Amarin Announces Patent Litigation Settlement Agreement with Teva
May 24 2018 - 04:35PM
Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical
company focused on the commercialization and development of
therapeutics to improve cardiovascular health, announced today
a settlement agreement with Teva Pharmaceuticals USA, Inc. (Teva)
that resolves Amarin’s previously reported Vascepa® (icosapent
ethyl) patent litigation as it relates to Teva’s abbreviated new
drug application seeking U.S. Food and Drug Administration (FDA)
approval of generic forms of Vascepa (icosapent ethyl) capsules.
This patent litigation continues in the United States District
Court for the District of Nevada with parties West-Ward
Pharmaceuticals Corp. and Dr. Reddy’s Laboratories, Inc. and their
affiliated entities.
“We are delighted to announce this settlement
with Teva as it reinforces our confidence in Amarin’s patent
portfolio and allows us to avoid the incremental litigation expense
and distraction associated with Teva’s participation,” said John F.
Thero, president and chief executive officer of Amarin.
In the lawsuit, Amarin alleges that the generic
forms of Vascepa adverse parties seek to market in the United
States infringe upon multiple issued patents owned by Amarin. As
part of the settlement agreement, Teva may first begin selling its
generic version of Vascepa in the United States on August 9, 2029,
or earlier under certain customary circumstances. The agreement is
subject to a required review by the U.S. Federal Trade Commission
and the U.S. Department of Justice.
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 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 related to Amarin’s patents and its confidence they will
adequately protect Vascepa against generic competition. 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 herein include the following: events that could interfere
with the continued validity or enforceability of a patent; and
Amarin's ability generally to maintain adequate patent protection
and successfully enforce patent claims against third parties. 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.
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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