Unigene Laboratories, Inc. announced that the company is accelerating the development of its lead proprietary anorexigenic peptide, UGP281. An anorexigenic peptide is one that diminishes or controls appetite and offers potential therapeutic benefit to morbidly obese patients. The company expects to file an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) and initiate phase I clinical studies in the first half of 2012.

Given Unigene's aggressive cash conservancy and revenue generation initiatives since launching its new corporate strategy in the fourth quarter of 2010, the acceleration of the UGP281 program will not impact Unigene's cash runway. The company reiterates its financial guidance and continues to expect its cash position to last into the second half of 2012.

As previously reported, Unigene is also currently exploring the opportunity to license a pharmacologically distinct sister analogue to a veterinary partner for companion animal obesity to subsidize a portion of the human proof of concept development costs of UGP281.

Ashleigh Palmer, Unigene's president and CEO stated, “We believe our decision to accelerate UGP281's development could have tremendous strategic benefits for Unigene as we have the potential to address a significant unmet medical need. The launch of our turnaround strategy following Victory Park Capital's debt restructuring last year, coupled with the successful implementation of cash conservancy and revenue generation initiatives, provides the near-term funding for the accelerated development of UGP281.” Palmer continued, “Our goal is to file an IND and commence the clinical testing of UGP281 in the first half of 2012.”

Unigene's lead satiety compound, UGP281, a potent anorexigenic peptide, has demonstrated substantial decreases in food consumption and weight in multiple in vivo preclinical studies. Unigene's Peptelligence core competence will allow UGP281 to be manufactured and delivered by way of our proprietary recombinant production and oral delivery technologies. Potential competitors with peptide or protein based drugs are likely to have to resort to injectable, depot or patch formulations. Longer term oral studies with UGP281 in dog models are currently ongoing.

Dr Nozer Mehta, Unigene's vice president of Research and Development commented, “UGP281 is a custom designed potent amylin receptor super agonist and is an analogue of naturally occurring peptide hormones. It has a very favourable pharmacological profile in terms of selectivity, safety and potency. These attributes offer the potential for a therapeutic product without the safety issues of several small molecule drugs or drug combinations. We, therefore, believe UGP281 has the potential to fill the void left by a spate of recent late-stage obesity drug development failures.”

Obesity is associated with increased risk for coronary heart disease, diabetes, cancer, hypertension, stroke, depression, sleep apnea and overall mortality. Moderate weight loss (5-10%) has been shown to significantly decrease many of these risks. With the Centres for Disease Control and Prevention (CDC) estimating the total economic cost of obesity-associated diseases in the US to be in the order of $90 billion per year or more, there remains a high unmet medical need and compelling socioeconomic justification for effective and safe anti-obesity agents.

Unigene Laboratories, Inc. is a leader in the design, delivery, manufacture and development of peptide-based therapeutics and is building a robust portfolio of proprietary partnerships in this expanding drug class based on its Peptelligence platform.