Unigene Welcomes FDA Advisory Committee Review of Salmon Calcitonin Advisory Committee to Weigh Therapeutic Benefit of Calcitonin Drugs Against Potential Risk of Cancer
BOONTON, N.J., Jan. 15, 2013 /PRNewswire/ -- Unigene Laboratories, Inc. (PINK: UGNE), a leader in the design, delivery, manufacture and development of peptide-based therapeutics, today announced that the Food & Drug Administration (FDA) has posted notice of an Advisory Committee Meeting scheduled on March 5, 2013 to discuss whether the benefit of calcitonin salmon for the treatment of postmenopausal osteoporosis outweighs a potential risk of cancer.
The Advisory Committee meeting is a public forum where experts in the field will provide advice and recommendations to the FDA. The meeting was announced in the Federal Register, Vol. 78, No. 9 / Monday, January 14, 2013 / Notices. Unigene is the manufacturer of Fortical Nasal Spray, a calcitonin containing product indicated for the treatment of osteoporosis that is distributed in the USA by Upsher Smith Laboratories, Inc. Unigene's licensee, Tarsa Therapeutics, is developing an oral calcitonin tablet for the treatment of postmenopausal osteoporosis.
Ashleigh Palmer, Unigene's Chief Executive Officer, stated, "We are pleased that an Advisory Committee will be assembled to weigh the benefit of calcitonin salmon for the treatment of postmenopausal osteoporosis. In particular, we applaud the FDA for its willingness to receive input from external experts and concerned citizens in a public forum."
Mr. Palmer continued, "As noted previously, the decision of the EMA to limit the use of calcitonin-containing medicines in Europe due to a potential perceived cancer risk was based on a retrospective analysis of long-finished clinical trials involving certain calcitonin products unrelated to Unigene or its licensees. Extensive clinical research by Unigene and Tarsa Therapeutics, including a completed Phase 3 study of Tarsa's oral calcitonin for the treatment of postmenopausal osteoporosis, has consistently demonstrated that the drug possesses a positive safety and efficacy profile, which mirrors calcitonin's nearly 30 years of use as an approved medicine."
In October 2012, Tarsa presented data at the American Society for Bone and Mineral Research 2012 Annual Meeting assessing whether there was any sign of increased cancer risk in the 694 women who participated in the company's two separate year-long trials of its investigational oral calcitonin for the treatment and prevention of post-menopausal osteoporosis. The assessment concluded that the combined safety data from these trials demonstrated no signal of carcinogenicity.
About Unigene Laboratories, Inc.
Unigene Laboratories, Inc. is a leader in the design, delivery, manufacture and development of peptide-based therapeutics. The Company is building a robust portfolio of proprietary partnerships in this expanding drug class based on its Peptelligence™ platform. Peptelligence™ encompasses extensive intellectual property covering drug delivery and manufacturing technologies, unsurpassed research and development expertise, and proprietary know-how representing a genuine distinctive competence. Core Peptelligence™ assets include proprietary oral and nasal peptide drug delivery technologies, and proprietary, high-yield, scalable and reproducible E. coli-based manufacturing technologies.
Safe Harbor statements under the Private Securities Litigation Reform Act of 1995: This press release contains forward-looking statements, including statements relating to the Advisory Committee Meeting scheduled on March 5, 2013 to discuss whether the benefit of calcitonin salmon for the treatment of postmenopausal osteoporosis outweighs a potential risk of cancer, including the outcome of such meeting and Unigene's ability to build a robust portfolio of proprietary partnerships in peptide-based therapeutics based on its Peptelligence™ platform. 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 known and unknown risk factors include, but are not limited to: the delay in obtaining or the failure to obtain regulatory approvals for our products and the products of our licensees that may generate royalty and milestone payments to us, our ability to achieve product sales and royalties, competition, our dependence on other companies to commercialize, manufacture and sell products using our technologies and our ability to enter into favorable new agreements with such companies, our ability to cut expenses and maintain efficiencies, our ability to enter into new financing arrangements, 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 clinical trials, our dependence on patents and other proprietary rights and the risks associated with patent litigation, 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, general economic and business conditions, our history of losses and ability to achieve profitability, litigation and other risk factors discussed in our Securities and Exchange Commission ("SEC") filings, including our annual report on Form 10-K and our quarterly reports on Form 10-Q. 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, but are not the exclusive means of identifying forward-looking statements. In addition, any statements that refer to expectations, projections, contingencies, goals, targets or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements and are not statements of historical fact. Except as required by applicable law, including the securities laws of the United States and the rules and regulations of the SEC, we are under no obligation to publicly update or revise any forward-looking statements after the date of this release.
SOURCE Unigene Laboratories, Inc.