EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

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Investor Contact:

The Investor Relations Group

Damian McIntosh/Dian Griesel, Ph.D.

Phone: 212-825-3210

Unigene and Upsher-Smith File Patent Infringement Lawsuit

Against Canadian Drug Manufacturer

FAIRFIELD, N.J. – July 25, 2006 — Unigene Laboratories, Inc. (OTCBB: UGNE) and Upsher-Smith Laboratories, Inc. have jointly filed in the U.S. District Court for the Southern District of New York a patent infringement lawsuit against Apotex Inc., a Canadian generic pharmaceutical manufacturer, and Apotex Corp., its U.S. subsidiary. The suit was brought in response to Apotex’s filing of an Abbreviated New Drug Application (ANDA) seeking approval of a nasal spray product that claims to be a generic equivalent of Fortical® calcitonin-salmon (rDNA origin) Nasal Spray, the nasal calcitonin product for the treatment of postmenopausal osteoporosis that is manufactured by Unigene and marketed by Upsher-Smith. The filing of the lawsuit automatically stays FDA approval of Apotex’s ANDA for at least 30 months, unless an adverse court decision occurs earlier. Apotex is currently the defendant in a patent infringement lawsuit involving a nasal calcitonin formulation developed and patented by Novartis.

“It is our firm intention to defend our patent rights,” commented Dr. Ronald S. Levy, Executive Vice President of Unigene. “We continue to be very enthusiastic about the commercial opportunity that Fortical represents. According to NDC data, at the end of May Fortical had captured 24% of the nasal calcitonin market. We believe that it is being accepted as a safe, effective and well-tolerated alternative to established osteoporosis therapies.”

Unigene and Upsher-Smith are represented in the action by Morgan & Finnegan, LLP, in New York, an intellectual property law firm. Upsher-Smith is Unigene’s exclusive U.S. marketing partner for Fortical. Both parties will contribute to the litigation costs.

About Fortical

Fortical is indicated for the treatment of postmenopausal osteoporosis in women greater than five years postmenopause with low bone mass relative to healthy premenopausal women. Recommended in conjunction with adequate calcium and vitamin D intake. The most common adverse events were rhinitis, other nasal symptoms, back pain, arthralgia, epistaxis and headache. Periodic nasal examinations are recommended; if nasal ulceration occurs, discontinue treatment until healed. Because calcitonin-salmon is a protein, the possibility of systemic allergic reaction exists. For more information and complete product information and most common adverse events for Fortical® Nasal Spray, visit www.upsher-smith.com or call 1-800-654-2299.


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. Fortical®, 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 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.

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 about Upsher-Smith Laboratories, Inc., call 800-654-2299 or visit www.upsher-smith.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 ability of our products to gain market acceptance and increase market share, 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.