Biotech Values

[mcbio]

The point is even after anti-hypertension medication was adjusted, patients's blood pressure still went up at 6-month. What happens next 6-month, 6-month after that because RA is chronic disease?

I think it's clear we're never going to agree on RIGL. And that's okay. ; ) Blood pressure is very slightly up at the end of 6 months. I don't think it's a compounding effect as you seem to be suggesting. The 2-3 mm increase during the first month goes down after anti-hypertension medication is adjusted. That blood pressure increase on average stays down at that lower level and that's why you see only a 0.5-1.0 mm mean increase in blood pressure at the end of 6 months. If the blood pressure increase were some type of compounding effect, even after blood pressure medication adjustment, presumably it would be a lot higher than a miniscule 0.5-1.0 mm mean increase at the end of 6 months.

How long FDA would require for long term safety data when the risk is obviously there? How much do they have to rule out before approval? At this point, risk/benefit profile isn't that attractive to me.

I know management made the point before that Roche's Actemra is approved for RA even though it can cause an increase in blood pressure. Not sure if you have any thoughts on that. But, RIGL has guided for an NDA filing from AZN in 2013. AZN got very little requests from the FDA in terms of changes that needed to be made to the design of the Phase 3 trials. If the FDA had asked, or otherwise hinted at the need to run really long-term cardiovascular studies before even considering filing, I don't think we'd see guidance for a 2013 NDA filing. They have been running ongoing extension studies from earlier trials to monitor safety so I believe there have been patients on the drug for a few years (and again, to date, there has been absolutely no difference in cardiovascular outcomes in any arms) so by the time of the 2013 NDA filing, AZN/RIGL should have a safety database of at least 4 years or so on a bunch of patients. Either way, given that I am most concerned with the merit of RIGL as an investment, I think the overriding point is that the market is pretty much pricing in failure for the oral RA drug (or at least minimal expectations for success). And it's that reason that I am tempted to consider RIGL again.

They are too early. I haven't seen data to have opinion, or to put value on them.

The inhaled syk drug partnered with PFE is already in Phase 2 for chronic asthma. RIGL said it is as effective as steroids but works much quicker. They are testing the drug longer-term in the Phase 2 trials. They have enough cash on hand to support operations into 2013 and will be using that to move the many drugs in its pipeline (the JAK-3 drug for transplant rejection, the novel MS drug, etc.) through to PoC. I realize most will fail, as is the norm in biotech, but if just one of these succeeds, you're looking at another interesting opportunity above and beyond the oral RA drug.