Celgene

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 for $2.9 billion, which produced Abraxane, for the treatment of cancer.

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.

Major products included Revlimid (lenalidomide) and Pomalyst (pomalidomide) and the immunology drug Otezla (apremilast).

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.

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.

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.

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.

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. 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.

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.