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Pharmacyclics First To Announce Breakthrough Therapy Designation In Oncology From The U.S. Food And Drug Administration

Stocks in this article: PCYC

Conference CallFurther updates will be provided during the upcoming quarterly conference call on February 14, 2013 at 4:30 p.m. EDT. To participate in the conference call, please dial 1-877-407-0778 for domestic callers and 1-201-689-8565 for international callers. To access the live audio broadcast or the subsequent archived recording, log on to http://ir.pharmacyclics.com/events.cfm. The archived version of the webcast will be available for 30 days on the Investor Relations section of the company's Web site at http://www.pharmacyclics.com.

About Mantle Cell LymphomaMCL is an aggressive type of B-cell non-Hodgkin lymphoma (NHL) that usually occurs in older adults. The disease typically begins in the lymph nodes but can spread to other tissues, such as bone marrow and liver. Ibrutinib targets the B-cell receptor pathway an important pathway in malignant B-cell growth and proliferation. In the United States there are approximately 5,000 new cases of MCL each year.

About Waldenstrom's macroglobulinemia Waldenstrom's macroglobulinemia is rare type of lymphoma. The disease begins with a malignant change to the B-cell during its maturation so that it continues to reproduce more malignant B-cells resulting in an overproduction of monoclonal immunoglobulin M antibody (IgM). WM is a hematologic malignancy for which no established standard of care - or approved therapeutic exists. In the United States there are approximately 1,500 new cases each year.

About IbrutinibIbrutinib is an investigational drug designed to specifically target and selectively inhibit an enzyme called Bruton's tyrosine kinase (BTK). BTK is a key mediator of at least three critical B-cell pro-survival mechanisms occurring in parallel – regulating apoptosis, adhesion, and cell migration and homing. Through these multiple actions, BTK helps to direct malignant B-cells to lymphoid tissues, thus allowing access to a micro environment necessary for survival.

The effectiveness and safety of ibrutinib alone or in combination with other treatments is being studied in several B-cell malignancies, including chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, Waldenstrom's macroglobulinemia and multiple myeloma. To date five Phase III trials have been initiated with ibrutinib and a total of 27 trials are currently registered on clinicaltrials.gov.

About PharmacyclicsPharmacyclics ® is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. Our mission and goal 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 healthcare needs; and to identify promising product candidates based on scientific development and administrational expertise, develop our products in a rapid, cost-efficient manner and pursue commercialization and/or development partners when and where appropriate.

Presently, Pharmacyclics 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 viable commercialization.

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