Dec. 11, 2012, 7:30 a.m. EST
Amarin Announces Additional Vascepa(R) (icosapent ethyl) Supplier
Fourth API Supplier Further Solidifies Worldwide Supply Chain
BEDMINSTER, N.J. and DUBLIN, Ireland, Dec 11, 2012 (GlobeNewswire via COMTEX) -- Amarin Corporation plc AMRN -0.32% , a biopharmaceutical company focused on the development of therapeutics to improve cardiovascular health, today announced the addition of an exclusive consortium of companies led by Slanmhor Pharmaceutical, Inc. (Slanmhor) to its planned active pharmaceutical ingredient (API) global supply chain for Vascepa(R) (icosapent ethyl) capsules. Slanmhor was spun-out from Ocean Nutrition Canada (ONC) prior to the May 2012 acquisition of ONC by Royal DSM N.V. (DSM), a global leader in life sciences and materials sciences. Amarin now has a total of four API suppliers for Vascepa API for Amarin to utilize to support the global commercialization of Vascepa, subject to appropriate regulatory approvals.
Slanmhor, based in Halifax, Nova Scotia, Canada, is led by CEO Robert Orr, a pioneer and industry leader in the omega-3 manufacturing industry and the former Chairman and CEO of ONC, the world's largest supplier of concentrated omega-3 fatty acid products. In producing API for Amarin, Slanmhor, through exclusive agreements, is collaborating with DSM/ONC for the supply of intermediate omega-3 oil, and Novasep, a global leader in purification technologies and API manufacturing. The Slanmhor/DSM/Novasep consortium offers one of the most well established omega-3 current good manufacturing practice (cGMP) API manufacturing solutions globally and further solidifies Amarin's capability to reliably source Vascepa.
"We have found very few companies with the technical ability to produce Vascepa to our unique specifications. The addition of this exclusive Slanmhor consortium rounds out our global diversity and expands our potential capacity to meet the anticipated market demand for Vascepa," said Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. "Pooling the resources of four of the world's leading omega-3 API manufacturers supports the commercial potential of Vascepa by providing for additional scalability and reliability to Amarin's supply chain."
Amarin's current plan is to launch Vascepa based on product produced by its existing API supplier, Nisshin Pharma. Amarin has agreed to a protocol with FDA for the qualification of additional API suppliers. Amarin's plan is for Slanmhor, along with BASF and Chemport, to complete all necessary qualification steps to facilitate the submission of supplemental New Drug Applications that seek approval for Amarin's new suppliers to manufacture Vascepa for use in the United States.
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(R) (icosapent ethyl), Amarin's first FDA approved product, is a patented, ultra pure omega-3 fatty acid comprising not less than 96% EPA. For more information about Vascepa visit www.vascepa.com . For more information about Amarin visit www.amarincorp.com .
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About DSM -- Bright Science. Brighter Living.(TM)
Royal DSM is a global science-based company active in health, nutrition and materials. By connecting its unique competences in Life Sciences and Materials Sciences DSM is driving economic prosperity, environmental progress and social advances to create sustainable value for all stakeholders. DSM delivers innovative solutions that nourish, protect and improve performance in global markets such as food and dietary supplements, personal care, feed, pharmaceuticals, medical devices, automotive, paints, electrical and electronics, life protection, alternative energy and bio-based materials. DSM's 22,000 employees deliver annual net sales of around EURO9 billion. The company is listed on NYSE Euronext. More information can be found at www.dsm.com
Novasep, headquartered in Pompey, France, is a global provider of cost-effective and sustainable solutions to produce active molecules at the required purity. Novasep's unique offering includes process development services; purification equipment and turnkey processes; contract manufacturing services; and complex active molecules to serve pharmaceutical; biopharmaceutical; agrochemical; fine chemical; food and functional ingredients; and bio-industries. Novasep employs 1,200 people and has a global footprint including numerous FDA inspected API manufacturing plants, biopharmaceutical production sites and equipment manufacturing facilities.
Slanmhor Pharmaceutical, Inc. is a Canadian corporation with headquarters in Halifax, Nova Scotia. Slanmhor specializes in the manufacture and supply chain management of omega-3 based Active Pharmaceutical Ingredients. Slanmhor is a wholly-owned subsidiary of Clearwater Fine Foods, Inc., a Canadian based investment holding company with principal holdings that also include seafood harvesting, processing and telecommunications.
This press release contains forward-looking statements, including statements about the manufacturing capacity and qualification of Vascepa suppliers and planned regulatory approvals and timing related thereto. 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 the following: uncertainties associated generally with reliance on third parties, manufacturing capabilities, supply of pharmaceutical product and related regulatory approvals. 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.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Amarin Corporation plc
CONTACT: Amarin contact information:
Stephen D. Schultz
Investor Relations and Corporate Communications
In U.S.: +1 (908) 719-1315
Dec. 11, 2012, 7:30 a.m. EST