Unigene Laboratories, Inc. a leader in the design, delivery, manufacture and development of peptide-based therapeutics announced that the company has entered into a Development Services and Clinical Supply Agreement with GlaxoSmithKline (GSK).
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. These activities are related to the active pharmaceutical ingredient and finished drug product for an oral formulation of a recombinantly produced investigational parathyroid hormone (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 programme.
Unigene is developing its investigational oral PTH in collaboration with GSK as part of an exclusive worldwide licensing agreement. The Company's oral PTH is currently in phase 2 with top-line results from this study expected before year end.
Ashleigh Palmer, president and chief executive officer of Unigene Laboratories, Inc., said, "We have made tremendous progress with our phase 2 programme since the beginning of the year and are thrilled to be working closely with GSK on the most advanced oral PTH in development. We believe the signing of this agreement reflects our validated, proprietary oral peptide delivery technology and state-of-the-art recombinant manufacturing capabilities and our growing leadership in the peptide sector." Palmer, continued, "We are highly focused on advancing our oral PTH that we believe has the potential to address such an important medical need."
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 $4 million in December to cover costs associated with the phase 2 study, and also received an additional $4 million payment in May upon completion of phase 2 patient enrolment, and 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. Once the phase 2 study has been completed and based on a review of the data, GSK may elect to assume responsibility for all future development and commercialization of the product.
Unigene Laboratories, Inc. is a leader in the design, delivery, manufacture and development of peptide-based therapeutics. The company is building a robust portfolio of proprietary partnerships in this expanding drug class based on its Peptelligence platform. Peptelligence encompasses extensive intellectual property covering delivery and manufacturing technologies, unsurpassed research and development expertise, and proprietary know-how representing a genuine distinctive competence.