A little late but for the curious here it is. Readme to follow.
Q2 2007 InterMune Earnings Call Notes
[most of the content is either a direct quote or paraphrasing something that was side items in brackets are additional observations]
Pirfenidone
. Study conduct of the CAPACITY program has been excellent, notably a very low rate of patient
dropouts have been observed to date after over fifteen months since the first patient was enrolled
191/Hepatology
. Have toxicology programs and studies up to 28 days. [no cardio tox, BI program had in 28 day animal studies]
1A Observations
. A significantly higher than anticipated plasma level of InterMune 191 was seen in patients, in dose cohorts where the drug was administered with food. We did explore the food effect purposely in the single ascending dose study. It was not explored at all doses, but at a selection of doses. And, yes, the results were consistent.
. Plasma levels of 191 were observed in all dose groups in the SAD study
. Range of potentially efficacious doses to examine in the multi-dose Phase Ib study identified. Doses in this range
were well tolerated in the SAD study.
. All adverse events reported in subjects receiving 191 were mild in severity, short-lived, and resolved spontaneously without intervention.
. No serious adverse events were reported in the SAD study.
1B Design
. We plan to administer 191 for a period of 14 days to three ascending dose cohorts of treatment naïve chronic hepatitis C patients infected with HCV genotype 1. Twice per day and three times per day dosing regimens will be studied. And the study may be expended to additional cohorts of treatment naive patients based on results from the first three planned cohorts. In addition, a single cohort of non-responder patients is planned.
. Will be dosing with food. We have said repeatedly that the food effect was not something we expected to see. And I think it is fair to say, again, we didn't expect it, because we hadn't seen it in animal models. And I think it is fair to say that that was one of the most important observations in terms of thinking about the changes.
. We really don't want to find ourselves in a situation where we're in the middle, or partially through Phase II and have to go back and sort of approach exploring different doses or differing dosage intervals. And that has happened in some instances with other therapeutic ongoing in HCV. I would just throw that out as one example of we would like to go into Phase II pretty sure that we are encompassing the range of doses and dose schedules that we want to look at.
. On dosing changes in amendment - we didn't discuss specifically what doses we were looking at previously... will just say that for the reasons that we have talked about we did move lower.
. Initial top-line data expected in Q1 2008
Financials
. Entered revised supply agreement with Boehringer Ingelheim no longer have 91.6 million in minimum purchases over next five years. 5.5 million paid to BI in 2007 to restructure agreement.
. Total revenue in the second quarter of 2007 was $25.4 million, Actimmune revenue was $14.5 million
. 2007 R&D expense expected to be in a range of approximately $100 million to $110 million, net of development cost
reimbursements under the Roche collaboration
. G&A expense expected to be in a range of $25 million to $35 million.
. $15 million more in milestone expected from Roche (15 month from when original deal signed by Roche). [Puts it around Q1 2008]
