Amarin Corporation
 | |
| Public | |
| Traded as | NASDAQ: AMRN |
| Industry | Biotechnology |
| Founded | 1993 |
| Headquarters | Bedminster, New Jersey U.S. |
| Products | Vascepa (AMR-101) |
Number of employees | 50+ |
| Website |
www www |
Amarin Corporation is a biopharmaceutical company headquartered in Bedminster, New Jersey. The company develops and markets medicines for the treatment of cardiovascular disease. Amarin develops the drug Vascepa (AMR-101) which is a prescription grade omega-3 fatty acid.
In December 2007, the company acquired Ester Neurosciences Limited for 8.1 million USD.[1] Amarin CEO Joe Zakrzewski has said that the company would like to first work on building its infrastructure out to commercialize the drug in the United States.[2]
On July 26, 2012, their lead-candidate drug named Vascepa (AMR-101) received FDA-approval.[3][4] Vascepa will also be a key competitor against GlaxoSmithKline's Lovaza.[5]
Products and development
Vascepa
Amarin's only product is Vascepa, an approved prescription grade Omega-3 fatty acid drug (Ethyl eicosapentaenoic acid) that helps with the management of 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), Vascepa showed a decrease in triglycerides. Unlike Vascepa's competitor Lovaza, which can raise median LDL-C from 40% to 50%, Vascepa did not result in a significant increase in median LDL-C.[6]
In April 2011, Amarin's ANCHOR study which was to treat patients with high triglycerides (200 mg/dL to less than 500 mg/dL), Vascepa also displayed a decrease LDL-C. Another unique detail about the ANCHOR study is that Vascepa was able to get approved for the patient population of 200 mg/dL to less than 500 mg/dL, unlike Lovaza which was not approved for this patient population.[7][8]
These studies displayed that Vascepa reduced triglyceride levels and other important lipid and inflammation biomarkers, including Apo-B, non-HDL-C, Total-Cholesterol, VLDL-C, Lp-PLA2, and hs-CRP.[9]
On 10/16/2013, after FDA's ADCOM panel voted 9-2 against recommending an expanded drug label for Vascepa, for treatment of cardiovascular disease, shares dropped over 60%. As of 02/01/2015 their stock price had not recovered.
In March 2016, after losing a court case, the FDA agreed to allow some off-label marketing.[10]
Executives
Management Team (July 2012) :[11]
- John Thero: President[11]
- Aaron Berg: Senior Vice President, Marketing & Sales[12]
- Joseph T. Kennedy: Senior Vice President, General Counsel and Secretary, Chief Compliance Officer[11]
- Steven Ketchum: President of Research and Development, Senior Vice President[11]
- Stuart Sedlack: Senior Vice President, Corporate Development[11]
- Paresh Soni, M.D., Ph.D.: Senior Vice President and Head of Development[11]
- Declan Doogan, M.D.: Chief Medical Officer[11]
Board of Directors
As of July 2012 :
- Joseph S. Zakrzewski: Chief Executive Officer and Executive Chairman of the Board of Directors[13]
- Joseph Anderson, Ph.D.: Partner at Abingworth LLP[13]
- Lars Ekman, Ph.D.: Lead Independent Director, Executive Partner of Sofinnova Ventures[13]
- Carl L. Gordon, Ph.D., CFA: General Partner and Co-Head of Private Equity of OrbiMed Advisors LLC[13]
- James Healy, M.D., Ph.D.: General Partner at Sofinnova Ventures, Board Member of Cellective, CoTherix, Novacea, and Intermune.[13]
- Jan van Heek: Principal and Partner at BioPoint Group[13]
- Patrick O'Sullivan: Chairman of the Board of Directors of Merrion Pharmaceuticals and as Director of Warner Chilcott Plc.[13]
- Kristine Peterson: Chief Executive Officer at Valeritas, Inc.[13]
References
- ↑ "Amarin Signs Agreement to Acquire Ester Neurosciences - Health News - redOrbit". RedOrbit. 5 December 2007. Retrieved 27 July 2012.
- ↑ "Amarin: Mover of the Day - CNBC". April 18, 2011. Retrieved 26 July 2012.
- ↑ "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.
- ↑ "Amarin Prescription Fish-Oil Pill Approved - TheStreet". Retrieved 26 July 2012.
- ↑ "http://www.reuters.com/article/2012/07/26/us-amarin-fda-vascepa-idUSBRE86P1SX20120726". Reuters. 26 July 2012. Retrieved 27 July 2012. External link in
|title=(help) - ↑ "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.
- ↑ "The Rise Of Amarin's Fish Oil Should Have GSK Worried - Seeking Alpha". Seeking Alpha. Retrieved 21 March 2012.
- ↑ "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.
- ↑ "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.
- ↑ FDA Concedes Defeat on Off-Label Drug Marketing; Amarin can market its fish-oil product (Vascepa) for unapproved indications. March 2016
- 1 2 3 4 5 6 7 "Amarin – Senior Management Team". Retrieved 26 July 2012.
- ↑ http://investor.amarincorp.com/releasedetail.cfm?ReleaseID=822991
- 1 2 3 4 5 6 7 8 "Amarin – Board Of Directors". Retrieved 26 July 2012.
External links
- "Amarin corporate website".
- "Official Vascepa website".
- NYtimes Press Releases for Amarin Corporation