History

Celgene Corporation is a global integrated biopharmaceutical company primarily engaged in the discovery, development and commercialisation of innovative therapies designed to treat cancer, immune system disorders and inflammatory diseases where there are limited treatment options for patients. There are hundreds of clinical trials at major medical centres worldwide evaluating compounds from Celgene.

Marketed therapies and investigational compounds include those for incurable haematological cancers and solid tumours as well as immune-inflammatory related diseases including; multiple myeloma (MM), myelodysplastic syndromes (MDS), chronic lymphocytic leukaemia (CLL), chronic myelomonocytic leukaemia (CMML), mantle cell lymphoma (MCL), acute myeloid leukaemia (AML), non-Hodgkin’s lymphoma (NHL), pancreatic cancer, breast cancer, non-small lung cancer, melanoma, psoriasis, psoriatic arthritis and Crohn’s disease.

Global timeline

The timeline will take you from our founding through our exponential growth over the past three decades.

1986

  • David Stirling, Ph.D. and Sol Barer, Ph.D. plant the seed that will become Celgene
  • Celgene becomes an independent biotechnology company

1987

  • Celgene IPO (initial public offering)

1988

  • Discovers novel enzyme for the stereo selective synthesis of chiral compounds

1990

  • Receives patent for enzymatic chiral resolution technology that forms the basis of Chiral Chemicals Business

1991

  • Demonstrates bio-treatment system

1992

  • Licenses patent for uses of thalidomide from Rockefeller University

1993                                                                                                                        

  • Publishes clinical trial results for the use of thalidomide in inhibiting the progression of HIV-1 and cachexia1
  • Tests new compounds believed to increase efficacy and reduce side effects of thalidomide

1994

  • Dr. Sol Barer named President and Chief Operating Officer

1995

  • Thalidomide receives U.S. Food and Drug Administration (FDA) approval* for expanded access to thalidomide for AIDS patients suffering from cachexia2

1996                                                                                                                                     

  • John Jackson named Chief Executive Officer
  • Submits New Drug Application (NDA) filing for thalidomide
  • Designs and demonstrates new immunomodulatory compounds, known as IMiD®compounds
  • Files patent for lenalidomide

1997

  • Jerry Zeldis, M.D., Ph.D., joins as Celgene’s first Chief Medical Officer
  • First multiple myeloma (MM) patient receives thalidomide under compassionate use Investigational New Drug application (IND)3

1998

  • Forms System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.®) delivery programme
  • Receives FDA approval for thalidomide for the treatment of erythema nodosum leprosum (ENL)4
  • Dr. David Stirling becomes first Chief Scientific Officer

1999

  • Bob Hugin joins Celgene as Chief Financial Officer
  • New England Journal of Medicine publishes landmark MM paper involving thalidomide5

2000

  • Secondary public offering
  • Acquires Signal Pharmaceuticals

2001

  • Dexmethylphenidate receives FDA approval for the treatment of Attention Deficit Hyperactivity Disorder (ADHD)6
  • Lenalidomide is tested in three Phase I/II clinical trials with refractory MM patients

2003

  • Celgene acquires Anthrogenesis
  • Bob Hariri, M.D., Ph.D., Chief Executive Officer, Celgene Cellular Therapeutics, joins Celgene

2004

  • Celgene Headquarters moves to Summit, New Jersey, USA
  • FDA grants fast-track designation to lenalidomide in both MM and MDS7
  • FDA approves azacitidine for the treatment of MDS8

2005

  • Celgene is included in the NASDAQ 100
  • FDA approves lenalidomide for the treatment of patients with MDS (del 5q)9
  • FDA approves dexmethylphenidate hydrochloride (an extended-release formulation) for the treatment of attention deficit hyperactivity disorder (ADHD)10
  • FDA approves paclitaxel albumin bound nanoparticles for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy11
  • Internal decision to bring the clinical benefits of innovative therapies to patients around the world

2006

  • Celgene UK and Ireland affiliate established
  • FDA approves thalidomide plus dexamethasone as a first-line treatment for MM12
  • Dr. Sol Barer becomes Chief Executive Officer
  • Completion of campus in Boudry, Switzerland
  • FDA approves lenalidomide plus dexamethasone as a second-line treatment for MM13
  • Celgene is included in the S&P 500

2007

  • European Medicines Agency (EMA)** and the Swiss Medic approves lenalidomide plus dexamethasone as a second line treatment for MM14,15
  • Celgene’s revenue surpasses $1 billion

2008

  • Reports first Phase II data for apremilast as an oral pluripotent immunomodulator in psoriasis16
  • First patient receives Celgene Cellular Therapeutic’s human placenta-derived stem cells for acute lymphoblastic leukaemia17
  • Celgene acquires Pharmion
  • EMA approves thalidomide as a first line treatment for MM18
  • EMA approves azacitidine for the treatment of patients with high-risk MDS and a subset of acute myeloid leukaemia (AML)19
  • Lenalidomide was granted the Prix Galien USA 2008 Award for Special Therapeutic Development

2010

  • Bob Hugin becomes Celgene’s Chief Executive Officer
  • Perry Karsen becomes Chief Operations Officer
  • Jackie Fouse becomes Chief Financial Officer
  • Establishes Celgene Institute of Translational Research Europe (CITRE)
  • Celgene acquires Gloucester Pharmaceuticals, and begins marketing romidepsin to treat cutaneous T-cell lymphoma20
  • Japan grants approval to market lenalidomide for MM and MDS (del 5q)21
  • Celgene acquires Abraxis BioScience. The transaction adds paclitaxel albumin bound nanoparticles to the Company’s existing portfolio of leading cancer products
  • Paclitaxel (for the treatment of pancreatic cancer) becomes the first product utilising nab® platform technology to be approved by the FDA and EMA. 22
  • Azacitidine is commended in the UK Prix Galien Orphan Drug Award category

2011

  • FDA approves romidepsin for the treatment of peripheral T-cell lymphoma for patients who have received at least one prior therapy 23

2012

  • Celgene acquires Avila Therapeutics
  • In May, New England Journal of Medicine publishes three lenalidomide Phase III trials in patients with newly diagnosed MM24,25,26
  • FDA approves paclitaxel albumin bound nanoparticles for the first line treatment of advanced non-small cell lung cancer27

2013

  • EMA approves paclitaxel albumin bound nanoparticles (in combination with gemcitabine) for first-line treatment of adult patients with metastatic pancreatic cancer28
  • FDA approves pomalidomide for third line treatment of patients with MM29
  • EMA approves lenalidomide for the treatment of MDS del (5q)14
  • EMA approves pomalidomide in combination with dexamethasone for the treatment of relapsed and refractory MM30
  • FDA approvespaclitaxel albumin bound nanoparticles to treat patients with metastatic pancreatic cancer11

2014

  • Apremilast becomes the first oral therapy approved by the FDA for the treatment of adults with active psoriatic arthritis (PsA)31
  • FDA approves apremilast for the treatment of patients with moderate to severe plaque psoriasis32

2015                                                                  

  • EMA approves apremilast for the treatment of adult patients with moderate to severe chronic plaque psoriasis who failed to respond to systemic therapy including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA). Also approved for PsA in adults who fail on non-biological DMARDs33
  • FDA and EMA expand approval of lenalidomide for use in combination with dexamethasone to include all patients with newly diagnosed MM34

*FDA approval relates to the review undertaken by the administration’s physicians and scientists to demonstrate the drug’s benefits outweigh its known risks and the drug can be manufactured in a way that ensures a quality product. If the drug is approved it can be marketed in the United States.

**EMA approval relates to the evaluation used by the European Commission to decide whether a medicine can be authorised for marketing in the European Union. The company producing a medicine can only market it once the medicine has received a marketing authorisation from the European Commission.


References:

1 Makonkawkeyoon S, Limson-Pobre R N, et al. Thalidomide inhibits the replication of human immunodeficiency virus type 1. Proceedings of the National Academy of Sciences of the United States of America. 1993:90(13):5974-5978

2 U.S. Food and Drug Administration approval of THALOMID for expanded access to thalidomide for AIDS patients suffering from cachexia. 1995. Data on file

3 First MM patient receives THALOMID under compassionate use Investigational New Drug application. 1997. Data on file

4 FDA approval for thalidomide for the treatment of erythema nodosum leprosum. 1998. Data on file

5 Singhal S, Mehta J et al. Antitumor activity of thalidomide in refractory multiple myeloma.New England Journal of Medicine. 1999:18;341(21):1565-71

6 U.S. Food and Drug Administration approval of FOCALIN. 2001. Data on file

7 U.S. Food and Drug Administration grants fast-track designation to REVLIMID in both MM and MDS. 2004. Data on file

8Kaminskas E, Farrell AT, et al. FDA drug approval summary: azacitidine (5-azacytidine, Vidaza) for injectable suspension. The Oncologist 2005; 10:176–182

9 U.S. Food and Drug Administration approval of REVLIMID for the treatment of patients with del 5q myelodysplastic syndromes. 2005. Data on file

10 U.S. Food and Drug Administration approval of FOCALIN XR for the treatment of attention deficit hyperactivity disorder (ADHD). 2005. Data on file

11U.S. Food and Drug Administration. FDA approves Abraxane for late-stage pancreatic cancer  September 2013. Available from:http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm367442.htm(Last accessed: April 2015)

12 U.S. Food and Drug Administration. FDA Approves Thalomid (thalidomide) to Treat Multiple Myeloma (online) May 2006. Available from:http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm095651.htm(Last accessed: April 2015)

13 U.S. Food and Drug Administration. FDA approves lenalidomide oral capsules (Revlimid) for use in combination with dexamethasone in patients with multiple myeloma  June 2006. Available from:http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm095626.htm  (Last accessed: April 2015)

14 European Medicines Agency. Summary of product characteristics – Revlimid 2.5 mg hard capsules (online) Available from:http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000717/WC500056018.pdf (Last accessed: April 2015)

15 Swiss Medic approves REVLIMID® plus dexamethasone for the treatment of MM. 2007.Data on file

16 ClinicalTrials.gov Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate-to-Severe Plaque-Type Psoriasis (Core Study) (online) November 2014. Available from: https://clinicaltrials.gov/ct2/show/NCT00773734?term=Apremilast&rank=1  (Last accessed: April 2015)

17First patient receives Celgene Cellular Therapeutic’s human placenta-derived stem cells for acute lymphoblastic leukaemia, a landmark treatment. 2008. Data on file

18 European Medicines Agency. European public assessment reportThalidomide Celgene 50 mg Hard Capsules (online) April 2013. Available from:http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000823/WC500037050.pdf (Last accessed: April 2015)

19 European Medicines Agency. Summary of product characteristics – Vidaza 25 mg/ml powder for suspension for injection[online] December 2013. Available from:

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000978/WC500050239.pdf (Last accessed: April 2015)

20 Celgene acquires Gloucester Pharmaceuticals, and begins marketing ISTODAX® to treat cutaneous T-cell lymphoma. 2010. Data on file

21 Japan grants approval to market REVLIMID® for MM and MDS (del 5q). 2010. Data on file

22 ABRAXANE® becomes the first product utilising nab® platform technology to be approved by the FDA and EMA. 2010. Data on file

23 U.S. Food and Drug Administration approves ISTODAX® for the treatment of peripheral T-cell lymphoma. 2011. Data on file

24 Palumbo A, Hajek R et al. Continuous Lenalidomide Treatment for Newly Diagnosed Multiple Myeloma. New England Journal of Medicine. 2012: 366 (19):1759-69

25 McCarthy PL, Owzar K et al. Lenalidomide after Stem-Cell Transplantation for Multiple Myeloma. New England Journal of Medicine. 2012: 366:1770-81

26 Attal M, Lauwers-Cances V et al. Lenalidomide Maintenance after Stem-Cell Transplantation for Multiple Myeloma. New England Journal of Medicine. 2012: 366: 1782-1791

27 U.S. Food and Drug Administration. Paclitaxel (Abraxane) (online) October 2012. Available from: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm323668.htm
(Last accessed: April 2015)

28 European Medicines Agency. Summary of product characteristics –Abraxane 5 mg/ml powder for suspension for infusion (online) January 2013. Available from:http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000778/WC500020435.pdf(Last accessed: April 2015)

29 U.S. Food and Drug Administration. News release. FDA approves Pomalyst for advanced multiple myeloma. (online) February 2013. Available from:http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm338895.htm(Last accessed: April 2015)

30 European Medicines Agency. Summary of product characteristics – Imnovid 1mg (online) August 2013. Available from:http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002682/WC500147717.pdf (Last accessed: April 2015)

31 U.S. Food and Drug Administration.  FDA approves Otezla to treat psoriatic arthritis.(online) March 2014. Available from:http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm390091.htm(Last accessed: April 2015)

32FDA approves apremilast for the treatment of patients with moderate to severe plaque psoriasis. 2014. Data on file

33European Medicines Agency. Summary of product characteristics – Otezla  (online) Available from:  http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003746/WC500182627.pdf(Last accessed: April 2015)

34 UKMI. New Drugs Online Report for lenalidomide (online) Available from: http://www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=4907(Last accessed: April 2015)

 


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Date of preparation: May 2015