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Digging into Amarin's REDUCE-IT, including new data presented during the American College of Cardiology’s scientific session

Ticker(s): AMRN

Who's the expert?

Name: Dr Michael H. Davidson - MD

Institution: University of Chicago

  • Professor of Medicine and Director of the Lipid Clinic at the University of Chicago & founding board member of the National Lipid Association.
  • Has conducted over 1000 clinical trials, published more than 300 medical journal articles and written three books on Lipidology.
  • Research background encompasses both pharmaceutical and nutritional clinical trials including extensive research on statins, novel lipid-lowering drugs, and omega-3 fatty acids. 
  • Co-founder of Omthera Pharma — a small biotech that developed a competing fish-oil-derived drug, Epanova, later acquired by AstraZeneca.

Interview Questions
Q1.

Join & add your own questions via the orange "Add a Question" button below!

Added By: c_admin
Q2.

Why do you think Vascepa succeeded here when other fish-oil derived medicines have not?

Added By: adamfeuerstein
Q3.

What role should Vascepa play in clinical care after the REDUCE-IT study?

Added By: adamfeuerstein
Q4.

Do you think the benefits of these medicines will be limited to those with elevated triglycerides?

Added By: adamfeuerstein
Q5.

Could you please talk about Amarin's IP in relation to EPANOVA and what happened in the court case filed by Amarin that kept AZN from selling Epanova and if you think Amarin's pure EPA formulation is generally defensible from OTC high strength supplements trying to leverage Amarin's R-IT R&D spend?

Added By: user282f0563
Q6.

There seems to be a perception that the STRENGTH trial outcomes are important to give validation to the REDUCE-IT data. But aren't Epanova and Vascepa quite different chemically? Could you talk about this chemical difference especially in terms of EPA and DHA content? Also, doesn't the JELIS study already give some validity to the REDUCE-IT data, considering both were pure EPA products?

Added By: sentiv
Q7.

It has been cited that 50-70mm people in the US have CV risk factors beyond LDL. How do you think about the size/scale of the market opportunity for CV risk reduction beyond controlling LDL, and where does EPA fit into this picture?

Added By: user57e78d62
Q8.

Were you surprised that the strong (25%+) relative risk reduction demonstrated in REDUCE-IT trial was observed across all baseline TG groups; including the lowest (81-190 mg/dl, median of 163) tertile? What are the implications of these “TG independent” results, especially with respect to overall patient opportunity and physician prescribing habits?

Added By: user57e78d62
Q9.

Given the significant reduction in cardiovascular events seen in both REDUCE-IT and JELIS, coupled with its attractive safety profile, is there any reason to believe that EPA in adjunct with Statins should not be the Standard of Care going forward? What is the process and/or timeline for updating guideline from organizations such as National Lipid Association, AHA/ACC, etc.

Added By: user57e78d62
Q10.

Out of the almost 40mm people in the US taking statins, what percentage do you think have additional CV risk factor and could benefit from using EPA as an adjunct therapy? What will it take for EPA therapy to significantly penetrate this opportunity? 

Added By: user57e78d62
Q11.

How important are cardiovascular outcome trials to FDA? What is the likely impact on physician prescribing habits given Vascepa's position as the first drug in the market with a successful trial, published results in NEJM/JACC, and presentations at AHA/ACC, etc.

Added By: user57e78d62
Q12.

How persuasive were Vascepa data presented at ACC showing further reduction in second/third heart attacks?

Added By: adamfeuerstein
Q13.

What do you think the relative importance of DHA and EPA are in determining whether a fish-oil-derived medicine is effective?

Added By: adamfeuerstein
Q14.

Could you explain the rationale between the creation of Epanova, in which you played a key role, and the design of the STRENGTH study?

Added By: adamfeuerstein
Q15.

Will the outcome of the STRENGTH study change physician perceptions of Vascepa? In which ways?

Added By: adamfeuerstein
Q16.

From a user: "If the same study would be done using a highly purified fish oil like the one I take from Life Extension Foundation called Clearly EPA/DHA with a dose in 4 capsules of EPA 1500 mg and DHA 1000mg,and without the change they have to make in the natural molecule in order to get a patent, how do you know that you wouldn’t get the same or better result with the natural form ? If someone does that study this drug with the altered molecule would suddenly lose value. The other important question is: What are the side effects of this altered molecule?"

Added By: joe_mccann
Q17.

How would you see Lipid Management Guidelines could be impacted based on results of REDUCE-IT trial?; what will be the potential effect on Lipid Management for patients with higher CV risk, high LDL and normal TG levels?

Added By: cuicas

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