Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical
company focused on the commercialization and development of
therapeutics, today announced that a clinical trial
of Vascepa® (icosapent ethyl) capsules in a patient
population with severe hypertriglyceridemia (TG ≥500 mg/dL)
has been commenced in Mainland China, or China, by Amarin's
partner, Eddingpharm. Under the
parties' February 2015 agreement, Eddingpharm is
responsible for Vascepa
development, regulatory activities,
commercialization and associated costs, including
managing and funding this
pivotal registration study.
Similar to the MARINE trial conducted by Amarin,
the trial being conducted by Eddingpharm in China is a
multi-center, placebo-controlled, randomized, double-blind, 12-week
study that is enrolling patients with severe hypertriglyceridemia,
more commonly known as very high triglycerides, or VHTG. The
study’s primary endpoint is the percentage change in triglyceride
levels from baseline compared to placebo after 12 weeks of
treatment. Eddingpharm anticipates that the study will be completed
within the next two years. This clinical trial puts Vascepa
on track to be the first ever pure prescription grade EPA based
drug product in China. The parties believe the commercial
opportunity in China is largely based on the prevalence of
hypertriglyceridemia, which is estimated to affect around 17.7%1 of
the adult Chinese population, about 185 million people.2
In November 2010, Amarin reported top-line
results for the MARINE trial which met its primary and other key
efficacy endpoints. The MARINE trial demonstrated that Vascepa
4g/day significantly lowered triglycerides by 33% compared to
placebo without increasing LDL-C (non-significant decrease of 2%
vs. placebo). In addition, Vascepa demonstrated a statistically
significant decrease compared to placebo in multiple other
important lipid biomarkers in MARINE including non-high-density
lipoprotein cholesterol (non-HDL-C), apolipoprotein B (apo B),
lipoprotein-phospholipase A2 (Lp-PLA2), very low-density
lipoprotein cholesterol (VLDL-C), total cholesterol (TC) and the
inflammatory marker high-sensitivity C-reactive protein
(hsCRP).
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. Amarin's clinical program
includes a commitment to an ongoing outcomes study. Vascepa®
(icosapent ethyl), Amarin's first FDA approved product, is a
highly-pure, omega-3 fatty acid product available by
prescription. For more information about Vascepa visit
www.vascepa.com. For more information about Amarin visit
www.amarincorp.com.
About Eddingpharm
Eddingpharm is a fast-growing Chinese specialty
pharmaceutical company, committed to bringing to the Chinese
healthcare market high-quality medicines from all over the world,
providing patients with more treatment options and better
healthcare opportunities. Eddingpharm promotes the communication
and collaboration between Chinese clinical experts and leading
international medical research institutes, and provides academic
support to Chinese clinical doctors. Eddingpharm has a strong
footprint in top tier cities – the core healthcare market in China
– and is growing rapidly in lower tier cities. Eddingpharm’s wide
and expanding coverage includes more than 17,000 hospitals and
15,000 pharmacies in 30 provinces with a sales force of over 1,000
professional personnel. Eddingpharm has successfully expanded its
product portfolio through in-licensing, joint ventures, strategic
alliances, exclusive distribution, and other forms of collaboration
with multinational pharmaceutical companies, specialty
pharmaceutical companies, and biotech companies in the US and
Europe. For more information, visit www.eddingpharm.com
About VASCEPA® (icosapent ethyl)
capsules
Vascepa® (icosapent ethyl) capsules are a
single-molecule prescription product consisting 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. Amarin has been issued multiple patents
internationally based on the unique clinical profile of Vascepa,
including the drug’s ability to lower triglyceride levels in
relevant patient populations without raising LDL-cholesterol
levels.
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.
Vascepa has been approved for use by the United
States Food and Drug Administration (FDA) as an adjunct to diet to
reduce triglyceride levels in adult patients with severe (≥500
mg/dL) hypertriglyceridemia. 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.
Forward-looking statements
This press release contains forward-looking
statements, including statements about the potential for successful
development and commercialization of Vascepa in China; the
efficacy, safety and therapeutic benefits of Vascepa and the
commercial success of the collaboration effort and agreement; and
the potential and timing for regulatory approvals and commercial
opportunities that may result therefrom. 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 the ability to effectively commercialize Vascepa
will depend in part on the ability to clinically develop Vascepa in
China successfully, obtain necessary regulatory approvals, create
market demand for Vascepa through education, marketing and sales
activities, achieve market acceptance of Vascepa, receive adequate
levels of reimbursement from third-party payers, develop and
maintain a consistent source of commercial supply at a competitive
price, and maintain patent and exclusivity protection. Other
factors include uncertainties associated with clinical trials,
regulatory reviews, commercial success, new collaborations and the
ability of commercial partners to work together effectively to
achieve intended results. 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 Amarin
communicates with its investors and the public using the company
website (http://www.amarincorp.com/), the investor relations
website (http://investor.amarincorp.com/), 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 Amarin posts on
these channels and websites could be deemed to be material
information. As a result, Amarin encourages investors, the
media, and others interested in Amarin to review the information
that is posted on these channels, including the investor relations
website, on a regular basis. This list of channels may be
updated from time to time on Amarin’s investor relations website
and may include social media channels. The contents of
Amarin’s website or these channels, or any other website that may
be accessed from its website or these channels, shall not be deemed
incorporated by reference in any filing under the Securities Act of
1933.
References:
1) Huang et al. Population Health Metrics 2014, 12:282) Derived
from China National Bureau of Statistics, 2010,
http://www.stats.gov.cn/tjsj/pcsj/rkpc/6rp/indexch.htm
Amarin contact information:
Investor Relations:Elisabeth Schwartz Investor
Relations and Corporate Communications Amarin Corporation plc
In U.S.: +1 (908) 719-1315 investor.relations@amarincorp.com
Lee M. Stern Trout Group In U.S.: +1 (646) 378-2992
lstern@troutgroup.com
Media Inquiries: Kristie Kuhl Finn Partners
In U.S.: +1 (212) 583-2791 Kristie.kuhl@finnpartners.com
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