Celgene

{{short description|American biopharmaceutical company}} {{Infobox company | name = Celgene Corporation | logo = 150px | type = Subsidiary | traded_as = {{NASDAQ was|CELG}} | industry = Biotechnology | founded = {{start date and age|1986}}  | parent = Bristol Myers Squibb | location = Summit, New Jersey, U.S. | key_people = Robert J. Hugin (executive chairman) Mark Alles (CEO) | founder = Sol J. Barer | products = Revlimid Abraxane Pomalyst/Imnovid Thalomid Idhifa | revenue = {{increase}} $15.281 billion (2018) | net_income = {{increase}} $4.046 billion (2018) | assets = {{increase}} $35.480 billion (2018) | equity = {{decrease}} $6.161 billion (2018) | num_employees = 8,852 (2018) | footnotes = <ref name=10K>{{cite web | url=https://www.sec.gov/Archives/edgar/data/816284/000081628419000014/a2018123110-k.htm | title=Celgene Corporation 2018 Form 10-K Annual Report | publisher=U.S. Securities and Exchange Commission | date=February 21, 2019}}</ref> }}

'''Celgene Corporation''' is an American pharmaceutical company that makes cancer and immunology drugs. Its major product is Revlimid (lenalidomide), which is used in the treatment of multiple myeloma, and also in certain anemias. The company is incorporated in Delaware, headquartered in Summit, New Jersey, and a subsidiary of Bristol Myers Squibb (BMS) since its acquisition in 2019.<ref name="acquisition">[https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-completes-acquisition-celgene-creating-le Bristol-Myers Squibb Completes Acquisition of Celgene, Creating a Leading Biopharma Company], PM BMS, November 20, 2019; retrieved May 20, 2020</ref>

==History== Celgene was originally a unit of Celanese. In 1986, Celanese completed the corporate spin-off of Celgene following the merger of Celanese with American Hoechst.<ref>{{Cite book | title=Die Biotechnologie-Industrie Ein Einführungs-, Übersichts- und Nachschlagewerk | isbn=978-3-662-47160-9 | edition=1. Aufl. 2016 | location=Berlin, Heidelberg | oclc=943795815 | last1=Schüler | first1=Julia | date=February 11, 2016}}</ref><ref>{{Cite book | last=Goldman | first=Lawrence | url=https://books.google.com/books?id=nbGcAQAAQBAJ&q=In+1986%2C+Celanese+completed+the+corporate+spin-off+of+Celgene&pg=PA289|title=Oxford Dictionary of National Biography 2005-2008 | date=March 7, 2013 | publisher=OUP Oxford | isbn=978-0-19-967154-0 | pages=289 | language=en}}</ref>

In August 2000, Celgene acquired Signal Pharmaceuticals, Inc., a privately held company that developed pharmaceuticals to regulate disease-related genes.<ref>{{Cite news | url=https://www.nytimes.com/2000/07/01/business/company-news-celgene-thalidomide-maker-adds-signal.html | title=Company News; Celgene, Thalidomide Maker, Adds Signal | agency=Bloomberg News |work=The New York Times | date=July 1, 2000 | url-access=limited | issn=0362-4331}}</ref> Signal Pharmaceuticals was rebranded as Celgene Research San Diego.<ref>{{cite web | url=https://www.sec.gov/Archives/edgar/data/816284/000136231009002329/c80967e10vk.htm | title=Celgene Corporation 2008 Form 10-K Annual Report | publisher=U.S. Securities and Exchange Commission | date=February 5, 2009}}</ref>

In December 2002, Celgene acquired Anthrogenesis, a privately held New Jersey–based biotherapeutics company and cord blood banking business, which is developing technology for the recovery of stem cells from placental tissues following the completion of full-term successful pregnancies. Anthrogenesis was rebranded as Celgene Cellular Therapeutics.<ref>{{Cite book |url=https://books.google.com/books?id=Z_oKBAAAQBAJ&q=Anthrogenesis+renamed+Celgene+Cellular+Therapeutics&pg=PA556 |last1=Atala |first1=Anthony | title=Translational Regenerative Medicine |last2=Allickson |first2=Julie |publisher=Academic Press|isbn=978-0-12-410457-0 | pages=559 | date=December 1, 2014}}</ref>

In 2006, Celgene certified McKesson Specialty, a specialty pharmacy, as one of a group of pharmacies contracted to launch lenalidomide (Revlimid). As a specialty drug, lenalidomide is only available through the a distribution network consisting of specialty pharmacies contracted by the company.<ref>{{Cite news | url=https://www.drugtopics.com/view/mckesson-specialty-certified-launch-revlimid |title=McKesson Specialty certified to launch Revlimid | work=Drug Topics | date=February 20, 2006}}</ref>

In March 2008, Celgene acquired Pharmion Corporation for $2.9 billion.<ref>{{Cite press release | url=https://www.biospace.com/celgene-corporation-completes-2-9-billion-acquisition-of-pharmion-corporation | title=Celgene Corporation Completes $2.9 Billion Acquisition of Pharmion Corporation | work=BioSpace | date=March 10, 2008}}</ref>

In January 2010, Celgene acquired Gloucester Pharmaceuticals.<ref>{{Cite book |last=Brahmachari |first=Goutam | url=https://books.google.com/books?id=7wlqDQAAQBAJ&q=In+January+2010%2C+Celgene+acquired+Gloucester+Pharmaceuticals&pg=PA46 |title=Bioactive Natural Products: Opportunities and Challenges in Medicinal Chemistry | year=2012 |publisher=World Scientific |isbn=978-981-4335-37-9 |pages=46 |language=en}}</ref>

In June 2010, Celgene agreed to acquire Abraxis BioScience for $2.9 billion, which produced Abraxane, for the treatment of cancer.<ref>{{Cite news |last=Pollack | first=Andrew | url=https://www.nytimes.com/2010/07/01/health/01drug.html | title=Prominent Drug Chief to Sell Abraxis BioScience to Celgene for $2.9 Billion | work=The New York Times | date=June 30, 2010 | url-access=limited | issn=0362-4331}}</ref><ref>{{Cite news | url=https://www.reuters.com/article/us-abraxis-takeover-celgene-idUSTRE65T1Z120100630 |title=Celgene to buy Abraxis BioScience for $2.9 billion | first1=Toni | last1=Clarke | first2=Anand | last2=Basu | first3=Lewis | last3=Krauskopf | editor-first1=Dave | editor-last1=Zimmerman |work=Reuters |date=June 30, 2010}}</ref>

In November 2011, Celgene relocated its United Kingdom headquarters from Windsor, Berkshire, to Stockley Park, near Heathrow airport which is also the home of GlaxoSmithKline's UK operations.<ref>{{cite news | url=https://pharmafile.com/news/celgene-opens-new-headquarters-uk/ | title=Celgene opens new headquarters in UK | work=Pharmafile | date=November 21, 2011}}</ref>

In January 2012, Celgene agreed to acquire Avila Therapeutics, a privately held biotechnology company for $925 million, with $350 million in cash.<ref>{{Cite news | url=https://www.fiercebiotech.com/biotech/updated-celgene-snaps-up-avila-therapeutics-925m-buyout | title=UPDATED: Celgene snaps up Avila Therapeutics in $925M buyout | first=John | last=Carroll | work=FierceBiotech | date=January 26, 2012}}</ref>

In December 2013, Celgene and OncoMed joined a cancer Stem cell therapy development agreement with demcizumab and five other biologics from OncoMed's pipeline.<ref>{{cite news | url=https://www.genengnews.com/news/oncomed-celgene-in-3-3b-cancer-stem-cell-collaboration/ | title=OncoMed, Celgene in $3.3B+ Cancer Stem Cell Collaboration | work=Mary Ann Liebert | date=December 3, 2013}}</ref>

In October 2014, Sutro Biopharma entered into an agreement with Celgene Corporation to discover and develop multispecific antibodies and antibody drug conjugates (ADCs).<ref>{{Cite news |url=https://www.bizjournals.com/sanfrancisco/blog/biotech/2014/10/celgene-celg-sutro-biopharma-adcs-immuno-oncology.html |title=Celgene lands option to buy Sutro Bio in potential $1 billion deal | work=American City Business Journals | date=October 2014 | url-access=subscription}}</ref> This followed the December 2012 collaboration between the two companies and focused on the field of immuno-oncology.<ref>{{Cite news | url=https://www.genengnews.com/topics/drug-discovery/celgene-sutro-cancer-antibody-adc-partnership-grows-to-1b/ | title=Celgene-Sutro Cancer Antibody-ADC Partnership Grows to $1B+ | work=Mary Ann Liebert | date=October 23, 2014}}</ref>

In April 2015, Celgene announced a collaboration with AstraZeneca, worth $450 million, to study their Phase III immuno-oncology drug candidate MEDI4736.<ref>{{cite news | url=https://www.genengnews.com/news/astrazeneca-inks-1-8b-in-immuno-oncology-deals-as-q1-profit-dips/ | title=AstraZeneca Inks $1.8B in Immuno-Oncology Deals as Q1 Profit Dips | work=Mary Ann Liebert | date=April 24, 2015}}</ref>

That same month, Celgene exercised its option to acquire Quanticel for up to $485 million to enhance its cancer drug pipeline.<ref>{{cite news | url=https://www.genengnews.com/news/celgene-to-acquire-quanticel-for-up-to-485m/ | title=Celgene to Acquire Quanticel for Up-to-$485M | work=Mary Ann Liebert | date=April 27, 2015}}</ref> Celgene had invested in Quanticel in April 2011.<ref>{{Cite news | url=https://www.fiercebiotech.com/biotech/celgene-to-funnel-45m-into-startup-quanticel-for-targeted-cancer-drugs | title=Celgene to funnel $45M into startup Quanticel for targeted cancer drugs | work=FierceBiotech | date=November 4, 2011}}</ref>

In June 2015, Celgene exercised its option to license Lyceras RORgamma agonist portfolio for up to $105 million to develop its Phase I lead compound LYC-30937 for the treatment of inflammatory bowel disease. The licensing opportunity gave Celgene the option to acquire Lycera.<ref>{{Cite news | url=https://www.genengnews.com/news/celgene-licenses-lyceras-immune-modulators-in-up-to-105m-deal/ | title=Celgene Licenses Lycera’s Immune Modulators in Up-to-$105M+ Deal | work=Mary Ann Liebert | date=January 11, 2016}}</ref><ref>{{Cite press release | url=https://www.prnewswire.com/news-releases/lycera-announces-celgene-has-exercised-its-option-to-license-portfolio-of-ex-vivo-rorgamma-agonist-compounds-under-global-strategic-collaboration-300201777.html | title=Lycera Announces Celgene Has Exercised its Option to License Portfolio of Ex Vivo RORgamma Agonist Compounds under Global Strategic Collaboration | publisher=PR Newswire | date=January 11, 2016}}</ref>

In July 2015, the company announced it would acquire Receptos for $7.2 billion in a move to strengthen the company's inflammation and immunology areas.<ref>{{cite press release | url=https://www.sec.gov/Archives/edgar/data/1463729/000119312515252504/d90640dex991.htm |title=Celgene to Acquire Receptos, Advancing Leadership in Immune-Inflammatory Diseases | publisher=U.S. Securities and Exchange Commission | date=July 14, 2015}}</ref>

In May 2016, the company announced it would launch partnership with Agios Pharmaceuticals, developing metabolic immuno-oncology therapies.<ref>{{cite news | url=https://www.genengnews.com/news/celgene-agios-launch-1b-metabolic-immuno-oncology-alliance/ | title=Celgene, Agios, Launch $1B+ Metabolic Immuno-oncology Alliance | work=Mary Ann Liebert | date=May 17, 2016}}</ref>

In October 2016, the company acquired EngMab AG for $600 million.<ref>{{cite news | title=Celgene buys EngMab for $600M and will head into clinic next year | url=https://www.fiercebiotech.com/biotech/celgene-600m-engmab-biotech-buy-to-head-into-clinic-next-year | first=Ben | last=Adams | work=FierceBiotech | date=October 3, 2016}}</ref><ref>{{cite news | url=https://www.thestreet.com/story/14455526/1/celgene-could-be-bulking-up-very-fast.html |title=Celgene Could Be Bulking Up Very Fast |first=Armie Margaret |last=Lee | work=TheStreet.com |date=January 19, 2018}}</ref>

In January 2017, the company announced it would acquire Delinia for up to $775 million, increasing the company's autoimmune disease therapy offerings.<ref>{{Cite news | url=https://www.wsj.com/articles/celgene-to-pay-up-to-775-million-to-buy-biotech-startup-delinia-1485439414 | title=Celgene to Pay Up to $775 Million to Buy Biotech Startup Delinia | first=Brian | last=Gormley | work=The Wall Street Journal | date=January 26, 2017 | url-access=subscription}}</ref>

In January 2018, Celgene announced it would acquire Impact Biomedicines for $7 billion, adding fedratinib, a kinase inhibitor with potential to treat myelofibrosis.<ref>{{Cite news | url=https://www.reuters.com/article/us-impact-biomedicines-m-a-celgene-idUSKBN1EW0U9 |title=Celgene to buy Impact Biomedicines for up to $7 billion | first=Elizabeth | last=Dilts | editor-first1=Lisa | editor-last1=Shumaker | editor-first2=Rosalba | editor-last2=O'Brien | work=Reuters | date=January 8, 2018}}</ref>

In March 2018, the company acquired Juno Therapeutics for $9 billion.<ref>{{Cite press release | url=https://www.sec.gov/Archives/edgar/data/816284/000114420418012947/tv487762_99-2.htm | title=CELGENE COMPLETES ACQUISITION OF JUNO THERAPEUTICS, INC., ADVANCING GLOBAL LEADERSHIP IN CELLULAR IMMUNOTHERAPY | via=U.S. Securities and Exchange Commission | location=Summit, New Jersey | date=March 6, 2018}}</ref><ref>{{cite news | url=https://www.reuters.com/article/us-biotech-m-a-idUSKBN1FB20V |title=Biotech M&A takes off as Sanofi and Celgene spend $20 billion | first1=Ben | last1=Hirschler | first2=Sudip | last2=Kar-Gupta | first3=Michael | last3=Erman | editor-first1=Edmund | editor-last1=Blair | editor-first2=Alexander | editor-last2=Smith | work=Reuters | date=January 22, 2018}}</ref> That month, the company paid $101 million to partner with Vividion on the discovery of small molecules that hit hard-to-drug proteins.<ref>{{Cite news | url=https://www.fiercebiotech.com/biotech/celgene-pays-101m-to-work-vividion-hard-to-drug-proteins | title=Celgene pays $101M to work with Vividion on hard-to-drug proteins | first=Nick Paul | last=Taylor | work=FierceBiotech | date=March 5, 2018}}</ref>

In January 2019, the company committed to pay up to $980 million to license TRPH-395, a small molecule that targets protein-protein interactions and epigenetic regulation in leukemia and lymphoma.<ref>{{Cite news | url=https://www.fiercebiotech.com/biotech/celgene-inks-1b-deal-for-a-preclinical-epigenetic-blood-cancer-drug-from-canada | title=Celgene inks $1B deal for a preclinical epigenetic blood cancer drug from Canada | first=Conor | last=Hale | work=FierceBiotech | date=January 29, 2019}}</ref>

In March 2019, the company partnered with Exscientia on three of its drug programs targeting oncology and autoimmunity.<ref>{{Cite news | url=https://www.fiercebiotech.com/biotech/celgene-taps-exscientia-s-ai-drug-discovery-tech-for-3-new-programs | title=Celgene taps Exscientia’s AI drug discovery tech for 3 new programs | first=Amirah | last=Al Idrus | work=FierceBiotech | date=March 21, 2019}}</ref>

In November 2019, Bristol-Myers Squibb (BMS) acquired the company for $74 billion in the largest pharmaceutical acquisition to date.<ref>{{Cite press release | url=https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-completes-acquisition-celgene-creating-le | title=Bristol-Myers Squibb Completes Acquisition of Celgene, Creating a Leading Biopharma Company | publisher=Bristol-Myers Squibb | date=November 20, 2019}}</ref><ref>{{Cite news | url=https://www.barrons.com/articles/bristol-myers-stock-celgene-merger-completed-wednesday-ftc-amgen-psoriasis-drug-otezla-51574088694 | title=At Long Last, Bristol-Myers Buys Celgene | first=Josh | last=Nathan-Kazis | work=Barron's | date=November 20, 2019 | url-access=subscription}}</ref><ref>{{Cite news | url=https://www.marketwatch.com/story/bristol-myers-squibb-completes-74-billion-acquisition-of-celgene-2019-11-20 | title=Bristol-Myers Squibb completes $74 billion acquisition of Celgene | first=Jon | last=Swartz | work=MarketWatch | date=November 20, 2019 | url-access=limited}}</ref> As part of the acquisition, Amgen acquired the Otezla drug program from Celgene for $13.4 billion.<ref>{{Cite press release | url=https://www.prnewswire.com/news-releases/amgen-completes-acquisition-of-otezla-apremilast-300962932.html | title=Amgen Completes Acquisition Of Otezla (apremilast) | publisher=PR Newswire | date=November 21, 2019}}</ref><ref>{{Cite news | url=https://www.wsj.com/articles/amgen-to-buy-otezla-for-13-4-billion-in-cash-11566816794 |last2=Kellaher | first1=Jared S. | last1=Hopkins | first2=Colin |title=Bristol-Myers Moves Closer to Buying Celgene |work=The Wall Street Journal |date=August 27, 2019 |issn=0099-9660}}</ref> Activist investor Starboard Value opposed the deal, nominating five alternative potential directors on the Bristol-Myers board;<ref>{{Cite news | url=https://www.wsj.com/articles/starboard-value-nominates-five-to-bristol-myers-board-11550683021 | title=Activist Investor Starboard Unhappy With Bristol-Myers' Deal to Buy Celgene | last=Lombardo | first=Cara | work=The Wall Street Journal | last2=Maidenberg | first2=Micah | date=February 20, 2019 | url-access=subscription |issn=0099-9660}}</ref> however, it retracted its opposition after Institutional Shareholder Services and Glass Lewis supported the transaction and it appeared to have enough shareholder support.<ref>{{Cite news | url=https://www.reuters.com/article/business/starboard-abandons-campaign-to-scuttle-bristol-myers-celgene-deal-idUSKCN1RA1ME/ | title=Starboard abandons campaign to scuttle Bristol-Myers-Celgene deal | first1=Svea | last1=Herbst-Bayliss | first2=Michael | last2=Erman | work=Reuters | date=March 29, 2019}}</ref>

===Company origin and acquisition history=== The following is an illustration of the company's major mergers and acquisitions and historical predecessors (this is not a comprehensive list): {{Tree list}} * '''Celgene''' (Spun off from Celanese in 1986, acquired by Bristol-Myers Squibb in 2019) ** Signal Pharmaceuticals, Inc (Acq 2000) ** Anthrogenesis (Acq 2002) ** Pharmion Corporation (Acq 2008) ** Gloucester Pharmaceuticals (Acq 2009) ** Abraxis BioScience Inc (Acq 2010) ** Avila Therapeutics, Inc (Acq 2012) ** Quanticel (Acq 2015) ** Receptos (Acq 2015) ** EngMab AG (Acq 2016) ** Delinia (Acq 2017) ** Impact Biomedicines (Acq 2018) ** Juno Therapeutics (Acq 2018) *** AbVitro (Acq 2016) *** RedoxTherapies (Acq 2016) {{Tree list/end}}

===Management history=== In March 2016, Bob Hugin, the company's long serving CEO, retired from his position and took the role of executive chairman. Bob Hugin was succeeded in the CEO role by Mark Alles. At the same time, Jacqualyn Fouse was named as the company's president and COO; Fouse had joined the company in 2010 as the CFO. Effective June 30, 2017, Dr. Fouse resigned and was succeeded by Scott Smith, president of the company's Global Inflammation & Immunology Franchise, who joined the company in 2008.<ref>{{Cite news |url=https://www.genengnews.com/news/a-year-into-job-celgene-president-and-coo-said-to-retire/ |title=A Year into Job, Celgene President and COO Said to Retire | work=Mary Ann Liebert | date=February 24, 2017}}</ref>

==Finances== For the fiscal year 2017, Celgene reported earnings of US$2.539 billion, with an annual revenue of US$13.003 billion, an increase of 15.8% over the previous fiscal cycle.<ref>{{Cite web |url=https://www.macrotrends.net/stocks/charts/CELG/celgene/revenue |title=Celgene Revenue 2006-2018 {{!}} CELG |website=www.macrotrends.net }}</ref> {| class="wikitable float-left" style="text-align: right" !Year !Revenue in mil. USD$ !Net income in mil. USD$ !Total Assets in mil. USD$ !Employees |- |2005 |537 |64 |1,258 | |- |2006 |899 |69 |2,736 | |- |2007 |1,406 |226 |3,611 | |- |2008 |2,255 |−1,534 |4,445 | |- |2009 |2,690 | 777 |5,389 | |- |2010 |3,626 | 881 |10,177 | |- |2011 |4,842 |1,318 |10,006 | |- |2012 |5,507 |1,456 |11,734 | |- |2013 |6,494 |1,450 |13,378 |5.100 |- |2014 |7,670 |2,000 |17,340 |6,012 |- |2015 |9,256 | 1,602 |26,964 |6,971 |- |2016 |11,229 |1,999 |28,086 |7,132 |- |2017 |13,003 |2,940 |30,141 |7,467 |}

==Products== Major products included Revlimid (lenalidomide) and Pomalyst (pomalidomide) and the immunology drug Otezla (apremilast).<!-- no ind'n here a/o 2016 November of logic of organizing drugs in order Vid, Rev, Thal, Alker, Foc, and indic'ns chronologically within drug.

As article is on company, not drugs per se, IMO most logical for users is by drug's date of first approval, and chrono w/in drug. Would be nice to provide users w/ switch to reverse order, and switch to choose among (1) that and (2) drugs in chrono or reverse chrono order, and chrono within drug. But that would take more wiki-skill -->

{| class="wikitable" style="text-align:center" |+ Product Portfolio |- valign="bottom" ! width="10%" |Brand Name ! width="25%" |Drug Name(s) ! width="45%" |Indication ! width="25%" |Date Approved (USA)<ref>{{cite web | title=Drugs@FDA: FDA Approved Drug Products | url=https://www.accessdata.fda.gov/scripts/cder/daf/ | publisher=Food and Drug Administration}}</ref> ! width="15%" |Partner |- valign="top" |'''Alkeran''' |melphalan |palliative treatment of multiple myeloma and for the palliation of non-resectable epithelial carcinoma of the ovary |01-17-1964 |GlaxoSmithKline |- valign="top" |'''Alkeran''' |melphalan hydrochloride |the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate |11-18-1992 |GlaxoSmithKline |- valign="top" |- valign="top" | |- valign="top" |'''Thalomid''' |thalidomide |acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrences |07-16-1998 |   |- valign="top" |'''Thalomid''' |thalidomide |(in combination with dexamethasone) treatment of patients with newly diagnosed multiple myeloma |05-25-2006 | GlaxoSmithKline |- valign="top" | |- valign="top" |'''Focalin''' |dexmethylphenidate hydrochloride CII |attention deficit hyperactivity disorder (ADHD) in children and adolescents |11-13-2001

|Novartis

|'''Revlimid''' |lenalidomide |transfusion dependent anemia due to low or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5 q cytogenetic abnormality with or without additional cytogenetic abnormalities |12-27-2005 |   |- valign="top" |'''Revlimid''' |lenalidomide |(in combination with dexamethasone) treatment of multiple myeloma patients who have received at least one prior therapy |06-29-2006 |   |}

===Product-related history=== In July 1998, Celgene received approval from the FDA to market Thalomid for the acute treatment of the cutaneous manifestations of moderate to severe ENL.<ref>{{cite web | url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020785 | title=Drugs@FDA: FDA-Approved Drugs: New Drug Application (NDA): 020785 | publisher=Food and Drug Administration}}</ref>

In April 2000, Celgene reached an agreement with Novartis Pharma AG to license d-MPH, Celgene's chirally pure version of RITALIN. The FDA subsequently granted approval to market d-MPH, or Focalin, in November 2001.<ref>{{cite web | url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021278 | title=Drugs@FDA: FDA-Approved Drugs: New Drug Application (NDA): 021278 | publisher=Food and Drug Administration}}</ref>

In December 2005, Celgene received approval from the FDA to market Revlimid for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Focalin XR was later launched by Celgene and Novartis in 2005.<ref>{{cite web | url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021802 | title=Drugs@FDA: FDA-Approved Drugs: New Drug Application (NDA): 021802 | publisher=Food and Drug Administration}}</ref>

In May 2006, Celgene received approval for Thalomid in combination with dexamethasone for the treatment of patients with newly diagnosed multiple myeloma.

In June 2007, Celgene received full marketing authorization for Revlimid in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy by the European Commission.

==Pipeline== * Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5). Ozanimod causes lymphocyte retention in lymphoid tissues. The mechanism by which ozanimod exerts therapeutic effects in multiple sclerosis is unknown, but may involve the reduction of lymphocyte migration into the central nervous system. Ozanimod is in development for immune-inflammatory indications including ulcerative colitis and Crohn's disease.<ref>{{cite press release | url=https://www.biospace.com/analysis-showed-oral-ozanimod-reduced-brain-volume-loss-across-all-age-subgroups-in-adults-with-relapsing-multiple-sclerosis | title=Analysis Showed Oral Ozanimod Reduced Brain Volume Loss Across All Age Subgroups in Adults with Relapsing Multiple Sclerosis | work=Biospace | date=May 7, 2019}}</ref> * Celgene developed several products within several areas of research (MM, MDS, AML, Lymphoma, CLL, Beta-Thalassemia, Myelofibrosis, Solid Tumors, Inflammation & Immunology.<ref name=10K/>

==Litigation== ===Antitrust allegations=== In 2009, Dr. Reddy's Laboratories requested, and Celgene refused to provide, a samples of Celgene's anticancer drug THALOMID (thalidomide). Dr. Reddy's Laboratories sought the material for bioequivalency studies required to bring its own, generic, version of thalidomide to market. In response to the refusal, Dr. Reddy's Laboratories filed a Citizen's Petition with the FDA asking the Agency to adopt procedures that would ensure generic applicants the right to buy sufficient samples to perform bioequivalence testing of drugs that were subject to REMS distribution restrictions.

Celgene denied that it had behaved anti-competitively, arguing that the legislative history strongly suggested that Congress considered and rejected a proposed guaranteed access procedure like the one proposed by Dr. Reddy's. Celgene further argued that requiring innovator companies to sell their products to potential generic competitors would violate its intellectual property rights and subject it to liability risks in the event that patients were harmed in Dr. Reddy's studies.

In 2018, Celgene was at the top of a list of companies that the FDA identified as refusing to release samples to competitors to create generics.<ref>{{Cite web |url=https://www.legalreader.com/f-d-make-public-generic-blocking-practices-drug-companies/ |title=F.D.A. Makes Public Generic-Blocking Practices of Drug Companies | last=Teller | first=Sara E. | website=Legal Reader |date=May 29, 2018}}</ref>

Generic manufacturer Lannett Company initiated antitrust litigation that accused Celgene of using its REMS for THALOMID (thalidomide) to violate the anti-monopolization provisions of the Sherman Act. In early 2011, the district court denied Celgene's motion to dismiss. The case was set for trial beginning in February 2012, but the parties settled before the trial began, thereby postponing further judicial review of antitrust claims premised on alleged abuse of REMS distribution restrictions.<ref>{{cite web | title=Life Science Update |url=https://www.lexology.com/library/detail.aspx?g=a7522360-b0eb-493a-907b-1ff06a72165c |publisher=Baker Botts LLP | date=February 28, 2012}}</ref>

===Fraud allegations=== In July 2017, Celgene agreed to pay $280 million to government agencies to settle allegations that it caused the submission of false claims or fraudulent claims for non-reimbursable uses of its drugs Revlimid and Thalomid to Medicare and state Medicaid programs.<ref>{{cite press release |url=https://www.justice.gov/usao-cdca/pr/celgene-agrees-pay-280-million-resolve-fraud-allegations-related-promotion-cancer-drugs |title=Celgene Agrees to Pay $280 Million to Resolve Fraud Allegations Related to Promotion of Cancer Drugs For Uses Not Approved by FDA | publisher=United States Department of Justice |date=July 24, 2017}}</ref> In its July 2017 10-Q, Celgene disclosed that it resolved the matter in full for $315 million, including fees and expenses.<ref>{{Cite web | url=https://www.sec.gov/Archives/edgar/data/816284/000081628417000009/a2017063010q.htm |title=United States Securities and Exchange Commission - Quarterly Report Puruant to Section 13 or 15 (d) of the Securities Exchange Act of 1934 | publisher=U.S. Securities and Exchange Commission | date=June 30, 2017}}</ref> The case was brought under the False Claims Act by Beverly Brown, a former Celgene sales representative.<ref>{{cite news | url=https://www.nytimes.com/2017/07/25/health/celgene-to-pay-280-million-to-settle-fraud-suit-over-cancer-drugs.html | last=Thomas | first=Katie | title=Celgene to Pay $280 Million to Settle Fraud Suit Over Cancer Drugs | work=The New York Times | date=July 25, 2017}}</ref>

=== Price increases === Celgene and BMS repeatedly raised the price of its primary drug, Revlimid, from $218 per pill in 2005 to $892 in 2023, while the cost to manufacture remained approximately $0.25 per pill throughout this period.<ref name="ProPublica">{{cite web |last=Allen |first=Arthur |date=October 31, 2023 |title=How a Drug's High Cost Is Hidden in Plain Sight |url=https://www.propublica.org/article/revlimid-price-cancer-celgene-drugs-fda-multiple-myeloma |access-date=May 13, 2025 |website=ProPublica}}</ref>

==References== {{Reflist|2}}

==External links== {{Finance links historical | name = Celgene | sec_cik = CELG }}

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