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Tuesday, July 02, 2019 7:14:52 AM
Amarin increased its 2019 sales guidance to $380 million to $420 million from the $350 million it had expected, citing more robust estimated revenue. For the second quarter, the biopharmaceutical company said it expects sales of $97 million to $101 million .
Amarin said it plans to double its sales force to 800 representatives by October as part of its effort to promote Vascepa, following the priority review designation of the drug's supplemental new drug application. The FDA's deadline to review Vascepa is Sept. 28 , the company said.
The drug has the potential to become first prescription product available for cardiovascular risk reduction in patients with elevated triglyceride levels despite statin therapy, the company said. The company submitted the sNDA to the FDA in March after seeing positive results of its REDUCE-IT cardiovascular outcomes study.
Plans to market Vascepa outside of the U.S. are unchanged, the company said, adding that it intends to apply for regulatory approval in the European Union by the end of 2019.
"While Amarin remains optimistic that Vascepa will generate billions of dollars in revenue in the years to come, the history of other therapies for chronic conditions suggests that growth builds over multiple years, and thus, the company is not prepared to provide quantified guidance regarding revenue levels beyond 2019," the company said.
Write to Dave Sebastian at dave.sebastian@wsj.com
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