1/17/2017 ZYTIGA® Approved In The EU For Use In The Treatment Of Metastatic Castration-Resistant Prostate Cancer Before Chemotherapy | Johnson & Johnson
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`PRODUCTS & OPERATING COMPANY
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`ZYTIGA® Approved In The EU For Use In The Treatment Of
`Metastatic Castration-Resistant Prostate Cancer Before
`Chemotherapy
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`Beerse, Belgium, 11 January 2013. Janssen-Cilag International NV (Janssen) announced today that the European Commission (EC)
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`has approved an extension to the license of the oral, once-daily medication ZYTIGA (abiraterone acetate). The approved broader
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`indication for ZYTIGA now includes its use, in combination with prednisone or prednisolone, for the treatment of metastatic
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`castration-resistant prostate cancer (mCRPC), in adult men who are asymptomatic or mildly symptomatic after failure of androgen
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`deprivation therapy in whom chemotherapy is not yet clinically indicated.[1]
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`Until now, ZYTIGA with prednisone and prednisolone has only been approved to treat men with mCRPC whose disease has
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`progressed on or after a docetaxel-based chemotherapy regimen. This latest approval means that eligible men will potentially be able
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`to benefit from treatment with ZYTIGA earlier in the treatment pathway.
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`The EC's decision follows recommendations from the Committee for Medical Products for Human Use (CHMP) of the European
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`Medicines Agency[2] that were based on data from the Phase III COU-AA-302 study[3] This was the first randomised study to
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`demonstrate a radiographic progression-free survival (rPFS) benefit and a strong trend in overall survival (OS) in this patient
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`population.
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`Jane Griffiths, Company Group Chairman, Janssen Europe, Middle-East, Africa, commented, "This decision by the European
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`Commission is hugely welcomed news. It marks another important step forward in the treatment of men with advanced castration-
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`resistant prostate cancer. Treating men with ZYTIGA before they undergo chemotherapy has been shown to improve outcomes in
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`many patients, both in terms of extending survival and in bettering quality of life. The fact that ZYTIGA's licence has now been
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`extended to include this indication will help fill a critical medical need and, we hope, serve to significantly improve the lives of many
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`men across Europe suffering from this disease."
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`NOTES TO EDITORS
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`About the COU-AA-302 study[3]
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`-ENDS-
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`Study COU-AA-302 is a Phase III, international, randomised, double-blind, placebo controlled study which evaluated ZYTIGA plus
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`prednisone/prednisolone compared to placebo plus prednisone/prednisolone in 1,088 asymptomatic or mildly symptomatic men with
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`mCRPC who had not received prior chemotherapy. The co-primary endpoints of the study were radiographic progression-free survival
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`(rPFS) and overall survival (OS).
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`The results were published in The New England Journal of Medicine in December 2012.[4] The data demonstrated a statistically
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`significant improvement in rPFS in the abiraterone acetate plus prednisone/prednisolone arm (ZYTIGA arm) of the study compared
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`to the placebo plus prednisone/prednisolone (control) arm.(cid:160) Additionally, treatment with ZYTIGA plus prednisone/prednisolone
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`resulted in a longer OS than with placebo (median OS in the ZYTIGA arm was not reached because progression events occurred
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`more slowly in the ZYTIGA arm compared to the control arm. At the time of the interim analysis, statistical significance for OS was
`Amerigen Exhibit 1150
`Amerigen v. Janssen IPR2016-00286
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`not reached.
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`1/17/2017 ZYTIGA® Approved In The EU For Use In The Treatment Of Metastatic Castration-Resistant Prostate Cancer Before Chemotherapy | Johnson & Johnson
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`In February 2012 an Independent Data Monitoring Committee (IDMC) unanimously recommended unblinding of this study after the
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`pre-specified analysis. Based on the results, the IDMC also recommended that patients in the control arm be offered treatment with
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`ZYTIGA .
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`Secondary Endpoints[3]
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`Treatment with ZYTIGA plus prednisone also demonstrated significant improvements in secondary study endpoints compared to the
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`control arm. Specifically, longer time until:
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`Opiate use for cancer pain
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`Initiation of cytotoxic chemotherapy for prostate cancer
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`Deterioration in performance status (Eastern Cooperative Oncology Group (ECOG*) performance score of one point or more)(cid:160)
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`PSA progression, based on The Prostate Cancer Clinical Trials Working Group (PCWG2) criteria
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`* The ECOG performance score is a standard measure used to assess functional status of a patient and is often used to determine
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`prognosis and appropriate treatment.
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`Safety Findings in the COU-AA-302 study[3]
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`Patients in the ZYTIGA arm of the study experienced more grade 3 and grade 4 adverse events than those in the control arm,
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`including cardiac disorders (6% vs. 3%) and hypertension (4% vs. 3%), as well as increases in alanine aminotransferase (ALT) and
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`aspartate aminotransferase (AST) (5.4% vs. 0.8% and 3.0% vs. 0.9%, respectively). Fatigue was the most common adverse event
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`observed in the study.
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`About metastatic castration-resistant prostate cancer
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`Metastatic castration-resistant prostate cancer occurs when cancer has metastasised (spread) beyond the prostate to other parts of
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`the body and the disease progresses despite serum testosterone below castrate levels.[5]
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`The prostate is a gland in men that produces part of the seminal fluid and is located around the urethra (under the bladder). In some
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`cases, cancer of the prostate can grow slowly. However, depending on factors including characteristics specific to the patient and the
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`tumour, prostate cancer also can grow very quickly and spread widely.[6]
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`In 2008, an estimated 370,000 new cases of prostate cancer were diagnosed in Europe, and nearly 90,000 men died from the
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`disease.[7]
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`About ZYTIGA [8]
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`Since its approval in 2011, ZYTIGA has been approved in more than 60 countries worldwide, many thousands of men have received
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`treatment with it, and it is quickly becoming one of the cornerstones of our oncology offerings.
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`ZYTIGA is the only approved therapy that inhibits production of androgen, which fuels prostate cancer growth, via inhibiting the
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`CYP17 enzyme complex present at three sources: the testes, adrenals and the tumour itself.
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`The U.S. Food and Drug Administration also recently approved an expanded indication.[9]
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`Side effects:[8]
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`IMPORTANT SAFETY INFORMATION
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`For a full list of side effects and for further information on dosage and administration, contraindications and other
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`precautions when using ZYTIGA, please refer to ZYTIGA's summary of product characteristics, which will be available
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`at http://www.ema.europa.eu/ema/
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`1/17/2017 ZYTIGA® Approved In The EU For Use In The Treatment Of Metastatic Castration-Resistant Prostate Cancer Before Chemotherapy | Johnson & Johnson
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`Most common: urinary tract infection, hypokalaemia, hypertension, peripheral oedema
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`Common: hypertriglyceridaemia, cardiac failure (including congestive heart failure, left ventricular dysfunction and decreased ejection
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`fraction), angina pectoris, arrhythmia, atrial fibrillation, tachycardia, increased alanine aminotransferase, fractures (includes all fractures
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`with the exception of pathological fracture), dyspepsia, haematuria and rash.
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`Uncommon: adrenal insufficiency.
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`About Janssen
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`The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet
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`medical needs of our time, including oncology, immunology, neuroscience, infectious disease, and cardiovascular and metabolic
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`diseases.
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`Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout
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`the world.
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`More information can be found at www.janssen-emea.com
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`The original language of this press release is English. Translations into French, German, Italian and Spanish are
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`provided by Business Wire as a courtesy.
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`References
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`[1] [Link to EC decision] [accessed January 2013]
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`[2] http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/002321/WC500134841.pdf [last
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`accessed January 2013]
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`[3] Ryan C.J et al. Interim analysis (IA) results of COU-AA-302, a randomized, phase III study of abiraterone acetate (AA) in
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`chemotherapy-naive patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). J Clin Oncol 30, 2012 (suppl; abstr
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`LBA4518)
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`[4] Ryan C.J et al. Abiraterone in Metastatic Prostate Cancer without Previous Chemotherapy. N Engl J Med 2012. DOI:
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`10.1056/NEJMoa1209096
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`[5] Hotte SJ, Saad F. Current management of castrate-resistant prostate cancer. Curr Oncol. 2010 September; 17(Supplement 2):
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`S72–S79.
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`[6] Mayo Clinic. "Prostate Cancer." http://www.mayoclinic.com/health/prostate-cancer/DS00043. [last accessed January 2013]
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`[7] http://globocan.iarc.fr/factsheet.asp [last accessed January 2013]
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`[8] ZYTIGA summary of product characteristics to be available on the EMA website: http://www.ema.europa.eu/ema/
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`[9] http://www.prnewswire.com/news-releases/us-fda-approves-expanded-zytiga-indication-for-treatment-of-metastatic-castration-
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`resistant-prostate-cancer-182852141.html [last accessed January 2013]
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`+1 732-524-2524
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