Janssen Submits Additional Marketing Applications for ZYTIGA® in the European Union and in the U.S. (y 2)

Drug Interactions - ZYTIGA(R) is an inhibitor of the hepatic drug-metabolising enzyme CYP2D6. Caution is advised when ZYTIGA(R) is administered with medicinal products activated by or metabolised by CYP2D6, particularly with medicinal products that have a narrow therapeutic index. Dose reduction of medicinal products with a narrow therapeutic index that are metabolised by CYP2D6 should be considered. Examples of medicinal products metabolised by CYP2D6 include metoprolol, propranolol, desipramine, venlafaxine, haloperidol, risperidone, propafenone, flecanide, codeine, oxycodone and tramadol (the latter three products requiring CYP2D6 to form their active analgesic metabolites).

Based on in vitro data, ZYTIGA(R) is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole) or inducers (e.g., phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital) should be avoided, or used with caution during treatment with ZYTIGA(R).

CONTACT: Media Inquiries Europe, Middle-East and Africa: Brigitte Byl,+32-14-60-71-72. Satu Glawe, +49-2638-94-99-63. Media Inquiries Global/US:Kellie McLaughlin, Janssen Global Services, LLC, +1-908-927-7477 office,+1-609-468-8356 cell. Lisa Vaga, Janssen Biotech, Inc., +1-908-218-7316office, +1-908-670-0363 cell. .Investor Relations: Stan Panasewicz,+1-732-524-2524 office. Louise Mehrotra, +1-732-524-6491 office