Leerink Swann Enigma

Analysts at Leerink Swann & Co. gave Biogen Idec (Nasdaq BIIB) an "outperform rating" for unclear reasons.

Note that my comments are unrelated to what I think (it is not a feeling -- I think patients and, even, doctors place too much personal feeling behind the medications to treat MS. MS is a diagnosis and medications are treatments. When they work for you -- or your patients -- great, but when they don't, it doesn't make them evil or CRAB. All it means is that you should work as the leader of your MS team to find a more suitable option for you -- remember, everything about MS is individualized, even the treatment) about Tysabri (natalizumab). Tysabri has great efficacy and tolerability data, but there are serious, if rare, potential infectious side effects.

The analyst writes, "...[g]iven Tysabri's generous suppression of CNS immunity, these events are not necessarily unexpected..." With most of the newer medications we are going to see a suppression, but that doesn't take away from the potential risks. Patient, carepartners, loved ones and neurologists are going to have to weigh risk vs. benefit, more than they have ever needed to in the past.

The MS community (and it is a community) has been lucky for the past 15 years -- we have had medications, which may be injectables, but have also been extremely safe. When we take or give these medications, we are not concerned about cancer, death or even serious life-threatening infections.

That is all changing -- Tysabri with PML, cladribine potentially with cancer (still unclear), fingolimod with cancers and life-threatening infections, teriflunomide's parent compound (leflunomide) with PML Campath with /itp /9idiopathic thrombocytopenic purpura) / other humoral autoimmune diseases, and the list goes on. BG0012 looks like it will be safer than the others, but it causes flushing and, most importantly has the inconvenience f being three times a day.

What are newly diagnosed multiple sclerosis patients going to do, when faced with the decision of four injectables and an oral medication. They may choose the "easy" orals, but they may also have responded to the older injectables (without the potentially life-threatening side effects). We physicians hate telling our patients that "you may not be doing as well as we would like, but you may have been worse without the medication." This may, however, be the closest we can come to predicitng patients' outcome (until we reach the holy grail of biomarkers). In my opinion, the MS community should come together to make educational programs for the newly diagnosed, highlighting the excellent safety and relative good efficacy of the older medications. I am fearful that new members of the community will be blind-sighted by the seductive sirens of oral medications.

The analyst goes on to say that, "... [n]otably, there appears to be a geographic clustering of these cases suggesting the risk of these events ex-Germany may be lower than the global rate would suggest...." I am unsure why that is relevant and how you can make such a statistical inference from a small sample size (expected to increase, but 10 at the current time). This may be intellectually disingenuous and unfair to casual, unwitting investors. This is akin to predicting and estimating the rate of PML with a constantly moving numerator (with a much faster rate than the denominator).

So what does this mean and should you buy or sell Biogen Idec or Elan stocks?



Maybe it depends if you are German or not and, alternatively, maybe it doesn't.


--
Dr. Daniel Kantor, MD BSE
Medical Director
Neurologique