Amarin Corporation plc (NASDAQ:AMRN) and HLS Therapeutics Inc.
(“HLS”), announced today an exclusive agreement between the parties
to register, commercialize and distribute Vascepa® (icosapent
ethyl) capsules in Canada. Amarin and HLS anticipate submitting an
application to Canadian regulatory authorities to seek approval to
commercialize Vascepa in Canada.
“We are excited to enter into a collaboration
with HLS to seek regulatory approval and commercialize Vascepa in
Canada,” stated John F. Thero, president and chief executive
officer of Amarin. “The proven track record of HLS’s leadership in
commercializing pharmaceutical products in Canada, along with our
shared vision and commitment, bestow confidence that we will
provide Vascepa as a treatment option for millions of
Canadians.”
“HLS is delighted to work with Amarin, as we
expect Vascepa to be the first highly pure, omega-3 fatty
acid product available by prescription in Canada,” stated
Greg Gubitz, chief executive officer of HLS Therapeutics. “Amarin’s
$200+ million cardiovascular outcomes study, REDUCE-IT, has a
significant number of Canadian key opinion leaders and clinical
sites involved. As cardiovascular disease is the number one killer
in the world1, HLS is proud to be associated with Amarin’s mission
to improve cardiovascular health.”
Heart disease is a leading cause of death in
Canada1. Twenty-five percent of Canadians have high triglycerides2,
a key comorbidity associated with cardiovascular disease, and about
2.4 million Canadians live with heart disease3. HLS and Amarin
believe Vascepa has the potential to become an important part of
the physician’s armamentarium in the treatment of the millions of
Canadians dealing with these conditions.
Under the agreement, HLS will be responsible for
regulatory and commercialization activities and associated costs.
Amarin is responsible for providing assistance towards local
filings, supplying finished product, maintaining intellectual
property and 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, 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 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. Vascepa is under various stages of
development for potential use in other indications that have not
been approved by the FDA. Vascepa is not approved for use in
Canada. Nothing in this press release should be construed as
promoting the use of Vascepa where not approved.
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 HLS Therapeutics
HLS Therapeutics Inc. is a specialty pharmaceutical company
acquiring and distributing commercial stage and legacy, branded
pharmaceutical drugs for the North American markets. HLS’s
management team is comprised of seasoned pharmaceutical executives
with a strong track record of success. Building on the expertise of
the founders, HLS is focused on treatment products for the central
nervous system, and cardiovascular specialties. For more
information about HLS, visit
www.hlstherapeutics.com.
Forward-looking statements
This press release contains forward-looking statements,
including expectations regarding regulatory submissions and
approvals and commercialization of Vascepa in Canada, as well as
timing related thereto; future expectation regarding timing and
continuation of Amarin's REDUCE-IT cardiovascular outcomes study;
statements regarding the potential and therapeutic benefits of
Vascepa; and potential milestone and other payments to be paid to
Amarin, an obligation of Amarin, under this agreement. These
forward-looking statements are not promises or guarantees and
involve substantial risks and uncertainties. In particular, as
disclosed in filings with the U.S. Securities and Exchange
Commission, Amarin's ability to effectively develop and
commercialize Vascepa will depend in part on its ability to
continue to effectively finance its business, efforts of third
parties, its ability to create market demand for Vascepa through
education, marketing and sales activities, to achieve increased
market acceptance of Vascepa, to receive adequate levels of
reimbursement from third-party payers, to develop and maintain a
consistent source of commercial supply at a competitive price, to
comply with legal and regulatory requirements in connection with
the sale and promotion of Vascepa and to maintain patent protection
for Vascepa. Among the factors that could cause actual results to
differ materially from those described or projected herein include
the following: uncertainties associated generally with research and
development, clinical trials and related regulatory approvals; the
risk that clinical data and regulatory reviews may alter current
expectations related to anticipated prospects for approval; the
risk that future legal determinations and interactions with
regulatory authorities may impact Vascepa marketing and sales
rights and efforts; the risk that Vascepa may not show clinically
meaningful effects in REDUCE-IT or support regulatory approvals for
cardiovascular risk reduction; and the risk that patents may not be
obtained or upheld in patent litigation. 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 we communicate with our
investors and the public using our company website
(www.amarincorp.com), our 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 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.
References
1 https://www.medpagetoday.com/PublicHealthPolicy/PublicHealth/67946?xid=nl_mpt_DHE_2017-09-16&eun=g811140d0r&pos=0
2
http://www.statcan.gc.ca/pub/82-625-x/2010001/article/11136-eng.htm3
https://www.canada.ca/en/public-health/services/diseases/heart-disease-heart-health.html
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: Ovidio Torres Finn Partners In U.S.: +1 (312)
329 3911 Ovidio.torres@finnpartners.com
HLS contact information:
Business and Media Contact: Gilbert Godin, President & COO
Email: g.godin@hlstherapeutics.com Phone: +1 (484)
232-3400 ext101
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