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Celgene

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Celgene Corporation
Company typePublic
IndustryBiotechnology
Founded1986
HeadquartersSummit, New Jersey, U.S.
Key people
Robert J. Hugin (Executive Chairman)
Sol J. Barer (Founder)
Mark Alles (CEO)
ProductsRevlimid
Abraxane
Pomalyst/Imnovid
Otezla
Thalomid
Idhifa
Revenue
  • Increase US$ 13.51 billion (2017)[1]
  • Increase US$ 5.5067 billion (2012)[1]
  • Decrease US$ 2.0 billion (2016)[1]
  • Increase US$ 1.4562 billion (2012)[1]
Total assets
  • Increase US$ 13.3782 billion (2013)[2]
  • Increase US$ 11.7343 billion (2012)[1]
Total equity
  • Decrease US$ 5.5899 billion (2013)[1]
  • Increase US$ 5.6945 billion (2012)[1]
Number of employees
4,182 (December 2010)[3]
Websitewww.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 Celgene 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.[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 October, the company acquired EngMab AG for $600 million.[17][18]

In January 2017, the company announced it would acquire Delinia for $775 million, increasing the company's autoimmune disease therapy offerings.[19]

In January 2018, Celgene announced it would acquire Impact Biomedicines for $7 billion, adding fedratinib, a kinase inhibitor with potential to treat myelofibrosis.[20] In the same month the company announced it would acquire Juno Therapeutics for $9 billion.[21]

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):

Celgene
Juno Therapeutics
(Acq 2018)

AbVitro
(Acq 2016)

RedoxTherapies
(Acq 2016)

 

Impact Biomedicines
(Acq 2018)

 

Delinia
(Acq 2017)

 

EngMab AG
(Acq 2016)

 

Receptos
(Acq 2015)

 

Quanticel
(Acq 2015)

 

Avila Therapeutics, Inc
(Acq 2012)

 

Abraxis BioScience Inc
(Acq 2010)

 

Gloucester Pharmaceuticals
(Acq 2009)

 

Pharmion Corporation
(Acq 2008)

 

Anthrogenesis
(Acq 2002)

 

Signal Pharmaceuticals, Inc
(Acq 2000)

 

Celgene
(Spun off from
Celanese in 1986)

Executive history

In March 2016, Bob Hugin, the company's long serving CEO, retired from his position and took the role of executive chairman.[22] Bob Hugin was succeeded in the CEO role by Mark Alles.[22] 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.[22] 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. [22] Dr. Fouse has been voted out by the board of directors on 2 April, 2018.

Products

Product Portfolio
Brand Name Drug Name(s) Indication Date Approved (USA)[23] Partner
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
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
Focalin dexmethlyphenidate hydrochloride CII attention deficit hyperactivity disorder (ADHD) in children and adolescents 11-13-2001 Novartis
Focalin XR dexmethlyphenidate hydrochloride CII attention deficit hyperactivity disorder (ADHD) in children, adolescents and adults 05-26-2005 Novartis
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  

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.[24]

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.[25] In its July 2017 10-Q, Celgene disclosed that it resolved the matter in full for $315 million, including fees and expenses.[26] The case was brought under the False Claims Act by Beverly Brown, a former Celgene sales representative.[27]

See also

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

References

  1. ^ a b c d e f g "CELGENE CORP /DE/ 2013 Annual Report Form (10-K)" (XBRL). United States Securities and Exchange Commission. February 13, 2014.
  2. ^ "CELGENE CORP /DE/ 2014 Q1 Quarterly Report Form (10-Q)" (XBRL). United States Securities and Exchange Commission. April 29, 2014.
  3. ^ "2010 Form 10-K, Celgene Corporation". United States Securities and Exchange Commission.
  4. ^ "Celgene Selects McKesson Specialty as a RevAssist Program Pharmacy Vendor to Launch REVLIMID: McKesson Specialty to Provide Dispensing, Reimbursement and Clinical Services", PRNewswire, Harahan, La., 13 February 2006, retrieved 5 November 2015
  5. ^ Celgene to Acquire Gloucester Pharmaceuticals Archived 2012-07-13 at archive.today, Dec. 7, 2009
  6. ^ "New Head Quarters for Celgene - Stockley Park greets new tenant". UK Construction magazine. 13 October 2011. Archived from the original on 30 October 2011. {{cite news}}: Unknown parameter |deadurl= ignored (|url-status= suggested) (help)
  7. ^ Celgene to Acquire Abraxis BioScience Inc. Archived 2012-07-16 at archive.today, Jun. 30, 2010
  8. ^ http://www.avilatx.com/news/2012_0126_AvilaCelgene.pdf. {{cite news}}: Missing or empty |title= (help)
  9. ^ "Grading Pharma in 2013". Forbes. December 31, 2013.
  10. ^ Staff (January 1, 2014). "OncoMed, Celgene in $3.3B+ Cancer Stem Cell Collaboration". Industry Watch. Gen. Eng. Biotechnol. News. p. 8.
  11. ^ "Sutro Biopharma and Celgene Corporation Enter Multi-Year Strategic Collaboration and Option to Acquire Agreement".
  12. ^ "GEN - News Highlights:AstraZeneca Inks $1.8B in Immuno-Oncology Deals as Q1 Profit Dips". GEN.
  13. ^ "GEN - News Highlights:Celgene to Acquire Quanticel for Up-to-$485M". GEN.
  14. ^ "Celgene Licenses Lycera's Immune Modulators in Up-to-$105M+ Deal". GEN.
  15. ^ "Celgene to Acquire Receptos for $7.2B". GEN.
  16. ^ "Celgene, Agios, Launch $1B+ Metabolic Immuno-oncology Alliance - GEN News Highlights - GEN". GEN.
  17. ^ https://www.fiercebiotech.com/biotech/celgene-600m-engmab-biotech-buy-to-head-into-clinic-next-year
  18. ^ https://www.thestreet.com/story/14455526/1/celgene-could-be-bulking-up-very-fast.html
  19. ^ http://www.genengnews.com/gen-news-highlights/celgene-buys-delinia-for-300m-to-acquire-treg-therapy-for-autoimmune-diseases/81253774
  20. ^ https://uk.reuters.com/article/uk-impact-biomedicines-m-a-celgene/celgene-to-buy-impact-biomedicines-for-up-to-7-billion-idUKKBN1EW0US
  21. ^ https://www.reuters.com/article/us-biotech-m-a/biotech-ma-takes-off-as-sanofi-and-celgene-spend-20-billion-idUSKBN1FB20V
  22. ^ a b c d "A Year into Job, Celgene President and COO Said to Retire". Genetic Engineering & Biotechnology News. February 24, 2017. Retrieved February 25, 2017.
  23. ^ "Drugs@FDA: FDA Approved Drug Products". Food and Drug Administration. Retrieved 2007-09-03.
  24. ^ Botts LLP, Baker. "Life Science Update". Baker Botts LLP. Retrieved February 28, 2012.
  25. ^ Thom Mrozek (July 24, 2017). "Celgene Agrees to Pay $280 Million to Resolve Fraud Allegations Related to Promotion of Cancer Drugs For Uses Not Approved by FDA". Department of Justice, U.S. Attorney’s Office, Central District of California. Retrieved July 27, 2017.
  26. ^ |url=https://www.sec.gov/Archives/edgar/data/816284/000081628417000009/a2017063010q.htm
  27. ^ Thomas, Katie (25 July 2017). "Celgene to Pay $280 Million to Settle Fraud Suit Over Cancer Drugs". The New York Times.
  • Official website
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