Celgene

Celgene Corporation

Type	Public
Traded as	NASDAQ: CELG NASDAQ-100 Component S&P 500 Component
Industry	Biotechnology
Founded	1986
Headquarters	Summit, New Jersey, U.S.
Key people	Sol J. Barer (Chairman) Robert J. Hugin (CEO)
Products	THALOMID REVLIMID
Revenue	US$ 4.842 billion (2011)[1]
Operating income	US$ 1.442 billion (2011)[1]
Net income	US$ 1.317 billion (2011)[1]
Total assets	US$ 10.005 billion (2011)[1]
Total equity	US$ 5.512 billion (2011)[1]
Employees	4,182 (December 2010)[1]
Website	www.celgene.com

Celgene Corporation is an American biotechnology company that manufactures drug therapies for cancer and inflammatory disorders. It is incorporated in Delaware and headquartered in Summit, New Jersey. The company's major products are Thalomid (thalidomide), which is approved for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum ("ENL"), as well as in combination with dexamethasone for patients with newly diagnosed multiple myeloma, and Revlimid (lenalidomide), for which the company has received FDA and EMA approval in combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy. Revlimid is also approved in the United States for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk Myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Both Thalomid and Revlimid are sold through proprietary risk-management distribution programs to ensure safe and appropriate use of these pharmaceuticals. Vidaza is approved for the treatment of patients with MDS. Celgene also receives royalties from Novartis Pharma AG on sales of the entire Ritalin family of drugs, which are widely used to treat Attention Deficit Hyperactivity Disorder (ADHD).

Celgene Cellular Therapeutics, a subsidiary, is a public cord blood bank.

History

In 1986, Celgene, originally a unit of the Celanese Corporation, was spun off as an independent company following the merger of Celanese Corporation with American Hoechst Corporation.

In July 1998, Celgene received approval from the FDA to market Thalamid 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 August 2000, Celgene acquired Signal Pharmaceuticals, Inc., a privately held company that searches for and develops pharmaceuticals that regulate disease-related genes. Signal Pharmaceuticals, Inc. now operates as Celgene Research San Diego, a wholly owned subsidiary of Celgene Corporation.

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 now operates as Celgene Cellular Therapeutics, a wholly owned subsidiary of Celgene.

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.

In May 2006, Celgene received approval for Thalamid 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.

In March 2008, Celgene closed its $2.9 billion acquisition of Pharmion Corporation.

In December 2009, Celgene announced the acquisition of Gloucester Pharmaceuticals.^[2]

In June 2010 Celgene Corporation and Abraxis BioScience Inc. jointly announced the signing of a definitive merger agreement in which Celgene has agreed to acquire Abraxis BioScience.^[3]

In 2010 Celgene looked to relocate its UK Head Quarters from Riverside House in Windsor to a new development Stockley Park, Uxbridge.^[4]

In January 2012, Celgene and Avila Therapeutics, Inc., a privately held biotechnology company developing targeted covalent drugs that treat diseases through protein silencing, announced a definitive merger agreement under which Celgene Corporation will acquire Avila Therapeutics, Inc. Under the terms of the merger agreement, Celgene will acquire Avila Therapeutics, Inc. for $350 million in cash, plus up to $195 million for milestones contingent upon the development and regulatory approval of AVL-292, as well as up to $380 million in potential milestone payments contingent upon the development and approval of candidates generated from the Avilomics platform.^[5]

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. ^[6]

Products

Litigation

Anti-trust allegations In June 2009, Dr. Reddy’s Laboratories filed a Citizen Petition accusing Celgene of “a company-wide campaign to block generic competition”. The petition asked FDA 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. Dr. Reddy’s also suggested that FDA refer any complaints about the anticompetitive use of REMS distribution restrictions to the FTC for investigation.

Celgene denied that it had behaved anticompetitively, 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.

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.

Celgene’s SEC filings reveal it has received two Civil Investigative Demands from the Federal Trade Commission, as well as a subpoena from the Connecticut Attorney General, seeking information on whether it used its REMS distribution restrictions for either REVLIMID® or THALOMID® to engage in unfair competition. Exact status of these investigations is unknown, however Celgene has publicly disclosed that it is continuing to respond to information requests from antitrust regulators, over three years after receiving the initial notice.^[8]

Intellectual Property Disputes

In 2009, Beth R. Jacobson filed suit against Celgene Corporation under the claims of "misappropriation of an idea" and "unjust enrichment" regarding the Company's sale of thalidomide for the treatment of multiple myeloma. The suit alleges that Ms. Jacobson developed the original and novel idea for treating multiple myeloma with thalidomide and therefore entitled to for 300 million in past damages and 25 percent of future sales. Celgene sought dismissal of the case, claiming she waited too long to file her complaint and that she had not presented sufficient evidence in support of her claims to merit a full trial. On April 14 Judge Faith S. Hochberg ordered the case could go ahead, stating that Ms. Jacobsen had advanced an “unprecedented theory,” that one could own the right to a medical therapy “outside the context of patent law or other established forms of intellectual property.” If the court agrees with Jacobson, Hochberg said, this would be “a significant expansion of the misappropriation concept beyond the extent to which it has heretofore been applied.”^[9]

On December 13, 2012 The Leonard and Madlyn Abramson Family Cancer Research Institute at Philadelphia’s University of Pennsylvania filed suit against the then head of Memorial Sloan-Kettering Cancer Center Dr. Craig Thompson. The complaint, which sought damages of more than one billion dollars, alleged that Craig breached his fiduciary duty to the school by using research he helped develop there to start his own company.^[10] Celgene, which had licensed the technology from Thompson's company, was listed as a co-defendent in one of two lawsuits filed against Thompson. The suit was settled when Thompson and Penn agreed to a licensing agreement in 2012^[11]

See also

• Pharmaceutical industry in Switzerland

References

External links

• Official website

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