Amarin Appoints Mark W. Salyer to New Position of Chief Commercial Officer
September 13 2017 - 6:00AM
Amarin Corporation plc (NASDAQ:AMRN) today announced that Mark W.
Salyer has joined Amarin as Chief Commercial Officer. In this newly
created position, Mr. Salyer will work to build on the company’s
recent revenue growth and lead future global commercial expansion
plans and execution, particularly related to the anticipated
landmark REDUCE-IT cardiovascular outcomes trial results. Mr.
Salyer has broad U.S. and international experience helping to grow
commercial operations and revenue at both large and small
companies. He has managed highly successful business units and
launched multiple industry-leading brands.
"Mark brings a strong track record of success coupled with
valuable experience and proven leadership to our management team to
help drive our anticipated expansion,” said John F. Thero,
President and Chief Executive Officer of Amarin. “We expect Mark’s
driven, people-oriented, hands-on approach to work well with our
existing commercial organization to help build on our growth.
Amarin remains on track to reach record product revenues of
$165 to $175 million in 2017. The timing of Mark’s
appointment as CCO aligns with our anticipation of results from the
important REDUCE-IT cardiovascular outcomes trial expected in Q2 or
Q3 of 2018.”
Most recently, Mr. Salyer was at Teva Pharmaceuticals as
Executive Vice President and General Manager of Teva Respiratory,
LLC. At Teva, he guided the formation of this branded products
division. Under Mr. Salyer’s leadership, the division grew
consistently for more than 10 years to revenue exceeding $1
billion, propelling Teva to among the leaders of the respiratory
market. Prior to Teva, Mr. Salyer held senior level commercial
positions at Glaxo SmithKline and Altana Pharma AG, where he
successfully led commercial growth at each organization. Mr.
Salyer holds a B.S. from Virginia Tech and an M.B.A. from Duke
University’s Fuqua School of Business, and is a CPA.
“I am delighted to join Amarin at this exciting time,” said Mr.
Salyer. “I am impressed by the opportunity presented by
Vascepa® and by the people I’ve met at Amarin. Amarin’s
success to date is undisputable and the future holds substantial
opportunities for even greater growth, in particular with the
potentially game-changing REDUCE-IT cardiovascular trial results
forthcoming. The opportunity to lead the commercial team at a
company on the cusp of an anticipated new frontier in preventive
cardiovascular therapy was too compelling an opportunity to not
seize, especially given the staggering mortality, morbidity and
costs of care among the affected patient population.”
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 also 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. 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.
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 cardiovascular 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.
Forward-looking statements
This press release contains forward-looking statements,
including expectations for continued commercial growth and revenue
levels, results and related timing and announcements with respect
to Amarin's REDUCE-IT cardiovascular outcomes study; expectations
related to the final outcomes of the REDUCE-IT study and the
anticipated successful completion of the REDUCE-IT study; and
statements regarding the potential and therapeutic benefits of
Vascepa and the significance of patents. 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 regulatory reviews
may alter current expectations; 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 adequately protect
Vascepa against competition. 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.
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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