Market Snapshot
  • U.S.
  • Europe
  • Asia
Ticker Volume Price Price Delta
DJIA 16,408.54 -16.31 -0.10%
S&P 500 1,864.85 2.54 0.14%
NASDAQ 4,095.52 9.29 0.23%
Ticker Volume Price Price Delta
STOXX 50 3,155.81 16.55 0.53%
FTSE 100 6,625.25 41.08 0.62%
DAX 9,409.71 91.89 0.99%
Ticker Volume Price Price Delta
NIKKEI 14,417.53 -0.15 -0.00%
TOPIX 1,166.59 0.04 0.00%
HANG SENG 22,760.24 64.23 0.28%

Amarin Announces Approval of Supplemental New Drug Application for Chemport as Additional Vascepa(R) Active Pharmaceutical



Amarin Announces Approval of Supplemental New Drug Application for Chemport as
Additional Vascepa(R) Active Pharmaceutical Ingredient Supplier

BEDMINSTER, N.J. and DUBLIN, Ireland, April 18, 2013 (GLOBE NEWSWIRE) --
Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on
the commercialization and development of therapeutics to improve
cardiovascular health, announced today the approval of the Supplemental New
Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to add
Chemport, Inc. as an additional Vascepa® (icosapent ethyl) active
pharmaceutical ingredient (API) supplier.

"This sNDA approval of Chemport as a supplier of Vascepa marks another
significant step for Amarin toward the goal of expanding our global supply
chain to support expected Vascepa demand, diversify our supply base, and
ensure cost-efficient supply," stated Joseph Zakrzewski, Chairman and Chief
Executive Officer of Amarin. "The addition of Chemport as an approved API
supplier supplements Amarin's current proven API supply source, Nisshin
Pharma, Inc."

The addition of Chemport contributes to the planned expansion of the Vascepa
manufacturing supply chain and is additional progress toward Amarin's goal to
protect the commercial potential of Vascepa to beyond 2030 through a
combination of patent protection, regulatory exclusivity, trade secrets and by
taking advantage of manufacturing barriers to entry. Along with this planned
expansion in supply, Amarin's significant progress includes expansion of
patent protection for Vascepa in the United States with 19 Amarin patents
either issued or allowed and over 30 additional patent applications being
prosecuted. Amarin is also pursuing patent applications related to Vascepa in
multiple jurisdictions outside the United States. In addition, Amarin has a
pending sNDA for a third API supplier (BASF) and has plans for the submission
of a fourth supplier in 2013.

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.

Forward-looking statements

This press release contains forward-looking statements, including statements
about the manufacturing capacity and qualification of Vascepa suppliers and
the timing and likelihood of regulatory submissions and approvals, the timing
of commercial launch of Vascepa and Amarin's ability to protect the commercial
potential of Vascepa. These forward-looking statements are not promises or
guarantees and involve substantial risks and uncertainties. Among the factors
that could cause actual results to differ materially from those described or
projected herein include uncertainties associated generally with dependence on
third parties, research and development, clinical trials and related
regulatory submissions and approvals; events that could interfere with the
issuance of a patent, or once issued, the continued validity or enforceability
of a patent; Amarin's ability to maintain adequate patent protection and
successfully enforce patent claims against third parties; commercializing
Vascepa without violating the intellectual property rights of others; obtain
regulatory exclusivity and take advantage of manufacturing barriers to entry.
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.

CONTACT: Joseph Bruno
         Investor Relations and Corporate Communications
         Amarin Corporation
         In U.S.: +1 (908) 719-1315
         investor.relations@amarincorp.com

company logo
Sponsored Links
Advertisement
Advertisements
Sponsored Links
Advertisement