Navigation Links
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
Date:4/17/2011

in lipid science focused on the treatment of cardiovascular disease. The Company's lead product candidate is AMR101 (icosapent ethyl). The Company reported positive, statistically significant top-line results for both of its two pivotal Phase 3 clinical trials, the MARINE trial (investigation of AMR101 as a treatment for patients with very high triglycerides [>500 mg/dL]), as reported on November 29, 2010 and the ANCHOR trial, as reported above.  The Company is planning to file an NDA for AMR101 before the end of Q3, 2011. The Company is evaluating which data, in addition to safety data, from the ANCHOR trial to include in this NDA.  If the ANCHOR results are added to the NDA, the NDA would seek approval for the indication studied in the MARINE trial with the ANCHOR results either as a separate indication for use or referenced in the label as data supporting the safe use of AMR101 in the treatment of high triglyceride levels in statin-treated patients who have mixed dyslipidemia. In order to obtain a separate indication for AMR101 based on the ANCHOR trial results, the FDA requires that we have a clinical outcomes study substantially underway at the time of the NDA filing. The Company is in the late stages of designing this outcomes study. The results of an outcomes study are not required for FDA approval of the broader indication and an outcomes study is not required for the indication being studied in the MARINE trial.  The MARINE and ANCHOR trials were conducted under separate Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). Amarin also has next-generation lipid candidates under evaluation for preclinical development.

Disclosure Notice

This press release contains forward-looking statements, including statements about the success of clinical trial results the timing of and content of regulatory filings, the likelihood of approval, the potential label of any approved drug, comp
'/>"/>

SOURCE Amarin Corporation plc
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. Amarin Proceeding to Phase 3 With AMR101 for Hypertriglyceridemia
2. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
3. Thomson Scientific Publishes The Ones to Watch - A Quarterly Review of Phase Changes in the Pharmaceutical Pipeline
4. Progen Engages Leading CRO to Assist with Phase 3 Trial of PI-88
5. The Multiple Myeloma Research Consortium (MMRC) and Proteolix Initiate Phase 2 Clinical Trial Investigating Carfilzomib for the Treatment of Multiple Myeloma
6. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
7. Multiple Myeloma Research Consortium (MMRC) Partners with Novartis to Advance Phase II Study of Deacetylase Inhibitor
8. Positive Kuvan(TM) Pivotal Phase 3 Trial Results Published in The Lancet
9. Potential Safety Issue Identified in Ongoing Phase 2 Clinical Study of HCV-796
10. TaiGen Biotechnology Successfully Completes Patient Recruitment for Phase II Trial of Nemonoxacin for Treatment of Adult Community Acquired Pneumonia (CAP)
11. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/30/2014)... , July 30, 2014  There is still ... organization,s success. The 10th Annual Institute for Supply ... for Excellence in Supply Management is open for ... the understanding and importance of supply management by ... and best supply management practices.  Entries are due ...
(Date:7/30/2014)... Mich. , July 30, 2014 Advanced Photonix ... quarter (ending June 27, 2014) financial results on Monday, August ... be released after the close of the market and the ... the results at 4:30 p.m. EDT on the same day. ... Kurtz (CEO and Director), Rob Risser (COO ...
(Date:7/30/2014)... Inc. (NASDAQ: HOLX ) today announced its ... 2014. Third Quarter Financial Highlights and Recent ... reflecting operational growth of 0.5% and a positive currency ... the prior year. , Revenues grew in three ... grew 3.5%. , GYN Surgical revenues grew 3.5%. ...
Breaking Medicine Technology:Institute for Supply Management, Michigan State University to recognize companies with excellent supply management practices 2Advanced Photonix to Webcast Fiscal 2015 First Quarter Earnings 2Hologic Announces Third Quarter Fiscal 2014 Operating Results 2Hologic Announces Third Quarter Fiscal 2014 Operating Results 3Hologic Announces Third Quarter Fiscal 2014 Operating Results 4Hologic Announces Third Quarter Fiscal 2014 Operating Results 5Hologic Announces Third Quarter Fiscal 2014 Operating Results 6Hologic Announces Third Quarter Fiscal 2014 Operating Results 7Hologic Announces Third Quarter Fiscal 2014 Operating Results 8Hologic Announces Third Quarter Fiscal 2014 Operating Results 9Hologic Announces Third Quarter Fiscal 2014 Operating Results 10Hologic Announces Third Quarter Fiscal 2014 Operating Results 11Hologic Announces Third Quarter Fiscal 2014 Operating Results 12Hologic Announces Third Quarter Fiscal 2014 Operating Results 13Hologic Announces Third Quarter Fiscal 2014 Operating Results 14Hologic Announces Third Quarter Fiscal 2014 Operating Results 15Hologic Announces Third Quarter Fiscal 2014 Operating Results 16Hologic Announces Third Quarter Fiscal 2014 Operating Results 17
... findings presented today show that CONCERTA® (OROS® methylphenidate ... medication with data that demonstrate a significant treatment ... 12.5 hours in children with Attention Deficit Hyperactivity ... medical condition characterized by inattention, hyperactivity and impulsivity(1) ...
... Orexigen® Therapeutics, Inc. (Nasdaq: OREX ), a ... announced unaudited financial results for the three months ended ... September 30, 2009 , As of September 30, ... equivalents and an additional $50.9 million in investment securities, ...
Cached Medicine Technology:CONCERTA(R) in the Classroom: New Data on Attention in Children With ADHD 2CONCERTA(R) in the Classroom: New Data on Attention in Children With ADHD 3CONCERTA(R) in the Classroom: New Data on Attention in Children With ADHD 4CONCERTA(R) in the Classroom: New Data on Attention in Children With ADHD 5CONCERTA(R) in the Classroom: New Data on Attention in Children With ADHD 6CONCERTA(R) in the Classroom: New Data on Attention in Children With ADHD 7Orexigen(R) Therapeutics Announces Third Quarter 2009 Financial Results 2Orexigen(R) Therapeutics Announces Third Quarter 2009 Financial Results 3Orexigen(R) Therapeutics Announces Third Quarter 2009 Financial Results 4Orexigen(R) Therapeutics Announces Third Quarter 2009 Financial Results 5Orexigen(R) Therapeutics Announces Third Quarter 2009 Financial Results 6Orexigen(R) Therapeutics Announces Third Quarter 2009 Financial Results 7Orexigen(R) Therapeutics Announces Third Quarter 2009 Financial Results 8Orexigen(R) Therapeutics Announces Third Quarter 2009 Financial Results 9Orexigen(R) Therapeutics Announces Third Quarter 2009 Financial Results 10
(Date:7/30/2014)... NJ (PRWEB) July 30, 2014 Within weeks freshman ... excitement and promise. Each hopes this will be a time of ... reason for each to pause; it may not be as easy ... 80% of students will switch their major at least once and ... time and energy and the costs are exacerbated when switching in ...
(Date:7/30/2014)... Falls Church, VA (PRWEB) July 30, 2014 ... Investigations , Understanding Advanced Critical Thinking Skills and ... , **Presented by Immel Resources and FDAnews**, Sept. ... , CAPA has been the #1 reason for ... plan makes it clear: Developing a successful CAPA ...
(Date:7/30/2014)... 2014 Good Neighbor Community Services ... upcoming episode of Innovations with Ed Begley Jr, ... and show times TBA. , In this segment, ... Services’ vision to redefine the traditional approach to ... services. Through passion, innovation, determination, excellence, and collaboration, ...
(Date:7/30/2014)... July 30, 2014 SF Cable, distributor ... the lowest prices on the internet with guaranteed customer ... two lengths and two colors. These lightning cords are ... , The high quality SF Cable Lightning to ... digital signal delivering faster charging and syncing. Compatible with ...
(Date:7/30/2014)... Carmel, IN (PRWEB) July 30, 2014 ... announce the opening of its new Carmel office on ... his staff will finally be moving to the state-of-the-art ... The cozy and innovative space will allow for one-on-one ... satisfying cosmetic surgery experience. , Dr. Hamilton’s new ...
Breaking Medicine News(10 mins):Health News:Advice to College Freshman from Author Garrett Miller 2Health News:Advice to College Freshman from Author Garrett Miller 3Health News:FDAnews Workshop: Conducting Advanced Root Cause Analysis CAPA Investigations, Sept. 17-18, 2014, Raleigh, NC 2Health News:FDAnews Workshop: Conducting Advanced Root Cause Analysis CAPA Investigations, Sept. 17-18, 2014, Raleigh, NC 3Health News:FDAnews Workshop: Conducting Advanced Root Cause Analysis CAPA Investigations, Sept. 17-18, 2014, Raleigh, NC 4Health News:Good Neighbor Community Services to be Featured in an Upcoming Episode of Innovations With Ed Begley, Jr. 2Health News:SF Cable Delivers Certified Lightning Cable in Multiple Sizes and Colors 2Health News:Hamilton Facial Plastic Surgery Opens New Carmel Office 2
... , MANCHESTER, N.H., Aug. 18 Anthem Blue Cross ... offer coverage for the administration of the H1N1 (swine flu) vaccine ... administration will be covered for members whose benefit plans provide coverage ... coverage of seasonal flu vaccine administration for those whose health plans ...
... , , , ... premier health information network, today announced its partnership with Blue ... in health care and reduce the cost of care administration ... Network to support the secure exchange of administrative health information ...
... , SAN FRANCISCO, Aug. 18 ... determine taste and smell, has been awarded $750,000 by the ... expertise to asthma by defining the nerves that contract the ... severity of these episodes. , , ...
... , , ... the country,s premier Medicare-based software, consulting and education solutions ... America,s Health Insurance Plans (AHIP) Medicare and Medicaid Conference ... D.C. The conference will focus on the leading concerns ...
... , , ATLANTA, ... company providing risk, cost and care management solutions, recently signed a ... on the needs of Taft-Hartley Organizations and public employees, representing approximately ... considered and evaluated a number of legacy vendors within the marketplace ...
... , , , ... report from market research firm KLAS*, Siemens Healthcare,s SOMATOM(R) ... systems . Powerful and cost-effective, the SOMATOM Emotion ... brain, chest, and abdomen examinations, but also undertake high-end, detailed examinations, ...
Cached Medicine News:Health News:Anthem Blue Cross and Blue Shield in New Hampshire Announces Decision to Cover H1N1 Vaccine Administration 2Health News:Availity Teams with Blue Cross and Blue Shield of Minnesota to Improve Health Care Efficiencies 2Health News:Availity Teams with Blue Cross and Blue Shield of Minnesota to Improve Health Care Efficiencies 3Health News:$750,000 Awarded for Cutting-Edge Research to Reduce the Severity of Asthma Attacks 2Health News:Burgess(TM) to Sponsor and Present at the 2009 AHIP 'Medicare & Medicaid' Conference 2Health News:Union HealthShare Signs Multi-Year, Multi-Million Dollar Agreement with North Star Health 2Health News:Union HealthShare Signs Multi-Year, Multi-Million Dollar Agreement with North Star Health 3Health News:Siemens Emotion CT Receives Top Rating in KLAS Report 2Health News:Siemens Emotion CT Receives Top Rating in KLAS Report 3
Colloidal Gold Conjugated, Goat anti-human IgA (Alpha Chain) - 50 OD...
Polyester ribbons (3) impregnated with different OD values of conjugated Protein A...
Polyester ribbon impregnated with conjugated Protein A - .13 OD per sq. cm....
Polyester ribbon impregnated with conjugated Protein A - .25 OD per sq. cm....
Medicine Products: