pharmacyclics inc (PCYC) Key Developments
Pharmacyclics Inc. Announces European Medicines Agency Issues Positive Opinion, Recommends Full Approval of IMBRUVICA® (ibrutinib) to Treat Waldenstrom's Macroglobulinemia
May 22 15
Pharmacyclics Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending a change to the terms of the marketing authorization for IMBRUVICA® (ibrutinib) in the European Union to indicate the treatment of adult patients with Waldenström's macroglobulinemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.1 WM is a rare, slow growing form of blood cancer.2 IMBRUVICA is also the first and only FDA-approved treatment for WM in the United States.3 The CHMP recommendation follows the January 2015U.S. Food and Drug Administration (FDA) full approval of IMBRUVICA to treat all lines of patients with WM. IMBRUVICA is jointly developed and commercialized in the United States by Pharmacyclics and Janssen Biotech Inc. In Europe, Janssen-Cilag International NV (Janssen) holds the marketing authorization and its affiliates market IMBRUVICA in EMEA (Europe, Middle East, Africa), as well as the rest of the world. IMBRUVICA is already approved in Europe to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL) and adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy or in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy. WM currently affects approximately 23,000 patients in the G7 countries (United States, France, Germany, Italy, Japan and the United Kingdom).3 The CHMP recommendation was based on a multi-center, Phase II study that evaluated the efficacy and tolerability of IMBRUVICA in 63 patients with previously treated WM. Initial data from the study submitted for review in the EU showed an overall response rate (ORR) of 87.3% after a median duration of treatment of 11.7 months.
Pharmacyclics Inc. Announces Unaudited Consolidated Earnings Results for First Quarter Ended March 31, 2015
May 1 15
Pharmacyclics Inc. announced unaudited consolidated earnings results for first quarter ended March 31, 2015. For the quarter, the company reported total revenue of $205,772,000, income from operations of $3,781,000, income before income taxes of $4,233,000, net income of $4,147,000 or $0.05 per diluted share, non-GAAP net income of $33,970,000 or $0.43 per diluted share compared to the total revenue of $119,377,000, income from operations of $18,225,000, income before income taxes of $18,263,000, net income of $18,275,000 or $0.23 per diluted share, non-GAAP net income of $31,261,000 or $0.4 per diluted share for the same quarter a year ago.
Pharmacyclics Inc.(NasdaqGS:PCYC) dropped from NASDAQ Biotechnology Index
Apr 20 15
Pharmacyclics Inc. will be removed from NASDAQ Biotechnology Index.
Pharmacyclics, Inc. Announces Initiation of PCYC-1135-CA, Multi-Center Study
Apr 1 15
Pharmacyclics Inc. announced the initiation of PCYC-1135-CA, a multi-center study that will investigate the use of ibrutinib (IMBRUVICA®) in combination with MEDI4736, an investigational, anti-PD-L1 immune checkpoint inhibitor being developed by AstraZeneca. The Phase Ib/II study will examine the safety, tolerability and effectiveness of this investigational combination in individuals with relapsed or refractory (R/R) non-small cell lung cancer (NSCLC), breast cancer, and pancreatic cancer. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech Inc. The Phase Ib portion of the study will primarily seek to determine the safety, tolerability, and appropriate dose of ibrutinib when combined with MEDI4736 to treat individuals with these cancers. The Phase II portion of the study will be conducted in three distinct cohorts to determine the safety and effectiveness of the treatment combination in individuals with R/R NSCLC, breast and pancreatic cancers. The clinical study will aim to enroll approximately 160 subjects at approximately 20 sites in the U.S.
Pharmacyclics Inc. Announces New Pre-Clinical and Clinical Data for ibrutinib (IMBRUVICA)
Mar 19 15
Pharmacyclics Inc. announced that new pre-clinical and clinical data for ibrutinib (IMBRUVICA®) will be highlighted at the 2015 American Association for Cancer Research (AACR) Annual Meeting to be held April 18 " 22, 2015, in Philadelphia, PA. Several company-sponsored and investigator-initiated abstracts have been accepted for presentation as oral and poster sessions highlighting data in solid tumor and blood cancers. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech Inc. Long-term treatment with single-agent ibrutinib 420 mg leads to durable responses including complete responses in CLL (Abstract CT132) Clinical Trials Minisymposium. IMBRUVICA (ibrutinib) is a first-in-class, oral, once-daily therapy that inhibits a protein called Bruton's tyrosine kinase (BTK).1 BTK is a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells.1,2 IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.