Unigene

Unigene is developing its investigational oral PTH in collaboration with GSK as part of an exclusive worldwide licensing agreement.

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

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Ashleigh Palmer, President and Chief Executive Officer of Unigene Laboratories, Inc., said, We have made tremendous progress with our Phase 2 program since the beginning of the year and are thrilled to be working closely with GSK on the most advanced oral PTH in development.

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Unigene licensed its oral calcitonin program to Tarsa Therapeutics and expects an NDA filing with the FDA before year end.

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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.

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In addition, Unigene is eligible to receive tiered double-digit royalties in the low-to-mid teens on global sales.

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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.

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Unigene's technologies have extensive clinical and partner validation.

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In addition, Unigene has a manufacturing license agreement with Novartis, which is completing three Phase 3 studies of oral calcitonin for the treatment of osteoporosis and osteoarthritis.

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Under the terms of the agreement, Unigene will receive up to approximately $2.2 million in milestone payments from GSK to undertake certain development and manufacturing activities.

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