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


FAIRFIELD, N.J. -- Unigene Laboratories, Inc. (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
: UGNE) and Yale University yesterday presented data at the 29th 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.

The poster presentation was entitled "Rapid Site-Specific Bone Growth by a Combination of Bone Marrow Ablation bone marrow ablation Oncology The destruction of BM with radiation or drugs , PTH PTH
abbr.
parathyroid hormone


Parathyroid hormone (PTH)
A chemical substance produced by the parathyroid glands. This hormone is a major element in regulating calcium in the body.
 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  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 Fracture Repair Definition

Fracture repair is the process of rejoining and realigning the ends of broken bones. This procedure is usually performed by an orthopedist, general surgeon, or family doctor.
. Our team of researchers at Unigene and Yale, along with leading clinicians in interventional radiology interventional radiology Imaging A subspecialty of radiology that provides Diagnostic information–eg, CT-guided 'skinny' needle biopsies and dye injection for analysis of various lumina and tracts–eg, arteriography, cholangiography, antegrade  and orthopedic surgery Orthopedic Surgery Definition

Orthopedic (sometimes spelled orthopaedic) surgery is surgery performed by a medical specialist, such as an orthopedist or orthopedic surgeon, trained to deal with problems that develop in the bones, joints, and ligaments
 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 spinal fusion
n.
A surgical procedure in which vertebrae are joined. Also called spondylosyndesis.


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 ir·ri·gate
v.
To wash out a cavity or wound with a fluid.
 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 calcitonin /cal·ci·to·nin/ (-to´nin) a polypeptide hormone secreted by C cells of the thyroid gland, and sometimes of the thymus and parathyroids, which lowers calcium and phosphate concentration in plasma and inhibits bone resorption.  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 pros·thet·ic
adj.
1. Serving as or relating to a prosthesis.

2. Of or relating to prosthetics.



prosthetic

serving as a substitute; pertaining to prostheses or to prosthetics.
 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([R]), Unigene's nasal calcitonin product for the treatment of postmenopausal post·men·o·paus·al
adj.
Of or occurring in the time following menopause.


postmenopausal Change of life Gynecology adjective Referring to the time in ♀ when menstrual periods stop for ≥ 1 yr
 osteoporosis, received FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 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 Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
 statements under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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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Date:Sep 20, 2007
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