Shares of Aspreva Pharmaceuticals slipped a bit this morning after the company and Roche announced that they would not be pushing ahead with a regulatory filing for CellCept, a new therapy for lupus nephritis. The therapy missed its late-stage primary endpoint--it was unable to demonstrate superiority to intravenous cyclophosphamide. There have been no new therapies [1]Â approved for lupus in the U.S. in more than 40 years.
-Â check out the announcement [2]
Related Articles:
Aspreva's CellCept fails late-stage superiority study. Report [3]
Aspreva Pharmaceuticals drug fails Phase III trial. Report [4]
CellCept wins orphan status. Report [5]
Links:
[1] http://www.fiercebiotech.com/story/developers-testing-new-therapies-for-lupus/2007-01-23?utm_source=related&utm_medium=internal
[2] http://www.fiercebiotech.com/press-releases/press-release-aspreva-provides-update-lupus-nephritis-development-program
[3] http://www.fiercebiotech.com/story/aspreva-s-cellcept-fails-late-stage-superiority-study/2007-06-27?utm_source=related&utm_medium=internal
[4] http://www.fiercebiotech.com/story/aspreva-pharmaceuticals-drug-fails-phase-iii-trial/2006-10-27
[5] http://www.fiercebiotech.com/story/spotlight-cellcept-wins-orphan-status/2006-01-04