Unigene and Yale Present Longer-Term Animal Data for Novel Site-Directed Bone Growth Technology

FAIRFIELD, N.J.--(BUSINESS WIRE)--Unigene Laboratories, Inc. (OTCBB: UGNE) and Yale University yesterday presented data at the 29^th Annual Meeting of the American Society for Bone and Mineral Research in Honolulu, Hawaii that demonstrated the ability to preserve new bone created using their proprietary Site-Directed Bone Growth Technology.

“Rapid Site-Specific Bone Growth by a Combination of Bone Marrow Ablation, PTH and Bisphosphonate Therapy.”

The poster presentation was entitled “Rapid Site-Specific Bone Growth by a Combination of Bone Marrow Ablation, PTH and Bisphosphonate Therapy.” The data illustrated that the technology promotes rapid, targeted new bone formation within the thigh bone of an animal that can be maintained for an extended period of time by treatment with a bone building agent, such as PTH, followed by a commonly used bone protective agent, such as a bisphosphonate. The presentation will be posted this week on Unigene’s website, www.unigene.com.

“Although still in the early stages of development, we continue to believe that this technology could represent an important breakthrough in the prevention and treatment of certain commonplace but serious bone-related 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. Our team of researchers at Unigene and Yale, along with leading clinicians in interventional radiology and orthopedic surgery at Johns Hopkins Medical School, continues its work with animal models to evaluate the ability of the technology for various applications. 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 in animals after only three weeks of PTH therapy was documented previously by various techniques and resulted in improvement in the strength and biomechanical properties of the targeted bone. Earlier studies 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. The most recent results extend those findings to three months and confirm the extensive creation of bone preferentially at the desired location.

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.

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 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. 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 [phone] or visit www.unigene.com. For information about Fortical, visit www.fortical.com.

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