Janssen Biotech, Inc. / Johnson & Johnson (Janssen)

Oncology Corporate Profile

HQ Location

800 Ridgeview Road
Horsham, PA 19044

Company Description

Janssen Biotech (formerly Centocor Ortho Biotech) has ways of making your immune system behave itself. The Johnson & Johnson (J&J) subsidiary makes blockbuster biotech drug Remicade, a monoclonal antibody used to treat a number of autoimmune conditions, or diseases in which the body's immune system attacks its own tissues. It is approved in the US and Europe for several indications including Crohn's disease, ulcerative colitis, psoriasis, arthritis, and ankylosing spondylitis (a type of arthritis of the spine). The company also makes anemia therapy Procrit, oncology drugs Doxil and Leustatin, psoriasis drug Stelara, and immunosuppressant Orthoclone for organ transplantation.

Website: http://www.janssenbiotech.com/

Brand Generic Indication
Darzalex® daratumumabDarzalex® is a CD38-directed cytolytic antibody indicated:
- in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy
- in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor
- as monotherapy, 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 or who are doublerefractory to a PI and an immunomodulatory agent.
Doxil®doxorubicin HCl liposome injection)Doxil® is an anthracycline topoisomerase inhibitor indicated for:

• Ovarian cancer, after failure of platinum-based chemotherapy.

• AIDS-related Kaposi's Sarcoma, after failure of prior systemic chemotherapy or intolerance to such therapy.

• Multiple Myeloma, in combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy.
Erleada™apalutamideErleada™ is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer
Procrit®epoetin alfaProcrit® is an erythropoiesis-stimulating agent (ESA) indicated for treatment of anemia due to chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis and zidovudine in HIV-infected patients. The effects of concomitant myelosuppressive chemotherapy and upon initiation, there is a minimum of two additional months of planned chemotherapy. Reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery.
Zytiga®abiraterone acetateZytiga® is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer.

View additional information on commercial products here »

  • Brand
  • Generic
  • Investigational
Brand / Product Class Area of Study Phase Partnership
ibrutinib / PCI-32765Bruton's tyrosine kinase (BTK) inhibitor2nd line metastatic Chronic Lymphocytic Leukemia (CLL)IIIPharmacyclics
ibrutinib (+ bendamustine and rituximab) / PCI-32765Bruton's tyrosine kinase (BTK) inhibitor2nd line metastatic Chronic Lymphocytic Leukemia (CLL)IIIPharmacyclics
ibrutinib / PCI-32765Bruton's tyrosine kinase (BTK) inhibitor2nd line metastatic Mantle Cell Lymphoma (MCL)IIIPharmacyclics
Zytiga® / abiraterone acetate / CB-7630inhibitor of the steroidal enzyme 17 alpha-hydroxylase/C17,20 lyase (oral)1st line metastatic hormone-refractory Prostate cancer (HRPC)III
ibrutinib / PCI-32765Bruton's tyrosine kinase (BTK) inhibitor2nd line metastatic Mantle Cell Lymphoma (MCL)IIPharmacyclics
Zytiga® / abiraterone acetate / CB-7630inhibitor of the steroidal enzyme 17 alpha-hydroxylase/C17,20 lyase (oral)Breast cancerII
ibrutinib (+ R-CHOP) / PCI-32765Bruton's tyrosine kinase (BTK) inhibitor1st line metastatic B-Cell Non Hodgkin Lymphoma (NHL)IPharmacyclics
JNJ-64052781CD19 antigen modulatorVarious cancer typesI

Source: http://www.janssenbiotech.com/

Recent News Headlines

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

11/3/2016 04:35 pm

(Yahoo! Finance) Nov 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 Annual Meeting.

NICE Turns Down Janssen's Imbruvica For Rare Blood Cancer

10/14/2016 04:21 pm

(PharmaTimes [UK]) Oct 13, 2016 - Cost regulators for the NHS in England and Wales have turned down Janssen's Imbruvica for treating some people with Waldenstrom's macroglobulinaemia (WM) - a rare type of slow growing non-Hodgkin's lymphoma.

Geron Provides Update on Imetelstat Trials Being Conducted by Janssen

9/13/2016 04:19 pm

(Geron) Sept 12, 2016 - Geron Corporation today provided updates on the clinical trials being conducted by Janssen Research & Development, LLC, of the telomerase inhibitor imetelstat. Planned internal reviews of initial data from both trials have been completed by Janssen, and both trials are continuing in order to evaluate additional and more mature data.

Janssen: Submits Application to the European Medicines Agency (EMA) to Expand Use of DARZALEX® (daratumumab) to Include Combination with Standard of Care Regimens

8/25/2016 04:22 pm

(4-traders) Aug 23, 2016 - Phase 3 data supporting submission suggests potential clinical benefit of daratumumab as a backbone therapy in combination with either a proteasome inhibitor (PI) or an immunomodulatory agent for relapsed multiple myeloma patients.

Janssen Submits Application To U.S. FDA To Expand Indication For Daratumumab (DARZALEX®)

8/18/2016 12:18 pm

(TheStreet) Aug 17, 2016 - Janssen Biotech, Inc. announced today a supplemental Biologics License Application (sBLA) for daratumumab (DARZALEX ®) has been submitted to the U.S. Food and Drug Administration (FDA).

NICE Says Novartis’ And Janssen’s Cancer Drugs Are Not Cost Effective

8/18/2016 12:17 pm

(European Pharmaceutical Review) Aug 18, 2016 - In new draft guidance, the National Institute for Health and Care Excellence (NICE) has advised that everolimus, for treating advanced breast cancer after endocrine therapy, and ibrutinib, for treating relapsed or refractory mantle cell lymphoma, be removed from the Cancer Drugs Fund for not being cost effective.

Bristol-Myers Squibb Announces New Research Collaboration with Janssen in Immuno-Oncology Focused on Lung Cancer

7/26/2016 12:12 pm

(Yahoo! Finance) July 26, 2016 - Bristol-Myers Squibb Company today announced a new clinical research collaboration with Janssen Biotech, Inc. to evaluate Bristol-Myers Squibb’s Immuno-Oncology (I-O) agent Opdivo (nivolumab) and Janssen’s Live Attenuated Double–Deleted (LADD) Listerial monocytogenes cancer immunotherapy, expressing mesothelin and EGFRvIII (JNJ-64041757), in patients with non-small cell lung cancer (NSCLC).

New Cancer Immunotherapy Drugs Linked To Arthritis in Some Patients

6/24/2016 12:02 pm

(Johns Hopkins Medicine) June 23, 2016 - A small number of cancer patients taking the immunotherapy drugs ipilimumab and nivolumab may be at some higher-than-normal risk of developing autoimmune joint and tissue diseases, including inflammatory arthritis, according to a preliminary study at Johns Hopkins.

Janssen’s EPREX® (epoetin alfa) Demonstrates Effectiveness as a Treatment for Anaemia in Patients with Low or Intermediate-1 Risk Myelodysplastic Syndromes

6/13/2016 05:01 pm

(StreetInsider) June 11, 2016 - Final results from Phase 3 EPOANE 3021 study also showed significantly fewer patients needing transfusion and significant improvements in quality of life.

Moffitt Cancer Center Researchers Present Phase 1 Study Results of Selinexor Combination Therapy for Multiple Myeloma Patients

6/7/2016 02:01 pm

(Moffitt) June 6, 2016 - Moffitt Cancer Center will present results from a phase 1 study of selinexor in combination with liposomal doxorubicin and dexamethasone in patients with relapsed and refractory multiple myeloma. The findings will be discussed Monday, June 6, during the American Society of Clinical Oncology Annual Meeting in Chicago.

NICE Asks Janssen To Make Case For Imbruvica on CDF

6/1/2016 04:44 pm

(PharmaTimes [UK]) June 1, 2016 - Janssen has slammed a draft decision by the National Institute for Health and Care Excellence rejecting NHS funding for its cancer drug Imbruvica to treat patients with Chronic Lymphocytic Leukaemia (CLL).

Genmab Achieves USD 30 Million Milestone in DARZALEX (daratumumab) Collaboration with Janssen

5/31/2016 04:19 pm

(MSN Money) May 30, 2016 - Genmab to receive USD 30 million milestone payment from Janssen; milestone triggered by first commercial sale of DARZALEX in Europe.

MacroGenics Enters Collaboration and License Agreement with Janssen to Develop New DART Molecule for Treatment of Cancer

5/18/2016 05:45 pm

(Yahoo! Finance) May 18, 2016 - MacroGenics, Inc. today announced a global collaboration and license agreement for MGD015, a preclinical bispecific molecule, with Janssen Biotech, Inc.

Post-Mortem Cancer Study Goes National

5/13/2016 11:05 am

(Cancer Research UK) May 13, 2016 - Cancer Research UK has today announced a £4 million investment to expand the UK's first ever national study collecting blood and tissue samples from patients who have died from cancer, in a bid to shed light on what happens during the final stages of the disease.

Immunomedics Reports Responses With Sacituzumab Govitecan (IMMU-132) in Patients With Metastatic Solid Cancers Who Failed Prior Checkpoint-Inhibitor Therapy

5/2/2016 11:01 am

(Yahoo! Finance) Apr 29, 2016 - Immunomedics, Inc. today announced that objective durable responses have been achieved with sacituzumab govitecan, its lead antibody-drug conjugate (ADC), in a number of patients with advanced, metastatic solid cancers, after failing multiple prior therapies, some including checkpoint inhibitors (CPIs).

Janssen’s IMBRUVICA® (ibrutinib) Receives Positive CHMP Opinion for Expanded Use in Previously Untreated Chronic Lymphocytic Leukaemia Patients

4/29/2016 04:25 pm

(Yahoo! Finance) Apr 29, 2016 - Recommendation based on RESONATE™-2 trial which showed IMBRUVICA significantly improved progression-free survival and prolonged overall survival versus chlorambucil.

Next Generation ACO Model Letter of Intent Deadline Extended

4/25/2016 11:04 am

(ACCC) Apr 21, 2016 - The Centers for Medicare & Medicaid Services (CMS) announced that the deadline for submission of a Next Generation ACO Model Letter of Intent (LOI) has been extended to May 20, 2016.

FDA Panel Meets To Discuss Sarepta Muscular Dystrophy Drug

4/25/2016 11:04 am

(Reuters) Apr 25, 2016 - Hundreds of patients and advocates packed a hotel ballroom in Hyattsville, Maryland on Monday to try to persuade advisors to the U.S. Food and Drug Administration to support approval of an experimental drug to treat Duchenne muscular dystrophy.

Roche ‘Very Optimistic’ On Prospects For New Cancer Drugs

4/19/2016 02:00 pm

(Financial Times) Apr 19, 2016 - Roche said its efforts to catch up with Merck and Bristol-Myers Squibb in cancer immunotherapies was on track as fresh data reinforced excitement over the new generation of tumour-fighting drugs.

Study: Don't Bother With Brain Imaging in Early NSCLC

4/11/2016 11:01 am

(MedPage Today) Apr 8, 2016 - Brain imaging showed no benefit in patients with early-stage non-small cell lung cancer (NSCLC) without neurologic symptoms in a secondary analysis of data from a large, nationwide lung screening trial.

BRIEF-Morphosys Says Sues Janssen Biotech, Genmab A/S For Patent Infringement

4/5/2016 04:20 pm

(Reuters) Apr 4, 2016 - Morphosys AG says it filed a lawsuit in United States (U.S.) District Court of Delaware against Janssen Biotech, and Genmab, A/S for patent infringement.

Janssen Announces the Initiation of Two Studies Evaluating Daratumumab (DARZALEX®) and Atezolizumab in Multiple Myeloma and Solid Tumor

3/22/2016 05:49 pm

(StreetInsider) Mar 21, 2016 - Janssen and Genentech will enter clinical collaboration to assess dual monoclonal antibody (mAb) combination therapy.

Janssen’s Zytiga Boosts Survival In Early-Stage Prostate Cancer

3/14/2016 04:25 pm

(Pharmafile [UK]) Mar 14, 2016 - Janssen has announced data from a post-hoc analysis of a Phase III trial showing that Zytiga plus prednisone boosted overall survival (OS) by 11.8 months compared placebo plus prednisone, in men with early and less aggressive metastatic castration-resistant prostate cancer (mCRPC) who had not received chemotherapy.

NICE Turns Down Janssen's Imbruvica For CLL

3/2/2016 05:47 pm

(PharmaTimes [UK]) Mar 2, 2016 - Patients with chronic lymphocytic leukaemia (CLL) living in England and Wales are unlikely to get access to Janssen UK’s Imbruvica on the NHS after the drug was turned down by cost regulators.

Is Metastatic Prostate Cancer Tailor-Made For Precision Oncology?

2/29/2016 12:00 pm

(Fred Hutch News Service) Feb 29, 2016 - New study shows a single biopsy could provide enough molecular information to guide individualized therapy for prostate cancer patients

Yale Researchers Discover Underlying Cause of Myeloma

2/11/2016 11:04 am

(Yale News) Feb 10, 2016 - Yale Cancer Center researchers have identified what causes a third of all myelomas, a type of cancer affecting plasma cells. The findings, published Feb. 10 in the New England Journal of Medicine, could fundamentally change the way this cancer and others are treated.

Janssen Voluntarily Suspends FAAH Inhibitor Phase 2 Trials In Wake Of Bial Tragedy

1/20/2016 06:11 pm

(Forbes) Jan 20, 2016 - While their drug has shown no adverse reactions in Phase 1 studies or ongoing Phase 2 trials to date, Janssen discontinues FAAH inhibitor dosing in two trials until more is known about the Bial drug trial tragedy in Rennes, France.

Geron Announces Initiation of Janssen Phase 2/3 Clinical Trial of Imetelstat in Myelodysplastic Syndromes

1/14/2016 06:01 pm

(NASDAQ) Jan 14, 2016 - Geron Corporation today announced the dosing of the first patient in a Phase 2/3 clinical trial to evaluate imetelstat in patients with myelodysplastic syndromes (MDS).

Dr. Paul Janssen Award for Biomedical Research Issues 2016 Call for Nominations

1/5/2016 06:42 pm

(bizjournals.com) Jan 5, 2016 - The Dr. Paul Janssen Award for Biomedical Research today opens its 2016 call for nominations. This prestigious award recognizes individuals whose basic or clinical discoveries have made, or have the potential to make, significant contributions toward improving human health.

NICE Welcomes Astellas' Xtandi but Rejects Janssen's Zytiga

12/11/2015 12:55 pm

(PharmaTimes [UK]) Dec 11, 2015 - There was mixed news for prostate cancer patients in England and Wales this week after cost regulators for the NHS published preliminary guidelines supporting the use of Astellas’ Xtandi but rejecting Janssen’s Zytiga.

Genmab Achieves USD 5 Million Milestone in Daratumumab Collaboration with Janssen

12/9/2015 07:48 pm

(CNNMoney) Dec 9, 2015 - Genmab A/S announced today it has reached a USD 5 million milestone in its daratumumab collaboration with Janssen Biotech, Inc. The milestone payment was triggered by progress in the ongoing Phase II study ("Carina" LYM2001) of daratumumab in NHL.

Strong Cancer Trial Data For Janssen At ASH 2015

12/8/2015 05:19 pm

(Pharmafile [UK]) Dec 8, 2015 - Janssen presented new cancer trial data at the 57th Annual American Society of Haematology (ASH) meeting Orlando, Florida – with study results for Darzalex (daratumumab) proving a highlight.

Aduro Biotech Receives Milestone Payment From Janssen for Submission of Investigational New Drug Application for ADU-741 in Prostate Cancer

11/18/2015 05:56 pm

(Yahoo! Finance) Nov 18, 2015 - Aduro Biotech, Inc. today announced that it has received a milestone payment from Janssen Biotech, Inc. for Aduro’s submission of an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration for ADU-741, a LADD immunotherapy product candidate for the treatment of prostate cancer.

Halozyme Announces First Clinical Dosing Of Janssen's Daratumumab Using ENHANZE™ Technology

11/4/2015 05:49 pm

(CNNMoney) Nov 4, 2015 - Halozyme Therapeutics, Inc. today announced that Janssen Biotech, Inc. has dosed the first patient in a clinical trial evaluating subcutaneous (SC) delivery of daratumumab with Halozyme's proprietary ENHANZE™ technology in multiple myeloma.

Aduro Biotech Receives Milestone Payment From Janssen for Acceptance of Investigational New Drug Application for ADU-214 in Lung Cancer

10/29/2015 05:08 pm

(TheStreet) Oct 29, 2015 - Aduro Biotech, Inc. today announced that it has received a milestone payment from Janssen Biotech, Inc. for the acceptance of Aduro's Investigational New Drug (IND) Application by the U.S. Food and Drug Administration for ADU-214, a LADD immunotherapy product candidate for the treatment of lung cancer.

Study Shows Promise Of Precision Medicine For Most Common Type Of Lymphoma

7/20/2015 11:01 am

(NCI) July 20, 2015 - A clinical trial has shown that patients with a specific molecular subtype of diffuse large B-cell lymphoma (DLBCL) are more likely to respond to the drug ibrutinib (Imbruvica) than patients with another molecular subtype of the disease. The study appeared online July 20, 2015, in Nature Medicine.

One Proteasome Inhibitor Tops Another in Relapsed Myeloma

6/16/2015 11:04 am

(MedPage Today/The Gupta Guide) June 15, 2015 - Patients with relapsed myeloma lived twice as long without progression when treated with carfilzomib (Kyprolis) versus bortezomib (Velcade), a large randomized trial showed.

FDA Panel to Discuss Lilly's Lung Cancer Drug Approval

6/2/2015 05:01 pm

(Reuters) June 2, 2015 - The U.S. Food and Drug Administration said a panel of experts would discuss a marketing application from Eli Lilly & Co on a new targeted lung cancer treatment.

ASCO '15: ImmunoGen Finds Redemption in Strong Ovarian Cancer Drug Results

6/1/2015 06:00 pm

(TheStreet) June 1, 2015 - The perception that ImmunoGen can't develop a drug successfully on its own will probably improve Monday when post-ASCO trading kicks in.

U.S. Food and Drug Administration Accepts Supplemental Biologics License Application for Opdivo+Yervoy Regimen in Patients with Previously Untreated Advanced Melanoma

6/1/2015 05:01 pm

(StreetInsider) June 1, 2015 - Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab)+Yervoy (ipilimumab) regimen in patients with previously untreated advanced melanoma.

Merck Drug Helps Colon Cancer Patients With DNA Repair Defect

5/29/2015 02:03 pm

(Bloomberg) May 29, 2015 - A small study found that Merck & Co.’s immune system-triggering drug Keytruda shrank tumors in colon cancer patients with a specific gene flaw, showing that genetic tests may help identify those likely to benefit from immune therapy treatments.

Roswell Park Opens Oncology-Focused Pharmacy

5/28/2015 12:04 pm

(RPCI) May 27, 2015 - Roswell Park Cancer Institute (RPCI) opened a new specialty pharmacy dedicated to the prescription needs of cancer patients.

Personalized Healthcare and Early Cancer Detection at the Heart of MIT's Research in Singapore

5/15/2015 12:05 pm

(Forbes) May 14, 2015 - Researchers are working on a "blood test" that could replace the more invasive biopsy, and open also the doors to personalized treatments of the disease.

Merck Gets Breakthrough Designation for Hepatitis C Drugs

4/8/2015 12:03 pm

(Wall Street Journal) Apr 8, 2015 - Merck & Co. said Wednesday that its hepatitis C drugs have been designated breakthrough therapies by the U.S. Food and Drug Administration.

Number of Childhood Cancer Survivors Increasing, Most Have Morbidities

4/1/2015 12:01 pm

(AACR) Apr 1, 2015 - The prevalence of childhood cancer survivors is estimated to have increased, and the majority of those who have survived five or more years beyond diagnosis may have at least one chronic health condition.

New Cancer Drugs 'Vastly Overestimated', Says Contrarian Analyst

3/31/2015 11:04 am

(Reuters) Mar 31, 2015 - A hot new class of drugs designed to help the body's own immune system fend off cancer by blocking a protein called PD-1 is going to be big - but not nearly as big as investors think, according to a new analysis.

Multiple Data Presentations Demonstrate Positive Direct Patient Impact of Oncotype DX® Breast Cancer Test Globally

3/20/2015 11:05 am

(CNNMoney) Mar 20, 2015 - Genomic Health, Inc. today announced that 11 studies were presented at the 14th St. Gallen International Breast Cancer Conference, including positive results from a real-life observational study in Ireland.

Kite Pharma Strengthens Its T Cell Receptor (TCR) Cancer Gene Therapy Platform Through Acquisition of T-Cell Factory B.V. (TCF(TM))

3/17/2015 11:03 am

(TheStreet) Mar 17, 2015 - Kite Pharma, Inc. today announced that it has further strengthened its TCR product platform and established a European presence through the acquisition of T-Cell Factory B.V. (TCF(TM)), a privately held Dutch company, which has been renamed Kite Pharma EU.

Cerulean Establishes Clinical Collaboration with the GOG Foundation to Study CRLX101 in Combination with Weekly Paclitaxel in Relapsed Ovarian Cancer

3/3/2015 11:00 am

(Cerulean) Mar 3, 2015 - Cerulean Pharma Inc., a leader in Dynamic Tumor Targeting™, today announced it has signed a clinical research agreement with the GOG Foundation Inc. to conduct an open-label Phase 1b clinical trial of its lead product candidate, CRLX101, in combination with weekly paclitaxel in patients with relapsed ovarian cancer.

Zykadia Recommended For Approval in Advanced Non Small Cell Lung Cancer

2/27/2015 11:05 am

(EMA) Feb 27, 2015 - The European Medicines Agency (EMA) has recommended granting a conditional marketing authorisation for Zykadia (ceritinib).