UGNE Unigene Announces Licensing and Manufacturing Agreements for Calcitonin with
ovartis; Unigene Eligible to Receive $18.7 Million in Addition to Royalties
FAIRFIELD, N.J., Apr 8, 2004 (BUSINESS WIRE) -- Unigene Laboratories, Inc.
(OTCBB: UGNE) has signed licensing and clinical supply agreements with Novartis
Pharma AG (NYSE: NVS) to provide for the recombinant production of calcitonin,
the active ingredient used in various formulations for the treatment of
osteoporosis. Under the terms of these agreements Unigene is eligible to receive
$18.7 million, including an initial payment of $5.6 million. In addition,
Unigene is eligible to receive royalties on sales of any current or future
Novartis products that will contain calcitonin made using Unigene's process.
The license agreement grants Novartis a worldwide license to produce recombinant
calcitonin under Unigene's patented process for manufacturing recombinant
peptides. Unigene will sell calcitonin to Novartis to support Novartis'
development programs. Unigene remains free to develop and commercialize its own
products containing calcitonin, including its oral product under development and
FORTICAL(R), its nasal product that recently received an approvable letter from
the U.S. Food and Drug Administration.
"This arrangement will allow Unigene and Novartis to independently advance their
commercial interests in calcitonin using the same production platform,"
commented Dr. Warren Levy, President and CEO of Unigene. "Our patented
manufacturing process allows for the cost-effective large-scale production of
peptides to support their worldwide commercialization as oral or nasal
therapeutics. In addition to potentially providing a highly desirable revenue
stream, the agreements provide Unigene with a potential source of supply for
recombinant calcitonin that far exceeds our current capacity, thereby avoiding
the need for significant capital expenditures for construction of a larger
production facility. This increased supply of recombinant calcitonin will be
essential to support the development and commercialization of our oral
calcitonin product."
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 and the
worldwide rights for its oral PTH technology to GlaxoSmithKline. 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.
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.
CONTACT: Investor Contact:
The Investor Relations Group
Damian McIntosh/Dian Griesel, Ph.D., 212-825-3210
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