Celgene

American biopharmaceutical company

Celgene Corporation is a 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).

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. In August 2000, Celgene acquired Signal Pharmaceuticals, Inc., a privately held company that developed pharmaceuticals to regulate disease related genes. Signal Pharmaceuticals was rebranded as Celgene Research San Diego. 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. 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. In March 2008, Celgene acquired Pharmion Corporation for $2.9 billion. In January 2010, Celgene acquired Gloucester Pharmaceuticals. In June 2010, Celgene agreed to acquire Abraxis BioScience. It purchased the biotechnology company for $2.9 billion in its expansion into drugs that attack solid tumors. Abraxis produced Abraxane, the cancer fighting drug that can be given in high doses. In January 2012, Celgene agreed to acquire Avila Therapeutics, Inc., a privately held biotechnology company for $925 million, with $350 million in cash. Citing a market capitalization of US$67 billion, and stock appreciation of 107%, Celgene was Forbes Magazine's number 2 ranked drug company of 2013. In 2014, Celgene and OncoMed Pharmaceuticals joined a cancer stem cell therapeutic development agreement with demcizumab and five other biologics from OncoMed's pipeline. That same year, Sutro Biopharma entered into an agreement with Celgene Corporation to discover and develop multispecific antibodies and antibody drug conjugates (ADCs). This followed the December 2012 collaboration between the two companies and focused on the field of immuno oncology. In April 2015, Celgene announced a collaboration with AstraZeneca, worth $450 million, to study their Phase III immuno oncology drug candidate MEDI4736. That same month, Celgene announced it would acquire Quanticel for up to $485 million in order to enhance its cancer drug pipeline. Celgene had invested in Quanticel in April 2011. In June 2015, Celgene announced it had licensed 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. 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. In May 2016, the company announced it would launch partnership with Agios Pharmaceuticals, developing metabolic immuno oncology therapies. In October 2016, the company acquired EngMab AG for $600 million. In January 2017, the company announced it would acquire Delinia for $775 million, increasing the company's autoimmune disease therapy offerings. In January 2018, Celgene announced it would acquire Impact Biomedicines for $7 billion, adding fedratinib, a kinase inhibitor with potential to treat myelofibrosis. Also in January 2018, the company announced it would acquire Juno Therapeutics for $9 billion.

The company's Summit headquarters are located along the 7.3 mile main line of the abandoned Rahway Valley Railroad. Some have advocated for the railbed's conversion to a pedestrian and cyclist linear park and rail trail.

In January 2019, the company announced it would be acquired by Bristol Myers Squibb for $74 billion ($95 billion including debt), a deal that would become the largest pharmaceutical company acquisition ever. Celgene shareholders would receive one BMY share as well as $50 in cash for each Celgene share held, valuing Celgene at $102.43 a share; representing a 54% premium to the previous days closing price. The deal was approved by shareholders in April 2019. In August 2019, Amgen announced it would acquire the Otezla drug programme from Celgene for $13.4 billion, as part of Celgene and Bristol Myers Squibb's merger deal. The Bristol Myers acquisition closed on November 20, 2019. In November 2019, Bristol Myers Squibb (BMS) announced that it has completed its acquisition of Celgene following the receipt of regulatory approval from all government authorities required by the merger agreement and, as announced on April 12, 2019, approval by Bristol Myers Squibb and Celgene stockholders. Bob Hugin was succeeded in the CEO role by Mark Alles. YearRevenuein mil. USD$Net incomein mil. USD$Total Assetsin mil. USD$Employees2005537641,2582006899692,73620071,4062263,61120082,255−1,5344,44520092,690 7775,38920103,626 88110,17720114,8421,31810,00620125,5071,45611,73420136,4941,45013,3785.10020147,6702,00017,3406,01220159,256 1,60226,9646,971201611,2291,99928,0867,132201713,0032,94030,1417,467

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. 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. 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. 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.

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. Celgene develops several products within several areas of research (MM, MDS, AML, Lymphoma, CLL, Beta Thalassemia, Myelofibrosis, Solid Tumors, Inflammation & Immunology.

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. 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.

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. In its July 2017 10 Q, Celgene disclosed that it resolved the matter in full for $315 million, including fees and expenses. The case was brought under the False Claims Act by Beverly Brown, a former Celgene sales representative.