Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical
company focused on the commercialization and development of
therapeutics to improve cardiovascular health, along with Biologix
FZCo, a company based in the United Arab Emirates and a pioneer in
the distribution of pharmaceutical and biological products in the
Middle East and North Africa, today announced that the Ministry of
Public Health in Lebanon has approved Vascepa® (icosapent ethyl)
capsules as a prescription medication for use in Lebanon as an
adjunct to diet to reduce triglyceride (TG) levels in adult
patients with severe (TG > 500 mg/dL) hypertriglyceridemia. This
approval is a result of the collaborative effort by the parties
since the start of their 2016 agreement to register and
commercialize Vascepa in multiple countries in the Middle East and
North Africa (MENA) region.
“We are excited that patients in Lebanon will
have the opportunity to benefit from Vascepa,” said John F. Thero,
president and chief executive officer of Amarin. “Biologix, our
distribution partner for the MENA region, is demonstrating its
expertise in gaining regulatory approvals for innovative products
and will now begin using its experience to promote appropriate use
of Vascepa. We hope that this will be the first of a series of
anticipated approvals to be received for Vascepa outside the United
States.”
The approval of Vascepa in Lebanon is the first of a series of
anticipated approvals for Vascepa in the MENA region. While
the timing of additional approvals is difficult to predict given
the varied regulatory processes in each country, additional
approvals for Vascepa by other countries in the MENA region are
possible in 2018 with additional approvals to follow. The
revenue potential for Vascepa outside the United States is
anticipated to be relatively modest until Vascepa is approved in
additional countries.
Under the agreement, Biologix is responsible for
registering Vascepa in the licensed territory, as well as providing
all marketing, sales, and distribution services for the product.
Amarin is responsible for providing regulatory assistance, supply
and maintaining intellectual property in the region.
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 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 Biologix FZCo
Biologix FZCO (Biologix) is a leading promoter
and distributor of Biotech products in the MENA region, based in
Dubai, UAE. The company was founded in 2002 by Lebanese nationals
and is serviced by Algorithm, a leading Lebanon based,
pharmaceutical manufacturers company that has operations across the
Middle East and North Africa. Biologix offers regulatory,
medical, marketing, sales and distribution support to its partners
with a direct presence in 17 countries of the Middle East and North
Africa including Saudi Arabia, UAE, Kuwait, Bahrain, Oman, Qatar,
Yemen, Iran, Iraq, Lebanon, Jordan, Egypt, Libya, Tunisia, Algeria,
Syria and Morocco. Biologix focuses on the following therapeutics
areas: oncology-hematology, cardio-metabolic, neurology, rare
diseases and pain & inflammation.
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, known in scientific literature as
AMR101, has been designated a new chemical entity by the FDA.
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 the MENA region;
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 and in other territories
outside the United States. 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,
including the ability to effectively commercialize Vascepa, will
depend in part on the parties’ ability to obtain necessary
regulatory approvals in the MENA region, 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 Annual Report on
Form 10-K. 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.
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.comMedia Inquiries: Kristie Kuhl Finn Partners
In U.S.: +1 (212) 583-2791 Kristie.kuhl@finnpartners.com
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