USPTO issues patent to Unigene's peptide-based therapeutics for obesity

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.