5/3/11 cc notes
1. Opening remarks ( by Rich Levy)
Rux NDA and MAA in June; NDA expected to receive 6 month review; currently preparing for expected advisory meeting; launch later this year
Best of ASCO presentation with cc follow-up in evening
Both Comfort abstracts to be presented in Europe
Rux MF - - initiated low platelet count trial
Rux advanced PV - - most US sites active; NVS enrolling
Other Rux P1 , P2 - - other leukemias, other hematological malignancies, solid tumors with COG and MD Anderson
Rux pancreatic and lymphoma - - both 2nd ½ 2011
RA - - LLY to complete enrollment by 2nd ½ 2011
Sheddase - - analysis of tissue samples mid-year to determine whether to proceed with P3
IDO - - P1 solid tumors; dose escalation complete by year-end; also, melanoma and ovarian likely for P2
CMET - - trying to find maximum tolerated dose
Another oncology IND coming
Cash 3/31/11 = 383 M
2. q & a - - all rux, unless noted
(i ) plans for commercial buildout? NVS role? 1st to market advantage? - - hiring regional managers and salespeople by 3rd q; working on global brand name; allows us to shape and define market for 2-3 years
(ii) what are physicians most focused on? - - spoke to > 1000; thrombocytopenia, shrink spleen by 10%, relief of symptoms, efficacy, manage side effects; anemia not a focus
(iii) comfort 1 patients remain on drug? - - vast majority; minimal dropout rate
(iv) technology used for sustained release(SR) version? Once a day? - - smoother profile; lower peak; need more than 1 trial to get to market; protect market base against future once a day competitor; greater compliance
(v ) ASCO and EHA presentations different? - - no
(vi) RA - - thoughts on PFE’s deaths? JAK1/2 vs pan JAK profiles? - - unsure; our JAK trials have older patients with CV diseases and we haven’t seen CV problems; RA patients at more risk for CV disease in general; encouraged by PFE’s efficacy and safety profile; we haven’t seen heart disease or respiratory failures; doesn’t know whether JAK1/2 vs pan JAK makes a difference
(vii) PV - - enrollment in Response study? - - working with US academic centers; NVS sites enrolling; running slightly behind year-end start goal
(viii) CMET milestone for what? - - no direct answer
(ix) rux pricing ? - - no direct answer
(x) NVS have expanded access in Europe? - - not sure; after they file, some countries will have
(xi) SR formulation show benefit for myelosuppression? - - no
(xii) NVS use US data to file? - - yes
(xiii) dosing for low platelet study? - - 5 mg BID not as effective as high dose; 10 mg BID almost as effective
(xiv) what will be the most successful dose for low platelet count patients? - - expect 10 mg BID
(xv) those patients who get thrombocytopenia, are they more sensitive to the drug or is it their starting point? - - starting point
(xvi) other data in addition to ASCO or EHA? - - no
3. impressions
solid call; highlights were: best at ASCO; no heart disease or respiratory failures seen
sales
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