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)
Operating income	US$ 1.442 billion (2011)
Net income	US$ 1.317 billion (2011)
Total assets	US$ 10.005 billion (2011)
Total equity	US$ 5.512 billion (2011)
Employees	4,182 (December 2010)
Website	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.

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.

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

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.

Legal Trouble

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

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 summarily denied Celgene’s motion to dismiss. Although the court did not issue a reasoned opinion, the ruling suggests that some courts may look favorably upon antitrust claims based on alleged abuse of REMS.

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.

Misapropriation of Ideas and Research 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. On April 14 Judge Faith S. Hochberg ordered the case could go ahead.

On December 13 The Leonard and Madlyn Abramson Family Cancer Research Institute at Philadelphia’s University of Pennsylvania institute filed suit against Celgene and then head of Memorial Sloan-Kettering Cancer Center Dr. Craig. The complaint for more than a billion dollars alleged that Thompson formed Agios Pharmaceuticals and got funding from Celgene in order to exploit research developed at the University. The suit was settled when Thompson and Penn agreed to a licensing agreement in 2012

In November 2012 the Securities and Exchange Commission named Celgene's Director of Financial Reporting, John Lazorchak one of the ringleaders of a sophisticated insider trading network, along with employees from Sanofi and Stryker. The SEC asserts the group picked up insider tips on acquisitions and regulatory applications, feeding the information to others who would buy and sell the stock.

Political Criticism

In 2012 Celgene received criticism for its membership in the Americans Legislative Exchange Council (ALEC) from a coalition of students, labor, and community groups in New Jersey. The groups alleged that ALEC's policies are often extreme and controversial citing ALEC legislation that would defund public healthcare services, make it harder for students, minorities, and the poor to vote, promotes disinvestment from public services, advocates for the privatization of public services including schools and Medicare, and other examples. Greg Chesmore, Celgene's Senior Director of State Government Relations responded on November 16 reaffirming Celgene's membership in ALEC saying "the reason for our participation in ALEC is consistent with Celgene's vision, mission, values, and fully aligned with our commitment to improve the lives of patients worldwide".

Products

Product Portfolio

Brand Name	Drug Name(s)	Indication	Date Approved (USA)	Partner
Vidaza	azacitidine	treatment of patients with refractory anemia,chronic myelomonocytic leukemia	05-19-2004
Revlimid	lenalidomide	transfusion dependent anemia due to low or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5 q cytogenetic abnormality with or without additional cytogenetic abnormalities	12-27-2005
Revlimid	lenalidomide	(in combination with dexamethasone) treatment of multiple myeloma patients who have received at least one prior therapy	06-29-2006
Thalomid	thalidomide	acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrences	07-16-1998
Thalomid	thalidomide	(in combination with dexamethasone) treatment of patients with newly diagnosed multiple myeloma	05-25-2006	GlaxoSmithKline
Alkeran	melphalan	palliative treatment of multiple myeloma and for the palliation of non-resectable epithelial carcinoma of the ovary	01-17-1964	GlaxoSmithKline
Alkeran	melphalan hydrochloride	the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate	11-18-1992	GlaxoSmithKline
Focalin	dexmethlyphenidate hydrochloride	attention deficit hyperactivity disorder (ADHD) in children and adolescents	11-13-2001	Novartis
Focalin XR	dexmethlyphenidate hydrochloride	attention deficit hyperactivity disorder (ADHD) in children, adolescents and adults	05-26-2005	Novartis

External links

• Official website