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Johnson & Johnson Reports 2013 Second-Quarter Results:
Date:7/16/2013

otic for the acute and maintenance treatment of schizophrenia in adults; VELCADE® (bortezomib), a treatment for multiple myeloma;  PREZISTA® (darunavir), a treatment for HIV; and sales of recently launched products.

The strong sales results of recently launched products included ZYTIGA® (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer; XARELTO® (rivaroxaban), an oral anticoagulant; and INCIVO® (telaprevir), a direct acting antiviral protease inhibitor, for the treatment of genotype-1 chronic hepatitis C virus.

During the quarter, the U.S. Food and Drug Administration (FDA) approved SIMPONI® (golimumab) for the treatment of moderately to severely active ulcerative colitis in adult patients who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine.

Additionally, the FDA granted Breakthrough Therapy Designation for daratumumab for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and IMiD. Daratumumab is an investigational human CD38 monoclonal antibody licensed from Genmab A/S.

In addition, a New Drug Application was submitted to the FDA under Breakthrough Therapy Designation for the use of ibrutinib in previously treated patients with chronic lymphocytic leukemia /small lymphocytic lymphoma, and for use in previously treated patients with mantle cell lymphoma.

Also during the quarter, a Marketing Authorization Application was submitted to the European Medicines Agency seeking approval for simeprevir (TMC435). Simeprevir is
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