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Thanks Capt for the additional requirements info !!
One of the key differences in Canada vs. most EU countries is that in Canada each Province & Territory has its own set of processes and procedures to gain access and reimbursement. They still don't have all on board. They just last week obtained British Columbia.
exwannabe: You should read Amarin’s opening brief (document 15, filed 3/21/2023) as well as the remaining briefs filed in case 23-1169 still pending before the CAFC. The transcript of oral arguments held in early April 2024 is archived. You may discover that what you are saying/opining is not free of controversy in this case.
Agreed........it's kind of like.....DHA is great for the brain...... the challenge is how do you get it to the brain? IF generic V is equivalent to brand V, it doesn't have the same bio-availability because of inferior delivery.
Zip, when generics are approved the PK/PD is evaluated by the FDA to insure they are "the same".
So the degree to which the issue exists, it has been blessed by the FDA. And that makes it a tough argument to make that the FDA is wrong.
Not saying the FDA is not wrong, just saying not an easy fight.
My GP already knew about V so made it easier. Would like to get my wife on it. 10 years younger than me but
she is remission from Lymphoma a couple of years ago and has suffered from Crohn's for many years. Not sure
if V would help. Never know until we do know.
This study is interesting because it shows that higher intensity statins are more effective in reducing LDL-c, and by extension reduces CVD risk more than low-intermediate statins? This assumption has been used often (especially in Germany) to promote the idea that REDUCE-IT would have been less effective if all the patients were on high intensity statins.
However, we know from recent REDUCE-IT findings (ACC24 and others), that CVD RR is significant and consistent regardless of statin type or intensity or LDL-c levels. And… BTW regardless of TG or Lp(a) levels. All of this demonstrates that the MOA for VASCEPA® is along different pathways than traditional LLT’s.
Dare I say it again? “It’s the EPA stupid.” And the EPA/AA ratio.
FYI - I googled to understand when we might get the Appeal decision and got this....
Finnegan
Federal Circuit Basics: Managing the Substance and Procedure of a Patent Appeal
After the case is argued and submitted, the Federal Circuit will issue a decision and enter judgment.64 Written opinions may be designated as precedential or nonprecedential. Additionally, the court may issue a summary affirmance under Federal Circuit Rule 36. Timing can vary depending on the case and the panel, but the average time from argument to decision at the Federal Circuit for precedential patent cases is about three to four months.65 For nonprecedential patent cases, the average time from argument to decision is a little over one month.66 And summary affirmances under Federal Circuit Rule 36 are typically issued within a week of oral argument.67 In 2018, the Federal Circuit summarily affirmed in 42% of its patent decisions.68
JRoon
What are the key difference for how Vazkepa will be marketed in EU vs Canada ?
How big of a difference will these make, in your opinion please
If France, Italy, and Germany eventually approve a reimbursement plan then the EU market is about 10x Canada (equal+ to USA).
Originally Canada had 5+ year revenue goals for Vascepa of 80-100MM dollars
Why will Vascepa sell in EU if Canada sales have been less than stellar
I really was hoping for big win in Canada that would give strong confidence for Europe reapplications
TIA
Epadel 900 has a much higher dosage does it not? Copied from your link.
Dosing schedule (How to take this medicine)
·For improvement of ulcers, pain and coldness associated with arteriosclerosis obliterans : In general, for adults, take 600 mg of the active ingredient at a time, three times a day, right after each meal. The dosage may be adjusted according to age or symptoms.
For hyperlipidemia : In general, for adults, take 900 mg of the active ingredient at a time, twice a day, or 600 mg at a time, three times a day, right after meals. If the triglyceride level is abnormal, the dosage may be increased up to 900 mg at a time, three times a day, depending on the degree of abnormality.
This medicine contains 900 mg of the active ingredient in a packet (45 capsules). Strictly follow the instructions in any case.
Nice job RT...... I need to try asking mine again....... last time I asked, I had to tell them what V actually was.
Asked my GP for a prescription for Vascepa at my annual physical exam even though I do not
have any indications other than being over 65. Asked for a DAW.
CVS charging me $9.
My prescription coverage is through UHC
Happy to pay this price...hope it stays the same
the description says "granular" form. Is Vascepa granular or powder form?
Out of curiosity, how are the generic EPADEL pills packaged?
Epadel is in gel caps with individual doses packaged in a high barrier foil packet. Most likely MA inside the packet too. There's more than one way to skin the oxidation cat and Mochida went the packaging route vs loose pills rattling around in an open to atmosphere bottle with a thicker gel cap. So you really cant say if Mochida would be on par with Generic as it's a different system entirely.
https://synapse.inc/medicine/11513/Agents_affecting_metabolism/EPADEL_S900
True, I've been saying it for years.
Amarin has the patent on its superior encapsulation, which affords better lab and clinical results than the encapsulation that generics are using.
This introduces the question of whether generic V is really "biosimilar" to Vascepa!...It is something that Amarin or a BP that acquires should explore.
North, I agree. That was my point. HLS is not doing this at the behest of Amarin.
HLS is in trouble, and they need to drive revenue and cut costs as much as possible.
If PFE were the potential prospective buyer, there would be no reason for HLS to end its Vascepa partnership with Amarin...It would need to be another BP that has expressed significant interest in buying Amarin.
Of course, we retail shareholders would be last to know.
Reading the HLS PR, the Canadian outfit is terminating the agreement with PFE for its benefit, not Amarin’s benefit.
Public may share its views on competition in the healthcare industry with task force HCMC, Healthcare Monopolies and Collusion, by contacting:
HealthyCompetition.gov
DOJ antitrust division has formed a task force to investigate monopolies in healthcare sector, per CNBC-TV.
I wonder whether that investigation will help share price of AMRN in small cap sector.
We had similar issues when we co-promoted with Kowa early on. They weren't selling enough to offset the royalty.
But Amarin has no control over how HLS sells their products. Why would HLS do this for Amarin's benefit?
Thanks Capt. So is their encapsulation roughly the same method as generic IPE?
Thanks, I've posted this many times.
The ending of the Pfizer partnership in Canada with HLS is in my opinion a definitive signal something is brewing. Denner is cleaning the slate for the buyout most likely.
Yikes! All mine in IRA. Sweet!
Oakmark CEO was just on CNBC-TV talking about healthcare. He liked Centene’s new management; recall a settlement in AMRN’s past involving Hikma and a Centene subsidiary. No mention of PFE, AMRN, or HLS Therapeutics in Canada.
HLTRF currently quoted at $3.45. No chart or news provided by TD Ameritrade for that ticker symbol
Yes to all those taxes you mentioned. Not sure if you are old enough and on Medicare or not, but higher incomes jack up your Medicare premium as well. Another thing that irks me is that there is only one break point for cap gains. What I mean is investments held less than a year and those more than a year. It would be nice if there was some additional treatment for investments held 5 and 10 years. Before 1986, you could also average your income over 4 years, but not since then. I also seem to think, if my memory serves me, that it was the same administration that started the taxation of SS benefits.
The 225K was for US market. It would be a lot lower for Canada but a lot higher than V
I don’t know the details of how the market is split. I do know that Pfizer recently had a drug approved for ATTR-CM (VYNDAQEL)which costs around 225k a year. I am sure even if that is the case, with the limited time they have, the reps are going to focus on that as they will make a lot more money on that.
To your point though, Canada was never going to be a big driver of revenue and financial success for the company.
Chromosome , isn't the market in Canada split between Cardiologists and Primary Care with PFE only marketing to Primary Care ?
It would seem that since the R-IT trial was mostly secondary prevention CAD patients ...Cardiologists would be the main market .
Primary Care have enough trouble keeping their CAD patients on Statins which are very low cost and in the case of Crestor at least ...small pills and only once a day .
Secondary prevention patients ( prior MI , stroke etc ) are probably more willing to add 4 large caps to their daily med routine .
But IMHO all this is largely irrelevant to AMRN's bottom line .
Their main challenge is to gain more reimbursements in the EU and ramp up sales there before US revenue declines any faster then already seen in Q1 numbers
Kiwi
ORBAPU (or Capt), do we know if Epadel uses the same encapsulation method as Vascepa?
Here is a study of branded EPADEL vs. generic from 2020.
https://www.scirp.org/journal/paperinformation?paperid=103416
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.
This is what I'm hoping for. All of my shares are in taxable accounts, and I have a LOT of shares (200K). I already have significant earned income, so that, plus cap gains, plus my state cap gains (7%), plus NIIT tax (3.8%) is a killer. I'm looking at 31% tax on gains that I would love to defer over a few years (that would help avoid that high cap gains rate and NIIT tax).
Yes the time factor a rep has with a doc is an important mention. A lot of docs are not that fond of rep visits and if they are a busy practice they want to get back to their waiting patients. If it is a practice with no patients then the rep can visit with the doc all day but it won’t matter since that doc is writing hardly any scripts. Like you say a million times zero is 0.
JRoon, that's my point.....we don't know if they've looked into this.
In a tangential note to you mentioning holding shares of a possible acquiring company. If the acquisition price is significant enough (>$5 per share), it would definitely be preferable to have the deal go down as cash + shares, or just shares, as that would enable postponing to a degree cap gains taxes and minimizing higher income effects to other things such as Medicare premiums escalation.
Exactly…I get the rationale for choosing PFE in Canada as a partner but to your point, in the hierarchy of what the reps carry in their bags, V was probably somewhere in the bottom. Given limited time with physicians, reps are lucky to bring up two drugs in their bag. Even an army of sales reps can’t change that dynamic since a million times 0 is still zero (well you get the analogy)
Ram, do you really think that a bunch of Monday-morning quarterbacks on an anonymous internet forum know more about the scientific studies being done on IPE than the scientists that run the largest provider of IPE?
Honestly, that's crazy-talk.
The one thing we do know is that we don't know if they did any research on this already.
Not necessarily. What this highlights is the poor return of partnerships. I believe JT mentioned this dynamic when considering partnerships in the EU. V just becomes one out of a hundred other drugs in the salesperson’s bag. Plus they will usually focus their efforts on pushing the drugs that are most profitable to their company. Only way BP really pushes V is if they own it.
J.T. had intentions of making Amarin into a BP by using Vascepa revenues to develop new indications for EPA meds and to acquire additional meds...Now Denner has intentions of selling Amarin to a BP with more assets
In retrospect, I believe that Amarin could actually have become a BP if everything hadn't came crashing down, due to the judge DU decision and the lack of U.S. courts' enforcement of infringement laws...I hope that Denner is more successful than J.T. was and I look forward to holding shares in the fortunate acquiring BP.
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