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Preparing for Amarin's REDUCE-IT Data Read-Out for Vascepa in Patients with Elevated Cardiovascular Risk

Ticker(s): AMRN

Who's the expert?

Name: Dr Matthew Budoff - MD

Institution: UCLA

  • Professor of Medicine and Endowed Chair of Preventive Cardiology at UCLA.
  • Treats hundreds of patients with hypertriglyceridemia, has prescribed Vascepa, and  has been in practice 25 years advancing procedures that can help doctors identify cardiac patients early and place them on a therapeutic path to prevent a heart attack.
  • Works on at least 20 active medical research trials at any given time, and has authored or co-authored over 800 research papers, seven books, and 45 book chapters. 

Interview Questions
Q1.

What will you be looking for, or paying close attention to, when the REDUCE-IT results are announced?

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Q2.

Assuming REDUCE-IT is positive and the benefit is clinically meaningful, how will your use of Vascepa in patients change?

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Q3.

What would you consider to be a clinically meaningful reduction in CV events?

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Q4.

Which is important from clinical aspects as well as from investment points of view:1.     Primary endpoints or2.     Secondary endpoints

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Q5.

Typically, what will be next course of action by Amarin if the Reduce-it results are significant? Or in other words, when is it likely to be formally approved by FDA as sNDA is already in place with FDA since ADCOM in 2013

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Q6.

Can you give your opinion on the strengths and weaknesses of the CHERRY study and how important you see plaque volume reduction and stabilization as a primary MOA in the reduction of MACE in Reduce-IT.

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Q7.

There has been some questions from Dr Nissen from Cleveland Clinic about the placebo used in REDUCE-IT trial being mineral oil. This was used for all Amarin's trials and was approved by FDA SPA. Is the use of mineral oil as placebo a legitimate issue or is this more related to the fact that Dr Nissen is the PI of AMRN's main competitor (AstraZeneca's STRENGTH study)? Could you comment on mineral oil as placebo?

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Q8.

Vascepa consists of pure EPA while other products, including Lovaza, are a mix of EPA & DHA. Is this an important distinction?

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Q9.

Do you feel that the chances for a successful REDUCE-IT trial are being discounted due to ignorance over the differences between "fish oil" and Vascepa?

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Q10.

And flip the question: If REDUCE-IT fails, will you stop Prescribing Vascepa, even for the approved indications?

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Q11.

Please explain “cardiovascular outcomes or event rates” -- what sort of events does this include?

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Q12.

Do the types of CV events that drive the benefit (if observed) matter to you?

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Q13.

Would you mind clarifying the difference between the “powering” and “strength” of the REDUCE-IT trial? Is that different because this is an event driven study?

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Q14.

His thoughts on the relevance of the JELIS study to the outcome of REDUCE-IT?

  • In Japan, ethyl-EPA is marketed under the product name of Epadel by Mochida Pharmaceutical Co. and is indicated for hyperlipidemia and peripheral vascular disease. In an outcomes study called the Japan EPA Lipid Intervention Study, or JELIS study, which consisted of more than 18,000 patients followed over multiple years, Epadel, when used in conjunction with statins, was shown to reduce cardiovascular events by 19% compared to the use of statins alone. In this study, cardiovascular events decreased by approximately 53% compared to statins alone in the subset of primary prevention patients with triglyceride levels of ≥150 mg/dL (median of 272 mg/dL at entry) and HDL-C <40 mg/dL. Epadel has been approved and available by prescription in Japan for over a decade. In 2013, the Japan Ministry of Health approved Epadel for over-the-counter sales. JELIS provides supportive but not conclusive data that EPA drug therapy may reduce major coronary events. JELIS results cannot be generalized to populations outside of Japan due to limitations in the study’s design.

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Q15.

What is the purpose of the REDUCE-IT study? Can you place the study in context of CV medicine, particularly for the patients enrolled.REDUCE-IT -- a multinational, prospective, randomized, double-blind, placebo-controlled study, is the first prospective cardiovascular outcomes study of any drug in a population of patients who, despite stable statin therapy, have elevated triglyceride levels.

  • Based on the results of REDUCE-IT, we plan to seek additional indicated uses for Vascepa. In REDUCE-IT, cardiovascular event rates for patients on stable statin therapy plus 4 grams per day of Vascepa will be compared to cardiovascular event rates for patients on stable statin therapy plus placebo. Enrollment 8,175 patients

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Q16.

What do you believe would be the main driver for CV reduction with Vascepa? Lowering of triglycerides? Anti-inflammatory properties? Other factors? What is the mechanism of action here?  

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Q17.

What would be market cap for the following scenario?1.     If the Reduce-it results are significantly exceeding the target2.     If the Reduce-it results are mediocre3.     If the Reduce-it results don’t meet the target

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Q18.

What's your general view of EPA and/or DHA role in reducing triglycerides and reduction of CV risk.Are you a Skeptic? Believer? Has your opinion shifted over time?

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Q19.

A bit redundant , but could you walk through the various data scenarios for REDUCE-IT (assuming safety is good) and how you believe it would change prescribing habits? 15% reduction, 14%-10%?, 10%-5%?, 5%-0%?

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Q20.

What are the currently approved medicines to reduce triglycerides

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Q21.

Will there be any difference on Lipid/inflammatory level measurements between Anchor trial and Reduce-it outcome trail;As a layman I assume that Vascepa taken over a period of 4-5 median years under Reduce-it is expected to reduce the lipid & inflammatory levels even further lower than Anchor trail. Is my understanding correct?

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Q22.

There seems to be quite a few omega-3 outcomes studies out there (meta-analysis in JAMA, ASCEND, VITAL ....). Amarin has said REDUCE-IT is right drug, right dose, right population. Do you agree or disagree?

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Q23.

Follow-up to Q16: Why is there a steady ~15M prescriptions a year of fenofibrates, even after outcomes study failures, and even after FDA label updates? Implications for Vascepa if it fails in REDUCE-IT?

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Q24.

What's your current view on Safety and Efficacy for Vascepa?

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Q25.

Triglycerides: What are they? Why are they bad?

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Q26.

If a person is under medical treatment with Vascepa + Statin, say for example to reduce TG from 300, this person will continue to take this medicine till his death? Or this person will take this medicine for several months (for example for six months) and then stop for several months (say for six months) and start over again and continues?

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Q27.

How to extrapolate between the number of scripts sales versus number of high TG patients, for example, if  Vascepa takes an average/year 10 % market share out of a total 78 million people with TG 150 - 500, then is that mean 7.8 million scripts sales per year?

Added By: c_admin
Q28.

If Reduce-it is successful, is there a possibility to use Vascepa as a standalone medicine instead of using it along with statins for reduction of TGs, CVDs, Pes, SEs, etc…?What are the other medical conditions for which Amarin is likely to test Vascepa in future?

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Q29.

Can you discuss the specific results that you have seen in your patients as a result of putting them on Vascepa and the typical timeline that they need to be on it before they start to see them? Also, are there any off-label conditions that you can note Vascepa proving beneficial in treating?

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Q30.

Do you feel that competitive binding between AA and EPA is the primary MOA in reducing inflammation? Do you think this is dose dependant and may be the cause of the previous trial failures that used low dose EPA or mixed EPA/DHA?

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Q31.

Can you handicap the outcome of the REDUCE-IT study based on prior studies of EPA and/or DHA?

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Q32.

If REDUCE-IT hits the primary endpoint (15% reduction), how do you see prescription rates growing? (I think Adam asked this already) Is that comparable to the grow rates of the PCKS9s?

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Q33.

Can you Describe your current use of Vascepa for patients.

  • How is patient compliance? 4 g -> 4 pills per day.
Do you prescribe or recommend OTC fish oil and/or generic Lovaza prior to Vascepa?

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Q34.

The use of fish oil supplements is controversial because previous studies, including large meta-analyses, have failed to show heart benefits. What’s your view of these studies and does it raise the risk that REDUCE-IT will fail to demonstrate a meaningful CV benefit?

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Q35.

What is the role of HDL and does inclusion of “only” HDL patients less than 40 matter?

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