Amarin Corporation plc (Nasdaq:AMRN) and Kowa Pharmaceuticals
America, Inc., two biopharmaceutical companies focused on the
development and commercialization of therapeutics to improve
cardiovascular health, today announced an agreement to co-promote
Amarin's flagship product, Vascepa® (icosapent ethyl) capsules, in
the United States. Vascepa is approved for use in the United
States as an adjunct to diet to reduce triglyceride levels in adult
patients with severe (≥ 500 mg/dL) hypertriglyceridemia. In
bringing together two companies focused on the primary care and
cardiovascular health communities, the agreement is designed to
benefit a greater number of patients.
The agreement provides for the near-term expansion of Vascepa
promotional efforts through use of Kowa Pharmaceuticals America's
sales force to substantially increase both the number of sales
targets reached and the frequency of sales calls on existing sales
targets. Under the agreement, Kowa Pharmaceuticals America will
employ its sales force of approximately 250 sales representatives
to co-promote Vascepa in the United States augmenting Amarin's
approximately 130 sales representatives and more than doubling
Amarin's current sales detail frequency through primary and
secondary details. Kowa Pharmaceuticals America's sales force is
expected to begin its Vascepa promotional efforts in May 2014 to
its existing target audience of primary care physicians and
cardiologists.
Kowa Pharmaceuticals America has a successful track record of
launching and commercializing drugs for the treatment of
cardiovascular disease in the United States, including its flagship
statin product, LIVALO® (pitavastatin). Kowa Pharmaceuticals
America's sales team calls on many of the same physicians who are
current and potential prescribers of Vascepa. The planned
expansion in Vascepa promotional effort under the co-promotion
agreement is expected to build on the significant base of progress
Amarin has made and to help expand the use of Vascepa for patients
in need.
Under the agreement, Kowa Pharmaceuticals America will pay for
certain incremental costs associated with the use of its sales
force that are associated with the commercialization of Vascepa,
such as sample costs and costs for promotional and marketing
materials. Each party has agreed to deliver specified
minimal primary detail equivalents and spend specified minimal
amounts on sample, promotional and marketing costs. Amarin's
commitments under the agreement are within its commercialization
plans prior to the agreement. Amarin will continue to control
marketing of the product and recognize all revenue from sales of
Vascepa. Amarin will compensate Kowa Pharmaceuticals America with a
co-promotion fee based on a percentage of Vascepa gross margins
that increase during the agreement's term, from the high single
digits in 2014 to the low twenty percent levels in 2018, subject to
certain adjustments. The initial term of the agreement extends
through 2018.
"With the support of Kowa Pharmaceuticals America, we anticipate
increasing the rate of Vascepa prescription and revenue growth as
together we help educate physicians regarding the use of Vascepa as
therapy for severe hypertriglyceridemia through promotion of its
highly favorable efficacy and safety profile," stated John F.
Thero, President and Chief Executive Officer of
Amarin. "Kowa's commercial reach and customer base make it a
valuable commercial partner for Amarin. Kowa Pharmaceuticals
America has a highly motivated and talented sales force that
complements Amarin's sales team and substantially increases its
reach into our target market. Kowa Pharmaceuticals America has
a strong and proven leadership team, a solidified presence in the
cardiovascular and lipid-lowering marketplace and a track record of
success. We look forward to a successful collaboration with
Kowa Pharmaceuticals America and to creating significant value for
both companies and their customers."
"Our goal has been to help physicians address patient-care
concerns by offering important medications and support programs,"
said Ben Stakely, Chief Executive Officer and President of Kowa
Pharmaceuticals America, Inc. "We have been very impressed
with Vascepa's favorable efficacy and safety profile and look
forward to working with Amarin to significantly expand Vascepa
promotional efforts in the United States. By entering into
this agreement with Amarin, we can now speak to a range of
important lipid-related issues that impact our target physicians'
practices. We are proud of our current portfolio and excited
about bringing new FDA-approved treatments, such as Vascepa, to
more patients in need. With its favorable efficacy and safety
profile, our team is excited about this opportunity to work with
Amarin to help maximize the value of Vascepa."
Vascepa commercialization progress
Vascepa was launched by Amarin in early 2013. Sales of
Vascepa in 2013 resulted in net revenues for Amarin of
approximately $26.4 million. Vascepa labeling reflects a spectrum
of favorable effects on lipid and lipoprotein parameters at 4
g/day, including statistically significant reductions in TG, Apo B,
VLDL-C, and non-HDL-C, with no increase in LDL-C, also known as bad
cholesterol, and a safety profile that is comparable to placebo.
The most common reported adverse reaction (incidence > 2% and
greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for
placebo). With the benefit of this clinical profile, Amarin made
significant progress throughout 2013 in multiple areas of the
Vascepa commercialization plan. Vascepa is now available on
formulary to over 200 million lives in the United States, including
over 100 million with Tier 2 coverage. The conversion of these
lives to Tier 2 status has helped enable Amarin to grow the Vascepa
prescriber base to over 16,000 physicians since launch.
About Vascepa® (icosapent ethyl)
capsules
Vascepa® (icosapent ethyl) capsules, known in scientific
literature as AMR101, is a highly pure-EPA omega-3
prescription product in a 1 gram capsule.
Indications 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 and should be used 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).
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
Vascepa has been approved for use by the 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 marketing 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.
Vascepa® (icosapent ethyl), Amarin's first FDA approved product, is
a patented, ultra pure omega-3 fatty acid product comprising not
less than 96% EPA. For more information about Vascepa visit
www.vascepa.com. For more information about Amarin visit
www.amarincorp.com.
About Kowa Company Ltd. and Kowa Pharmaceuticals
America, Inc.
Kowa Company, Ltd. (Kowa) is a privately held multinational
company headquartered in Nagoya, Japan. Established in 1894, Kowa
is actively engaged in various manufacturing and trading activities
in the fields of pharmaceutical, life science, information
technology, textiles, machinery and various consumer products.
Kowa's pharmaceutical division is focused on cardiovascular
therapeutics, with sales of the company's flagship product, LIVALO®
(pitavastatin) totaling ¥ 51 billion ($505 million*) in Japan
fiscal year ending March 2013, and was launched in the United
States in June 2010.
Kowa Pharmaceuticals America, Inc. is a cardiovascular and
primary care pharmaceutical company focused primarily in the area
of cardiology. The company started in 2001 as ProEthic
Pharmaceuticals, Inc., and a majority stake in the company was
acquired by Kowa Company, Ltd. in September 2008. A privately held
company, Kowa Pharmaceuticals America focuses its efforts on the
acquisition, licensing and marketing of pharmaceutical products.
For more information about Kowa Pharmaceuticals America, visit
www.kowapharma.com.
*exchange rate used 1USD = 102JPY
Forward-looking statements
This press release contains forward-looking statements,
including statements about the potential for increased prescription
and revenue growth from the sale of Vascepa in connection with the
co-promotion agreement; the efficacy, safety and therapeutic
benefits of Vascepa and the commercial success of Vascepa and the
co-promotion effort and agreement. These forward-looking statements
are not promises or guarantees and involve substantial risks and
uncertainties. In particular, the ability to effectively
commercialize Vascepa will depend in part on the ability to 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, and to maintain patent protection. Among the
factors that could cause actual results to differ materially from
those described or projected herein include the following:
uncertainties associated with new collaborations and the ability of
commercial partners to work together effectively to achieve
intended results; related cost may increasing beyond expectations;
and the risk that patent applications may not result in issued
patents. 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 Annual Report on
Form 10-K. 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://www.amarincorp.com/investor-splash.html), 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.
CONTACT: Amarin contact information:
Michael Farrell or Joseph Bruno
Amarin Corporation
In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com
Kowa Pharmaceuticals America, Inc. contact information:
Lisa Garman
Kowa Pharmaceuticals America, Inc.
Mobile: 334-296-1917
lgarman@kowapharma.com
Amarin (NASDAQ:AMRN)
Historical Stock Chart
From Apr 2024 to May 2024
Amarin (NASDAQ:AMRN)
Historical Stock Chart
From May 2023 to May 2024