Welcome!

News Feed Item

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

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
SYS-CON Events announced today that Twistlock, the leading provider of cloud container security solutions, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Twistlock is the industry's first enterprise security suite for container security. Twistlock's technology addresses risks on the host and within the application of the container, enabling enterprises to consistently enforce security policies, monitor...
The Internet of Things is clearly many things: data collection and analytics, wearables, Smart Grids and Smart Cities, the Industrial Internet, and more. Cool platforms like Arduino, Raspberry Pi, Intel's Galileo and Edison, and a diverse world of sensors are making the IoT a great toy box for developers in all these areas. In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists discussed what things are the most important, which will have the most profound e...
In his keynote at 19th Cloud Expo, Sheng Liang, co-founder and CEO of Rancher Labs, discussed the technological advances and new business opportunities created by the rapid adoption of containers. With the success of Amazon Web Services (AWS) and various open source technologies used to build private clouds, cloud computing has become an essential component of IT strategy. However, users continue to face challenges in implementing clouds, as older technologies evolve and newer ones like Docker c...
Automation is enabling enterprises to design, deploy, and manage more complex, hybrid cloud environments. Yet the people who manage these environments must be trained in and understanding these environments better than ever before. A new era of analytics and cognitive computing is adding intelligence, but also more complexity, to these cloud environments. How smart is your cloud? How smart should it be? In this power panel at 20th Cloud Expo, moderated by Conference Chair Roger Strukhoff, pane...
The goal of Continuous Testing is to shift testing left to find defects earlier and release software faster. This can be achieved by integrating a set of open source functional and performance testing tools in the early stages of your software delivery lifecycle. There is one process that binds all application delivery stages together into one well-orchestrated machine: Continuous Testing. Continuous Testing is the conveyor belt between the Software Factory and production stages. Artifacts are ...
Blockchain is a shared, secure record of exchange that establishes trust, accountability and transparency across supply chain networks. Supported by the Linux Foundation's open source, open-standards based Hyperledger Project, Blockchain has the potential to improve regulatory compliance, reduce cost and time for product recall as well as advance trade. Are you curious about Blockchain and how it can provide you with new opportunities for innovation and growth? In her session at 20th Cloud Exp...
@ThingsExpo has been named the Most Influential ‘Smart Cities - IIoT' Account and @BigDataExpo has been named fourteenth by Right Relevance (RR), which provides curated information and intelligence on approximately 50,000 topics. In addition, Right Relevance provides an Insights offering that combines the above Topics and Influencers information with real time conversations to provide actionable intelligence with visualizations to enable decision making. The Insights service is applicable to eve...
SYS-CON Events announced today that Grape Up will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct. 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Grape Up is a software company specializing in cloud native application development and professional services related to Cloud Foundry PaaS. With five expert teams that operate in various sectors of the market across the U.S. and Europe, Grape Up works with a variety of customers from emergi...
SYS-CON Events announced today that Hitachi, the leading provider the Internet of Things and Digital Transformation, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Hitachi Data Systems, a wholly owned subsidiary of Hitachi, Ltd., offers an integrated portfolio of services and solutions that enable digital transformation through enhanced data management, governance, mobility and analytics. We help globa...
SYS-CON Events announced today that Juniper Networks (NYSE: JNPR), an industry leader in automated, scalable and secure networks, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Juniper Networks challenges the status quo with products, solutions and services that transform the economics of networking. The company co-innovates with customers and partners to deliver automated, scalable and secure network...
Developers want to create better apps faster. Static clouds are giving way to scalable systems, with dynamic resource allocation and application monitoring. You won't hear that chant from users on any picket line, but helping developers to create better apps faster is the mission of Lee Atchison, principal cloud architect and advocate at New Relic Inc., based in San Francisco. His singular job is to understand and drive the industry in the areas of cloud architecture, microservices, scalability ...
SYS-CON Events announced today that CA Technologies has been named "Platinum Sponsor" of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, New York, and 21st International Cloud Expo, which will take place in November in Silicon Valley, California.
Back in February of 2017, Andrew Clay Schafer of Pivotal tweeted the following: “seriously tho, the whole software industry is stuck on deployment when we desperately need architecture and telemetry.” Intrigue in a 140 characters. For me, I hear Andrew saying, “we’re jumping to step 5 before we’ve successfully completed steps 1-4.”
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain.
@DevOpsSummit has been named the ‘Top DevOps Influencer' by iTrend. iTred processes millions of conversations, tweets, interactions, news articles, press releases, blog posts - and extract meaning form them and analyzes mobile and desktop software platforms used to communicate, various metadata (such as geo location), and automation tools. In overall placement, @DevOpsSummit ranked as the number one ‘DevOps Influencer' followed by @CloudExpo at third, and @MicroservicesE at 24th.