Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
PD,
Brain Cholesterol Regulates Alzheimer’s Plaques
That’s surprising
PREPARE-IT part 2 should avoid the failure of Fluvoxamine trial:
Placebo-Controlled Randomized Trial in Nonhospitalized Adults With Mild COVID-19
In this contactless, double-blind, placebo-controlled randomized trial, nonhospitalized adults with mild COVID-19 confirmed by SARS-CoV-2 polymerase chain reaction (PCR) assay within 7 days of symptom onset were randomized to receive fluvoxamine up to 100 mg three times daily or matching placebo for 15 days. The primary endpoint was clinical deterioration (defined as having dyspnea or hospitalization for dyspnea or pneumonia and oxygen saturation [SpO2] <92% on room air or requiring supplemental oxygen to attain SpO2 ≥92%) within 15 days of randomization. Participants self-assessed their blood pressure, temperature, oxygen saturation, and COVID-19 symptoms and reported the information by email twice daily.3
Participant Characteristics
A total of 152 participants were randomized to receive fluvoxamine (n = 80) or placebo (n = 72).
The mean age of the participants was 46 years; 72% were women, 25% were Black, and 56% had obesity.
Results
None of 80 participants (0%) who received fluvoxamine and six of 72 participants (8.3%) who received placebo reached the primary endpoint (absolute difference 8.7%; 95% CI, 1.8% to 16.5%; P = 0.009).
Five participants in the placebo arm and one in the fluvoxamine arm required hospitalization.
Only 76% of the participants completed the study, and 20% of the participants stopped responding to the electronic survey during the study period but were included in the final analysis.
Limitations
The study had a small sample size.
A limited number of events occurred.
Ascertaining clinical deterioration was challenging because all assessments were done remotely.
Interpretation
In this small placebo-controlled trial, none of the participants who received fluvoxamine and six (8.3%) of those who received placebo reached the primary endpoint. However, due to the study’s reliance on participant self-reports and missing data, it is difficult to draw definitive conclusions about the efficacy of fluvoxamine for the treatment of COVID-19.
Event rate of Fluvoxamine trial is about the same as Regeneron and GSK's, but the number of total participants and events are significantly different.
Total participants
- Fluvoxamine: 152
- Regeneron: 1484
- GSK: 583
- PREPARE-IT part 2: 2000
Total events
- Fluvoxamine: 6
- Regeneron: 31
- GSK: 24
- PREPARE-IT part 2: ???
If PREPARE-IT part 2 has event rate of greater than 2% (n=40), it should be enough for EUA if statistically significant.
The goal of PREPARE-IT part 2:
Two Anti-SARS-CoV-2 Monoclonal Antibodies have been approved for EUA, Casirivimab plus imdevimab, and Sotrovimab.
Casirivimab plus imdevimab: The primary outcome of COVID-19-related hospitalization or death from any cause was reported in 7 of 736 participants (1.0%) in the casirivimab 600 mg plus imdevimab 600 mg IV arm and in 24 of 748 participants (3.2%) in the placebo arm (P = 0.0024), demonstrating a 2.2% absolute reduction and a 70% relative reduction in hospitalization or death among the casirivimab plus imdevimab recipients compared to the placebo recipients.
Sotrovimab: The primary endpoint was the proportion of participants who were hospitalized (for ≥24 hours) or who died from any cause by Day 29. Endpoint events occurred in 3 of 291 participants (1%) in the sotrovimab arm and 21 of 292 participants (7%) in the placebo arm (P = 0.002), resulting in a 6% absolute reduction and an 85% relative reduction in hospitalizations or death among the sotrovimab recipients compared to the placebo recipients.
Both studies have relatively low event rates, but seems like it doesn't matter to FDA. If Vascepa can show the same effect (even slightly inferior effect is fine as long as statistically significant given its lower cost), that's a big win.
Does anybody know if Amarin has patent for COVID19?
From my recollection, the event rate of PREPARE-IT part 1 is about 6%, meaning about 120 events out of 2000 participants.
The other way around.
134 events in the PLACEBO arm
vs
98 events in the VACCINE arm
If PREPARE-IT part 1 showed the same results as Moderna, SP of AMRN will rocket. PREPARE-IT part 1 is for prevention in population with high exposure risk, and event rate is probably low (could be same as Moderna study). PREPARE-IT part 2 has totally different population from Moderna study.
Agree. Healthcare community is now very skeptical about new COVID-19 treatment partially due to recent ivermectin study in Egypt.
IMO, there is no way they can sell Kymriah at this moment.
https://www.pib.gov.in/PressReleasePage.aspx?PRID=1725254
Are they selling Kymriah (CAR-T)?
https://www.gnhindia.com/search/?search=KYMRIAH
Not sure if they are selling Vascepa or just posted on their website.
https://www.gnhindia.com/search/?search=Vascepa
As of July 12, P2 website was no longer recruiting. Not sure before that.
We may hear part 2 result anytime.
Amarin's Vascepa PREPARE-IT (n=4k) is wrapping up since inclusion has endedhttps://t.co/N9WJ0LxBJ6
— Everlast Research Group (@EverlastDD) July 11, 2021
Primary and study completion dates are June and July 2021. 4-28 days treatment arm and 4-60 days prevention armhttps://t.co/WrU2h9UGUx
Publication could be soon.$AMRN $MTNB pic.twitter.com/velzyM08rt
Causes of Non-Adherence
Patient-Related
Patient-related factors leading to non-adherence include low health literacy, lack of understanding of the disease being treated, attitudes concerning the effectiveness of the treatment, negative previous experience with pharmacological therapies, presence of psychological problems, and/or cognitive impairment
Physician-Related
Complex drug regimens prescribed by physicians, lack of adequate explanation about the disease and the benefits and potential AEs of medications, and multiple physicians with inconsistent messages all contribute to medication non-adherence.
Healthcare-Related
The economics of the health care market place severely limits the time a physician can spend with an individual patient. This can interfere with adequate patient education about medications, assessment of medication-taking behaviors and encouragement of adherence to prescribed medication regimens. The involvement of several physicians and the necessity of multiple visits to pharmacies to fill/refill different prescriptions, including different refill dates for patients’ prescriptions, predict worse medication adherence.
Multiple factors
NRx: A new prescription is defined as dispensed prescriptions given a new number by the pharmacy, not necessarily new therapy for the patient.
Per google search, Kaiser has 8 million in CA and Blue shield of CA has 4.5 million
duke, no, please forward it to IR. Thanks!
NS, I totally agree with you. If we expect short term win, we will disappoint.
NS, me neither. It seems that they don't intend to cover V (4 g a day) at all. Also, I don't know why they cover only 0.5 g capsule, not 1g capsule. It's a long battle.
NS, my point is GV is sold largely in CA. Blue Shield of California is the largest medical insurance provider in CA. Blue Shield of California does cover only 0.5g of V, 2 capsules a day (= 1g a day).
jasbg
Does anybody know which state/region GV is available? Does that state/region have specific insurance (eg, in Hawaii, HAWAII Medical Services Association: HMSA is dominant)?
That could be a happy problem for AMRN because only significant demand could cause it.
They launched GV this week, so we will see next week
Just variation
ESC congress 2021
PREPARE-IT: Icosapent Ethyl Versus Placebo in People Exposed to COVID-19
Speaker: Rafael Diaz (Estudios Cardiologicos Latinoamerica (ECLA) - Rosario, Argentina)
Cardiovascular benefits outweigh risks in patients with atrial fibrillation in REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial)
Presenter: Brian Olshansky (VETERANS HEALTH ADMINISTRATION - Iowa City, United States of America)
REDUCE-IT PRIOR MI: Reduction in Ischemic Events, Including Cardiovascular Mortality, with Icosapent Ethyl in Patients with Prior Myocardial Infarction
Assigned Presenter: Deepak Bhatt (Harvard Medical School - Boston, United States of America)
Explanations for contrasting results of REDUCE-IT vs. STRENGTH
Great Debate: controversy – do patients benefit from omega-3 fatty acids?
Omega-3 fatty acids differentially alter the expression of detoxification enzymes and nitric oxide bioavailability in endothelial cells during IL-6 exposure
Presenter: Preston Mason (Brigham And Women'S Hospital, Harvard Medical School - Boston, United States of America)
Omega-3 fatty acids differentially reduced expression of neutrophil degranulation-associated proteins in endothelial cells during IL-6 exposure
Presenter: Preston Mason (Brigham And Women'S Hospital, Harvard Medical School - Boston, United States of America)
Agree. If its size is about the same as Vascepa, would not have any positive effect on Amarin's future
zip, I asked Mochida's IR who said it (content volume and capsule size) is undisclosed as well as commercialize plan in US.
"Among other terms in the agreement, Amarin obtained an exclusive license to certain Mochida intellectual property to advance Amarin’s interests in the United States and certain other territories and the parties will collaborate to research and develop new products and indications based on EPA for Amarin’s commercialization in the United States and certain other territories. The potential new product and indication opportunities contemplated under this agreement are in relatively early stages of development."
https://investor.amarincorp.com/news-releases/news-release-details/amarin-and-mochida-announce-collaboration-future-development-epa
If MND-2119 is smaller and easier to be swallowed than Vascepa, it would replace Vascepa with new patent and exclusivity.
Mochida Pharmaceutical said on June 22 that it has filed for the Japan approval of MND-2119, a once-daily soft capsule version of its high-purity ethyl icosapentate (EPA) agent Epadel (ethyl icosapentate).This is an upgraded formulation of Epadel.
https://pj.jiho.jp/article/244669
Monk44
Given AMRN's API maximum capacity which is probably about 2,000 mt (= 300-350K scripts/week = about 2 billion sales) for the next 1-2 years, market cap $6-8 billion = SP $15-20 would be reasonable unless positive COVID trial. The more they have API capacity, the higher their market cap/SP will be