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anti, "Low doses of aspirin -- as little as 81 milligrams per day, or the amount found in one chewable baby aspirin -- can reduce the risk of repeat heart attacks by about 20 percent in those who have already experienced one. In people who suffered from unstable chest pain, the use of aspirin cuts the risk of second heart attacks by 50 percent. The Food and Drug Administration approved aspirin for this use in 1985, but the practice is still underused,"
It takes time. Be patient.
https://www.washingtonpost.com/archive/lifestyle/wellness/1997/08/05/aspirin-the-worlds-most-popular-pill-turns-100/caa961d1-c7a4-42c7-b1ac-550193a9a21f/
liz, thanks for posting, more detail below:
Ionis Pharmaceuticals announces Pfizer update on vupanorsen study
Ionis Pharmaceuticals (IONS) announced that Pfizer (PFE) has provided an update on the Phase 2b study of vupanorsen, formerly IONIS-ANGPTL3-LRx. Vupanorsen is an investigational antisense therapy being developed for indications in cardiovascular, or CV, risk reduction and severe hypertriglyceridemia, or SHTG. In the dose-ranging study in subjects with elevated non-HDL-C and triglycerides, or TG, the study met its primary endpoint, achieving a statistically significant reduction in non-HDL-C at all doses tested at 24 weeks, compared to placebo. In addition, subjects treated with vupanorsen achieved statistically significant reductions in TG and ANGPTL3 at all dose levels at 24 weeks, compared to placebo. The most common adverse events were injection site reactions, which occurred most often in the highest vupanorsen dose group. The most common laboratory abnormalities were increases in liver enzymes, alanine aminotransferase and aspartate aminotransferase and were seen primarily at the higher doses. There were no Hy's Law cases in vupanorsen-treated subjects, and no meaningful changes in bilirubin. Certain doses of vupanorsen were associated with increases from baseline in hepatic fat fraction, measured by magnetic resonance imaging proton density fat fraction at Week 24, compared to placebo. No subject had a confirmed platelet count abnormality or a confirmed reduction in the estimated glomerular filtration rate. There were no serious adverse events related to treatment. The incidence of SAEs was similar between active and placebo groups. The global multicenter, double-blind, placebo-controlled, dose-ranging Phase 2b study TaRgeting ANGPTL3 with an aNtiSense oLigonucleotide in AdulTs with dyslipidEmia enrolled 286 participants with dyslipidemia, defined in this study as participants with elevated non-HDL-C and TG, who are receiving a stable dose of a statin. Participants received either 80 mg, 120 mg or 160 mg every 4 weeks, or 60 mg, 80 mg, 120 mg or 160 mg every two weeks via subcutaneous injection. The study was designed to assess the efficacy, safety, tolerability and pharmacokinetics of vupanorsen, and the primary endpoint was percent change from baseline in non-HDL-C at week 24.
jas, what sour day? Amarin is up!
Thanks Ns. Judge Hall's opinion came out on August 3rd, 2021 and the hearing was on 5/26/21. That's 10 weeks from hearing till opinion. Judge Andrew's hearing was on Oct 8, 2021, so using the same timeline, his ruling should be around 12/17/2021.
hay, Judge Hall's opinion came out on August 3rd, 2021 while Judge Andrew's hearing was on Oct 8, 2021. Do you or anybody remember Judge Hall's original hearing date? Once you have that date, you can estimate when will Judge Andrew issue his opinion.
one, I'll rule out acquiring pipeline assets hence secondary offering. In the covid era, KM should be smart enough to delay acquiring any drugs to add to sales rep's bags. It would be like selling ice to the Eskimos. Furthermore, Amarin doesn't even have a person in charge of business development so I don't see how it can even identify the right pipeline asset.
Please forward to KM who should copy Novartis:
Novartis AG bet big on its new cholesterol-busting drug. To overcome the tricky market for new heart medicines, it is pursuing an unconventional strategy that turns the traditional drug launch on its head.
Rather than seeking to grab the attention of patients and winning support from individual physicians, the Swiss pharmaceutical giant is focusing on the people who run large hospital systems. Its pitch: A large-scale rollout of the drug, called Leqvio, could avert thousands of heart attacks and strokes.
Despite heart disease being the No. 1 killer in the U.S., the strategy could prove challenging to pull off. It would count on the endorsement of cardiologists, who are often hesitant to adopt new treatments when they already have a bevy of tried-and-trusted medicines in their arsenal. It would also depend on the support of insurers, who have previously been reluctant to pay for pricey new heart drugs.
But if Novartis succeeds, it could unlock a lucrative market that has proven tough for others to crack. Leqvio was at the center of Novartis’s $9.7 billion acquisition of The Medicines Co. two years ago. The drug would need to hit $3 billion to $4 billion in annual sales to justify the price tag, according to analysts. Novartis says it expects Leqvio to become one of its biggest sellers.
Novartis plans to promote Leqvio to doctors through its existing sales force for heart-failure drug Entresto. But, unlike other big drug launches, sales representatives won’t play the starring role. “We’re talking about thousands of reps that we’re not hiring,” said Marie-France Tschudin, president of Novartis Pharmaceuticals.
The company says it plans to approach around 200 hospital systems across the U.S. It wants to help them identify, through electronic health records, heart patients who struggle to control their cholesterol with existing drugs. The hospital would then offer these patients Leqvio to prevent further heart problems, in a process more akin to a vaccine drive than a drug launch. Novartis expects to finalize agreements after the Food and Drug Administration completes its review of Leqvio, which the company expects early next year.
Central to the idea is that hospitals would set criteria for eligible patients and set up systems to identify them “instead of having each physician making a call for that individual patient,” said Ms. Tschudin.
Some health systems already take this so-called population health approach. “That proactive management is not new to us,” said Mike Evans, chief pharmacy officer at Danville, Pa.-based Geisinger, which runs 13 hospitals in Pennsylvania. “An ounce of prevention is a pound of cure.”
https://www.wsj.com/articles/novartis-rethinks-sales-strategy-for-new-cholesterol-drug-launch-11637510400?mod=hp_lista_pos3
rose, that's for EU. US might work differently.
Novartis plans new sales approach for cholesterol lowering drug - WSJ
https://seekingalpha.com/news/3773170-novartis-plans-new-sales-approach-for-cholesterol-lowering-drug-wsj
https://www.wsj.com/articles/novartis-rethinks-sales-strategy-for-new-cholesterol-drug-launch-11637510400?mod=pls_whats_news_us_business_f
Note that Novartis' drug has not yet gain US approval and is still waiting for its outcome data.
I think AMRN should copy NVS's approach (NVS target LDL level) using electronic health records targeting TG>150 mg/dL level.
After digesting last week's activists' news, I think we need to leverage IHUB posters' collective AMRN shareholding (20M shares based on my estimate) to
1) request a direct dialog, perhaps direct line with Mike Kalb (don't want to bother our capable CEO KM), with the company in order to improve shareholder value
2) contact activists such as Denner to express our support to their activist effort
We should strike while the iron is hot and not waste our collective shareholding power. May I nominate Lizzy and the Captain?
Teva's en banc request was filed on Oct 7, 2021:
https://fedcircuitblog.com/wp-content/uploads/2021/10/Petition-18-1976.pdf
So we should know the answer shortly.
Ns, I am the furthest from being a legal mind and would appreciate if board legal eagles could weigh in.
kiwi, thanks for the detailed reply. I might buy some KZR if the upcoming secondary is priced at a good discount.
Ns, this one for you:
Know Your En Banc Petition Process—How An En Banc Petition In GlaxoSmithKline v. Teva Led To A New Panel Argument Without Apparent En Banc Action
https://www.jdsupra.com/legalnews/know-your-en-banc-petition-process-how-8369487/
skip, what happens to your option pinning theory?
Agree. However, it's not even funny that the GSK Vs Teva case has the most number of amicus which I hope is not a deciding factor in granting the review. I think it's about time for PFE to use some of its lobbying capital on this case.
Kiwi, are you still holding AUPH?
Ns, thanks for posting. I saw the DMF case, filed on 10/12/21, was recently denied review by the CAFC. So I think GSK Vs Teva decision should be coming up soon.
https://fedcircuitblog.com/wp-content/uploads/2021/10/Petition-21-153.pdf
skip, since "The only question I have about yesterday's action is who was buying.", so my question to you is: who were selling yesterday? TIA.
Or 4 times Amarin's EV.
9, I don't think better CEO talent was available and could be bought. Even assuming one's available, I can't justify the extra $50M as even a miracle worker couldn't have done much better than KM in the last four months during the covid era.
Cynical, you shorted AMRN at $16 and didn't say a word until the stock traded at $4 to tell us to sell. That's not nice of you. Why do you treat us like that?
Retired, according to KM, partnership wouldn't work because V would be the 4th or 5th drug on rep's bag (remember Kowa?). I think KM is right, just give him some time. He has the appropriate experience and energy to right the ship.
BI, "Amarin is considering suing what sounded like two of three pharmaceutical chains"? That's news to me, where do you see that?
Novartis Has a Big Pile of Cash and Investors Are Demanding Action
https://www.bloomberg.com/news/articles/2021-11-18/novartis-has-a-big-pile-of-cash-and-investors-demanding-action?utm_source=google&utm_medium=bd&cmpId=google&sref=ZkFd9UXR
Exactly two years ago, Dicerna and Novo Nordisk Enter Agreement to Discover and Develop RNAi Therapies for Liver-Related Cardio-Metabolic Diseases:
https://investors.dicerna.com/news-releases/news-release-details/dicerna-and-novo-nordisk-enter-agreement-discover-and-develop
Today, Novo Nordisk to Acquire Dicerna
https://www.streetinsider.com/Business+Wire/Novo+Nordisk+to+Acquire+Dicerna/19237880.html
On August 16th, 2021, HLS Therapeutics inks promotional agreement with Pfizer for Vascepa in Canada
https://seekingalpha.com/news/3730616-hls-therapeutics-inks-promotional-agreement-with-pfizer-for-vascepa-in-canada
On ???, Pfizer and Amarin ???
jas, just try my best to catch up to you.
alm, you might not have listened to enough JT CC. He is the master of "you know", you know!
liz, "JT comment about the proposed offer was not acceptable to the "shareholders"? JT never said that. Such "proposed offer" was about settlement agreement with Hikma not BO terms.
Thanks Dew!
rose, value meant value not cost basis.
Anybody knows why XLRN goes up by $6 today? Can't be due to HSR expiration which was never in doubt. TIA.
Ns, thanks for posting. Only 10 positions to be exact.
marjac, thanks for the "postes" update. Glad he is doing well.
W, $29/sh equate to $12.5B.
I just realized we have 3 activitist funds circling AMRN:
1) BVF: 11.4M
2) Sarissa : 8.5M
3) EPADI II : 20M
Let's join forces!
Alex Denner orchestrated the sale of MDCO to NVS for $10B:
https://endpts.com/activist-investor-alex-denner-in-the-spotlight-again-as-the-medicines-company-shrinks-its-board/
https://biotechnologycommunity.com/md_news/novartis-strikes-9-7b-takeover-of-medicines/
Amarin jumps after activist Sarissa discloses stake in 13-F filing
https://seekingalpha.com/news/3771486-amarin-jumps-after-activist-sarissa-discloses-stake-in-13-f-filing
FFS's bearish call almost timed perfectly.
Know, please be more inclusive. 9 is a very valuable contributor to this board.