Celgene Corporation (CELG)

Oncology Corporate Profile

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HQ Location

86 Morris Avenue
Summit, NJ 7901

Company Description

Celgene is a multinational biopharmaceutical company committed to improving the lives of patients worldwide. Celgene's mission as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

Website: http://www.celgene.com

Brand Generic Indication
Alkeran®melphalanAlkeran® tablets are indicated for the palliative treatment of multiple myeloma and for the palliation of non-resectable epithelial carcinoma of the ovary.
IDHIFA® enasidenibIDHIFA® is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA approved test.
Istodax®romidepsinIstodax® is a histone deacetylase (HDAC) inhibitor indicated for: treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy; treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy. These indications are based on response rate. Clinical benefit such as improvement in overall survival has not been demonstrated.
Pomalyst®pomalidomidePomalyst® is a thalidomide analogue indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval is based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.
Revlimid®lenalidomideRevlimid® is a thalidomide analogue indicated for the treatment of patients with:

-Multiple myeloma (MM), in combination with dexamethasone.
-MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT).
-Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.
-Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.

Limitations of Use: Revlimid® is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.
Thalomid®thalidomideThalomid® in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma. The effectiveness of Thalomid® is based on response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in survival.
Vidaza®azacitidineVidaza® is indicated for the treatment of patients with the following myelodysplastic syndrome subtypes: refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia.

View additional information on commercial products here »

  • Brand
  • Generic
  • Investigational
Brand / Product Class Area of Study Phase Partnership
enasidenib / AG-221IDH2 inhibitorAcute Myelogenous Leukemia (AML)IIIAgios Pharmaceuticals Inc.
CC-486DNA methylation inhibitorMyelodysplastic Syndrome (MDS)III
amrubicinalkylating agentSmall Cell Lung Cancer (SCLC)IIIDainippon Sumitomo
CC-486DNA methylation inhibitorVarious cancer typesIII
Abraxane® / nab-paclitaxelmicrotubule inhibitor1st line metastatic Breast cancerIII
Abraxane® / nab-paclitaxelmicrotubule inhibitor1st line metastatic MelanomaIII
Pomalyst® / pomalidomide / CC-4047immune system modulator2nd line metastatic Multiple MyelomaIII
Pomalyst® / pomalidomide / CC-4047immune system modulatorMyelofibrosisIII
Revlimid® / lenalidomideimmune system modulatorChronic Lymphocytic Leukemia (CLL)III
Revlimid® / lenalidomide (+ rituximab)immune system modulatorMarginal Zone Lymphoma (MZL)III
Revlimid® / lenalidomideimmune system modulatorMyelodysplastic Syndrome (MDS)III
Revlimid® / lenalidomideimmune system modulatorNon-Hodgkin's Lymphoma (NHL)III
Thalidomide Pharmion® / thalidomideimmune system modulatorMultiple MyelomaIII
sotatercept / ACE-011activin inhibitorAnemia in Myelodysplastic Syndrome (MDS)II
CC-496DNA methylation inhibitoBreast cancerII
CC-223mTOR inhibitorVarious cancer typesII
Abraxane® / nab-paclitaxelmicrotubule inhibitorBladder cancerII
Abraxane® / nab-paclitaxelmicrotubule inhibitorOvarian cancerII
Istodax® / romidepsindepsipeptideVarious cancer typesII
Vidaza® / azacitidineantimetabolite (cytidine analog) (oral)Myelodysplastic Syndrome (MDS)II
Vidaza® / azacitidineantimetabolite (cytidine analog) (oral)Various cancer typesII
ACE-536type II activin receptorAnemia in Myelodysplastic Syndrome (MDS)IAcceleron
CC-292BTK inhibitorChronic Lymphocytic Leukemia (CLL)I
CC-122pleiotropic pathway modulatorChronic Lymphocytic Leukemia (CLL)I
CC-122pleiotropic pathway modulatorDiffuse large B-cell Lymphoma (DLBCL)I
CC-122pleiotropic pathway modulatorGlioblastoma Multiforme (GBM)I
CC-122pleiotropic pathway modulatorHepatocellular carcinoma (HCC)I
CC-115DNA-PK/TOR kinase inhibitorVarious cancer typesI
durvalumab / MEDI-4736anti-PD-L1 therapyVarious cancer typesIAstraZeneca

View additional information on product candidates here »

Source: http://www.celgene.com

Recent News Headlines

Here’s the Surprising Reason IBM is Partnering with Celgene

11/2/2016 04:38 pm

(TIME) Nov 1, 2016 - Big Blue has found yet another business application for its precocious cognitive computing system.

Celgene May Be Ready to Lap Bristol

10/28/2016 05:30 pm

(Bloomberg/Gadfly blog) Oct 28, 2016 - The distinction between big biotech and big pharma has grown increasingly moot as several biotechs have gotten larger than their much older peers.

Celgene Skips the Placebo, Fails Drug Development 101

10/19/2016 04:45 pm

(TheStreet) Oct 19, 2016 - Celgene is not some dinky micro-cap biotech lacking the resources or knowledge to conduct a rigorous clinical trial, so omitting a placebo arm from the GED-0301 study is inexcusable.

Celgene and Sage Bionetworks Announce Technology Collaboration to Develop Observational Study Using the Apple ResearchKit Framework

10/19/2016 04:25 pm

(Stockhouse) Oct 18, 2016 - Celgene Corporation and Sage Bionetworks today announced a collaboration to develop an iPhone application utilizing the Apple ResearchKit framework to improve the understanding of the burden of disease for patients living with chronic anemia due to myelodysplastic syndromes (MDS) or beta-thalassemia.

Celgene Crohn’s Drug Benefit Supported by Image Data in Trial

10/17/2016 04:33 pm

(Bloomberg) Oct 16, 2016 - Celgene Corp.’s experimental pill for Crohn’s disease helped more patients than analysts expected, reinforcing positive results of an earlier study and likely boosting investors’ confidence in the drug’s chances of approval.

Celgene and Agios Announce Collaborations with Abbott for Diagnostic Identification of IDH Mutations in AML

10/12/2016 04:29 pm

(NASDAQ) Oct 12, 2016 - Companion diagnostic technology to be utilized with enasidenib (AG-221/CC-90007) and AG-120 development programs for relapsed/refractory acute myeloid leukemia (AML); approximately 20% of AML patients have an IDH mutation.

Celgene CEO: Myeloma And Glioblastoma Both Priorities

10/5/2016 04:22 pm

(BioPharma Dive) Oct 4, 2016 - Celgene’s CEO Mark Alles said during a recent R&D day that the company is expanding beyond multiple myeloma research toward brain cancer, saying the company is aggressively developing a drug, marizomib, directed against glioblastoma.

Billboards and Websites Push Costly Prostate Cancer Treatment With Unknown Long-Term Benefits

10/5/2016 07:02 am

(STAT/Kaiser Health News) Oct 4, 2016 - Men hoping to avoid some of the dreaded side effects of prostate cancer treatment are shelling out tens of thousands of dollars for a new procedure whose long-term effects are unknown, even though insurers, including Medicare, generally won’t pay for it.

Scoop: Celgene Targets a Cure For Myeloma/Lymphoma With $600M EngMab Buyout

10/3/2016 05:49 pm

(Endpoints News) Sept 30, 2016 - Celgene has completed a deal to acquire the Swiss biotech EngMab for $600 million, adding a new BCMA-targeting multiple myeloma program to the pipeline, Endpoints News has learned. And it’s putting the new tech to work with its ongoing efforts on CAR-T and CD-3 antibodies with an eye on finding a cure for myeloma and lymphoma.

Celgene Data Offer A Rorschach Test To Wall Street

9/12/2016 05:07 pm

(Forbes) Sept 12, 2016 - For Celgene, the giant biotechnology company that turned thalidomide into a series of big-selling blood cancer drugs, the most watched event of the fall was supposed to be the release of data on GED-0301, a new treatment for Crohn's disease.

Agios Blood Cancer Drug Heading to Early FDA Filing by Partner Celgene

9/7/2016 05:05 pm

(TheStreet) Sept 7, 2016 - The first targeted blood cancer drug from Agios Pharmaceuticals will be submitted for approval in the U.S. by the end of the year, faster than investors expected.

From Nightmare Drug to Celgene Blockbuster, Thalidomide Is Back

8/24/2016 04:06 pm

(Bloomberg) Aug 22, 2016 - Celgene Corp. has built itself into a biotech powerhouse, rebranding the drug thalidomide using a slightly different name: Thalomid.

Wales Endorses NHS Use Of Celgene’s Revlimid

8/1/2016 04:15 pm

(PharmaTimes [UK]) Aug 1, 2016 - Around 300 patients with multiple myeloma in Wales will get National Health Service access to treatment with Celgene's Revlimid after the drug was recommended for first-line use by cost regulators.

Celgene Accused of Using Charities in ‘Scheme to Gain Billions’

8/1/2016 04:05 pm

(Bloomberg) Aug 1, 2016 - Celgene Corp. donated hundreds of millions of dollars to charities that help patients afford high-priced drugs for multiple myeloma and other cancers “as part of a core business scheme to gain billions” from U.S. taxpayers, according to allegations in federal court filings.

Celgene Can't Expand Revlimid Approval Into Non-Hodgkin Lymphoma Just Yet

7/26/2016 04:53 pm

(TheStreet) July 25, 2016 - Celgene will not seek approval for Revlimid as a maintenance therapy for patients with diffuse large B-cell lymphoma based on the lack of a survival benefit in a clinical trial.

Celgene Drug Fails To Extend Survival In Lymphoma Study

7/26/2016 12:13 pm

(Reuters) July 25, 2016 - Celgene Corp said on Monday that its flagship drug Revlimid failed to extend survival as a maintenance therapy for a type of blood cancer after patients had responded to prior treatment.

With Celgene Deal, Jounce Lands $261M And a “Trusting Partner”

7/19/2016 04:17 pm

(Xconomy Boston) July 19, 2016 - It’s getting harder and harder to stand out in the increasingly crowded cancer immunotherapy field. But with a wide-ranging alliance being announced this morning, three-year-old Jounce Therapeutics has been able to make its mark.

Celgene, Jounce Therapeutics in Early Cancer Immunotherapy Development Pact

7/19/2016 12:09 pm

(TheStreet) July 19, 2016 - Tuesday's deal has Celgene paying $225 million to privately held Jounce Therapeutics to partner on the development of "next generation" cancer immunotherapies. Celgene is also taking a $36 million equity stake in Jounce.

Genmab Provides Update on Marketing Authorization Application for Arzerra® (ofatumumab) as Maintenance Therapy for Patients with Relapsed CLL

6/23/2016 11:02 am

(Genmab) June 23, 2016 - Genmab A/S announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion for the use of Arzerra® (ofatumumab) as maintenance therapy for patients with relapsed chronic lymphocytic leukemia (CLL). The Marketing Authorization Application (MAA) was submitted by Novartis in July 2015 under the ofatumumab collaboration between Novartis and Genmab.

Four NCI Cancer Centers Announce Landmark Research Consortium and Collaborations with Celgene

6/22/2016 06:48 pm

(Penn Medicine) June 22, 2016 - Today, The Abramson Cancer Center at the University of Pennsylvania, The Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, and The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai announced the establishment of a research consortium focused on accelerating the discovery and development of novel cancer therapeutics and diagnostics for the benefit of patients.

FDA Offers New Draft Guidance on Bioequivalence Studies for 19 Generics, 19 Revisions

6/17/2016 12:02 pm

(Regulatory Focus) June 16, 2016 - The US Food and Drug Administration (FDA) on Thursday released 38 new and revised draft guidance documents for drugmakers looking to begin research and development for new generics, including for some blockbuster drugs that have not yet lost patent protection.

Acceleron and Celgene Announce Updated Results from an Ongoing Phase 2 Study of Luspatercept in Beta-Thalassemia Presented at the 21st Congress of the European Hematology Association

6/10/2016 03:54 pm

(NASDAQ) June 10, 2016 - Longer term data with investigational drug luspatercept show sustained increases in hemoglobin levels, reduced transfusion burden, and improved patient reported quality of life measures in patients with beta-thalassemia.

Acceleron and Celgene Announce Updated Results from an Ongoing Phase 2 Study of Luspatercept in Myelodysplastic Syndromes at the 21st Congress of the European Hematology Association

6/10/2016 03:53 pm

(NASDAQ) June 10, 2016 - Preliminary results show that treatment with investigational drug luspatercept results in clinically meaningful increases in hemoglobin and durable transfusion independence in patients with lower risk myelodysplastic syndromes.

Canada's Health Technology Assessment Agency Gives Positive Recommendation for OPDIVO To Treat Non-Small Cell Lung Cancer

6/9/2016 11:02 am

(Montreal Gazette) June 8, 2016 - Canada's national health technology assessment body (CADTH) today made its final, positive recommendation for OPDIVO™ (nivolumab) for the treatment of non-small cell lung cancer (NSCLC), a reflection of the strong clinical evidence that supports the benefits of this immuno-oncology treatment of adult patients with advanced or metastatic NSCLC who progressed on or after chemotherapy.

Biogen Plunges as Multiple Sclerosis Drug Fails in Trial

6/7/2016 02:05 pm

(Bloomberg) June 7, 2016 - Biogen Inc. plunged in early trading Tuesday after an experimental drug for multiple sclerosis, investors and patients had hoped might alter the course of the neurological disease, failed in a mid-stage trial.

Cancer Patients Miss Appointments, Prescriptions Due To Inability To Afford Care

6/6/2016 02:02 pm

(UNC Health Care) June 3, 2016 - More than one-in-four cancer patients had to pay more for medical care than they could afford, according to a study led by UNC Lineberger member Stacie Dusetzina, PhD. A reported 18 percent were unable to afford their prescription medications.

Precision Medicine Approach May Expand Therapeutic Options for Patients

6/4/2016 04:03 pm

(2016 ASCO Annual Meeting) June 4, 2016 - Researchers reported encouraging early results from a phase II trial that matches patients with molecular abnormalities in the tumor to corresponding targeted treatments.

'Collective Wisdom' on Display at ASCO 2016

6/2/2016 12:00 pm

(MedPage Today) June 1, 2016 - Immunotherapy, heme malignancies, women's issues, MACRA in focus.

Cancer Researchers Struggle To Persevere With Limited Funds

6/1/2016 11:05 am

(Hartford Courant) June 1, 2016 - Dr. Roy Herbst, chief of medical oncology at Yale's Smilow Cancer Hospital, is running one site of a lung cancer clinical trial that fits exactly into the goals of the Obama administrations' new cancer moonshot.

Agios Shopped New Cancer Research Program Around Before Partnering With Celgene

5/19/2016 05:53 pm

(Boston Business Journal/BioFlash blog) May 18, 2016 - Agios Pharmaceuticals shopped around its newly-announced research program on metabolic immuno-oncology to other biotechs before deciding to go with its partner since 2010, Celgene, according to executives.

Agios, Celgene Jump into Immuno-Oncology in Revamped Alliance

5/18/2016 05:44 pm

(Xconomy Boston) May 17, 2016 - Agios Pharmaceuticals rode a wide-ranging partnership with Celgene to a big IPO a few years ago. Today the two companies are partnering once again in a deal that will see Agios try its hand at the increasingly competitive field of cancer immunotherapy.

Celgene, Agios Expand, Amend Cancer Drug Partnership

5/18/2016 04:52 pm

(TheStreet) May 17, 2016 - Celgene is paying $200 million for development rights to early research Agios is conducting into new drug targets that alter the metabolism of immune cells to help kill cancer cells.

Celgene, Agios Expand, Amend Cancer Drug Partnership

5/18/2016 11:22 am

(TheStreet) May 17, 2016 - Celgene is paying $200 million for development rights to early research Agios is conducting into new drug targets that alter the metabolism of immune cells to help kill cancer cells.

Significant Toxicity of Mitoxantrone in Patients With Multiple Sclerosis: Cancer

5/13/2016 11:04 am

(AJMC) May 13, 2016 - Researchers in Germany have discovered that mitoxantrone—used to treat aggressive, relapsing, or progressive multiple sclerosis—can increase the risk of leukemia and colorectal cancer in those being treated.

CancerCare® Releases Landmark Patient Access and Engagement Report

5/11/2016 11:03 am

(CancerCare) May 11, 2016 - A landmark report illustrating the many physical, emotional, financial, practical and informational needs cancer patients experience during and after clinical treatment was released today by CancerCare, a national nonprofit organization that provides free psychosocial support, education and financial assistance to anyone affected by cancer.

'You've Got Cancer' Can Take Devastating Mental Toll

4/28/2016 12:02 pm

(U.S. News & World Report/HealthDay News)) Apr 28, 2016 - A cancer diagnosis is dreaded by all, and a new study details the psychological damage it often leaves in its wake for patients.

Mistakes By Both Sides Led To Vidaza NICE Rejection, Says Celgene

4/18/2016 05:01 pm

(Pharmaforum [UK]) Apr 15, 2016 - Celgene has said it will fight to ensure patients get access to its blood cancer drug Vidaza (azacitadine) following its rejection by NICE, saying that mistakes by both organisations led to a huge difference in cost-effectiveness estimates.

Lung Cancer Clinicians Urged to Look Beyond RCT Data

4/14/2016 11:03 am

(Medscape Medical News) Apr 14, 2016 - Clinicians will increasingly have to turn to observational and registry data, rather than data from randomized controlled trials (RCTs), to provide the evidence that will support informed decision-making in the treatment of lung cancer, according to a leading expert.

UCLA Research Suggests That Gut Bacteria Could Help Prevent Cancer

4/14/2016 11:01 am

(UCLA) Apr 13, 2016 - Researchers have shown that various types of intestinal bacteria might be factors in both causing and preventing obesity, and in other conditions and diseases. Now, a UCLA study suggests that it could also potentially be used to reduce the risk for some types of cancer.

A Simple Tool to Ease Cancer's Side Effects

4/12/2016 11:03 am

(Wall Street Journal) Apr 11, 2016 - In a test, researchers at Mount Sinai try light therapy to help the fatigue and depression that many cancer patients feel.

First Cancer Patient In Europe Scanned In Cambridge Using New Technique Showing Whether Drugs Work

4/11/2016 11:01 am

(Cancer Research UK) Apr 11, 2016 - The first cancer patient in Europe has been scanned with a revolutionary imaging technique that could enable doctors to see whether a drug is working within a day or two of starting treatment.

Patient and Provider Perspectives on Palliative Care Discussed at NCCN

4/1/2016 11:01 am

(AJMC) Mar 31, 2016 - During the opening session at the National Comprehensive Cancer Network 21st Annual Conference, healthcare providers came together to discuss palliation from the provider and the patient perspective.

FDA Permits Use Of Roche Test To Screen Donated Blood For Zika

3/30/2016 12:05 pm

(Reuters) Mar 30, 2016 - The U.S. Food and Drug Administration said it would allow the use of an experimental test to screen donated blood for the Zika virus.

EBCC-10 NEWS: Physical Activity Does Not Influence Breast Density; Protective Effect Against Breast Cancer Is Due To Other Mechanisms

3/9/2016 11:02 am

(ECCO) Mar 9, 2016 - Women whose breasts are more dense have a greater risk of developing breast cancer than those with less breast density, and physical activity is known to have a protective effect against the disease.

Drug Makers Would Pay For Tossing Cancer Patient Waste Under RI Bill

3/8/2016 11:03 am

(STAT/Pharmalot) Mar 8, 2016 - A new bill introduced in Rhode Island would require drug makers to pay for the cost of collecting and disposing of human waste — poop, urine, and vomit — from some cancer patients.

Aspirin Found To Reduce Overall Cancer Risk

3/3/2016 11:05 am

(Harvard Gazette) Mar 3, 2016 - An analysis of data from two long-term epidemiologic studies has found that regular use of aspirin significantly reduces the overall risk of cancer, an effect that primarily reflects a lower risk of colorectal cancer and other tumors of the gastrointestinal tract.

Trump's Health Plan Includes Obamacare Repeal, Drug Re-Importation

3/3/2016 11:05 am

(Bloomberg) Mar 2, 2016 - The Republican front-runner laid out his seven-point plan to replace the Affordable Care Act on his website Wednesday.

Penn Study: Immune Therapy Breaks Down Wall around Pancreatic Tumors for Chemo to Attack

2/29/2016 12:01 pm

(Penn Medicine) Feb 29, 2016 - CD40 agonists re-educate macrophages to chip away at tumor microenvironment.

Old Red Dye Shows Promise as New Cancer Foe

2/26/2016 11:04 am

(Reuters) Feb 26, 2016 - Modern cancer drugs supercharge immune systems, target specific gene mutations and pack modified viruses into vaccines. Amid the increasing sophistication, one investigational treatment stands out for its simplicity.

Chemo Better Option Following Pancreatic Cancer Surgery: Study

2/26/2016 11:04 am

(VUMC/news@Vanderbilt) Feb 25, 2016 - A multicenter study led by Vanderbilt University Medical Center (VUMC) investigators found that pancreatic cancer patients who underwent surgery and received chemotherapy lived longer and had fewer cancer recurrences in other parts of the body than patients who also received chemoradiation therapy.