Transcript of Amarin Corporation (AMRN) MARINE Trial Top-Line Results Conference Call November 29, 2010

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1 Transcript of Participants Joseph S. Zakrzewski, Executive Chairman and Chief John F. Thero, President Declan Doogan, M.D., Chief Medical Officer Paresh Soni, M.D., Ph.D., Senior Vice President and Harold E. Bays, M.D., FACP, Louisville Metabolic and Atherosclerosis Research Center, Medical Director Presentation Operator Greetings ladies and gentlemen and welcome to the Amarin Corporation Conference Call. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press *0 on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mr. Joseph Zakrzewski, Executive Chairman and Chief for Amarin Corporation. Thank you, Mr. Zakrzewski, you may begin. Thank you, Claudia. Welcome to Amarin Corporation s MARINE Trial Top-Line Results Conference Call. I will note that on Amarin s corporate website under the Investor Relations tab, Events And Presentations, at the very bottom there are a couple of additional slides that you might find helpful during this call or to see after this call. As Claudia said, I m Joseph Zakrzewski. I m the Chairman and Chief Executive Officer of Amarin. Joining me today on the call from Amarin are John Thero, our President; Dr. Declan Doogan, our Chief Medical Officer; and Paresh Soni, Head of Development. In addition, we re pleased to be joined by Dr. Harold Bays, who is the Medical Director of the Louisville Metabolic and Atherosclerosis Research Center and a principal investigator of the MARINE study. This is an incredibly exciting day for Amarin and we re glad to be joined by everyone. We re extremely pleased to present the top-line results of the MARINE trial. This was a pivotal Phase 3 trial investigating Amarin s lead product AMR101 for the treatment of patients with very high triglycerides. While I ve asked the three doctors on the call 1

2 to describe the MARINE trial top-line results, before doing so I m going to ask John Thero to make the necessary legal disclaimers. John F. Thero Amarin Corporation President Thank you. I remind everyone that today s call will include statements that are not historical and may be characterized as forward-looking statements as define by the Private Securities Litigations Reform Act of 1995 including, without limitation, statements regarding the timing and results of our clinical trials, the timing of our planned announcement and publication of these results, our current expectations regarding regulatory filings, approvals, and potential indications for our product candidates, duration of patent protection, and the potential market opportunity for our product candidate including the number of patients that could potentially benefit from AMR101. These statements involve various risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements and these include the risks and uncertainties under the heading Risk Factors in our most recent annual report on Form 20-F and other periodic filings we report with the SEC. Also these reports are available on our website at They re also available through the SEC s website. These forward-looking statements are only predictions and actual results or plans may vary materially from those projected. The forward-looking statements we make on the call today are based upon our belief and expectations as of today, November 29, 2010 only. We do not undertake any obligation to revise or update these forwardlooking statements. After our prepared comments, we ll open this call to questions. Our aim is to complete this discussion prior to the market opening at 9:30. I ll now turn the call over to Declan Doogan for some background information on AMR101. Declan Doogan, M.D. Amarin Corporation Chief Medical Officer Thank you, John. We re excited to present today the top-line data from our MARINE study, a standalone pivotal Phase 3 trial addressing one of two patient populations being addressed in Amarin s Phase 3 clinical program of AMR101, Amarin s lead product candidate. The Phase 3 program is being carried out under special protocol assessment agreements of the FDA. But before I begin, I want to recognize the MARINE trial study team for their enthusiasm, diligence, and superb execution that led not only to a positive outcome but results being available a year earlier than initially projected. AMR101, ethyl icosapentate, E-EPA, is a semi-synthetic single active ingredient drug in the omega-3 class that is currently being evaluated for the treatment of high and very high triglyceride levels. Elevated triglyceride levels are increasingly being recognized as a significant modifiable risk factor for cardiovascular disease alongside low density lipoprotein cholesterol or LDL-C, bad cholesterol. 2

3 The National Cholesterol Education Program Adult Treatment Panel III or NCEP ATP III indicates that patients high triglycerides defined as reaching 200 mg/dl and 500 mg/dl are indicated to receive pharmacological therapy as a secondary goal after LDL-C. Often these patients have persistent high triglyceride even after taking other lipid-altering medications; multiple simultaneous lipid disorders known as mixed dyslipidemia. Very high triglycerides are defined as triglyceride over 500 mg/dl and patients with such triglyceride level require triglyceride-lowering therapy to prevent clinical sequelae. In prior clinical studies, this patient population experienced an increased in LDL-C of up to 50% when treated with current triglyceride-lowering drug and in some cases, these increases can increase LDL-C levels into ranges associated with higher patient risk. Despite treatment guidelines, that suggest that patients with very high triglyceride level be actively treated, the majority is not. We believe that this is due to limitations of existing therapy. Two therapies which have been historically used to treat such patients are niacin, which cannot be tolerated by many patients and may negatively impact blood glucose, and fibrates which have not conclusively demonstrated clinical benefit and have various side effects. The most recent class of triglyceride-lowering therapies are the prescription omega-3 fatty acids. To date, only one prescription omega-3, Lovaza or Omacor has been approved in the US for the treatment of very high triglycerides. Lovaza is a highly pure and concentrated omega-3 formulation that is over 80% comprised of E-EPA and ethyl docosahexaenoic acid or E-DHA as well as other fatty acids. Lovaza was approved in 2004 based on clinical studies conducted over a decade ago. The only approved triglyceride-lowering dose of Lovaza is 4 grams per day. According to the Lovaza NDA, 2 grams is an ineffective dose. Lovaza is a safe and effective drug for the treatment of very high triglycerides but, like fibrates, has been shown in clinical studies to increase LDL-C by between 40% and 50%. In addition it has the adverse effects of eructation, dyspepsia, and skin rashes. The increases in LDL-C are large enough that in some cases the patient s LDL-C levels that may have been normal may reach levels that require additional cholesterol-lowering therapy. The Amarin scientific team believes that DHA is the component of Lovaza associated with an increase of LDL-C. Because of the LDL increase even in statin-treated patients, current prescription omega-3 therapy is not approved for patients with high triglycerides who are also on statin therapy. Currently, an estimated 3.8 million people in the US have very high triglycerides and are eligible for medical therapy, this being the population for Lovaza in the US. An additional 36 million adults of elevated triglyceride in the range of 200 to 500 mg/dl and many of these individuals require additional statin therapy for LDL cholesterol management. No prescription omega-3 drug is approved in the mixed dyslipidemic patient population. We will present shortly the data from MARINE trial. This is the largest study ever conducted in the very high triglyceride population. The purpose of the trial was to evaluate the effectiveness of AMR101 in patients with very high triglyceride over 500 mg/dl. It is important to point out that, unlike any earlier prescription omega-3 studies of patients with very high triglycerides in which none of the patients were on 3

4 statin therapy, 25% of the patients in the MARINE trial were in background statin therapy. We believe this reflects real medical practice in this statin era. Before we get to the results of the MARINE study, I d like to mention that AMR101 is also being studied in a second different population; that is the ANCHOR study. This study consists of patients with high triglyceride levels between 200 mg/dl and 500 mg/dl who are all on stable statin therapy for elevated LDL-C. In the US, no prescription omega-3 is presently approved for treating this patient population which includes 36 million patients. While in addressing a very high triglyceride population, we seek to be best in class with the AMR101. In this larger population of patient with high triglycerides, we seek to be first in class with AMR101. I will now turn the call over to Paresh Soni for the MARINE top-line data presentation. Thank you, Declan. I d just like to remind people who called in late that there are slides on our website that you can refer to that contain some of the data and some context around the program. Today, we are very excited to present to you the results of our first Phase 3 trial, the MARINE study, investigating AMR101 in patients with very high triglyceride. The MARINE trial met its primary endpoints defined as the percent change in triglyceride levels from baseline to week 12 for both the 4-gram and the 2-gram doses. The MARINE trial, as you have just heard, is the largest randomized controlled trial ever conducted for the treatment of patients with very high triglyceride. It was a multicenter placebo controlled randomized double blind 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101. The study enrolled 229 patients with fasting triglyceride levels greater than or equal to 500 mg/dl. The study was required to meet a stringent level of statistical significant of 1%, that is, a P-value of less than 0.01 as agreed to in our Special Protocol Assessment with the FDA. Twenty-five percent of the patients were on background statin therapy and the baseline characteristics were evenly distributed across the treatment groups. Moving on to the data, the trial met the primary endpoint which was the median percent reduction in triglyceride for both treatment groups compared to placebo. The 4-gram group showed a significant median change of 33% compared to placebo with a P-value of less than and the 2-gram group showed a significant median change of 20% compared to the placebo group with a P-value equal to The median baseline triglyceride level was 703 mg/dl for the placebo group, 680 mg/dl for the 4-gram group, and 657 mg/dl for the 2-gram group. In the pre-specified secondary analysis in the sub-group that had baseline values of greater than 750 mg/dl, and this constituted 39% of the population or 88 patients in total, the median difference from placebo increased to 45% for the 4-gram dosing group and 33% for the 2-gram dosing group, both of which were statistically significant with P-values of for the 4-gram dose and for the 2-gram dose, respectively. The median baseline triglyceride levels in these sub-groups were a 1052 mg/dl, 902 mg/dl, and 948 mg/dl for placebo, 4-gram, and 2-gram groups, 4

5 respectively. In addition, the sub-group of patients that were on background statin therapy had even greater median reduction in triglycerides which was also statistically significant than compared to those who are not on statin therapy. Moving on to the other endpoint, we are very pleased to announce today that AMR101 did not result in an elevation in LDL-C at either the 4-gram dose or the 2-gram dose compared to placebo. In fact, the median LDL-C decreased 2.3% in the group treated with 4 grams of AMR101. This is the only triglyceride-lowering therapy studied in this population with very high triglycerides to date to show a lack of elevation in LDL-C. Importantly, there was a statistically significant decrease in median % non-hdl cholesterol compared to placebo with both of the AMR101 groups. There was an 18% reduction for the 4-gram group and an 8% reduction for the 2-gram group, both of which was statistically significant. In addition, we also saw a statistically significant reduction in several important lipid parameters including apolipoprotein B, also known as Apo-B; lipoprotein phospholipase A2 or Lp-PLA2; and total cholesterol, most with P-value less than Apo-B is a sensitive marker of residual cardiovascular risks and is considered to be a better predictor than LDL cholesterol. Lp PLA2 is an enzyme found in blood and atherosclerotic plaque; high levels have been implicated in the development and progression of atherosclerosis. We look forward to sharing further details at upcoming scientific meetings with you. AMR101 was well tolerated with no treatment related serious adverse events. With respect to side effects for Lovaza such as eructation or belching and dyspepsia or stomach upset, the profile of AMR101 looked very good and similar to placebo. Similarly, the profile of AMR101 with respect to other side effects reported by less pure omega-3 products, for example, the incidence of flu-like symptom, infection, skin rash, was also very encouraging, both compared to other products and to placebo. Overall, the safety profile AMR101 compared favorably to all existing triglyceridelowering therapies. While the majority of our patients studied were from Western populations, they were no differences in the response rates between Western and non-western population. We are looking forward to reviewing the results with the FDA and presenting more detail later at upcoming scientific meetings. Based on the timing and the nature of the results of this trial, we now believe that we can submit an NDA to the FDA in This is earlier than our previously stated guidance. We would like to remind you that the ongoing ANCHOR study is investigating a different patient population, these are patients with high triglycerides who are also on statin therapy for elevated LDL cholesterol levels. So Amarin is pursuing two separate treatment indications in these two studies. 5

6 I will be available at the end of the call for questions you may have regarding our trial results. Meanwhile, let me hand you over to Harold Bays to say a few words about the clinical interpretation of the data as a prescribing physician, a lipidologist, and principal investigator for the trial. Harold, welcome. Harold E. Bays, M.D., FACP Louisville Metabolic and Atherosclerosis Center Medical Director Well, thank you very much, Paresh. I m appreciative to be part of this well-designed and well-conducted study with AMR101. As was mentioned, AMR101 is a first in class EPA triglyceride-lowering agent which represents a new clinical entity with a different clinical profile than fibrates and previously approved prescription omega-3 drugs. The MARINE study is the largest controlled trial conducted in patients with very high triglycerides which is defined as greater than 500 mg/dl. This is clinically important because elevated triglyceride levels are an important modifiable atherosclerotic coronary heart disease risk factor and lowering triglycerides in patients with very high triglyceride level has health benefits such as potentially reducing the risk of triglyceride induced pancreatitis, other complications as well as improving atherosclerotic coronary heart disease risk factors. In the MARINE trial, AMR101 reduced triglyceride levels to within the range observed with commonly approved triglyceride-lowering drugs. It was surprising to me as a clinician and investigator that AMR101 demonstrated no statistical increase in LDL cholesterol levels despite a study population of patients with triglycerides greater than 500 mg/dl. Many clinicians are aware and many have concerns that some existing triglyceride-lowering agents may raise LDL cholesterol 40% to 50% in patients with very high triglyceride level. That was not found with AMR101 in the MARINE trial. Again, AMR101 demonstrated no statistical increase in LDL cholesterol level. Another surprise to me as a clinician was the degree of triglyceride-lowering efficacy in the statin-treated group which exceeded the triglyceride lowering in the non-statin treated group. Yet another unique finding was that AMR101 significantly reduced Apo-B which is thought by many clinicians to be a better predictor of atherosclerotic coronary heart disease risk than other lipid parameters such as LDL cholesterol level. Finally, it was reassuring that the safety and tolerability of AMR101 was similar with placebo. The bottom line is that elevated triglycerides are a common feature found with diabetes mellitus, adiposity, metabolic syndrome, and fatty liver disease which are increasing in worldwide prevalence. I believe that the results of the MARINE trial suggest that AMR101 may prove to represent a first in class pure EPA triglyceridelowering agent that not only represents a new clinical entity but a potential novel 6

7 therapy with favorable lipid efficacy effects that differ from many common triglyceridelowering agent such as fibrates and previously approved prescription omega-3 drugs. Now, let me turn the call back to Joe from Amarin. Thank you, Harold. As everyone can tell, folks are incredibly excited about the study results on this call and throughout Amarin. We believe that the MARINE trial results support blockbuster potential for AMR101. Worldwide sales of Lovaza/Omacor last year were more than a billion dollars. In 2010 alone, the projection for the drug is over a billion in the United States. The product targets growing primary care lipid market. According to the available data, there are more than 40 million adults in the US alone with triglyceride levels above 200 mg/dl. Patients with this level of triglycerides are clinically indicated to receive triglyceride-lowering therapy. Data shows that, in fact, less than 4% are on a prescription medication. Based on the results of the MARINE study and our anticipated results of the ongoing ANCHOR study, we believe that AMR101 is positioned to overcome limitations of existing therapies in treating these patients. Triglycerides have become increasingly recognized as an independent risk factor for cardiovascular disease. While statins form the backbone of lipid-lowering therapy, a high residual risk of cardiovascular events remains. Statins reduce cardiovascular disease but do not obliterate it. We believe that the MARINE trial results support that AMR101 is safe and effective with no increase in LDL-C. AMR101 is well positioned to be used in combination with statins. Furthermore, we believe that the MARINE trial results are consistent with the results from the large JELIS study conducted in Japan, which also was a pure EPA product, showed a significant improvement in clinical outcomes when added to statin therapy. This patient population for that trial of the JELIS study was over 16,000. The MARINE data has confirmed that AMR101 has the potential for a best in class profile. We have shown them both doses activity and that AMR101 does not increase LDL-C, an extraordinary result. We are also studying AMR101 for a mixed dyslipidemia indication in patients with triglyceride levels of 200 to 500 mg/dl. This is the ANCHOR study, a population for which AMR101 aims to be first in class as well. The fact that AMR101 increased the efficacy on triglyceride lowering in the statintreated group in the MARINE trial is incredibly encouraging. Furthermore, the safety results of the MARINE trial are consistent with our understanding that there are clinical advantages to having high omega-3 purity and that removal of DHA may be helpful in both not increasing LDL-C because DHA degrades more rapidly than EPA, about 5 to 10 folds by the way, and also in reducing side effects. This is a point known that EPA has incredibly anti-inflammation properties relative to DHA. 7

8 We believe that the clinical profile for AMR101, combined with the large market opportunity it is poised to address, and the special protocol assessment agreement in placed with the FDA, give us a very clear path forward to realize the tremendous potential value of AMR101. We believe that these positive data from MARINE create multiple opportunities for successful commercialization. Another benefit of a positive MARINE trial result is the opportunities that it s created to grow our US and international patent and IP portfolio. We recently already advanced multiple additional patent claims to add to our growing portfolio of intellectual properties related to AMR101. As with prior patent filings, these new claims that we ve been in the process of filing on the heels of the data and prior to that will protect AMR101 through 2030 and beyond. Lastly, while our current emphasis is on execution and focus, the MARINE trial results provide further evidence that AMR101 may be in fact effective in treating the various other risk factors of atherosclerosis or in being developed as a combination therapy with statins. With that, I would like to hand you back to the operator and open the line for questions. Operator Ladies and gentlemen, if you would like to ask a question, please press *1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press *2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the * keys. Once again, if you would like to ask a question, please press *1 on your telephone keypad at this time. Our first question is coming from the line of Joseph Schwartz with Leerink Swann. Please state your questions. Joseph Schwartz Leerink Swann Good morning. Congratulations on the fantastic data. I was wondering about the for the 2-gram dose, is there a threshold that you are aware of that the FDA uses for approval? I know that you had powered the study for a 30% reduction, but the results are so strong that you were able to get a nice low P-value for the 2-gram dose at a lower reduction. Do you think that would be sufficient? I think with LDL, historically, the FDA has considered a 20% reduction. Is it the same for triglycerides? Paresh or Declan, would you like to take that? 8

9 Sure. Declan Doogan, M.D. Amarin Corporation Chief Medical Officer Paresh will comment then I will. Go ahead. To answer your question, Joe, the goal here was to achieve statistical significance and the study was powered to detect a minimum difference from placebo of 30%. That doesn t mean that we had to achieve 30% but we had to achieve statistical significance and these results confirmed and the fact that the 2-gram and the 4-gram dose did work, that this was a robustly designed study. We agreed with the FDA that we had a conservative testing method for testing for both the doses to account for multiple comparisons. So we did a step-down testing, I m not sure if you re familiar with that, but we tested the 4-gram dose first. That had to meet the stringent P-value of 0.01 and then only to be compared to the 2-gram dose and that also met the stringent P-value of 0.01 and this was agreed to in the SPA agreement with the FDA. I would just like to point out that in the above 750 mg/dl group, the efficacy of both doses increased, and in fact to 45% for the 4-gram dose and to 33% for the 2-gram dose. So obviously, although our average or our mean baseline for the overall population was lower than the Lovaza studies, when you actually look at the higher baseline group, the efficacy is enhanced. I ll pass it on to Declan to add any comment. Declan Doogan, M.D. Amarin Corporation Chief Medical Officer Yes. I would just say that this study shows that 2 grams is a clinically efficacious and potentially approvable dose and it would be highly appropriate to provide that option to patients. Yeah. This is Joseph Zakrzewski. Just one final comment here. When looking at Lovaza and having been involved in that as the COO of Reliant, the studies that are in the label are in the 40% range of reduction. The studies that Lovaza had conducted ranged anywhere from 20% to 40% so one has to be careful to compare apples to apples here. There were a number I think there were about 8 to 10 studies done on Lovaza and our results are right in range. So I just wanted to make that point. Joseph Schwartz Leerink Swann Okay. Great. And as a followup, does this accelerate your partnering strategy at all? I would assume there would be significant interest now and you probably wouldn t need to wait for ANCHOR since much of this data probably bodes well for ANCHOR. 9

10 Yeah. We will continue the aggressive partnering strategy, Joe, as we talked about on the last call as well as looking at the opportunities that are also available to us to commercialize ourselves and being very opportunistic. Again, we think that partnering is the right approach here. I will tell you that even this morning, I ve gotten a couple of early morning calls from some potential partners and I expect things to be pretty intense here through the holidays and we ll see where it goes. You know, beauty is in the eye of the beholder and so is value and we ll do what s in the best interest of the shareholders, but I do expect quite a lot of interest coming off of this announcement. Joseph Schwartz Leerink Swann Well, congratulations again. Thanks, Joe. Operator Our next question is coming from the line of David Moskowitz with Madison Williams. Please state your questions. David Moskowitz Madison Williams Excellent. Thanks. And I would like to offer my congratulations as well. So I have a couple questions focusing on the LDL side of things. So we re looking at some very good data on a median basis for LDL. But the FDA will be concerned with outliers on the LDL data. So can you give us some comfort or give us some discussion on what the range of the LDL elevation looks like? This is Joe, David. I assume the question is at the higher triglyceride levels in the testing, what happened to LDL, is that the? David Moskowitz Madison Williams Yes, sure. Right. If you want to look at the sub-analyses of patients above 750, yes, that would be great. Okay. Okay. Paresh, you want to take that one? Sure. To answer your question, David, even at that sub-group with the higher than 750, the differences on placebo were not statistically significant. We looked at the median LDL changes and there was no significant either at the 2-gram or the 4-gram dose. So we still did not raise the LDL in the group. 10

11 David Moskowitz Madison Williams Okay. And just, again, focusing the question on outliers, I imagine there might be a couple that are on the high end. Anything surprising there that? We don t have that data yet. The purpose of today s call was to give you the top-line data and we will be getting that in a few weeks time but we don t have and as I said, in the overall population, no difference on placebo; below 750, no difference; above 750, no difference on placebo. But we don t have that at the moment. But, Paresh, what we do know is the folks above the 750, the average range that we reported in the release was about 800, is that correct? If I have that right. Yes, yes. That s right. So at 800, most I mean just to put it bluntly, at 800, no statistical difference in LDL- C. Just to add a very quick point. The baseline median LDLs were actually normal or they were around between 80 mg/dl and 90 mg/dl. They were expected to go up and it still didn t go up. Yeah. David Moskowitz Madison Williams Excellent. And that is the same baseline that we saw in the Lovaza trials as well, I believe. Yes, very similar. Very similar. 11

12 David Moskowitz Madison Williams Okay. And then just looking at the statin-treated group, could you talk about why we might be seeing better triglyceride lowering in that group? And also, what happened to the LDL levels in that patient population? Paresh, you want to take that? Sure. The LDL elevation there was no significant difference in the LDLs between the 2-gram versus placebo or 4-gram versus placebo either on patients with statins or patients without statins. As to your question about why the statin-treated group responded better, that s an interesting question. I think it s possible that there s some synergistic effect between EPA and statins. We don t know yet. We d love to do more science around it and we are planning to do that. We also noted that the JELIS study was the only study to show an improvement in outcomes on top of statin therapy and that was with pure EPA so maybe there is some connection there. Also, you show a reduction in triglycerides and no increase in LDL in the JELIS study, a very large study, 18,500 patients with pure EPA. Unlike in (GISSI-P) study, which did not have statins, but we did see an increase in LDL-C there. So, you know, we look forward to getting more data on this. David Moskowitz Madison Williams I guess last question is you mentioned that there was 25% statin used in the MARINE trial and you called that sort of a real-world setting. Can you just talk about that a little bit? Is that really what we should expect to see in this patient population? And why didn t the Lovaza trials have 25% statin use? Let me make a few comments on that, David. You know, the Lovaza studies were done in the 90s when statin use was not that prevalent. If you do a study in this day and age, you cannot exclude patients from taking statins. As Joe said, it s the backbone of therapy. You have to allow patients on statin. The way we designed the study is that we did not exclude patients from having statins. We recommended that they discontinue unless it is contraindicated. So, for example, if the patient had a high risk for CHD based on ATP III guidelines, we wouldn t want to take them off the statins because it s not ethical to do that and it s not scientifically correct. We also think it s more real world today to allow patients to be on statins and then add the non-statin therapy, namely AMR101 in this case, on top of that. So that s how we did it. We didn t actually ask all the patients to be on statins but remember, the ANCHOR trial is different, where everybody would be on the statin, a priori as defined by the protocol; and those patients have baseline values of 200 to 500 mg/dl. So that s how we designed the study. 12

13 In the real world, we think many of these patients will be on statins because it has some triglyceride-lowering effect though it s not a potent triglyceride-lowering effect. And I would just like to ask Harold if he wants to add any comments to what I ve just said. Harold is more experienced with this, obviously. Harold E. Bays, M.D., FACP Louisville Metabolic and Atherosclerosis Center Medical Director Yes. Thank you, Paresh. I guess this is one of those situations where I should really thank the Amarin team because, just as Paresh mentioned, I mean you could have taken these two ways. You could have said, well, we re going to try to mirror this development program similar to that of prior omega-3 fatty acid development programs and what we re going to do is we will only include those patients who either are not on statin therapy or who must discontinue statin therapy and we could have done that and I can just say this and I hope I m not in trouble for saying this but, you know, one of the reasons there was an a priori evaluation in the statin-treated arm was because there was a belief among many that there may be less triglyceride lowering in the particular group being that statins can have significant triglyceride-lowering effect. So this was mainly this a priori analysis was done on the basis of science. It wasn t based upon anticipation of a better result, okay? And but again, to the credit of the Amarin team, it was felt that this was better reflective of real world and I m pleased to hear Paresh say it was the right thing to do. It was the ethical thing to do. So as an investigator in the trial from a practical taking care of patients standpoint, I have the option that if I had a patient who is on a statin and had very high triglycerides and I felt that stopping the statin was inappropriate that meant I could still enroll my patient into the trial. And as it turns out, you know, sometimes when you do things purely based upon science and doing what s right, it doesn t always pay off, but in this case, it did. And so as many of you have stated, I would just like to echo the comments that I ve heard from the people asking questions, firstly, I would also like to congratulate the Amarin team for what I think is a really good study from a scientific standpoint but also from a real world you know, what might happen from a patient s standpoint. Operator Thank you. Our next question is coming from the line of Duane Nash with Wedbush Securities. Please state your questions. Duane Nash Wedbush Securities Good morning and thank you for taking the questions. You mentioned an anticipated 2011 NDA filing. Would such a filing also include the ANCHOR results, if successful? 13

14 Let me take that one, Duane. This is Joe. We are in the process of working through that whole scenario. Clearly with this great data a year early, one could make arguments about separating the NDAs. So until we see that data, we will not know but I think all options are open but clearly, getting the data that we ve got now, we are busy assuming there s an NDA filing around this and then an NDA filing around the ANCHOR study as well and at least in our heads, I think right now thinking about two separate filings. However having said that, again, we re still very early into the data. We got it very late Wednesday night and the team has been, as you can imagine, very active over the Thanksgiving weekend preparing for today. Duane Nash Wedbush Securities And then one followup. Do you think it will be likely that you ll be able to get mention of the apparent synergy with statin drugs in the FDA label? We are ever so hopeful from the business side. I don t know if Declan or Paresh want to say anything about that. Declan Doogan, M.D. Amarin Corporation Chief Medical Officer Maybe I could answer that. I think it is unlikely you would see FDA allowing that in the label because it was not considered part of the protocol design or with the analysis plan. However, we will be negotiating, obviously, the most appropriate label with the FDA when the time comes. But I wouldn t actually look at that at this point. Duane Nash Wedbush Securities Is there any data that could come out of the ANCHOR trials that could further support the idea of synergy? Paresh, you want to take that? Thank you, Duane. We think that s possible. We re doing some in vitro work, which we re hoping to publish soon this year with an investigator at Harvard looking at potential lipid peroxidation effects with EPA plus statins and, in fact, also DHA plus statins. And we ve seen some very interesting data from that which we haven t disclosed as of yet, but there may be something that could come up from that. Just to add one more point to what Declan said, the statin subgroup in this population was 25% of the patient population. That s about just close to 60 patients and if you look at the slide in the website that we posted this morning with all the Lovaza trials, the six Lovaza trials, the largest trial there is actually only 42 patients and in fact, the total pooled number of the six trials is 190 patients which is still smaller than our 229. So what I m saying is the statin sub-group was, firstly, an a priori analysis. It wasn t a 14

15 posthoc analysis. And secondly, it was a significantly sized sub-group with about 20 patients per group. So I think we re in a good position a strong position to negotiate with the FDA some claims around that. However, as Joe said, it s too early to tell. Duane Nash Wedbush Securities Great. Well, thanks very much and congratulations. Operator Our next question is coming from the line of Ritu Baral with Canaccord Adams. Please state your questions. Ritu Baral Canaccord Adams Congratulations, guys, as well. My question goes actually back to the statin therapies that the MARINE patients were on. Looking at the dose of statins that these patients were on and the type of statins was there anything unexpected or anything that might be different between the MARINE population and the ANCHOR population? Paresh, you want to take that one? Thanks, Joe. Hi, Ritu. Actually, I don t have the data yet, you know, but I guess when you break it down into different statins in the 60 patients, subgroups are going to be quite small. I don t have the dose of them and I don t have the different statins used as yet, but we re looking forward to getting that data in the next few weeks. Ritu Baral Canaccord Adams Okay. And the statin dose that the patients were on was that fixed during the course of the trial? Yes, it was fixed but we didn t pre-specify any target LDL-C or anything. Basically, if the patient was in a background statin and controlled and they still had a triglyceride level above 500, they were eligible to enter the study provided they met all the other inclusion and exclusion criteria. Ritu Baral Canaccord Adams Great. And Joe, based on what you said about the volatility and stability of EPA versus DHA and going back to the safety and tolerability profile, are there any details within the data set that you have right now that would lead you to, I guess, be able to say anything comparatively between what tolerability might be between Lovaza and AMR101? 15

16 I would just say the following that if you look at their label, the Lovaza label that s on the website and you look at the results we have that are less than or better than placebo, little to no eructation, little to no dyspepsia, inflammation, skin rashes, again, I would say that preliminarily and, again, we re comparing Ns of 200 patients here and we re also doing that in terms of small Ns in terms of people affected but at least anecdotally, as a minimum, there appears to be something very significant there, okay, in the groups that I just mentioned. Ritu Baral Canaccord Adams Okay. And the data that you received today, one, do you think that it will that it essentially will be enough to support your new chemical entity extension on your patents? And will it have any impact on how you are designing the outcomes trial for the mixed dyslipidemia indication? Yeah. I would say the following, too, that these results have been the focus of an entire weekend of work on not just data compiling but on patent filing. And we were absolutely delighted to see many of the unexpected results whether it goes to inflammation, whether it goes to LDL, whether it goes to Apo-B or Lp-PLA2 and we actually think there s a big argument to be made here, as I said in my comments earlier, that we re looking at a platform here that could go well beyond what we re talking about today. Now having said that, it s on the heels of four days of review of the information but we re incredibly excited. In terms of the Outcomes point of your question, I m going to turn that over to Declan and Paresh who are better able to answer that. Declan Doogan, M.D. Amarin Corporation Chief Medical Officer Paresh, you want to take that and I ll follow up. Sure. I think it definitely helps us especially showing that both doses are active here in the study and that the combination with statins actually you get no blunting of the effect on LDL-C. In fact, you clearly get no change in LDLs whether you re taking a statin or not taking a statin and that the drug works in both populations. So in fact, I think some of these data underwrites the rationale for the outcomes study and the need to do an outcome study. And I think it s very supportive of the outcomes study especially the inflammatory markers that we ve seen like Lp-PLA2 improve and Apo-B improved. Apo-B is really an important new marker which is becoming more and more recognized by lipidologists and endocrinologists as representing the total atherogenic burden instead of just focusing on LDL cholesterol. We re waiting for more data especially on more inflammatory markers and we don t have it yet and we look forward to publishing things like CRP levels in the future. And all that really supports the outcomes study and underwrites actually our confidence in the outcomes study. I ll pass it on to Declan to add any more comments to that. 16

17 Declan Doogan, M.D. Amarin Corporation Chief Medical Officer I think that since we have Harold on the line here, it might be good to have his comments on the potential for an outcomes study with a product with the profile as we understand it today. Harold? Harold E. Bays, M.D., FACP Louisville Metabolic and Atherosclerosis Center Medical Director Well, I m a little hesitant to answer that question in that I know Paresh has assured me that certain things have been disclosed to everyone but I want to make sure I don t mess things up. So, Paresh, can you tell me where or tell everyone where we stand with what s the meaning of any planned outcomes study? What does that mean as far as labeling is concerned? So we have disclosed that an outcomes study will be supportive of the ANCHOR indication. We haven t started that yet but we re working with potential partners to fund that study and we have a protocol that s already being developed and in quite advanced stages. It will support the ANCHOR claim and we ve disclosed that in the past to investors and in our SEC filings. Harold E. Bays, M.D., FACP Louisville Metabolic and Atherosclerosis Center Medical Director When you say ANCHOR claim, can I ask you what is it okay to ask what that means when you say ANCHOR claims? This is in support of the treatment of mixed dyslipidemia in patients who are on statins who have a residual triglyceride level of 200 mg/dl to 500 mg/dl. Harold E. Bays, M.D., FACP Louisville Metabolic and Atherosclerosis Center Medical Director Okay. Am I permitted to comment on that? Yes, go ahead. We don t have too much time though, Harold. Harold E. Bays, M.D., FACP Louisville Metabolic and Atherosclerosis Center Medical Director Okay. Well, let me just say that know, if anyone were to obtain a treatment indication for triglyceride levels between 200 mg/dl to 500 mg/dl, I think that would be a big deal with regard to the clinical treatment of patients with hypertriglyceridemia. 17

18 Ritu Baral Canaccord Adams Great. Thanks, guys. Operator Our next question is coming from Mark Monane with Needham & Company. Please state your questions. Mark Monane Needham & Company Good morning. Thank you. Nice Thanksgiving for the company and potentially for many patients going forward. Congratulations. Two questions. One is sticking with a food theme, is this a tastes great, less filling result that we ve seen here in terms of the effect on triglycerides being positive in decreasing triglycerides as well as no effect on the LDL? Which one would you say is more clinically important at this point? This is Joe. Just to comment. To us as we still work through the data, I think we all expected it, the triglyceride lowering. The surprise was the LDL effect or the significance of the lack of effect. So I would say we re absolutely delighted with one. It s sort of like where one of your children coming home from the holidays, you re delighted. One you didn t expect to come home but he came home as well and but you re equally glad to have both of them. That s the only way I can speak to the elation that we feel right now. Mark Monane Needham & Company Okay. That was helpful. And then in followup, one often thinks about, in LDL at least, hitting the target, meaning as set up by the ATP guidelines. How important is it to hit the target here, meaning lowering triglycerides to 500 or below? Do you see benefits do you expect to see benefit for patients who have marked reductions in their triglycerides even if they don t make it to below 500? Paresh, you want to take that? I think it s more a question for Harold, I mean Okay. just to add quickly. For LDL, there s no goal here and these patients have normal baseline, the median baseline is normal anyway. For triglycerides, there is no treatment goal as far as I m aware according to ATP III guidelines. I don t know if that will change in the next version. Harold, you want to add something to that? 18

19 Harold E. Bays, M.D., FACP Louisville Metabolic and Atherosclerosis Center Medical Director Yes. I d like to actually comment to both of those last questions. The first question was what appears to be the most clinically significant to clinicians and I would say that the triglyceride lowering without the rise in LDL cholesterol will be what would be most important to many primary care clinicians, but I will tell you there s information that s been alluded to in the data set that we really can t get specific into that I think are going to be even more interesting to lipidologists, okay? So I mean that s all without being able to go through the entire data set, you know, I really can t explain that but I mean I think it is alluded to in the press release. As far as achievement of treatment goals, as you know, the manner in which triglycerides are addressed by the NCEP ATP III guidelines is through measurement of non-hdl cholesterol. And I know time is limited so I m not going through that other than to say that as stated in the press release and as announced here with the MARINE trial, AMR101 did significantly reduce non-hdl cholesterol which is essentially the manner in which elevated triglyceride level are assessed with regard to reducing or potentially reducing atherosclerotic risk. Mark Monane Needham & Company That was helpful. Thank you for the added information. Operator Our next question is coming from Edward Tenthoff with Piper Jaffray. Please state your questions. Edward Tenthoff Piper Jaffray Great. Thank you very much and congrats on the data. I think most of the questions have been answered. But if I could just ask a little bit around the IP strategy in terms of how some of these filings specifically you see extending the patent life. If you can give us a little bit more color there, that would be really helpful. Yeah and again, this is Joe. And again, we have to be careful as we re in the process of filing this but we already have an EPA greater than 80% patented out there. We have other patents on file that have to do with the formulation. We have patents to do with each of the studies and trials. You can envision IP around this LDL event that we ve just seen. You can look at the side effect profile that we ve just talked about in a number of patents. You can talk about the Apo-B and the Lp-PLA2 and those reductions or those effects of that continuing to build a fence around the IP story for this. Now, we ve already got a drug that s in some cases not in your 96% EPA purity and above and in many cases, 99% pure, very difficult to manufacture and when you have the results that we have in combination with the intellectual property around it, we feel very, very confident in discussing with our patent agents and officers and litigators that we re in a very good position right now. But it s all about, you know, can you build a portfolio, can you show that what you ve got now is a platform patent 19

20 estate. And what we think we believe we have right now is something that goes well beyond cardiovascular in my mind. Edward Tenthoff Piper Jaffray That s really great. Thanks for the added colored there and congrats on the data. Thank you. Operator And our last question is coming from the line of Jason Kantor with RBC Capital Markets. Please state your questions. Jason Kantor RBC Capital Markets Well, all of my questions have been asked. I just wanted to add my congratulations to everyone and say the data looks really good. Thanks. Thanks, Jason. Operator As this brings us to the end of our Q&A session, I will now turn the floor back over to management for any closing comments. Well, I would just state that, again, we re delighted to have everyone on the call today. I see from my list, there s well over 200 people at least officially online on the phone and many others on the website. And we re just thankful for the support of the community, our shareholders, but ultimately, this is about what s doing right for patients and we do think that what we ve got here and it s a culmination of a lot of great work by team Amarin who has put significant hours into making what we hope is a very revolutionary therapy for treating triglycerides without increasing LDL and ultimately benefiting patients around the world. And thank you. Operator Ladies and gentlemen, this does conclude today s teleconference. You may disconnect your lines at this time and we thank you for your participation. 20

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