Unigene Laboratories, Inc., a leader in the design, delivery, manufacture and development of peptide-based therapeutics, announced that all patients have completed the course of therapy in the phase 2 study of an experimental oral parathyroid hormone (PTH) analog for the treatment of osteoporosis in postmenopausal women. Unigene is developing its oral PTH in collaboration with GlaxoSmithKline as part of an exclusive worldwide licensing agreement.
Ashleigh Palmer, president and chief executive officer of Unigene Laboratories, Inc., said, “Completing all treatment rounds and patient final visits in the phase 2 study of our proprietary oral formulation of the recombinantly produced PTH analog is a key milestone in the advancement of this investigational product for women with postmenopausal osteoporosis. We now look forward to assessing the data and presenting top-line results by year-end, while working closely with GSK on the next stages of development.”
The phase 2 study of Oral PTH for the treatment of osteoporosis in postmenopausal women is a multicenter, double blind with respect to placebo, randomized, repeat dose placebo controlled study that includes an open label comparator arm of the Forsteo injectable formulation. The primary endpoint is an increase in bone mineral density (BMD) at the lumbar spine in subjects at 24 weeks in 93 postmenopausal osteoporotic women following once daily treatment with the orally delivered PTH analog compared to baseline. Secondary endpoints will evaluate biochemical markers of bone formation and resorption, as well as the safety, tolerability and pharmacokinetics of the oral formulation.
The company expects to report top-line results before year-end.
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 to cover costs associated with the phase 2 study, and also received an additional $4 million payment in May 2011 upon completion of Phase 2 patient enrollment, 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.
Osteoporosis is a disease in which bones become brittle and so are more likely to break. In osteoporotic women and men, the density and quality of bone are reduced, leading to deterioration of the skeleton and increased risk of fracture. It’s often diagnosed only after an osteoporosis-related fracture happens because prior to such an event, the patient has no outward signs or symptoms. The disease has a significant impact on patients’ quality of life and it is estimated that one in three women and one in five men over the age of 50 will develop osteoporosis during their lifetimes.
The prevalence of osteoporosis is growing as the number of post-menopausal women rises, along with the general increase in life expectancy. Osteoporosis affects an estimated 75 million people in Europe, the US and Japan. In women over 45, osteoporosis accounts for more days spent in hospital than many other diseases, including diabetes, heart attack and breast cancer. There is currently no cure for osteoporosis, but available treatments can strengthen bones and help reduce the risk of fractures.
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.