Novartis' annual R&D day highlights two ahead-of-schedule submissions to US FDA

At its annual R&D day, held in London, UK, Swiss drug major Novartis reported that a number of compounds were moving into pivotal trials. The drug candidates which are advancing into late-stage tests are: FTY720 (fingolimod) for multiple sclerosis; QAB149 (indacaterol) for chronic obstructive pulmonary disease and asthma; AG0178 (agomelatine) for depression; ABF656 (Albuferon) for hepatitis C; RAD001 (everolimus) for cancer; and SOM230 (pasireotide) for Cushing's disease.

Chief executive Daniel Vasella noted that the company has made several new submissions since January 2006. These include applications for new compounds, as well as new indications for medicines already available to patients throughout the world.

Dr Vasella noted that, in 2006, two US and European Union regulatory submissions were completed ahead of schedule: Tasigna (nilotinib) as a new treatment option for patients with resistance and/or intolerance to treatment with Gleevec/Glivec for certain forms of chronic myeloid leukemia; and Aclasta/Reclast (zoledronic acid) as a once-yearly bisphosphonate infusion for postmenopausal osteoporosis.