Webcast to Commence at 7:15 p.m. CT / 8:15
p.m. ET, Saturday, November 10, 2018
Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company
focused on the commercialization and development of therapeutics to
improve cardiovascular health, looks forward to the presentation of
primary results of Amarin’s landmark cardiovascular outcomes study
of Vascepa® (icosapent ethyl), the REDUCE-IT™ study, as a
late-breaker at the 2018 Scientific Sessions of American Heart
Association (AHA) on November 10, 2018 in Chicago, Illinois, as
previously disclosed. Amarin expects the following activities
at AHA will be of most interest to Amarin investors:
- Presentation of REDUCE-IT clinical trial results: Saturday,
Nov. 10, 2018 at 2:18 p.m. Central Time (CT) / 3:18 p.m. Eastern
Time (ET)
- Amarin investor/analyst conference call to discuss REDUCE-IT
results: Saturday, Nov. 10, 2018 at 7:15 p.m. CT / 8:15 p.m.
ET
- Continuing medical education programs with REDUCE-IT on the
agenda (the curriculum of which is developed independently of
Amarin): Sunday, Nov. 11, 2018 at 6:30 p.m. CT / 7:30 p.m. ET and
Monday, Nov. 12, 2018 at 6:00 a.m. CT / 7:00 a.m. ET
Presentation of REDUCE-IT Clinical Results
Presentation of REDUCE-IT primary clinical trial
results is classified by the AHA as late-breaking clinical trial
results and listed as Main Event 1 for timeframe described
above. A link to the notice of this presentation is provided
at:http://www.abstractsonline.com/pp8/#!/4682/presentation/59402.
The AHA makes available a live stream and
archived webcast of the REDUCE-IT primary clinical trial results
presentation
at:https://professional.heart.org/professional/EducationMeetings/MeetingsLiveCME/ScientificSessions/UCM_488605_Sessions-ReSS-LIVE.jsp.
In connection with the presentation of such
results, Amarin plans to issue a press release describing the trial
results.
Presentation of the REDUCE-IT clinical trial
results is scheduled immediately following presentation and
discussion of results from a clinical trial known as VITAL. VITAL
is an NIH-funded trial of vitamin D3 and 1 gram of an omega-3
mixture (prescription Lovaza) for the primary prevention of cancer
and cardiovascular disease in a nationwide United States cohort of
25,874 adults not selected for elevated cardiovascular or cancer
risk. Amarin does not know the results of the VITAL study. In
the past, including results of the ASCEND study reported earlier
this year, omega-3 mixtures have not demonstrated significant
cardiovascular benefit on top of contemporary medical therapy.
These results with omega-3 mixtures have not shown benefit and
differ from the success reported with the unique single active
ingredient in Vascepa in the REDUCE-IT study and a similar product
in the JELIS study conducted in Japan.
Amarin Investor/Analyst Conference Call
Amarin today announced that it plans to hold a
meeting Saturday at 7:15 p.m. CT / 8:15 p.m. ET with investors and
analysts who are attending AHA to discuss the results of the trial
presented earlier in the day. Amarin intends to broadcast this
meeting live via webcast. The meeting will include comments from
representatives of Amarin.
This call will commence at the time shown above.
The webcast will be accessible through the investor relations
section of the company’s website at www.amarincorp.com. The call
can also be heard via telephone by dialing 877-407-8033. 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 (inside the United States) or 919-882-2331 (outside
the United States). A replay of the call will also be available
through the company's website shortly after the call. For both
dial-in numbers please use conference ID 39894.
Investors and analysts who are attending AHA and
who wish to attend this meeting in person should inform Elisabeth
Schwartz per the contact information below. Space at the
meeting will be limited.
Continuing Medical Education Programs
Two live independently conducted continuing
education programs for healthcare professionals are scheduled
during AHA with discussion of REDUCE-IT results known to be part of
their curriculum. Space in these CME programs is limited.
Information regarding these CME programs is available via the
websites of the organizers of the programs. Accessibility to such
programs via webcast live or on an enduring basis is being
evaluated by the organizers. The organizers are Medtelligence and
Vindico, respectively. Information regarding the Sunday evening
event is available at http://events.medtelligence.net/ha18htg.html.
Information regarding the Monday morning event is available at
https://www.eventbrite.com/e/advancing-science-in-residual-cardiovascular-risk-will-new-cardiovascular-outcomes-trials-bring-a-registration-51595011067.
Amarin provided an unrestricted educational grant to support these
programs, however, Amarin is not responsible for the organization
or content of these presentations. Amarin does not control
individual access to such programs. Description of these
programs here is provided for informational purposes reflecting the
interest level in REDUCE-IT results. No material new information is
expected to be presented in these programs.
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 lipid
science and the potential therapeutic benefits of polyunsaturated
fatty acids. 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
The REDUCE-IT cardiovascular outcomes study
commenced in 2011, enrolled and followed 8,179 randomized patients,
and was conducted based on a special protocol assessment agreement
with FDA.
REDUCE-IT is the first global cardiovascular
outcomes study to prospectively evaluate the effect of Vascepa, or
any therapy, in adult patients with LDL-C controlled to between
41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and
various cardiovascular risk factors including persistent elevated
TGs between 150-499 mg/dL (median baseline 216 mg/dL) and either
established cardiovascular disease (secondary prevention cohort) or
diabetes mellitus and at least one other CV risk factor (primary
prevention cohort). The design of the REDUCE-IT cardiovascular
outcomes study was published in March 2017 in Clinical Cardiology1
and can be found in the R&D section on the company’s website at
www.amarincorp.com.
The REDUCE-IT hypothesis tested whether
additional cardiovascular risk reduction beyond LDL-C controlled
with statin therapy could be achieved in high risk patients with
the putative cardioprotective effects of Vascepa 4 grams/day.
Independent of REDUCE-IT, Amarin has worked to further support the
REDUCE-IT hypothesis with published scientific findings based on
various degrees of evidence that show EPA may interrupt the
atherosclerotic process (e.g., plaque formation and instability) by
beneficially affecting cellular functions thought to contribute to
atherosclerosis and cardiovascular events and by beneficially
affecting lipid, lipoprotein and inflammation biomarkers.2, 3, 4,
5, 6
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.7,
8
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.9, 10, 11, 12
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. 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.
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. 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.
Forward-Looking
Statements
This press release contains forward-looking
statements, including expectations regarding scientific
presentation. These forward-looking statements are not promises or
guarantees and involve substantial risks and uncertainties. In
addition, Amarin's ability to effectively commercialize Vascepa
will depend in part on its ability to continue to effectively
finance its business, efforts of third parties, its ability to
create market demand for Vascepa through education, marketing and
sales activities, to achieve market acceptance of Vascepa, to
receive adequate levels of reimbursement from third-party payers,
to develop and maintain a consistent source of commercial supply at
a competitive price, to comply with legal and regulatory
requirements in connection with the sale and promotion of Vascepa
and to maintain patent protection for Vascepa. 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 sales may not meet
expectations and related cost may increase beyond expectations; the
risk that patents may not be upheld in patent litigation and
applications may not result in issued patents sufficient to protect
the Vascepa franchise. 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 http://www.amarincorp.com/), the investor relations website
(http://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, Brinton EA, Jacobson TA,
Miller M, Tardif J-C, Ketchum SB, Doyle RT Jr, Murphy SA, Soni PN,
Braeckman RA, Juliano RA, Ballantyne CM and on behalf of the
REDUCE-IT Investigators. Rationale and design of REDUCE-IT:
Reduction of Cardiovascular Events With Icosapent
Ethyl–Intervention Trial. Clin Cardiol.
2017;40:138-148.2 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need
for adjunctive dyslipidemia therapy in hypertriglyceridemia
management. J Am Coll Cardiol. 2018;72(3):330-343.3 Borow KM,
Nelson JR, Mason RP. Biologic plausibility, cellular effects, and
molecular mechanisms of eicosapentaenoic acid (EPA) in
atherosclerosis. Atherosclerosis. 2015;242(1):357-366.4 Nelson JR,
Wani O, May HT, et al. Potential benefits of eicosapentaenoic acid
on atherosclerotic plaques. Vascul Pharmacol. 2017;91:1–9.5 Mason
RP, Dawoud H, Jacob RF, et al. Eicosapentaenoic acid improves
endothelial function and nitric oxide bioavailability in a manner
that is enhanced in combination with a statin. Biomed Pharmacother.
2018;103:1231-1237.6 Takamura M, Kurokawa K, Ootsuji H, et al.
Long-term administration of eicosapentaenoic acid improves
post-myocardial infarction cardiac remodeling in mice by regulating
macrophage polarization. J Am Heart Assoc. 2017;6(2). pii:
e004560.7 American Heart Association. 2018. Disease and Stroke
Statistics-2018 Update.8 American Heart Association. 2017.
Cardiovascular disease: A costly burden for America projections
through 2035.9 Budoff M. Triglycerides and triglyceride-rich
lipoproteins in the causal pathway of cardiovascular disease. Am J
Cardiol. 2016;118:138-145.10 Toth PP, Granowitz C, Hull M, et al.
High triglycerides increase cardiovascular events, medical costs,
and resource utilization in a real-world analysis of statin-treated
patients with high cardiovascular risk and well-controlled
low-density lipoprotein cholesterol [abstract]. Circulation.
2017;136(suppl 1):A15187.11 Nordestgaard BG. Triglyceride-rich
lipoproteins and atherosclerotic cardiovascular disease - New
insights from epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.12 Nordestgaard BG, Varbo A. Triglycerides and
cardiovascular disease. Lancet. 2014; 384: 626–635.
Amarin Contact Information
Investor Relations:Elisabeth SchwartzInvestor
Relations and Corporate CommunicationsAmarin Corporation
plcIn U.S.: +1 (908)
719-1315investor.relations@amarincorp.com
Lee M. SternTrout GroupIn U.S.: +1 (646)
378-2992lstern@troutgroup.com
Media Inquiries: Christy Maginn Burson-Marsteller In U.S.:
+1 (646) 280-5210 Christy.Maginn@bm.com
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