WCK1110
`Wockhardt Bio AG v. Janssen Oncology, Inc.
`IPR2016-01582
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`1
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`4/18/2017
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`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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`-
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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)
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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 |eve|s.[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 201 1, 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 US. 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 is summary of product characteristics, which will be available
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`at http://www. ema.europa.eu/ema/
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`https://www.j nj .com/m edia—center/press-rel eases/zytiga-approved- i n-the—eu-for-use— i n-the—treatm ent-of-m etastatic-castration-resistant— prostate-cancer-before. . .
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`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
`diseases.
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`Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout
`the world.
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`More information can be found at www.ianssen-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_|ibrary/Summary_of_opinion/human/OO2321/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:
`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):
`872—879.
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`[6] Mayo Clinic. "Prostate Cancer." http://www.mayoclinic.com/health/prostate—cancer/DSOOO43. [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-f0r-treatment-of-metastatic-castration-
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`resistant-prostate-cancer-182852141.html [last accessed January 2013]
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`Media Contact:
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`Brigitte Byl
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`+32 (0) 14 60 7172
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`bby|@its.jnj.com
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`Investor Relations:
`
`Stan Panasewicz
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`+1 732—524—2524
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