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Amarin Corporation

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Amarin Corporation
Company typePublic
Nasdaq: AMRN
IndustryBiotechnology
Founded1993
HeadquartersBedminster, New Jersey U.S.
ProductsVascepa (AMR-101)
Number of employees
50+
Websitewww.amarincorp.com
www.vascepa.com

Amarin Corporation is a biopharmaceutical company founded in 1993 and headquartered in Bedminster, New Jersey. The company develops and markets medicines for the treatment of cardiovascular disease. It has developed the drug Vascepa (AMR-101), a prescription grade omega-3 fatty acid.

In July 2012, their lead-candidate drug named Vascepa (AMR-101) received FDA-approval.[1][2] competing against GlaxoSmithKline's Lovaza.[3]

History

Amarin Corporation was founded in 1993[citation needed] or 1999.[4] In 2002, the company suffered losses worth $37 million, 2003 losses exceeded $19 million. [4] As of 2005 it was developing neurology drugs. It developed Miraxion to treat serious hereditary neurodegenerative disease.[4]

In December 2007, Amarin acquired Ester Neurosciences Limited for 8.1 million USD.[5] In 2011 CEO Joe Zakrzewski said that the company would like to first work on building its infrastructure out to commercialize the drug in the United States.[6]

Products and development

Vascepa

Amarin's only product is Vascepa, an approved prescription grade Omega-3 fatty acid drug (Ethyl eicosapentaenoic acid) to treat hypertriglyceridemia. Vascepa's clinical-data trials were the MARINE and ANCHOR studies.

In November 2010, Amarin's MARINE study, which was to treat patients with very high triglycerides (>500 mg/dL), showed Vascepa decreased triglycerides. Unlike Vascepa's competitor Lovaza, which can raise median LDL-C from 40% to 50%, Vascepa did not significantly increase the median LDL-C.[7]

In April 2011, Amarin's ANCHOR study which treated patients with high triglycerides (200 mg/dL to less than 500 mg/dL), Vascepa decreased LDL-C. The studies showed that Vascepa reduced triglyceride levels and other lipid and inflammation biomarkers, including Apo-B, non-HDL-C, Total-Cholesterol, VLDL-C, Lp-PLA2, and hs-CRP.[8]

In July 2012, Vascepa (AMR-101) received FDA-approval.[9][10] competing against GlaxoSmithKline's Lovaza.[11] Unlike Lovaza Vascepa was approved for patients with triglycerides of 200 mg/dL to less than 500 mg/dL.[12][13]

On 10/16/2013 after FDA's ADCOM panel had voted 9-2 against recommending to expand Vascepa's label for treatment of cardiovascular disease, shares dropped over 60%.[citation needed] As of 02/01/2015 their stock price had not recovered.[citation needed]

In March 2016, after losing a court case, the FDA agreed to allow some off-label marketing.[14]

Executives

Management Team (July 2012) :[15]

  • John Thero: President[15]
  • Aaron Berg: Senior Vice President, Marketing & Sales[16]
  • Joseph T. Kennedy: Senior Vice President, General Counsel and Secretary, Chief Compliance Officer[15]
  • Steven Ketchum: President of Research and Development, Senior Vice President[15]
  • Stuart Sedlack: Senior Vice President, Corporate Development[15]
  • Paresh Soni, M.D., Ph.D.: Senior Vice President and Head of Development[15]
  • Declan Doogan, M.D.: Chief Medical Officer[15]

Board of Directors

As of July 2012 :

  • Joseph S. Zakrzewski: Chief Executive Officer and Executive Chairman of the Board of Directors[17]
  • Joseph Anderson, Ph.D.: Partner at Abingworth LLP[17]
  • Lars Ekman, Ph.D.: Lead Independent Director, Executive Partner of Sofinnova Ventures[17]
  • Carl L. Gordon, Ph.D., CFA: General Partner and Co-Head of Private Equity of OrbiMed Advisors LLC[17]
  • James Healy, M.D., Ph.D.: General Partner at Sofinnova Ventures, Board Member of Cellective, CoTherix, Novacea, and Intermune.[17]
  • Jan van Heek: Principal and Partner at BioPoint Group[17]
  • Patrick O'Sullivan: Chairman of the Board of Directors of Merrion Pharmaceuticals and as Director of Warner Chilcott Plc.[17]
  • Kristine Peterson: Chief Executive Officer at Valeritas, Inc.[17]

See also

References

  1. ^ "Amarin Announces FDA Approval of Vascepa(TM) (icosapent ethyl) Capsules for the Reduction of Triglyceride Levels in Adult Patients With Severe Hypertriglyceridemia". Retrieved 26 July 2012.
  2. ^ "Amarin Prescription Fish-Oil Pill Approved - TheStreet". Retrieved 26 July 2012.
  3. ^ "http://www.reuters.com/article/2012/07/26/us-amarin-fda-vascepa-idUSBRE86P1SX20120726". Reuters. 26 July 2012. Retrieved 27 July 2012. {{cite web}}: External link in |title= (help)
  4. ^ a b c "Simon Kukes Prefers Drugs to Oil". Kommersant. 25 January 2005. Retrieved 1 October 2016.
  5. ^ "Amarin Signs Agreement to Acquire Ester Neurosciences - Health News - redOrbit". RedOrbit. 5 December 2007. Retrieved 27 July 2012.
  6. ^ "Amarin: Mover of the Day". CNBC. April 18, 2011. Retrieved 26 July 2012.
  7. ^ "Amarin Announces Successful MARINE Phase 3 Clinical Trial Results Published in The American Journal of Cardiology (NASDAQ:AMRN)". Amarin Corp. September 1, 2011. Retrieved 26 July 2012.
  8. ^ "Amarin's Phase 3 MARINE and ANCHOR Study Data to be Presented at American Heart Association's Scientific Sessions 2011 (NASDAQ:AMRN)". Amarin Corp. 14 November 2011. Retrieved 26 July 2012.
  9. ^ "Amarin Announces FDA Approval of Vascepa(TM) (icosapent ethyl) Capsules for the Reduction of Triglyceride Levels in Adult Patients With Severe Hypertriglyceridemia". Retrieved 26 July 2012.
  10. ^ "Amarin Prescription Fish-Oil Pill Approved - TheStreet". Retrieved 26 July 2012.
  11. ^ "http://www.reuters.com/article/2012/07/26/us-amarin-fda-vascepa-idUSBRE86P1SX20120726". Reuters. 26 July 2012. Retrieved 27 July 2012. {{cite web}}: External link in |title= (help)
  12. ^ "The Rise Of Amarin's Fish Oil Should Have GSK Worried". Seeking Alpha. Retrieved 21 March 2012.
  13. ^ "Amarin's AMR101 Phase 3 ANCHOR Trial Meets all Primary and Secondary Endpoints with Statistically Significant Reductions in Triglycerides at Both 4 Gram and 2 Gram Doses and Statistically Significant Decrease in LDL-C (NASDAQ:AMRN)". Amarin. 18 April 2011. Retrieved 26 July 2012.
  14. ^ FDA Concedes Defeat on Off-Label Drug Marketing; Amarin can market its fish-oil product (Vascepa) for unapproved indications. March 2016
  15. ^ a b c d e f g "Amarin – Senior Management Team". Archived from the original on 27 June 2012. Retrieved 26 July 2012. {{cite web}}: Unknown parameter |deadurl= ignored (|url-status= suggested) (help)
  16. ^ http://investor.amarincorp.com/releasedetail.cfm?ReleaseID=822991
  17. ^ a b c d e f g h "Amarin – Board Of Directors". Retrieved 26 July 2012.
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