Pfizer has withdrawn from its collaboration with Unigene over an oralformulation of calcitonin that the two companies had been developing for the treatment of osteoporosis. Pfizer took the decision, citing "technical and scientific reasons," after concluding an analysis of data from a Phase I/II study comparing Unigene's oral drug with Novartis' intranasal Miacalcic brand.
While each of the three doses of oral calcitonin tested achieved calcitonin blood levels significantly above those reported with Miacalcic, neither product was able to effect significant changes in the bone markers that were analyzed in this study. Unigene notes that the lack of an effect may be explained by the fact that none of the enrolled patients received calcium supplements, in contrast to earlier trials of calcitonin replacement for osteoporosis. The company adds that it has an ongoing study looking at the use of its oral product alongside calcium supplementation, and preliminary data from this study have suggested that both the oral and intranasal products achieved significant changes in bone markers.
All the rights relating to the program have reverted to Unigene, which says it has now initiated discussions with third parties "that have expressed significant interest in completing the development of the oral calcitonin product." Unigene originally licensed rights to the drug to Warner-Lambert, which merged with Pfizer last year (Marketletters passim).
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