Upsher-Smith reiterated its continuing disappointment in the longer than expected review process by the FDA, but clarified that neither company has received any communication of a decision by the FDA regarding the approval of Fortical(R) calcitonin-salmon (rDNA origin) Nasal Spray, a patented nasal calcitonin product for the treatment of postmenopausal osteoporosis. Both companies remain optimistic that a final decision will be rendered by the FDA shortly.
Upsher-Smith also emphasized that the restructuring and elimination of positions at Upsher-Smith resulting from the lengthy approval process will have no impact on their commitment to Fortical(R) and its long-term success in the marketplace.
About Upsher-Smith
Upsher-Smith Laboratories, Inc. is a fully integrated pharmaceutical company that manufactures and markets prescription pharmaceutical, OTC and cosmetic products. Upsher-Smith is also actively involved in licensing innovative compounds that are in clinical development. For more information regarding this press release or Upsher-Smith Laboratories, Inc., please contact Phill Dritsas at 763-315-2167 or visit http://www.upsher-smith.com .
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. Unigene is awaiting approval from the FDA for Fortical(R), its nasal calcitonin product for the treatment of osteoporosis. 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 Upsher-Smith Laboratories, Inc.; Unigene Laboratories, Inc.
