Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company
focused on improving cardiovascular health, announced today
that it received notice today from the U.S. Food and Drug
Administration (FDA) that the FDA plans to hold an advisory
committee meeting (AdCom), tentatively scheduled for November 14,
2019, in connection with its review of the pending supplemental new
drug application (sNDA) for expansion of Vascepa® (icosapent ethyl)
labeling based on the REDUCE-IT™ cardiovascular outcomes study.
Before this communication, the FDA had been silent as to whether it
would convene an AdCom in connection with its review of the
REDUCE-IT sNDA. The FDA expressed, based on the timing of its
recent decision to convene an AdCom, that November 14th is the
earliest date on which it could hold an AdCom due to scheduling
constraints for such a meeting.
Accordingly, Amarin does not expect the FDA to
take action on the sNDA by the previously announced September 28,
2019 Prescription Drug User Fee Act (PDUFA) goal date. Amarin did
not receive notice from the FDA of a PDUFA date extension. In light
of the tentative AdCom date, Amarin anticipates that the PDUFA date
will be extended, assuming a typical three-month extension, to a
date in late December 2019. If so, this anticipated revised PDUFA
date timing would offset three of the four months that were
expected to be gained from FDA’s earlier determination to conduct a
priority review of the REDUCE-IT sNDA. Prior to such
determination, Amarin had expected a PDUFA goal date in January
2020, based on a standard 10-month review. Amarin plans to update
the investment community after appropriately definitive information
is available related to a new PDUFA date.
The FDA informed Amarin in its August 8th notice
that the agency is in the process of developing the agenda for the
AdCom meeting. Topics to be raised by the FDA for discussion at an
AdCom meeting are typically announced publicly by the agency in
connection with its publication of its briefing book. Under the
FDA’s standard process, the FDA briefing book is scheduled to be
published 48 hours prior to the start of the AdCom meeting. Because
Vascepa, assuming anticipated FDA approval of the pending sNDA,
would be the first drug approved based on the large patient
population studied in REDUCE-IT, Amarin anticipates that discussion
of REDUCE-IT results at the AdCom will be broad. At this time,
Amarin expects topics to be reviewed at an AdCom meeting for the
sNDA regarding Vascepa to be consistent with those discussed at
similar meetings held by the FDA such as, but not limited to,
topics covered as part of the publication of REDUCE-IT primary
results in The New England Journal of Medicine1 and additional
results published in the Journal of American College of
Cardiology2, including review of the study conduct, populations
studied, efficacy and safety. Because regulatory reviews are
typically fluid and not definitive interactions between the sponsor
and agency on individual elements of an application and related
information, Amarin does not plan to update investors further on
ongoing communications with regulatory authorities except with
respect to potential updates regarding any change to the expected
timing of the AdCom or the PDUFA date.
“We look forward to the planned advisory
committee meeting as an opportunity to highlight the landmark
REDUCE-IT data and the important role we expect Vascepa should play
in the treatment of cardiovascular disease in appropriate
patients,” stated John Thero, president and chief executive officer
of Amarin. “We plan to continue to work collaboratively with the
FDA on the pending REDUCE-IT sNDA while we prepare for a robust
launch of REDUCE-IT data assuming approval of Vascepa before the
end of 2019 for a cardiovascular risk reduction indication based on
REDUCE-IT.”
Amarin intends to continue to move forward with
its plans to double the size of its sales force to support the
launch of Vascepa. Amarin plans to use the anticipated
three-month delay in the PDUFA clock to better prepare for the
assumed launch of Vascepa including more time to hire and train new
sales representatives. To the extent that new sales managers and
representatives are hired prior to the expanded label for Vascepa,
Amarin intends to have them join the company’s existing sales team
in promoting Vascepa based on its current indication and existing
promotional messaging.
Event Details:
The conference call can be heard live on the
investor relations section of the company's website at
www.amarincorp.com, or via telephone by dialing 877-407-8033 within
the United States or 201-689-8033 from outside the United States. A
replay of the call will be made available for a period of two weeks
following the conference call. To hear a replay of the call, dial
877-481-4010, PIN: 53214. A replay of the call will also be
available through the company's website shortly after the call.
To Ask Questions:
During the teleconference, following prepared
remarks, management will respond to questions from investors and
analysts, subject to time limitations. Participants in the live
teleconference will be provided an opportunity to ask questions.
Investors may also e-mail their questions to
investor.relations@amarincorp.com. e-mail questions will be
accepted until Thursday, August 8, 2019 at 6:30 p.m. ET.
About Amarin
Amarin Corporation plc. is a rapidly growing,
innovative pharmaceutical company focused on developing
therapeutics to improve cardiovascular health. Amarin’s product
development program leverages its extensive experience in
polyunsaturated fatty acids and lipid
science. Vascepa (icosapent ethyl) is Amarin's first
FDA-approved drug and is available by prescription in the United
States, Lebanon and the United Arab Emirates. Amarin’s commercial
partners are pursuing additional regulatory approvals for Vascepa
in Canada, China and the Middle East. For more information about
Amarin, visit www.amarincorp.com. About
REDUCE-IT™
REDUCE-IT1 was an 8,179-patient multinational
cardiovascular outcomes study completed in 2018. REDUCE-IT
evaluated the effect of prescription pure EPA therapy as an add-on
to statins in patients with high cardiovascular risk who, despite
stable statin therapy, had elevated triglyceride levels (at least
135 mg/dL). A large portion of the male and female patients
enrolled in this outcomes study were diagnosed with type 2
diabetes.
More information on the REDUCE-IT study results can be found
at www.amarincorp.com.
About Cardiovascular Disease
Worldwide, cardiovascular disease (CVD) remains
the #1 killer of men and women. In the United States CVD leads to
one in every three deaths – one death approximately every 38
seconds – with annual treatment cost in excess of $500 billion.3,
4
Multiple primary and secondary
prevention trials have shown a significant reduction of 25% to
35% in the risk of cardiovascular
events with statin therapy, leaving significant
persistent residual risk despite the achievement of target LDL-C
levels.5
Beyond the cardiovascular risk associated with
LDL-C, genetic, epidemiologic, clinical and real-world data suggest
that patients with elevated triglycerides (TG) (fats in the blood),
and TG-rich lipoproteins, are at increased risk for cardiovascular
disease.6-9
About Vascepa® (icosapent
ethyl) Capsules
Vascepa (icosapent ethyl) capsules are a
single-molecule prescription product consisting of the omega-3 acid
commonly known as EPA in ethyl-ester form. Vascepa is not
fish oil, but is derived from fish through a stringent and complex
FDA-regulated manufacturing process designed to effectively
eliminate impurities and isolate and protect the single molecule
active ingredient from degradation. Vascepa, known in
scientific literature as AMR101, has been designated a new chemical
entity by the FDA. Amarin has been issued multiple patents
internationally based on the unique clinical profile
of Vascepa, including the drug’s ability to lower triglyceride
levels in relevant patient populations without raising
LDL-cholesterol levels.
Indication and Usage Based on Current FDA-Approved Label (not
including REDUCE-IT results)
- Vascepa (icosapent ethyl) is indicated as an adjunct to
diet to reduce triglyceride (TG) levels in adult patients with
severe (≥500 mg/dL) hypertriglyceridemia.
- The effect of Vascepa on the risk for pancreatitis
and cardiovascular mortality and morbidity in patients with severe
hypertriglyceridemia has not been determined.
Important Safety Information for Vascepa Based on
Current FDA-Approved Label (not including REDUCE-IT
results) (Includes Data from Two 12-Week Studies (n=622)
(MARINE and ANCHOR) of Patients with Triglycerides Values of 200 to
2000 mg/dL)
- Vascepa is contraindicated in patients with known
hypersensitivity (e.g., anaphylactic reaction)
to Vascepa or any of its components.
- In patients with hepatic impairment, monitor ALT and AST levels
periodically during therapy.
- Use with caution in patients with known hypersensitivity to
fish and/or shellfish.
- The most common reported adverse reaction (incidence >2% and
greater than placebo) was arthralgia (2.3% for Vascepa, 1.0%
for placebo). There was no reported adverse reaction >3% and
greater than placebo.
- Adverse events and product complaints may be reported by
calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
- Patients receiving treatment with Vascepa and other
drugs affecting coagulation (e.g., anti-platelet agents) should be
monitored periodically.
- Patients should be advised to
swallow Vascepa capsules whole; not to break open, crush,
dissolve, or chew Vascepa.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
Important Safety Information for Vascepa based on
REDUCE-IT, as previously reported in The New England
Journal of Medicine1 publication of the primary results of the
REDUCE-IT study:
- Excluding the major adverse cardiovascular events (MACE)
results described above, overall adverse event rates in REDUCE-IT
were similar across the statin plus Vascepa and the
statin plus placebo treatment groups.
- There were no significant differences between treatments in the
overall rate of treatment emergent adverse events or serious
adverse events leading to withdrawal of study drug.
- There was no serious adverse event (SAE) occurring at a
frequency of >2% which occurred at a numerically higher rate in
the statin plus Vascepa treatment group than in the
statin plus placebo treatment group.
- Adverse events (AEs) occurring in 5% or greater of patients and
more frequently with Vascepa than placebo were: –
peripheral edema (6.5% Vascepa patients versus 5.0%
placebo patients), although there was no increase in the rate of
heart failure in Vascepa patients – constipation
(5.4% Vascepa patients versus 3.6% placebo patients),
although mineral oil, as used as placebo, is known to lower
constipation, and – atrial fibrillation
(5.3% Vascepa patients versus 3.9% placebo patients),
although there were reductions in rates of cardiac arrest, sudden
death and myocardial infarctions observed
in Vascepa patients
- There were numerically more SAEs related to bleeding in the
statin plus Vascepa treatment group although overall
rates were low with no fatal bleeding observed in either group and
no significant difference in adjudicated hemorrhagic stroke or
serious central nervous system or gastrointestinal bleeding events
between treatments.
- In summary, Vascepa was well tolerated with a safety
profile generally consistent with clinical experience associated
with omega-3 fatty acids and current FDA-approved labeling of such
products.
Vascepa has been approved for use by the
United States Food and Drug Administration (FDA) as an adjunct to
diet to reduce triglyceride levels in adult patients with severe
(≥500 mg/dL) hypertriglyceridemia. FDA has not reviewed and opined
on a supplemental new drug application related to REDUCE-IT. FDA
has not reviewed the information herein or determined whether to
approve Vascepa for use to reduce the risk of MACE.
Nothing in this press release should be construed as promoting the
use of Vascepa in any indication that has not been
approved by the FDA.
Important Cautionary Information About These
Data
Further REDUCE-IT data assessment and data
release could yield additional useful information to inform greater
understanding of the trial outcome. For example, detailed data
assessment by regulatory authorities, such as the FDA and
Health Canada, will continue and take several months to complete
and announce. The AdCom process and the final evaluation by
regulatory authorities of the totality of efficacy and safety data
from REDUCE-IT may include some or all of the following, as well as
other considerations: new information or analyses affecting the
degree of treatment benefit on studied endpoints; study conduct and
data robustness, quality, integrity and consistency; additional
safety data considerations and risk/benefit considerations; and
consideration of REDUCE-IT results in the context of other clinical
studies. Because regulatory reviews are typically fluid and not
definitive interactions between sponsor and agency on individual
elements of an application and related information, Amarin does not
plan to update investors on ongoing communications with regulatory
authorities. Amarin plans to announce the final outcome of such
regulatory reviews when appropriate.
Recurrent event analyses for the total primary
endpoint events and for the total key secondary endpoint in
REDUCE-IT as published in the Journal of the American College
of Cardiology were conducted using a series of statistical models.
These analyses were tertiary or exploratory endpoints; most of the
models used were prespecified and one was post hoc. Each
recurrent event statistical model has inherent strengths and
weaknesses, with no single model considered definitive or
outperforming the other models, and this is an evolving field of
science. Nonetheless, results from the total primary and total key
secondary endpoint events analyses are consistent across the
various recurrent event statistical models and are also consistent
with the original primary and secondary endpoint results. Together,
the REDUCE-IT recurrent event analyses and the original primary and
key secondary endpoint analyses support the robustness of the
clinical benefit of Vascepa therapy in reducing
cardiovascular risk.
Forward-Looking Statements
This press release contains forward-looking
statements, including statements about anticipated FDA review of
the REDUCE-IT sNDA and the timing of such review, and Amarin’s
plans for commercial expansion related thereto. These
forward-looking statements are not promises or guarantees and
involve substantial risks and uncertainties. Among the factors that
could cause actual results to differ materially from those
described or projected herein include the following: uncertainties
associated generally with research and development, clinical trials
and related regulatory approvals; the risk that data
interpretations or other information from third parties, the
regulatory review process, regulatory authorities and in connection
with an AdCom could be made public that are negative or may delay
approval or limit Vascepa’s marketability; the risk that special
protocol assessment (SPA) agreements with the FDA are not a
guarantee that FDA will approve a product candidate; the risk
associated with the FDA's rescinding the REDUCE-IT SPA agreement;
the risk related to FDA advisory committee meetings; and the risk
that the FDA may not complete its review of the REDUCE-IT sNDA
within the timing expected. A further list and description of these
risks, uncertainties and other risks associated with an investment
in Amarin can be found in Amarin's filings with the U.S. Securities
and Exchange Commission, including its most recent Quarterly Report
on Form 10-Q. Existing and prospective investors are cautioned not
to place undue reliance on these forward-looking statements, which
speak only as of the date hereof. Amarin undertakes no obligation
to update or revise the information contained in this press
release, whether as a result of new information, future events or
circumstances or otherwise
Availability of Other Information About
Amarin
Investors and others should note that Amarin
communicates with its investors and the public using the company
website (www.amarincorp.com), the investor relations website
(investor.amarincorp.com), including but not limited to investor
presentations and investor FAQs, Securities and Exchange Commission
filings, press releases, public conference calls and webcasts. The
information that Amarin posts on these channels and websites could
be deemed to be material information. As a result, Amarin
encourages investors, the media, and others interested in Amarin to
review the information that is posted on these channels, including
the investor relations website, on a regular basis. This list of
channels may be updated from time to time on Amarin’s investor
relations website and may include social media channels. The
contents of Amarin’s website or these channels, or any other
website that may be accessed from its website or these channels,
shall not be deemed incorporated by reference in any filing under
the Securities Act of 1933.
References
1 Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Risk
Reduction with Icosapent Ethyl for Hypertriglyceridemia. N
Engl J Med 2019;380:11-22.
2 Bhatt DL, Steg PG, Miller M, et al. Effects of Icosapent
Ethyl on Total Ischemic Events: From REDUCE-IT. J Am Coll
Cardiol 2019;73(22):2791-2802.
3 American Heart Association. 2018. Disease and Stroke
Statistics-2018 Update.
4 American Heart Association. 2017. Cardiovascular disease:
A costly burden for America projections through 2035.
5 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for
adjunctive dyslipidemia therapy in hypertriglyceridemia
management. J Am Coll Cardiol. 2018;72(3):330-343.
6 Budoff M. Triglycerides and triglyceride-rich
lipoproteins in the causal pathway of cardiovascular
disease. Am J Cardiol. 2016;118:138-145.
7 Toth PP, Granowitz C, Hull M, et al. High triglycerides
are associated with increased cardiovascular events, medical costs,
and resource use: A real-world administrative claims analysis of
statin-treated patients with high residual cardiovascular
risk. J Am Heart Assoc. 2018;7(15):e008740.
8 Nordestgaard BG. Triglyceride-rich lipoproteins and
atherosclerotic cardiovascular disease - New insights from
epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.
9 Nordestgaard BG, Varbo A. Triglycerides and
cardiovascular disease. Lancet. 2014;384:626–635.
Amarin Contact Information
Investor Relations Inquiries: Elisabeth
Schwartz Investor Relations Amarin Corporation plc In U.S.: +1
(908) 719-1315 investor.relations@amarincorp.com
Lee M. Stern Solebury Trout In U.S.: +1 (646)
378-2992lstern@soleburytrout.com
Media Inquiries: Gwen Fisher Corporate
Communications Amarin Corporation plc In U.S.: +1 (908)
325-0735 pr@amarincorp.com
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