Company Overview of Pharmacyclics Inc.
Pharmacyclics, Inc., a biopharmaceutical company, 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 cl...
999 East Arques Avenue
Sunnyvale, CA 94085
Founded in 1991
Key Executives for Pharmacyclics Inc.
Chairman and Chief Executive Officer
Chief Financial Officer, Principal Accounting Officer and Treasurer
Executive Vice President of Corporate Affairs
Compensation as of Fiscal Year 2014.
Pharmacyclics Inc. Key Developments
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.
Pharmacyclics LLC Highlights Results from a Sub-Analysis of the Phase III RESONATE™ (PCYC-1112) Trial
May 31 15
Pharmacyclics LLC highlighted results from a sub-analysis of the Phase III RESONATE™ (PCYC-1112) trial, which found that previously-treated patients with chronic lymphocytic leukemia (CLL) who adhered to the recommended 420 mg dose of IMBRUVICA® (ibrutinib) experienced improved progression-free survival (PFS; the primary endpoint) as assessed by an Independent Review Committee (IRC), compared to patients who took lower doses or missed doses, regardless of high-risk genetic factors. The data will be presented at the 51st American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL at 8:00 a.m. CT. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech Inc. The poster provides insights from the RESONATE trial specific to the importance of adhering to the recommended 420 mg once-daily dose of IMBRUVICA in previously-treated CLL patients (n=195). After 8.3 months of treatment, patients treated with IMBRUVICA had a mean dose intensity – defined as the proportion of actually administered versus planned doses of IMBRUVICA 420 mg – of 95% (median 100%). The majority of dose interruptions restarted at 420 mg; 3.6% of patients experienced one dose reduction and 0.5% experienced two dose reductions due to adverse events (AEs). Notably, the recommended 420 mg dose was associated with longer PFS rates (median not reached) compared to those patients who took lower doses (11 months), regardless of high-risk factors including del 17p, del 11q or p53 mutations. Patients who consistently missed their IMBRUVICA dose for eight or more consecutive days experienced more events compared to patients who did not experience such dose holds (31% vs. 13%, respectively). The mean duration of missed doses in patients who missed more than one week of therapy was 26 days.
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