Biotech Values

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Q1 2009 InterMune Earnings Call/PR Notes

Seeking Alpha Transcript: http://seekingalpha.com/article/134455-intermune-inc-q1-2009-earnings-call-transcript
8k: http://www.sec.gov/Archives/edgar/data/1087432/000119312509094436/d8k.htm
PR: http://phx.corporate-ir.net/phoenix.zhtml?c=100067&p=irol-newsArticle&ID=1282933&highlight=

191/HCV:
. ~35% of R&D budget
. 20 million milestone on initiation of Phase 2B
. Other partnered compounds in early stages of advancement but no detail on when to expect an IND. Excited about a couple in particular with differentiated characteristics. Goal of next-generation are improved PK, resistance profile or activity against various resistant mutants, et cetera.
. “Ritonavir-boosting is a theoretical option for any protease inhibitor or any compound to boost the activity. So it’s a possibility, but it’s something that we are not at liberty to disclose at this point.”

. INFORM (Please see EASL Call for more info #msg-37312942)
“70% of patients in the last two cohorts had levels of virus in their blood below the level of quantification by the diagnostic assay and 33% of these patients had no detectable virus in their blood.”
“the median baseline viral load in these two cohorts was in the range 2 million international units of HCV/RNA per ml of plasma or 2 times 6 logs. And the level of undetectability for the assay was 20 international units per ml, a median 5 log drop is the maximum effect that could have been delivered by any therapy before reaching the level of viral undetectability or the level below which the assay cannot detect additional log drops. In other words, the direct antiviral agent combination of 191 and 7128 in the INFORM study maximized the median viral load reduction that was possible in these two cohorts, more log drop was not possible. So these results are truly impressive.
no treatment related to serious adverse events, dose reductions or discontinuations.
no drug-drug interactions between the compounds.

Pirfenidone/IPF:
. Nothing new to report (expected at ATS) re differences in two CAPACITY studies. At ATS will provide more color. Webcast to go along with Dr. Paul Noble presentation
. 520 in preclinical models has better PK profile. Idea would be to fewer doses/reduced amount. Perhaps better tolerability as well.
. Talks to partner early stages, most interested in EU but open to other types of deals. Not necessarily going to do a deal (will only do if deem it favorable terms).
. No (current) plans to study Pirfenidone in other indications.

Milestones:
May 19, 2009: ATS Presentation of CAPACITY Results (company will have webcast as well)
Summer ’09: US NDA submission for Pirfenidone
Summer ’09: Initiate 191 Phase 2B
End ’09: EMEA MAA submission for Pirfenidone
Q4 ’09 (AASLD): Present data on additional INFORM cohorts
Q4 ‘09/Q1 ’10: 12 Week (RVR) data from 191 Phase 2B