Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company
focused on improving cardiovascular health, today provided a
business update, including that the company is increasing revenue
guidance for 2019 and planning to further increase its commercial
expansion efforts to align with its progress and outlook that the
realizable opportunity for Vascepa® (icosapent ethyl) is larger
than previously believed. These revised plans follow estimated
record revenues for the quarter ended June 30, 2019 and assume
expanded FDA labelling for Vascepa.
sNDA Update
As previously announced, Amarin submitted an
sNDA to the U.S. Food and Drug Administration (FDA) on March 28,
2019, seeking to expand the indication for Vascepa. The sNDA was
based on the positive results of the landmark REDUCE-IT™
cardiovascular outcomes study. If approved, the expanded label is
expected to allow for considerably broader promotion of Vascepa in
the United States. As announced in May 2019, the FDA accepted the
sNDA for filing and granted Priority Review designation with an
assigned PDUFA goal date of September 28, 2019.
The FDA grants Priority Review designation to
applications for drugs that, if approved, have the potential to
offer significant improvements in the effectiveness and safety of
the treatment of serious conditions when compared to standard
applications. Assuming the FDA approves this sNDA, Vascepa is
anticipated to be the first drug with an indication to reduce
residual cardiovascular risk in patients with statin-managed
LDL-cholesterol, but persistent elevated triglyceride (TG) levels,
an important indicator of cardiovascular disease. The results of
the REDUCE-IT study were published in The New England Journal of
Medicine in November 2018.1 Additional results and analysis of
total recurrent events observed in REDUCE-IT were published in the
Journal of American College of Cardiology in March 2019.2
Vascepa is currently indicated as an adjunct to
diet to reduce TG levels in adults with severe (TG ≥500 mg/dL)
hypertriglyceridemia, an important but much smaller patient
population than can be addressed with an approval of this sNDA.
To date, the FDA has not informed Amarin as to
whether it plans to convene an Advisory Committee meeting (AdCom)
to review the sNDA. As previously disclosed, Amarin continues
to prepare in the event that an AdCom is convened. If Amarin is
informed definitively that there will or will not be an AdCom, the
company plans to update investors accordingly.
Preliminary (Unaudited) First Half 2019 Financial
Results
Record Revenue Levels Achieved:
Net total revenue for the three and six months ended June 30, 2019
are estimated to have reached between $97 and $101 million and
between $170 and $174 million, respectively. Both the second
quarter and first half of 2019 results represent record revenue
levels for Amarin. These results, which are subject to
auditor review, represent an increase of approximately $44 to $48
million (approximately 84% to 92%) for the second quarter of 2019
over the corresponding period of 2018 and an increase of
approximately $73 to $77 million (approximately 76% to 80%) for the
first half of 2019 over the corresponding period of 2018.
These results consist predominantly of U.S. sales-driven increases
in prescriptions for Vascepa. Wholesaler inventory levels of
Vascepa were within normal industry ranges at the end June
2019.
Current Assets: Amarin ended
June 2019 with cash and cash equivalents of approximately $221
million (compared to $211 million at March 31, 2019), approximately
$94 million in net accounts receivable and approximately $47
million in inventory.
No Debt, Except Remaining Balance of
Royalty Bearing Instrument: Amarin ended June 2019 with no
debt except the remaining balance on its royalty bearing instrument
which is repaid at a rate of 10% of Vascepa revenues; aggregate
repayment of less than $74 million remains until this royalty-like
obligation is fully extinguished.
2019 Financial and Operational Guidance
Amarin initially provided guidance for 2019 in
its press release dated January 4, 2019. Amarin now makes the
following updates to that guidance:
2019 Revenue Guidance:
Forecasting Vascepa revenue levels at this early stage remains
difficult. Based on estimated total revenue results for the first
half of 2019 which exceeded prior expectations, Amarin increases
its guidance for 2019 net total revenue to a range of $380 to $420
million. While Amarin remains optimistic that Vascepa will generate
billions of dollars in revenue in the years to come, the history of
other therapies for chronic conditions suggests that growth builds
over multiple years, and thus, the company is not prepared to
provide quantified guidance regarding revenue levels beyond
2019.
Commercial Expansion in United
States: Amarin has accelerated and further expanded its
commercialization plans for Vascepa in the United States.
Amarin intends to increase the size of its U.S. sales force to
approximately 800 sales representatives with the aim of having its
expanded team hired, trained and deployed by October 2019. This
increase would represent a doubling of the size of Amarin’s current
sales force.
The timing of such expansion had been
accelerated in part due to the priority review designation of the
sNDA for Vascepa. Assuming label expansion for Vascepa on the
September 28, 2019 PDUFA date, Amarin expects to have educational
and promotional materials available by early October 2019 to
promote Vascepa based on the new label.
The size of the planned expansion reflects the
result of evaluations involving multiple contributing factors.
Previously Amarin had estimated the potential expansion of its
sales force to reach between 600 and 800 sales representatives and
for the expansion to potentially occur in phases. The decision to
expand the sales force to approximately 800 sales representatives
by October 2019 was based on new information including the
encouraging progress being made by sales representatives hired at
the start of 2019, positive feedback from physicians with deep
understanding of the REDUCE-IT data, additional data on the
commercial opportunity that exists in detailing physicians who have
not yet been educated about Vascepa and data suggesting that
education of healthcare professionals regarding Vascepa will be
improved if our sales representatives call on physicians with
greater frequency. As a reminder, in late 2018, Amarin hired,
trained and deployed 265 new and qualified sales representatives
within approximately three months after learning the results of
REDUCE-IT. At the time, more than 20,000 applications were received
for the 265 open sales positions. Based on this track record and
the robust results of Vascepa clinical trials, Amarin is confident
it can double its sales force to 800 sales representatives by
October 2019.
While Amarin is confident that expanding its
sales force will result in meaningful revenue growth beyond 2019,
the company’s revenue guidance for 2019 as described above
anticipates little incremental contribution in 2019 from these
newly hired sales representatives. Based on available data, it
typically requires multiple months for newly hired sales
representatives to become meaningfully productive particularly if
they are calling on healthcare professionals who also are new to
Vascepa, which will be the case for a large part of such sales
force expansion.
Amarin intends to support its expanded U.S. sales team with
multiple promotional and educational programs. All such initiatives
will be aimed at providing truthful and non-misleading information
to lead to improved patient care. Included in Amarin’s promotion
plans is a direct-to-consumer advertising campaign, subject to
review by the FDA’s Office of Prescription Drug Promotion (OPDP).
The company anticipates submitting proposed Vascepa advertisements
to OPDP in October 2019. Based on the timeline for other companies
getting consumer advertising reviewed by FDA following new
labelling, assuming new Vascepa labelling, launch of such branded
advertising is anticipated in the second quarter of 2020.
Plans for commercialization of Vascepa outside
of the United States remain unchanged, including intentions to
submit for regulatory approval of Vascepa in the European Union
near the end of 2019.
Comment from Amarin’s President and
CEO
“We are pleased with the progress made to date,
including the significant revenue growth we’ve achieved for
Vascepa,” commented John Thero, president and chief executive
officer of Amarin. “We anticipate Vascepa revenue growth to
accelerate further after label expansion approval and with a larger
sales team, and then again after we commence promotion of Vascepa
for cardiovascular risk reduction on television and through other
media. We are preparing for a robust launch of REDUCE-IT data with
the aim of helping physicians improve patient care for millions of
patients with residual cardiovascular risk after their cholesterol
is controlled, as identified by elevated triglycerides.”
About Amarin
Amarin Corporation plc. is a rapidly growing,
innovative pharmaceutical company focused on developing
therapeutics to improve cardiovascular health. Amarin’s product
development program leverages its extensive experience in
polyunsaturated fatty acids and lipid
science. Vascepa (icosapent ethyl) is Amarin's first
FDA-approved drug and is available by prescription in the United
States, Lebanon and the United Arab Emirates. Amarin’s commercial
partners are pursuing additional regulatory approvals for Vascepa
in Canada, China and the Middle East. For more information about
Amarin, visit www.amarincorp.com. About
REDUCE-IT™
REDUCE-IT1 was an 8,179-patient multinational
cardiovascular outcomes study completed in 2018. REDUCE-IT
evaluated the effect of prescription pure EPA therapy as an add-on
to statins in patients with high cardiovascular risk who, despite
stable statin therapy, had elevated triglyceride levels (at least
135 mg/dL). A large portion of the male and female patients
enrolled in this outcomes study were diagnosed with type 2
diabetes.
More information on the REDUCE-IT study results can be found
at www.amarincorp.com.
About Cardiovascular Disease
Worldwide, cardiovascular disease (CVD) remains
the #1 killer of men and women. In the United States CVD leads to
one in every three deaths – one death approximately every 38
seconds – with annual treatment cost in excess of $500 billion.3,
4
Multiple primary and secondary
prevention trials have shown a significant reduction of 25% to
35% in the risk of cardiovascular
events with statin therapy, leaving significant
persistent residual risk despite the achievement of target LDL-C
levels.5
Beyond the cardiovascular risk associated with
LDL-C, genetic, epidemiologic, clinical and real-world data suggest
that patients with elevated triglycerides (TG) (fats in the blood),
and TG-rich lipoproteins, are at increased risk for cardiovascular
disease.6-9
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 from degradation. 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.
Indication and Usage Based on Current FDA-Approved Label (not
including REDUCE-IT results)
- 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 Based on
Current FDA-Approved Label (not including REDUCE-IT
results) (Includes Data from Two 12-Week Studies (n=622)
(MARINE and ANCHOR) of Patients with Triglycerides Values of 200 to
2000 mg/dL)
- Vascepa is contraindicated in patients with known
hypersensitivity (e.g., anaphylactic reaction)
to Vascepa or any of its components.
- In patients with hepatic impairment, monitor ALT and AST levels
periodically during therapy.
- 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.
- Adverse events and product complaints may be reported by
calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
- Patients receiving treatment with Vascepa and other
drugs affecting coagulation (e.g., anti-platelet agents) should be
monitored periodically.
- Patients should be advised to
swallow Vascepa capsules whole; not to break open, crush,
dissolve, or chew Vascepa.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
Important Safety Information for Vascepa based on
REDUCE-IT, as previously reported in The New England
Journal of Medicine1 publication of the primary results of the
REDUCE-IT study:
- Excluding the major adverse cardiovascular events (MACE)
results described above, overall adverse event rates in REDUCE-IT
were similar across the statin plus Vascepa and the
statin plus placebo treatment groups.
- There were no significant differences between treatments in the
overall rate of treatment emergent adverse events or serious
adverse events leading to withdrawal of study drug.
- There was no serious adverse event (SAE) occurring at a
frequency of >2% which occurred at a numerically higher rate in
the statin plus Vascepa treatment group than in the
statin plus placebo treatment group.
- Adverse events (AEs) occurring in 5% or greater of patients and
more frequently with Vascepa than placebo were: –
peripheral edema (6.5% Vascepa patients versus 5.0%
placebo patients), although there was no increase in the rate of
heart failure in Vascepa patients – constipation
(5.4% Vascepa patients versus 3.6% placebo patients),
although mineral oil, as used as placebo, is known to lower
constipation, and – atrial fibrillation
(5.3% Vascepa patients versus 3.9% placebo patients),
although there were reductions in rates of cardiac arrest, sudden
death and myocardial infarctions observed
in Vascepa patients
- There were numerically more SAEs related to bleeding in the
statin plus Vascepa treatment group although overall
rates were low with no fatal bleeding observed in either group and
no significant difference in adjudicated hemorrhagic stroke or
serious central nervous system or gastrointestinal bleeding events
between treatments.
- In summary, Vascepa was well tolerated with a safety
profile generally consistent with clinical experience associated
with omega-3 fatty acids and current FDA-approved labeling of such
products.
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. FDA has not reviewed and opined
on a supplemental new drug application related to REDUCE-IT. FDA
has not reviewed the information herein or determined whether to
approve Vascepa for use to reduce the risk of MACE.
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.
Important Cautionary Information About
These Data
Further REDUCE-IT data assessment and data
release could yield additional useful information to inform greater
understanding of the trial outcome. For example, detailed data
assessment by regulatory authorities, such as the FDA and
Health Canada, will continue and take several months to complete
and announce. The final evaluation by regulatory authorities of the
totality of efficacy and safety data from REDUCE-IT may include
some or all of the following, as well as other considerations: new
information or analyses affecting the degree of treatment benefit
on studied endpoints; study conduct and data robustness, quality,
integrity and consistency; additional safety data considerations
and risk/benefit considerations; and consideration of REDUCE-IT
results in the context of other clinical studies. Because
regulatory reviews are typically fluid and not definitive
interactions between sponsor and agency on individual elements of
an application and related information, Amarin does not plan to
update investors on ongoing communications with regulatory
authorities. Amarin plans to announce the final outcome of such
regulatory reviews when appropriate.
Recurrent event analyses for the total primary
endpoint events and for the total key secondary endpoint in
REDUCE-IT as published in the Journal of the American College
of Cardiology were conducted using a series of statistical
models. These analyses were tertiary or exploratory endpoints; most
of the models used were prespecified and one
was post hoc. Each recurrent event statistical model has
inherent strengths and weaknesses, with no single model considered
definitive or outperforming the other models, and this is an
evolving field of science. Nonetheless, results from the total
primary and total key secondary endpoint events analyses are
consistent across the various recurrent event statistical models
and are also consistent with the original primary and secondary
endpoint results. Together, the REDUCE-IT recurrent event analyses
and the original primary and key secondary endpoint analyses
support the robustness of the clinical benefit
of Vascepa therapy in reducing cardiovascular risk.
Forward-Looking Statements
This press release contains forward-looking
statements, including expectations regarding revenue and
prescription growth, including updated revenue guidance for 2019;
sales force expansion and marketing initiatives expected in 2019
and beyond; FDA regulatory review, including the timing and outcome
of such review; the applicability and reliability of REDUCE-IT
results; and the expected outcome and timing of review elements and
market dynamics for Vascepa. These forward-looking
statements are not promises or guarantees and involve substantial
risks and uncertainties. In addition, Amarin's ability to
effectively commercialize Vascepa will depend in part on
its ability to continue to effectively finance its business,
efforts of third parties, its ability to gain regulatory approvals,
create market demand for Vascepa through education,
marketing and sales activities, to achieve 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
reviews and approvals; the risk that sales may not meet
expectations and related cost may increase beyond expectations; the
risk that patents may not be upheld in patent litigation and
applications may not result in issued patents sufficient to protect
the Vascepa franchise. 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 (www.amarincorp.com), the investor relations website
(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.
References |
|
|
1 |
Bhatt DL, Steg PG, Miller M, et
al. Cardiovascular Risk Reduction with Icosapent Ethyl for
Hypertriglyceridemia. N Engl J Med 2019;380:11-22. |
2 |
Bhatt DL, Steg PG, Miller M, et
al. Effects of Icosapent Ethyl on Total Ischemic Events: From
REDUCE-IT. J Am Coll Cardiol 2019;73(22):2791-2802. |
3 |
American Heart Association. 2018.
Disease and Stroke Statistics-2018 Update. |
4 |
American Heart Association. 2017.
Cardiovascular disease: A costly burden for America projections
through 2035. |
5 |
Ganda OP, Bhatt DL, Mason RP, et
al. Unmet need for adjunctive dyslipidemia therapy in
hypertriglyceridemia management. J Am Coll Cardiol.
2018;72(3):330-343. |
6 |
Budoff M. Triglycerides and
triglyceride-rich lipoproteins in the causal pathway of
cardiovascular disease. Am J Cardiol. 2016;118:138-145. |
7 |
Toth PP, Granowitz C, Hull M, et
al. High triglycerides are associated with increased cardiovascular
events, medical costs, and resource use: A real-world
administrative claims analysis of statin-treated patients with high
residual cardiovascular risk. J Am Heart
Assoc. 2018;7(15):e008740. |
8 |
Nordestgaard BG.
Triglyceride-rich lipoproteins and atherosclerotic cardiovascular
disease - New insights from epidemiology, genetics, and
biology. Circ Res. 2016;118:547-563. |
9 |
Nordestgaard BG, Varbo A.
Triglycerides and cardiovascular
disease. Lancet. 2014;384:626–635. |
Amarin Contact Information
Investor Relations: Elisabeth Schwartz Investor Relations Amarin
Corporation plc In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com (investor
inquiries)
Media Inquiries: Gwen Fisher Corporate Communications Amarin
Corporation plc In U.S.: +1 (908) 325-0735
pr@amarincorp.com
Lee M. Stern Solebury Trout In U.S.: +1 (646)
378-2992lstern@soleburytrout.com
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