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Unigene Announces Positive Top-Line Results of Phase 2 Oral PTH Study for the Treatment of Osteoporosis in Postmenopausal Women
Date:11/9/2011

ry endpoints evaluated biochemical markers of bone formation and resorption, as well as the safety, tolerability and pharmacokinetics of the oral formulation.

About Unigene-GSK Exclusive Worldwide Licensing Agreement

On December 10, 2010, Unigene entered into an amended and restated exclusive worldwide license agreement with GSK to develop and commercialize an oral formulation of a recombinantly produced PTH analog for the treatment of osteoporosis in postmenopausal women. Under the terms of the amended and restated agreement, Unigene was responsible for the manufacture of the PTH and the conduct of the Phase 2 study. To date, the Company received a total of $8 million in relation to the Phase 2 study.  Unigene is eligible to receive further payments of up to approximately $140 million based on the achievement of regulatory and commercialization milestones. In addition, Unigene is eligible to receive tiered double-digit royalties in the low-to-mid teens on global sales. Based on a review of the Phase 2 data, GSK may elect to assume responsibility for all future development and commercialization of the product.

Unigene will formally submit the Phase 2 Clinical Study Report to GSK by the end of the year.  GSK has up to 75 days following submission of the report to inform Unigene whether it will proceed with the clinical development of the oral formulation of a recombinantly produced PTH analog for the treatment of osteoporosis in postmenopausal women pursuant to the terms of the exclusive worldwide licensing agreement.

About Osteoporosis

Osteoporosis is a disease in which bones become brittle and so are more likely to break. In osteoporotic women and men, the density and quality of bone are reduced, leading to deterioration of the skeleton and increased risk of fracture. It's often diagnosed only after an osteoporosis-related fracture happens because prior to such an event, the patient has no outward signs or
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SOURCE Unigene Laboratories, Inc.
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