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Amarin Idea Proposal (AMRN)

Amarin Idea Proposal (AMRN)
 

Will Amarin’s Vascepa become the next blockbuster cardiovascular drug?

Report Available: September 5, 2019

 

Blueshift’s initial research found AMRN with its one drug portfolio, Vascepa, growing sales and gearing up for major expansion. Vascepa, an omega-3 acid know as EPA, is derived from fish and has been on the market since 2012 for reducing high triglycerides. The recent positive REDUCE-IT trial and submission of a supplemental New Drug Application (sNDA) to expand use of the drug to reduce the risk of major cardiovascular events has the Street anticipating Vascepa as the next blockbuster and asking whether the traditionally slow-moving medical community will adopt it for the new indication. Another challenge for AMRN is whether it can undertake and succeed with the required sales and marketing effort to achieve blockbuster status.

 

Observations

  1. AMRN reported a Q2 loss but beat EPS and revenue expectations and provided an aggressive full-year guidance forecast. AMRN posted record revenue of $100.8 million which represents a YY increase of 91.5%. Prescriptions for the triglyceride-lowering medication increased by 76% year to year based on data from Symphony Health and 73% according to IQVIA.
  2. AMRN’s REDUCE-IT trial results and subsequent data reviews were outstanding. Vascepa showed up to a 30% reduction of cardiovascular events such as heart attacks or stroke compared to placebo in statin-treated patients. Treatment with Vascepa resulted in a 25% reduction for first events, 32% for second events, 31% for third events, and a 48% reduction for a 4th or greater event.
  3. The excellent  REDUCE-IT results have motivated the American Diabetes Association to update its treatment standards to include Vascepa even before it has been approved for the new indication by the FDA. It is estimated that 10 million diabetics in the U.S. with an elevated risk of cardiovascular disease might benefit from Vascepa. This potential expansion of the TAM for Vascepa is driving high expectations for its future sales.
  4. The Institute for Clinical and Economic Review (ICER), a U.S.-based price watchdog, also rewarded AMRN’s Vascepa by reporting that it is cost-effective as an add-on to statins for patients with abnormally high triglyceride levels. The designation as a cost-effective treatment should help in securing third-party payments for Vascepa if it receives FDA approval for the new indication.
  5. With great trial results, medical association endorsements, and high expectations for a September Vascepa indication expansion, AMRN plans to double the size of its sales force and expand its marketing effort. By October, AMRN expects to have 400 new sales professionals on board with a target of contacting 70,000 to 80,000 healthcare professionals.
  6. Despite all the positive news, there are some concerns that the trial data may have been skewed and Vascepa could lead to elevated LDLs. Other critics question whether a mid-cap company has the resources to successfully execute a massive sales and marketing effort. Talk of a takeover by a large-cap pharma company that can scale a sales launch have been in the air for some time, but nothing has come to fruition as of yet.

 

How likely is AMRN’s Vascepa to reach blockbuster status if it receives FDA sNDA approval? Will the medical community adopt Vascepa for reducing CV events? How long will it take for adoption of Vascepa for the CV prevention indication? Will Vascepa’s 800 sales reps be what it takes to drive sales to the $1 billion-plus level? How meaningful are the ADA and ICER endorsements? To answer these and other questions, Blueshift will gather data and issue a market research report from independent sources in the following areas: Cardiologists, Endocrinologists, Drug sales channel, and Industry specialists.  

 

Companies: Amarin Corporation plc (AMRN), AbbVie Inc. (ABBV), AstraZeneca plc (AZN), GlaxoSmithKline plc (GSK)

 

Research Begins: August 19, 2019

 

To see other ideas Blueshift Research is currently working on, please click here.

 

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