Company Overview of Pharmacyclics LLC
Pharmacyclics LLC focuses on developing and commercializing novel therapies for the treatment of cancer and immune-mediated diseases in the United States. The company markets IMBRUVICA, a first-in-class, oral, once-daily, single-agent therapy used for the treatment of patients with: chronic lymphocytic leukemia (CLL) who have received at least one prior therapy; all lines of CLL with deletion of the short arm of chromosome 17; mantle cell lymphoma who have received at least one prior therapy; and all lines of waldenström's macroglobulinemia (WM). Its products candidate in clinical development includes IMBRUVICA BTK inhibitor, which is under phase I, II, III clinical trials for the treatment ...
999 East Arques Avenue
Sunnyvale, CA 94085
Founded in 1991
Key Executives for Pharmacyclics LLC
Chairman and Chief Executive Officer
Chief Financial Officer, Principal Accounting Officer and Treasurer
Executive Vice President of Corporate Affairs
Compensation as of Fiscal Year 2015.
Pharmacyclics LLC Key Developments
Pharmacyclics LLC and Janssen Biotech Inc. Announce Submission of a Supplemental New Drug Application for IMBRUVICA (ibrutinib) for Treatment-Naive Chronic Lymphocytic Leukemia
Sep 14 15
AbbVie announced that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) based on the randomized, multi-center, open-label Phase III RESONATETM-2 (PCYC-1115) trial assessing the use of IMBRUVICA® (ibrutinib) versus chlorambucil in treatment-naive chronic lymphocytic leukemia (CLL) patients aged 65 years or older. AbbVie announced top-line findings from the trial in June 2015 showing that IMBRUVICA improved progression-free survival (PFS; primary endpoint) and multiple secondary endpoints including overall survival (OS) and overall response rate (ORR) in treatment-naive patients with CLL. IMBRUVICA is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie Company and Janssen Biotech Inc. IMBRUVICA is currently approved for the treatment of patients with CLL who have received at least one prior therapy and CLL patients (including treatment-naive) who have del 17p, a genetic aberration that occurs when part of chromosome 17, the location of the tumor suppressor gene p53, has been lost or deleted. The data have been submitted for publication in a peer-reviewed journal and presentation at an upcoming medical conference.
Pharmacyclics Announces Positive Top-Line Results from Phase III trial
Jun 5 15
Pharmacyclics has announced positive top-line results from a Phase III trial (RESONATE-2) investigating the safety and efficacy of Imbruvica (ibrutinib; 420 milligrammes) versus chlorambucil in treatment-nave chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) patients aged 65 years or older. The global, randomised, multi-centre, open-label study enrolled 269 patients and met its primary endpoint as measured by an improvement in progression-free survival (PFS), as well as multiple secondary endpoints of overall survival (OS)and an overall response rate (ORR) with Imbruvica compared with chlorambucil. The trial was designed under a special protocol assessment (SPA) agreement with the US FDA. Detailed results from the trial will be published in a peer-reviewed journal and presented at an upcoming medical meeting. The positive clinical trial results mark a milestone for AbbVie and its partner Janssen Biotech (subsidiary of Johnson & Johnson; J&J, US), as it is first to demonstrate head-to-head safety and efficacy versus chemotherapy in the clinical programme. Pharmacyclics' head of oncology Danelle James noted the transformative nature of the study that could replace cytotoxic chemotherapy as a first-line treatment for CLL in older patients with orally administered Imbruvica. The promising oncology drug is currently approved for the second-line treatment of CLL, or first-line treatment of CLL in patients with a 17p deletion, among other types of B-cell malignancies, such as Waldenstrom's acroglobulinaemia and mantle cell lymphoma. Expansion of the breakthrough therapy-designated drug's label to the first-line CLL setting will be good news for AbbVie and J&J; the partners share in the commercialisation of the drug in the United States. J&J retains rights for Imbruvica outside the US. The drug is being investigated as monotherapy or a combination regimen for a variety of haematological malignancies across 13 Phase III trials and 67 registered clinical trials in the US. AbbVie has acquired Pharmacyclics in 2015 for USD 21 billion, gaining access to Imbruvica that generated USD 548 million in global sales in 2014, with annual US sales anticipated to reach USD 1 billion this year 2015.
Pharmacyclics LLC Announces Ibrutinib Improves Survival for Treatment-Naive CLL Patients in RESONATE-2 Trial
Jun 4 15
Pharmacyclics LLC announced that ibrutinib or IMBRUVICA improved progression-free survival (PFS; primary endpoint) and multiple secondary endpoints including overall survival or OS and overall response rate (ORR) in treatment-naïve patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL, respectively) in the final analysis of the Phase III RESONATE-2 (PCYC-1115) trial. RESONATE-2 is a randomized, multi-center, open-label study assessing the use of ibrutinib versus chlorambucil in treatment-naïve CLL/SLL patients aged 65 years or older. This is the first head-to-head trial in the clinical program that evaluates the safety and efficacy of ibrutinib versus traditional chemotherapy. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech Inc. RESONATE-2 is a Pharmacyclics-sponsored trial and its protocol and specific performance goals were established in a special protocol assessment or SPA with the U.S. Food and Drug Administration.
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March 4, 2015