Pharmacyclics, Inc. (PCYC) Tops Q1 EPS Views; Updates on IMBRUVICA

Pharmacyclics, Inc. (NASDAQ: PCYC) reported Q1 EPS of $0.40, $0.23 better than the analyst estimate of $0.17. Revenue for the quarter came in at $119.4 million versus the consensus estimate of $105.38 million.

Clinical Update

IMBRUVICA clinical trials are active in all regions including US, Europe, Asia Pacific, Canada and Latin America. Currently IMBRUVICA™ is being developed in 8 different B-cell malignancies. There are 11 Phase III clinical trials initiated with IMBRUVICA™ and a total of 43 trials are registered on www.clinicaltrials.gov, of these 21 are in combination with standards of care and 22 are as single agents. Total planned enrollment for all these studies is approximately 7,500 patients participating in IMBRUVICA™ trials. As of today there are 7 Phase III studies focused on patients with CLL, two designed for patients with MCL, one for patients with diffuse large B-cell lymphoma and one for patients with follicular lymphoma. To date, over 3,000 patients have been treated in company sponsored trials, conducted in over 35 countries around the globe and involving more than 800 principal investigators

During the first quarter of 2014 we dosed our first patient in a Phase I Rheumatoid Arthritis trial with our BTK inhibitor for auto-immune indications. We are anticipating preliminary data from this trial by the end of the year 2014.

The company participated in the 105th American Association for Cancer Research (AACR) Meeting (Harnessing Breakthroughs – Targeting Cures) in April 2014. During the conference, IMBRUVICA™ was presented in 1 mini-symposium, 3 oral sessions and 6 posters. Highlights from the meeting include two pre-clinical presentations on IMBRUVICA™'s impact in Graft-vs-host disease (GvHD) and HER-2 positive Breast Cancer, both of which support future clinical studies.

The company also announced in April that at the American Society of Clinical Oncology (ASCO) 50th Annual Meeting in Chicago, Illinois May 30 - June 3, 2014 there will be two oral presentations. Our first Phase III data from the PCYC-1112 (RESONATE™) study of single agent IMBRUVICA™ (ibrutinib) vs. ofatumumab, an established therapy in relapsed refractory CLL, which will be highlighted in the ASCO press briefing, a distinction given to less than 1% of all presentations.

The additional oral presentation shows data from an Independent Efficacy Evaluation of IMBRUVICA™ (ibrutinib) after three years of long-term follow-up in patients with CLL. In addition the company will present three poster presentations of clinical data of IMBRUVICA™ (ibrutinib). It includes an update of a Phase Ib/II Study evaluating IMBRUVICA™ (ibrutinib) in combination with Ofatumumab in Patients with CLL/SLL. There will also be a review of resistance mutations, which are uncommon for patients on IMBRUVICA™ (ibrutinib). Additionally preliminary safety and efficacy data of IMBRUVICA™ (ibrutinib) in patients (pts) with hairy cell leukemia (HCL) will be reviewed. IMBRUVICA™ is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc.

IMBRUVICATM (ibrutinib) – Selected Clinical Trial Updates

Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma (CLL/SLL)

• RESONATE™ (PCYC-1112): Phase III study of IMBRUVICA™ versus ofatumumab in patients with relapsed/refractory (R/R) CLL/SLL was initiated in the second quarter of 2012. This is a randomized, multi-center, open-label Phase III trial of IMBRUVICA™ as a monotherapy. This 391 patient study met its primary end point of PFS as well as a key secondary endpoint of overall survival at the pre-planned interim analysis in January 2014. We have filed the study data with the FDA in April 2014 and expect a review by the agency to be completed within the first half of 2015.
• RESONATE™-17 (PCYC-1117): Open label, single arm, Phase II study of IMBRUVICA™ as a mono-therapy in patients with CLL who have deletion of chromosome 17p and who did not respond to or relapsed after at least one prior treatment (a high unmet need population) was initiated in the first quarter of 2013. The primary endpoint of the study is overall response rate (ORR). This global study completed its enrollment of 145 patients in Q3 of 2013, more than two quarters ahead of schedule. Patients will be followed for 12 months after the enrollment of the last patient for an assessment of ORR.
• RESONATE™-2 (PCYC-1115): Phase III study of IMBRUVICA™ versus chlorambucil in newly diagnosed elderly CLL/SLL patients was initiated in the first quarter of 2013. This is a randomized, multicenter, open-label trial of IMBRUVICA™ as a monotherapy versus chlorambucil in patients 65 years or older with treatment naïve CLL/SLL. The study design was agreed upon with the FDA under a Special Protocol Assessment (SPA). The primary objective of the study is to demonstrate a clinically significant improvement in PFS when compared to chlorambucil. Pharmacyclics has completed enrollment of 273 patients worldwide in January 2014, approximately 9 months ahead of the original schedule. A data read out is anticipated in the second half of 2015.
• HELIOS (CLL3001): Phase III study of IMBRUVICA™ in combination with bendamustine and rituximab in patients with R/R CLL/SLL was initiated in the third quarter of 2012. This is a randomized, multi-center, double-blinded, placebo-controlled trial of IMBRUVICA™ in combination with bendamustine and rituximab versus placebo in combination with bendamustine and rituximab (BR) in R/R CLL/SLL patients who have received at least one line of prior therapy. The primary objective of the study is to demonstrate a clinically significant improvement in PFS when compared to bendamustine and rituximab. This study completed enrollment of 578 patients worldwide in Q1, 2014.
• BRILLIANCE (CLL3002): Phase III study of IMBRUVICA™ versus rituximab in patients with R/R CLL/SLL was initiated in the fourth quarter of 2013. This is a randomized, open-label, multi-center study to evaluate the efficacy and safety of versus rituximab in adult Chinese patients with R/R CLL or SLL with active disease requiring treatment, who have failed at least 1 prior line of therapy and are not considered appropriate candidates for treatment or retreatment with purine analog-based therapy or combination chemo-immunotherapy. The primary objective of the study is to demonstrate a clinically significant improvement in PFS. The enrollment target of this study is 150 patients.
• Third party sponsored: Phase III study of IMBRUVICA™ versus IMBRUVICA™ + rituximab versus bendamustine + rituximab in frontline newly diagnosed elderly (> 65 Years of Age) CLL/SLL patients (Alliance A041202) was initiated by the National Cancer Institute in the fourth quarter of 2013. This is a randomized, multi-center study designed to evaluate the improvement in PFS of IMBRUVICA™ with or without rituximab vs bendamustine and rituximab. Secondary outcome measures include overall survival and duration of response. The enrollment target of this multi-center study is 523 patients, enrollment initiated during the first quarter 2014.
• Third party sponsored: Phase III study in treatment naive, young fit patients with CLL, comparing the combination of IMBRUVICA™ and Rituxan to chemo immunotherapy of FCR (fludarabine, cyclophosphamide, and rituximab), (ECOG1912), was initiated by the Eastern Cooperative Oncology Group in the first quarter of 2014. This is a randomized study designed to evaluate the improvement in PFS of IMBRUVICA™ with rituximab vs FCR. Secondary outcome measures include overall survival and adverse events. The enrollment target of this multi-center study is 519 patients.
• Third party sponsored: Phase III study in untreated, intermediate and high-risk patients with CLL, comparing monotherapy IMBRUVICA™ to placebo or no therapy, (CLL12), was initiated by the German Study Group in the first quarter of 2014. This is a randomized study designed to evaluate the improvement in event-free survival (EFS) of IMBRUVICA™ vs. watch and waiting. Secondary outcome measures include ORR and PFS. The enrollment target of this multi-center study is 302 patients.

Mantle Cell Lymphoma (MCL)

• RAY (MCL3001): Phase III study of IMBRUVICA™ versus temsirolimus in R/R MCL patients was initiated in the fourth quarter of 2012. This is a randomized, multi-center, open-label trial of IMBRUVICA™ as a monotherapy versus temsirolimus in R/R MCL patients who received at least one prior rituximab-containing chemotherapy regimen. The primary endpoint of the study is PFS. The enrollment target of this global study was 280 patients. This trial completed enrollment in Q4 of 2013.
• SHINE (MCL3002): Phase III study of IMBRUVICA™ in combination with BR in elderly patients with newly diagnosed MCL was initiated in the second quarter of 2013. This is a randomized, multi-center, double-blinded, placebo-controlled trial of IMBRUVICA™ plus BR versus placebo plus BR in patients 65 years or older with newly diagnosed MCL. The primary endpoint of the study is PFS. The enrollment target of this global study is 520 patients.

Diffuse Large B-cell Lymphoma (DLBCL)

• PHOENIX (DBL3001): Phase III study of IMBRUVICA™ in combination with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in patients with newly diagnosed non-GCB subtype of DLBCL was initiated in the third quarter of 2013. This is a randomized, multi-center, double-blinded, controlled trial of IMBRUVICA™ plus rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) versus R-CHOP in patients with newly diagnosed non-GCB subtype DLBCL. The primary endpoint of the study is to demonstrate a clinically significant improvement in event-free survival when compared to R-CHOP. The enrollment target of this global study is 800 patients.

Follicular Lymphoma (FL)

• PCYC 1125: Phase II multicenter, open-label, study of IMBRUVICA™, in combination with Rituximab in previously untreated subjects with follicular lymphoma was initiated in the fourth quarter of 2013. The primary endpoint of this study is overall response rate. The enrollment target of this study is 80 patients.
• DAWN (FLR2002): Phase II study of IMBRUVICA™ in patients with R/R FL was initiated in the second quarter of 2013. This is a multi-center, open-label, single-arm, global trial of IMBRUVICA™ in patients with chemoimmunotherapy-resistant FL, whose disease has relapsed from at least 2 prior lines of therapy, including at least 1 rituximab combination chemotherapy regimen. The primary endpoint of this study is overall response rate. The enrollment target of this global study is 110 patients.
• SELENE (FLR3001): Phase III study of IMBRUVICA™ in patients with R/R indolent Non-Hodgkin's Lymphoma (iNHL) was initiated in the first quarter of 2014. This is a randomized, multi-center, placebo-controlled Phase III trial of in combination with either BR or R-CHOP in patients with previously treated indolent Non-Hodgkin Lymphoma (iNHL). The primary endpoint of this study is progression free survival. The enrollment target of this global study is 400 patients.

Marginal Zone Lymphoma (MZL)

• PCYC-1121: Phase II study of IMBRUVICA™ in patients with R/R marginal zone lymphoma was initiated in the fourth quarter of 2013. This is a multi center, open-label, monotherapy study to evaluate the safety and efficacy of IMBRUVICA™ in patients with R/R marginal zone lymphoma. The primary endpoint of this study is overall response rate and the enrollment target of this study is 60 patients.

Waldenstrom's Macroglobulinemia (WM)

• Third party sponsored: Phase II study of IMBRUVICA™ in patients with R/R Waldenstrom's Macroglobulinemia was initiated in the second quarter of 2012. This is a multicenter, open label study of monotherapy IMBRUVICA™ in patients with WM who failed at least one prior therapy. The primary endpoint of this study is ORR. The study will also assess the safety and tolerability of IMBRUVICA™ as well as progression-free survival. This study is sponsored by the Dana-Farber Cancer Institute and completed enrollment of 63 patients with data recently presented at ASH 2013 and included in the "Best of ASH".

Multiple Myeloma (MM)

• PCYC-1111: Phase II study of IMBRUVICA™ in patients with R/R multiple myeloma was initiated in the first quarter of 2012. This is a Phase II, multi-center, open-label trial designed to assess the safety and efficacy of IMBRUVICA™ as a single agent and in combination with dexamethasone in patients with R/R MM. At this time, an expansion of cohorts 1, 2 and 3 (420mg, 560mg with dexamethasone, and 840mg) is not planned due to the fact that the protocol-defined response rate was not achieved. The Company is expanding the fourth dosing cohorts (840mg with dexamethasone) as it crossed a minimum pre-defined boundary of efficacy. The clinical development focus of IMBRUVICA™ in this indication will be in combination therapies.
• PCYC-1119: Phase I/IIb study of IMBRUVICA™ in combination with carfilzomib in patients with R/R MM was initiated in the third quarter of 2013. The Phase I portion of this study is a dose escalation study designed to assess the safety and recommended Phase IIb dose of IMBRUVICA™ and carfilzomib. The Phase IIb portion will be a randomized, double-blind, placebo controlled study to evaluate the efficacy of IMBRUVICA™ and carfilzomib versus carfilzomib and placebo. The primary endpoint of the Phase IIb portion of the study is progression-free survival. The enrollment target of this study is 176 patients.

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