Unigene Laboratories, Inc. (OTCBB: UGNE) today announced that the Company terminated its amended and restated exclusive worldwide license agreement and related development services and clinical supply agreement with GlaxoSmithKline (GSK) pertaining to an oral formulation of a recombinantly produced parathyroid hormone (PTH) analog for the treatment of osteoporosis in postmenopausal women. The termination of these agreements followed notification by GSK of its decision not to proceed based on its internal evaluation criteria. As a result, Unigene regains the exclusive worldwide rights to its oral PTH program with no financial obligations to GSK. Unigene also announced that through cost saving initiatives along with the licensing of its validated, industry-leading oral peptide drug delivery technology, based on the Company's current projections, cash flow is expected to fund business operations into the second half of 2012.
Ashleigh Palmer, President and CEO, stated, "We respect GSK's decision and remain extremely pleased with the positive and statistically significant Phase 2 data reported last month. These results have further validated Unigene's proprietary oral peptide drug delivery technology and, importantly, clearly demonstrate the viability of an oral PTH product, having successfully achieved proof-of-concept. 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."
On November 9, 2011, Unigene announced positive top-line results of its Phase 2 clinical study evaluating an experimental oral PTH analog for the treatment of osteoporosis in 93 postmenopausal women. The study achieved its primary endpoint with statistical significance and was conducted by Unigene as part of the now terminated agreements. The Company will be reimbursed by GSK for all invoiced work in connection with the conduct of the study through November 30, 2011.
The primary objective of the study was to assess the change in bone mineral density (BMD) at the lumbar spine, a clinically validated predictor of fracture risk. The study demonstrated once-daily treatment with 5mg of orally delivered PTH resulted in a statistically significant mean increase in BMD at the lumbar spine of 2.2 percent (p<0.001) at week 24 as compared to baseline.
Secondary endpoints in the Phase 2 study evaluated an open label comparator arm of injectable Forsteo® (teriparatide), an approved treatment for osteoporosis, and placebo to assess the changes in BMD at the lumbar spine at 24 weeks. The Forsteo® comparator arm showed a statistically significant increase in BMD compared to baseline, consistent with previously reported data. The placebo arm showed a non-significant decline in BMD. Safety, tolerability, pharmacokinetics (PK) and biochemical markers of bone formation and resorption were also evaluated in the study. Positive trends in bone formation at week 24 were seen in both the oral PTH and Forsteo® arms. Importantly, the 5mg dose of oral PTH demonstrated consistency of exposure at weeks 1 and 24 with the appropriate pulsatile PK profile. There were no drug-related serious adverse events and no occurrences of hypercalcemia which is a common side effect of PTH therapies. The most common adverse event in the oral PTH arm was abdominal pain.
Unigene will now seek to publish the full data set of the statistically significant Phase 2 results in a scientific journal and appropriate scientific conferences in 2012.
Palmer continued, "Our oral PTH product candidate has the potential to transform the lives of the estimated 75 million people in Europe, the US and Japan who are impacted by osteoporosis, while redefining the $5 billion global marketplace for pharmaceutical treatments for the disease. The PTH injectable market alone currently represents approximately $1 billion with sales expected to double over the next two to three years. At present, there is no cure for osteoporosis. Available treatments can strengthen bones and help reduce the risk of fractures, but require a painful injection to deliver the drug with serious side effects. Our oral PTH has the potential to greatly improve patient compliance and convenience while offering a therapeutic effect that has demonstrated statistically significant results and is comparable to the currently approved, gold-standard therapies."
Unigene Laboratories, Inc.