Will Biogen Win From Novartis MS Drug Safety Label Change?

An FDA communication was issued on Tuesday regarding the Novartis drug named Gilenya. Interestingly enough, Novartis shares were hardly lower on Tuesday. One of the reasons is that PML news has simply become an acceptable risk — and it was Biogen that took its own big valuation hit from PML cases years ago. Biogen shares were higher on Tuesday, but not by the same magnitude as might have been seen in years past.

The FDA report said:

FDA is warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Gilenya (fingolimod) for multiple sclerosis (MS). These are the first cases of PML reported in patients taking Gilenya who had not been previously treated with an immunosuppressant drug for MS or any other medical condition. As a result, information about these recent cases is being added to the drug label.

Gilenya is an immunomodulator shown to benefit patients with relapsing forms of MS. This type of MS causes attacks or relapses, which are periods of time when symptoms get worse. Immunomodulators alter the immune system to reduce inflammation. PML is a rare and serious brain infection caused by the John Cunningham (JC) virus. The JC virus is a common virus that is harmless in most people but can cause PML in some patients who have weakened immune systems, including those taking immunosuppressant drugs.

In an August 2013 Drug Safety Communication, FDA reported that a patient developed PML after taking Gilenya. PML could not be conclusively linked to Gilenya in this case because prior to Gilenya treatment the patient had been treated with an immunosuppressant drug that can cause PML and during Gilenya treatment the patient had received multiple courses of intravenous corticosteroids, which can weaken the immune system.

This is a good news vs. bad news situation for Biogen – and for Novartis.  The good news here is that PML is now nothing new. The bad news is that Biogen probably just wants to forget that there were ever problems and focus on growing its business ahead.

Novartis shares were down 0.75% at $103.60 in late-Tuesday trading. Biogen had an intraday pop higher that was short-lived, and its shares were up 2% at $330.50 late in the day. That gain is certainly better than nothing, but it just seems from an outsider’s view that PML is just a risk that comes with MS drugs.

For the record, Biogen shares were treated far worse when its first cases on PML were out. Still, there were fewer MS treatments then and that was a long time ago when Biogen was more dependent on that drug. It was also a time when MS patients were not used to knowing about the PML risk.