JP Morgan 26th Annual Healthcare Conference Notes
Pulmonology/Pirfenidone
. Subtle change to no longer saying December/January but just January
. Think rapid uptake for a new IPF therapy. More reliable diagnostic tools (HRCT), consensus guidelines, patient referral and advocacy networks, growing government and political recognition
. Beyond Orphan many IP filings (acquired anti-Fibrotic and TNF-Alpha patents with Marnac deal)
. All milestones and royalties eliminated in Marnac deal. 80% of total cost only paid if successful. Unique situation at Marnac led to opportunity to consolidate and took advantage of it.
. Starting to give more details on registration and commercialization strategy (Project late '09 and Early '10 if favorable data to reach US and EU respectively). Estimate 85 person US sales force, modest advertising and promotion. x-US still undecided.
HCV/191
. In Q1 top-line viral kinetic and safety results from at least 3 naive cohorts.
. More Full data from all cohorts reported in spring conference DDW or EASL
. Continue to state believe 191 has superiority potential.
. Emphasized combination therapy.
1. Synergy of 191 with Pegasys in vitro (prior info.) expect to see same type of synergy
2. Phase 1B Monotherapy not helpful in knowing best dose in triple therapy.
3. Believe regimens in front have opportunity to improve open the tolerability and think as they go to Phase 3 more apparent
4. Talked about synergy of Pharmasset polymerase in combo therapy.
. Emphasized outstanding safety and tolerability thus far. "Frankly unfounded speculation around 191 and that pressure valve was released yesterday" (take that Adam F. et. al. :))
. Continue getting dose escalation to get dose response data in case need it later. In parallel submit to EU authorization for triple combination study to begin in Q2
. Tolerability crucial to us.
. Exclusive provider of protease inhibitors to Roche
