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Thursday, 05/09/2019 8:57:52 AM

Thursday, May 09, 2019 8:57:52 AM

Post# of 425640
AMRN Partner in Canada Q1-Results & CEO Comments

""Q1 was a solid start to the year with good financial performance from our foundational products, positive new developments with Vascepa and the promising expansion of our product portfolio," said Greg Gubitz, CEO of HLS.

"Regarding Vascepa, we were granted priority review status by Health Canada, which could significantly reduce the timeline to bring this innovative therapy to Canadians. Subsequent to quarter-end, on April 29, 2019, we announced that we had filed our NDS for Vascepa with Health Canada."

"Also, during Q1, Amarin released new data from the REDUCE-IT™ trial, indicating that Vascepa reduced total major adverse cardiac events—first and subsequent—by 30% compared to placebo over a five-year period, which further demonstrates significant risk reduction with the product. In addition, in March, the American Diabetes Association issued updates to their Standards of Medical Care in Diabetes for 2019 stating that for patients with diabetes and atherosclerotic cardiovascular disease or other cardiac risk factors that are on a statin with controlled low density cholesterol (LDL-C), but elevated triglycerides (135-499), the addition of icosapent ethyl (Vascepa) should be considered to reduce cardiovascular risk. We are excited with the prospects for Vascepa and we believe that, if approved, it could ultimately generate revenue in Canada in a range of CDN $150-250 million per year. We believe this a conservative view and these new developments give us greater confidence in our outlook."   
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