Unigene Laboratories and GlaxoSmithKline have amended agreements relating to exclusive worldwide license, development services, and clinical supply for an oral formulation of a recombinantly produced parathyroid hormone (PTH) analog for the treatment of osteoporosis in postmenopausal women. GSK decided not to pursue development based on its internal evaluation criteria, allowing Unigene to regain exclusive worldwide rights to the oral PTH program with no financial obligations to GSK.
Ashleigh Palmer, Unigene’s president and chief executive officer, stated, “We respect GSK’s decision and remain extremely pleased with the positive and statistically significant Phase II data reported last month. Given our extremely successful turnaround track record and proven business development competence, we are confident we will find the best advanced stage development partner and licensee over the course of the coming year to not only continue but accelerate the development and commercialization of our promising oral PTH program.”
Unigene recently reported positive Phase II results from an oral PTH analog study for the treatment of osteoporosis in 93 postmenopausal women. The study achieved its primary endpoint with statistical significance. Unigene will be reimbursed by GSK for all work in connection with the conduct of the study through November 30, 2011.
Unigene Regains Rights to Osteoporosis Therapy
Published December 5, 2011
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