`
`PRODUCTS & OPERATING COMPANY
`
`ZYTIGA® Approved In The EU For Use In The Treatment Of
`Metastatic Castration-Resistant Prostate Cancer Before
`Chemotherapy
`
`Beerse, Belgium, 11 January 2013. Janssen-Cilag International NV (Janssen) announced today that the European
`Commission (EC) has approved an extension to the license of the oral, once-daily medication ZYTIGA (abiraterone
`®
`acetate). The approved broader indication for ZYTIGA now includes its use, in combination with prednisone or
`prednisolone, for the treatment of metastatic castration-resistant prostate cancer (mCRPC), in adult men who are
`asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet
`clinically indicated.[1]
`
`Until now, ZYTIGA with prednisone and prednisolone has only been approved to treat men with mCRPC whose disease
`has progressed on or after a docetaxel-based chemotherapy regimen. This latest approval means that eligible men will
`potentially be able to benefit from treatment with ZYTIGA earlier in the treatment pathway.
`®
`
`The EC's decision follows recommendations from the Committee for Medical Products for Human Use (CHMP) of the
`European Medicines Agency[2] that were based on data from the Phase III COU-AA-302 study[3] This was the first
`randomised study to demonstrate a radiographic progression-free survival (rPFS) benefit and a strong trend in overall
`survival (OS) in this patient population.
`
`Jane Griffiths, Company Group Chairman, Janssen Europe, Middle-East, Africa, commented, "This decision by the
`European Commission is hugely welcomed news. It marks another important step forward in the treatment of men with
`advanced castration-resistant prostate cancer. Treating men with ZYTIGA before they undergo chemotherapy has been
`shown to improve outcomes in many patients, both in terms of extending survival and in bettering quality of life. The fact
`that ZYTIGA's licence has now been extended to include this indication will help fill a critical medical need and, we hope,
`serve to significantly improve the lives of many men across Europe suffering from this disease."
`
`NOTES TO EDITORS
`
`-ENDS-
`
`About the COU-AA-302 study[3]
`Study COU-AA-302 is a Phase III, international, randomised, double-blind, placebo controlled study which evaluated
`ZYTIGA plus prednisone/prednisolone compared to placebo plus prednisone/prednisolone in 1,088 asymptomatic or
`®
`mildly symptomatic men with mCRPC who had not received prior chemotherapy. The co-primary endpoints of the study
`were radiographic progression-free survival (rPFS) and overall survival (OS).
`
`The results were published in The New England Journal of Medicine in December 2012.[4] The data demonstrated a
`statistically significant improvement in rPFS in the abiraterone acetate plus prednisone/prednisolone arm (ZYTIGA arm)
`®
`of the study compared to the placebo plus prednisone/prednisolone (control) arm. Additionally, treatment with ZYTIGA
`®
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`https://www.jnj.com/media-center/press-releases/zytiga-approved-in-the-eu-for-use-in-the-treatment-of-metastatic-castration-resistant-prostate-cancer-before-chemotherapy
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`MYLAN PHARMS. INC. EXHIBIT 1141 PAGE 1
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`Page 2 of 4
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`plus prednisone/prednisolone resulted in a longer OS than with placebo (median OS in the ZYTIGA arm was not
`®
`reached because progression events occurred more slowly in the ZYTIGA arm compared to the control arm. At the time
`®
`of the interim analysis, statistical significance for OS was not reached.
`
`In February 2012 an Independent Data Monitoring Committee (IDMC) unanimously recommended unblinding of this study
`after the pre-specified analysis. Based on the results, the IDMC also recommended that patients in the control arm be
`offered treatment with ZYTIGA .
`®
`
`Secondary Endpoints[3]
`Treatment with ZYTIGA plus prednisone also demonstrated significant improvements in secondary study endpoints
`®
`compared to the control arm. Specifically, longer time until:
`
`• Opiate use for cancer pain
`• Initiation of cytotoxic chemotherapy for prostate cancer
`• Deterioration in performance status (Eastern Cooperative Oncology Group (ECOG*) performance score of one
`point or more)
`• PSA progression, based on The Prostate Cancer Clinical Trials Working Group (PCWG2) criteria
`
`* The ECOG performance score is a standard measure used to assess functional status of a patient and is often used to
`determine prognosis and appropriate treatment.
`Safety Findings in the COU-AA-302 study[3]
`Patients in the ZYTIGA arm of the study experienced more grade 3 and grade 4 adverse events than those in the control
`®
`arm, including cardiac disorders (6% vs. 3%) and hypertension (4% vs. 3%), as well as increases in alanine
`aminotransferase (ALT) and aspartate aminotransferase (AST) (5.4% vs. 0.8% and 3.0% vs. 0.9%, respectively). Fatigue
`was the most common adverse event observed in the study.
`
`About metastatic castration-resistant prostate cancer
`Metastatic castration-resistant prostate cancer occurs when cancer has metastasised (spread) beyond the prostate to
`other parts of the body and the disease progresses despite serum testosterone below castrate levels.[5]
`
`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 cases, cancer of the prostate can grow slowly. However, depending on factors including characteristics
`specific to the patient and the tumour, prostate cancer also can grow very quickly and spread widely.[6]
`
`In 2008, an estimated 370,000 new cases of prostate cancer were diagnosed in Europe, and nearly 90,000 men died
`from the disease.[7]
`
`About ZYTIGA [8]
`®
`Since its approval in 2011, ZYTIGA has been approved in more than 60 countries worldwide, many thousands of men
`®
`have received treatment with it, and it is quickly becoming one of the cornerstones of our oncology offerings.
`
`ZYTIGA is the only approved therapy that inhibits production of androgen, which fuels prostate cancer growth, via
`®
`inhibiting the 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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`https://www.jnj.com/media-center/press-releases/zytiga-approved-in-the-eu-for-use-in-the-treatment-of-metastatic-castration-resistant-prostate-cancer-before-chemotherapy
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`Side effects:[8]
`
`IMPORTANT SAFETY INFORMATION
`
`For a full list of side effects and for further information on dosage and administration, contraindications
`and other precautions when using ZYTIGA, please refer to ZYTIGA's summary of product characteristics,
`which will be available at http://www.ema.europa.eu/ema/
`
`Most common: urinary tract infection, hypokalaemia, hypertension, peripheral oedema
`
`Common: hypertriglyceridaemia, cardiac failure (including congestive heart failure, left ventricular dysfunction and
`decreased ejection fraction), angina pectoris, arrhythmia, atrial fibrillation, tachycardia, increased alanine aminotransferase,
`fractures (includes all fractures with the exception of pathological fracture), dyspepsia, haematuria and rash.
`
`Uncommon: adrenal insufficiency.
`
`About Janssen
`The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most
`important unmet medical needs of our time, including oncology, immunology, neuroscience, infectious disease, and
`cardiovascular and metabolic diseases.
`
`Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people
`throughout the world.
`
`More information can be found at www.janssen-emea.com
`
`The original language of this press release is English. Translations into French, German, Italian and
`Spanish are provided by Business Wire as a courtesy.
`
`References
`[1] [Link to EC decision] [accessed January 2013]
`[2] http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/002321/WC500134841.pdf
`[last accessed January 2013]
`[3] Ryan C.J et al. Interim analysis (IA) results of COU-AA-302, a randomized, phase III study of abiraterone acetate (AA)
`in chemotherapy-naive patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). J Clin Oncol 30,
`2012 (suppl; abstr LBA4518)
`[4] Ryan C.J et al. Abiraterone in Metastatic Prostate Cancer without Previous Chemotherapy. N Engl J Med 2012. DOI:
`10.1056/NEJMoa1209096
`[5] Hotte SJ, Saad F. Current management of castrate-resistant prostate cancer. Curr Oncol. 2010 September; 17
`(Supplement 2): S72–S79.
`[6] Mayo Clinic. "Prostate Cancer." http://www.mayoclinic.com/health/prostate-cancer/DS00043. [last accessed January
`2013]
`[7] http://globocan.iarc.fr/factsheet.asp [last accessed January 2013]
`[8] ZYTIGA summary of product characteristics to be available on the EMA website: http://www.ema.europa.eu/ema/
`®
`
`https://www.jnj.com/media-center/press-releases/zytiga-approved-in-the-eu-for-use-in-the-treatment-of-metastatic-castration-resistant-prostate-cancer-before-chemotherapy
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`[9] http://www.prnewswire.com/news-releases/us-fda-approves-expanded-zytiga-indication-for-treatment-of-metastatic-
`castration-resistant-prostate-cancer-182852141.html [last accessed January 2013]
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`Media Contact:
`Brigitte Byl
`+32 (0) 14 60 71 72
`bbyl@its.jnj.com
`
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`Stan Panasewicz
`+1 732-524-2524
`
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`https://www.jnj.com/media-center/press-releases/zytiga-approved-in-the-eu-for-use-in-the-treatment-of-metastatic-castration-resistant-prostate-cancer-before-chemotherapy
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