Amarin reports net loss of $6.4 million, remains focused on bringing Miraxion for Huntington's to market

By Jennifer Lanning Drey

Eugene, Ore., May 11 - Amarin Corp. plc reported a net loss in the first quarter of $6.4 million or $0.08 per share, compared with a net loss of $3.7 million or $0.10 per share in the same quarter of 2005.

The net loss for the quarter primarily reflects its investment in research and development, particularly in two ongoing phase 3 trails with Miraxion in Huntington's disease, according to a company news release.

Amarin had cash of $33.3 million on March 31, compared to $6 million on the same date in the previous year. The company raised $6.3 million in the first quarter through the sale of 3.2 million ordinary shares and warrants for 0.3 million ordinary shares, according to the release.

"Our key priority is the successful conclusion of the phase 3 trials of Miraxion in Huntington's disease, where we've made significant progress in both U.S. and European clinical trials," said Rick Stewart, chief executive officer of Amarin, in a company conference call held Thursday.

Miraxion for Huntington's disease is being developed under a Special Protocol Assessment agreed with the Food and Drug Administration and has been granted fast track designation by the FDA as well as received orphan drug designation in the United States and Europe.

Amarin is well positioned to enroll 300 patients in the U.S. clinical trial of Miraxion in Huntington's disease by the end of next month as well as to enroll the full complement of 240 patients in the European trials by late summer, Stewart said in Thursday's conference call.

NDA possible by Q2 of 2007

U.S. patients enrolled next month will complete the trial in late 2006, and if the data is positive, Amarin expects to file a New Drug Application with the FDA in the second quarter of 2007 and have a response to it within six months of the file date, Stewart said during the conference call.

In preclinical studies, Miraxion was able to improve learning and memory, it showed multiple neuroprotective effects and was able to improve cell viability, thereby slowing neuronal apoptosis, or cell death, which is often associated with a number of neurodegenerative disorders such as Alzheimer's, Parkinson's and Huntington's diseases, according to a news release.

In the second quarter, Amarin will focus on expanding understanding of Miraxion's mechanism of action in the brain, which is fundamental to testing the drug as a treatment for other neurodegenerative disorders and melancholic depression, and therefore increasing its potential market, Stewart said.

Amarin is a London neuroscience company focused on the research, development and commercialization of novel drugs to treat central nervous system disorders.

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