESS WIRE)--Feb 27, 2007 - The initiation of a Phase III clinical study for osteoporosis by Nordic Bioscience, the development partner of Novartis Pharma AG, with oral calcitonin has triggered a $5.5 million milestone to be paid by Novartis to Unigene Laboratories, Inc. (OTCBB: UGNE).
Salmon calcitonin, the active pharmaceutical ingredient in Novartis' oral product, was produced using Unigene's patented manufacturing process, which was licensed to Novartis in 2004. In 2005, the technology was transferred successfully to Sandoz, an affiliate of Novartis, who produced multiple kilograms of calcitonin at a scale that represents a ten-fold increase above Unigene's current production capacity. Under the terms of that agreement, Unigene is eligible to receive up to $18.7 million in payments before royalties. Upon receipt of this milestone payment, Unigene will have received $13.7 million of that total.
"We are pleased that a pivotal study has started with an oral product made with our calcitonin manufacturing technology," commented Dr. Ronald S. Levy, Executive Vice President of Unigene. "This action confirms Novartis' intention to utilize Unigene's technology to commercialize the product. We believe that this study, combined with Novartis' planned study for oral calcitonin in osteoarthritis, will serve to highlight the significant potential market opportunities for calcitonin-based products in the future."
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 to Upsher-Smith Laboratories, worldwide rights for its oral PTH technology to GlaxoSmithKline and worldwide rights for its calcitonin manufacturing technology to Novartis. The Company is also manufacturing a second peptide for 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 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.
The Investor Relations Group
Daniel Berg/Dian Griesel, Ph.D., 212-825-3210
Janet Vasquez, 212-825-3210
Posted: February 2007