FAIRFIELD, N.J.--(BUSINESS WIRE)--Aug. 22, 2005--The transfer of
Unigene Laboratories, Inc. (OTCBB: UGNE) proprietary manufacturing
technology to Novartis for manufacturing calcitonin has been completed
successfully.
Sandoz, a Novartis affiliate, has concluded a manufacturing
campaign based on Unigene's process and produced multiple kilograms of
calcitonin at a scale that represents a ten-fold increase above
Unigene's current production capacity. Calcitonin produced by Sandoz
is projected to be used by Novartis in future studies including
clinical trials.
According to the terms of the agreement between Unigene and
Novartis signed in 2004, Novartis was granted an exclusive worldwide
license to produce recombinant calcitonin using Unigene's patented
process for manufacturing recombinant peptides. Under that agreement,
Unigene has received $8.2 million to date and is eligible to receive
up to $10.5 million in milestones in addition to royalties on sales of
any current or future Novartis products that will contain calcitonin
made using Unigene's process.
"The rapid implementation of our process in Sandoz's large-scale
facilities was made possible because of the efficient and productive
collaboration between Sandoz and Unigene scientists coupled with the
extensive recombinant manufacturing experience of Sandoz," commented
Dr. Warren P. Levy, President and CEO of Unigene. "We believe that the
Sandoz facility should be capable of supporting the future
requirements of Novartis and Unigene for calcitonin."
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.
Unigene has licensed the U.S. rights for its nasal calcitonin product
to Upsher-Smith Laboratories, worldwide rights for its oral PTH
technology to GlaxoSmithKline and worldwide rights for its calcitonin
manufacturing technology to Novartis. Fortical(R), Unigene's nasal
calcitonin product for the treatment of postmenopausal osteoporosis,
received FDA approval and was launched this month. 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.
Safe Harbor statements under the Private Securities Litigation
Reform Act of 1995: This press release contains forward-looking
statements regarding us and our business, financial condition, results
of operations and prospects. Such forward-looking statements include
those which express plans, anticipation, intent, contingency, goals,
targets or future development and/or otherwise are not statements of
historical fact. We have based these forward-looking statements on our
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subject to risks and uncertainties known and unknown which could cause
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and business conditions, our financial condition, competition, our
dependence on other companies to commercialize, manufacture and sell
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or circumstances, including any underlying assumptions, are
forward-looking statements. These forward-looking statements are not
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Therefore, our actual results could differ materially and adversely
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CONTACT: The Investor Relations Group
Investors: Damian McIntosh/Dian Griesel, Ph.D.
Media: Janet Vasquez
212-825-3210
SOURCE: Unigene Laboratories, Inc.
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