SUNNYVALE, Calif., Dec. 12, 2014 /PRNewswire/ -- Pharmacyclics, Inc. (NASDAQ: PCYC) today announced that it has been awarded BayBio’s 2014 Pantheon DiNA Award for Outstanding Company for its rapid development and commercialization of IMBRUVICA® (ibrutinib). The award was presented at BayBio’s 11th Annual Pantheon DiNA Awards ceremony in San Francisco.
BayBio, the Northern California affiliate of the Biotechnology Industry Association (BIO), represents 1,000 life sciences companies and institutions in Northern California. The Outstanding Company Award is given through an independent nomination and selection process to one company each year that has made the greatest advancement in and/or the greatest overall contribution to the Northern California life sciences industry in the prior year. Pharmacyclics was selected for the award due to its exceptional success with IMBRUVICA in a relatively short amount of time.
“We are honored to be recognized for the hard work and dedication of our team who made the rapid development and commercialization of IMBRUVICA possible,” said Bob Duggan, Chairman & CEO, Pharmacyclics. “We also thank the clinicians with whom we partnered, the thousands of patients who have participated in our clinical trials, our strategic partner Janssen, and the U.S. Food and Drug Administration for the important roles they all have played so that we could bring forward such a transformative therapy in near record time.”
IMBRUVICA received its first approval by the U.S. Food and Drug Administration (FDA) in November 2013 and has received two additional approvals within a nine-month period. In addition, IMBRUVICA was one of the first medicines to receive U.S. FDA approval via the new Breakthrough Therapy Designation pathway, and is the only product to have received three Breakthrough Therapy Designations. IMBRUVICA is already approved in 37 countries and a worldwide registration strategy is currently being pursued.
Pharmacyclics also was awarded the 2012 BayBio Pantheon DiNA Award for Outstanding Partnering.
IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc.
About IMBRUVICA®
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.1
IMBRUVICA is approved for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, and for the treatment of CLL patients with del 17p,1 a genetic mutation that occurs when part of chromosome 17 has been lost.
IMBRUVICA is also approved for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Accelerated approval was granted for the MCL indication based on overall response rate (ORR). Improvements in survival or disease-related symptoms have not been established. Continued approval for the MCL indication may be contingent upon verification of clinical benefit in confirmatory trials.1
IMBRUVICA is being studied alone and in combination with other treatments in several blood cancers including chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), Waldenstrom’s macroglobulinemia (WM), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and multiple myeloma (MM). Over 4,600 patients have been treated in clinical trials of IMBRUVICA conducted in 35 countries by more than 800 investigators. Currently, 13 Phase III trials have been initiated with IMBRUVICA and 55 trials are registered on www.clinicaltrials.gov. The overall clinical development program in CLL currently includes seven Phase III trials and covers all lines of therapy and various combinations of treatments.
IMBRUVICA was one the first medicines to receive U.S. FDA approval via the new Breakthrough Therapy Designation pathway, and is the only product to have received three Breakthrough Therapy Designations.
INDICATIONS
IMBRUVICA is indicated to treat people with:
- Chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.
- Chronic lymphocytic leukemia (CLL) with 17p deletion (a genetic mutation that occurs when part of chromosome 17 has been lost).
- Mantle cell lymphoma (MCL) who have received at least one prior therapy
- Accelerated approval was granted for this indication based on overall response rate. Improvements in survival or disease-related symptoms have not been established. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.
Patients taking IMBRUVICA for CLL should take 420 mg taken orally once daily (or three 140 mg capsules once daily).
Patients taking IMBRUVICA for MCL should take 560 mg taken orally once daily (or four 140 mg capsules once daily).
Capsules should be taken orally with a glass of water. Capsules should be taken whole. Do not open, break, split or chew the capsules.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions include hemorrhage, infection, cyptopenias, atrial fibrillation, second primary malignancies, and embryo-fetal toxicity.
The most common adverse reactions include thrombocytopenia, diarrhea, neutropenia, anemia, fatigue, musculoskeletal pain, peripheral edema, upper respiratory tract infection, nausea, bruising, dyspnea, constipation, rash, abdominal pain, pyrexia, vomiting, and decreased appetite.
For additional important safety information, please see Full Prescribing Information at http://www.imbruvica.com/downloads/Prescribing_Information.pdf.
About Pharmacyclics
Pharmacyclics®, Inc. (NASDAQ: PCYC) is a biopharmaceutical company focused on developing and commercializing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. The company’s mission is to build a viable biopharmaceutical company that designs, develops and commercializes novel therapies intended to improve quality of life, increase duration of life and resolve serious unmet medical needs. It will do so by identifying and controlling promising product candidates based on scientific development and administrative expertise, developing its products in a rapid, cost-efficient manner, and pursuing commercialization and/or development partners when and where appropriate.
Pharmacyclics markets IMBRUVICA and has three product candidates in clinical development and several preclinical molecules in lead optimization. The company is committed to high standards of ethics, scientific rigor, and operational efficiency as it moves each of these programs to commercialization. Pharmacyclics is headquartered in Sunnyvale, CA. To learn more, visit www.pharmacyclics.com. Pharmacyclics is on Twitter. Sign up to follow our Twitter feed @pharmacyclics at http://twitter.com/pharmacyclics.
1 IMBRUVICA Prescribing Information, July 2014.
2 Genetics Home Reference. Isolated growth hormone deficiency. Available from: http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency. Accessed November 2014.
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SOURCE Pharmacyclics, Inc.
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