• Identification and Analysis of Amarin Corp.'s Harbingers of Bankruptcy

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Identification and Analysis of Amarin Corp.’s Harbingers of Bankruptcy

 

Summary

Since having reported positive topline results from their REDUCE-IT trial in September of 2018, Amarin Corp.'s (NASDAQ: AMRN) stock price has risen over 500%. Much is assumed in this new valuation (~$6B MC as of June 2019), as the profitability of the Company is entirely dependent upon the potential commercial success of Vascepa. 

Lingering doubts as to the effectiveness of the therapy remain, however, due to the possibility that mineral oil had an adverse effect on the performance of the placebo group by (among other things) hindering drug absorption. We offer a substantial analysis that provides compelling evidence the results are in fact confounded, even to the extent that had another, truly inert placebo been chosen, the study would likely have failed to achieve its primary endpoint.

The investment community has largely overlooked the defensibility of the Company’s patent portfolio, taking it for granted that their IP is secure. We assail their patents and convincingly find each claim invalidated by prior art or otherwise not infringed by ANDA filers. Also provided is a section on barriers to expansion not given due weight by market participants and analysts.

 

TOTAL REPORT LENGTH: 250 pages; 85,173 words; 528 citations


 

Table of Contents:

1. Impact of Light Paraffin Oil Placebo on the Interpretation of REDUCE-IT Trial Results

               1.1 Summary

               1.2 Introduction

               1.3 Effect of Between Group Differences in Biomarkers on ASCVD Risk

               1.4 Extrapolating the Potential Attenuation of Statin Efficacy in the REDUCE-IT Trial

               1.5 The Role of CRP in Evaluating ASCVD Event Risk in REDUCE-IT

                           1.5.1 Log-transformed hs-CRP Data

    1.5.2 To What Extent Does the Increased CRP Levels in the REDUCE-IT Placebo Group Confound Results?

               1.6 Potential Impact of Mineral Oil on Cardiac Medications

                           1.6.1 Additional Observations That Infer Drug Malabsorption in REDUCE-IT

               1.7 Confirmation of an Adverse Impact of Mineral Oil on Drug Absorption

               1.8 Direct Evidence of an Inhibitory Effect of Mineral Oil on Drug Absorption

               1.9 Drug-Drug Interaction Studies

               1.10 Why Didn't the DMC Recommend the REDUCE-IT Trial be Halted for Safety?

              1.11 Additional Apologetics

              1.12 Discussion 

               1.13 Conclusions

 

2. The Assailability of Amarin Corp.’s Patent Portfolio

                2.1 Obviousness and Prior Art

                2.2 The Doctrine of Inherent Disclosure

                2.3 The FDA Orange Book

                2.4 Background

                2.5 Invalidating Amarin’s Patents     

2.5.1 Did Amarin Insiders Commit Antitrust Violations by Submitting the ‘146 Patent to the Orange Book?

2.5.2 The ‘554 and '594 Patents and Doctrine of Equivalents

2.5.3 The ‘728, ‘677 and ‘652 Patents

2.5.4 The ‘727 and ‘086 Patents

2.5.5 The '920, '335, and Remaining Patents

                2.6 Current Litigation: An Ever-Present Danger

                2.7 The Epanova Double Standard

                2.8 Aren’t OTC Omega-3 Products Infringing?

                2.9 A Case in Point: Indivior Inc. v. DRL

                2.10 Acquiring Amarin Corp. Would be Detrimental

 

3. Factors Affecting Vascepa Market Penetration

                3.1 The Accessibility and Cost Savings of OTC EPA

                 3.2 Critique of Amarin’s U.S. ITC Complaint [UPDATED]

                 3.3 Evidence Vascepa Can Cause Organ Damage

                 3.4 Sales of Prescription OM3 in Similar Indications Present a Ceiling

                 3.5 The European Market: Why it Has Been Ignored

3.5.1 How the EU Market Would Be Lost Shortly After an Approval

                 3.6 Can Amarin “Control the Supply?”

                3.7 The Threat of Matinas BioPharma's MAT9001

                3.8 All Signs Point to No Buyout

                 3.9 Concluding Remarks

                3.10 Conflicts of Interest

                3.11 References 

 


Reasons to Purchase the Report:

The Report will inform firms, individual investors, and other interested parties of the highly material drawbacks to an investment in or acquisition of Amarin Corp. and contrariwise, the potential profitability in adopting a short-sale positionas well as the vulnerabilities of Vascepa’s IP that may rightly be assailed.

 

The Report provides insights on the following pointers:

Analysis of REDUCE-IT Trial Results: An in-depth research paper that unearths relevant data from extensive sources, applying them to and discovering serious problems with the reliability of the trial data in a convincing manner, including a granular review of relevant data from the REDUCE-IT trial itself heretofore overlooked by commentators, going much beyond the discussion of hindrances to statin absorption.

Patent Invalidation/Non-infringement: Detailed overview of where Amarin Corp. stands with their IP, as well as the state of and what to expect from their current patent litigations, divulging a preponderance of prior art references that inherently or explicitly invalidate each of Amarin’s patents covering Vascepa, or otherwise show them not infringed by ANDA filers. Also included is an overview on the current state of affairs in the courts and a timeline on due process.

Barriers to Entry: Comprehensive information as to the limitations of Amarin’s potential to achieve market penetration (US and EU) even should all go well in the courts and with FDA (and later, EMEA), including present and future competition, as well as other less well-known economic and regulatory hindrances. Also included is an extensive analysis on the potential long-term destructive effects of fatty acid ethyl esters such as Vascepa, and a critique of Amarin’s ITC complaint (UPDATED), including arguments from multiple points of view.

 

Consultation:

As part of the purchase of the Report, we make ourselves available to answer any and all questions on (or challenges to) our research and commit to respond within 48 hours.

 

 

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Identification and Analysis of Amarin Corp.'s Harbingers of Bankruptcy

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