Unigene Laboratories Reaches $5.5 Million Milestone With Novartis

FAIRFIELD, N.J. - The initiation of a Phase III clinical study for osteoporosis by Nordic Bioscience, the development partner of Novartis Pharma AG, with oral calcitonin has triggered a $5.5 million milestone to be paid by Novartis to Unigene Laboratories, Inc. (OTCBB: UGNE).

Salmon calcitonin, the active pharmaceutical ingredient in Novartis’ oral product, was produced using Unigene’s patented manufacturing process, which was licensed to Novartis in 2004. In 2005, the technology was transferred successfully to Sandoz, an affiliate of Novartis, who produced multiple kilograms of calcitonin at a scale that represents a ten-fold increase above Unigene’s current production capacity. Under the terms of that agreement, Unigene is eligible to receive up to $18.7 million in payments before royalties. Upon receipt of this milestone payment, Unigene will have received $13.7 million of that total.

“We are pleased that a pivotal study has started with an oral product made with our calcitonin manufacturing technology,” commented Dr. Ronald S. Levy, Executive Vice President of Unigene. “This action confirms Novartis’ intention to utilize Unigene’s technology to commercialize the product. We believe that this study, combined with Novartis’ planned study for oral calcitonin in osteoarthritis, will serve to highlight the significant potential market opportunities for calcitonin-based products in the future.”