Celgene

Celgene was an American biopharmaceutical company whose principal research and commercial activities centered on cancer, blood disorders, and immune-mediated diseases. The company originated as a business unit of Celanese and became an independent company in 1986 after the corporate restructuring associated with the Celanese–American Hoechst combination. It developed from a relatively specialized biotechnology operation into a major global pharmaceutical company through internal drug development, licensing, research collaborations, and a long sequence of acquisitions. Celgene’s most important commercial franchise was built around immunomodulatory drugs. Revlimid, the brand name for lenalidomide, became the company’s central product and was used primarily in multiple myeloma, as well as in selected myelodysplastic syndromes and other hematologic conditions. Pomalyst, known as Imnovid in some markets, extended the same broad therapeutic platform through pomalidomide and was used in multiple myeloma. Thalomid, the company’s thalidomide product, was approved for specified cancer and inflammatory indications under restricted distribution arrangements. Celgene also commercialized Otezla, an oral phosphodiesterase-4 inhibitor used for conditions including psoriatic arthritis and plaque psoriasis, before selling that program to Amgen as part of the Bristol Myers Squibb transaction. The company expanded its scientific base through the 2000 acquisition of Signal Pharmaceuticals, which became Celgene Research San Diego, and the 2002 acquisition of Anthrogenesis, subsequently renamed Celgene Cellular Therapeutics. It later acquired or invested in companies and programs spanning oncology, inflammation, immunology, stem-cell science, small-molecule discovery, antibody-drug conjugates, and cellular therapy. Notable transactions included Pharmion, Abraxis BioScience, Receptos, Impact Biomedicines, and Juno Therapeutics. These deals added products such as Abraxane, development assets such as ozanimod and fedratinib, and platform capabilities related to immuno-oncology and engineered cell therapies. Celgene’s growth was accompanied by controversy. Its restricted distribution systems for Thalomid and other products drew disputes with generic-drug manufacturers over access to samples for bioequivalence testing. The company also settled allegations under the False Claims Act concerning the promotion or reimbursement of Revlimid and Thalomid for uses alleged to be non-reimbursable by government programs. The commercial success of Revlimid, together with repeated price increases reported over the product’s life, made Celgene a prominent subject in debates over specialty-drug pricing and pharmaceutical market exclusivity. In January 2019, Bristol Myers Squibb announced an agreement to acquire Celgene. The transaction closed in November 2019 and was valued at approximately $74 billion according to contemporary company and market reporting. As part of the transaction, Amgen acquired Otezla for approximately $13.4 billion to address competition concerns. Celgene ceased to operate as an independent publicly traded company and became part of Bristol Myers Squibb. Its principal products, research programs, and scientific capabilities were absorbed into the acquiring company’s oncology, hematology, and immunology organization.

Celgene began as a unit of Celanese and became independent in 1986 following the corporate changes associated with the merger of Celanese and American Hoechst. Its early identity was tied to pharmaceutical and biotechnology research rather than to a broad primary-care portfolio. The company gradually established a stronger platform in oncology and hematology, particularly through immunomodulatory compounds and products subject to controlled distribution systems. In 1998, Celgene received United States approval for Thalomid for the acute treatment of the cutaneous manifestations of moderate-to-severe erythema nodosum leprosum. The product’s history was closely associated with strict safeguards because of thalidomide’s well-known teratogenic risks. In 2000, Celgene acquired Signal Pharmaceuticals, a company working on disease-related gene regulation; the acquired operation became Celgene Research San Diego. Celgene also reached an agreement with Novartis concerning d-methylphenidate, later marketed as Focalin, although the company’s long-term strategic center became oncology rather than central-nervous-system medicines. The company’s pivotal growth product was Revlimid, or lenalidomide. The United States Food and Drug Administration approved it in 2005 for a form of transfusion-dependent myelodysplastic syndrome associated with a deletion of chromosome 5q. In 2006, Thalomid gained an additional multiple-myeloma indication in combination with dexamethasone, and in 2007 the European Commission authorized Revlimid with dexamethasone for certain multiple-myeloma patients. Revlimid subsequently became Celgene’s largest and most recognizable product, supporting expansion into research, commercial infrastructure, and external innovation. Celgene used acquisitions to broaden its pipeline and therapeutic reach. It acquired Anthrogenesis in 2002 and renamed the business Celgene Cellular Therapeutics. Pharmion was acquired in 2008 for approximately $2.9 billion, strengthening the company’s hematology and oncology presence. In 2010, Celgene acquired Gloucester Pharmaceuticals and agreed to acquire Abraxis BioScience, whose principal product was Abraxane. The company later pursued platform and pipeline assets through acquisitions and collaborations with organizations including Avila Therapeutics, OncoMed, Sutro Biopharma, AstraZeneca, Quanticel, Lycera, Receptos, Agios, EngMab, Delinia, Impact Biomedicines, Juno Therapeutics, Vividion, and Exscientia. These transactions reflected several strategic themes. In oncology, Celgene sought assets for multiple myeloma, myelodysplastic syndromes, acute myeloid leukemia, lymphomas, solid tumors, and myelofibrosis. In inflammation and immunology, it pursued therapies for inflammatory bowel disease and autoimmune disorders. In emerging modalities, it invested in stem-cell research, multispecific antibodies, antibody-drug conjugates, cellular therapy, and computational or chemical approaches to difficult drug targets. The acquisition of Receptos added ozanimod, an oral sphingosine-1-phosphate receptor modulator being developed for immune-inflammatory diseases. The acquisition of Impact Biomedicines added fedratinib, a kinase inhibitor program associated with myelofibrosis. Juno brought a major cellular-immunotherapy platform. Management changed in 2016, when long-serving chief executive Bob Hugin became executive chairman and Mark Alles succeeded him as chief executive. Jacqualyn Fouse became president and chief operating officer, later leaving that role in 2017; Scott Smith succeeded her as president of the company’s Global Inflammation and Immunology Franchise. During this period, Celgene remained a significant publicly traded specialty-pharmaceutical company, but its dependence on Revlimid also exposed it to scrutiny over pricing, intellectual-property protection, restricted distribution, and future generic competition. Celgene faced litigation and regulatory controversy concerning access to Thalomid samples. Dr. Reddy’s Laboratories sought samples for generic bioequivalence studies, while Celgene argued that compelled access could create intellectual-property and liability concerns. Lannett separately brought antitrust allegations related to the use of restricted distribution arrangements; the matter settled before trial. In 2017, Celgene agreed to a government settlement concerning allegations that claims for Revlimid and Thalomid had been submitted for uses not reimbursable by Medicare or state Medicaid programs. The company also became part of later public criticism regarding increases in the price of Revlimid. Bristol Myers Squibb announced its agreement to acquire Celgene in January 2019. The transaction closed in November 2019 after shareholder and regulatory processes. Amgen acquired Otezla in connection with the deal, while Celgene’s remaining business became part of Bristol Myers Squibb. Celgene therefore no longer exists as an independent operating or listed company, although its major products and research assets continue within BMS.

1. 2019Bristol Myers Squibb acquisition completed

   Celgene became a subsidiary of Bristol Myers Squibb; Otezla was sold to Amgen in connection with the transaction.

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2. 2018Juno Therapeutics acquired

   Celgene completed its acquisition of Juno Therapeutics, adding cellular-immunotherapy capabilities.

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3. 2015Receptos acquisition announced

   Celgene announced the acquisition of Receptos to strengthen inflammation and immunology.

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4. 2010Abraxis BioScience acquisition agreed

   Celgene agreed to acquire Abraxis BioScience and its Abraxane oncology product.

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5. 2008Pharmion acquired

   Celgene acquired Pharmion, expanding its hematology and oncology portfolio.

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6. 2005Revlimid receives initial FDA approval

   Revlimid was approved for a specified myelodysplastic-syndrome population associated with deletion 5q cytogenetic abnormality.

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7. 2002Anthrogenesis acquired

   Celgene acquired Anthrogenesis, which became Celgene Cellular Therapeutics.

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8. 2000Signal Pharmaceuticals acquired

   Celgene acquired Signal Pharmaceuticals and renamed the operation Celgene Research San Diego.

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9. 1998Thalomid receives United States approval

   The FDA approved Thalomid for acute treatment of specified cutaneous manifestations of erythema nodosum leprosum.

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10. 1986Celgene becomes an independent company

    Celgene was spun off from Celanese following the Celanese–American Hoechst corporate combination.

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Specialty biopharmaceutical company focused on high-value medicines for cancer, hematologic disorders, and immune-inflammatory diseases, with a strategy combining proprietary research, licensing, partnerships, and acquisitions.

• RevlimidHematology and oncology2005

  Revlimid is the brand name for lenalidomide, an immunomodulatory medicine and Celgene’s principal commercial product. It became an important treatment in multiple myeloma and was also approved for selected myelodysplastic-syndrome indications, including disease associated with deletion 5q. Its distribution and safety controls, as well as its commercial pricing and patent position, were recurring subjects of public and legal scrutiny. Revlimid remains associated with Bristol Myers Squibb following the acquisition of Celgene.

• Pomalyst / ImnovidHematology and oncology2013

  Pomalyst, marketed as Imnovid in some countries, is pomalidomide, an immunomodulatory agent developed for multiple myeloma. It extended Celgene’s established lenalidomide and thalidomide research franchise and was used in combination regimens for patients with previously treated disease. The product became part of Bristol Myers Squibb’s hematology portfolio after the 2019 acquisition.

• ThalomidOncology and inflammatory disease1998

  Thalomid is Celgene’s controlled-distribution formulation of thalidomide. It received approval for erythema nodosum leprosum and later for newly diagnosed multiple myeloma in combination with dexamethasone. Because thalidomide can cause severe fetal harm, access was subject to stringent risk-management and distribution requirements. Those controls later became central to disputes involving generic sample access and antitrust claims.

• OtezlaImmunology2014

  Otezla is apremilast, an oral phosphodiesterase-4 inhibitor used for immune-mediated dermatologic and rheumatologic conditions, including plaque psoriasis and psoriatic arthritis. Celgene developed the product as part of its inflammation and immunology franchise. The Otezla program was divested to Amgen in 2019 as a remedy associated with Bristol Myers Squibb’s acquisition of Celgene.

• AbraxaneOncology2005

  Abraxane is a nanoparticle albumin-bound formulation of paclitaxel used in cancer treatment. Celgene obtained the product and related business through its acquisition of Abraxis BioScience. It broadened Celgene’s commercial oncology portfolio beyond its immunomodulatory hematology products before the company was acquired by Bristol Myers Squibb.

• 2019Agree to Bristol Myers Squibb acquisitionM&A

  Celgene and Bristol Myers Squibb combined their oncology, hematology, immunology, and research portfolios in a major pharmaceutical transaction.

  What changed. Bristol Myers Squibb acquired Celgene; the transaction closed in November 2019. Amgen acquired Otezla in a related divestiture.

  Aftermath. Celgene ceased to be an independent listed company and became a Bristol Myers Squibb subsidiary.

  Reported transaction value. Approximately US$74 billion (2019)

  • Amgen — Amgen acquired Otezla in connection with the transaction and associated competition remedies.
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• 2018Acquire Juno TherapeuticsM&A

  Celgene pursued a larger position in cellular immunotherapy and engineered cancer treatments.

  What changed. Celgene acquired Juno Therapeutics in a transaction reported at approximately $9 billion.

  Aftermath. Juno’s cellular-therapy platform became part of Celgene’s oncology research organization and later moved into Bristol Myers Squibb.

  Reported acquisition value. Approximately US$9 billion (2018)

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• 2015Acquire ReceptosM&A

  Celgene wanted to expand its inflammation and immunology franchise.

  What changed. The company announced an agreement to acquire Receptos for approximately $7.2 billion.

  Aftermath. The deal added Receptos’s ozanimod program and strengthened Celgene’s immune-inflammatory pipeline.

  Reported acquisition value. Approximately US$7.2 billion (2015)

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• 2008Acquire PharmionM&A

  Celgene sought to strengthen its hematology and oncology business through the acquisition of Pharmion.

  What changed. Celgene acquired Pharmion in a transaction reported at approximately $2.9 billion.

  Aftermath. The acquisition expanded Celgene’s oncology and hematology capabilities.

  Reported acquisition value. Approximately US$2.9 billion (2008)

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• 2018FDA criticism over access to samplesControversy

  The FDA listed Celgene among companies reported to have refused potential generic manufacturers access to samples needed for development and testing of competing products.

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• 2017False Claims Act settlement involving Revlimid and ThalomidControversy

  Celgene agreed to resolve government allegations that it caused false or fraudulent claims to be submitted for certain uses of Revlimid and Thalomid that were not reimbursable by Medicare or state Medicaid programs. Contemporary disclosures described a total resolution amount that included fees and expenses.

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• 2009Thalomid sample-access and antitrust disputeControversy

  Generic-drug companies challenged Celgene’s refusal to provide Thalomid samples for bioequivalence testing. Related litigation alleged that the restricted distribution system was used to impede generic competition; the principal case settled before trial.

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• Revlimid pricing criticismControversy

  Celgene and, later, Bristol Myers Squibb faced public criticism over repeated increases in Revlimid’s price. Specific price comparisons vary by source and time period; no financial figure is included here because the supplied material does not provide a verifiable source URL for the stated amounts.

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• 2019Celgene agrees to be acquired by Bristol Myers Squibb

  Bristol Myers Squibb announced and completed its acquisition of Celgene, ending Celgene’s independent existence and incorporating its medicines and research portfolio into BMS.

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• 2019Amgen acquires Otezla program in connection with Celgene transaction

  Amgen acquired Otezla as part of the broader Celgene transaction and associated competition remedies.

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• 2009Celgene and Dr. Reddy’s Laboratories dispute access to Thalomid samples

  A dispute over access to Thalomid samples for generic bioequivalence work contributed to a broader debate about restricted distribution programs and generic competition.

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1. Celgene
2. Celgene corporate website