Attached files

file filename
EX-99.9 - PHARMACYCLICS INCex999to8k207380_11052012.htm
EX-99.4 - PHARMACYCLICS INCex994to8k207380_11052012.htm
EX-99.8 - PHARMACYCLICS INCex998to8k207380_11052012.htm
EX-99.6 - PHARMACYCLICS INCex996to8k207380_11052012.htm
EX-99.1 - PHARMACYCLICS INCex991to8k207380_11052012.htm
EX-99.2 - PHARMACYCLICS INCex992to8k207380_11052012.htm
EX-99.5 - PHARMACYCLICS INCex995to8k207380_11052012.htm
EX-99.7 - PHARMACYCLICS INCex997to8k207380_11052012.htm
EX-99.3 - PHARMACYCLICS INCex993to8k207380_11052012.htm
EX-99.12 - PHARMACYCLICS INCex9912to8k207380_11052012.htm
EX-99.18 - PHARMACYCLICS INCex9918to8k207380_11052012.htm
EX-99.15 - PHARMACYCLICS INCex9915to8k207380_11052012.htm
EX-99.10 - PHARMACYCLICS INCex9910to8k207380_11052012.htm
EX-99.16 - PHARMACYCLICS INCex9916to8k207380_11052012.htm
EX-99.13 - PHARMACYCLICS INCex9913to8k207380_11052012.htm
EX-99.14 - PHARMACYCLICS INCex9914to8k207380_11052012.htm
EX-99.17 - PHARMACYCLICS INCex9917to8k207380_11052012.htm
EX-99.11 - PHARMACYCLICS INCex9911to8k207380_11052012.htm
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): November 5, 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
xxx
(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.
 
Pharmacyclics, Inc. submitted eighteen abstracts to the American Society of Hematology (“ASH”) which summarize data on PCI-32765 and PCI-24781 to be presented at their annual meeting in Atlanta,GA from December 8 through 11, 2012.  On November 5, 2012, the ASH released such abstracts to the public by posting them on its website. The eighteen abstracts are:
 
 
·
Clinical ASH Presentations for BTK Inhibitor Ibrutinib (PCI-32765)
 
 
o
Interim Results of an International, Multicenter, Phase 2 Study of Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib (PCI-32765), in Relapsed or Refractory Mantle Cell Lymphoma (MCL):  Durable Efficacy and Tolerability with Longer Follow-up
 
o
The Btk inhibitor Ibrutinib in combination with rituximab is well tolerated and displays profound activity in high-risk Chronic Lymphocytic Leukemia (CLL) patients
 
o
The Bruton’s Tyrosine Kinase (BTK) Inhibitor Ibrutinib Promotes High Response Rate, Durable Remissions, and Is Tolerable in Treatment Naïve (TN) and Relapsed or Refractory (RR) CLL or SLL Patients Including Patients with High-Risk (HR) Disease: New and Updated Results of 116 Patients in a Phase Ib/II Study
 
o
The Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, has Preferential Activity in the ABC Subtype of Relapsed/Refractory de Novo Diffuse Large B-cell Lymphoma (DLBCL): Interim Results of a Multicenter, Open-label, Phase 2 Study
 
o
The Bruton’s Tyrosine Inhibitor Ibrutinib (PCI-32765) is Active and Tolerated in Relapsed Follicular Lymphoma
 
o
Early Changes in Cytokines, Chemokines and Indices of Bone Metabolism in a Phase 2 Study of the Bruton Tyrosine Kinase (Btk) Inhibitor, Ibrutinib (PCI-32765) in Patients with Relapsed or Relapsed/Refractory MM
 
o
A Phase I Trial of the Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib (PCI-32765), in Combination with Rituximab (R) and Bendamustine in Patients with Relapsed/Refractory Non-Hodgkin’s Lymphoma (NHL)
 
o
Rapid Decrease in Overall Tumor Burden On Ibrutinib (PCI-32765) in CLL Despite Transient Increase in ALC Indicates a Significant Degree of Treatment Induced Cell Death
 
o
Ibrutinib rapidly improves platelet counts in chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL) patients and has minimal effects on platelet aggregation

 
·
Clinical ASH Presentations for HDAC Inhibitor Abexinostat (PCI-24781)
 
 
o
A Phase II Multicenter Study of the Histone Deacetylase Inhibitor (HDACi) Abexinostat (PCI-24781) in Relapsed/ Refractory Follicular Lymphoma (FL) and Mantle Cell Lymphoma (MCL)
 
 
 

 
 
 
o
Abexinostat (S 78454), an oral Pan-Histone Deacetylase (HDAC) Inhibitor in patients with refractory or relapsed Hodgkin’s Lymphoma, non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia. Results of a Phase I dose-escalation study in 35 patients
 
 
·
Non-Clinical ASH Presentations
 
 
o
In vivo inhibition of BCR activation in high-risk CLL patients on therapy with Bruton’s tyrosine kinase inhibitor Ibrutinib: correlative studies from an ongoing Phase 2 clinical trial
 
o
In Vivo Effects of Ibrutinib on BCR Signaling, Tumor Cell Activation and Proliferation in Blood and Tissue-Resident Cells of Chronic Lymphocytic Leukemia Patients
 
o
Global inhibition of Bruton’s Tyrosine Kinase (Btk) Delays the Development and Expansion of Chronic Lymphocytic Leukemia (CLL) in the TCL1 Mouse Model of Disease
 
o
Ibrutinib Is an Irreversible Molecular Inhibitor of Interleukin-2 Inducible Kinase: Expanding Therapeutic Potential and Modulating a Th1 Selective Pressure in CD4 T-Cells
 
o
Bruton’s Tyrosine Kinase (BTK) Inhibitor Ibrutinib (PCI-32765) blocks hairy cell leukemia (HCL) survival, proliferation, and BCR signaling: a new therapeutic approach for HCL
 
o
Activity of Bruton’s Tyrosine Kinase (BTK) Inhibitor Ibrutinib (PCI-32765) in B-cell Acute Lymphoblastic Leukemia (B-ALL)
 
o
BTK Inhibition Targets In Vivo CLL Proliferation Through Its Effects On B-Cell Receptor Signaling Activity

 
The full text of the abstracts are attached to this Current Report on Form 8-K as Exhibits 99.1 through 99.18 and incorporated herein by reference.
 
The information in Item 7.01 of this Form 8-K, and the related exhibits, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act ”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
 
Item 9.01     Financial Statements and Exhibits.
 
(d)    Exhibits.
 
 
Exhibit No.
Description of Exhibits
 
99.1
 
Abstract - Interim Results of an International, Multicenter, Phase 2 Study of Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib (PCI-32765), in Relapsed or Refractory Mantle Cell Lymphoma (MCL):  Durable Efficacy and Tolerability with Longer Follow-up
 
 
 
2

 
 
99.2
 
Abstract - The Btk inhibitor Ibrutinib in combination with rituximab is well tolerated and displays profound activity in high-risk Chronic Lymphocytic Leukemia (CLL) patients
 
99.3
 
Abstract - The Bruton’s Tyrosine Kinase (BTK) Inhibitor Ibrutinib Promotes High Response Rate, Durable Remissions, and Is Tolerable in Treatment Naïve (TN) and Relapsed or Refractory (RR) CLL or SLL Patients Including Patients with High-Risk (HR) Disease: New and Updated Results of 116 Patients in a Phase Ib/II Study
 
99.4
 
Abstract - The Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, has Preferential Activity in the ABC Subtype of Relapsed/Refractory de Novo Diffuse Large B-cell Lymphoma (DLBCL): Interim Results of a Multicenter, Open-label, Phase 2 Study
 
99.5
 
Abstract - The Bruton’s Tyrosine Inhibitor Ibrutinib (PCI-32765) is Active and Tolerated in Relapsed Follicular Lymphoma
 
99.6
 
Abstract - Early Changes in Cytokines, Chemokines and Indices of Bone Metabolism in a Phase 2 Study of the Bruton Tyrosine Kinase (Btk) Inhibitor, Ibrutinib (PCI-32765) in Patients with Relapsed or Relapsed/Refractory MM
 
99.7
 
Abstract - A Phase I Trial of the Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib (PCI-32765), in Combination with Rituximab (R) and Bendamustine in Patients with Relapsed/Refractory Non-Hodgkin’s Lymphoma (NHL)
 
99.8
 
Abstract - Rapid Decrease in Overall Tumor Burden On Ibrutinib (PCI-32765) in CLL Despite Transient Increase in ALC Indicates a Significant Degree of Treatment Induced Cell Death
 
99.9
 
Abstract - Ibrutinib rapidly improves platelet counts in chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL) patients and has minimal effects on platelet aggregation
 
99.10
 
Abstract - A Phase II Multicenter Study of the Histone Deacetylase Inhibitor (HDACi) Abexinostat (PCI-24781) in Relapsed/ Refractory Follicular Lymphoma (FL) and Mantle Cell Lymphoma (MCL)
 
99.11
 
Abstract - Abexinostat (S 78454), an oral Pan-Histone Deacetylase (HDAC) Inhibitor in patients with refractory or relapsed Hodgkin’s Lymphoma, non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia. Results of a Phase I dose-escalation study in 35 patients
 
 
 
3

 
 
99.12
 
Abstract - In vivo inhibition of BCR activation in high-risk CLL patients on therapy with Bruton’s tyrosine kinase inhibitor Ibrutinib: correlative studies from an ongoing Phase 2 clinical trial
 
99.13
 
Abstract - In Vivo Effects of Ibrutinib on BCR Signaling, Tumor Cell Activation and Proliferation in Blood and Tissue-Resident Cells of Chronic Lymphocytic Leukemia Patients
 
99.14
 
Abstract - Global inhibition of Bruton’s Tyrosine Kinase (Btk) Delays the Development and Expansion of Chronic Lymphocytic Leukemia (CLL) in the TCL1 Mouse Model of Disease
 
99.15
 
Abstract - Ibrutinib Is an Irreversible Molecular Inhibitor of Interleukin-2 Inducible Kinase: Expanding Therapeutic Potential and Modulating a Th1 Selective Pressure in CD4 T-Cells
 
99.16
 
Abstract - Bruton’s Tyrosine Kinase (BTK) Inhibitor Ibrutinib (PCI-32765) blocks hairy cell leukemia (HCL) survival, proliferation, and BCR signaling: a new therapeutic approach for HCL
 
99.17
 
Abstract - Activity of Bruton’s Tyrosine Kinase (BTK) Inhibitor Ibrutinib (PCI-32765) in B-cell Acute Lymphoblastic Leukemia (B-ALL)
 
99.18
 
Abstract - BTK Inhibition Targets In Vivo CLL Proliferation Through Its Effects On B-Cell Receptor Signaling Activity

 
4

 
 
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.
 
November 6, 2012
 
 
PHARMACYCLICS, INC.
   
   
 
By:
/s/ Joshua T. Brumm
   
Name:
Joshua T. Brumm
   
Title:
Executive Vice President, Finance

 
5

 
 
Exhibit Index
 
Exhibit No.
Description of Exhibits
 
99.1
 
Abstract - Interim Results of an International, Multicenter, Phase 2 Study of Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib (PCI-32765), in Relapsed or Refractory Mantle Cell Lymphoma (MCL):  Durable Efficacy and Tolerability with Longer Follow-up
 
99.2
 
Abstract - The Btk inhibitor Ibrutinib in combination with rituximab is well tolerated and displays profound activity in high-risk Chronic Lymphocytic Leukemia (CLL) patients
 
99.3
 
Abstract - The Bruton’s Tyrosine Kinase (BTK) Inhibitor Ibrutinib Promotes High Response Rate, Durable Remissions, and Is Tolerable in Treatment Naïve (TN) and Relapsed or Refractory (RR) CLL or SLL Patients Including Patients with High-Risk (HR) Disease: New and Updated Results of 116 Patients in a Phase Ib/II Study
 
99.4
 
Abstract - The Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, has Preferential Activity in the ABC Subtype of Relapsed/Refractory de Novo Diffuse Large B-cell Lymphoma (DLBCL): Interim Results of a Multicenter, Open-label, Phase 2 Study
 
99.5
 
Abstract - The Bruton’s Tyrosine Inhibitor Ibrutinib (PCI-32765) is Active and Tolerated in Relapsed Follicular Lymphoma
 
99.6
 
Abstract - Early Changes in Cytokines, Chemokines and Indices of Bone Metabolism in a Phase 2 Study of the Bruton Tyrosine Kinase (Btk) Inhibitor, Ibrutinib (PCI-32765) in Patients with Relapsed or Relapsed/Refractory MM
 
99.7
 
Abstract - A Phase I Trial of the Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib (PCI-32765), in Combination with Rituximab (R) and Bendamustine in Patients with Relapsed/Refractory Non-Hodgkin’s Lymphoma (NHL)
 
99.8
 
Abstract - Rapid Decrease in Overall Tumor Burden On Ibrutinib (PCI-32765) in CLL Despite Transient Increase in ALC Indicates a Significant Degree of Treatment Induced Cell Death
 
99.9
 
Abstract - Ibrutinib rapidly improves platelet counts in chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL) patients and has minimal effects on platelet aggregation
 
99.10
 
Abstract - A Phase II Multicenter Study of the Histone Deacetylase Inhibitor (HDACi) Abexinostat (PCI-24781) in Relapsed/ Refractory Follicular Lymphoma (FL) and Mantle Cell Lymphoma (MCL)
 
99.11
 
Abstract - Abexinostat (S 78454), an oral Pan-Histone Deacetylase (HDAC) Inhibitor in patients with refractory or relapsed Hodgkin’s Lymphoma, non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia. Results of a Phase I dose-escalation study in 35 patients
 
 
 
6

 
 
99.12
 
Abstract - In vivo inhibition of BCR activation in high-risk CLL patients on therapy with Bruton’s tyrosine kinase inhibitor Ibrutinib: correlative studies from an ongoing Phase 2 clinical trial
 
99.13
 
Abstract - In Vivo Effects of Ibrutinib on BCR Signaling, Tumor Cell Activation and Proliferation in Blood and Tissue-Resident Cells of Chronic Lymphocytic Leukemia Patients
 
99.14
 
Abstract - Global inhibition of Bruton’s Tyrosine Kinase (Btk) Delays the Development and Expansion of Chronic Lymphocytic Leukemia (CLL) in the TCL1 Mouse Model of Disease
 
99.15
 
Abstract - Ibrutinib Is an Irreversible Molecular Inhibitor of Interleukin-2 Inducible Kinase: Expanding Therapeutic Potential and Modulating a Th1 Selective Pressure in CD4 T-Cells
 
99.16
 
Abstract - Bruton’s Tyrosine Kinase (BTK) Inhibitor Ibrutinib (PCI-32765) blocks hairy cell leukemia (HCL) survival, proliferation, and BCR signaling: a new therapeutic approach for HCL
 
99.17
 
Abstract - Activity of Bruton’s Tyrosine Kinase (BTK) Inhibitor Ibrutinib (PCI-32765) in B-cell Acute Lymphoblastic Leukemia (B-ALL)
 
99.18
 
Abstract - BTK Inhibition Targets In Vivo CLL Proliferation Through Its Effects On B-Cell Receptor Signaling Activity

 
 
 
7