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If BO now, $15-20 would be reasonable. If GIA and able to expand API capacity smoothly, $50-100 in 5-10 years is not unrealistic.
NS, my prediction is 2,000,000 scripts/week only in US in 10 years.
PD, totally agree. I don't think they should sell authorized generic vascepa at this moment.
Everybody underestimates the potential of icosapent ethyl (IPE). To say the least, IPE will be sold in 10 million people in US in the long run (in 10-15 years), so as in EU and China, meaning 30 million TAM.
In order to cover 30 million people, we need 50K mt of API which almost equals to a maximum capacity of EPA production in the world. Currently, about 1 million mt of fish oil is produced a year, only about 10-15% of which (100-150K mt) is consumed by human, and only 0.2% of which (2K mt) is pharma grade fish oil (EPA, EPA/DHA). The company who has more API will win.
NS, CCSB's current capacity is 100 mt/year = 16,000 scripts/week. By next year, it will be 300 mt/year = 50,000 scripts/week.
It seems that they will most likely finish recruitment in August or September, and need to wait additional 6 months. Readout may be at the end of this year, or early next year.
Result of MITIGATE?
Join us tomorrow to discuss pragmatic RCTs embedded within an integrated and learning health system. @asgmd1 @ThidaChanTan @rvparikh @MDSolomonMD @DrRichardIsaacs @norcalcath @irenechen_md @texhern https://t.co/b6rWx9KLwt
— Andrew P. Ambrosy, MD (@KPHeartDoc) June 18, 2021
at least twice
2019
https://investor.amarincorp.com/static-files/efd8259f-7919-4599-b623-00acc6cc9611
and so on
2020
https://investor.amarincorp.com/static-files/7b804a94-abd3-4fbc-b6bc-184ba1278033
https://investor.amarincorp.com/static-files/fbce2a40-20fb-46f2-8434-b4e668e59d69
https://investor.amarincorp.com/static-files/19c60090-4721-42c7-9161-733e5fcae0b1
https://investor.amarincorp.com/static-files/05298a27-0cbb-4c6c-8f28-c88125812106
I see. Thank you for letting me know!
STIPULATION AND ORDER that Amarin's time to answer, move or otherwise respond to the Complaint is extended until 7/19/2021. Signed by Magistrate Judge Zahid N. Quraishi on 5/24/2021.
https://www.pacermonitor.com/public/case/40022951/DR_REDDYS_LABORATORIES_INC_v_AMARIN_PHARMA,_INC_et_al
I don't know exactly why, but likely related to sensitive, confidential info, or trade secret
Yes, everybody except for Amarin is upset because they can't infringe
They have enough supply for MARINE indication
"This Case is Under Seal." per PACER.
My point is Lovaza/Epanova most likely increase EPA/AA level without CVD benefit, which is why EPA/AA level itself should not be a treatment target. I think important thing is EPA level in the blood relative to DHA level.
Let's say AA level is the same in R-IT and STRENGTH, and AA=50. (I assume that DHA would not affect EPA level or AA level).
EPA/AA ratio: (We don't know exact number)
- Placebo in both trials: 25/50 = 0.5
- Strength: 90/50 = 1.8 (follow up study recently published in JAMA cardiology: 120/50 =2.4)
- R-IT: 150/50 = 3
In STRENTH trial, even EPA/AA level 3-5 time higher than placebo, there was no CVD benefit. That is why we (including you?) are thinking DHA is inhibiting the effect of EPA. I think the higher DHA level is, the more it is inhibiting EPA effect.
Yes, they are definitely aware of Vascepa, but have decided not to cover it for some reason.
Kiwi, it seems that US insurance companies don't care ICER report, not like NICE guideline in UK.
Kiwi,
At NLA summer of lipids conference June 4-6, I did NOT see any physicians/PhDs/dietitians who disagree with remarkable Reduce-IT trial result despite recent STRENGTH trial.
He gets a kick of fighting with or defeating somebody. Just ignore him.
https://www.cleveland.com/medical/2008/04/conflictofinterest_concerns_ra.html
Why can't facts/evidence change people's mind?
I haven't read this book yet, which may answer why he is so stubborn.
https://www.amazon.com/Influential-Mind-Reveals-Change-Others-ebook/dp/B06XC621TK/ref=sr_1_1?dchild=1&gclid=Cj0KCQjwweyFBhDvARIsAA67M70uCituWUocBjF5mWSJ9udsGZEBdUuCwd3jvyJWYexcdc5hjQHAF5QaAmqOEALw_wcB&hvadid=255823189637&hvdev=c&hvlocphy=9032812&hvnetw=g&hvqmt=e&hvrand=3821260865638581933&hvtargid=kwd-355962951492&hydadcr=22560_9636788&keywords=the+influential+mind&qid=1622956004&sr=8-1
Kiwi, I don't have any comment on EPA/AA ratio other than the following quote.
Kiwi, I don't think lowering TG level is enough given negative study in DHA/EPA, fenofibrate, etc. EPA level is also not enough due to STRENGTH trial. Could be EPA/DHA ratio in the blood?
Dr. Peter Libby has changed my viewpoint regarding HDL.
The Omega-3/Fish Oil/EPA War
https://www.amazon.com/Cholesterol-Wars-Skeptics-Preponderance-Evidence/dp/0123739799
Everybody, let's subscribe it and give 5 stars!
The Anti-Inflammatory and Antioxidant Properties of n-3 PUFAs: Their Role in Cardiovascular Protection
(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7554783/)
Fatty Acid Treatment with Pure Omega-3 Eicosapentaenoic Acid Ethyl Ester for Patients with Cardiovascular Diseases: Differences between Branded (EPADEL®) and Generic Products
(Fatty Acid Treatment with Pure Omega-3 Eicosapentaenoic Acid Ethyl Ester for Patients with Cardiovascular Diseases: Differences between Branded (EPADEL®) and Generic Products)
Background: Omega-3 polyunsaturated fatty acids (PUFAs) have some protective benefits for patients with coronary artery and cerebrovascular diseases. Eicosapentaenoic acid (EPA) drugs are prescribed as branded (B: EPADEL?) or generic products but no data exist concerning the differences in treatment outcomes between these products. Methods and Results: We investigated the differences in the serum levels of EPA, docosahexaenoic acid (DHA) and arachidonic acid (AA), and the EPA/AA ratios through blood sampling six months after daily administration of 1800 mg of EPADEL? and a generic EPA drug was initiated for 96 patients with cardiovascular diseases. All patients received these PUFA treatments while continuing with baseline therapy. After 6 months of administration, EPADEL? produced better results than the generic (G) product (EPA; baseline: 59.4 ± 25.5 µg, B: 215.5 ± 58.8 µg, G: 199.7 ± 63.8 µg, B vs G, p < 0.0005; AA; baseline: 197.4 ± 44.6 µg, B: 158.3 ± 36.3 µg, G: 163.6 ± 38.9 µg, B vs G, p < 0.02, as mean ± SD). Conclusions: There were clear differences between EPA branded and the generic products. Further study is required to determine whether the benefits from the branded product justify the higher price compared to the generic drug cost.
Effect of omega-3 dietary supplements with different oxidation levels in the lipidic profile of women: a randomized controlled trial
(https://pubmed.ncbi.nlm.nih.gov/23863036/)
Health effects of oxidized EPA and DHA oils (https://onlinelibrary.wiley.com/doi/full/10.1002/lite.201600013)
Research on the health effects of oxidized EPA and DHA omega-3 oils is still emerging, but there is no evidence that normal usage of omega-3 oils results in adverse health effects due to oxidation. Some researchers have expressed concern that oxidative products from oils may promote cardiovascular issues or cancer. The fear is that consumption of oxidized products will lead to inflammation and oxidation of tissues in the human body.
This is a controversial issue. The literature does not clearly de- monstrate whether oxidized lipid products in our food effectively enter our bodies, or whether they play any significant role in com- parison to the established roles of oxygenated lipids that are used in our body as signaling substances. Our bodies are well-equipped to handle oxygen, and we also consume a certain level of oxidized lipids in our normal diets. In fact, some oxygenated lipid products produced within our bodies are believed to be beneficial, particu- larly in both initiating and resolving inflammation. Whereas oxi- dized lipids may be formed and employed locally by the body in inflamed tissues, it does not mean ingesting the same or similar substances from rancid oil would deliver the substances at the same concentration to the same tissue and have the same biological ef- fect. The fear that oxidized lipids present in food are unhealthy is likely over-stated because the suggestion is that anything oxidized is bad. Like most unwanted molecules derived from food, any ab- sorbed substances are typically dealt with quickly by first-pass me- tabolism in the liver, and for peroxides and reactive species in parti- cular by the multiple antioxidant systems in the body. In addition, we have an innate aversion for consuming rancid foods, which ef- fectively self-limits our ingestion of food items that are oxidized.
In 2012, GOED commissioned a thorough safety assessment of EPA and DHA that concluded: “Studies in both healthy and un- healthy populations looked at effects on specific lipid oxidation or oxidative stress parameters, which are difficult to interpret. End- points such as TBARS, lymphocyte phagocytic activity, in vitro or ex vivo determination of lag time and oxidation rate of LDL, and in
vitro rate of formation of conjugated dienes do not appear to have a strong evidence base to support their validated in vivo relevance as biomarkers for a disease or compromised health state [3].”
Two studies assessing the health impacts of oxidized fish oils have been conducted to date in humans [4, 5]. Both studies were gold-standard randomized, double-blind, placebo-controlled trials and both compared the impact of a highly oxidized fish oil, a regu- lar fish oil, and a placebo on a wide variety of established markers of oxidation and antioxidative systems.
In the first study, after seven weeks of supplementation with 8 grams of oil per day, the authors found no signs of oxidative stress in any of the groups after looking at nine different measures (4-HHE, 4-HNE, 8-iso-prostaglandin F2a, alpha-tocopherol, total glutathione, glutathione reductase, glutathione peroxidase, catalase, and C-Reactive Protein) of oxidative stress in the blood and urine [4]. This study demonstrated that high dosages of highly oxidized fish oil do not induce oxidative stress in our bodies.
The second study was conducted by the same group and used the same study design, but looked at four additional markers of oxida- tive stress related to vascular inflammation (intercellular adhesion molecule 2 (sICAM-2), soluble vascular adhesion molecule 1 (sVCAM-1), interleukin 6 (IL-6) and oxidized LDL cholesterol) [5]. Again, no impact on these markers was found with consump- tion of abnormally oxidized fish oil.
Dozens of human studies have measured the effects of consum- ing regular EPA and DHA supplements on oxidative stress in hu- mans as well. Overall, the evidence suggests that intake of commer- cially available products does not increase markers of oxidative stress in humans, but rather to the contrary, beneficially reduces some of these markers. Furthermore, the current understanding of these observations points to the role of EPA and DHA as sensors for oxidative stress in the body that activate our antioxidative de- fenses to help us protect our bodies from oxidation.
It should also be noted that some oxidation products from EPA and DHA may actually be beneficial to health. Nakagawa et al. ob- served that 4-HHE increases after fish oil consumption and protects vascular function [6].
Most toxicology studies with respect to oxidized oils have been conducted in animals utilizing dosages or levels of oxidation that are unrealistic in the human diet. The animal studies conducted on consumption of oxidized oils have primarily used vegetable oils and have identified isoprostanes, malonaldehyde, and 4-HNE as potentially atherogenic and genotoxic compounds. However, in the past 15 years:
• 35 human clinical studies have measured the effects of EPA and DHA oils on isoprostane levels, nearly all of which have found either no effect, or reductions in the levels of these mar- kers [send request for reference list to info@goedomega3.com]. The couple of studies that observed increases in isoprostane lev- els were at very high dosage levels or in conditions where the body was put under stress.
• 20 human clinical studies have measured the effects of EPA and DHA oils on malondialdehyde (MDA) levels, and none have observed an increase in MDA levels [send request for re- ference list to info@goedomega3.com].
• One human clinical study has measured the effect of EPA and DHA oils on 4-HNE and found no effect [4].
Pain up to 16,000 scripts/week is expected based on generics' capacity.