| FAIRFIELD, N.J., Jun 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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