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ASH 2016: Janssen to Present 43 Abstracts with Data on Ibrutinib, Daratumumab and Other Compounds Showing Treatment Advances in Malignant and Non-Malignant Hematologic Conditions
ASH 2016: Janssen to Present 43 Abstracts with Data on Ibrutinib, Daratumumab and Other Compounds Showing Treatment Advances in Malignant and Non-Malignant Hematologic Conditions
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Key data include Phase 2 five-year follow-up data for ibrutinib in CLL and updated Phase 3 depth of response data for daratumumab in combination with standard of care therapies for patients with multiple myeloma who have received at least one prior therapy

RARITAN, NJ, November 3, 2016 – New data for the first-in-class BTK inhibitor ibrutinib and immunotherapy daratumumab are among the 13 oral presentations from Janssen Research & Development, LLC to be featured at the 58th American Society of Hematology (ASH) Annual Meeting. In total, 43 company-sponsored abstracts for both approved and investigational oncology and cardiovascular compounds have been accepted for presentation – the largest presence of company data at ASH to date. More than 30 investigator-initiated studies for these compounds also will be presented. In addition to ibrutinib and daratumumab, data for the oral anticoagulant rivaroxaban and investigational compound imetelstat will be presented at this year’s meeting. “The unprecedented showing of Janssen data at ASH this year underscores the transformative potential of our approved medicines, as well as the real promise of the investigational compounds in our expanding pipeline,” said William N. Hait, M.D., Ph.D., Global Head, Janssen Research & Development. “We are committed to continuing to explore how these compounds can change the way we diagnose, treat and intercept the many drivers of malignant and non-malignant hematologic conditions for patients with significant unmet medical needs.”

Key company-sponsored data presentations include:

  • Ibrutinib: Five-year follow-up data from two Phase 2 trials will provide an in-depth look into the extended use of ibrutinib as a monotherapy in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). This is the longest follow-up data of ibrutinib to date.

  • The five-year CLL/SLL data will be presented as an oral presentation at 5:00 p.m. PT on Saturday, December 3 (Abstract #233).
  • Ibrutinib: Results from a Phase 2 study assessing the use of ibrutinib in patients with another type of B-cell malignancy, marginal zone lymphoma (MZL), who have received at least one prior therapy, will be presented for the first time. Data from this study were submitted to the U.S. Food and Drug Administration (FDA) in September 2016 as part of a supplemental New Drug Application (sNDA) to expand the current indication for IMBRUVICA.

  • The MZL data will be presented as an oral presentation at 6:15 p.m. PT on Monday, December 5 (Abstract #1213).
  • Daratumumab: Updated analyses from the pivotal Phase 3 CASTOR and POLLUX clinical trials will shed light on the depth of response for daratumumab in combination with bortezomib and dexamethasone, or lenalidomide and dexamethasone, in patients with multiple myeloma who have received at least one prior line of therapy. Data from the CASTOR/POLLUX studies were submitted to the FDA in August 2016 as part of a supplemental Biologics License Application (sBLA) to expand the current indication for DARZALEX.[1]

  • The updated CASTOR data will be presented as an oral presentation at 5:15 p.m. PT on Monday, December 5 (Abstract #1150).
  • The updated POLLUX data will be presented as an oral presentation at 5:30 p.m. PT on Monday, December 5 (Abstract #1151).
  • Daratumumab: An evaluation of minimal residual disease (MRD) – a measure of cancer cells that remain after treatment – among patients receiving daratumumab in the Phase 3 CASTOR and POLLUX trials will also be presented. These data will serve as the first and most comprehensive prospective study of MRD from a Phase 3 trial in the relapsed/refractory setting for multiple myeloma.

  • These data will be presented as an oral presentation at 5:15 p.m. PT on Saturday, December 3 (Abstract #246).
  • Rivaroxaban: Data will be presented evaluating the efficacy, safety and cost-savings of rivaroxaban for the treatment of venous thromboembolism (VTE) in people with cancer. VTE is the second leading cause of death in people with active cancer.

  • These data will be presented as an oral presentation at 1:15 p.m. PT on Saturday, December 3 (Abstract #144).
  • Additional VTE data will be presented as an oral presentation at 4:45 p.m. PT on Monday, December 5 (Abstract #1178).

A full list of company-sponsored abstracts to be presented at the meeting follows below:

Abstract No.
Title
Date/Time
Ibrutinib
Oral Presentations


Abstract #233
Five-year experience with single-agent ibrutinib in patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia/small lymphocytic leukemia

Oral Session
Saturday, December 3
5:00 p.m. PT

Abstract #234
Updated efficacy and safety from the Phase 3 RESONATE-2 study: ibrutinib as first-line treatment option in patients 65 years and older with chronic lymphocytic leukemia/small lymphocytic leukemia

Oral Session
Saturday, December 3
5:15 p.m. PT

Abstract #473
A multicenter open-label Phase 1b/2 study of ibrutinib in combination with lenalidomide and rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
Oral Session
Sunday, December 4
5:30 p.m. PT
Abstract #1213
Single-agent ibrutinib demonstrates efficacy and safety in patients with relapsed/refractory marginal zone lymphoma: a multicenter, open-label, Phase 2 study
Oral Session
Monday, December 5
6:15 p.m. PT
Abstract #1217
Ibrutinib as treatment for chemoimmunotherapy-resistant patients with follicular lymphoma: first results from the open label, multicenter, Phase 2 DAWN study
Oral Session
Monday, December 5
7:15 p.m. PT
Poster Presentations


Abstract #1588
An open-label, sequential-design drug interaction study of the effect of omeprazole on the pharmacokinetics of ibrutinib in healthy adults
Poster Session
Saturday, December 3
5:30 – 7:30 p.m. PT
Abstract #2039
Single-agent ibrutinib vs standard of care for patients with relapsed/refractory (R/R) and treatment-naïve (TN) chronic lymphocytic leukemia (CLL): an adjusted comparison of RESONATE and RESONATE-2 with the French Lyon-Sud database

Poster Session
Saturday, December 3
5:30 – 7:30 p.m. PT

Abstract #2041
Outcomes of ibrutinib therapy by age in patients with CLL/SLL: analyses from Phase 3 trial data (RESONATE and RESONATE-2)
Poster Session
Saturday, December 3
5:30 – 7:30 p.m. PT
Abstract #2042
11q deletion (del11q) is not a prognostic factor for adverse outcomes for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) treated with ibrutinib: pooled data from 3 randomized Phase 3 studies
Poster Session
Saturday, December 3
5:30 – 7:30 p.m. PT
Abstract #1804
Ibrutinib combined with rituximab in treatment-naïve patients with follicular lymphoma: arm 1 + arm 2 results from a multicenter, open-label Phase 2 study
Poster Session
Saturday, December 3
5:30 PM - 7:30 p.m. PT
Abstract #2980
Pseudo-progression among patients with follicular lymphoma treated with ibrutinib in the Phase 2 DAWN study
Poster Session
Sunday, December 4
6:00 – 8:00 p.m. PT
Abstract #3964
A drug-drug interaction study of ibrutinib with moderate and strong CYP3A inhibitors in patients with B-cell malignancy
Poster Session
Monday, December 5
6:00 – 8:00 p.m. PT
Abstract #4397
Early changes in circulating T-cell immune profiles in patients with relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma: data from the Phase 3, double-blind HELIOS trial
Poster Session
Monday, December 5
6:00 – 8:00 p.m. PT
Abstract #4403

Systemic exposure of rituximab increased by ibrutinib: pharmacokinetic results from the HELIOS trial

Poster Session
Monday, December 5
6:00 – 8:00 p.m. PT
Abstract #4140
Ibrutinib potentiated NK cell-mediated cytotoxicity in mouse models of B-cell lymphomas
Poster Session
Monday, December 5
6:00 – 8:00 p.m. PT
Abstract #4383
Integrated and long-term safety analysis of ibrutinib in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)
Poster Session
Monday, December 5
6:00 – 8:00 p.m. PT
Abstract #4384
Changes in clinical stage identify different response categories among patients in IWCLL PR: analysis of CLL patients on the RESONATE study
Poster Session
Monday, December 5
6:00 – 8:00 p.m. PT

Daratumumab
Oral Presentations


Abstract #246
Evaluation of minimal residual disease (MRD) in relapsed/refractory multiple myeloma (RRMM) patients treated with daratumumab in combination with lenalidomide plus dexamethasone or bortezomib plus dexamethasone

Oral Session
Saturday, December 3
5:15 p.m. PT

Abstract #489
Efficacy of daratumumab, lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone for relapsed or refractory multiple myeloma among patients with 1 to 3 prior lines of therapy based on previous treatment exposure: updated analysis of POLLUX
Oral Session
Sunday, December 4
5:00 p.m. PT

Abstract #1149

Open-label, multicenter, dose escalation Phase 1b study to assess the subcutaneous delivery of daratumumab in patients (pts) with relapsed or refractory multiple myeloma (PAVO)

Oral Session
Monday, December 5
5:00 p.m. PT

Abstract #1150
Efficacy of daratumumab, bortezomib, and dexamethasone versus bortezomib and dexamethasone in relapsed or refractory myeloma based on prior lines of therapy: updated analysis of CASTOR

Oral Session
Monday, December 5
5:15 p.m. PT

Abstract #1151
Efficacy of daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone in relapsed or refractory multiple myeloma patients with 1 to 3 prior lines of therapy: updated analysis of POLLUX

Oral Session
Monday, December 5
5:30 p.m. PT

Poster Presentations


Abstract #2063
Overcoming the interference of daratumumab with immunofixation electrophoresis (IFE) using an industry-developed DIRA test: hydrashift 2/4 daratumumab
Poster Session
Saturday, December 3
5:30 – 7:30 p.m. PT
Abstract #2101
Potentiation of anti-myeloma activity of daratumumab with combination of cyclophosphamide, lenalidomide or bortezomib via a tumor secretory response that greatly augments macrophage-induced ADCP
Poster Session
Saturday, December 3
5:30 – 7:30 p.m. PT
Abstract #2133
Results of an early access treatment protocol (EAP) of daratumumab in United States patients with relapsed or refractory multiple myeloma
Poster Session
Saturday, December 3
5:30 – 7:30 p.m. PT
Abstract #2142
Use of montelukast to reduce infusion reactions in an early access treatment protocol of daratumumab in United States patients with relapsed or refractory multiple myeloma
Poster Session
Saturday, December 3
5:30 – 7:30 p.m. PT
Abstract #3313
Daratumumab, bortezomib and dexamethasone versus bortezomib and dexamethasone alone for relapsed or refractory multiple myeloma based on prior treatment exposure: updated efficacy analysis of CASTOR

Poster Session
Sunday, December 4
6:00 – 8:00 p.m. PT

Abstract #3340
Population pharmacokinetic and exposure-response analyses for daratumumab in combination therapies for patients with multiple myeloma who have received 1 or more prior lines of therapy

Poster Session
Sunday, December 4
6:00 – 8:00 p.m. PT

Abstract #3332
Comparative effectiveness of daratumumab monotherapy versus a real-world historical control from the Czech Republic in heavily pretreated and highly refractory multiple myeloma patients

Poster Session
Sunday, December 4
6:00 – 8:00 p.m. PT

Abstract #4414
Natural history of relapsed myeloma, refractory to immunomodulatory drugs and proteasome inhibitors: a multicenter IMWG study
Poster Session
Monday, December 5
6:00 – 8:00 p.m. PT
Abstract #4517
Adjusted comparisons suggest daratumumab is associated with prolonged survival compared with standard of care therapies in patients with heavily pre-treated and highly refractory multiple myeloma

Poster Session
Monday, December 5
6:00 – 8:00 p.m. PT

Abstract #4521
High-parameter mass cytometry (CyTOF) evaluation of relapsed/refractory multiple myeloma (MM) patients (pts) treated with daratumumab supports immune modulation as a novel mechanism of action

Poster Session
Monday, December 5
6:00 – 8:00 p.m. PT

Abstract #4531
Daratumumab in combination with lenalidomide plus dexamethasone induces clonality increase and t-cell expansion: results from a Phase 3 randomized study (POLLUX)

Poster Session
Monday, December 5
6:00 – 8:00 p.m. PT

Rivaroxaban
Oral Presentations


Abstract #144
Risk of venous thromboembolism recurrence among rivaroxaban treated patients who continued versus discontinued therapy: analyses among VTE patients
Oral Session
Saturday, December 3
1:15 p.m. PT
Abstract #533
External validation of a clinical and claims-based approach for predicting 90-day post-pulmonary embolism outcomes among U.S. veterans
Oral Session
Sunday, December 4
5:30 p.m. PT
Abstract #1178
Safety of anticoagulant therapies for treatment of venous thromboembolism in patients with cancer
Oral Session
Monday, December 5
4:45 p.m. PT
Poster Presentations


Abstract #1438
Subgroup analysis of patients with cancer in XALIA, a non-interventional study of rivaroxaban in routine treatment of deep vein thrombosis
Poster Session
Saturday, December 3
5:30 – 7:30 p.m. PT
Abstract #1447
Major bleeding events among cancer and non-cancer patients taking rivaroxaban for venous thromboembolism treatment in a Department of Defense health system cohort
Poster Session
Saturday, December 3
5:30 – 7:30 p.m. PT
Abstract #2337
Reduced costs and length-of-stay associated with rivaroxaban as compared to parenteral bridging and warfarin in pulmonary embolism patients managed in observation status
Poster Session
Saturday, December 3
5:30 – 7:30 p.m. PT
Abstract #3524
VTE-related healthcare resource utilization and costs associated with venous thromboembolism in cancer patients treated with anticoagulants
Poster Session
Sunday, December 4
6:00 – 8:00 p.m. PT
Abstract #4734
Healthcare resource utilization and costs associated with venous thromboembolism recurrence in patients with cancer
Poster Session
Monday, December 5
6:00 – 8:00 p.m. PT
Imetelstat
Poster Presentations


Abstract #1938
Dynamics of telomere length reflect the clonal suppression seen with the telomerase inhibitor imetelstat in patients with essential thrombocythemia
Poster Session
Saturday, December 3
5:30 – 7:30 p.m. PT
Abstract #4769
Characterization of disease, treatment patterns, and outcomes of patients with myelofibrosis: analysis of 2 United States commercial claims databases
Poster Session
Monday, December 5
6:00 – 8:00 p.m. PT

About IMBRUVICA® (ibrutinib)
IMBRUVICA was one of the first therapies to receive U.S. regulatory approval after having received Breakthrough Therapy Designation from the FDA. IMBRUVICA works by blocking a specific protein called Bruton's tyrosine kinase (BTK).[2] 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.[3] IMBRUVICA targets and blocks BTK, inhibiting cancer cell survival and spread. IMBRUVICA is jointly developed and commercialized by Janssen and Pharmacyclics LLC, an AbbVie company. For more information, visit www.IMBRUVICA.com.

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

  • Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL)
    · Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion
  • Waldenström’s macroglobulinemia (WM)
  • 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.

IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS

Hemorrhage - Fatal bleeding events have occurred in patients treated with IMBRUVICA®. Grade 3 or higher bleeding events (intracranial hemorrhage [including 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 IMBRUVICA®.

The mechanism for the bleeding events is not well understood. IMBRUVICA® may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies and patients should be monitored for signs of bleeding. Consider the benefit-risk of withholding IMBRUVICA® for at least 3 to 7 days pre- and postsurgery depending upon the type of surgery and the risk of bleeding.

Infections - Fatal and nonfatal infections have occurred with IMBRUVICA® therapy. Grade 3 or greater infections occurred in 14% to 29% of patients. Cases of progressive multifocal leukoencephalopathy (PML) have occurred in patients treated with IMBRUVICA®. Evaluate patients for fever and infections and treat appropriately.

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%) based on laboratory measurements occurred in patients treated with single agent IMBRUVICA®. Monitor complete blood counts monthly.

Atrial Fibrillation - Atrial fibrillation and atrial flutter (range, 6% to 9%) have occurred in patients treated with IMBRUVICA®, particularly in patients with cardiac risk factors, hypertension, acute infections, and a previous history of atrial fibrillation. Periodically monitor patients clinically for atrial fibrillation. Patients who develop arrhythmic symptoms (eg, palpitations, lightheadedness) or new-onset dyspnea should have an ECG performed. Atrial fibrillation should be managed appropriately and if it persists, consider the risks and benefits of IMBRUVICA® treatment and follow dose modification guidelines.

Hypertension - Hypertension (range, 6% to 17%) has occurred in patients treated with IMBRUVICA® with a median time to onset of 4.6 months (range, 0.03 to 22 months). Monitor patients for new-onset hypertension or hypertension that is not adequately controlled after starting IMBRUVICA®. Adjust existing antihypertensive medications and/or initiate antihypertensive treatment as appropriate.

Second Primary Malignancies - Other malignancies (range, 5% to 16%) including non-skin carcinomas (range, 1% to 4%) have occurred in patients treated with IMBRUVICA®. The most frequent second primary malignancy was non-melanoma skin cancer (range, 4% to 13%).

Tumor Lysis Syndrome - Tumor lysis syndrome has been infrequently reported with IMBRUVICA® therapy. Assess the baseline risk (eg, high tumor burden) and take appropriate precautions. Monitor patients closely and treat as appropriate.

Embryo-Fetal Toxicity - Based on findings in animals, IMBRUVICA® can cause fetal harm when administered to a pregnant woman. Advise women to avoid becoming pregnant while taking IMBRUVICA® and for 1 month after cessation of therapy. 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 (≥20%) in patients with B-cell malignancies (MCL, CLL/SLL, and WM) were neutropenia* (64%), thrombocytopenia* (63%), diarrhea (43%), anemia* (41%), musculoskeletal pain (30%), rash (29%), nausea (29%), bruising (29%), fatigue (27%), hemorrhage (21%), and pyrexia (21%).

*Based on adverse reactions and/or laboratory measurements (noted as platelets, neutrophils, or hemoglobin decreased).

The most common Grade 3 or 4 non-hematologic 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 reactions.

Approximately 4%-10% (CLL), 9% (MCL), and 6% (WM) of patients discontinued due to adverse reactions. Most frequent adverse reactions leading to discontinuation were pneumonia, hemorrhage, atrial fibrillation, rash and neutropenia (1% each) in CLL patients and subdural hematoma (1.8%) in MCL patients.

DRUG INTERACTIONS
CYP3A Inhibitors - Avoid coadministration with strong and moderate CYP3A inhibitors. If a moderate CYP3A inhibitor must be used, reduce the IMBRUVICA® dose.

CYP3A Inducers - Avoid coadministration 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 IMBRUVICA® dose.

Please see Full Prescribing Information: https://www.imbruvica.com/docs/librariesprovider7/default-document-library/prescribing_information.pdf.

About DARZALEX® (daratumumab) Injection, for Intravenous Infusion
DARZALEX® (daratumumab) injection for intravenous use is the first CD38-directed monoclonal antibody (mAb) approved anywhere in the world.[4] CD38 is a surface protein that is highly expressed across multiple myeloma cells, regardless of disease stage.[5] Daratumumab is believed to induce tumor cell death through multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), as well as through apoptosis, in which a series of molecular steps in a cell lead to its death.4 Daratumumab also demonstrates other effects on the immune system, including breaking down the cell membrane of immunosuppressive CD38+ regulatory T cells (Tregs) and myeloid derived suppressor cells (MDSCs).4 DARZALEX is being evaluated in a comprehensive clinical development program that includes five Phase 3 studies across a range of treatment settings in multiple myeloma, such as in frontline and relapsed settings. Additional studies are ongoing or planned to assess its potential for a solid tumor indication and in other malignant and pre-malignant diseases in which CD38 is expressed, such as smoldering myeloma and non-Hodgkin's lymphoma. DARZALEX was the first mAb to receive regulatory approval to treat relapsed or refractory multiple myeloma.4

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize DARZALEX. DARZALEX is commercialized in the U.S. by Janssen Biotech, Inc. For more information, visit www.DARZALEX.com.

DARZALEX® (daratumumab) Important Safety Information – Professional

CONTRAINDICATIONS - None

WARNINGS AND PRECAUTIONS
Infusion Reactions – DARZALEX® can cause severe infusion reactions. Approximately half of all patients experienced a reaction, most during the first infusion. Infusion reactions can also occur with subsequent infusions. Nearly all reactions occurred during infusion or within 4 hours of completing an infusion. Prior to the introduction of post-infusion medication in clinical trials, infusion reactions occurred up to 48 hours after infusion. Severe reactions have occurred, including bronchospasm, hypoxia, dyspnea, and hypertension. Signs and symptoms may include respiratory symptoms, such as cough, wheezing, larynx and throat tightness and irritation, laryngeal edema, pulmonary edema, nasal congestion, and allergic rhinitis. Less common symptoms were hypotension, headache, rash, urticaria, pruritus, nausea, vomiting, and chills.

Pre-medicate patients with antihistamines, antipyretics, and corticosteroids. Frequently monitor patients during the entire infusion. Interrupt infusion for reactions of any severity and institute medical management as needed. Permanently discontinue therapy for life-threatening (Grade 4) reactions. For patients with Grade 1, 2, or 3 reactions, reduce the infusion rate when re-starting the infusion.

To reduce the risk of delayed infusion reactions, administer oral corticosteroids to all patients the first and second day after all infusions. Patients with a history of obstructive pulmonary disorders may require additional post-infusion medications to manage respiratory complications. Consider prescribing short- and long-acting bronchodilators and inhaled corticosteroids for patients with obstructive pulmonary disorders.

Interference with Serological Testing - Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive Indirect Antiglobulin Test (Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab infusion. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient’s serum. The determination of a patient’s ABO and Rh blood type are not impacted. Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX®. Type and screen patients prior to starting DARZALEX®.

Interference with Determination of Complete Response - Daratumumab is a human IgG kappa monoclonal antibody that can be detected on both, the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein.

Adverse Reactions - The most frequently reported adverse reactions (incidence ≥20%) were: infusion reactions (48%), fatigue (39%), nausea (27%), back pain (23%), pyrexia (21%), cough (21%), and upper respiratory tract infection (20%).

Serious adverse reactions were reported in 51 (33%) patients. The most frequent serious adverse reactions were pneumonia (6%), general physical health deterioration (3%), and pyrexia (3%).

DRUG INTERACTIONS - No drug interaction studies have been performed

WHAT IS XARELTO®?
XARELTO® is a prescription medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation, not caused by a heart valve problem. For patients currently well managed on warfarin, there is limited information on how XARELTO® and warfarin compare in reducing the risk of stroke. XARELTO® is also a prescription medicine used to treat deep vein thrombosis and pulmonary embolism, and to help reduce the risk of these conditions occurring again. XARELTO® is also a prescription medicine used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery.

IMPORTANT SAFETY INFORMATION

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO®?

· For people taking XARELTO® for atrial fibrillation: People with atrial fibrillation (an irregular heart beat) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. XARELTO® lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO®, you may have increased risk of forming a clot in your blood.

· Do not stop taking XARELTO® without talking to the doctor who prescribes it for you. Stopping XARELTO® increases your risk of having a stroke.

· If you have to stop taking XARELTO®, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming.

· XARELTO® can cause bleeding, which can be serious, and rarely may lead to death. This is because XARELTO® is a blood thinner medicine that reduces blood clotting. While you take XARELTO® you are likely to bruise more easily and it may take longer for bleeding to stop.

You may have a higher risk of bleeding if you take XARELTO® and take other medicines that increase your risk of bleeding, including:

· Aspirin or aspirin-containing products

· Non-steroidal anti-inflammatory drugs (NSAIDs)

· Warfarin sodium (Coumadin®, Jantoven®)

· Any medicine that contains heparin

· Clopidogrel (Plavix®)

· Selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)

· Other medicines to prevent or treat blood clots

Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.

Call your doctor or get medical help right away if you develop any of these signs or symptoms of bleeding:
· Unexpected bleeding or bleeding that lasts a long time, such as:

· Nosebleeds that happen often

· Unusual bleeding from gums

· Menstrual bleeding that is heavier than normal, or vaginal bleeding

· Bleeding that is severe or that you cannot control

· Red, pink, or brown urine

· Bright red or black stools (looks like tar)

· Cough up blood or blood clots

· Vomit blood or your vomit looks like “coffee grounds”

· Headaches, feeling dizzy or weak

· Pain, swelling, or new drainage at wound sites

Spinal or epidural blood clots (hematoma): People who take a blood thinner medicine (anticoagulant) like XARELTO®, and have medicine injected into their spinal and epidural area, or have a spinal puncture, have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if:
· A thin tube called an epidural catheter is placed in your back to give you certain medicine

· You take NSAIDs or a medicine to prevent blood from clotting

· You have a history of difficult or repeated epidural or spinal punctures

· You have a history of problems with your spine or have had surgery on your spine

If you take XARELTO® and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain, tingling, numbness, muscle weakness, (especially in your legs and feet), or loss of control of the bowels or bladder (incontinence).
XARELTO® is not for patients with artificial heart valves.

WHO SHOULD NOT TAKE XARELTO®?

Do not take XARELTO® if you:

· Currently have certain types of abnormal bleeding. Talk to your doctor before taking XARELTO® if you currently have unusual bleeding.

· Are allergic to rivaroxaban or any of the ingredients of XARELTO®.

WHAT SHOULD I TELL MY DOCTOR BEFORE OR WHILE TAKING XARELTO®?

Before taking XARELTO®, tell your doctor if you:

· Have ever had bleeding problems

· Have liver or kidney problems

· Have any other medical condition

· Are pregnant or plan to become pregnant. It is not known if XARELTO® will harm your unborn baby. Tell your doctor right away if you become pregnant while taking XARELTO®. If you take XARELTO® during pregnancy, tell your doctor right away if you have bleeding or symptoms of blood loss.

· Are breastfeeding or plan to breastfeed. It is not known if XARELTO® passes into your breast milk. You and your doctor should decide if you will take XARELTO® or breastfeed.

Tell all of your doctors and dentists that you are taking XARELTO®. They should talk to the doctor who prescribed XARELTO® for you before you have any surgery, medical or dental procedure.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way XARELTO® works. Certain medicines may increase your risk of bleeding. See “What is the most important information I should know about XARELTO®?”

Especially tell your doctor if you take:

· Ketoconazole (Nizoral®)

· Itraconazole (Onmel™, Sporanox®)

· Ritonavir (Norvir®)

· Lopinavir/ritonavir (Kaletra®)

· Indinavir (Crixivan®)

· Carbamazepine (Carbatrol®, Equetro®, Tegretol®, Tegretol®-XR, Teril™, Epitol®)

· Phenytoin (Dilantin-125®, Dilantin®)

· Phenobarbital (Solfoton™)

· Rifampin (Rifater®, Rifamate®, Rimactane®, Rifadin®)

· St. John’s wort (Hypericum perforatum)

Ask your doctor if you are not sure if your medicine is one listed above. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

HOW SHOULD I TAKE XARELTO®?

Take XARELTO® exactly as prescribed by your doctor.

Do not change your dose or stop taking XARELTO® unless your doctor tells you to.

Your doctor will tell you how much XARELTO® to take and when to take it.

Your doctor may change your dose if needed.

If you take XARELTO® for:

· Atrial Fibrillation: Take XARELTO® 1 time a day with your evening meal.

· If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time.

· Blood clots in the veins of your legs or lungs:

o Take XARELTO® once or twice a day as prescribed by your doctor.

o Take XARELTO® with food at the same time each day.

o If you miss a dose of XARELTO®:

  • and take XARELTO® 2 times a day: Take XARELTO® as soon as you remember on the same day. You may take 2 doses at the same time to make up for the missed dose. Take your next dose at your regularly scheduled time.
  • and take XARELTO® 1 time a day: Take XARELTO® as soon as you remember on the same day. Take your next dose at your regularly scheduled time.

· Hip or knee replacement surgery: Take XARELTO® 1 time a day with or without food. If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time.

· If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take XARELTO®.

· Your doctor will decide how long you should take XARELTO®. Do not stop taking XARELTO® without talking to your doctor first.

· Your doctor may stop XARELTO® for a short time before any surgery, medical or dental procedure. Your doctor will tell you when to start taking XARELTO® again after your surgery or procedure.

· Do not run out of XARELTO®. Refill your prescription for XARELTO® before you run out. When leaving the hospital following a hip or knee replacement, be sure that you have XARELTO® available to avoid missing any doses.

· If you take too much XARELTO®, go to the nearest hospital emergency room or call your doctor right away.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO®?

Please see “What is the most important information I should know about XARELTO®?”

Tell your doctor if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You are also encouraged to report side effects to the FDA: visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.
You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).

Please click here for full Prescribing Information, including Boxed Warnings, and Medication Guide.

Trademarks are those of their respective owners.
Janssen and Bayer together are developing rivaroxaban.
For more information about XARELTO®, visit www.xarelto.com.

About Imetelstat
Janssen entered into an exclusive worldwide license and collaboration agreement with Geron Corporation (Nasdaq: GERN) in November 2014 to develop and commercialize imetelstat, an investigational telomerase inhibitor. Imetelstat is a specially designed and modified short oligonucleotide, which targets and binds directly with high affinity to the active site of telomerase. Imetelstat has not been approved for marketing by any regulatory authority.

About the Janssen Pharmaceutical Companies
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenUS and www.twitter.com/JanssenGlobal.

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Cautions Concerning Forward-Looking Statements
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 inherent in product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new products; manufacturing difficulties or delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; 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 January 3, 2016, 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.

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:
(DARZALEX, XARELTO and imetelstat):
1-800-526-7736

(IMBRUVICA –Pharmacyclics/AbbVie): 1-877-877-3536

[1] Janssen Biotech, Inc. “Janssen Submits Application to U.S. FDA to Expand Indication for Daratumumab (DARZALEX®).” Issued August 17, 2016.
[2] IMBRUVICA U.S. Prescribing Information, May 2016.
[3] Genetics Home Reference. Isolated growth hormone deficiency. Available from:
http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency. Accessed August 2016.
[4] DARZALEX Prescribing Information, November 2015.
[5] Lin P, Owens R, Tricot G, Wilson CS. Flow cytometric immunophenotypic analysis of 306 cases of multiple myeloma. Am J Clin Pathol. 2004;121:482–488. doi: 10.1309/74R4TB90BUWH27JX.

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