Last $132.11 USD
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pharmacyclics inc (PCYC) Details

Pharmacyclics, Inc., a biopharmaceutical company, designs, develops, and commercializes small-molecule drugs for the treatment of cancer and immune mediated diseases in the United States and internationally. The company offers IMBRUVICATM as a single agent for the treatment of patients with chronic lymphocytic leukemia who have received at least one prior therapy. Its products candidate in clinical development includes IMBRUVICA BTK inhibitor, which is under multiple Phase I, II, III clinical trials for the treatment of naive and relapsed/refractory chronic lymphocytic leukemia, naive and relapsed/refractory diffuse large B-cell lymphoma, naive follicular lymphoma, relapsed/refractory mantle cell lymphoma, relapsed/refractory follicular lymphoma, relapsed/refractory multiple myeloma, Waldenstrom's macroglobulinemia, and relapsed/refractory marginal zone lymphoma. The company is also developing a BTK inhibitor lead optimization program, which is in Phase I clinical trials targeting anti-inflammatory and autoimmune indications; PCI-27483, an inhibitor of Factor VIIa that is in multiple Phase I, II clinical trials for the treatment of cancer; and PCI-24781, a HDAC inhibitor abexinostat, which is in multiple Phase I, II clinical trials for the treatment of relapsed/refractory lymphomas and solid tumors. The company’s clinical development and product candidates are small-molecule enzyme inhibitors designed to target key biochemical pathways involved in human diseases with critical unmet needs. It has a collaboration and license agreement with Janssen Biotech, Inc. to develop and commercialize ibrutinib and related compounds; collaboration and license agreement with Les Laboratoires Servier to develop and commercialize abexinostat; and license agreement with Novo Nordisk A/S to research and develop PCI-27483. Pharmacyclics, Inc. was founded in 1991 and is headquartered in Sunnyvale, California.

535 Employees
Last Reported Date: 11/7/14
Founded in 1991

pharmacyclics inc (PCYC) Top Compensated Officers

Chairman and Chief Executive Officer
Total Annual Compensation: --
Chief Financial Officer and Principal Account...
Total Annual Compensation: $541.1K
Chief Operating Officer
Total Annual Compensation: $849.2K
Executive Vice President of Corporate Affairs
Total Annual Compensation: $126.2K
Chief of Quality & Technical Operations
Total Annual Compensation: $704.3K
Compensation as of Fiscal Year 2013.

pharmacyclics inc (PCYC) Key Developments

Pharmacyclics, Inc. Announces New IMBRUVICA(R) (ibrutinib) Phase II Data

New IMBRUVICA(R) (ibrutinib) Phase II data announced by Pharmacyclics Inc. during the 56th American Society of Hematology (ASH) Annual Meeting suggests 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 (MM). IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech Inc. Data from an open-label, Phase II dose escalation trial evaluated potential IMBRUVICA dosing regimens either as a monotherapy or in combination with dexamethasone 40mg in the treatment of 69 heavily pre-treated (relapsed or relapsed/refractory) patients. Efficacy and safety were assessed at four-week intervals using the International Myeloma Working Group (IMWG) response criteria for efficacy results and Common Terminology Criteria for AEs (CTCAE) to evaluate safety. Heavily pre-treated patients (median of 4.5 prior lines of therapy) who received IMBRUVICA 840mg daily in combination with dexamethasone 40mg weekly (n=20) experienced the higher clinical benefit rate of 25%, including one partial response (PR) and four minor responses (MR). Also, an additional five patients (25%) showed sustained stable disease (SD; >4 cycles). IMBRUVICA-treatment in combination with dexamethasone resulted in positive responses and disease stabilization which led to a median progression-free survival (PFS) of 5.6 months. As a result of this trend toward improved efficacy and manageable toxicities, investigators expanded the treatment group per protocol design. Twenty-three additional patients are currently enrolled in this cohort; follow-up is ongoing. Based on these encouraging data, IMBRUVICA is currently being evaluated as a combination agent to treat relapsed/refractory multiple myeloma with agents such as carfilzomib. The safety profile of IMBRUVICA was tolerable, with similar AE rates across dosing cohorts. Across all cohorts, 57% of patients experienced Grade 3 or greater adverse events (AEs). The most commonly reported non-hematologic AEs of any grade were: diarrhea (51%); fatigue (41%); nausea (35%); dizziness (25%); and, muscle spasms (23%). Myelosuppression had an overall incidence of any grade anemia (29%), thrombocytopenia (23%), and neutropenia (7%), with 16%, 9% and 4% being Grade 3, respectively. Notably, there were no clinically meaningful differences among dose levels. 33% of patients experienced a treatment-emergent serious AE. At the time of data cut-off, four patients remained on treatment; the most common reason for treatment discontinuation in 47% was progressive disease.

Pharmacyclics Announces Launch of informCLL(TM) Registry for Chronic Lymphocytic Leukemia (CLL) Patients

Pharmacyclics Inc. announced the launch of informCLL(TM), a large, observational, prospective registry that will explore the natural history of chronic lymphocytic leukemia (CLL), examine how IMBRUVICA(R) (ibrutinib) and other approved targeted therapies are being used to treat patients with CLL, and provide a comparison to treatments using conventional chemoimmunotherapy (CIT). IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech Inc. and the registry is a joint effort between the companies. Registry enrollment will begin in the first half of 2015. The CLL registry will enroll more than 1,000 patients with CLL or small lymphocytic lymphoma (SLL) from community and academic institutions across the United States. Patients participating in the registry should have received treatment with at least one prior therapy or have been determined to have high-risk disease, such as 17p deletion (del 17p), a genetic mutation which occurs when part of chromosome 17 has been lost or deleted and is associated with poor treatment outcomes. Most patients will be receiving treatment with a targeted agent.

Pharmacyclics Inc. Announces the Acceptance of a Type II Variation Application for IMBRUVICA(R) (Ibrutinib) by the European Medicines Agency

Pharmacyclics Inc. announced the acceptance of a Type II variation application for IMBRUVICA(R) (ibrutinib) by the European Medicines Agency (EMA). This submission, filed by strategic partner Janssen-Cilag International NV (Janssen), represents a potential label expansion for IMBRUVICA in the European Union (EU) for the treatment of adult patients with Waldenstrom's macroglobulinemia (WM), a rare type of B-cell lymphoma for which treatment options are limited in the EU. If approved, IMBRUVICA would be the first label specifically authorized to treat WM. IMBRUVICA is a first-in-class, oral, once-daily, therapy being jointly developed and commercialized in the United States (U.S.) by Pharmacyclics and Janssen Biotech Inc. Janssen affiliates will hold the marketing authorization and market IMBRUVICA in EMEA (Europe, Middle East, Africa), as well as the rest of the world, outside the U.S. The acceptance of the WM Type II variation submission for IMBRUVICA triggers a $20 million milestone payment to Pharmacyclics under its collaboration agreement with Janssen Biotech Inc. The EMA WM filing follows the supplemental New Drug Application submission for IMBRUVICA to the U.S. Food and Drug Administration (FDA), which was submitted by Pharmacyclics in October 2014, for its use in the treatment of patients with WM. Both the FDA and EMA filings were based on data from a Phase II study evaluating the use of IMBRUVICA in WM patients, which was led by Dr. Steven Treon from the Dana-Farber Cancer Institute.


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