The Future Of Omega-3 Based Lipid Management: All Eyes On Amarin [View article]
Jeremy's Friend What you wrote has been pretty much my experience to date also regarding off label for the Anchor indication . They were tho prescribing for the Marine indication Reduce it trial is a high risk group so I think it's likely we see data before 2016 if Vascepa is showing clinical benefit.
Steve ...you are wrong if you think Primary Care MD's don't listen to Cardiologists ....they certainly care what well known " cardio docs" believe Gary
Can Amarin Make Me A Believer This Thursday? [View article]
Quoth Thanks for posting your thoughts... because it brings forth opinions from many of use invested in the stock as well as patients who use these drugs .
But ...a word of advice ...don't mess with Biotech bill ....he does more DD then I have hours in the day for. :)
As long as script data increases and Anchor proceeds with no hick ups ....I have to be long . I don't expect much from the coming CC ..I just don't want to hear " the next 90 days will be exciting " Gary
Amarin: The Bull Argument (Or How I Learned To Stop Worrying And Love Vascepa) [View article]
Bond If I may address the last part . Re BASF ---they have made it very clear that they intend to expand their presence in the high quality dietary supplement Omega 3 market in Europe. As you may know --Greece and Spain ( to some extent ) have reduced their co pays on Omacor ( Lovaza in Europe ). BASF I believe intend to offer high quality alternatives
As regards back lash --- I can report from actual experience " since you complained about Niacin , why should I prescribe you Vascepa until I see outcome data " --- summary of my conversation with a Cardiologist. He suggested dietary supplement Omega 3's until he sees Outcome data even tho Vascepa is currently cheaper with coupons and FDA approved. Gary
Amarin: The Bull Argument (Or How I Learned To Stop Worrying And Love Vascepa) [View article]
Adam As some one that reads your columns and also has coronary artery disease may I offer the following . 1) the news of the combination of the hydroxy derivative of a statin ( Lipitor ) and Vascepa on the effects on lipids is some thing to pay attention to ...and may represent a real advance in the treatment of mixed dyslipidemia ( the Anchor indication ) 2) regarding back lash .....well you can thanks patients like myself who routinely were prescribed Niacin ...and hated the stuff ..and then confronted our Cardiologists over the costs and discomfort of taking it only to find it didn't work as they hoped for. You were referring to the Thrive Trial I believe ...The Accord trial also raised concerns about Niacin
So yes , some Cardiologists respond by saying " take dietary supplement fish oils until we have outcome data "....however many patients want the FDA seal of approval and do not want to be taking dietary supplement fish oils at 3-4 gm doses ...,that's a fact.
So there will be a certain market for Vascepa ....those that have high or very high TG's and can't get their LDL cholesterol to target range , those that don't want DS alternatives , and those who may have mixed dyslipidemia and are aware of the benefits of Vascepa in lowering inflammation
Should the Vascepa and hydroxy derivative of Lipitor ever be approved ....then you are looking at a very large market ...which makes buying AMRN at around these levels worth it as a speculative buy. JMO Gary
Amarin's Fish Oil: Looking Beyond Triglycerides [View instapost]
Onecard....yes your comments help ...just need to convince my docs .. who aren't convinced without outcome data .. Anyway we know Vascepa works ...just look at how mellow JL 's comments are now .....no more " off with their heads " attitude of YMB days since he's been on Vascepa :) Gary
Amarin's Fish Oil: Looking Beyond Triglycerides [View instapost]
Iggy Great article and very well written I will just report a different view on OTC ( dietary supplement ) fish oils as presented to me by Cardiologists at UCSF . They maintain that if you thoroughly research the reviews of dietary supplement fish oils on ConsumerLab .com you can find fish oil supplements of good reliable quality to achieve much of the benefits of Vascepa....and that's what they suggest to their patients until the Reduce Outcome trial data is out . Appreciate your comments Gary
Amarin's Performance Issues: Here To Stay? [View article]
Dallas Yes you make a very good argument for the bull case at these levels. My position is more a speculative bull at these levels until the extent of Tier 2 pricing is known ----Vascepa's coupons expire at the end of 2013 I believe..
A good source of information on CV drugs etc is The Heart.org and Heartwire . There you will find video lectures by Dr Christie Ballantyne ( Anchor trial ) etc --- some of the Cardiologists I know regularly chk this site.
I have my issues with Amarin Mgt ...particularly their claim that the emerging focus on treating dyslipidemia is moving from focusing on LDL to TG's. In my experience Cardiologists are still very focused on lowering LDL cholesterol and if anything see more benefit in lowering inflammation then in lowering TG's that are under 400. Of course all this could change when the Reduce it Trial data comes out ....and we will look to you to break the news : )
Amarin's Performance Issues: Here To Stay? [View article]
Hi Dallas You need to talk to Cardiologists ..not your local pharmacy or "place of medicine " Lipitor was the "go to " drug in my experience for anything to do with lipid problems ----many primary care MD's still see it that way . Cardiologist however ( as they should be ) are far more targeted in what they prescribe. There is a reason why the Reduce it trial is designed to see if by adding Vascepa to a statin in treatment, is more effective then the statin alone . The reason is that substantial CV risk remains despite the use of the statin wether its Crestor or Lipitor...... They won't compete , rather they will compliement
The one area you failed to cover is the role of inflammation and Vascepa's ability to lower inflammation. Suggest you read up on that ---poster Jesse Livermore covers it very well on Ihub. Gary
Amarin's Performance Issues: Here To Stay? [View article]
Dallas ---a good read but Whereisthefire above is correct . Crestor at 40mg dose will lower LDL cholesterol by 63% but only lower TG's 10-35 %. Lipitor at 80mg dose will lower LDL by 60% but only lower Tg's by 19-37%.
I doubt anyone is taking Crestor or Lipitor solely to reduce TG;s . The competition for the TG market is between Lovaza , Vascepa and dietary supplement versions of both .
I'm glad you clarified the info on Reduce it --- the message boards were about to get all worked up over the suggestion of a preliminary data release Gary
Amarin (AMRN) says the FDA has accepted its supplemental new drug application for Vascepa and set a December 20 target date to complete its regulatory review. The company's seeking approval of the the cholesterol-reducing fish-oil pill as an adjunct to diet for the treatment of high triglycerides with mixed dyslipidemia. Shares +6.2% in pre-market trading. [View news story]
OmegaWatcher. I'm not sure you can Vascazen a " prescription " Omega 3. In my experience MD's prescribe FDA approved drugs and /or suggest / recommend dietary supplements regulated as food.
By the way , please post the clinical trial data to show that your product in particular is effective in reducing CV events
By Adding Cost Effective Suppliers, Amarin Looks To Gain Market Share With Vascepa [View article]
Raiphey , Stevie , Yazzbro , Stevie , Onecard , Mandrake et al
Thanks for those comments .....thoughtful and well presented . Most of the Cardiologists I know share the view of Dr Mozaffarian of the Harvard School of Public Health ---see " Higher blood omega -3's associated with lower risk of premature death among older adults ". As you know --JL on IHUB doesn't think much of Dr Mozaffarian . I should pt out that 3 of the Cardiologist I know are research scientists at UCSF and have between them published over 200 articles on coronary heart disease , lipids etc in peer review journals .
Re some of your comments . Raiphey Cardiologists in my experience look at the whole lipid profile , blood pressure and glucose levels ---TG's under 500 are almost seen as almost a side issue --- they focus on BP , Glucose and LDL levels first . Yes ---Vascepa lowers small particle LDL count --its the EPA in Vascepa that does that but other products with very high EPA such as Epadel used in the Jelis study, have a very similar effect . Yazzbro Yes you are correct ---Tier 2 pricing is essential ---- Amarins coupon program expires at the end of 2013 I believe . Without widespread Tier 2 pricing and low go pays , Vascepa is likely to be an expensive drug. Steve.alt OTC fish oils --- actually I think dietary supplement fish oils is the correct term , anyway ---the main problem with the meat studies is that the dose was usually to low . You need about 3 gms daily for 6 wks to really effect your lipid profile . For those who say " Well in Jellis they used 1.8 gm of EPA ( Epadel ) --those folks were on a high fish diet ---combined equals about 3 gms a day 90% DS EPA fish oil has little effect on LDL levels in my experience. Re LDL levels in general " Its a straight line function between LDL levels and CAD ( coronary artery disease ) risk " --direct from some one who has published over 100 research articles in the field. You are correct -- half the people who have heart attacks have normal cholesterol levels ---what they often have is high Hs CRP levels ( inflammation ) and/or high blood pressure. Vascepa lowers inflammation which is a good reason to take it ---however those I know believe the same effect can be achieved by using high quality DS alternatives. Onecard I agree with most of what you write ---currently Vascepa is a deal with the coupons . Those I deal with however won't prescribe it without Outcome studies showing clinical benefit . They some times refer to Niacin , which they prescribed for years until a recent trial showed little to no benefit.. Mandrake Price you quoted was with coupons I assume ---glad you got such a deal . What do you think the price will be if they don't get tier 2 with your provider after the coupons expire ?
Great conversation folks --appreciate the feed back Gary
By Adding Cost Effective Suppliers, Amarin Looks To Gain Market Share With Vascepa [View article]
Onecardchuck The problem for Amarin is that dietary supplement EPA does lower TG's very effectively without raising LDL cholesterol
The advantage Amarin currently has is its coupon program that makes Vascepa cheaper then the EPA alternatives. ( Vascepa is also a better product --96% pure and FDA approved and monitored ).
The risk for Amarin is what happens when their coupon program expires at the end of 2013 I believe ----what will be the co pay coverage at that time ---how expensive will Vascepa be if your health provider doesn't provide coverage ( my guess is about $6.80 per 4 gm daily dose )---- and most importantly --will companies like BASF enter the field with high quality 90% EPA supplement versions of Vascepa at lower cost
Just because Vascepa becomes FDA approved for lowering TG's between 200-500 , doesn't mean MD's will prescribe it . The Cardiologists I know want outcome data to show clinical benefit ( they don't accept the Jelis study ---it was open labelled etc ) and are far more focused on LDL cholesterol levels .
They disagree with Amarin --- they are not shifting their focus from LDL cholesterol levels to TG levels --- for most patients . The see TG levels as residual risk By the way they seem more interested in Vascepa's ability to lower inflammation ----something noted by JL posting on IHUB
By Adding Cost Effective Suppliers, Amarin Looks To Gain Market Share With Vascepa [View article]
Well Heather a nice over view of Amarin from 20,000 ft .
Let me offer the "boots on the ground " perspective from some one that is a CAD ( coronary artery disease ) patient and who has also participated in a clinical trial with a cardiovascular drug and has the distinction of having my application to participate in Amarins Reduce it trial rejected twice !
Actually , failing to qualify for the Reduce it Trial is a good thing ---it means they figure my life expectancy ( or politely -- risk of an 'event ' ) is greater then 5 yrs.
So "boots on the ground " perspective is that you need to read the research by Dr Dariush Mozaffarian -associate professor in the Dept of Epidemiology at Harvard School of Public Health . This research is dismissed by a noted poster on IHUB --Jesse Livermore -- who I should note has greatly educated me on how to improve my own lipid profile ---- however ---the Cardiologists I know ( 3 of which have published research in the field ) generally agree with Dr Mozaffarian.
The key pt of Mozaffarians research is " the importance of adequate Omega -3 levels for cardiovascular health " --- ie eat more salmon and eat less red meat ---something JL would agree with
The whole idea that there is this giant market out there consisting of patients with TG 's over 150 ---- for the most part IMHO is a fantasy . Most Cardiologists in my experience won't even prescribe for TG's under 400 if they can get you to change your diet and exercise more ----- note to Harvey who posts on Yahoo
The challenge for Amarin IMHO is to get Vascepa to Tier 2 insurance co pay with as many health providers as possible as fast as possible . Amarins coupon program expires I believe at the end of 2013 .
The main challenge for Amarin tho is that in my experience , the Cardiologists I know , do not agree with Amarins' management about the importance of trigylceride levels in the Anchor indication ( 200-500 ) ----they are , for the most part ,far more focused on LDL cholesterol levels and see TG's as a side show.
I said above " for the most part " because with CAD patients like myself they want TG's under 135 however they aren't willing to prescribe Lovaza ( risk of raising LDL cholesterol ) and won't prescribe Vascepa until they see outcome data from the Reduce it Trial . Until then its dietary supplement alternatives --- of which ,fairly high quality versions of Lovaza and Vascepa , they maintain , are now available.. Gary
The Future Of Omega-3 Based Lipid Management: All Eyes On Amarin [View article]
I've emailed Amarin for a list of prescribing MD's in my area .
Gary
The Future Of Omega-3 Based Lipid Management: All Eyes On Amarin [View article]
What you wrote has been pretty much my experience to date also regarding off label for the Anchor indication . They were tho prescribing for the Marine indication
Reduce it trial is a high risk group so I think it's likely we see data before 2016 if Vascepa is showing clinical benefit.
Steve ...you are wrong if you think Primary Care MD's don't listen to Cardiologists ....they certainly care what well known " cardio docs" believe
Gary
Can Amarin Make Me A Believer This Thursday? [View article]
Thanks for posting your thoughts... because it brings forth opinions from many of use invested in the stock as well as patients who use these drugs .
But ...a word of advice ...don't mess with Biotech bill ....he does more DD then I have hours in the day for. :)
As long as script data increases and Anchor proceeds with no hick ups ....I have to be long . I don't expect much from the coming CC ..I just don't want to hear " the next 90 days will be exciting "
Gary
Amarin: The Bull Argument (Or How I Learned To Stop Worrying And Love Vascepa) [View article]
If I may address the last part .
Re BASF ---they have made it very clear that they intend to expand their presence in the high quality dietary supplement Omega 3 market in Europe.
As you may know --Greece and Spain ( to some extent ) have reduced their co pays on Omacor ( Lovaza in Europe ).
BASF I believe intend to offer high quality alternatives
As regards back lash --- I can report from actual experience
" since you complained about Niacin , why should I prescribe you Vascepa until I see outcome data " --- summary of my conversation with a Cardiologist.
He suggested dietary supplement Omega 3's until he sees Outcome data even tho Vascepa is currently cheaper with coupons and FDA approved.
Gary
Amarin: The Bull Argument (Or How I Learned To Stop Worrying And Love Vascepa) [View article]
As some one that reads your columns and also has coronary artery disease may I offer the following .
1) the news of the combination of the hydroxy derivative of a statin ( Lipitor ) and Vascepa on the effects on lipids is some thing to pay attention to ...and may represent a real advance in the treatment of mixed dyslipidemia ( the Anchor indication )
2) regarding back lash .....well you can thanks patients like myself who routinely were prescribed Niacin ...and hated the stuff ..and then confronted our Cardiologists over the costs and discomfort of taking it only to find it didn't work as they hoped for.
You were referring to the Thrive Trial I believe ...The Accord trial also raised concerns about Niacin
So yes , some Cardiologists respond by saying " take dietary supplement fish oils until we have outcome data "....however many
patients want the FDA seal of approval and do not want to be
taking dietary supplement fish oils at 3-4 gm doses ...,that's a fact.
So there will be a certain market for Vascepa ....those that have high or very high TG's and can't get their LDL cholesterol to target range , those that don't want DS alternatives , and those who may have mixed dyslipidemia and are aware of the benefits of
Vascepa in lowering inflammation
Should the Vascepa and hydroxy derivative of Lipitor ever be approved ....then you are looking at a very large market ...which makes buying AMRN at around these levels worth it as a speculative buy.
JMO
Gary
Amarin's Fish Oil: Looking Beyond Triglycerides [View instapost]
Anyway we know Vascepa works ...just look at how mellow JL 's comments are now .....no more " off with their heads " attitude of YMB days since he's been on Vascepa :)
Gary
Amarin's Fish Oil: Looking Beyond Triglycerides [View instapost]
Great article and very well written
I will just report a different view on OTC ( dietary supplement ) fish oils as presented to me by Cardiologists at UCSF .
They maintain that if you thoroughly research the reviews of dietary supplement fish oils on ConsumerLab .com you can find fish oil supplements of good reliable quality to achieve much of the benefits of Vascepa....and that's what they suggest to their patients until the Reduce Outcome trial data is out .
Appreciate your comments
Gary
Amarin's Performance Issues: Here To Stay? [View article]
Yes you make a very good argument for the bull case at these levels.
My position is more a speculative bull at these levels until the extent of Tier 2 pricing is known ----Vascepa's coupons expire at the end of 2013 I believe..
A good source of information on CV drugs etc is The Heart.org and Heartwire . There you will find video lectures by Dr Christie Ballantyne ( Anchor trial ) etc --- some of the Cardiologists I know regularly chk this site.
I have my issues with Amarin Mgt ...particularly their claim that the emerging focus on treating dyslipidemia is moving from focusing on LDL to TG's. In my experience Cardiologists are still very focused on lowering LDL cholesterol and if anything see more benefit in lowering inflammation then in lowering TG's that are under 400.
Of course all this could change when the Reduce it Trial data comes out ....and we will look to you to break the news : )
Good luck, keep writing
Gary
Amarin's Performance Issues: Here To Stay? [View article]
You need to talk to Cardiologists ..not your local pharmacy or "place of medicine "
Lipitor was the "go to " drug in my experience for anything to do with lipid problems ----many primary care MD's still see it that way .
Cardiologist however ( as they should be ) are far more targeted in what they prescribe.
There is a reason why the Reduce it trial is designed to see if by adding Vascepa to a statin in treatment, is more effective then the statin alone .
The reason is that substantial CV risk remains despite the use of the statin wether its Crestor or Lipitor...... They won't compete , rather they will compliement
The one area you failed to cover is the role of inflammation and Vascepa's ability to lower inflammation. Suggest you read up on that ---poster Jesse Livermore covers it very well on Ihub.
Gary
Amarin's Performance Issues: Here To Stay? [View article]
Crestor at 40mg dose will lower LDL cholesterol by 63% but only lower TG's 10-35 %.
Lipitor at 80mg dose will lower LDL by 60% but only lower Tg's by 19-37%.
I doubt anyone is taking Crestor or Lipitor solely to reduce TG;s .
The competition for the TG market is between Lovaza , Vascepa and dietary supplement versions of both .
I'm glad you clarified the info on Reduce it --- the message boards were about to get all worked up over the suggestion of a preliminary data release
Gary
Amarin (AMRN) says the FDA has accepted its supplemental new drug application for Vascepa and set a December 20 target date to complete its regulatory review. The company's seeking approval of the the cholesterol-reducing fish-oil pill as an adjunct to diet for the treatment of high triglycerides with mixed dyslipidemia. Shares +6.2% in pre-market trading. [View news story]
I'm not sure you can Vascazen a " prescription " Omega 3.
In my experience MD's prescribe FDA approved drugs and /or suggest / recommend dietary supplements regulated as food.
By the way , please post the clinical trial data to show that your product in particular is effective in reducing CV events
Gary
By Adding Cost Effective Suppliers, Amarin Looks To Gain Market Share With Vascepa [View article]
Gary
By Adding Cost Effective Suppliers, Amarin Looks To Gain Market Share With Vascepa [View article]
Thanks for those comments .....thoughtful and well presented .
Most of the Cardiologists I know share the view of Dr Mozaffarian of the Harvard School of Public Health ---see " Higher blood omega -3's associated with lower risk of premature death among older adults ".
As you know --JL on IHUB doesn't think much of Dr Mozaffarian .
I should pt out that 3 of the Cardiologist I know are research scientists at UCSF and have between them published over 200 articles on coronary heart disease , lipids etc in peer review journals .
Re some of your comments .
Raiphey
Cardiologists in my experience look at the whole lipid profile , blood pressure and glucose levels ---TG's under 500 are almost seen as almost a side issue --- they focus on BP , Glucose and LDL levels first .
Yes ---Vascepa lowers small particle LDL count --its the EPA in Vascepa that does that but other products with very high EPA such as Epadel used in the Jelis study, have a very similar effect .
Yazzbro
Yes you are correct ---Tier 2 pricing is essential ---- Amarins coupon program expires at the end of 2013 I believe .
Without widespread Tier 2 pricing and low go pays , Vascepa is likely to be an expensive drug.
Steve.alt
OTC fish oils --- actually I think dietary supplement fish oils is the correct term , anyway ---the main problem with the meat studies is that the dose was usually to low .
You need about 3 gms daily for 6 wks to really effect your lipid profile .
For those who say " Well in Jellis they used 1.8 gm of EPA ( Epadel ) --those folks were on a high fish diet ---combined equals about 3 gms a day
90% DS EPA fish oil has little effect on LDL levels in my experience.
Re LDL levels in general " Its a straight line function between LDL levels and CAD ( coronary artery disease ) risk " --direct from some one who has published over 100 research articles in the field.
You are correct -- half the people who have heart attacks have normal cholesterol levels ---what they often have is high Hs CRP levels ( inflammation ) and/or high blood pressure.
Vascepa lowers inflammation which is a good reason to take it ---however those I know believe the same effect can be achieved by using high quality DS alternatives.
Onecard
I agree with most of what you write ---currently Vascepa is a deal with the coupons .
Those I deal with however won't prescribe it without Outcome studies showing clinical benefit . They some times refer to Niacin , which they prescribed for years until a recent trial showed little to no benefit..
Mandrake
Price you quoted was with coupons I assume ---glad you got such a deal . What do you think the price will be if they don't get tier 2 with your provider after the coupons expire ?
Great conversation folks --appreciate the feed back
Gary
By Adding Cost Effective Suppliers, Amarin Looks To Gain Market Share With Vascepa [View article]
The problem for Amarin is that dietary supplement EPA does lower TG's very effectively without raising LDL cholesterol
The advantage Amarin currently has is its coupon program that makes Vascepa cheaper then the EPA alternatives. ( Vascepa is also a better product --96% pure and FDA approved and monitored ).
The risk for Amarin is what happens when their coupon program expires at the end of 2013 I believe ----what will be the co pay coverage at that time ---how expensive will Vascepa be if your health provider doesn't provide coverage ( my guess is about $6.80 per 4 gm daily dose )---- and most importantly --will companies like BASF enter the field with high quality 90% EPA supplement versions of Vascepa at lower cost
Just because Vascepa becomes FDA approved for lowering TG's between 200-500 , doesn't mean MD's will prescribe it .
The Cardiologists I know want outcome data to show clinical benefit ( they don't accept the Jelis study ---it was open labelled etc ) and are far more focused on LDL cholesterol levels .
They disagree with Amarin --- they are not shifting their focus from LDL cholesterol levels to TG levels --- for most patients .
The see TG levels as residual risk
By the way they seem more interested in Vascepa's ability to lower inflammation ----something noted by JL posting on IHUB
Gary
By Adding Cost Effective Suppliers, Amarin Looks To Gain Market Share With Vascepa [View article]
Let me offer the "boots on the ground " perspective from some one that is a CAD ( coronary artery disease ) patient and who has also participated in a clinical trial with a cardiovascular drug and has the distinction of having my application to participate in Amarins Reduce it trial rejected twice !
Actually , failing to qualify for the Reduce it Trial is a good thing ---it means they figure my life expectancy ( or politely -- risk of an 'event ' ) is greater then 5 yrs.
So "boots on the ground " perspective is that you need to read the research by Dr Dariush Mozaffarian -associate professor in the Dept of Epidemiology at Harvard School of Public Health .
This research is dismissed by a noted poster on IHUB --Jesse Livermore -- who I should note has greatly educated me on how to improve my own lipid profile ---- however ---the Cardiologists I know ( 3 of which have published research in the field ) generally agree with Dr Mozaffarian.
The key pt of Mozaffarians research is " the importance of adequate Omega -3 levels for cardiovascular health " --- ie eat more salmon and eat less red meat ---something JL would agree with
The whole idea that there is this giant market out there consisting of patients with TG 's over 150 ---- for the most part IMHO is a fantasy . Most Cardiologists in my experience won't even prescribe for TG's under 400 if they can get you to change your diet and exercise more ----- note to Harvey who posts on Yahoo
The challenge for Amarin IMHO is to get Vascepa to Tier 2 insurance co pay with as many health providers as possible as fast as possible . Amarins coupon program expires I believe at the end of 2013 .
The main challenge for Amarin tho is that in my experience , the Cardiologists I know , do not agree with Amarins' management about the importance of trigylceride levels in the Anchor indication ( 200-500 ) ----they are , for the most part ,far more focused on LDL cholesterol levels and see TG's as a side show.
I said above " for the most part " because with CAD patients like myself they want TG's under 135 however they aren't willing to prescribe Lovaza ( risk of raising LDL cholesterol ) and won't prescribe Vascepa until they see outcome data from the Reduce it Trial .
Until then its dietary supplement alternatives --- of which ,fairly high quality versions of Lovaza and Vascepa , they maintain , are now available..
Gary