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Janssen to Showcase Data from Five Compounds Including Daratumumab and IMBRUVICA at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting
Janssen to Showcase Data from Five Compounds Including Daratumumab and IMBRUVICA at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting
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·Note: This release corresponds to ASCO abstracts LBA8512, 8587, 8590, TPS8609, TPS8608, LBA7005, 7012, TPS8599, TPS8601, 7024, TPS7095, TPS7096, 5005, 5047, 5053, 5014, 5028, TPS5071, TPS5084, 10503, 6537, TPS5606

RARITAN, NJ, May 13, 2015 – Janssen Research & Development, LLC (Janssen) announced that data from five oncology treatments across the portfolio, including marketed and investigational compounds, will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting from May 29 – June 2, 2015 in Chicago, IL. More than two dozen company-sponsored abstracts have been accepted featuring data for daratumumab, ibrutinib (IMBRUVICA®), abiraterone acetate (ZYTIGA®), trabectedin (YONDELIS®) and ARN-509. Both daratumumab and ibrutinib data will be included during the official ASCO press program on Saturday, May 30th. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc.

“Janssen oncology is poised for another strong showing at ASCO this year, showcasing our continued strides to make a difference in the lives of people living with cancer,” said Peter F. Lebowitz, M.D., Ph.D., Global Oncology Head, Janssen. “Of the five Janssen compounds being featured, we are particularly excited about new daratumumab monotherapy data in multiple myeloma and ibrutinib combination data in chronic lymphocytic leukemia. We look forward to sharing these findings and remain committed to developing innovative, targeted medicines to lead the future of cancer treatment.”

Company-Sponsored Research to Be Presented
Daratumumab Five daratumumab abstracts have been accepted for presentation, all of which are sponsored/supported by Janssen. In August 2012, Janssen Biotech, Inc. and Genmab entered an agreement which granted Janssen an exclusive license to develop and commercialize daratumumab. Janssen is currently the sponsor of all but one study globally. Daratumumab data will be presented on Saturday, May 30th during the official ASCO press program. Daratumumab abstracts at ASCO include:

  • Phase 2 Study of daratumumab Monotherapy in Patients with ≥3 Lines of Prior Therapy or Double Refractory Multiple Myeloma (MM). (Abstract LBA8512)
    Oral abstract session: Myeloma. Tuesday, June 2 at 11:21 a.m. CDT in E354b.
    Lead Author: Sagar Lonial, Winship Cancer Institute, Emory University, Atlanta, Georgia, USA.
  • Pre-clinical Translational Studies of daratumumab in Patients with Myeloma or AL Amyloidosis Undergoing Autologous Hematopoietic Stem Cell Transplantation (SCT). (Abstract 8587)
    Poster Session: Lymphoma and Plasma Cell Disorders. Sunday, May 31 at 8:00 a.m. CDT in S Hall A.
    Lead Author: Chakra Chaulagain, Taussig Cancer Institute of Cleveland Clinic, Cleveland Clinic Florida, Weston, Florida, USA.
  • Assessing Clinical Response in Multiple Myeloma (MM) Patients Treated with Monoclonal Antibodies (mAbs): Validation of a daratumumab IFE Reflex Assay (DIRA) to Distinguish Malignant M-protein from Therapeutic Antibody. (Abstract 8590)
    Poster Session: Lymphoma and Plasma Cell Disorders. Sunday, May 31 at 8:00 a.m. CDT in S Hall A.
    Lead Author: Christopher McCudden, The Ottawa Hospital University of Ottawa, Ottawa, Ontario, Canada.

Trials in Progress:

  • Twin Randomized Studies of daratumumab Plus Standard of Care (lenalidomide/dexamethasone or bortezomib/dexamethasone [DRd or DVd]) Versus Rd or Vd Alone in Relapsed or Refractory Multiple Myeloma (MM). (Abstract TPS8609)
    Poster Session: Lymphoma and Plasma Cell Disorders. Sunday, May 31 at 8:00 a.m. CDT in S Hall A.
    Lead Author: Antonio Palumbo, Department of Hematology, University of Torino, Torino, Italy.
  • A Randomized Open-label Study of bortezomib, melphalan, and prednisone (VMP) Versus daratumumab Plus VMP in Patients with Previously Untreated Multiple Myeloma (MM) Patients who are Ineligible for High-dose Therapy. (Abstract TPS8608)
    Poster Session: Lymphoma and Plasma Cell Disorders. Sunday, May 31 at 8:00 a.m. CDT in S Hall A.
    Lead Author: Maria Victoria Mateos, University Hospital of Salamanca/IBSAL, Salamanca, Spain.

Ibrutinib

Ibrutinib data will be featured in 10 studies sponsored by either Janssen or its collaboration partner, Pharmacyclics, Inc. Ibrutinib data will be presented on Saturday, May 30th during the official ASCO press program. Ibrutinib abstracts at ASCO include:

  • First Results from a Phase 3 Study of ibrutinib in Combination with bendamustine and rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia. (Abstract LBA7005)
    Oral Abstract Session: Leukemia, Myelodysplasia, and Transplantation. Saturday, May 30 at 2:27 p.m. CDT in E Arie Crown Theater.
    Lead Author: Asher Alban Chanan-Khan, M.D., The Mayo Clinic, Jacksonville, Florida, USA.
  • Dose Adherence and Baseline Exposure Analysis of the ibrutinib 420 mg Dose Administered to Patients with Previously Treated CLL. (Abstract 7012)
    Poster Session: Leukemia, Myelodysplasia, and Transplantation. Sunday, May 31 at 8:00 a.m. CDT in S Hall A.
    Lead Author: Paul M. Barr, M.D., Wilmot Cancer Institute, University of Rochester, Rochester, New York, USA.
  • A Multicenter Open-label Phase 1b/2 Study of ibrutinib in Steroid Dependent or Refractory Chronic Graft Versus Host Disease. (Abstract 7024)
    Poster Session: Leukemia, Myelodysplasia, and Transplantation. Sunday, May 31 at 8:00 a.m. CDT in S Hall A.
    Lead Author: David Bernard Miklos, M.D., Ph.D., Stanford University Medical Center, Stanford, California, USA.
  • Long-term Activity of ibrutinib in Patients with Relapsed/Refractory Waldenström’s Macroglobulinemia. (Publication Only)
    Electronic publication, available on www.asco.org
    Lead Author: Richard Furman, M.D., Weill Cornell Medical College, New York, New York, USA.
  • Real World Treatment Patterns and Healthcare Resource Utilization (HRU) Among Chronic Lymphocytic Leukemia (CLL) Patients by Regimen. (Publication Only)
    Electronic publication, available on www.asco.org
    Lead Author: Dacosta Byfield, Optum, Eden Prairie, Minnesota, USA.
  • Real World Treatment Patterns, Healthcare Resource Utilization (HRU), and Costs Among Waldenstrom Macroglobulinemia (WM) Patients Initiating Therapy. (Publication Only)
  • Electronic publication, available on www.asco.org.
    Lead Author: L. Ellis, Janssen Scientific Affairs, LLC, Horsham, Pennsylvania, USA.

Trials in Progress:

  • A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of rituximab with or without ibrutinib for Waldenstrom’s Macroglobulinemia. (Abstract TPS8599)
    Poster Session: Lymphoma and Plasma Cell Disorders. Sunday, May 31 at 8:00 a.m. CDT in S Hall A.
    Lead Author: Meletios A. Dimopoulos, M.D., National and Kapodistrian, University of Athens, Athens, Greece.
  • A Phase 3 Study of ibrutinib in Combination with Either bendamustine and rituximab (BR) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in Subjects with Previously Treated Follicular Lymphoma or Marginal Zone Lymphoma. (Abstract TPS8601)
    Poster Session: Lymphoma and Plasma Cell Disorders. Sunday, May 31 at 8:00 a.m. CDT in S Hall A.
    Lead Author: Nathan Hale Fowler, M.D., The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
  • Randomized, Multicenter, Open-label, Phase 3 Study of the BTK inhibitor ibrutinib + obinutuzumab vs. chlorambucil + obinutuzumab in Patients with Treatment-naïve CLL/SLL. (Abstract TPS7095)
    Poster Session: Leukemia, Myelodysplasia, and Transplantation. Sunday, May 31 at 8:00 a.m. CDT in S Hall A.
    Lead Author: Ian Flinn, M.D., Sarah Cannon Research Institute, Nashville, Tennessee, USA.
  • A Multicenter, Open-label Phase 2a Study of ibrutinib with or without Cytarabine in Patients with Acute Myeloid Leukemia. (Abstract TPS7096)
    Poster Session: Leukemia, Myelodysplasia, and Transplantation. Sunday, May 31 at 8:00 a.m. CDT in S Hall A.
    Lead Author: Jorge Cortes, M.D., The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.

Abiraterone Acetate and ARN-509

Abiraterone acetate and ARN-509 data will be included in 10 Janssen-sponsored abstracts at ASCO, reaffirming the Company’s commitment to patient care in the prostate cancer treatment space:

  • Biological Heterogeneity in Localized High-Risk Prostate Cancer (LHRPC) from a Study of Neoadjuvant Abiraterone Acetate Plus Leuprolide Acetate (LHRHa) Versus LHRHa. (Abstract 5005)
    Oral Abstract Session: Genitourinary (Prostate) Cancer. Sunday, May 31 at 11:09 a.m. CDT in E Arie Crown Theater.
    Lead Author: Eleni Efstathiou, M.D., Ph.D., Associate Professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
  • Prognostic Index Model (PIM) for Overall Survival (OS) in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients without Prior Chemotherapy Treated With Abiraterone Acetate (AA). (Abstract 5047)
    Poster Session: Genitourinary (Prostate) Cancer. Saturday, May 30 at 1:15 p.m. CDT in E Arie Crown Theater.
    Lead Author: Charles Ryan, M.D., Professor of Clinical Medicine, Urology at the University of California, San Francisco, California, USA
  • IMAAGEN Trial Update: Effect of Abiraterone Acetate and Low Dose Prednisone on PSA and Radiographic Disease Progression in Patients with Non-Metastatic Castration-Resistant Prostate Cancer. (Abstract 5053)
    Poster Session: Genitourinary (Prostate) Cancer. Saturday, May 30 at 1:15 p.m. CDT in E Arie Crown Theater.
    Lead Author: Charles Ryan, M.D., Professor of Clinical Medicine, Urology at the University of California, San Francisco, California, USA
  • Early Circulating Tumor Cell Counts (CTC) Decline as a Biomarker of Response to Treatment in Castration-Resistant Prostate Cancer: Analysis of the COU-AA-301 and IMMC-38 Trials. (Abstract 5014)
    Poster Session: Genitourinary (Prostate) Cancer. Saturday, May 30 at 1:15 p.m. CDT in E Arie Crown Theater.
    Lead Author: David Lorente, M.D., Institute of Cancer Research, Division of Cancer Therapeutics, United Kingdom
  • Cost per Median Overall Survival Month for Abiraterone Acetate and Enzalutamide for Treatment of Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC).
    Electronic publication, available on www.asco.org.
    Lead Author: Dominic Pilon, M.A., The Analysis Group
  • Central Nervous System (CNS) Conditions in Abiraterone or Enzalutamide-Treated Prostate Cancer Patients.
    Electronic publication, available on www.asco.org.
    Lead Author: Dominic Pilon, M.A., The Analysis Group
  • Corticosteroid Use in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated with Abiraterone or Enzalutamide Using Real World Data from Three Databases.
    Electronic publication, available on www.asco.org.
    Lead Author: Lorie Ellis, Ph.D., Associate Director, Janssen Scientific Affairs
  • Phase 1b Study of ARN-509 with Abiraterone Acetate (AA) and Prednisone (P) in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC). (Abstract 5028)
    Poster Session: Genitourinary (Prostate) Cancer. Saturday, May 30 at 1:15 p.m. CDT in E Arie Crown Theater.
    Lead Author: Edwin Posadas, M.D., Cedars-Sinai’s Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California, USA

Trials in Progress:

  • A Phase 3 Randomized, Placebo-Controlled Double-Blind Study of ARN-509 Plus Abiraterone Acetate (AA) in Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC). (Abstract TPS5071)
    Poster Session: Genitourinary (Prostate) Cancer. Saturday, May 30 at 1:15 p.m. CDT in E Arie Crown Theater.
    Lead Author: Dana E. Rathkopf, M.D., Memorial Sloan Kettering Cancer Center, New York, New York, USA
  • The Role of Highly Selective Androgen Receptor (AR) Targeted Therapy in Men with Biochemically Relapsed Hormone Sensitive Prostate Cancer. (Abstract TPS5084)
    Poster Session: Genitourinary (Prostate) Cancer. Saturday, May 30 at 1:15 p.m. CDT in E Arie Crown Theater.
    Lead Author: Rahul Raj Aggarwal, M.D., Assistant Professor, University of California, San Francisco,

California, USA

Trabectedin Three trabectedin abstracts have been accepted for presentation and were sponsored by Janssen and PharmaMar, a wholly owned member of the Zeltia Group:

  • A Randomized Phase 3 Study of Trabectedin (T) or Dacarbazine (D) for the Treatment of Patients (pts) with Advanced Liposarcoma (LPS) or Leiomyosarcoma (LMS). (Abstract 10503)
    Oral Abstract Session: Sarcoma. Monday, June 1 at 4:00 p.m. CDT in S504.
    Lead Author: George D. Demetri, M.D., Dana-Farber Cancer Institute, Boston, Massachusetts, USA
  • Healthcare Resource Utilization and Cost Considerations in Patients with Soft Tissue Sarcoma Treated with Chemotherapy. (Abstract 6537)
    Poster Session: Health Services Research and Quality of Care. Monday, June 1 at 1:15 p.m. CDT in S Hall A.
    Lead Author: Chris M. Kozma, Ph.D., CK Consulting Associates, LLC, St. Helena Island, South Carolina, USA

Trial in Progress:

  • A Phase 3 Study of Trabectedin (T) plus Pegylated Liposomal Doxorubicin (PLD) versus PLD for Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer. (Abstract TPS5606)
    Poster Session: Gynecologic Cancer. Saturday, May 30 at 1:15 p.m. CDT in S Hall A.
    Lead Author: Robert L. Coleman, M.D., The University of Texas MD Anderson Cancer Center, Houston, Texas, USA

About Daratumumab
In August 2012, Genmab A/S granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab. Daratumumab is an investigational human IgG1k monoclonal antibody (mAb) that binds with high affinity to CD38 on surface of multiple myeloma cells and induces rapid tumor cell death through diverse mechanisms of action. Daratumumab is in Phase 3 clinical development for multiple myeloma, and may also have potential in other malignant and pre-malignant diseases on which CD38 is expressed. In May 2013, daratumumab was granted Breakthrough Therapy Designation by the FDA for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and IMiD.

About IMBRUVICA® (ibrutinib) IMBRUVICA was one of the first therapies to receive U.S. approval after having received the FDA’s Breakthrough Therapy Designation. IMBRUVICA works by blocking a specific protein called Bruton's tyrosine kinase (BTK).[1] The BTK protein transmits important signals that tell B cells to mature and produce antibodies and is needed by specific cancer cells to multiply and spread.1,[2] IMBRUVICA targets and blocks BTK, inhibiting cancer cell survival and spread.1 For more information, visit www.IMBRUVICA.com.

Additional Information about IMBRUVICA® INDICATIONS IMBRUVICAÒ is indicated to treat people with:

  • Mantle cell lymphoma (MCL) who have received at least one prior therapy

  • Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.
  • Chronic lymphocytic leukemia (CLL) who have received at least one prior therapy
  • Chronic lymphocytic leukemia (CLL) with 17p deletion
  • Waldenström’s macroglobulinemia (WM)

IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Hemorrhage - Fatal bleeding events have occurred in patients treated with IMBRUVICAÒ. Grade 3 or higher bleeding events (subdural hematoma, gastrointestinal bleeding, hematuria, and post-procedural hemorrhage) have occurred in up to 6% of patients. Bleeding events of any grade, including bruising and petechiae, occurred in approximately half of patients treated with IMBRUVICAÒ. The mechanism for the bleeding events is not well understood. IMBRUVICAÒ may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies. Consider the benefit-risk of withholding IMBRUVICAÒ for at least 3 to 7 days pre and post-surgery depending upon the type of surgery and the risk of bleeding.

Infections - Fatal and non-fatal infections have occurred with IMBRUVICAÒ therapy. Grade 3 or greater infections occurred in 14% to 26% of patients. Cases of progressive multifocal leukoencephalopathy (PML) have occurred in patients treated with IMBRUVICAÒ. Monitor patients for fever and infections and evaluate promptly.

Cytopenias - Treatment-emergent Grade 3 or 4 cytopenias including neutropenia (range, 19 to 29%), thrombocytopenia (range, 5 to 17%), and anemia (range, 0 to 9%) occurred in patients treated with IMBRUVICAÒ. Monitor complete blood counts monthly.

Atrial Fibrillation - Atrial fibrillation and atrial flutter (range, 6 to 9%) have occurred in patients treated with IMBRUVICAÒ, particularly in patients with cardiac risk factors, acute infections, and a previous history of atrial fibrillation. Periodically monitor patients clinically for atrial fibrillation. Patients who develop arrhythmic symptoms (e.g., palpitations, lightheadedness) or new-onset dyspnea should have an ECG performed. If atrial fibrillation persists, consider the risks and benefits of IMBRUVICAÒ treatment and dose modification.

Second Primary Malignancies - Other malignancies (range, 5 to 14%) including non-skin carcinomas (range, 1 to 3%) have occurred in patients treated with IMBRUVICAÒ. The most frequent second primary malignancy was non-melanoma skin cancer (range, 4 to 11%).

Tumor Lysis Syndrome - Tumor lysis syndrome has been reported with IMBRUVICAÒ therapy. Monitor patients closely and take appropriate precautions in patients at risk for tumor lysis syndrome (e.g., high tumor burden).

Embryo-Fetal Toxicity - Based on findings in animals, IMBRUVICAÒ can cause fetal harm when administered to a pregnant woman. Advise women to avoid becoming pregnant while taking IMBRUVICAÒ. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

ADVERSE REACTIONS

The most common adverse reactions (≥25%) in patients with B-cell malignancies (MCL, CLL, WM) were thrombocytopenia* (57%, 52%, 43%), neutropenia* (47%, 51%, 44%), diarrhea (51%, 48%, 37%), anemia* (41%, 36%, 13%), fatigue (41%, 28%, 21%), musculoskeletal pain (37%, 28%†, NA‡), bruising (30%, 12%†, 16%†), nausea (31%, 26%, 21%), upper respiratory tract infection (34%, 16%, 19%), and rash (25%, 24%†, 22%†). *Based on adverse reactions and/or laboratory measurements (noted as platelets, neutrophils, or hemoglobin decreased). †Includes multiple ADR terms. ‡Not applicable; no associated ADRs. The most common Grade 3 or 4 non-hematological adverse reactions (≥5%) in MCL patients were pneumonia (7%), abdominal pain (5%), atrial fibrillation (5%), diarrhea (5%), fatigue (5%), and skin infections (5%). Approximately 6% (CLL), 14% (MCL), and 11% (WM) of patients had a dose reduction due to adverse events. Approximately 5% (CLL), 9% (MCL), and 6% (WM) of patients discontinued due to adverse events. Most frequent adverse events leading to discontinuation were infections, subdural hematomas, and diarrhea in CLL patients and subdural hematoma (1.8%) in MCL patients.

DRUG INTERACTIONS
CYP3A Inhibitors - Avoid co-administration with strong and moderate CYP3A inhibitors. If a moderate CYP3A inhibitor must be used, reduce the IMBRUVICAÒ dose.
CYP3A Inducers - Avoid co-administration with strong CYP3A inducers.
SPECIFIC POPULATIONS Hepatic Impairment - Avoid use in patients with moderate or severe baseline hepatic impairment. In patients with mild impairment, reduce IMBRUVICAÒ dose. Please see full Prescribing Information: http://www.imbruvica.com/downloads/Prescribing_Information.pdf

About ZYTIGA® (abiraterone acetate)
Since its first approval in the U.S. in 2011, ZYTIGA has been approved in 100 countries. More than 195,000 men worldwide have received treatment with it, and it is quickly becoming one of the cornerstones of treatment for metastatic castration-resistant prostate cancer (mCRPC). More information about ZYTIGA, visit www.ZYTIGA.com.

Additional Information about ZYTIGA® INDICATION – ZYTIGA® (abiraterone acetate) in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).

IMPORTANT SAFETY INFORMATION Contraindications – ZYTIGA® (abiraterone acetate) is not indicated for use in women. ZYTIGA® can cause fetal harm (Pregnancy Category X) when administered to a pregnant woman and is contraindicated in women who are or may become pregnant.

Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess – Use with caution in patients with a history of cardiovascular disease or with medical conditions that might be compromised by increases in blood pressure, hypokalemia, or fluid retention. ZYTIGA® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Safety has not been established in patients with LVEF <50% or New York Heart Association (NYHA) Class III or IV heart failure (in study 1) or NYHA Class II to IV heart failure (in study 2) because these patients were excluded from these randomized clinical trials. Control hypertension and correct hypokalemia before and during treatment. Monitor blood pressure, serum potassium, and symptoms of fluid retention at least monthly.

Adrenocortical Insufficiency (AI) – AI was reported in patients receiving ZYTIGA® in combination with prednisone/prednisolone, after an interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of AI if prednisone/prednisolone is stopped or withdrawn, if prednisone/prednisolone dose is reduced, or if the patient experiences unusual stress. Symptoms and signs of AI may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA®. Perform appropriate tests, if indicated, to confirm AI. Increased dosages of corticosteroids may be used before, during, and after stressful situations.

Hepatotoxicity – Monitor liver function and modify, withhold, or discontinue ZYTIGA® dosing as recommended (see Prescribing Information for more information). Measure serum transaminases [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)] and bilirubin levels prior to starting treatment with ZYTIGA®, every two weeks for the first three months of treatment, and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the upper limit of normal (ULN) or the bilirubin rises above three times the ULN, interrupt ZYTIGA® treatment and closely monitor liver function.

Increased ZYTIGA® Exposures with Food - ZYTIGA® must be taken on an empty stomach. No food should be eaten for at least two hours before the dose of ZYTIGA® is taken and for at least one hour after the dose of ZYTIGA® is taken. Abiraterone Cmax and AUC0-∞ (exposure) were increased up to 17- and 10-fold higher, respectively, when a single dose of abiraterone acetate was administered with a meal compared to a fasted state.

Adverse Reactions – The most common adverse reactions (≥10%) are fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion.

The most common laboratory abnormalities (>20%) are anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT and hypokalemia.

Drug Interactions – ZYTIGA® is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. Avoid co-administration with CYP2D6 substrates that have a narrow therapeutic index. If an alternative cannot be used, exercise caution and consider a dose reduction of the CYP2D6 substrate. In vitro, ZYTIGA® inhibits CYP2C8. There are no clinical data on its use with drugs that are substrates of CYP2C8. Patients should be monitored closely for signs of toxicity related to the CYP2C8 substrate if used concomitantly with abiraterone acetate.

Based on in vitro data, ZYTIGA® is a substrate of CYP3A4. The effects of strong CYP3A4 inhibitors or inducers on the pharmacokinetics of abiraterone have not been evaluated, in vivo. Strong inhibitors and inducers of CYP3A4 should be avoided or used with caution during treatment with ZYTIGA®.

Use in Specific Populations – Do not use ZYTIGA® in patients with baseline severe hepatic impairment (Child-Pugh Class C).

About ARN-509

ARN-509 is a second generation androgen receptor (AR) antagonist being studied for the treatment of castration resistant prostate cancer (CRPC). In June 2013, Johnson & Johnson acquired Aragon Pharmaceuticals, Inc., including its investigational compound ARN-509, which works by inhibiting androgen receptor nuclear translocation and binding to androgen response elements.[3]

About YONDELIS® (trabectedin)
YONDELIS® (trabectedin) is a novel, multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata. The anti-cancer medicine works by preventing the tumor cells from multiplying and is approved in 77 countries, within North America, Europe, South America and Asia, for the treatment of advanced soft-tissue sarcomas as a single-agent, and in 70 countries for relapsed ovarian cancer in combination with DOXIL®/CAELYX® (doxorubicin HCl liposome injection).

Under a licensing agreement with PharmaMar, a wholly owned member of the Zeltia Group, Janssen Products, LP has the rights to develop and sell YONDELIS globally except in Europe, where PharmaMar SA holds the rights, and in Japan, where PharmaMar has granted a license to Taiho Pharmaceuticals Co., Ltd. If approved in the U.S., YONDELIS would be commercialized by Janssen Biotech, Inc.

About Janssen Research & Development, LLC
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, 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. Janssen Research & Development, LLC; Janssen Products, LP; and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com for more information.

About Janssen Biotech, Inc.
Janssen Biotech, Inc. redefines the standard of care in immunology, oncology, urology and nephrology. Built upon a rich legacy of innovative firsts, Janssen Biotech has delivered on the promise of new treatments and ways to improve the health of individuals with serious disease. Beyond its innovative medicines, Janssen Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and health care professionals have access to the latest treatment information, support services and quality care. For more information on Janssen Biotech, Inc. or its products, visit www.janssenbiotech.com. Follow us on Twitter at www.twitter.com/JanssenUS.

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 a focus on hematologic malignancies, prostate cancer and lung cancer; cancer interception with the goal of developing products that interrupt the carcinogenic process; biomarkers that may help guide targeted, individualized use of our therapies; as well as safe and effective identification and treatment of early changes in the tumor microenvironment. Please visit oncology.janssenrnd.com. ###

###

Media Inquiries:
Kellie McLaughlin
Phone: 1-908-927-7477
Mobile: 1-609-468-8356

Satu Kaarina Glawe
Mobile: 49 172 294 6264

Investor Relations:
Lesley Fishman
Phone: 1-732-524-3922

U.S. Medical Inquiries:
(daratumumab, ZYTIGA, YONDELIS and ARN-509):
1-800-526-7736

(IMBRUVICA: Pharmacyclics):
1-877-877-3536

  • (This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in new product development, including the uncertainty of clinical success and of obtaining regulatory approvals; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 28, 2014, including in Exhibit 99 thereto, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.)


    References:
    [1] IMBRUVICA Prescribing Information, January 2015
    [2] Genetics Home Reference. Isolated growth hormone deficiency. Available at: http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency. Accessed May 2015.
    [3] Rathkopf DE et al. Phase I Study of ARN-509, a Novel Antiandrogen, in the Treatment of Castration-Resistant Prostate Cancer. Journal of Clinical Oncology. 2013 Oct 1;31(28):3525-30. Available from: http://jco.ascopubs.org/content/early/2013/09/03/JCO.2013.50.1684. Accessed May 2015.
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