Saturday, December 08, 2007 6:40:33 PM
1-On a couple of occasions Dr. Porter strongly emphasized that based on what's been seen thus far it was extremely unlikely to have problems here is a quote from the Q3 call:
"I was as confident as I can be after a single-dose study that we were unlikely to have problems from, for example, those GI symptoms at the doses that we plan to study."
2-Sometime in 2008 we will likely hear more about InterMune's preclincal programs in Pulmonology and/or Hepatology. There are atleast 4 programs that have been alluded too (2nd generation Protease Inhibitor-Partnered with Roche with at least two families of compounds, 2nd target in Hepatology and multiple Pulmonology targets)
3-On several of the calls InterMune has made a point that if they generate a 2nd generation candidate to Roche that in addition to a similar package as 191 there would be an up-front payment to be negotiated and should Roche elect not to take the candidate forward InterMune can market it to someone else. My guess is this wouldn't happen. With what has been eluded too as advancing progress we may not be too far (year or so?) from this happening.
4-The Phase 1A had 64 volunteers, Vertex had just 24. One would wonder if InterMune really did a much wider and more thorough dose ranging study to be extra cautious. The 1B is comparable to Vertex (40 for 191 vs 36 for 950).
5-Given that dosing for the 1B was started at the end of September I think it is safe to say the first MAD has been completed and quite possibly the second and we may even already be in the third. Since there has been no PR/8-k I think it is safe to say the study has not been stopped. While this isn't a big deal it is a bit reassuring :).
6-While the company has been vague on when the 1B would be complete they have said a milestone from Roche would be received within 15 month. Since the deal was signed in October '06, 15 month puts it to January '07. What a coincidence :).
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