Data Presented at the 30th European Association of Urology (EAU) Congress Further Assesses Efficacy, Safety and Tolerability of ZYTIGA® (Abiraterone Acetate) in Both Pre- and Post- Chemotherapy Settings in mCRPC

Janssen-Cilag International NV (Janssen) announced today that four presentations on ZYTIGA^® (abiraterone acetate) will be made at the 30^th Annual European Association of Urology (EAU) Congress from 20^th – 24^th March 2015 in Madrid, Spain.

Thomas Stark, Vice-President, Medical Affairs, Janssen Europe, the Middle East and Africa said: “We look forward to sharing this range of additional data for abiraterone acetate which further investigates the safety, efficacy and tolerability profile of the treatment in both the pre and post chemotherapy settings, in patients with metastatic castration-resistant prostate cancer. These studies illustrate Janssen’s continued commitment to patients with prostate cancer and will give us a deeper understanding of the benefit abiraterone acetate can bring in a range of different settings.”

The abstracts presented at the EAU congress are listed below for reference in Central European Time (CET):

• Poster session 46: “Hormone therapy: Here to stay” on Sunday 22^nd March 2015 14.00 – 15.30
  • Assessment of Corticosteroid-associated Adverse Events With Long-term Exposure to Low-dose Prednisone Given With Abiraterone Acetate to Metastatic Castration-resistant Prostate Cancer Patients (abstract #564)¹
  • Abiraterone Acetate Improves Overall Survival In Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC): Impact Of Crossover And Baseline Prognostic Factors In The COU-AA-302 Final Analysis (abstract #556)²
  • Early Access Protocol With Abiraterone Acetate for European Patients With Metastatic Castration-resistant Prostate Cancer Progressing After Chemotherapy (abstract #557)³
• Poster session 55: “Non-hormonal systemic treatment of prostate cancer” on Sunday 22^nd March 2015 15.45 – 17.15
  • Response To Taxane Chemotherapy As First Subsequent Therapy After Abiraterone Acetate In Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC): Post Hoc Analysis Of COU-AA-302 (abstract #668)⁴

Please note that all abstracts accepted for presentation at the EAU congress are subject to the organisers’ embargo policies.

NOTES TO EDITORS

About Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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 2012, an estimated 417,000 new cases of prostate cancer were diagnosed in Europe, and nearly 92,000 men died from the disease.⁷

About ZYTIGA

Since 2011, ZYTIGA (abiraterone acetate) has been approved in more than 90 countries and been prescribed to more than 140,000 patients worldwide, and it is quickly becoming one of the cornerstones of Janssen’s 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.

Indication ⁸

In 2011, ZYTIGA in combination with prednisone/prednisolone was approved by the European Commission (EC) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

In December 2012, the EC granted an extension of the indication for ZYTIGA (abiraterone acetate) permitting its use, in combination with prednisone or prednisolone, for the treatment of mCRPC, in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.⁸

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 the summary of product characteristics, which is available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002321/human_med_001499.jsp&mid=WC0b01ac058001d124

Most common: urinary tract infection, hypokalaemia, hypertension, peripheral oedema, diarrhoea

Common: hypertriglyceridaemia, cardiac failure (including congestive heart failure, left ventricular dysfunction and decreased ejection fraction), angina pectoris, arrhythmia, atrial fibrillation, tachycardia, increased alanine aminotransferase and aspartate aminotransferase, fractures (includes all fractures with the exception of pathological fracture), sepsis, dyspepsia, haematuria, rash

Uncommon: adrenal insufficiency, myopathy, rhabdomyolysis

Rare: allergic alveolitis

Not known: myocardial infarction

About Janssen

Janssen-Cilag International NV is one of the Janssen Pharmaceutical Companies. Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g. multiple myeloma and prostate cancer), immunology (e.g. psoriasis), neuroscience (e.g. schizophrenia, dementia and pain), infectious disease (e.g. HIV/AIDS, hepatitis C and tuberculosis) and cardiovascular and metabolic diseases (e.g. diabetes). Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. More information can be found on www.janssen-emea.com. Follow us on www.twitter.com/janssenEMEA for our latest news.

Janssen in Oncology

In oncology, our goal is to fundamentally alter the way cancer is understood, diagnosed, and managed, reinforcing our commitment to the patients who inspire us. In looking to find innovative ways to address the cancer challenge, our primary efforts focus on several treatment and prevention solutions. These include disease area strongholds that focus on haematologic malignancies and prostate cancer; cancer interception with the goal of developing products that interrupt the carcinogenic process; biomarkers that may help guide targeted, individualised use of our therapies; as well as safe and effective identification and treatment of early changes in the tumour microenvironment.

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References

¹ Miller et al. Assessment of corticosteroid (CS)-associated adverse events (AEs) with long-term (LT) exposure to low-dose prednisone (P) given with abiraterone acetate (AA) to metastatic castration-resistant prostate cancer (mCRPC) patients (pts) (Abstract #564, EAU 2015)

² Mulders et al. Abiraterone acetate improves overall survival in chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC): Impact of crossover and baseline prognostic factors in the COU-AA-302 final analysis (Abstract #556, EAU 2015)

³ Saad et al. Response To Taxane Chemotherapy As First Subsequent Therapy After Abiraterone Acetate In Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC): Post Hoc Analysis Of COU-AA-302 (Abstract #668, EAU 2015)

⁴ Castellano et al. Early Access Protocol With Abiraterone Acetate for European Patients With Metastatic Castration-resistant Prostate Cancer Progressing After Chemotherapy (Abstract #557, EAU 2015)

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. Available at: http://www.mayoclinic.com/health/prostate-cancer/DS00043. Last accessed March 2015.

⁷ Ferlay J et al. Cancer incidence and mortality patterns in Europe: Estimates for 40 countries in 2012. European Journal of Cancer. 2013; 49: p1374–1403.

⁸ ZYTIGA^® summary of product characteristics. Available on the EMA website: http://www.ema.europa.eu/ema/ . Last accessed March 2015.

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