Unigene and GSK Broaden Deal in Anticipation of Phase III Trial in Postmenopausal Osteoporosis
Unigene will provide development services and clinical supply of oral PTH.!--h2>
Unigene Laboratories has expanded its arrangement with GlaxoSmithKline (GSK) to include development services and clinical supply of Unigene’s Phase II parathyroid hormone (PTH) analog. Under a deal inked in December 2010, GSK has the right to take over Phase III development and commercialization.
The oral peptide-based drug is being developed for the treatment of osteoporosis in postmenopausal women. Under the service and supply agreement, Unigene will receive up to approximately $2.2 million in milestone fees. The company will be responsible for producing the API and finished drug product in advance of GSK’s decision to study the molecule further. Phase II results are expected by year end.
“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,” says Ashleigh Palmer, president and CEO of Unigene.
Under the December exclusive, worldwide licensing agreement, Unigene is responsible for the manufacture of the PTH and the conduct of the Phase II study. The company received an up-front payment of $4 million to cover costs associated with the Phase II trial. It then received an additional $4 million fee in May upon completion of Phase II patient enrollment.
Unigene is eligible to further payments of up to approximately $140 million based on the achievement of regulatory and commercialization milestones. In addition, it may earn tiered double-digit royalties in the low-to-mid teens on global sales.
Unigene is leveraging its peptide technology Peptelligence for internal development of drug candidates as well as through partnerships. The platform includes peptide drug delivery (oral and nasal) and manufacturing technologies. Unigene’s focus is on relatively large peptides (>30 amino acids) and peptides that require nonparenteral delivery or large-scale production.
While the candidates Unigene is developing alone are at the preclinical stage, it has partnered compounds in various stages of clinical development. Besides GSK, the firm has a deal with Tarsa covering Phase III oral calcitonin.
Tarsa is developing the molecule under an exclusive, worldwide (excluding China) development and commercialization agreement signed in 2009. In March 2011, it reported positive Phase III data in the treatment of postmenopausal osteoporosis.
The study data will be used to support an NDA application likely by year-end. A marketing authorization application submission to the European regulatory agency is projected by early 2012.
In May Cara Therapeutics signed on Unigene to use its peptide-manufacturing technology to provide clinical supply material for Cara’s Phase I study of CR845. The firm is testing CR845, a peripherally acting kappa opioid agonist, as a treatment for acute and chronic pain. It is also in Phase II development as an IV formulation for the treatment of post-operative pain.
In addition, Unigene has a manufacturing license agreement with Novartis, which is completing three Phase III studies of oral calcitonin for the treatment of osteoporosis and osteoarthritis. The firm’s first product to reach the market, Fortical®, is a nasal spray calcitonin that received FDA approval in 2005 for the treatment of postmenopausal osteoporosis.