Amarin Corp. plc - der absolute Hit!
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| Eröffnet am: | 03.07.12 21:53 | von: JoWu81 | Anzahl Beiträge: | 100 |
| Neuester Beitrag: | 24.04.21 23:41 | von: Franziskauve. | Leser gesamt: | 27.888 |
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Hallo!
Meiner Meinung nach sollte die Aktie des britisch-amerikanischen Biotechunternehmens Amarin Corp. plc (NASDAQ: AMRN) ein absoluter Hit werden. Denn das Unternehmen hat, auf Basis von Fischöl, ein Medikament entwickelt, dass die schädlichen Fette im Blut (Triglyzerin) senken kann. Dabei waren die bisherigen Daten aus den klinischen Studien insgesamt absolut überragend. Kritiker werden nun einwenden, dass dies an der Kursentwicklung in den letzten Jahren nicht unbedingt ablesbar war/ist. Das ist auch soweit korrekt, liegt aber an anderen Dingen. Zunächst nämlich deuteten die vorgelegten Studiendaten von Amarin darauf hin, dass das Medikament nicht nur die schlechten Blutfette senken würde, sondern auch die guten Blutfette. Dieses "Problem" hat man jedoch mittlerweile behoben. Daher forderte die US-Gesundheitsbehörde FDA im letzten Jahr dann eine Ausweitung der klinischen Studien bzgl. dieses Medikamentes. Jedoch wohl weniger aufgrund der "Probleme", sondern vielmehr, weil man sich weitere Anwendungen dieses Medikamentes (von Seiten der FDA aber auch des Unternehmens) erhofft. Sollte sich diese Erwartung bestätigen, ist das Medikament daher ein wahrer Blockbuster mit Jahresumsätzen von mehreren Mrd. US-Dollar. Und da die US-Behörden dem Unternehmen zuletzt, in den vorherigen Jahren noch umstrittene, Patente zuerkannt haben, spricht eigentlich nahezu alles für einen positiven Ausgang (nach zugegeben langen Jahren des Hoffens (und Bangens) bzw. des Wartens). Alles in allem ist ein Investment in die Aktie daher immer noch spekulativ, ich halte diese Spekulation jedoch unter Chance/Risiko Aspekten heute für vertretbar. Erstes Kursziel dabei: 25$!!
Mehr Infos zur Aktie der Amarin Corp. plc findet Ihr auch hier, besonders die Kaufempfehlung von "hopelessly" hat mir dabei gefallen: Amarin Corp. plc - Empfehlungen. Hat sich hier vielleicht auch schon mal jemand mit dem Unternehmen bzw. der Aktie beschäftigt?
LG JoWu81
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Angehängte Grafik:
amrn_p_f.png (verkleinert auf 66%)
amrn_p_f.png (verkleinert auf 66%)
Der grundsätzliche Nutzen von Fischöl ist bis dato noch nicht geklärt (Endpunktstudien).
Der Mehrwert von Vascepa, vor allem der exorbitante Preis, gegenüber Nahrungsmittelergänzungspräparaten ist wohl mehr als fraglich. Wohl eher teure Laborkosmetik der Triglyzeridwerte ohne jeglichen Nutzen, Patent bis 2030 hin oder her, NCE hin oder her wird alles nicht umsatzrelevant sein im Moment.
Carol Peckham, Howard S. Weintraub, MDDisclosures
Jun 05, 2013
1 comment
NEJM Study on the Use of Fish Oil for Prevention of Cardiovascular Events
Looking at EPA
Other Thoughts on Triglycerides
References
Editors' Recommendations
Omega-3: Fishing Out the Recent Evidence
Fish Oils to Prevent Heart Disease
No Fish-Oil Benefit in Patients at High CVD Risk
Topic Alert
Receive an email from Medscape whenever new articles on this topic are available.
Add Cardiovascular Risk Management to My Topic Alert
Looking at EPA
Medscape: So, is fish oil then also out of the question for cardiovascular protection?
Dr. Weintraub: If you were to put 50 cardiologists and endocrinologists in the same room and ask them to name 1 study in which another medicine was added to a statin and there were meaningful significant reductions in cardiovascular events, they would probably look around and not be sure. I would say that one such study is JELIS,[11-13] which was conducted in Japan and added fish oil to a statin for patients with high cholesterol (6.5 mmol/L or greater). It's important to note that the study used only EPA, with a purity of something like 94% or 96%. At a mean follow-up of 4.6 years, they observed a 19% relative reduction in major coronary events in those on EPA, although the effect on triglycerides in that trial was not dramatic. Unstable angina and nonfatal coronary events were significantly reduced. Sudden cardiac death and coronary death did not differ between groups. Granted, nobody on our side of the pond thinks that trials populated exclusively with Asian participants would necessarily indicate the same results in people in Europe or the United States, but I think it's an interesting phenomenon.
A small US company has made its own version of EPA, icosapent ethyl (Vascepa®; Amarin Pharma), which has been approved. They conducted 2 studies: ANCHOR[14] and MARINE,[15] which allowed the FDA to approve icosapent ethyl for the same indication as the other approved fish oil (Lovaza®; GlaxoSmithKline), a combination of EPA and DHA, with a ratio of about 4:3.
The MARINE study looked at people with triglyceride levels over 500 mg/dL, which represents about 1% to 2% of the US population, and the ANCHOR study looked at those with triglyceride levels between 200 and 500 mg/dL, which reflects a larger proportion -- about 20% -- of the US population. One interesting observation was that using a statin along with EPA achieved much greater triglyceride reductions than using EPA without a statin, and the stronger the statin, the better the effect. So, the interaction between EPA and statins is intriguing. Fish oils may not be dead in the water for this reason alone.
The good news is that we're going to have to wait only 2 to 4 years for answers to the question of whether EPA is beneficial in high-risk patients. An event trial with at least 50% currently recruited is looking at the concomitant addition of icosapent ethyl to therapy in individuals with documented cardiovascular disease and/or diabetes.
I certainly haven't seen any studies in major journals on any comparative difference between the DHA/EPA combinations and the EPA-only agents. However, if you look at the FDA's Pharmaceutical Inspectorate (PI) for Lovaza, and in most of the data that the company has compiled, there is an average net increase in LDL cholesterol. Obviously this can turn some people off. We almost get the same kind of information that was out there with rosiglitazone, when, if you remember, LDL was increased in many of its studies. So, whether this mattered or not, certainly LDL is one of the few things in the lipid world that we have relative agreement on, that it is bad for you. There are some very interesting theories floating around, but I think that being LDL neutral and reducing inflammatory markers and triglycerides, as is indicated in the MARINE and ANCHOR studies on EPA, may be the difference in how these fish oil drugs behave.
« Previous PageSection 2 of 3
Next: Other Thoughts on Triglycerides
The Future; A Prediction
The FDA is clearly very interested in pushing companies to generate as much clinical trial data as possible. That’s not going to change. But the tenor of today’s meeting indicates that the agency is also much less worried about big drug safety scandals erupting than it was even three years ago. If FDA brass were worried about U.S. representative John Dingell or Senator Charles Grassley holding hearings, today’s meeting would have been less likely. This may be the most industry friendly FDA in years.
Companies will be expected to do lots of big, expensive trials to approve drugs for heart disease and diabetes. But they won’t all have to happen before approval. Investors shouldn’t expect that the rules of the era of the drug safety crisis, of Vioxx, the antibiotic Ketek, and Avandia, still apply.
What does this mean? Here’s a prediction: Amarin Pharmaceuticals is trying to launch a new prescription fish oil, Vascepa. Like all high-dose fish oil, the drug lowers triglycerides, particles of fat in the blood, and is approved for patients with very high triglyceride levels – higher than 500 milligrams per decileter. There is no clinical trials evidence that either Vascepa or its competitor, GlaxoSmithKline’s Lovaza, lowers the risk of heart attacks, strokes or deaths. Skeptics, including Nissen, believe that this means that Vascepa should not be approved for patients with triglycerides higher than 200 mg/dL.
But Amarin has an agreement with the FDA, called a special protocol assessment, saying the data it has produced should be sufficient for the expanded approval. It has funded the first ever clinical trial to show whether a fish oil product prevents heart attacks, strokes, chest pain, and stent procedures. Given this, I think it’s likely that the FDA will grant Amarin the wider indication without waiting for that trial to finish.
Get Alerts AMRN Hot Sheet
Price: $6.60 -0.3%
Rating Summary:
9 Buy, 3 Hold, 0 Sell
Rating Trend: Up
Today's Overall Ratings:
Up: 0 | Down: 1 | New: 1
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MKM Partners analyst Jon LeCroy weighed in on Amarin (NASDAQ: AMRN) Tuesday following news that NCE status on Vascepa was once again delayed. LeCroy said the NCE delay does have a silver lining, however.
"Obviously NCE designation is the preferred outcome but we view continued delays as better than no NCE, as delays effectively prevent Paragraph IV filings," the analyst notes. "While a lack of NCE designation is delaying generic filings, it also is perceived as preventing an acquisition of the company and Amarin shares may remain under pressure until an NCE decision is made. We expect the next
Orange Book update for June to occur around July 12."
The firm notes Vascepa prescriptions continue to grow but are running slightly below their previous estimates and they are slightly lowering 2013 and 2014 revenue and EPS estimates. That said, the firm views the 2013 consensus Vascepa revenue estimate of $57.4mn as "easily attainable."
LeCroy cut 2013 and 2014 revenue estimates to $68 million and $254.9 million, from $73.6 million and $263.7 million, previously. The firm's 2013 and 2014 EPS estimates are ($1.51) and ($0.82) from ($1.49) and ($0.78), previously.
The firm reiterated a Buy rating and price target of $12 on Amarin.
For an analyst ratings summary and ratings history on Amarin Corporation click here. For more ratings news on Amarin Corporation click here.
Shares of Amarin Corporation closed at $6.62 yesterday, with a 52 week range of $6.25-$15.96.
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HC Wainwright aufgerüstet Amarin mit dem $ 10 Kursziel unter Berufung auf eine attraktive Risiko / Rendite auf dem derzeitigen Niveau.
MFG
Chali
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Amarin erreichte unter SPA alle primary and secondary endpoints hat die Zulasssung für den Marine-Trail!
Jetzt wird wieder korrupiert seitens big pharma und FUD gestreut, da Vascepa von Amarin Lovaza haushochüberlegen ist!
z.B. wird diskutiert ob als Plabebo Mineralöl die Ergebnisse verfälscht hätte, jedoch genehmigte die FDA das Placebo unter Ihrem SPA:
The FDA agreed that light mineral oil
was acceptable as a placebo as long as the amount per capsule did not exceed the
amounts in FDA-approved products given by the same route of administration. Each
placebo capsule contained approximately 1 g of light mineral oil, which was dosed two
capsules twice daily with food, or about 4 mL/day. Mineral oil has been medically
used as a laxative at much higher doses of 15 – 45 mL/day.
Light mineral oil, also known as light liquid paraffin (LLP), is highly refined mineral
white oil and is a mixture of liquid hydrocarbons obtained from petroleum, which do
not contain any functional groups (e.g., no carboxyl groups in contrast with fatty acids
in vegetable oils) and are considered chemically inert with minimal systemic
absorption.
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