rosemountbomber
11 hours ago
Kiwi, echo your sentiments about Led Zeppelin. Saw them at the Forum in Montreal in 1970. Heck I was 18 then. Where did all that time go. I used to have a grandfather who always told us about how fast time went, and we all thought he was just nuts....and old. Turns out he was right, and we were nuts. If wonder if that dynamic is because when we are young, we have very little past and are always looking to the future. When we are older, we deem ourselves to have little future left and a lot of past, that we look back on. Anyway, being in Amarin has definitely aged some of us long timers.
CaptBeer
16 hours ago
Today is Friday, April 26, 2024. The NHS UK English Prescribing data for Feb. 2024 is now in. I’ve prepared a 5-slide summary for your review. You may view and download the PDF Report by clicking on this link:
https://drive.google.com/file/d/185s43ixMkxbEHGuwgF6D6GyhH3ceVW5U/view?usp=sharing
Here is a brief summary:
Slide #1: There are at least 13 products representing CVD Lipid Lowering Therapies (LLT Agents) as shown on this slide. Tables #1-3 show the number of dispensed LLT’s as Capsules, Tablets, injections etc. and the percentage of the Total for each agent.
Slide #2: Monthly summary of the Total LLT Market.
Slide #3: Monthly summary of the VAZKEPA® *Note that Feb. 2024 was 3.09% less than Jan. 2024. However, the Total Market (Slide #2), was -5.53% less than Jan. 2024
Slide #4: Monthly stacked chart that compares VAZKEPA® (Blue) vs. Omacor (Orange). *Note that while VAZKEPA® dropped 3.09%, Omacor dropped 6.03%.
Slide #5: VAZKEPA growth vs. Omacor.
Good Luck to All!
TalShu
19 hours ago
CBB,
Novo Nordisk: a potential Partner / Acquirer?
Novo Nordisk, the first European pharmaceutical company, employs 64,000 people in 80 offices around the world, and markets its products in 170 countries.
In China, it employs:
- +140 research employs
- +1,700 production employees
- +4,400 commercial employs spread over 8 branches
WHAT IS MOST IMPORTANT IS NOVO NORDISK’S KEEN INTEREST in establishing its presence in the cardiovascular space according to its Aspiration 2025.
It is highly advisable to watch the sessions and/or review the (PDF) presentations of Novo’s last March 7th during investors-day dubbed Capital Markets Day 2024, namely:
1) Corporate strategy, purpose and sustainability and
2) Cardiovascular and emerging therapy areas on (https://www.novonordisk.com/investors/capital-markets-day-2024.html).
While Novo Nordisk’s core therapeutic areas remain Obesity and Type 2 diabetes – treated with Wegovy and Ozempic respectively - it highlights that the “Innovative and Therapeutic Focus” of its Aspiration 2025 is to establish presence in cardiovascular and emerging therapy areas.
With regard to the cardiovascular space that accounts for 32% of global deaths, Novo Nordisk seeks to focus its portfolio on multiple targets in key segments:
1. Atherosclerotic cardiovascular disease
a. Dyslipidaemia: Globally, one third of ischemic heart disease is attributable to high cholesterol.
b. Systemic inflammation: Around half of ASCVD patients estimated to have residual inflammatory risk.
c. Uncontrolled and resistant hypertension: a leading risk factor for CVD, HF, CKD and premature death.
2. Heart failure
a. Heart failure with preserved ejection fraction: HFpEF is associated with high morbidity and mortality.
b. Transthyretin amyloid cardiomyopathy: ATTR-CM is a progressive, life-threatening disease.
In this perspective, Novo Nordisk’s investment approach is to build competitive pipelines through:
The near-term focus on:
- maximizing Ziltivekimab; and
- STRENGTHENING PIPELINE THROUGH INTERNAL AND EXTERNAL CANDIDATES.
The long-term focus on pursuing:
- new MoAs; and
- disease modification
At present, Novo Nordisk’s presence in the cardiovascular space is limited to its development pipeline consisting of 6 candidates that are the outcome of selected acquisitions and partnerships. Its three-pronged Ziltivekimab program is in Phase 3 and due to terminate in beginning of 2006, 2007 and 2028. The other five candidates are in either Phases 1 or 2.
Novo Nordisk wants to leverage the overlap of patients in its core therapy area (Obesity and Type 2 diabetes) with ASCVD and Heart failure.
Last March 8, the FDA approved the weight-loss drug Wegovy for lowering the risk of stroke and heart attack in overweight and obese adults who DO NOT have diabetes. It is worthwhile recalling that the American Diabetes Association recommended Vascepa as standard of care in March 2019.
Diabetes drug Ozempic and weight-loss drug Wegovy are chemically known as semaglutide, belonging to a class of drugs called GLP-1 agonists. Originally developed for type 2 diabetes, they also reduce food cravings and cause the stomach to empty more slowly.
Patients who are obese or overweight are at “a higher risk of cardiovascular death, heart-attack and stroke. Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health” said FDA.
Millions of people already take Novo’s GLP-1 drugs, but the FDA’s stamp of approval for the heart benefits is likely to open their use to more patients.
So far, initiating and monitoring therapy with drugs like Wegovy has been deferred to the primary care team. At present, cardiology groups need to incorporate these therapies into clinic and build up a clinical workflow to manage dose escalation, side effects, and insurance approval.
Healthcare professionals should monitor patients taking the medicine for kidney disease, diabetic retinopathy and depression or suicidal behaviors or thoughts, the FDA said.
In November 2023, Novo Nordisk published the full data from a large clinical trial that showed the obesity drug reduced the risk of non-fatal heart attack by 28%, non-fatal stroke by 7% and heart-related death by 15%, compared with a placebo, in patients with pre-existing heart conditions.
In the 17,604-patient trial with a mean duration of 33 months, the difference in heart protective benefits began to appear almost immediately after starting treatment in those who received Wegovy, suggesting the positive impact was due to more than weight loss.
Novo Nordisk’s application for adding Wegovy’s heart benefits to its European approval is currently under review by the European Union’s drug regulator EMA. It expects a decision this year.
Wegovy, which has been shown to help patients lose an average of 15% after 68 weeks of treatment, was first approved by the FDA to treat obesity in June 2021.
Although NOVO NORDISK AIMS at creating the first STAND ALONE CVD DRUG, Wegovy’s list price of $1,349 for a package with a month’s worth of shots, coupled with supply and manufacturing shortages, may still make it interested in considering Vascepa.
As a reminder, to win its proxy war Sarissa proposed achieving three strategic goals in order to bring about a turnaround of Amarin’s business and maximize shareholder value.
Among them was rejecting past management’s “flawed” “subscale commercial strategy” which leads to “the destruction of shareholder value” because for a one-drug company to follow a GIA Strategy globally “a large marketing infrastructure becomes an unavoidable fixed-cost.”
By affirming that Amarin’s “commercialization of one product is inefficient” and “Another company already in primary care and cardiology would likely need little incremental expense to sell Vascepa,” Sarissa clearly inferred that Amarin should either collaborate with or be sold to a BP.
To back its statement, Sarissa presented a comparison of the enterprise value (EV) of Amarin’s $0.5 billion with that of companies with primary care salesforce namely, SANOFI, NOVARTIS, Pfizer, MERCK, Novo Nordisk and Lilly.
Novo Nordisk ranked the second highest with an EV at $309 billion. The latter has almost doubled in 14 months boosted by the sale of diabetes medicine (GLP-1) Ozempic and obesity medication Wegovy. This might have been one weak signal. (See pages 17 & 18 on https://freeamarin.com/wp-content/uploads/2023/02/presentation-slides-opt.pdf)
CaptBeer
19 hours ago
Hi North,
I suppose my intent and correlation to the new CP lies within the long historical view of regulatory agencies such as the FDA and the EMA reguarding triglyceride serum levels in patients, and their relationship to CVD risk reduction.
Long before the REDUCE-IT trial and even before the MARINE & ANCHOR trials, the FDA considered TG reduction like LDL-c reduction, as a surrogate for CVD risk reduction. That is precisely why the FDA offered an SPA to Amarin in the ANCHOR trial that guaranteed a CVD label if Amarin promised to be at least 50% enrolled in the REDUCE-IT trial.
Unfortunately for Amarin & us, there were several negative RCT’s whose endpoints were significant TG reductions. The three trials shown below and in the illustration, caused the FDA to change their mind about TG’s as a surrogate for CVD risk reduction. After the infamous ANCHOR ADCOM the FDA quickly (13 days), rescinded the SPA and issued a Clear Response Letter (CRL).
• FIELD (2005, Fibrate)
• ACCORD-Lipid (2010, Fibrate)
• AIM-HIGH (2011, Niacin)
Since that time even more evidence has shown that powerful TG reducing agents like fenofibrates in (PROMINENT, 2022), have shown no clinical ASCVD benefits. As the HealthyWomen CP indicates, it’s past time to revise the CVD wording on fibrate drug labels. In the illustration I posted, I included additional evidence that extends beyond fibrates to niacin’s and mixed EPA/DHA agents.
Omega-3 mixtures may not have yet reached the level of evidence that fibrates have, but nevertheless, after many negative OMG-3 trials and 2 highly successful and one borderline EPA trial, it’s becoming increasingly clear:
“It’s the EPA Stupid.” (It’s a phrase, not a pejorative).
JRoon71
20 hours ago
I think these are the key points to take away from our current situation, with the bolded being the most critical...and I agree that Holt is basically buying time until their Plan comes together. Otherwise, they would (like most companies planning for a long future) lay out a well-designed vision and strategic plan to shareholders. In reality, Holt (like KM did) is just talking in platitudes.
Not having a long-term strategic vision indicates that the Sarissa BOD does not intend to take shareholders on a long ride....
Unfortunately, Holt’s narrative projects a low resolution of what he really understands by operational momentum while not outlining what the BOD’s plan is...
As to R&D Holt said he cannot reveal what Amarin is engaged in beyond “Our very important R&D group continues to focus on global regulatory support, market access as well as our scientific publication strategy to support our product globally.”...
In between two “operational momentum” utterances Holt is simply rehashing the same narrative of KM, dressed up in a new “look” ...
Holt is here merely entertaining us; buying time...
In short, what we retain from Holt’s narrative is the BOD’s focus on immediate, short-term, execution...
Shareholders are thus called upon to have faith in the BOD, to believe in what the BOD believes in, namely, having the right plan based on operational momentum to maximize shareholder value and strengthen Amarin’s position for strategic options (understand: partnerships or Buy Out) within the short-term.
TalShu
20 hours ago
Ziploc_1,
First of all, allow me to make an addendum to my post.
Curiously, the standard 10-K 2023 paragraph on “Collaboration with Mochida” did not this time refer to any fees paid by Amarin to Mochida during the year (page 8 out of 91).
Such announcement was made through the notes to the consolidated financial statements which stated:
1) “research and development costs include . . . license fees to the Company’s strategic collaboration with Mochida Pharmaceutical Co., Ltd., or Mochida.” (page F-11/F-35);
2) “In January 2023, 2022 and 2021, the Company exercised certain rights under the agreement, resulting in payments of $1.0 million, in each of such periods, to Mochida, which was recorded as research and development expense in the consolidated statement of operation.” (page F-30/F-35).
Secondly, Amarin’s strategic collaboration with Mochida based on the famous 2018 Agreement is shrouded in complete secrecy. Thus, one cannot expect Amarin divulging any information in the forthcoming CC on May 1st.
As a reminder, Patrick Holt made four public appearances since assuming his role as President & CEO on August 18, 2023.
In his maiden public appearance at Cantor Fitzgerald’s Fireside Chat on 26 September he completely avoided answering the first question addressed to him: “What’s your company’s strategic vision? Where’s the company now and where do you want to see it in say three to five years from now?”
Holt did not have answer. He even seemed surprised by it.
IMHO, this was a weak signal. Not having a long-term strategic vision indicates that the Sarissa BOD does not intend to take shareholders on a long ride. We are indeed far away from Karim Mikhaïl’s proposal to accompany shareholders in writing the Third Chapter of the Book of Amarin over not less than fifteen years from cozy tax heaven Zug in Switzerland. This is most welcome.
For Denner, the role of the BOD is to oversee the CEO and not work for the CEO. Thus, Holt’s narrative builds on the founding statement that “For the Board of Directors, the best path forward today is to remain focused on accelerating operational momentum.” This will become Holt’s catchword, repeated over and over again to convey the BOD’s focus on immediate short-term execution to create shareholder value.
Here are some examples:
- “The Sarissa leadership is focusing on enhancing immediate, short-term, operational momentum in all three key geographic areas.” This translates to extending the life cycle in the U.S.; proving revenue uptake in Europe; and promoting global expansion through partnerships which admittedly is in an “early stage.”
- “the most important thing I want to share with you is that fundamentally, we're focused on enhancing operational momentum alongside our cash preservation
approach” that we believe will drive the stock price forward. We're confident that we can achieve this.”
- “We believe we have the right plan based on operational momentum to drive shareholder value.”
- “We believe this focus on operational momentum will maximize shareholder value and position us for the future.”
- “We firmly believe this focus on operational momentum is the best path forward for Amarin and will more strongly position us for future strategic options.
Controlling costs and preserving cash are essential.”
- With regard to M&A, “operational momentum is the best path forward at this time and, as a result, strengthens our position for strategic options.”
- “2023 was a meaningful year for operational momentum.”
- “We believe we have the right plan, focus, and operational momentum to drive shareholder value.”
- “We believe the best path forward for us to both increase our value and put us in the best possible place for future strategic options is, today, to focus on our
current efforts around operational momentum, whether that be in Europe, in the U.S., or in the rest of world.”
Unfortunately, Holt’s narrative projects a low resolution of what he really understands by operational momentum while not outlining what the BOD’s plan is.
As to R&D Holt said he cannot reveal what Amarin is engaged in beyond “Our very important R&D group continues to focus on global regulatory support, market access as well as our scientific publication strategy to support our product globally.”
In between two “operational momentum” utterances Holt is simply rehashing the same narrative of KM, dressed up in a new “look” – for instance, “proving revenue uptake in Europe will be key”; “Look, to speak very frankly, the U.K. is not one of the fastest uptake markets in Europe;” “there's really not one size fits all in Europe;” “We’re in the very early stages, very preliminary stages of reconsidering what might be opportunities for us to reconsider our position in Germany.”
Holt is here merely entertaining us; buying time.
In short, what we retain from Holt’s narrative is the BOD’s focus on immediate, short-term, execution. To put it in his words: “the focus in the immediate term is really on executing what we have in our hands.”
Shareholders are thus called upon to have faith in the BOD, to believe in what the BOD believes in, namely, having the right plan based on operational momentum to maximize shareholder value and strengthen Amarin’s position for strategic options (understand: partnerships or Buy Out) within the short-term.
What is comforting is that Sarissa has gained way over two years, when compared to the Ariad take over, by having had full control of the BOD and a CEO nominated within six months. This may seem to have facilitated the BOD’s stress on the short-term “operational momentum.”
couldbebetter
2 days ago
TalShu, You raise many excellent questions, as always. I wonder
if Mochida's EPA product will compete with Vascepa in China or if
Mochida will pursue their drug (eventually) for CVD in China? Unless
AMRN has some plan to salvage its relationship with Mochida they
could become a problem for AMRN. Given the exclusivity that AMRN
has in Europe until 2039 it may end up that the greatest value AMRN
has as a BO candidate, is the value that Vazkepa has in Europe. My
view remains that only a Eurocentric BP is capable of optimizing sales
of Vazkepa in Europe. In other words, unless AMRN has protected
one-a-day version(s) of Vascepa, a BO deal (sooner rather than later)
makes the most sense. I used to think that AMRN would have some
sort of one a day version of Vascepa, unless they do, they need a BO.
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DMC8
17 minutes ago
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