CP: US$ 75.55
TP: US$ 90
CAP: US$ 5.5b
Third breakthrough designation for ibrutinib
C/JNJ received a breakthrough therapeutics designation for ibrutinib as a monotherapy for the treatment of CLL/SLL
patients with the 17p chromosome deletion, a high risk subset that responds well to ibrutinib. PCYC/JNJ is conducting a
patient study in
CLL patients with the 17p deletion (RESONATE). The designation provides a potential faster to market
regulatory path. This is the third indication to receive this designation; the other two were Waldenstrom's macroglobulinemia
(WM) and relapsed/refractory
mantle cell lymphoma (MCL).
Regulatory update expected at ASCO in June. We anticipate that PCYC will provide more specific guidance regarding
timing of regulatory filings and clinical trial implications of the breakthrough designation at ASCO.
ongoing: The ongoing SPARK trial is in patients that have failed Velcade. We expect this will support a broader
label including both Velcade failures and Velcade naïve patients based on the breakthrough designation.
Catalysts: WM data at 2013 ASCO, potent
ial 17p CLL data (RESONATE) and MCL data likely at 2013 ASH.
Valuation. Our $90 target assumes a launch in MCL in Q3:14, off
label use in CLL, and modest value for the Waldenstrom's
opportunity. Our valuation could go higher if the fNHL opportunity is bet
ter defined or if PCYC demonstrates efficacy in
myeloma. Longer treatment duration or substantial penetration of prevalence markets could drive higher estimates