From: VITAL Speaker Bureau <VITAL@phoenixgrp.

net>
Date: May 7, 2015 at 4:02:21 PM CDT
To: Undisclosed recipients:;
Subject: VITAL Speaker Update: Amarin Files First
Amendment Lawsuit vs. FDA
Dear Vascepa Speaker:
Thank you once again for your time and support as a Vascepa speaker.
The purpose of this communication is to provide information regarding an
important event at Amarin and a topic which may arise during speaker
events.
On May 7, 2015, Amarin and individual physicians, filed a lawsuit in federal
court in New York against the FDA asserting the right of Amarin to provide,
and the right of the physicians, to receive truthful, not misleading and fairly
balanced information about the results of the ANCHOR clinical study and
the state of research on the potential effects of VASCEPA. ANCHOR was
a study of VASCEPA in statin treated HTG patients i.e. 200 499 mg/dL.
That study successfully showed a reduction in TGs and other lipid markers
without a concomitant rise in LDL as compared to placebo. To date, the
FDA has denied Amarin the right to freely detail on this study and other
data related to Vascepa. The suit seeks to permit Amarin to deliver truthful,
non-misleading and fairly balanced information with medical professionals
about:

The ANCHOR clinical trial of Vascepa, which demonstrated the

effectiveness of Vascepa in lowering triglycerides and improving other
parameters in patients with high triglycerides.
o The ANCHOR study was conducted under a special protocol
assessment (SPA) agreement with FDA and met all primary and secondary
endpoints.

The potential of Vascepa to reduce the risk of cardiovascular disease

with the same claim permitted by FDA for use by omega-3 dietary
supplement products.

ANCHOR-related, peer-reviewed publications.

About the ANCHOR clinical trial
The ANCHOR trial studied the effect of Vascepa on adult patients with one
or more lipid disorders and high triglyceride levels (i.e., in the 200-499
mg/dL range) despite statin therapy.


All primary and secondary endpoints were achieved in the ANCHOR
trial, which showed that Vascepa was effective in lowering triglycerides and
had favorable effects on other lipid, lipoprotein and inflammatory
biomarkers, including non-high-density lipoprotein cholesterol.

Notably, the triglyceride-lowering effects of Vascepa were not

associated with increases in low-density lipoprotein cholesterol typical of
some omega-3 mixtures.

Scientific evidence suggests that drug therapy that lowers triglyceride

levels in patients with high triglycerides despite statin therapy reduces risks
associated with cardiovascular disease, such as heart attack or stroke.

Numerous national and international cardiovascular treatment

guidelines and position statements recommend drug therapy to
treat patients who have persistently high triglyceride levels (200
mg/dL and <500 mg/dL), despite statin therapy and lifestyle
changes to lower triglycerides and non-HDL cholesterol.

If asked about this lawsuit:

Medical question: You may respond with the information contained in

the above paragraph.

Legal question: You may respond that you are not in a position
to comment on the legal side of this lawsuit and refer the inquiry to
Amarin Legal c/o Natasha Nelson, Esq.
at compliance@amarincorp.com.
The lawsuit does not:

Force the FDA to approve an expanded indication for Vascepa based

on ANCHOR.

Seek to strike down off-label promotion laws and regulations as

unconstitutional.

Challenge the governments ability to prohibit pharmaceutical

companies, including Amarin, from disseminating false or misleading
information about their products.
This is a precedent-setting lawsuit that seeks to break new ground on the
rights of free speech. The timing for potential resolution of this case is very
fluid and difficult to predict accurately. In the meantime, we must remain
100% focused on the opportunity that we currently have in-hand with the
MARINE indication. If we receive a judgement in our favor, we will move
rapidly to deliver to you additional Company-approved training and
updated promotional speaker materials related to the courts interpretation
of free speech related to the ANCHOR results.

In the interim, it is important to remember that promotion of any ANCHOR

data or any information not pre-approved by Amarin is strictly prohibited.
You may continue to respond to unsolicited questions one-on-one,
consistent with your training. Thanks again for your continued efforts to
educate your colleagues and support of Vascepa!
Regards,
Aaron Berg
Senior Vice President, Marketing & Sales
President & President, R&D

Steven B. Ketchum
Senior Vice

2015 150538 05/2015

CONFIDENTIAL For internal use only. 2015.