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Unigene and Novartis Complete Technology Transfer For Calcitonin Manufacturing; Sandoz Successfully Concludes First Full-Scale Production Campaign
Aug 22, 2005 7:00:00 AM
Copyright Business Wire 2005
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 [phone] 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 current expectations and projections about future events and they are subject to risks and uncertainties known and unknown which could cause actual results and developments to differ materially from those expressed or implied in such statements. These forward-looking statements include statements about the following: general economic and business conditions, our financial condition, competition, our dependence on other companies to commercialize, manufacture and sell products using our technologies, the uncertainty of results of animal and human testing, the risk of product liability and liability for human trials, our dependence on patents and other proprietary rights, dependence on key management officials, the availability and cost of capital, the availability of qualified personnel, changes in, or the failure to comply with, governmental regulations, the failure to obtain regulatory approvals for our products and other risk factors discussed in our Securities and Exchange Commission filings.. 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.

Source: Unigene Laboratories, Inc.



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The Investor Relations Group
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Media: Janet Vasquez
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