Joshua Drumm, Ph.D. / Jason Rando
Tiberend Strategic Advisors, Inc.
|Unigene Announces Positive Top-Line Results of Phase 2 Oral PTH Study for the Treatment of Osteoporosis in Postmenopausal Women|
-Company’s industry leading oral peptide drug delivery platform receives further robust validation-
November 9, 2011 – Boonton, NJ – Unigene Laboratories, Inc. (OTCBB: UGNE), a leader in the design, delivery, manufacture and development of peptide-based therapeutics, today announced positive top-line results of its Phase 2 clinical study evaluating an experimental oral parathyroid hormone (PTH) analog for the treatment of osteoporosis in 93 postmenopausal women. The study achieved its primary endpoint with statistical significance. The Phase 2 study was conducted by Unigene as part of an exclusive worldwide option and licensing agreement with GlaxoSmithKline (GSK).
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.
Ashleigh Palmer, President and CEO, stated, “We are delighted to report these positive Phase 2 results from our oral PTH program. These results further validate Unigene’s proprietary oral peptide drug delivery technology and, importantly, we have demonstrated that the oral delivery of PTH is possible, having successfully achieved proof-of-concept. We now believe we have the opportunity to address an important unmet medical need. Unigene’s Peptelligence™ platform continues to lead the industry, and we are committed to ensuring our distinctive core competence dominates the growing peptide sector, establishing Unigene as the peptide partner of choice.”
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.
Nozer Mehta, Ph.D., Vice President, Research and Development, commented, “Unigene’s oral delivery technology achieved therapeutically effective blood levels of the experimental PTH analog and also showed acceptable variability to achieve the primary endpoint of the study. Compared to calcitonin, PTH is a peptide requiring greater consistency and specific drug delivery criteria to accomplish the appropriate pulsatile PK profile in order to be therapeutically effective to increase BMD. This positive Phase 2 clinical study demonstrates that our oral drug delivery platform was able to meet this rigorous pharmacological objective.”
Phase 2 Study Design
About Unigene-GSK Exclusive Worldwide Licensing Agreement
Unigene will formally submit the Phase 2 Clinical Study Report to GSK by the end of the year. GSK has up to 75 days following submission of the report to inform Unigene whether it will proceed with the clinical development of the oral formulation of a recombinantly produced PTH analog for the treatment of osteoporosis in postmenopausal women pursuant to the terms of the exclusive worldwide licensing agreement.
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.
Source: International Osteoporosis Foundation
About Unigene Laboratories, Inc.:
Safe Harbor statements under the Private Securities Litigation Reform Act of 1995: This press release contains forward- looking statements, including with respect to clinical studies of one of our licensees. We have based these forward-looking statements on our current expectations and projections about future events. These forward-looking statements are not guarantees of future performance and are subject to certain risks, uncertainties, and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various risk factors. These known and unknown risk factors include, but are not limited to: the delay in obtaining or the failure to obtain regulatory approvals for our products and the products of our licensees that may generate royalty and milestone payments to us, our ability to achieve product sales and royalties, competition, our dependence on other companies to commercialize, manufacture and sell products using our technologies, the ability of our products