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Celgene

From Alfawiki
Celgene Corporation
Company typePublic
IndustryPharmaceutical
PredecessorCelanese (division)
Founded1986
Defunct2019
FateAcquired by Bristol Myers Squibb
SuccessorBristol Myers Squibb
Headquarters
Summit, New Jersey
,
United States
Area served
Worldwide
Key people
Bob Hugin (executive chairman until 2016), Mark Alles (CEO from 2016), Jacqualyn Fouse (former president and COO), Scott Smith (CFO from 2017)
ProductsRevlimid (lenalidomide), Pomalyst (pomalidomide), Imnovid (pomalidomide), Otezla (apremilast), Abraxane, Thalomid, Focalin, Vidaza
OwnerBristol Myers Squibb (from 2019)
Number of employees
7,467 (2017)
ParentBristol Myers Squibb (from 2019)

Celgene Corporation, based in Summit, New Jersey, was a pharmaceutical firm focused on developing treatments for cancer and immune-related conditions. Its principal products included Revlimid (lenalidomide), used for multiple myeloma and accounting for 63% of 2018 sales; Pomalyst and Imnovid (Pomalidomide), also targeting multiple myeloma and representing 13% of revenue that year; and Otezla (Apremilast), prescribed for psoriasis, contributing 11% to 2018 earnings. In 2018, the United States market generated 66% of the company’s total income. Celgene was acquired by Bristol Myers Squibb in 2019, with Otezla later divested to Amgen.

History

Celgene began as a division within Celanese. Following Celanese’s merger with American Hoechst in 1986, Celgene was spun off as an independent entity.

In August 2000, Celgene enhanced its drug development capabilities through the acquisition of Signal Pharmaceuticals, which became Celgene Research San Diego.

By December 2002, Celgene expanded into biotherapeutics and cord blood banking by acquiring Anthrogenesis, subsequently renamed Celgene Cellular Therapeutics.

By 2006, the company had established a specialized pharmacy distribution system for lenalidomide (Revlimid), restricting sales to selected contracted pharmacies.

Celgene significantly broadened its portfolio in March 2008 by purchasing Pharmion Corporation for $2.9 billion.

The company continued its expansion with the acquisition of Gloucester Pharmaceuticals in January 2010, followed by the $2.9 billion acquisition of Abraxis BioScience in June 2010, which added the cancer treatment Abraxane to its offerings.

In November 2011, Celgene relocated its UK headquarters to Stockley Park near Heathrow Airport.

January 2012 saw the $925 million acquisition of Avila Therapeutics to strengthen its drug pipeline.

Celgene entered into a partnership with OncoMed in December 2013 to develop cancer stem cell therapies and extended its immuno-oncology collaborations with Sutro Biopharma, initiated in 2012 and expanded in 2014.

April 2015 brought a $450 million immuno-oncology collaboration with AstraZeneca focusing on the MEDI4736 drug, alongside the acquisition of Quanticel for up to $485 million to augment oncology assets.

In June 2015, Celgene licensed Lycera’s RORgamma agonist portfolio for up to $105 million, aiming to enhance treatments for inflammatory bowel disease.

July 2015 featured a major strategic acquisition of Receptos for $7.2 billion, bolstering its inflammation and immunology product lines.

In May 2016, a $1 billion collaboration was launched with Agios Pharmaceuticals targeting metabolic immuno-oncology therapies.

October 2016 included the purchase of EngMab AG for $600 million to advance clinical-stage projects.

January 2017 involved acquiring Delinia for up to $775 million to broaden autoimmune disease treatment options.

In January 2018, Celgene acquired Impact Biomedicines for $7 billion, adding fedratinib, a kinase inhibitor for myelofibrosis therapy.

March 2018 saw the $9 billion acquisition of Juno Therapeutics, enhancing cellular immunotherapy capabilities; additionally, Celgene invested $101 million in a partnership with Vividion focused on targeting challenging proteins.

Early in 2019, Celgene licensed TRPH-395 for up to $980 million aimed at leukemia and lymphoma treatments and partnered with Exscientia on AI-driven drug discovery programs in oncology and autoimmune diseases.

Celgene’s growth culminated in its November 2019 acquisition by Bristol-Myers Squibb for $74 billion—the largest pharmaceutical transaction at that time—with Otezla sold separately to Amgen for $13.4 billion. Despite initial resistance from activist investor Starboard Value, shareholder approval secured completion of the deal.

Company origin and acquisition history

Significant mergers and acquisitions that have influenced the company's development include:

  • Celgene (Originally spun off from Celanese in 1986, later acquired by Bristol-Myers Squibb in 2019)
    • Signal Pharmaceuticals, Inc (Acquired 2000)
    • Anthrogenesis (Acquired 2002)
    • Pharmion Corporation (Acquired 2008)
    • Gloucester Pharmaceuticals (Acquired 2009)
    • Abraxis BioScience Inc (Acquired 2010)
    • Avila Therapeutics, Inc (Acquired 2012)
    • Quanticel (Acquired 2015)
    • Receptos (Acquired 2015)
    • EngMab AG (Acquired 2016)
    • Delinia (Acquired 2017)
    • Impact Biomedicines (Acquired 2018)
    • Juno Therapeutics (Acquired 2018)
      • AbVitro (Acquired 2016)
      • RedoxTherapies (Acquired 2016)


Management history

In March 2016, Bob Hugin, who had served as CEO for an extended period, moved into the role of executive chairman. Mark Alles was named the new CEO. Jacqualyn Fouse, who had been CFO since 2010, advanced to president and COO but departed in June 2017. She was succeeded by Scott Smith, who had been leading the Global Inflammation & Immunology Franchise since 2008. This leadership transition was part of a strategic effort to enhance operational performance and drive business expansion.

Finances

For the fiscal year ending in 2017, the company achieved revenues totaling US$13.003 billion, marking a growth of 15.8% compared to the previous year. Net income stood at US$2.539 billion, reflecting strong market demand and successful strategic initiatives.

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

The company’s product lineup focuses primarily on major pharmaceutical agents including Revlimid (lenalidomide), Pomalyst (pomalidomide), and Otezla (apremilast), which serve oncology and immunology sectors.

Product Portfolio
Brand Name Drug Name(s) Indication Date Approved (USA) Partner
'\'Alkeran\ '\'melphalan\ 'palliative care for multiple myeloma and non-resectable epithelial ovarian carcinoma' '01-17-1964' '\'GlaxoSmithKline\
'\'Alkeran\ '\'melphalan hydrochloride\ 'palliative treatment for multiple myeloma patients unable to take oral medication' '11-18-1992' '\'GlaxoSmithKline\
'\'Thalomid\ '\'thalidomide\ 'management of erythema nodosum leprosum (ENL) and maintenance therapy to prevent ENL recurrence' '07-16-1998' ' '
'\'Thalomid\ '\'thalidomide\ 'used in combination with dexamethasone for newly diagnosed multiple myeloma' '05-25-2006' '\'GlaxoSmithKline\
'\'Focalin\ '\'dexmethylphenidate hydrochloride CII\ 'treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents' '11-13-2001' '\'Novartis\
'\'Focalin XR\ '\'dexmethylphenidate hydrochloride CII\ 'therapy for ADHD across children to adults' '05-26-2005' '\'Novartis\
'\'Vidaza\ '\'azacitidine\ 'used for refractory anemia and chronic myelomonocytic leukemia treatment' '05-19-2004' ' '
'\'Revlimid\ '\'lenalidomide\ 'treatment of transfusion-dependent anemia in myelodysplastic syndromes with deletion 5q cytogenetic abnormality' '12-27-2005' ' '
'\'Revlimid\ '\'lenalidomide\ 'combined with dexamethasone for multiple myeloma patients following prior therapies' '06-29-2006' ' '


Product-related history

In July 1998, Celgene obtained FDA authorization to distribute Thalomid for the acute management of cutaneous symptoms associated with moderate to severe erythema nodosum leprosum (ENL).

By April 2000, Celgene had licensed d-MPH, a chirally pure form of RITALIN, to Novartis Pharma AG. The FDA granted approval for d-MPH, which was introduced to the market as Focalin, in November 2001.

In December 2005, the FDA approved Revlimid for treating transfusion-dependent anemia in patients diagnosed with Low- or Intermediate-1-risk myelodysplastic syndromes (MDS) linked to deletion 5q cytogenetic abnormalities. That same year, Celgene and Novartis launched Focalin XR.

Thalomid received FDA approval in May 2006 for use alongside dexamethasone in treating newly diagnosed multiple myeloma. Subsequently, in June 2007, the European Commission authorized the combination of Revlimid and dexamethasone for multiple myeloma patients who had undergone prior treatment.

Pipeline

  • Ozanimod is an orally administered modulator of sphingosine 1-phosphate (S1P) receptors, specifically targeting the S1P1 and S1P5 subtypes. It functions by sequestering lymphocytes within lymphoid tissues and is being developed to address immune-inflammatory conditions such as ulcerative colitis and Crohn's disease, with additional potential use in multiple sclerosis.
  • Celgene’s development portfolio covers a broad spectrum of therapeutic areas including multiple myeloma (MM), myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), lymphoma, chronic lymphocytic leukemia (CLL), beta-thalassemia, myelofibrosis, solid tumors, as well as inflammatory and immunological disorders.

Antitrust allegations

In 2009, Dr. Reddy's Laboratories requested samples of Celgene's anticancer drug THALOMID (thalidomide) to conduct bioequivalence testing essential for launching a generic version. Celgene declined this request, leading Dr. Reddy's to submit a Citizen's Petition to the FDA seeking mechanisms that would guarantee generic manufacturers access to samples despite restrictions imposed under Risk Evaluation and Mitigation Strategies (REMS).

Celgene refuted claims of anti-competitive conduct by referencing legislative history that opposed mandated access procedures. The company argued that supplying competitors would infringe on its intellectual property rights and expose it to increased liability.

By 2018, the FDA identified Celgene among firms refusing to provide product samples necessary for generic drug development.

Lannett Company, a generic drug producer, initiated antitrust litigation alleging that Celgene misused REMS controls over THALOMID to breach Sherman Act regulations. The district court denied Celgene’s motion to dismiss in early 2011. Although the trial was scheduled for February 2012, the parties reached a settlement beforehand, postponing judicial evaluation of REMS-related antitrust allegations.

Fraud allegations

In July 2017, Celgene consented to a $280 million settlement addressing accusations that it submitted fraudulent claims for off-label uses of Revlimid and Thalomid to Medicare and Medicaid programs. The company reported total resolution expenses amounting to $315 million after including legal fees and other costs. This lawsuit originated under the False Claims Act through Beverly Brown, a former sales representative at Celgene.

Price increases

Celgene and BMS have dramatically increased the cost of their leading medication, Revlimid, from $218 per tablet in 2005 to $892 per tablet by 2023, even though the production expense has remained close to $0.25 per unit. This pricing approach has played a pivotal role in driving the companies' financial expansion and strengthening their position within the pharmaceutical sector.

See also

External links