Novartis fails with Phase III osteoporosis drug
Basel/Hervel – It may be the end of Novartis' lucky streak in osteoporosis. While the once a year osteoporosis injection Aclasta (a bisphosphonate) sells well, the Swiss pharma company had to break disastrous news from a three-year Phase 3 trial, Study 2303, conducted by its license partner Nordic Bioscience, assessing an oral formulation of calcitonin (SMC021) in the treatment of post-menopausal osteoporosis. Study 2303 failed to demonstrate a significant difference between treatment groups at three years for the primary endpoint, with no statistically significant treatment effect observed on the reduction of the occurrence of new vertebral fractures. Similarly, no statistical significant response was observed on key secondary endpoints such as new non-vertebral fractures or new clinical fractures. In 2004, Novartis bought the right to manufacture calcitonin from US- based Unigene Laboratories using Unigene’s patented peptide production process. Unigene's own oral formulation of salmon calcitonin is more successful and has reached Phase 3 statistical significance for its primary endpoint. “Although today’s news reduces the likelihood of near-term royalties under our manufacturing license with Novartis, it ironically now places Unigene in an exceptionally strong leadership position with respect to our oral peptide drug delivery platform", said Asleigh Palmer, Unigene's CEO.
In contrast to the pharma giant Novartis, little biotech Nordic Bioscience leaves the battlefield with its head held high. In June, the Danes established a Joint Development Vehicle (JDV) with Unigene to progress up to three of Unigene’s internally developed, proprietary calcitonin analogs through Phase 2 proof-of-concept in humans for the treatment of Type 2 diabetes, osteoarthritis and osteoporosis. Unigene and Nordic will each own 50% of the resulting JDV.