Celgene

Celgene Corporation

Type	Public
Traded as	NASDAQ: CELG NASDAQ-100 Component S&P 100 Component S&P 500 Component
Industry	Biotechnology
Founded	1986
Headquarters	Summit, New Jersey, U.S.
Key people	Robert J. Hugin (Executive Chairman) Sol J. Barer (Founder) Mark Alles (CEO)
Products	Thalomid Revlimid Abraxane Pomalyst/Imnovid Otezla
Revenue	US$ 6.4939 billion (2013)[1] US$ 5.5067 billion (2012)[1]
Operating income	US$ 1.8089 billion (2013)[1] US$ 1.7464 billion (2012)[1]
Net income	US$ 1.4499 billion (2013)[1] US$ 1.4562 billion (2012)[1]
Total assets	US$ 13.3782 billion (2013)[2] US$ 11.7343 billion (2012)[1]
Total equity	US$ 5.5899 billion (2013)[1] US$ 5.6945 billion (2012)[1]
Number of employees	4,182 (December 2010)[3]
Website	www.celgene.com

Celgene Corporation is an American biotechnology company that discovers, develops and commercializes medicines for cancer and inflammatory disorders. It is incorporated in Delaware and headquartered in Summit, New Jersey. The company's major product is Revlimid (lenalidomide), in combination with dexamethasone for the treatment of multiple myeloma patients. 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. Revlimid is 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 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 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 2006 Celegene certified McKesson Specialty, a specialty pharmacy, as one of a select group of RevAssist(SM) Program contract pharmacies to launch lenalidomide (trade name Revlimid). As a specialty drug, lenalidomide requires special handling and is therefore only available through the RevAssist program, a unique distribution network employing only certified, contracted specialty pharmacies.^[4]

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

In December 2009, Celgene announced the acquisition of Gloucester Pharmaceuticals.^[5]

In 2010 Celgene looked to relocate its UK headquarters from Riverside House in Windsor to a new development Stockley Park, Uxbridge.^[6] 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.^[7]

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.^[8]

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.^[9]

In 2014, Celgene and OncoMed Pharmaceuticals entered into a cancer stem cell therapeutic development agreement encompassing demcizumab and five other biologics from OncoMed's pipeline.^[10] Also in 2014, Sutro Biopharma entered into a strategic collaboration and option agreement with Celgene Corporation to discover and develop multispecific antibodies and antibody drug conjugates (ADCs). This new agreement follows the December 2012 collaboration between the two companies and focuses on the field of immuno-oncology, while further broadening the Sutro platform for discovery, development, and manufacture of best-in-class biotherapeutics.^[11]

In April 2015, Celgene announced it would commence a collaboration with Astrazeneca, worth $450 million, studying their Phase III immuno-oncology drug candidate MEDI4736.^[12] Later in the same month Celgene announced it would acquire Quanticel for up to $485 million aimed at enhancing their cancer drug pipeline through Quanticels epigenetic modifier targeting applications.^[13] In June 2015 Celgene announced it had licensed Lyceras RORgamma agonist portfolio for up to $105 million and continue to develop its Phase I lead compound LYC-30937 for the treatment of inflammatory bowel disease. The licensing opportunity gives Celgene the option to acquire Lycera.^[14] 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.^[15] News of the deal sent Celgene shares up 5.7% in after hours trading.

In May 2016, the company announced it would launch partnership with Agios Pharmaceuticals, developing metabolic immuno-oncology therapies. The deal could net more than $1 billion for Agios.^[16]

In January 2017, the company announced it would acquire Delinia for $775 million, increasing the company's autoimmune disease therapy offerings.^[17]

Company origin and acquisition history

The following is an illustration of the company's major mergers and acquisitions and historical predecessors (this is not a comprehensive list):

Executive history

In March 2016, Bob Hugin, the company's long serving CEO, retired his position and took the role of executive chairman.^[18] Bob Hugin was succeeded in the CEO role by Mark Alles.^[18] At the same time, Jacqualyn Fouse was named as the company's president and COO; Fouse had joined the company in 2010 as the CFO.^[18] Effective June 30, 2017, Dr. Fouse will purportedly step down and be succeeded by Scott Smith, president of the company's Global Inflammation & Immunology Franchise, who joined the company in 2008.^[18]

Products

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.

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.

Litigation

Anti-trust 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 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.^[20]

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.^[21] In its July 2017 10-Q, Celgene disclosed that it resolved the matter in full for $315 million, including fees and expenses.^[22] The case was brought under the False Claims Act by Beverly Brown, a former Celgene sales representative.^[23]

See also

• Biotech and pharmaceutical companies in the New York metropolitan area
• Pharmaceutical industry in Switzerland
• Sutro Biopharma

• Companies portal

References

External links

• Official website

• • Business data for Celgene: Google Finance
  • Yahoo! Finance
  • Reuters
  • SEC filings