Amarin Corporation plc (NASDAQ:AMRN), a
pharmaceutical company focused on improving cardiovascular health,
announced that two independently conducted studies, two moderated
poster sessions and three presentations based on research supported
by Amarin will be presented at the American Heart Association’s
(AHA) 2019 Scientific Sessions, November 16-18, in Philadelphia,
PA.
“Cardiovascular disease is the leading cause of death and the
costliest chronic disease in the U.S. today,”1 said Craig
Granowitz, M.D., Ph.D., senior vice president and chief medical
officer, Amarin. “It is imperative that we conduct and share
scientific research that may help address the often devastating,
debilitating and deadly conditions that now affect almost half of
Americans.2 Several of the scheduled presentations at AHA focus on
Amarin’s REDUCE-IT® study and provide further context on the
potential clinical and economic value of Vascepa® (icosapent ethyl)
as a treatment for people who have statin-controlled cholesterol
levels, yet have elevated triglyceride levels and are otherwise
still at high risk of cardiovascular events.”
Upcoming Featured Presentations
- Session FS.AOS.01 – Featured Science Population
Science, November 16, 7:30 – 7:40 a.m., Eastern U.S.
Time“Cost-Effectiveness of Icosapent Ethyl in
REDUCE-IT,” – presented by William S. Weintraub, M.D.,
MedStar Washington Hospital.
- Session FS.MDP.05 – Follow-up of Landmark Trials,
Moderated Science Poster, November 17, 4:20 – 4:25 p.m., Eastern
U.S. TimeMDP479, “REDUCE-IT USA: Results from the
3,146 Patients Randomized in the United States,” –
presented by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women’s
Hospital and Harvard Medical School.
- Session LBS.06 – Late Breaking Science VI: New
Frontiers in Lipid Therapy, November 18, 9:00 – 9:10 a.m., Eastern
U.S. Time“Effect of Icosapent Ethyl on Progression
of Coronary Atherosclerosis in Patients with Elevated Triglycerides
(200 – 499 mg/dL) on Statin Therapy (EVAPORATE study),” –
presented by Matthew J. Budoff, M.D., Los Angeles Biomedical
Research.
Other Upcoming Data Presentations
- Presentation Sa1056, “Purified Eicosapentaenoic Acid
Ameliorates Cardiac Fibrosis and Tissue Inflammation on
Spontaneously Hypertensive Rats,” – Giselle C. Meléndez,
M.D., Danielle Medina-Hernandez, Adam Pflum, M.D., Vivian
Xu, David M. Herrington, M.D., presented Saturday, November 16.,
1:30 – 2 p.m., Eastern U.S. Time.
- Presentation Su3237, “Improving Appropriate Use Of
Omega-3 Fatty Acids In Primary Care: Success Of Online CME,” –
Jelena Spyropoulos, Medscape Education, New York, NY;
George Boutsalis, David Anderson – presented Sunday, November 17,
12:30 – 1 p.m., Eastern U.S. Time.
- Presentation Mo1016, “Influence of Eicosapentaenoic and
Arachidonic Acid on Cholesterol Crystal Formation in Membranes
under Hyperglycemic Conditions,” – Samuel C.R. Sherratt,
B.S., R. Preston Mason, Ph.D. -- presented Monday, November 18,
11:30 a.m. – noon, Eastern U.S. Time.
- Moderated Poster Presentation MDP414, “Many Statin
Treated Persons with Borderline Triglyceride Levels are at Risk of
ASCVD,” – Nathan D. Wong, Wenjun Fan, Sephy Philip, Peter
P. Toth, and Craig Granowitz – presented Monday, November 18, 1:20
-1:25 p.m., Eastern U.S. Time.
As will be disclosed in the presentations listed above, much of
this independent research was funded by Amarin.
Vascepa is currently approved in the United States as an adjunct
to diet to reduce triglyceride levels in adult patients with severe
(≥500 mg/dL) hypertriglyceridemia. Amarin has submitted a
supplemental new drug application (sNDA) to the U.S. FDA for a
label expansion based on the REDUCE-IT study results showing
reduction of cardiovascular events in high-risk patients. The
Prescription Drug User Fee Act (PDUFA) target action date set by
the FDA to act on the sNDA is December 28, 2019. Assuming FDA
approval, Vascepa is positioned to become the first drug indicated
to reduce persistent residual cardiovascular risk in statin-managed
patients with elevated triglycerides (135 mg/dL or greater) and
other risk factors for cardiovascular disease. The approval of such
label expansion and the wording of the indication statement is
under regulatory review.
Investor Webcast on November 18, 4:30 p.m., Eastern U.S.
TimeAmarin will host a webcast at 4:30 p.m. Eastern U.S.
Time, November 18, 2019. The webcast will be accessible through the
investor relations section of the company’s website at
www.amarincorp.com. The webcast can also be heard via telephone by
dialing 877-407-8033. A replay of the webcast will be available for
two weeks following the webcast. To hear a replay of the webcast,
dial 877-481-4010 (inside the United States) or 919-882-2331
(outside the United States). A replay of the webcast will also be
available through the company's website shortly after the webcast.
For both dial-in numbers please use conference ID 55923.
About AmarinAmarin 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-IT, an 8,179-patient
cardiovascular outcomes study, was completed in 2018. REDUCE-IT was
the first multinational cardiovascular outcomes study that
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 proportion 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 DiseaseWorldwide,
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.6,7,8,9
About Vascepa® (icosapent ethyl)
CapsulesVascepa (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.
The FDA has not completed its review and made a final
determination 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
major adverse cardiovascular events in the REDUCE-IT patient
populationIndication 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 Medicine
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.
Important Cautionary Information About These
Data Further REDUCE-IT data assessment and data
release are expected to 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 time to complete and
announce. The FDA advisory committee process and the final
evaluation by regulatory authorities of the totality of efficacy
and safety data from REDUCE-IT is anticipated to 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. More detailed
presentation of such considerations is set forth in the risk
factors section of Amarin’s Quarterly Report on Form 10-Q filed
with the U.S. Securities and Exchange Commission. 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 further on ongoing communications with regulatory
authorities. Amarin plans to announce the final outcome of such
regulatory reviews when appropriate.
Forward-Looking StatementsThis press release
contains forward-looking statements, including statements regarding
the use of Vascepa to potentially help millions of patients. 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 reviews and approvals; the risk that data
interpretations or other information from third parties, the
regulatory review process, regulatory authorities and in connection
with an advisory committee 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
AmarinInvestors 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. Amarin Contact
Information
Investor Inquiries:Elisabeth SchwartzInvestor
RelationsAmarin Corporation plcIn U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com
Lee M. SternSolebury TroutIn U.S.: +1 (646) 378-2992
lstern@soleburytrout.com
Media Inquiries:Gwen FisherCorporate
Communications Amarin Corporation plcIn U.S.: +1 (908) 325-0735
pr@amarincorp.com
References
1 American Heart Association. 2017. Cardiovascular Disease: A
Costly Burden for America Projections Through 20352 The American
Heart Association's "Heart Disease and Stroke Statistics-2019
Update"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 (NASDAQ:AMRN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Amarin (NASDAQ:AMRN)
Historical Stock Chart
From Sep 2023 to Sep 2024