Unigene Laboratories, Inc. a leader in the design, delivery, manufacture and development of peptide-based therapeutics announced the dosing of the first subject in a phase II study with an experimental oral Parathyroid Hormone (PTH) analogue for the treatment of osteoporosis in postmenopausal women. Unigene is developing its oral PTH in collaboration with GlaxoSmithKline (GSK) as part of an exclusive worldwide licensing agreement.

Ashleigh Palmer, president and CEO of Unigene Laboratories, Inc., said, “The initiation of this oral PTH phase II study with our proprietary oral formulation of the recombinantly produced PTH analogue is a major accomplishment for Unigene, and we are thrilled with the significant progress we have made advancing this programme over the past nine months. Palmer added, “We are extremely grateful to our partner for its continued support and hope, through the results of this study, to be providing GSK with a compelling basis for electing to proceed with the next stages of development.”

This multi-centre, double blind with respect to placebo, randomized, repeat dose placebo controlled study will include an open label comparator arm of the Forsteo injectable formulation. The primary endpoint will be an increase in Bone Mineral Density (BMD) at the lumbar spine in subjects at 24 weeks in 93 postmenopausal osteoporotic women following once daily treatment with the orally delivered PTH analogue compared to baseline. Secondary endpoints will evaluate biochemical markers of bone formation and resorption, as well as the safety, tolerability and pharmacokinetics of the oral formulation.

Patient enrollment for this study is ongoing and expected to be completed in the first half of 2011. The Company expects to report top-line results before year end.

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 symptoms. The disease has a significant impact on patients' quality of life and it is estimated that one in three women and one in five men over the age of 50 will develop osteoporosis during their lifetimes.

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 is responsible for the manufacture of the PTH and the conduct of the Phase 2 study. The Company received an upfront payment of $4M to cover costs associated with the Phase 2 study, and will also receive an additional $4M payment upon completion of Phase 2 patient enrollment, as well as further payments of up to $142M based on the achievement of regulatory and commercialization milestones.

Unigene Laboratories, Inc. is a leader in the design, delivery, manufacture and development of peptide-based therapeutics.