Click here to close now.

SYS-CON MEDIA Authors: Plutora Blog, Elizabeth White, VictorOps Blog, Tim Hinds, Peter Silva

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
Even as cloud and managed services grow increasingly central to business strategy and performance, challenges remain. The biggest sticking point for companies seeking to capitalize on the cloud is data security. Keeping data safe is an issue in any computing environment, and it has been a focus since the earliest days of the cloud revolution. Understandably so: a lot can go wrong when you allow valuable information to live outside the firewall. Recent revelations about government snooping, along...
In his session at DevOps Summit, Tapabrata Pal, Director of Enterprise Architecture at Capital One, will tell a story about how Capital One has embraced Agile and DevOps Security practices across the Enterprise – driven by Enterprise Architecture; bringing in Development, Operations and Information Security organizations together. Capital Ones DevOpsSec practice is based upon three "pillars" – Shift-Left, Automate Everything, Dashboard Everything. Within about three years, from 100% waterfall, C...
SYS-CON Media announced that IBM, which offers the world’s deepest portfolio of technologies and expertise that are transforming the future of work, has launched ad campaigns on SYS-CON’s numerous online magazines such as Cloud Computing Journal, Virtualization Journal, SOA World Magazine, and IoT Journal. IBM’s campaigns focus on vendors in the technology marketplace, the future of testing, Big Data and analytics, and mobile platforms.
The explosion of connected devices / sensors is creating an ever-expanding set of new and valuable data. In parallel the emerging capability of Big Data technologies to store, access, analyze, and react to this data is producing changes in business models under the umbrella of the Internet of Things (IoT). In particular within the Insurance industry, IoT appears positioned to enable deep changes by altering relationships between insurers, distributors, and the insured. In his session at @Things...
HP and Aruba Networks on Monday announced a definitive agreement for HP to acquire Aruba, a provider of next-generation network access solutions for the mobile enterprise, for $24.67 per share in cash. The equity value of the transaction is approximately $3.0 billion, and net of cash and debt approximately $2.7 billion. Both companies' boards of directors have approved the deal. "Enterprises are facing a mobile-first world and are looking for solutions that help them transition legacy investme...
PubNub on Monday has announced that it is partnering with IBM to bring its sophisticated real-time data streaming and messaging capabilities to Bluemix, IBM’s cloud development platform. “Today’s app and connected devices require an always-on connection, but building a secure, scalable solution from the ground up is time consuming, resource intensive, and error-prone,” said Todd Greene, CEO of PubNub. “PubNub enables web, mobile and IoT developers building apps on IBM Bluemix to quickly add sc...
The cloud has transformed how we think about software quality. Instead of preventing failures, we must focus on automatic recovery from failure. In other words, resilience trumps traditional quality measures. Continuous delivery models further squeeze traditional notions of quality. Remember the venerable project management Iron Triangle? Among time, scope, and cost, you can only fix two or quality will suffer. Only in today's DevOps world, continuous testing, integration, and deployment upend...
Data-intensive companies that strive to gain insights from data using Big Data analytics tools can gain tremendous competitive advantage by deploying data-centric storage. Organizations generate large volumes of data, the vast majority of which is unstructured. As the volume and velocity of this unstructured data increases, the costs, risks and usability challenges associated with managing the unstructured data (regardless of file type, size or device) increases simultaneously, including end-to-...
Sensor-enabled things are becoming more commonplace, precursors to a larger and more complex framework that most consider the ultimate promise of the IoT: things connecting, interacting, sharing, storing, and over time perhaps learning and predicting based on habits, behaviors, location, preferences, purchases and more. In his session at @ThingsExpo, Tom Wesselman, Director of Communications Ecosystem Architecture at Plantronics, will examine the still nascent IoT as it is coalescing, includin...
The excitement around the possibilities enabled by Big Data is being tempered by the daunting task of feeding the analytics engines with high quality data on a continuous basis. As the once distinct fields of data integration and data management increasingly converge, cloud-based data solutions providers have emerged that can buffer your organization from the complexities of this continuous data cleansing and management so that you’re free to focus on the end goal: actionable insight.
Between the compelling mockups and specs produced by your analysts and designers, and the resulting application built by your developers, there is a gulf where projects fail, costs spiral out of control, and applications fall short of requirements. In his session at DevOps Summit, Charles Kendrick, CTO and Chief Architect at Isomorphic Software, will present a new approach where business and development users collaborate – each using tools appropriate to their goals and expertise – to build mo...
The Internet of Things (IoT) is causing data centers to become radically decentralized and atomized within a new paradigm known as “fog computing.” To support IoT applications, such as connected cars and smart grids, data centers' core functions will be decentralized out to the network's edges and endpoints (aka “fogs”). As this trend takes hold, Big Data analytics platforms will focus on high-volume log analysis (aka “logs”) and rely heavily on cognitive-computing algorithms (aka “cogs”) to mak...
Operational Hadoop and the Lambda Architecture for Streaming Data Apache Hadoop is emerging as a distributed platform for handling large and fast incoming streams of data. Predictive maintenance, supply chain optimization, and Internet-of-Things analysis are examples where Hadoop provides the scalable storage, processing, and analytics platform to gain meaningful insights from granular data that is typically only valuable from a large-scale, aggregate view. One architecture useful for capturing...
When it comes to the Internet of Things, hooking up will get you only so far. If you want customers to commit, you need to go beyond simply connecting products. You need to use the devices themselves to transform how you engage with every customer and how you manage the entire product lifecycle. In his session at @ThingsExpo, Sean Lorenz, Technical Product Manager for Xively at LogMeIn, will show how “product relationship management” can help you leverage your connected devices and the data th...
In the consumer IoT, everything is new, and the IT world of bits and bytes holds sway. But industrial and commercial realms encompass operational technology (OT) that has been around for 25 or 50 years. This grittier, pre-IP, more hands-on world has much to gain from Industrial IoT (IIoT) applications and principles. But adding sensors and wireless connectivity won’t work in environments that demand unwavering reliability and performance. In his session at @ThingsExpo, Ron Sege, CEO of Echelon...