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Unigene’s First Site-Directed Bone Growth Patent Issues

Friday, May 29, 2009

Boonton, NJ -- Unigene Laboratories, Inc. (OTCBB: UGNE) reported that its first patent covering its Site-Directed Bone Growth (SDBG) technology has issued. The technology, jointly invented in collaboration with Dr. Agnès Vignery at the Yale School of Medicine, is designed to facilitate and accelerate bone growth at precisely targeted locations in the body using a simple surgical procedure that can be performed on an outpatient basis with minimal invasiveness. Animal studies have shown that, in combination with one or more therapeutic compounds, SDBG can grow significant amounts of high quality bone.

The claims of U.S patent #7,531,518, "Method of Fostering Bone Formation and Preservation," provide broad protection for the inducement of rapid bone growth at specific skeletal sites and its subsequent preservation using a variety of therapeutic agents, such as parathyroid hormone, calcitonin and bisphosphonates. Several other patent applications covering the SDBG program are currently being reviewed by the U.S. Patent and Trademark Office.

"The issuance of this first patent provides us with broad intellectual property protection for this novel technology," stated Dr. Warren Levy, President and CEO of Unigene. "This patent and the potential issuance of other patent applications could provide Unigene with a comprehensive family of patents that would cover a variety of bone ailments that affect a large segment of the population. Although still in the early stages of development, SDBG may ultimately allow surgeons to stimulate rapid bone growth in patients with low bone density in areas such as the hip or spine. In addition, SDBG may ultimately be used to accelerate the rate of fracture healing. We believe that potential future applications may include the treatment or prevention of hip and vertebral fractures, the replacement of current vertebroplasty techniques, the stabilization of prosthetic devices, and the repair of long bone fractures."

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 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 For information about Fortical, visit

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.

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