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Unigene's U.S. NDA for FORTICAL-R-, Its Nasal Osteoporosis Product, Accepted for Review; $3 Million Milestone Achieved in Upsher-Smith Agreement
MONDAY, MAY 05, 2003 8:05 AM
- BusinessWire
FAIRFIELD, N.J., May 5, 2003 (BUSINESS WIRE) -- Unigene Laboratories, Inc.'s (UGNE) New Drug Application ("NDA") for FORTICAL(R), its nasal calcitonin product for treating osteoporosis, has been accepted for review by the U. S. Food and Drug Administration ("FDA").
This event triggers a $3 million milestone payment from Upsher-Smith Laboratories, the Company's exclusive U.S. licensing partner.
"We expect our current manufacturing operation for bulk calcitonin to meet the needs of Upsher-Smith in the U.S. as well as the anticipated demand for the nasal calcitonin product from prospective markets outside of the U.S.," commented Dr. Warren P. Levy, President and CEO of Unigene. "We are committed to being in position to support product launch as soon as approval is granted, and we are taking the necessary steps to accomplish this goal. Our considerable manufacturing experience with calcitonin and the valuable input and assistance we are receiving from Upsher-Smith will hopefully enable us to receive regulatory approval in a timely fashion."
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. In addition to the Upsher-Smith collaboration, Unigene has licensed to GlaxoSmithKline the worldwide rights to its oral PTH product. 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.
The Investor Relations Group
Lisa Lindberg/Dian Griesel, Ph.D., 212/825-3210
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(c) 2003 Business Wire. All reproduction, other than for an individual user`s reference, is prohibited without prior written permission.
Die Kapitalausstattung gefällt mir auch prima. | | Period Ending: | Dec 31, 2002 | Sep 30, 2002 | Jun 30, 2002 | Mar 31, 2002 | | Total Revenue | $1,195,088 | $826,199 | $556,700 | $79,971 | | Cost Of Revenue | N/A | N/A | N/A | N/A | | Gross Profit | $1,195,088 | $826,199 | $556,700 | $79,971 | | | Operating Expenses | | Research And Development | $2,582,022 | $1,800,274 | $1,931,740 | $1,821,929 | | Selling General And Administrative Expenses | $844,523 | $672,571 | $953,521 | $547,586 | | Non Recurring | N/A | N/A | N/A | N/A | | Other Operating Expenses | N/A | N/A | N/A | N/A | | | Operating Income | ($2,231,457) | ($1,646,646) | ($2,328,561) | ($2,289,544) | | Total Other Income And Expenses Net | ($268,534) | $766,741 | $2,511,080 | $1,093 | | Earnings Before Interest And Taxes | ($2,499,991) | ($879,905) | $182,519 | ($2,288,451) | | Interest Expense | $358,528 | $354,038 | $344,883 | $547,978 | | Income Before Tax | ($2,858,519) | ($1,233,943) | ($162,364) | ($2,836,429) | | Income Tax Expense | ($754,632) | $272,125 | N/A | ($272,125) | | Equity Earnings Or Loss Unconsolidated Subsidiary | N/A | N/A | N/A | N/A | | Minority Interest | N/A | N/A | N/A | N/A | | Net Income From Continuing Operations | ($2,103,887) | ($1,506,068) | ($162,364) | ($2,564,304) | | | Nonrecurring Events | | Discontinued Operations | N/A | N/A | N/A | N/A | | Extraordinary Items | N/A | N/A | N/A | N/A | | Effect Of Accounting Changes | N/A | N/A | N/A | N/A | | Other Items | N/A | N/A | N/A | N/A | | Net Income | ($2,103,887) | ($1,506,068) | ($162,364) | ($2,564,304) | | Preferred Stock And Other Adjustments | N/A | N/A | N/A | N/A | | | Net Income Applicable To Common Shares | ($2,103,887) | ($1,506,068) | ($162,364) | ($2,564,304) |
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