Some notes from the InterMune Wachovia call today
I'll try to update the ReadMe First after the February 8th Q4 Call. I also caught the Vertex call and on first listen heard a couple things encouraging (for InterMune longs). One in particular was the mention about combining with possibility of combining with other PI in earlier stage of development [read into it what you will].
• Pirfenidone trial “currently enrolling and enrolling well”
• 191 in Phase 1 studies as we speak, proof of concept data in 2007, February 8th give more in terms of timing
• Number of research projects in pulmonary and hepatology and we look forward to advancing other products from that effort in the future.
• We were very encouraged by that [Shionogi] news.
• Actimmune today is actually a little higher now but about 60K per year.
• Composition of matter for Actimmune expires 2022 in US. Orphan drug in US and Europe. US and Canadian rights.
• Pirfenidone world-wide rights (excluding Japan, Korea and Taiwan). Method of use patent expires 2011 and have Orphan drug. Relying on it for exclusivity in US and Europe.
• Recently announced top-line results in PR of Phase 3, very encouraging for us. About 250 patients. Primary end-point was VC. Did disclose a significant effect vs. placebo. Did not disclose P value, InterMune knows but not allowed to disclose.
• Number of patients roughly same (we are running 2 trials), dosing different but on mg/kg are very similar (our 800 similar to their 600 on Japanese population), change in percent predicted vs. vital capacity (modest differences; measure lung capacity).
• Phase 1A initiated in December and Mfg milestone in January. Significant since complex molecule and showed able to produce relevant quantities for study.
• Next 8-9 months should get another 25 million.
• Are working with Roche to develop follow on compounds and similar financial terms.
• 170 million in cash + 60 million Roche up-front + 10 million January – Q4 burn.
• Note due 2011, in money (21.63) low coupon rate. Well position there.
• 33 million outstanding, 41 fully diluted. Shelf of 175 million filed.
• February 8th financial results and 2007 guidance and discuss milestones for R&D programs (191 and other programs). Pirfenidone capacity enrollment expected to be completed in 2nd half of year.
• [Question] What we said is there are 2 interim looks (for efficacy). Very specific about not saying when/if they occurred just saying they have very specific efficacy stopping boundaries.
• [Question] Shionogi planning to file end of march (what said publicly). Not disclosed when they plan to present or further disclose data from trial. We have data sharing so do or will have access to data but unable to comment. Will use it to inform our own trial.
• [Question] Haven’t talked much to manufacturing aspect. Are encouraged by progress as is Roche. Key issue since complexity of molecule. Confident we can solve issues and made great progress. Certainly for trials/needs ahead of us can support that.
• [Question] Material for Phase 1 produced much earlier. Material looking ahead to completing Phase 1 and beyond. Material for Phase 1 produced well before December.
• [Question] There are additional deliveries scheduled. Achieved certain scale with production that was important achievement with the milestone.
• [Question] Phase 1A/Phase 1B Study. Proof of concept data this year. More information on February 8th.
