Biotech Values

[biotech jim]

slides posted suvorexant

I listened to the call re suvorexant, and I make the following observations:

Interesting that in the reported studies that WASO (wake after sleep onset) was consistent at months 1, 2 and 3 in a 3 month study, but that LPS (latency to persistent sleep) was reduced at 3 months compared to 1 and 2 months.

A small fatigue signal was observed in the 009 study.

In response to a question, one of the presenters stated that scheduling will not be a differentiator, prob because all current sleep drugs are schedule 4 and docs are used to this. Scheduling will take place during/after the review by the CNS big wigs at the FDA.

Another question was will MRK perform a head to head study with a GABAergic? Difficult to do since no GABAergic is approved for chronic use.

Another question regarding next day effects off of drug (I commented on this earlier today)? There is a small signal, but they did a driving safety study and apparently nothing was seen, a real life driving study not a simulated driving study. Will be interesting to see that data.

In response to anther question, of the current sleep market, 30% of patients are chronic insomniacs and they account for 60% of the current scrips.

Another question regarded other potential indications of dual orexin receptor antagonists. MRK has a back up compound MK-6096. They are studying that compound in 3 indications (Different compound for different indications due to pricing and other reasons.) These are described in clincaltrials.gov

a) Diabetic neuropathic pain

b) Migraine prevention

c) Adjunct to antidepressant drugs where efficacy is insufficient