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 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 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 Omega-3 fatty acid drug (Ethyl eicosapentaenoic acid) used to treat hypertriglyceridemia that received FDA approval in July 2012.[1][2] competing against GlaxoSmithKline's Lovaza.[7] Unlike Lovaza Vascepa was approved for patients with triglycerides of 200 mg/dL to less than 500 mg/dL.[8][9]
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%. 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]
See also
References
- 1 2 "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.
- 1 2 "Amarin Prescription Fish-Oil Pill Approved - TheStreet". Retrieved 26 July 2012.
- ↑ "FDA approves Amarin's heart pill". Reuters. 26 July 2012. Retrieved 27 July 2012.
- 1 2 3 "Simon Kukes Prefers Drugs to Oil". Kommersant. 25 January 2005. Retrieved 1 October 2016.
- ↑ "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.
- ↑ "FDA approves Amarin's heart pill". Reuters. 26 July 2012. Retrieved 27 July 2012.
- ↑ "The Rise Of Amarin's Fish Oil Should Have GSK Worried". 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.
- ↑ FDA Concedes Defeat on Off-Label Drug Marketing; Amarin can market its fish-oil product (Vascepa) for unapproved indications. March 2016