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Unigene Reports Third Quarter 2011 Financial Results
Date:11/9/2011

160;Under the terms of the agreement, Unigene will receive up to approximately $2.2 million in payments from GSK to undertake certain development and manufacturing activities related to the active pharmaceutical ingredient and finished drug product of an oral formulation of a recombinantly produced investigational PTH analog for the treatment of osteoporosis in postmenopausal women in advance of GSK's potential decision to study the molecule in a Phase 3 study.  

On October 20, 2011, the Company announced that all dosing has been completed with the Phase 2 study.  Based on a review of the Phase 2 data, GSK may elect to assume responsibility for all future development and commercialization of the product.

Oral Calcitonin Program with Tarsa TherapeuticsIn 2009, Unigene licensed its late-stage oral calcitonin formulation to Tarsa Therapeutics (Tarsa), a venture financed company founded exclusively to conduct Phase 3 clinical testing and prepare Unigene's proprietary oral calcitonin formulation for commercialization. Unigene owns a 20% equity position in Tarsa on a fully diluted basis, subject to liquidating preferences. The Company is also eligible to receive sales-related milestone payments and royalties on worldwide sales excluding China.  

On September 19, 2011, Unigene announced that Tarsa presented positive Phase 3 data from its ORACAL trial of OSTORA™ during the annual American Society for Bone and Mineral Research (ASBMR) 2011 meeting. The data demonstrated that OSTORA achieved all of the efficacy endpoints in the trial, indicated that the safety profile of OSTORA did not substantially differ from nasal calcitonin or placebo and that OSTORA also appeared to be significantly less immunogenic than nasal calcitonin spray.  Developed by Unigene and licensed to Tarsa, OSTORA™ is an oral recombinant salmon calcitonin tablet in development for the treatment of postmenopausal osteoporosis.

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SOURCE Unigene Laboratories, Inc.
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