Amarin Announces Publication of Case Study Results Describing
Reductions in Multiple Lipid Parameters for Individual
Hyperlipidemic Patients Switched to Vascepa(R)
BEDMINSTER, NJ and DUBLIN,
IRELAND--(Marketwired - June 11, 2014) - 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.
Amarin contact informationMike FarrellInvestor Relations and
Corporate CommunicationsAmarin CorporationIn U.S.: +1 (908)
719-1315investor.relations@amarincorp.com
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