8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 22, 2012

PHARMACYCLICS, INC.
(Exact name of registrant as specified in its charter)
Delaware	000-26658	94-3148201
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)
995 E. Arques Avenue, Sunnyvale, California		94085-4521
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (408) 774-0330

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 7.01 Regulation FD Disclosure.

On May 22, 2012, Pharmacyclics, Inc., a Delaware corporation (the “Company”), announced that clinical abstracts on Bruton’s Tyrosine Kinase inhibitor, ibrutinib (formerly, PCI-32765) have been selected for oral presentations at the 17th Congress of the European Hematology Association (EHA), June 14-17, 2012 in Amsterdam, The Netherlands.

The Company plans to issue a material update on the ibrutinib clinical development program and its results in a press release after the EHA oral presentations.

The foregoing description is qualified in its entirety by reference to the Company’s Press Release dated May 22, 2012 attached hereto as Exhibit 99.1 and copies of the abstracts, copies of which are attached hereto as Exhibit 99.2 and Exhibit 99.3, and are incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d)           Exhibits.

Exhibit No.	Description
99.1	Press Release dated May 22, 2012.
99.2	Abstract:  The Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib (PCI-32765) is Highly Active and Tolerable in Relapsed or Refractory (R/R) and Treatment Naïve (TN) Chronic Lymphocytic Leukemia (CLL) Patients, Updated Results of a Phase Ib/II Study
99.3	Abstract:  Combination of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib with Bendamustine and Rituximab is Active and Tolerable in Patients with  Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL), Interim Results of a Phase Ib/II Study

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Current Report on Form 8-K to be signed on its behalf by the undersigned hereunto duly authorized.

May 22, 2012

PHARMACYCLICS, INC.
By:	/s/ Rainer M. Erdtmann
	Name: Rainer M. Erdtmann
	Title: Vice President, Finance & Administration and Secretary

EX-99.1

Exhibit 99.1

Pharmacyclics Announces Oral Presentations of Ibrutinib (PCI-32765) at the 17th Congress of the European Hematology Association

Sunnyvale, CA., May 22, 2012 -- Pharmacyclics, Inc. (NASDAQ: PCYC) today announced that clinical abstracts on Bruton’s Tyrosine Kinase inhibitor, ibrutinib (formerly, PCI-32765) have been selected for oral presentations at the 17th Congress of the European Hematology Association (EHA), June 14-17, 2012 in Amsterdam, The Netherlands.

The update on data presented specifically includes: 1) updated safety and efficacy data, including progression free survival, from the phase Ib/II CLL single agent trial in relapsed or refractory and treatment naïve patients (PCYC-1102-CA); 2) safety and efficacy data from the phase Ib CLL combination trial with bendamustine and rituximab in relapsed or refractory patients (PCYC-1108-CA). Pharmacyclics plans to issue a material update on the ibrutinib clinical development program and its results in a press release after the EHA oral presentations.

Oral Presentation at EHA, Amsterdam, The Netherlands (June 14-17, 2012)

Date/Time: Saturday, June 16, 2012; 8:00 AM – 8:15 AM CET

Location: Elicium 1

Abstract # 1970: The Bruton's Tyrosine Kinase Inhibitor Ibrutinib (PCI-32765) is Highly Active and Tolerable in Relapsed or Refractory and Treatment Naïve Chronic Lymphocytic Leukemia Patients, Updated Results of a Phase Ib/II Study.

Dr. Susan M. O'Brien et al. MD Anderson Cancer Center, Houston, Texas.

Oral Presentation at EHA, Amsterdam, The Netherlands (June 14-17, 2012)

Date/Time: Saturday, June 16, 2012; 8:15 AM – 8:30 AM CET

Location: Elicium 1

Abstract # 1590: Combination of the Bruton's tyrosine kinase inhibitor PCI-32765 with bendamustine/rituximab in patients with relapsed/refractory chronic lymphocytic leukemia: Interim results of a phase Ib/II study.

Dr. Jennifer Brown et al. Dana-Farber Cancer Institute, Boston, Massachusetts.

Ibrutinib is an oral first-in-class, selective, irreversible Bruton's tyrosine kinase (BTK) inhibitor being investigated for its potential in treating patients with chronic lymphocytic leukemia, mantle cell lymphoma, diffuse large B cell lymphoma, follicular lymphoma, and multiple myeloma, all of which are considered B-cell malignancies.  Ibrutinib is being jointly developed by Pharmacyclics, Inc. and Janssen Biotech, Inc.

About Pharmacyclics

Pharmacyclics® is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. Our mission and goal is to build a viable biopharmaceutical company that designs, develops and commercializes novel therapies intended to improve quality of life, increase duration of life and resolve serious unmet medial healthcare needs; and to identify promising product candidates based on scientific development expertise, develop our products in a rapid, cost-efficient manner and pursue commercialization and/or development partners when and where appropriate.

Presently, Pharmacyclics has three product candidates in clinical development and several preclinical molecules in lead optimization. We are committed to high standards of ethics, scientific rigor, and operational efficiency as we move each of these programs to viable commercialization.

The Company is headquartered in Sunnyvale, California and is listed on NASDAQ under the symbol PCYC. To learn more about how Pharmacyclics advances science to improve human healthcare visit us at http://www.pharmacyclics.com.

Contact:

Ramses Erdtmann

Vice President of Finance

Phone: 408-215-3325

EX-99.2

Exhibit 99.2

The Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib (PCI-32765) is Highly Active and Tolerable in Relapsed or Refractory (R/R) and Treatment Naïve (TN) Chronic Lymphocytic Leukemia (CLL) Patients, Updated Results of a Phase Ib/II Study

SUSAN O'BRIEN, MD, MD,RICHARD R. FURMAN, MD, STEVEN E. COUTRE, MD, JAN A. BURGER, MD, PHD, KRISTIE A. BLUM, MD, JEFF SHARMAN, MD, IAN W. FLINN, MD, PHD, BARBARA GRANT, MD, NYLA A. HEEREMA, PHD, AMY J. JOHNSON, PHD, TASHEDA NAVARRO, DANELLE JAMES, MD, ERIC HEDRICK, MD, AND JOHN C. BYRD

Background: BTK is an essential mediator of B-cell receptor signaling and a critical kinase for lymphoma cell survival.  Ibrutinib (PCI-32765), an oral, selective, irreversible inhibitor of BTK, inhibits proliferation, migration and adhesion in CLL cells.  The combination of fludarabine, cyclophosphamide and rituximab have markedly improved outcomes of younger-fit patients in the first and second-line setting.  However, effective salvage regimens for patients who develop treatment resistance are lacking.  Fludarabine-based therapy, while effective is toxic and carries significant risk of morbidity and mortality in elderly pts.  Patients who relapse following fludarabine-based regimens and older CLL patients represent a high priority for new therapeutic approaches.   A multi-cohort Phase Ib/II trial evaluated 2 doses of single-agent ibrutinib in TN and R/R CLL/SLL patients.   Aims: The primary objective was to determine the safety of 2 dose regimens.  Secondary objectives were to assess the preliminary efficacy, PK, and long-term safety.  Methods:  Patients with R/R CLL who had failed at least 2 lines of therapy (including a purine analog) and TN CLL patients >65 years old were treated with oral ibrutinib at doses of 420mg or 840mg administered daily for 28-day cycles until disease progression (PD).   Results: The data cut-off for R/R patients was 10/25/11 and 12/10/11 for TN patients.61 patients were enrolled to the R/R cohorts- 27 patients (420mg) and 34 patients (840mg).31 patients were enrolled to the TN cohorts- 26 patients (420mg) and 5 patients (840mg). The 840mg TN cohort was terminated after comparable activity and safety between doses was shown in R/R patients.  Median age was 64 and 71 years for R/R and TN patients respectively.   59% of R/R and 61% of TN patients had baseline cytopenias consistent with advanced stage disease. Unmutated IgVH was present in 79% of R/R and 43% of TN patients. Del17p was present 36% (R/R) and 6% (TN) of patients. The majority of AEs have been Gr<=2 in severity, most commonly diarrhea, nausea, and fatigue.  Hematologic toxicity >= G3 was infrequent.   Response (ORR; PR + CR) by IWCLL criteria in the 420mg R/R cohort was 67% with 12.6 months median follow-up. In the 840mg R/R cohort ORR is 68% at 9.3 months median follow-up. An additional 22%, and 24% of patients in these R/R cohorts, respectively, achieved a nodal response with residual lymphocytosis (NodR).  With 10.7 months median follow-up the ORR in the 420mg TN cohort is 73% including 8% CRs with morphologically normal marrows.    With only 4.6 mo median follow-up, ORR in the 840mg TN cohort is 40%. An additional 12%, and 20% of patients in these TN cohorts, respectively, achieved a NodR.  ORR was independent of high-risk factors. Estimated 12 month PFS for those pts treated at 420 mg dose is 88% for R/R patients and 93.3% for TN patients.  Conclusions:  PCI-32765 is highly active and well tolerated in R/R and elderly TN CLL patients. No differences in activity or toxicity were noted between the two dose levels.  The high ORR and very low PD rate indicate that ibrutinib warrants further study in CLL.

EX-99.3

Exhibit 99.3

Combination of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib with Bendamustine and Rituximab is Active and Tolerable in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL), Interim Results of a Phase Ib/II Study

Jennifer R. Brown, Jacqueline Barrientos,  Ian W. Flinn,  Paul Barr, Jan Burger, Tasheda Navarro, Danelle F. James, Eric Hedrick, Jonathan W. Friedberg, Susan O'Brien,

Background:  Bruton's Tyrosine Kinase (BTK) is an essential mediator of B cell receptor signaling and a critical kinase for lymphoma cell survival.  Ibrutinib (PCI-32765), is an oral, selective, irreversible inhibitor of BTK, that inhibits proliferation, migration and adhesion in CLL cells.  Single agent ibrutinib administered to relapsed/refractory CLL patients was highly active as evidenced by an IWCLL overall response rate (ORR) of 67% and estimated 12 month PFS of 86% (O’Brien ASH 2011). Bendamustine (B) and rituximab (R) (BR) is also active in relapsed/refractory CLL patients with an ORR of 59% and median PFS of 15 months (Fischer JCO 2011).  We report interim data on the combination of ibrutinib with BR.  Aims:  The primary objective of the study is to evaluate the safety of ibrutinib in combination with BR administered to relapsed or refractory CLL patients.  The secondary objective is to estimate the efficacy of the combination.  Methods: Relapsed/refractory CLL patients received ibrutinib 420 mg orally daily for 28-day (D) cycles (C) until disease progression (PD). B was administered 70 mg/m2 on D1 and D2 combined with R 375 mg/m2 on D0 for C1 and 500 mg/m2 on D1 for subsequent courses for a maximum of 6 cycles.  Response was evaluated according to IWCLL criteria. Results: 30 patients were enrolled. The median age of patients was 62 yrs (range 41-82).  46% of patients were Rai stage III/IV and the median # of prior therapies was 2 (range 1-4).  37% and 13% were considered refractory (treatment free interval <12 mo) to a purine analog containing regimen or BR, respectively. Bulky disease (lymph nodes >= 5 cm) was present in 52% of patients.  Adverse events (AE) have been generally consistent with that expected with BR. Gr 3/4 neutropenia and thrombocytopenia have been noted in 47% and 10% of patients, respectively.   Grade >=3 non-hematologic AEs potentially related to ibrutinib included rash (3 pts) and fatigue and tumor lysis reported in 2 pts each.  There were no Gr 3/4 infusion reactions.  SAEs occurred in 10% of patients including one aforementioned case of TLS, one cellulitis, and one neutropenic fever. There have been no discontinuations due to AEs and no deaths on study. At a median follow-up of 4.9 mos (range 2.7-8.3 mo) 16 patients have completed BR (median 6 cycles, range 2-6) and 14 patients are still receiving BR.  The ORR is 90% (27/30 patients) (CR 10%, PR 80%). 2 additional patients achieved a nodal response with residual lymphocytosis.  Responses appear independent of high-risk features. 90% of patients remain on study; reasons for discontinuation include PD (n=2) and 1 pt pursuing SCT.   Conclusions: Ibrutinib, administered in combination with BR, is safe and highly active. The high ORR, low rate of PD, and good tolerability compare very favorably with historical controls, warranting additional investigation of this combination.