ARNA and VVUS

Well, the day is nearly at hand for Vivus.

No, not the FDA PDUFA date, but the Advisory Committee meeting about its drug Qnexa. The briefing docs (http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM218824.pdf) were released this morning in preparation for the meeting on Thursday. Investors were expecting an easy efficacy review and a searching safety evalaution. They got what they expected and therefore VVUS is up today. Arena is trailing along, up slightly in sympathy.

I do not know much about VVUS. I want to emphasize I've been following ARNA and not VVUS, so the data I know is imcomplete. However, being me, a couple comments are always in order.

I looked at the safety review summary on pages 3-6 and although it most headlines seem to indicate a relatively benign safety review, it looks bad. Suicidal thoughts, birth defect potential, and this (regarding topiramate, one of the two drugs Qnexa is comprised of):

"associated, in a dose-related manner, with an increased incidence of cognitive-associated adverse events including confusion, psychomotor slowing, difficulty with concentration/attention, and difficulty with memory, speech or language problems, particularly word-finding difficulties."

Hmmm, one less plate of pasta, or fumbling for the right word?

It will certainly be black-boxed for pregnant women, and have strong language for those who may become pregnant.

I think ARNA will get approval by itself, but this market seems to favor VVUS right now. I am considering buying puts on VVUS, as the AC meeting is right before options expiration. They carry quite a premium, so I have no specific strike price in mind - just something to think about.

Regards,
Trond