Unigene Laboratories Granted US Patent for Peptide-Based Technology for Treatment of Obesity

Unigene Laboratories Granted US Patent for Peptide-Based Technology for Treatment of Obesity

- Intellectual Property Governs Peptide Therapeutics Targeting Appetite Suppression and Obesity -

BOONTON, N.J., Jan. 11, 2012 /PRNewswire/ -- Unigene Laboratories, Inc. (OTCBB: UGNE), a leader in the design, delivery, manufacture and development of peptide-based therapeutics, today announced that it had been granted U.S. Patent No. 8,076,291 from the United States Patent and Trademark Office (USPTO). The patent, which was issued on December 13, 2011, provides intellectual property (IP) protection for peptides and pharmaceutical compositions containing such peptides for the suppression of appetite and treating obesity in warm-blooded animals, including humans. The patent issued with 30 claims, including 11 independent claims.

The patent covers certain calcitonin analogs with enhanced appetite suppressant activity but which are less potent bone anti-resorptive agents.

"The issuance of this key patent strengthens Unigene's patent estate and is yet one more example of our continuing efforts to establish a robust intellectual property portfolio for our development programs and, specifically, for our proprietary high potential therapeutic peptides and oral peptide delivery technology platform," remarked Ashleigh Palmer, President and CEO of Unigene Laboratories, Inc. "Importantly, this newly issued patent protects UGP281, a potent anorexigenic peptide, which remains a high priority for Unigene and has the potential to address an extremely important unmet medical need for the rapidly growing morbidly obese patient population."

In February 2011, Unigene announced plans to accelerate the development of UGP281 following successful preclinical studies in rat and dog models. In a 20 day chronic dosing study, young rats injected daily with UGP281 at doses of 5 mcg/kg and 20 mcg/kg exhibited an immediate acute dose dependent reduction in food intake of 55% and 84%, respectively and a sustained weight loss relative to placebo of 5.7% and 8.8%, respectively. A placebo-controlled study in Beagle dogs with enteric-coated oral capsules containing UGP281 demonstrated a sustained weight reduction of >8% compared to placebo for a period of 5 weeks. In comparative studies at comparable concentrations, UGP281 demonstrates greater reductions in body weight than other peptide drugs currently in development. Based on the results to date in animal models, UGP281 was well tolerated and offers the potential of a patient friendly orally dosed peptide therapy for the management of obesity.

Unigene expects to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) and commence a Phase 1 study with UGP281 before year end.

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 PeptelligenceTM platform. Peptelligence encompasses extensive intellectual property covering 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 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 whether: the Company will achieve the highlighted multiple near-term catalysts and unlock significant value over the next 12 months; the key elements are in place to address the Company's debt in 2012; there will be significant growth in the Company in 2012; the Company will continue to deliver results; the Company's near-term milestones will allow it to extend its cash runway, address the debt and continue to unlock the Company's growth potential and shareholder value; the Company will present full data of oral parathyroid hormone (PTH) analog Phase 2 results in peer review journal and/or prestigious scientific congress; the Company will be successful in seeking a licensing partner for oral PTH program; the Company will continue to build a robust portfolio of feasibility studies on behalf of various pharmaceutical companies evaluating Unigene's PeptelligenceTM platform for oral delivery of proprietary peptides across a broad spectrum of high potential valuation therapeutic areas; whether the Company will be able to convert at least one PeptelligenceTM feasibility study into a definitive license agreement with significant milestones and royalties; the Company will file an IND and begin Phase 1 clinical testing of its lead metabolic peptide, UGP281, targeting patients with morbid obesity; the Company will select a lead molecule for Type 2 diabetes indication under the joint development vehicle (JDV) with Nordic Bioscience; the Company will announce preclinical results for Type 2 diabetes indication under JDV with Nordic Bioscience; the Company will advance its own pipeline of novel, proprietary peptide product candidates focused on metabolic disease and inflammation; a licensing partner for the Company's oral PTH program will be found and an agreement will be entered into; will present the full date from the Phase 2 PTH study in a peer review journal and/or prestigious scientific congress over the course of 2012; Tarsa's oral calcitonin program will be successful, a product will be approved and any sales-related milestone payments and royalties will be paid to the Company on worldwide sales, excluding China; Tarsa will report top-line results from its TAR01-201 study in the second half of 2012; Tarsa will file an NDA submission to the FDA for OSTORA in the second half of 2012; the Company will file an Investigational New Drug (IND) application with the FDA and initiate Phase 1 clinical studies of UGP281 before the end of 2012; the lead molecule for the Type 2 diabetes indication will be selected by the Company with Nordic, early-stage preclinical studies will be conducted and the preclinical results of a lead molecule will be reported in the second half of 2012; at least one feasibility study will convert into a high-value milestone and royalty payment licensing agreement over the next 6-9 months; Cara will report the results from its Phase 1 study in the first quarter of 2012; the Company is well positioned to capitalize on the numerous opportunities that its oral peptide delivery platform and pipeline are expected to realize in 2012; the Company will secure a development partner and licensee for its oral PTH program and, if so, whether it will become a game-changing treatment option for the estimated 75 million people in Europe, the US and Japan who are impacted by osteoporosis; the Company and its stockholders will reap rewards and achieve substantial growth in 2012; and the Company's current cash flow will be sufficient to fund its business operations into the second half of 2012. We have based these forward-looking statements on our current expectations and projections about future events, including our cash flow projections. 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.