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Thursday, November 21, 2013 11:35:27 AM
Rough Draft
Ms. Mundy
I am writing you because an article of yours came up in some research regarding FDA corruption. The article written March of 2009 titled, "Political Lobbying Drove FDA Process" was a very well written article and because of recent events, seems to be timeless. I am hoping you would be interested in another story regarding possible FDA corruption. A little history:
Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Vascepa® (icosapent ethyl) is Amarin's first FDA approved product and is available in the United States by prescription. Vascepa is the first and only pure EPA omega-3 fatty acid that has been clinical proven to significantly reduce TG levels without increasing LDL-C levels and provide a spectrum of additional lipid treatment benefits with a tolerability and safety profile similar to placebo.
Beginning this year, Amarin began selling Vascepa in the Marine Indication (trigs >500 mg/dl) and submitted an sNDA to expand the label to the Anchor Indication (trigs 200-500 mg/dl). In both studies, Vascepa proved its efficacy in lowering Trigs, Cholesterol and Inflammation Markers while maintaining a safety profile compared to a placebo. The FDA ordered an ADCOM for Oct 16th. At this meeting it was clear what the intention of the FDA was and how it stacked and steered the Panel to a negative vote. The FDA questioned whether or not this drug would reduce Cardio-Vascular events even though it was never the intention of the sponsor. Amarin and the FDA were already involved in the Reduce-It study that would determine outcomes. Just as important, the FDA used the results of three different studies (Accord-Lipid, Aim-High and HPS2-Thrive), using different compound (fibrates and niacin) with a different patient subgroup (trigs <200 mg/dl) to rescind the SPA agreement it had with Amarin. These studies were well known by the FDA prior to the ADCOM and were never mentioned in the sNDA letter or at any point prior to the ADCOM.
Interestingly enough, earlier this year a Citizens Petition (Lovaza Citizen Petition, Feb 2013) was filed by John Fuson and Crowell and Moring LLP. This petition it seems, was nothing more than an attempt to delay the New Chemical Entity decision by the FDA for Amarin's drug Vascepa. The petition's main goal was to have Vascepa's API listed into the OB retroactively by GSK drug Lovaza. In August, the FDA failed to rule on the petition, ignoring it's own rules, therefore resulting in a further delay in the NCE decision. John Fuson also happens to be a former employee of the FDA and has represented GlaxoSmithKline in an antitrust case in 2005. Keep in mind the Citizens Petition has delayed the NCE decision for Amarin's Vascepa benefitting it's competitor GSK's Lovaza.
All of these actions have resulted in major financial ruin for the company and it's shareholders. Unfortunately, main street media has chosen to ignore this story completely but I am hoping with your history of uncovering FDA corruption, that the story may grow. If you have any questions, please email me and I will do my best to provide answers. Thank you for your time.
Respectfully,
Recent AMRN News
- Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Portugal • GlobeNewswire Inc. • 07/17/2024 08:15:00 PM
- Amarin to Report Second Quarter 2024 Financial Results and Host Conference Call on July 31, 2024 • GlobeNewswire Inc. • 07/17/2024 12:00:00 PM
- Amarin Partner EddingPharm Receives Regulatory Approval for VASCEPA® (Icosapent Ethyl) in Mainland China for Cardiovascular Risk Reduction (CVRR) • GlobeNewswire Inc. • 07/08/2024 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/04/2024 11:30:10 AM
- Amarin Board of Directors Announces CEO Transition • GlobeNewswire Inc. • 06/04/2024 11:30:00 AM
- Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Greece and Announces Exclusive Marketing and Commercialization Agreement with Vianex S.A. • GlobeNewswire Inc. • 05/28/2024 12:15:23 PM
- Amarin to Present at H.C. Wainwright 2nd Annual BioConnect Investor Conference • GlobeNewswire Inc. • 05/06/2024 12:00:00 PM
- Amarin Reports First Quarter 2024 Business Update and Financial Results • GlobeNewswire Inc. • 05/01/2024 11:00:00 AM
- Amarin Applauds HealthyWomen’s Citizen’s Petition Urging FDA To Take Further Action On Fenofibrate Prescribing in Patients at Risk of Cardiovascular Event • GlobeNewswire Inc. • 04/24/2024 06:00:01 PM
- Amarin Announces Results of Annual General Meeting of Shareholders • GlobeNewswire Inc. • 04/22/2024 12:00:25 PM
- Amarin to Report First Quarter 2024 Financial Results and Host Conference Call on May 1, 2024 • GlobeNewswire Inc. • 04/15/2024 12:00:00 PM
- Amarin Highlights Key Data Providing Mechanistic Insights into Eicosapentaenoic Acid (EPA) at ACC.24 • GlobeNewswire Inc. • 04/08/2024 12:00:00 PM
- New REDUCE-IT® Analyses Show VASCEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups • PR Newswire (Canada) • 04/08/2024 10:30:00 AM
- New REDUCE-IT® Analyses Show VASCEPA®/VAZKEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups • GlobeNewswire Inc. • 04/06/2024 07:30:00 PM
- Amarin Provides Update on VAZKEPA® (Icosapent Ethyl) Intellectual Property Portfolio in Europe • GlobeNewswire Inc. • 04/03/2024 12:00:00 PM
- Research Evaluating Benefits of VASCEPA®/VAZKEPA® (icosapent ethyl) to be Presented at the American College of Cardiology’s (ACC) Annual Scientific Session & Expo • GlobeNewswire Inc. • 03/25/2024 12:00:00 PM
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 03/04/2024 10:30:53 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 03/04/2024 01:00:24 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 02/29/2024 12:06:26 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/29/2024 12:05:56 PM
- Amarin Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update • GlobeNewswire Inc. • 02/29/2024 12:00:00 PM
- Amarin to Report Fourth Quarter and Full Year 2023 Financial Results and Host Conference on February 29, 2024 • GlobeNewswire Inc. • 02/15/2024 01:00:00 PM
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