Biotech Values

[DewDiligence]

NVS concludes Gilenya safety update with modified FDA and EMA labels:

http://www.sec.gov/Archives/edgar/data/1114448/000110465912026649/a12-10059_36k.htm

The updated FDA label for Gilenya indicates that all patients initiating treatment with Gilenya should have an electrocardiogram (ECG) prior to the first dose of the medicine and after the six-hour first-dose observation period in addition to hourly measurement of blood pressure and heart rate. Additionally, specific initiation guidance for patients is now provided to better aid healthcare providers. Further, there are revised recommendations on how to re-initiate therapy should Gilenya be interrupted.

The changes to the EMA label are similar but not quite identical to the FDA changes and are described in http://www.sec.gov/Archives/edgar/data/1114448/000110465912026647/a12-10059_46k.htm .

Bottom line: NVS still expects Gilenya to be a very big-selling drug.