Unigene Laboratories, Inc. a leader in the design, delivery, manufacture and development of peptide-based therapeutics announced that the company has completed patient enrollment of its phase II study with an experimental oral Parathyroid Hormone (PTH) analogue for the treatment of osteoporosis in post-menopausal women. Unigene is developing its oral PTH in collaboration with GlaxoSmithKline (GSK) as part of an exclusive worldwide licensing agreement. According to the agreement with GSK, Unigene will receive a $4M milestone payment for completion of Phase 2 patient enrollment.

Ashleigh Palmer, president and CEO, Unigene Laboratories Inc., said, “The completion of enrollment in this phase II study with our proprietary oral formulation of the recombinantly produced PTH analogue is a significant development milestone for Unigene. We are thrilled to have achieved this goal and remain focused on advancing this program that we believe has the potential to address an important medical need.” Palmer continued, “I am extremely impressed with the Unigene team's execution of this study in just four months since the signing of our collaboration with GSK, and believe this not only showcases our clinical trial expertise, but represents an important competitive advantage.”

This multi-centre, double blind with respect to placebo, randomized, repeat dose placebo controlled study will include an open label comparator arm of the Forsteo injectable formulation. The primary endpoint will be an increase in Bone Mineral Density (BMD) at the lumbar spine in subjects at 24 weeks in 93 post-menopausal osteoporotic women following once daily treatment with the orally delivered PTH analogue 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.

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.

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 post-menopausal 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 II study. The company received an upfront payment of $4M to cover costs associated with the phase II study, and will also receive an additional $4M payment upon completion of phase II patient enrollment, as well as further payments of up to $142M 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.