Unigene and Yale Present Novel Site-Directed Bone Growth Technology for Strengthening Bones
8:00a ET June 27, 2007 (Business Wire)
Unigene Laboratories, Inc. (OTCBB: UGNE) and Yale University presented animal data this week demonstrating the ability to strengthen bone by a minimally-invasive surgical procedure followed by the administration of parathyroid hormone (PTH).
A poster entitled "Rapid Site-Specific Bone Growth by a Combination of Bone Marrow Ablation and Anabolic Therapy" was presented at the 17th Scientific Meeting of the International Bone and Mineral Society in Montreal, Canada. The presentation will be posted this week on Unigene's website, www.unigene.com.
"Although still in the early stages of development, we believe that this technology may represent an important breakthrough in the prevention and treatment of certain commonplace but serious medical conditions," commented Dr. Warren Levy, President and CEO of Unigene. "There is an important unmet need for a rapid, minimally-invasive procedure to strengthen specific bones that are at risk of fracture, or to accelerate fracture repair. If future animal and human studies confirm the utility of this technology, it could represent a much more attractive alternative for patients considering hip replacement, spinal fusion, vertebroplasty or other common bone-related surgeries."
About Site-Directed Bone Growth (SDBG)
The patent-pending SDBG technology involves the synergistic combination of a proprietary device to irrigate the marrow of a targeted bone and the systemic administration of a biological compound, such as PTH, that promotes bone growth. The appearance of new bone after only three weeks of PTH therapy was documented in study animals by various techniques and caused improvement in the strength and biomechanical properties of the targeted bone. The study results also demonstrated that the use of calcitonin following PTH treatment protected the new bone that was created. The amount of new bone observed following the combined use of PTH and calcitonin far exceeded that achieved by treatment with PTH or calcitonin alone.
In clinical practice, the technology may find application in skeletal sites such as the spine, hip or wrist for preventing fractures of bones weakened by osteoporosis, to accelerate fracture repair and bone healing, or to reinforce the implantation of prosthetic devices. The potential markets for these technologies include the prevention and/or treatment of vertebral compression fractures, hip fractures and long bone fractures. The market for products and procedures for each of these indications currently exceeds $1 billion annually. This technology may also be useful in treating chronic back pain, an indication involving expenditures of more than $5 billion in 2006.
Unigene has established an active collaboration with leading clinicians in interventional radiology, neurobiology and orthopedic surgery at Johns Hopkins Medical School to explore the various potential clinical applications of this technology.
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 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.
Unigene Investor: The Investor Relations Group Daniel Berg/Dian Griesel, Ph.D., 212-825-3210 or Media: Lynn Granito, 212-825-3210
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