AMRN Amarin Corp PLC

Amarin Corporation plc (NASDAQ: AMRN), a biopharmaceutical company focused on
the commercialization and development of therapeutics to improve cardiovascular
health, announced today the publication of a retrospective analysis of patient
cases that examined the effect on lipid parameters in hyperlipidemic patients
who were switched from Lovaza® (omega-3-acid ethyl esters) capsules, a mixture
of omega fatty acids, to Vascepa® (icosapent ethyl) capsules, the only pure-EPA
prescription omega-3 product, to potentially achieve better outcomes in
triglyceride (TG) and low-density lipoprotein cholesterol (LDL-C) levels.1
During the studied period, most of the 14 patients switched to Vascepa
experienced reductions in levels of triglyceride (TG), total cholesterol (TC),
low-density lipoprotein cholesterol (LDL-C), and non-high-density lipoprotein
cholesterol (non-HDL-C).


The publication, titled, "A Retrospective Case Series of the Lipid Effects of
Switching from Omega-3 Fatty Acid Ethyl Esters to Icosapent Ethyl in
Hyperlipidemic Patients," was authored by Richard S. Castaldo, MD, is now
available electronically through Postgraduate Medicine (available at:
https://postgradmed.org/doi/10.3810/pgm.2014.05.2775) and is scheduled for print
publication in the May 2014 issue. Dr. Castaldo conducted a retrospective chart
review at 4 medical practice locations in Western New York of 14 treated
patients who were initially diagnosed with high TG levels, or hyperlipidemia,
and whose lipid parameters were measured two or more months after being switched
to 4 g/day EPA-only Vascepa from 4 g/day Lovaza. The patients ranged from 45 to
79 years of age and were on their same prescription lipid-lowering background
medication at the same dose throughout the studied period, with 10 patients on a
statin, and 4 patients on a cholesterol absorption inhibitor. After being
switched from Lovaza to Vascepa, 12 patients experienced a decrease in TG and
LDL-C levels and 13 patients experienced a decrease in TC and non-HDL-C levels.
Changes in high-density lipoprotein cholesterol (HDL-C) levels were also
assessed, but the results were mixed, with no change in 1 patient, decreases in
9 patients, and increases in 4 patients. Dr. Castaldo's chart review also found
Vascepa to be well tolerated with a safety profile consistent with that
referenced in the U.S. Food and Drug Administration (FDA) approved label for
Vascepa. 


"We have heard many anecdotal reports of the success physicians have had with
Vascepa since its launch last year," said Steven B. Ketchum, Ph.D., President of
Research and Development of Amarin. "The results published by Dr. Castaldo
provide important hypothesis generating evidence of the potential benefit of
treating patients with EPA-only Vascepa that requires additional study for
substantiation. These real-world results are exciting and encouraging when
considered alongside the findings of the pivotal Phase 3 studies conducted with
Vascepa, which demonstrated that EPA-only Vascepa reduced TG levels without
increasing levels of bad cholesterol, LDL-C, in patients with high and very high
triglyceride levels."


Important information on related clinical trials and study result limitations

The results of Phase 3 studies of Vascepa, the MARINE and ANCHOR studies, were
published online in the American Journal of Cardiology in June 2011 and July
2012, respectively, and are available electronically through PubMed (available
at: http://www.ncbi.nlm.nih.gov/pubmed/21683321 for the MARINE clinical study
and http://www.ncbi.nlm.nih.gov/pubmed/22819432 for the ANCHOR clinical study).


Vascepa® (icosapent ethyl) capsules, Lovaza® (omega-3-acid ethyl esters)
capsules, Omtryg™ (omega-3-acid ethyl esters A) capsules, and Epanova®
(omega-3-carboxylic acids) capsules are each FDA approved for the same
indication, with each product having different labeled safety and efficacy
information based on underlying clinical data sets that are publicly available
in their respective FDA-approved labeling.1 Vascepa, Lovaza, and Epanova are all
approved by FDA for their specified use based on prospective blinded randomized
studies compared to placebo. Omtryg was approved for its use by FDA based on a
three-arm study that included Lovaza and placebo arms. The most recent FDA
reviewed study results of Lovaza are included in the FDA-approved label for
Omtryg. 


FDA-reviewed and labeled clinical trial results of Lovaza, Omtryg, and Epanova,
all of which are mixtures of multiple omega acids, including EPA, DHA and other
components, reflect increases in LDL-C levels in studied populations. No
prospective blinded randomized head-to-head studies have been conducted between
Vascepa and any other product, and there can be no assurance that the results
published in the above retrospective case study review could be repeated in
other studies or that the results shown in the case study review could be
obtained for patients switched to Vascepa from other TG-lowering therapies. 


In addition to its currently approved indication, Vascepa is under various
stages of development for potential use in indications that have not been
approved by the FDA. Most patients with records reviewed in the published study
were not in the patient population in which Vascepa is approved for use by the
FDA. Amarin had no role in individual case study selection in the review,
including the initial triglyceride levels of studied patients. 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 or promoting the superiority of
Vascepa to any other prescription product. 


Amarin provided financial support for Dr. Castaldo's work on the case study
review and the related publication.


About Vascepa® (icosapent ethyl) capsules

Vascepa® (icosapent ethyl) capsules, known in scientific literature as AMR101,
is a patented, pure-EPA omega-3 prescription product in a 1 gram capsule.


Indications and Usage



--  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



--  Vascepa is contraindicated in patients with known hypersensitivity
    (e.g., anaphylactic reaction) to Vascepa or any of its components and
    should be used 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).



FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM

About Amarin

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), Amarin's first FDA approved product, is a
patented, ultra-pure omega-3 fatty acid product comprising not less than 96% EPA
and is available by prescription. For more information about Vascepa visit
www.vascepa.com. For more information about Amarin visit www.amarincorp.com.


Forward-Looking Statements

This press release contains forward-looking statements, including statements
about the potential efficacy, safety and therapeutic benefits of Amarin's
product candidates, Amarin's clinical trial results, including statements about
the clinical importance of certain parameters and the impact and potential
impact of Vascepa on such parameters. 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 uncertainties associated generally with
research and development, clinical trials and related regulatory reviews and
approvals, including the risk that historical clinical trial results may not be
predictive of future results if replicated in larger patient populations and
that studied lipid parameters may not have clinically meaningful effect or
support regulatory approvals. 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 we communicate with our investors and the
public using our company website (www.amarincorp.com), our investor relations
website (http://www.amarincorp.com/investor-splash.html), 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 we post on these channels and websites could be deemed to be
material information. As a result, we encourage investors, the media, and others
interested in Amarin to review the information that we post on these channels,
including our investor relations website, on a regular basis. This list of
channels may be updated from time to time on our investor relations website and
may include social media channels. The contents of our website or these
channels, or any other website that may be accessed from our website or these
channels, shall not be deemed incorporated by reference in any filing under the
Securities Act of 1933.


1 Vascepa® is a registered trademark of the Amarin group of companies. Other
trademarks used are not affiliated with Amarin. Lovaza® is a registered
trademark of the GlaxoSmithKline group of companies. Omtryg™ is a trademark of
Trygg Pharma AS. Epanova® is a registered trademark of the AstraZeneca group of
companies. Full prescribing information for each product can be found through
the FDA website at
http://www.accessdata.fda.gov/Scripts/cder/drugsatfda/index.cfm. 



FOR FURTHER INFORMATION PLEASE CONTACT: 

Amarin contact information

Mike Farrell
Investor Relations and Corporate Communications
Amarin Corporation
In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com

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