| FAIRFIELD, N.J., Aug 02, 2007 (BUSINESS WIRE) -- Unigene Laboratories, Inc. (OTCBB: UGNE) has initiated a clinical
study in the U.S. with its proprietary formulation of oral calcitonin
for the treatment of osteoporosis.
The tablets used in the study utilize an improved solid dosage
form of Unigene's Enteripep(R) oral delivery technology. The novel
dosage form is the subject of a recently filed patent application and
has already been shown in animal studies to deliver a more consistent
dose of calcitonin while maintaining therapeutic blood levels of this
peptide. An earlier version of the Enteripep technology has previously
been used to successfully deliver calcitonin, parathyroid hormone
(PTH) and several other therapeutically- important peptides in human
and animal studies.
"Unigene has conducted a rigorous solid dosage form development
effort over the last year to improve our proprietary delivery
technology by reducing the variability of the dose to the patient,
which has been a persistent problem for peptide oral delivery
technologies," stated Dr. Warren Levy, President and CEO of Unigene.
"We believe that the novel formulation not only achieves that goal,
but also simplifies the manufacturing process. We also believe that
the improved formulation should be applicable to the oral delivery of
several other peptides that are currently in Unigene's pipeline."
Unigene previously licensed its Secrapep(R) manufacturing
technology to Novartis for a second formulation of oral calcitonin
that entered Phase III clinical studies earlier this year for
osteoporosis and osteoarthritis.
About Unigene Laboratories, Inc.:
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
Investors:
The Investor Relations Group
Daniel Berg/Dian Griesel, Ph.D., 212-825-3210
or
Media:
Lynn Granito, 212-825-3210
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