Pharmacyclics, Inc. focuses on developing and commercializing small-molecule drugs for the treatment of cancer and immune mediated diseases. Marketed Product - IMBRUVICA (ibrutinib) IMBRUVICA is approved by the U.S. Food and Drug Administration (FDA) as a single agent for the treatment of patients with mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) who in each case have received at least one prior therapy. The FDA approval for these indications was based on overall response rate (ORR). IMBRUVICA is a new agent that inhibits the function of Bruton's tyrosine kinase (BTK). BTK is a key signaling molecule of the B-cell receptor signaling complex that plays an important role in the survival of malignant B-cells. IMBRUVICA blocks signals that stimulate malignant B-cells to grow and divide uncontrollably. IMBRUVICA became commercially available in the United States in 2013. IMBRUVICA is being marketed principally through a commercial team with relevant expertise in the promotion, distribution and reimbursement of oncology/hematology drugs. In 2013, the company established its commercial organization to support the commercialization of IMBRUVICA in the U.S. The company’s collaboration partner Janssen Biotech, Inc. (Janssen) already has an Oncology Sales Organization in place. IMBRUVICA is being studied in multiple Phase I, II and III studies and continues to be developed for the treatment of other B-cell malignancies. In addition to IMBRUVICA, the company has three other product candidates in clinical development and various preclinical molecules in primary optimization, including a BTK inhibitor targeting anti-inflammatory and autoimmune indications entering the clinic with a Phase I study, an inhibitor of Factor VIIa (PCI-27483) and a Histone deacetylases (HDAC) inhibitor, abexinostat, in Phase I and II clinical trials in solid tumors and hematological malignancies. BTK Inhibitor Program The company engages in the development of orally bioavailable inhibitors of BTK, a signaling protein that is critically important for the activity of B-cells (immune cells that can develop into antibody producing cells). It is using a multi-tier preclinical testing strategy to develop novel inhibitors of BTK for anti-inflammatory and autoimmune diseases. The company developed IMBRUVICA, which has been commercialized for MCL and CLL patients, who in each case have received at least one prior therapy, and has demonstrated clinical activity and tolerability in Phase I, II and III clinical trials in various B-cell malignancies. Factor VII is an enzyme that becomes activated (FVIIa) by binding to the cell surface protein tissue factor (TF), a protein found in the body that helps to trigger the process of blood clotting in response to injury. The company’s Factor VIIa inhibitor PCI-27483 is a first-in-human small molecule inhibitor that selectively targets FVIIa. PCI-27483, claimed as a composition of matter, is covered by granted patents in the U.S., Canada, Japan, China, and India. The company has pending patent applications covering PCI-24783, as compositions of matter, in the U.S., and Europe. As of December 31, 2013, the duration of the granted patents in the U.S., Canada, Japan, China and India that claim PCI-27483 as compositions of matter is through December 2023, subject to any patent term extensions that may be obtained in certain territories. ABEXINOSTAT (PCI-24781) PAN-HDAC INHIBITOR Abexinostat is an orally dosed, broad spectrum, hydroxamic acid-based small molecule HDAC inhibitor that has been evaluated in Phase I and II clinical trials for refractory solid tumors and lymphoma by Pharmacyclics and its ex-U.S. partner, Les Laboratoires Servier of Paris, France (Servier). In 2009, the company entered into a collaboration agreement with Servier, pursuant to which it granted Servier an exclusive license for its pan-HDAC inhibitors, including abexinostat, for territories throughout the world excluding the United States and its possessions. Business Strategy The key elements of the company’s business strategy include focusing on creating novel, patentable, differentiated biopharmac
pharmacyclics inc (PY2:Frankfurt)
999 East Arques Avenue
Sunnyvale, CA 94085
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