Pharmacyclics Enters Into Agreement With Roche To Evaluate IMBRUVICA And GAZYVA In Lymphoma And Leukemia

Pharmacyclics, Inc.

today announced that it has entered into a master clinical drug supply agreement with Roche

to evaluate the safety, tolerability and preliminary efficacy of IMBRUVICA(R) (ibrutinib), an oral Bruton's tyrosine kinase (BTK) inhibitor, in combination with GAZYVA(R) (obinutuzumab), a new CD20-directed antibody that attacks targeted cells both directly and together with the body's immune system, in patients with non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL). The agreement allows for multiple studies to be considered and conducted. Initially, a Phase 3 study will be conducted by Pharmacyclics in CLL/SLL. Plans to evaluate the combination for NHL currently are in development. IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc. Both products are approved and marketed for the treatment of CLL. IMBRUVICA is used to treat CLL in patients who have received one prior therapy, and in CLL patients with deletion of the short arm of chromosome 17 (del 17p CLL), including treatment naive and previously treated del 17p CLL patients. GAZYVA is used with the chemotherapy drug, chlorambucil, to treat CLL in patients with previously untreated chronic lymphocytic leukemia. The use of these products in combination is investigational only. "We are committed to evaluating the potential activity of IMBRUVICA as a single agent and in combination with other agents to determine the benefits that IMBRUVICA may provide through a variety of uses across several hematologic malignancies," said Bob Duggan, Chairman & CEO, Pharmacyclics. "We look forward to a rewarding and productive partnership with Roche to evaluate our product with GAZYVA in order to deliver new treatment options to patients with NHL and CLL." The study of the investigational combination of IMBRUVICA and GAZYVA through several investigator-sponsored trials also is being considered. Additional details of the agreement were not disclosed.