Novartis Pharma's ($NVS) oral formulation of calcitonin to treat for post-menopausal osteoporosis failed to meet its primary endpoint or key secondary endpoints in a crucial critical trial.
Development partner Unigene Laboratories ($UGNE) announced the news Nov. 14. The company contracted to make the calcitonin for the trial, and Emisphere contributed its proprietary oral drug delivery technology.
Osteoporosis is a disease that reduces bone density and makes bones brittle.
The Phase III trial, known cryptically as Study 2303, and conducted by Novartis' license partner Nordic Bioscience, showed no statistically significant improvement on the rate of new vertebral fractures at three years, or the rate of other fractures, Unigene said. In one small bit of good news, the study in one subgroup generated an increase in bone density in the lumbar spine relative to placebo.
Unigene President and CEO Ashleigh Palmer noted in a statement that the mixed news "reduces the likelihood of near-term royalties" with Novartis under the company's manufacturing license.
Unigene inked a global licensing deal with Novartis in 2004 to allow Novartis to make calcitonin using Unigene's patented process. The deal is worth up to $18.7 million before royalties, and Unigene said it has received $13.7 million so far.
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