Pure EPA Vascepa® Now Available in New, Smaller Half-Gram Capsule Size
October 25 2016 - 7:00AM
Amarin Corporation plc (NASDAQ:AMRN) announced today the
introduction of a smaller 0.5-gram capsule size for
Vascepa® (icosapent ethyl) available now in retail pharmacies
nationwide. The smaller capsule is in addition to the original and
currently available 1-gram size Vascepa capsule.
A photo accompanying this announcement is available
at http://www.globenewswire.com/NewsRoom/AttachmentNg/3f18752c-0265-452a-b8e2-1920b8267071
“Amarin is dedicated to listening to patients
and healthcare providers in an effort to deliver solutions that
help make it easier for patients to take their doctor prescribed
medication,” said Aaron Berg, senior vice president of marketing
and sales of Amarin. “We are pleased to now offer the first and
only half-gram prescription omega-3 alternative for the subset of
patients who prefer a smaller capsule.”
The FDA-approved dosing for Vascepa continues to
be four grams per day, taken as two grams twice daily, with food.
Based on market research with healthcare providers, Amarin believes
that the majority of patients taking Vascepa will continue to be
prescribed the 1-gram size Vascepa capsule.
About Vascepa® (icosapent ethyl)
capsules
Vascepa capsules are a single-molecule prescription product
consisting of 1-gram or 0.5-gram 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.
Vascepa is known in scientific literature as AMR101.
FDA-approved Indication 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.
- 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.
- Patients receiving treatment with Vascepa and other
drugs affecting coagulation (e.g., anti-platelet agents) should be
monitored periodically.
- In patients with hepatic impairment, monitor ALT and AST levels
periodically during therapy.
- Patients should be advised to
swallow Vascepa capsules whole; not to break open, crush,
dissolve, or chew Vascepa.
- Adverse events and product complaints may be reported by
calling 1‑855‑VASCEPA or the
FDA at 1‑800‑FDA‑1088.
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, Amarin's first FDA-approved
product, is a highly-pure, EPA-only, omega-3 fatty acid
product available by prescription in a 1-gram or 0.5-gram capsule
size. 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 company’s plans for the launch of
Vascepa 0.5-gram capsules and expectations on patient use and
preference. These forward-looking statements are not promises or
guarantees and involve substantial risks and uncertainties. There
can be no guarantee that this product launch will be a commercial
success. In particular, management's expectations regarding Vascepa
sales could be affected by, among other things, the uncertainties
inherent in the launch of variations of existing commercial
products; reliance on third parties and unexpected manufacturing,
safety or quality issues. A further list and description of these
risks and other uncertainties 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.
Amarin Contact Information:
Investor Relations:
Gene Mack
Investor Relations
Amarin Corporation plc
In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com
Lee M. Stern
Trout Group
In U.S.: +1 (646) 378-2922
lstern@troutgroup.com
Media Inquiries:
Kristie Kuhl
Finn Partners
In U.S.: +1 (212) 582-2791
kristie.kuhl@finnpartners.com
Amarin (NASDAQ:AMRN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Amarin (NASDAQ:AMRN)
Historical Stock Chart
From Sep 2023 to Sep 2024