7/28/11 cc notes
1. Opening remarks
Rux NDA submitted 6/3; has verbally confirmed that it has been granted priority review and PDUFA date is 12/3
NVS submitted rux MAA in june
Finalizing distribution network and patient assistance program
Response advanced PV trial behind schedule - - in dialogue with FDA; study protocol to be amended to accelerate enrollment; proposed keeping dual endpoints of phlebotomy independence and spleen size reduction; reduce study size; relax entry criteria
Other rux trials, especially P2 pancreatic study that was initiated this month
050 P2b is on track and 3 month placebo controlled phase of trial expected to complete in early ‘12
Sheddase 7839 - - still analyzing
IDO and cMet inhibitors continue in P1; haven’t reached MTD for either compound; future IDO trial 1st ½ ’12 in metastatic melanoma or advanced ovarian
Cash 6/30/11 - - 364 M
2. q & a
( i) revised PV study because of lower market opportunity or overly stringent enrollment criteria? - - latter; if amended, will go back to recruit same patients; high screen failure rate; relatively easy fix
(ii) how long to gain agreement to amend study? - - have to revise SPA; doesn’t see it dragging on; if agreed to quickly, will not change guidance for when study will be completed
(iii) why are people failing screening process? - - one example - - patients are phlebotomy dependent and have big spleens; criteria say that have to have either or both elevated white blood cell counts or elevated platelet counts; but many patients don’t meet all these criteria
(iv) how did this criteria screwup happen? - - no direct answer
(v) have to go thru new SPA process? - - it’s an amendment to a protocol - - perhaps 45 days
(vi) label indication would be the same? - - new potential label will increase patient population
(vii) re: rux NDA, will there be an advisory panel? - - haven’t been notified, but preparing for one
(viii) how soon after approval would you launch rux? - - 10 days
(ix) any guidance from NVS re: rux advisory panel? - - none to date
(x) any guidance from NVS re: rux launch? - - we handle US and we talk to them re: common interests
(xi) 050 3 month data? - - it will be up to LLY as to when to release, PR or medical meeting
(xii) re: PV, still optimistic that can be done under SPA? - - yes
(xiii) re: sheddase, commercial analysis now part of decision? - - 2 new treatments have emerged; wants to see if market still there
(xiv) ASCO transfusion independence criteria, any progress on standard guidelines? - - new guidelines would make sense
(xv) post approval requirements for rux? - - durability, probably not survival-related
(xvi) rux payor mix? - - medicare 40%; self-pay 12%; Medicaid 5%; commercial pay 43%
(xvii) what will rux price be? - - no direct answer; probably ~ 60 k; could be higher
(xviii) are all PV sites recruiting now? - - they are waiting on revised criteria; the sites are OK
(xix) comparable products to rux? - - gleevec, tasigna, sprycel, sutent, etc.
(xx) anticipated uptake of rux? - - slow and steady
(xxi) what % of potential rux US patients are severe, moderate, mild ? - - 1/3 each
(xxii) PV screen failures, thinking of getting rid of intolerant of HU? - - that would help some, but the white blood cell/platelet count is bigger issue
(xxiii) P2 PV data, 2/3 of patients titrated dose lower than 10 mg BID. Same expectation for P3? What’s the impact on pricing vis-à-vis MF pricing? - - 10 mg BID will be starting dose; titration will still occur; flat pricing regardless of strength
(xxiv) communicated with CMS yet? - - more important for infused products, not oral ones
(xxv) rux P2 pancreatic pre-clinical activity? - - in mice
(xxvi) P1 / 2 rux data for other hematological cancers? - - ASH ‘12
(xxvii) share count? - - 190 M
3. impressions
sounded like the rux NDA and launch are in good shape; we’ll see how easily it will be to recover from PV screwup; surprised that, after ASCO, no one called him re: his bombastic statement : “I will guarantee you that there is no difference( in transfusion independence between us and Cytopia)”
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