London, United Kingdom, February 18, 2003– Amarin Corporation plc (NASDAQ: AMRN) announced today that Zelapar™ (selegiline HCl orally disintegrating tablets) has received an approvable letter from the U.S. Food and Drug Administration (FDA) for a New Drug Application (NDA) filed by a subsidiary of Elan Corporation plc (NYSE: ELN). The FDA accepted the NDA for filing in April 2002.
"We look forward to the remaining requirements of the FDA being expeditiously fulfilled," commented Rick Stewart, Amarin's Chief Executive. "Upon exercise of our option, Zelapar will complement our currently marketed Parkinson's disease product, Permax® (pergolide mesylate) tablets, progressing Amarin toward its stated goal of becoming a leader in the treatment of movement disorders."
Amarin has the exclusive option to acquire the U.S. rights to Zelapar from Elan. Zelapar, a novel and proprietary formulation of selegiline, is an MAO-B inhibitor that addresses the dopamine deficiency, which characterizes Parkinson's disease. Zelapar is an oral tablet using the patented Zydis® fast-dissolving technology of RP Scherer Corporation, a unit of Cardinal Health, Elan's licensor. Zelapar is being developed as an adjunct treatment to levodopa for the symptoms of Parkinson's disease. Selegiline, the active ingredient in Zelapar, is approved for this indication in a conventional tablet form. The Zelapar tablet dissolves in seconds and is absorbed in the tissues of the mouth. There is no need to swallow or use liquid in conjunction with this dosage.
Amarin will hold a conference call to discuss its 2002 annual earnings report later this month, and will provide specific details for the call in a forthcoming release. The approval and launch of a generic to Permax, Amarin's dopamine agonist for the treatment of Parkinson's disease, has resulted in a requirement to review the intangible asset value of Permax. It is expected that a substantial non-cash, exceptional charge will be taken. The final amount will be provided in Amarin's full year 2002 earnings report, to be released later this month.
Amarin Corporation, plc (NASDAQ: AMRN) is a specialty pharmaceutical company focused on neurology and pain management. Amarin has multiple pharmaceutical products on the US market along with a development pipeline that includes two late-stage candidates: Zelapar (selegiline HCl orally disintegrating tablets) for Parkinson's disease and LAX-101, a proprietary compound for Huntington's Disease. For press releases and other Company information, visit our websites at www.amarincorp.com and www.amarinpharma.com.