Executive Summary

Novartis announces the submission of NDAs for the oncologic Tasigna (nilotinib) and osteoporosis therapy Aclasta (zoledronic acid infusion) during its annual pipeline update Nov. 28 in London. The company had been predicting 2007 filings for both applications (1Pharmaceutical Approvals Monthly May 2006, p. 3). The Tasigna application, filed in both the U.S. and Europe, seeks an indication for treatment of chronic myeloid leukemia; Novartis also announced a global nilotinib expanded access program called ENACT that will be available to eligible patients in all phases of Philadelphia chromosome-positive CML who are resistant to or intolerant of Novartis' Gleevec (imatinib). Novartis seeks to differentiate Aclasta in the crowded osteoporosis market with its once-yearly administration and complete range of claims for "vertebral, both clinical and non-clinical vertebral diagnosed by x-ray, as well as hip and non-vertebral sites," Global Pharma Development Head James Shannon told investors...