Amarin Partner HLS Therapeutics Completes Reimbursement Negotiations with Pan-Canadian Pharmaceutical Alliance (pCPA) for VASCEPA® (icosapent ethyl)
April 26 2022 - 8:49AM
Amarin Corporation plc (NASDAQ:AMRN) announced today its partner
HLS Therapeutics has completed negotiations with Canada’s
pan-Canadian Pharmaceutical Alliance (pCPA) for the terms and
conditions under which VASCEPA® (icosapent ethyl) would qualify for
public market reimbursement in Canada. Following these
negotiations, HLS has signed a Letter of Intent (LOI) which allows
HLS to work with all participating provincial jurisdictions to
secure coverage from publicly funded drug plans across Canada, and
for VASCEPA to potentially be added to their respective plans.
"The completion of pCPA’s assessment regarding
reimbursement represents an important milestone towards advancing
the potential reach of therapies across Canada,” said Karim
Mikhail, president & chief executive officer, Amarin
Corporation. “We look forward to continued efforts to secure
coverage across the various Canadian jurisdictions, which would
significantly increase access to VASCEPA for statin-treated
patients with established cardiovascular disease and elevated
triglycerides across Canada.”
In September 2017, Amarin and HLS Therapeutics
entered into an exclusive commercialization agreement between the
parties to register, commercialize and distribute VASCEPA capsules
in Canada. Under the agreement, HLS is responsible for regulatory
and commercialization activities and associated costs. Amarin is
responsible for providing assistance towards local filings,
supplying finished product and maintaining intellectual property.
Prior to the study’s completion, Amarin had also been responsible
for continuing the development and funding of REDUCE-IT®. Terms of
the agreement include up-front and milestone payments to Amarin of
up to US$65.0 million. These payments include a non-refundable
upfront payment of US$5.0 million, which Amarin received when the
agreement was reached, as well as development, regulatory and
sale-based milestones totaling up to an additional US$60.0 million.
The agreement also provides for HLS to pay Amarin tiered double
digit royalties on net sales of VASCEPA in Canada. Amarin is
obligated to supply finished product to HLS under negotiated supply
terms. The agreement for supply and commercialization is for Canada
only and includes all Canadian provinces.
About Amarin Amarin is an innovative
pharmaceutical company leading a new paradigm in cardiovascular
disease management. From our foundation in scientific research to
our focus on clinical trials, and now our commercial expansion, we
are evolving and growing rapidly. Amarin has offices in
Bridgewater, New Jersey in the United States, Dublin in Ireland,
Zug in Switzerland, and other countries in Europe as well as
commercial partners and suppliers around the world. We are
committed to increasing the scientific understanding of the
cardiovascular risk that persists beyond traditional therapies and
advancing the treatment of that risk.
About VASCEPA® (icosapent ethyl)
CapsulesVASCEPA (icosapent ethyl) capsules are the
first-and-only prescription treatment approved by the U.S. Food and
Drug Administration (FDA) comprised solely of the active
ingredient, icosapent ethyl (IPE), a unique form of
eicosapentaenoic acid. VASCEPA was launched in the United States in
January 2020 as the first and only drug approved by the U.S. FDA
for treatment of the studied high-risk patients with persistent
cardiovascular risk after statin therapy. VASCEPA was initially
launched in the United States in 2013 based on the drug’s initial
FDA approved indication for use as an adjunct therapy to diet to
reduce triglyceride levels in adult patients with severe (≥500
mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been
prescribed over ten million times. VASCEPA is covered by most major
medical insurance plans. In addition to the United States, VASCEPA
is approved and sold in Canada, Lebanon and the United Arab
Emirates. In Europe, in March 2021 marketing authorization was
granted to icosapent ethyl in the European Union for the reduction
of risk of cardiovascular events in patients at high cardiovascular
risk, under the brand name VAZKEPA®.
Indications and Limitation of Use (in the United
States)
VASCEPA is indicated:
- As an adjunct to maximally tolerated
statin therapy to reduce the risk of myocardial infarction, stroke,
coronary revascularization and unstable angina requiring
hospitalization in adult patients with elevated triglyceride (TG)
levels (≥ 150 mg/dL) and
- established
cardiovascular disease or
- diabetes mellitus
and two or more additional risk factors for cardiovascular
disease.
- As an adjunct to diet to reduce TG
levels in adult patients with severe (≥ 500 mg/dL)
hypertriglyceridemia.
The effect of VASCEPA on the risk for pancreatitis in patients
with severe hypertriglyceridemia has not been determined.
Important Safety Information
- VASCEPA is contraindicated in patients
with known hypersensitivity (e.g., anaphylactic reaction) to
VASCEPA or any of its components.
- VASCEPA was associated with an
increased risk (3% vs 2%) of atrial fibrillation or atrial flutter
requiring hospitalization in a double-blind, placebo-controlled
trial. The incidence of atrial fibrillation was greater in patients
with a previous history of atrial fibrillation or atrial
flutter.
- It is not known whether patients with
allergies to fish and/or shellfish are at an increased risk of an
allergic reaction to VASCEPA. Patients with such allergies should
discontinue VASCEPA if any reactions occur.
- VASCEPA was associated with an
increased risk (12% vs 10%) of bleeding in a double-blind,
placebo-controlled trial. The incidence of bleeding was greater in
patients receiving concomitant antithrombotic medications, such as
aspirin, clopidogrel or warfarin.
- Common adverse reactions in the
cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent
than placebo): musculoskeletal pain (4% vs 3%), peripheral edema
(7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial
fibrillation (5% vs 4%).
- Common adverse reactions in the
hypertriglyceridemia trials (incidence >1% more frequent than
placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs
0.3%).
- Adverse events may be reported by
calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
- Patients receiving VASCEPA and
concomitant anticoagulants and/or anti-platelet agents should be
monitored for bleeding.
FULL U.S. FDA-APPROVED VASCEPA
PRESCRIBING INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
Forward-Looking StatementsThis press release
contains forward-looking statements which are made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995, including beliefs about the potential for VASCEPA
(marketed as VAZKEPA in Europe); beliefs about icosapent ethyl
(IPE)’s role concerning patients suffering from cardiovascular
disease (CVD) and impacts on the risk of heart attack, stroke or
other fatal or non-fatal cardiovascular events for patients who
suffered a prior heart attack, as well as general beliefs about the
safety and effectiveness of VASCEPA. These forward-looking
statements are not promises or guarantees and involve substantial
risks and uncertainties. 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 Amarin’s annual report on Form
10-K for the full year ended 2021. Existing and prospective
investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date they
are made. Amarin undertakes no obligation to update or revise the
information contained in its forward-looking statements, whether as
a result of new information, future events or circumstances or
otherwise. Amarin’s forward-looking statements do not reflect the
potential impact of significant transactions the company may enter
into, such as mergers, acquisitions, dispositions, joint ventures
or any material agreements that Amarin may enter into, amend or
terminate. Availability of Other Information About Amarin
communicates with its investors and the public using the company
website (www.amarincorp.com) and the investor relations website
(investor.amarincorp.com), including but not limited to investor
presentations, 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 Inquiries:
Investor Relations Amarin Corporation plc In U.S.: +1 (908)
719-1315 IR@amarincorp.com (investor inquiries)
Media Inquiries: Communications Amarin Corporation plc In U.S.:
+1 (973) 906-1526PR@amarincorp.com (media inquiries)
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