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.
No. Amarin has eight-days to respond to opinion.
So HAS probably won't have anything to say before then.
Do you have any info regarding HAS conference held yesterday?
U.K. Draft Agenda for 1/11/22 meeting
https://www.nice.org.uk/event/tacc-january-2022
Also known as the reasonable idiot standard.
without the full legend the likelihood anyone could randomly pick the correct p value for USPTO overrule purposes is... as we've seen, statistically low.
If only Du could've known non-significance on cropped-table
... EPADI (and Ziploc) argue, then it would have made a world of difference
The two bottom lines cropped from the table indicated that the difference in APO-B between the active and passive arms of the Kura study was NS (i.e.non significant) ... This is what made the cropping so important for judge Du's decision in favor of obviousness.
EPADI's case is so weak ...
... that they alternate between hinting they may bring a derivate suit against Amarin and demanding Amarin throw their reputation in the trash by joining frivolous claims of fraud and hallucinations about cropped tables.
EPADI's case is so weak ...
... that they are now going to a third party asking them to "convince" Amarin to join their lawsuit and subject themselves to Rule 11 sanctions. (Maybe you coulda breaka some legs.)
EPADI's case is so weak ...
... I'm beginning to think they are a front for a short hedge fund.
I guess if EPADI's suit had a substantive legal basis there would not be any need for such groveling. But, hey, if Jim Jones says drink the Kool-Aid there are always people that will. Line up.
Yea, but you're the guy ...
utterly and completely devoid of merit
Maybe, just maybe ...
Amarin's non-participation is the result of corporate covering up of negligence
Really now; please point out all this negativity.
His comment sounds really negative about PIT 2 result
You should write novels.
Probably he was too nervous to ignore the question because he was almost against the rule.
Why can't he say nothing.
He can't say anything, but "no".
Botto said "no" was not referring to P-IT-2
If Dr. Botto was referring to PIT2
Okay, who asked HLS CEO this question?
https://renmark-drupal.s3.amazonaws.com/vndr/hls-therapeutics-inc/2021-10-05/index.html
Click on Slide 24 on the video.
If the rage fits ...
It is really curious what the publication of a scientific publication generates in the investors of a drug…
The profile of these people is repeated: aggressive and arrogant.
It's just science .
Individual vs. full reimbursement in Denmark
Amarin hasn't received "full" reimbursement yet, and thus why Amarin has not PR-ed,
-------------------------------------------
In some cases, you can get individual reimbursement for your medical expenses, which means that the reimbursement grant is given to you personally.
Your doctor assesses your needs and applies for individual reimbursement to us.
Application
If the doctor's application for individual reimbursement is approved, we will send the grant to your e-Boks. If you are exempted from using e-Boks, we will send the grant by ordinary mail. If your name and address information in the CPR register is protected and you do not use e-Boks, we will not send you information about the grant.
https://laegemiddelstyrelsen.dk/en/reimbursement/individual-reimbursement/
ECLA certainly leaves something to be desired
The list of clinical trials on their website is years out of date, and never contained the PREPARE-IT studies
The Argentina National Registry of clinical trials (ReNis) contains no entries for PREPARE-IT.
Orlandini told me in late May that there were regulatory reasons making it impossible to getting REDUCE-IT 3 underway - yea, no shiite, I wonder how the FDA would feel about a CRO that didn't place their studies on the clinicaltrials.gov site.
OT - After verifying from two Danish sources that Vazkepa was fully good to go in Denmark, I reached out to IR this morning and asked why this milestone had not been announced.
And KM did say
He should be bringing smaller pharmaceutical companies on to sell Vazkepa in smaller European countries rather than trying to sell the small company's product.
Okay, I have mulled it over
take some time and mull it over
So, KM is telling small pharmaceuticals ...
duke, yes it is how I'm interpreting it. Potential partner should meet the following criteria:
1) cardiometabolic space
2) small company
3) not launched in EU yet
It's more a not-so-veiled-threat to PFE
what KM said might even be consistent with PFE as a “partner”
Curfman pushing the CV patent obviousness defense today
Even if Amarin can show infringement, to prevail in this lawsuit, it will have to face an invalidity challenge. The challenge will most likely focus on the JELIS study. That study purportedly suggested that purified EPA could reduce cardiovascular risks in patients with abnormal lipid levels who were on statin therapy.
During the prior Nevada lawsuit, the parties debated the relevance of the JELIS study. Amarin argued that the JELIS study was flawed, whereas the generics argued that Amarin had previously relied upon the JELIS study in its bid to the FDA for a cardiovascular indication Vascepa®. Either way, JELIS presents a validity challenge to the patents now asserted by Amarin, and this will likely form a focal point of the case.
Amarin appears to have contemplated this in selecting patents to assert against Hikma. One very interesting patent is the ‘537 patent. This is not a homegrown Amarin patent. Rather, this patent is owned by the Japanese company, Mochida Pharmaceutical, which is the manufacturer for Epadel, another EPA drug. (This is likely why Mochida is a plaintiff in this lawsuit.) Even though Amarin does not own this patent, it has an exclusive license, which permits it to bring suit.
The ‘537 patent has an earlier priority date than the other two asserted patents. During prosecution, the ‘537 patent also appears to have preliminarily overcome considerable prior art related to JELIS in the process of being granted by the Patent Office. Moreover, the patent is based upon the Saito article, which studied the use of EPA in patients enrolled in JELIS with no history of cardiovascular events. Therefore, the ‘537 patent is likely to be very important to this case.
https://blog.petrieflom.law.harvard.edu/2021/09/23/fish-oil-patent-battle/#more-30373
Who you gonna believe ...
... the SA author or your lying eyes? Unless of course you don't think the official Denmark links indicating "marketed" and "reimbursable prices" mean anything.
This SA author assumes Denmark doesn't approve until H1/22
Subsidized cost of Vazkepa in Denmark
Prescriptions in Denmark are not part of the free health care system in Denmark. You are given an allowance and only pay a portion of your costs. How much you will pay is based on a sliding scale. Here is how it works. If you are over 18 the following applies to you.
Although you need to pay for your prescriptions, some medication is reimbursable. You will be given an allowance for medication on the reimbursable register, which is worked out according to a sliding scale as follows, over a 12-month period:
• DKK 0 – 980 (€130): 0% of reimbursement
• DKK 980 – 1625 (€130 – 217): 50% of reimbursement
• DKK 1625 – 3520 (€217 – 471): 75% of reimbursement
• over DKK 3520: 85% of reimbursement
• over DKK 19,078 (€2553): 100% of reimbursement
Whenever you buy a reimbursable medicine, it is automatically reported to the Central Reimbursement Register (CTR). This will be monitored by the health authorities, so the more your CTR balance grows within a reimbursement period of one year, the more reimbursement you will receive. This is partly to ensure that people with chronic illnesses needing a large number of repeat prescriptions do not end up paying a fortune.
Footnote: There are also subsidies for people with chronic illness, people who may be dying and or in financial difficulty. These must be approved via your physician and the Lægemiddelstyrelsen.
So, by my calculation. Vazkepa for a year if you don't have private or supplemental insurance will cost about 4109 kr or $648 USD. Many folks will have supplemental insurance that will cover the non-reimbursable portion of the public system cost. The $235 per month I posted earlier was in Norwegian Kroner instead of Danish Krone. The monthly cost of 2,017 Danish Krone comes out to $318 USD (271 euro) before subsidies are applied. These costs include V.A.T. (25%) and fees, which of course Amarin will not share in. Coincidentally, removing the V.A.T. and fees gets us back to about $235 give or take a couple bucks but I don't know for sure how much the fees are.
https://medicinpriser.dk/default.aspx?lng=2
http://xnet.dkma.dk/indlaegsseddel/leaflets/leaflets.faces
https://www.expatfocus.com/denmark/health/prescriptions-in-denmark-what-is-available-and-how-to-ensure-you-get-the-right-level-of-care-5728/
Vazkepa in Denmark is cost reimbursable
https://medicinpriser.dk/default.aspx?lng=2
Can't say for sure
Does this mean that the drug is now available in Denmark?
Cost of Vazkepa in Denmark - 2.017,90 Kroner
As of 9/20/21
$235
https://min.medicin.dk/Medicin/Praeparater/9844
Look under "Pakninger, priser, tilskud og udlevering"
Probably within 1-2 months after "publication date"
... before drugs in England make it into the NHS
Could be a little quicker with berotralstat (orphan status)
https://www.nice.org.uk/guidance/indevelopment/gid-ta10736
https://www.nice.org.uk/guidance/indevelopment/gid-ta10650
France is likely to have economic assessment completed and reimbursement set before U.K.
https://drugdevelopment.labcorp.com/content/dam/covance/assetLibrary/salessheets/Pricing-Reimbursement-France-SSCMA053.pdf
Moderator thanks sponsors ...
... HLS and Pfizer
https://www.investorvillage.com/uploads/87669/files/IPE_Symposia.pdf
This was incredibly well-done and came across as a very objective look at IPE rather than hyping Vascepa. If webinar becomes available I would recommend viewing - HLS and Pfizer will certainly be encouraging doctors to watch. Preston Mason presentation was very good as were most presentations that I saw.
Bhatt just slams Copenhagen meta-analysis study.
https://www.investorvillage.com/uploads/87669/files/IPE_Symposia.pdf
Even if Mitigate events increase now with Delta
... it will not yield interim analyses when they are in the home stretch
Event rates may have been low at the time that statement was made ....June ?
No interim analyses in Mitigate
Aggregate event rates (blinded and both groups pooled) have been reviewed on a monthly basis and they are overall low. Thus, they will have to wait for follow-up to be complete to achieve any potentially meaningful results.
After everyone had read the KM NJ interview
Th article had a note appended three days later:
(Editor’s note: While the cash price for the heart medicine Vascepa is 77% more than the generic for non-insured patients, Amarin, the company that makes the drug, said the wholesale list price is 12% higher.)
Bhatt indirectly to Nissen: Get over it
Bhatt emphasized that the mineral oil issue alone cannot explain icosapent ethyl's benefits.
"The issue of placebo choice and potential changes in biomarkers has been thoroughly reviewed by the FDA, Health Canada, and the European Medicines Agency, all of whom have granted a broad approval for icosapent ethyl that largely mirrors the REDUCE-IT inclusion criteria," he said.
"Furthermore, for anyone who cannot get over the issue of placebo choice, icosapent ethyl has also been studied in two other randomized trials which did not use any placebo that still show its benefits – JELIS with a significant 19% reduction in clinical endpoints and CHERRY with a significant benefit on intravascular ultrasound endpoints," he added.
https://www.medpagetoday.com/meetingcoverage/esc/94270?fr=operanews
https://www.ajmc.com/view/reduce-it-vs-strength-still-missing-pieces-in-the-omega-3-puzzle
Thanks much for posting JBW.
Amarin has it right in a parallel universe ...
... where times are reversed
The presentation is at 2 pm CEST or 8:00 am ET.
PREPARE-IT PRESENTATION SATURDAY AT ABOUT 5:30 p.m EST
Late Breaking Trials - COVID-19
Topic: Other
Session type: Late-Breaking Science
Date: 28 August
Start time: 23:00
End time: 23:45
Channel: Channel 1 - COVID-19
Presentations
Colchicine in Patients Hospitalized with COVID-19; Speaker: Rafael Diaz (Estudios Cardiologicos Latinoamerica (ECLA) - Rosario, Argentina)
The Michelle trial: Medically Ill hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis with rivaroxaban ThErapy; Speaker: Eduardo Ramacciotti (Science Valley Research Institute - Santo Andre, Brazil) Ramacciotti_MD
Insights into the Effects of the COVID-19 Pandemic: Comprehensive Analysis from the GUIDE-HF Trial; Speaker: Michael Zile ( Medical University of South Carolina & VA Med Ctr - Charleston, S C, United States of America)
PREPARE-IT: Icosapent Ethyl Versus Placebo in People Exposed to COVID-19; Speaker: Rafael Diaz (Estudios Cardiologicos Latinoamerica (ECLA) - Rosario, Argentina)
https://digital-congress.escardio.org/ESC-Congress/sessions/2520-late-breaking-trials-covid-19
Risky new plan
...says the Jersey columnist
Company behind heart drug could have folded after loss in courts. Instead, it goes all-in with risky new plan
https://www.nj.com/business/2021/08/company-behind-heart-drug-could-have-folded-after-loss-in-courts-instead-it-goes-all-in-with-risky-new-plan.html
Then, in March 2020, U.S federal courts invalidated several patents for Vascepa, opening the door to generic competition and potentially shrinking sales of the company’s once-promising drug.
Amarin’s stock price fell by 50% virtually overnight.
The court rulings could have been a death sentence for a company like Amarin. Instead, it has rebounded with a risky, unusually aggressive strategy for a small drugmaker that markets and sells a single pill.
Karim Mikhail, Amarin’s CEO and a 22-year veteran of Merck, said the company will launch sales of Vascepa next month in the European Union and plans to expand into Asia and Africa next year. The company also has added sales staff to battle generic drugmakers for U.S. sales.
“People who fought for the value that this product brings to the market are not letting go today,” he said. “They risked their careers … to prove a point that this product brings enormous benefit.”
It plans to thread the needle to profitability with overseas sales and fighting off U.S. generic competitors by pushing doctors to prescribe Vascepa to more heart patients. Here in the U.S., it must do so by selling a drug that on average costs 77% more than generics.
J.P. Morgan analyst Jessica Fye still believes Vascepa will be successful, she said in investor notes, but sales will ramp up over 10 years.
This month, former Amarin CEO John Thero was succeeded by Mikhail, Merck’s former chief marketing officer in Europe and emerging markets. His appointment and the expansion of Amarin’s sales staff indicated the company plans to go it alone.
“Investors may be disappointed in the transition and that it may signal no near-term merger and acquisition on the table (which is the clear and primary bull case to the stock),” Jefferies analyst Michael Yee wrote in a recent investor note.
Big pharmaceutical companies typically buy up startups to avoid the risk and expense of drug development. But companies like Amarin are rarely acquisition targets, according to studies by Michael Kinch, director of the Center for Drug Discovery at Washington University in St. Louis.
Vascepa joins a long list of cardiovascular drugs over the past two decades dominated by blockbusters marketed by Pfizer, Merck, Schering-Plough and AstraZeneca.
The most commonly prescribed heart medicines are today available as low-cost generics. And generics typically capture 95% of the brand-name’s sales three months after generic drugs hits the market, according to Wall Street analysts.
The generic version of Vascepa, has not experienced that level of success.
Mikhail said Vascepa was notoriously difficult to manufacture and the raw ingredients difficult to acquire in bulk. “Clearly, the generics never thought they would win this case,” he said. “The evidence is they were not ready with supply.”
The FDA says Vascepa’s mechanism in action to reduce stroke and heart attacks is “not completely understood.” Amarin claims the drug has anti-inflammatory properties and it has announced several academic centers are studying Vascepa as a possible treatment for colorectal cancer as well as Covid.
Mikhail said preliminary Covid study data is scheduled for release next week at the European Society of Cardiology Congress.
“You look at what Covid patients die from, they mostly die because of an inflammatory storm,” he said. “If the study is positive, and it has value in delaying progression in Covid patients … that would be incredible.”
It would also give Amarin another escape hatch to deliver shareholder value.
Permits licensee to do something otherwise prohibited
is there some technical definition to license
HLS needed Amarin consent to sublicense to Pfizer
2.1.3 Licensee’s Right to Sublicense. Licensee shall have the right to sublicense those rights granted to it under Sections 2.1.1 and 2.1.2 to (a) Affiliates, subject to Licensee’s prior written notice to Amarin of the identity of such Affiliate and the purpose of such sublicense, and (b) Third Parties, subject to first obtaining Amarin’s prior written consent (such consent not to be unreasonably withheld, conditioned or delayed) (each of (a) and (b), a “Sublicensee”); [***]