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Janssen Oncology Data to be Presented at 2013 American Society of Hematology (ASH) Annual Meeting


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© Business Wire 2013
2013-11-19 14:34:01 -

Janssen Research and Development / Division of Janssen Pharmaceutica NV announced that data related to five Janssen compounds have been selected for presentation at the 55 th American Society of Hematology (ASH) Annual Meeting in New Orleans, USA. Fifteen company-sponsored abstracts will be presented, out of a total of 433 abstracts involving Janssen hematology compounds. Data includes presentations on the investigational use of ibrutinib, recently approved by the U.S. Food and Drug Administration/FDA; siltuximab, an investigational anti Interleukin-6 (IL-6) chimeric monoclonal antibody for treating multicentric Castleman disease (MCD); daratumumab, an investigational human CD38 monoclonal antibody being studied in multiple myeloma and other B-cell malignancies; VELCADE ® (bortezomib), a treatment for patients with multiple myeloma, and DACOGEN ® (decitabine), a medicine to treat patients

suffering from acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).

“Therapies for hematologic malignancies are the cornerstone of our broad oncology portfolio at Janssen R&D,” said Peter F. Lebowitz, M.D., Ph.D., global oncology therapeutic area head, Janssen Research & Development, LLC. “It’s rewarding to have such a comprehensive array of data presented at ASH, across our oncology compounds, particularly as we look ahead to potential regulatory milestones for ibrutinib and siltuximab.”


List of Company-sponsored Research to Be Presented

Ibrutinib


Ibrutinib data will be featured in more than 40 abstracts, including both company-sponsored research and investigator-initiated studies. The following studies sponsored by either Janssen or Pharmacyclics have been selected for presentation.



- Ibrutinib in combination with bendamustine and rituximab is active and tolerable in patients with relapsed/refractory CLL/SLL: final results of a phase 1b study. (Abstract 525)


Oral session: CLL: Therapy, excluding Transplantation.

Chemoimmunotherapy Clinical Trials. Monday, December 9 at 3:15 pm CST in Ernest N. Morial Convention Center, 220-222


- Combining ibrutinib with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP): updated results from a phase 1b study in treatment-naïve patients with CD20-positive B-cell non-Hodgkin’s lymphoma (NHL). (Abstract 852)


Oral session: Lymphoma: Therapy with Biological Agents, Excluding Pre-Clinical Models: Aggressive Lymphomas. Tuesday, December 10 at 8:45 am CST in Ernest N. Morial Convention Center, La Nouvelle Ballroom AB


- Changing the treatment paradigm for previously treated chronic lymphocytic leukemia patients with del(17p) karyotype. (Abstract 2872)


Poster session: CLL: Therapy, excluding Transplantation: Poster II.

Sunday, December 8 at 6:30-8:30 pm CST in Ernest N. Morial Convention Center, Hall E


- The Bruton’s tyrosine kinase (BTK) inhibitor ibrutinib (PCI-32765) monotherapy demonstrates long-term safety and durability of response in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) patients in an open-label extension study. (Abstract 4163)


Poster session: CLL: Therapy, excluding Transplantation: Poster I.

Monday, December 9 at 6:00-8:00 pm CST in Ernest N. Morial Convention Center, Hall E

Siltuximab


There are a total of three siltuximab abstracts scheduled for presentation at ASH, including both company-sponsored research and investigator-initiated studies. The following company-sponsored siltuximab data have been selected for presentation.



- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy and Safety Of Siltuximab, An Anti-Interleukin-6 Monoclonal Antibody, In Patients With Multicentric Castleman’s Disease (Abstract 505)


Oral session: Lymphoma: Therapy with Biological Agents, Excluding Pre-Clinical Models: Immunotherapy for Indolent Lymphomas. Monday, December 9 at 2:45-4:15 pm CST in Ernest N. Morial Convention Center, La Nouvelle Ballroom AB


- An Open-Label, Phase 2, Multicenter Study Of The Safety Of Long-Term Treatment With Siltuximab (an Anti-Interleukin-6 Monoclonal Antibody) In Patients With Multicentric Castleman’s Disease (Abstract 1806)


Poster session: Lymphoma: Therapy with Biologic Agents, excluding Pre-Clinical Models: Poster I. Saturday, December 7 at 5:30-7:30 pm CST in Ernest N. Morial Convention Center, Hall G

Daratumumab


A total of three daratumumab abstracts have been selected for presentation and were jointly supported by Janssen and Genmab A/S.

- CD38-Targeted Immunochemotherapy of Multiple Myeloma: Preclinical Evidence for its Combinatorial Use in Lenalidomide and Bortezomib Refractory/Intolerant MM Patients (Abstract 277)


Oral session: Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Drug Resistance. Monday, December 9 at 7 am CST in Ernest N. Morial Convention Center, 391-392


- Daratumumab, a Novel Human Anti-CD38 Monoclonal Antibody, Shows Anti-tumor Activity in Mouse Models of MCL, FL and CLL (Abstract 378)


Oral session: Lymphoma: Pre-Clinical – Chemotherapy and Biologic Agents: Modulating the Immune System in Lymphoma. Monday, December 9 at 11:45 am CST in Ernest N. Morial Convention Center, 220-222


- Preliminary Safety and Efficacy Data of Daratumumab in Combination with Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma (Abstract 1986)


Poster session: Myeloma: Therapy, excluding Transplantation: Poster I. Saturday, December 7 at 5:30-7:30 pm CST in Ernest N. Morial Convention Center, Hall G

VELCADE ®


There are a total of 311 abstracts, including both company-sponsored research and investigator-initiated studies. The following VELCADE clinical study data have been selected for presentation and were sponsored by Janssen or jointly sponsored by Janssen and Millennium: The Takeda Oncology Company.



- Higher Cumulative Bortezomib Dose Results In Better Overall Survival (OS) In Patients With Previously Untreated Multiple Myeloma (MM) Receiving Bortezomib-Melphalan-Prednisone (VMP) In The Phase 3 VISTA Study (Abstract 1968)


Poster session: Myeloma: Therapy, excluding Transplantation: Poster I. Saturday, December 7 at 5:30-7:30 pm CST in Ernest N. Morial Convention Center, Hall G


- Cost-Utility Of Bortezomib In Induction Treatment Prior To Autologous Stem-Cell Transplantation (ASCT) In Previously Untreated Multiple Myeloma Patients In Canada (Abstract 1735)


Poster session: Health Services and Outcomes Research: Poster I.

Saturday, December 7 at 5:30-7:30 pm CST in Ernest N. Morial Convention Center, Hall E


- Quantifying The Risk Of Heart Failure Associated With Proteasome Inhibition: A Retrospective Analysis Of Heart Failure Reported In Phase 2 and Phase 3 Studies Of Bortezomib (Btz) In Multiple Myeloma (MM) (Abstract 3187)


Poster session: Myeloma: Therapy, excluding Transplantation: Poster II. Sunday, December 8 at 6:30-8:30 pm CST in Ernest N. Morial Convention Center, Hall G


- Retrospective Matched-Pair Analysis Of The Efficacy and Safety Of Bortezomib Plus Dexamethasone Versus Bortezomib Monotherapy In Patients (Pts) With Relapsed Multiple Myeloma (MM) (Abstract 3177)


Poster session: Myeloma: Therapy, excluding Transplantation: Poster II. Sunday, December 8 at 6:30-8:30 pm CST in Ernest N. Morial Convention Center, Hall G

DACOGEN ®


There are a total of 76 DACOGEN abstracts, including both company-sponsored research and investigator-initiated studies. The following DACOGEN data have been selected for presentation and were sponsored by Janssen.



- Decitabine In Advanced Chronic Myelomonocytic Leukemia (Abstract 1573)


Poster session: Myelodysplastic Syndromes: Poster I. Saturday, December 7, 2013 at 5:30 PM-7:30 pm CST in Ernest N. Morial Convention Center, Hall E


- Pilot Study To Evaluate The Prevalence Of Actionable Oncogenic Mutations In Patients With Relapsed Refractory Multiple Myeloma (Abstract 755)


Oral session: Myeloma: Biology and Pathophysiology, excluding Therapy: Microenvironment. Monday, December 9, 2013 at 7:15 pm CST in Ernest N. Morial Convention Center, 388-390


About Ibrutinib

Janssen Biotech, Inc. and Pharmacyclics, Inc. entered a collaboration and license agreement in December 2011 to jointly develop and commercialize ibrutinib. On October 30, 2013, Janssen-Cilag International NV (Janssen) announced it had submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ibrutinib for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) or relapsed or refractory mantle cell lymphoma (MCL).

On November 13 th , 2013, the FDA in the U.S. granted approval for the use of ibrutinib in patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Ibrutinib is the first in a class of medicines called Bruton's tyrosine kinase (BTK) inhibitors. BTK is an important protein involved in mediating the cellular signaling pathways which control B-cell maturation and survival. Ibrutinib is the first in a new class of drugs specifically designed to target and inhibit BTK. Ibrutinib forms a strong covalent bond with BTK, which inhibits the excessive transmission of cell survival signals within the malignant B cells and stops their excessive build up in these protected environmental areas. The efficacy and safety of ibrutinib alone and in combination with other treatments is being studied in several blood cancers. 1,2,3


About Siltuximab

Siltuximab is an investigational, anti Interleukin-6 (IL-6) chimeric monoclonal antibody that targets and binds to human IL-6. IL-6 is a multifunctional cytokine produced by various cells such as T cells, B cells, monocytes, fibroblasts and endothelial cells. Dysregulated, or imbalanced, overproduction of IL-6 from activated B cells in affected lymph nodes has been implicated in the pathogenesis of multicentric Castleman disease (MCD), a rare blood disorder. 4 Information about ongoing studies with siltuximab can be found on clinicaltrials.gov.

On September 3, 2013, Janssen announced simultaneous submissions of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) and a Biologic License Application (BLA) to the United States Food and Drug Administration (U.S. FDA) for siltuximab for the treatment of patients with MCD who are HIV-negative and HHV-8-negative.
Siltuximab has been granted orphan drug status in MCD; is has been granted accelerated assessment in the EU and a priority review in the U.S.



About Daratumumab

In August 2012 : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww .. , Genmab A/S granted Janssen Biotech, Inc. an exclusive worldwide license to develop and commercialize daratumumab. Daratumumab is an investigational human monoclonal antibody (mAb) with broad spectrum cytotoxic activity. It targets the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells and may also have potential in other cancers on which CD38 is expressed. In May 2013 : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Ffil .. , 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. Daratumumab has also received Orphan Drug Designation from the US FDA and the EMA for the treatment of multiple myeloma.


About VELCADE ® (bortezomib) 5

VELCADE ® (bortezomib) is a medicine used to treat the blood-based cancer known as multiple myeloma. It contains an active substance called bortezomib and is the first in a specific class of medicines known as proteasome inhibitors. Proteasomes are present in all cells and play an important role in controlling cell function, growth and also how cells interact with the other cells around them. Bortezomib reversibly interrupts the normal working of cell proteasomes causing myeloma cancer cells to stop growing and die.

VELCADE is approved for use in the following groups.

- patients who have not been treated before and who are not suitable for high-dose chemotherapy with a blood stem-cell transplant. In these patients, VELCADE is used in combination with melphalan and prednisone;
- patients who have not been treated before and who are going to receive high-dose chemotherapy followed by a blood-stem-cell transplant. In this group of patients, VELCADE is used in combination with the medicine dexamethasone, or with dexamethasone plus thalidomide;
- as a mono therapy, in patients whose disease is progressive and who have failed to respond to at least one other treatment and have already had, or cannot undergo, a blood-stem-cell transplant.

VELCADE has a predictable safety profile and a favorable benefit–risk ratio. The most common side effects reported with VELCADE include fatigue, gastrointestinal adverse events, transient thrombocytopenia and neuropathy.

VELCADE is the market leader in the treatment of frontline non-transplant eligible multiple myeloma, with more than 400,000 patients treated worldwide. VELCADE is co-developed by Millennium Pharmaceuticals: The Takeda Oncology Company and Janssen Pharmaceutical Companies. Millennium is responsible for commercialisation of VELCADE in the U.S., Janssen Pharmaceutical Companies are responsible for commercialisation in Europe and the rest of the world. Takeda Pharmaceutical Company Limited and Janssen Pharmaceutical K.K.
co-promote VELCADE in Japan.


About DACOGEN ® (decitabine) 6

DACOGEN ® (decitabine), a DNA hypomethylating agent, is approved for use in the EU in adult patients (age 65 years and above) with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organisation (WHO) classification, who are not candidates for standard induction chemotherapy. Acute myeloid leukemia (AML) is an aggressive, fast-growing cancer that starts inside the bone marrow with production of abnormal blood cells.

DACOGEN® is currently approved for the treatment of myelodysplastic syndromes (MDS) in more than 35 countries worldwide including the United States, Brazil, China, India, Korea, Russia and Turkey.

DACOGEN works through incorporation into the DNA (genetic material) of cells where it blocks the activity of enzymes called DNA methyltransferases (DNMTs), which are responsible for promoting the development and progression of cancer. By blocking DNMTs, decitabine blocks the division of tumour cells and leads to their death. The most common side effects with DACOGEN are pyrexia (fever), anaemia (low red blood cell count) and thrombocytopenia (low blood count of platelets).

Janssen-Cilag International NV and its affiliates hold marketing and development rights for DACOGEN in all markets except the United States, Canada,Mexico and Japan, where rights are maintained by our strategic partner, Eisai Inc. and its affiliates.

Details about our complete clinical program are posted on clinicaltrials.gov.



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, Janssen develops innovative products, services and healthcare solutions to help people throughout the world. More information can be found at www.janssen-emea.com : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww .. .

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.

# # #


(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. 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 unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research and Development / Division of Janssen Pharmaceutica NV, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 30, 2012. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww .. , www.jnj.com : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww .. or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

References


1 Buggy JJ and Elias L. Bruton tyrosine kinase (BTK) and its role in B-cell malignancy. Int Rev Immunol. 2012;31:119-132.

2 Woyach JA, Johnson AJ, and Byrd JC. The B-cell receptor signaling pathway as a therapeutic target in CLL. Blood.
2012;120(6):1175-1184.

3 Davis RE, Ngo VN, Lenz G, et al. Chronic active B-cell receptor signaling in diffuse large B-cell lymphoma. Nature.
2010;463(7277):88-92.

4 El-Osta HE, Kurzrock R. Castleman's disease: From basic mechanisms to molecular therapeutics. Oncologist. 2011;16(4):497-511.

5 VELCADE EPAR Available at: www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medic .. : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww .. .
Accessed November 2013.

6 DACOGEN EPAR Available at: www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medic .. : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww .. .
Accessed November 2013.

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For JanssenMedia Inquiries:US: Kellie

McLaughlinPhone: 1-908-927-7477Mobile: 1-609-468-8356orEU:
Satu Kaarina GlawePhone: +49 (0) 2638 947 9218Mobile: +49

(172) 294-6264orInvestor Relations:Stan
PanasewiczPhone: 1-732-524-2524orLouise MehrotraPhone:
1-732-524-6491


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