FAIRFIELD, N.J.--(BUSINESS WIRE)--Dec. 19, 2007--Unigene
Laboratories, Inc. (OTCBB: UGNE) reports that a comparative analysis
of various osteoporosis therapies has been published, concluding that
there is insufficient evidence to support claims of superior
effectiveness among the drugs reviewed.
The study, commissioned by the Agency for Healthcare Research and
Quality, Department of Health and Human Services, is entitled "The
Comparative Effectiveness of Treatments to Prevent Fractures in Men
and Women with Low Bone Density or Osteoporosis." The study was
performed by the Southern California/RAND Evidence-based Practice
Center to assist physicians, patients, private- and public-sector
organizations in making informed decisions about pharmaceutical
alternatives for osteoporosis and reviewed data for bisphosphonates,
calcitonin, parathyroid hormone, estrogen, selective estrogen receptor
modulators and testosterone.
The leading category of osteoporosis drugs is the bisphosphonates,
with established efficacy in reducing fractures in osteoporosis
patients. However, according to the report, not enough scientific
evidence exists to establish whether bisphosphonates are better at
preventing fractures than calcitonin, estrogen or raloxifene.
Additionally, certain bisphosphonates have been associated with
osteonecrosis. Separately, the FDA is currently conducting a safety
review of all bisphosphonate products and their possible link to
atrial fibrillation, an established risk factor for stroke.
Findings in the report cite evidence that calcitonin has also
demonstrated a reduction in fracture risk among post-menopausal women
as well as men. The global history of calcitonin products demonstrates
an impressive safety profile, with products being administered to
patients for more than 35 years with virtually no significant side
effects.
Calcitonin is the active ingredient in Fortical(R), a nasal
calcitonin product developed by Unigene and marketed by Upsher-Smith
Laboratories.
"The study suggests that many of the available products are
effective in treating osteoporosis sufferers, yet there is little
evidence to support differentiation of the products based on
effectiveness," commented Dr. Warren Levy, President and CEO of
Unigene. "The study also indicates that adherence to the therapy is an
important factor in patient outcome. We hope that this study will
encourage physicians and patients to recognize that, if there are
acceptable alternatives for patients with osteoporosis or low bone
density, and long-term therapy is desirable, then the side
effect/safety profile of each drug should be considered carefully
before treatment decisions are made."
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.
CONTACT: Unigene Investor:
The Investor Relations Group
Dian Griesel, Ph.D.
212-825-3210
or
Media:
Lynn Granito, 212-825-3210
SOURCE: Unigene Laboratories, Inc.
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