PHARMACYCLICS - Ibrutinib - Promising to Deliver More
Our risk-reward analysis suggests that there is meaningful upside on positive PhIII data and approval of Ibrutinib (PCI-32765, PhIII, BTK inhibitor, partnered with JNJ, PhIII, CLL/SLL/PLL, MCL; PhII, DLBCL, MM, FL) in next two years. Ibrutinib, a winner in the making – oral, once-daily dosing, high degree of B-cell specificity, has demonstrated remarkable efficacy and safety profile: i) Tumor reduction (response) in heavily pretreated pts, ii) Responses in pts previously treated with chemotherapy and with aggressive disease, iii) Durable responses – many pts still on drug after prolonged period of time, and iv) Patient tolerability including lack of bone marrow damage. Ibrutinib is a best-in-class among leukemia drugs, showed durable efficacy in Tx-naïve (TN) and refractory (R/R) CLL and MCL pts as a monotherpay and in combination studies which suggests a mega buster sales potential.
