PHARMACYCLICS, INC.
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(Exact Name of Registrant as specified in Charter)
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Delaware
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000-26658
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94-3148201
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(State or Other Jurisdiction
of Incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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995 E. Arques Avenue, Sunnyvale, California
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94085-4521
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(Address of Principal Executive Offices)
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(Zip Code)
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Registrant’s telephone number, including area code: (408) 774-0330
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(Former Name or Former Address, if Changed Since Last Report.)
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Item 8.01.
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Regulation FD Disclosure.
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·
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On December 5, 2014, the Company announced the launch of informCLL™, a large, observational, prospective registry that will explore the natural history of chronic lymphocytic leukemia (“CLL”), examine how IMBRUVICA® and other approved targeted therapies are being used to treat patients with CLL, and provide a comparison to treatments using conventional chemoimmunotherapy. The registry enrollment will begin in the first half of 2015.
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On December 6, 2014, the Company announced new Phase II data suggesting that IMBRUVICA® demonstrates anti-tumor activity both as a single-agent and as combination therapy in heavily pre-treated patients with relapsed or relapsed/refractory multiple myeloma.
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On December 8, 2014, the Company announced new IMBRUVICA® Phase II data that demonstrates its potential utility as a combination therapy when used with rituximab. The data suggests that the overall efficacy and safety profile of IMBRUVICA® is well tolerated when combined with rituximab in patients with relapsed or refractory mantle cell lymphoma (“MCL”). Additionally, data from a multi-center, Phase Ib/II trial also suggest that when IMBRUVICAâ and rituximab are combined in patients with relapsed CLL, short-term lymphocytosis, which sometimes is associated with IMBRUVICAâ treatment, decreased and patients experienced faster clearing of leukemia cells from the bloodstream versus patients who received IMBRUVICAâ alone.
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On December 8, 2014, the Company announced new, longer term data in IMBRUVICA® patients with relapsed/refractory CLL, including high-risk CLL patients with deletion 17p (del 17p). Results from the Phase III RESONATE™ (PCYC-1112) trial demonstrated an 84% progression-free survival (“PFS”) rate in all patients with previously treated CLL or small lymphocytic lymphoma who received IMBRUVICA® and a 94% PFS rate in patients who received only one prior therapy at 12 months. Separately, follow-up data was reported from Phase II RESONATETM-17 (PCYC-1117), the largest prospective trial dedicated to studying CLL or SLL patients with del 17p. The data showed that IMBRUVICAâ was associated with an 83% overall response rate (ORR) at a median follow up of 11.5 months. At 12 months, the estimated PFS was 79%.
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On December 8, 2014, the Company announced new, 27-month IMBRUVICA® median follow-up data which supports the use of IMBRUVICA® over longer periods of time in patients with relapsed/refractory MCL, an aggressive type of lymphoma. More than 30% of IMBRUVICA® patients remained progression-free after two years with no new or unexpected adverse events occurring during that time. Nearly half (47%) of the 111 patients treated were still living at the time of the data analysis. A second Phase II trial looked at IMBRUVICA®'s efficacy and safety as a single-agent treatment for MCL patients who previously had received rituximab combination therapy and at least two cycles of bortezomib.
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Exhibit No.
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Description
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99.1
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Press Release dated December 5, 2014: “Pharmacyclics Announces Launch of informCLL™ Registry for Chronic Lymphocytic Leukemia (CLL) Patients”
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99.2 |
Press Release dated December 6, 2014: “IMBRUVICA® (ibrutinib) Data Suggests Promise in Multiple Myeloma”
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99.3
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Press Release dated December 8, 2014: “IMBRUVICA® (ibrutinib) in Combination with Rituximab Data Shows Positive Benefit-Risk Profile in Hematologic Malignancy”
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99.4
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Press Release dated December 8, 2014: “Longer Follow-Up IMBRUVICA® (ibrutinib) Treatment Demonstrates Sustained Efficacy in Patients with Difficult-to-Treat Chronic Lymphocytic Leukemia (CLL)”
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99.5
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Press Release dated December 8, 2014: “IMBRUVICA® (ibrutinib) Data Demonstrates Safety and Durability of Response at Two-Year Follow-up in Mantle Cell Lymphoma”
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PHARMACYCLICS, INC.
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By:
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/s/ Manmeet Soni | |
Name: Manmeet Soni
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Title: Chief Financial Officer
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Exhibit No.
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Description
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99.1
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Press Release dated December 5, 2014: “Pharmacyclics Announces Launch of informCLL™ Registry for Chronic Lymphocytic Leukemia (CLL) Patients”
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99.2 |
Press Release dated December 6, 2014: “IMBRUVICA® (ibrutinib) Data Suggests Promise in Multiple Myeloma”
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99.3
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Press Release dated December 8, 2014: “IMBRUVICA® (ibrutinib) in Combination with Rituximab Data Shows Positive Benefit-Risk Profile in Hematologic Malignancy”
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99.4
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Press Release dated December 8, 2014: “Longer Follow-Up IMBRUVICA® (ibrutinib) Treatment Demonstrates Sustained Efficacy in Patients with Difficult-to-Treat Chronic Lymphocytic Leukemia (CLL)”
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99.5
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Press Release dated December 8, 2014: “IMBRUVICA® (ibrutinib) Data Demonstrates Safety and Durability of Response at Two-Year Follow-up in Mantle Cell Lymphoma”
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