Molecular Medicine (MLM) Molmed (3 lettori)
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cloca
voglia di pedalare
non crea problemi subito anche il mese dopo o + . a me su tutti e 2 i pc. se ti accade sai cosa fare .
Reato
In molle carne vermes nascuntur
Io sono dentro $AMRN da ieri, in seguito a questa news: Amarin Announces FDA New Chemical Entity Market Exclusivity Determination for Vascepa(R) (icosapent ethyl) Capsules (NASDAQ:AMRN), anche se non ne comprendo appieno la portata, se qualcuno vuole commentare ne sarei felice
cloca
voglia di pedalare
Io sono dentro $AMRN da ieri, in seguito a questa news: Amarin Announces FDA New Chemical Entity Market Exclusivity Determination for Vascepa(R) (icosapent ethyl) Capsules (NASDAQ:AMRN), anche se non ne comprendo appieno la portata, se qualcuno vuole commentare ne sarei felice
ma , difendono il brevetto di questo non farmaco , per me è sempre stato un integratore. se si mangia un po' di sardelle o sgombri è meglio.
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In molle carne vermes nascuntur
webclaudio
Windsurf
Ciao Cloca , nell'entroterra gardesano 22' e leggermente coperto , la Giant come và ? Guardo Bikechannel ...
viralic
Forumer storico
Ciao, conosco Amarin ela seguo da circa 3 anni. Ti posto una recente disamina sul titolo, con i rischi connessi ma anche le speranze.
FDA Finally Decides No Foul On Amarin Fish Oil Product NCE Claim
Jun. 1, 2016 1:36 PM ET
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It has taken almost four years, but the FDA has finally decided that Amarin (NASDAQ:AMRN) can claim its fish oil treatment Vascepa is a new chemical entity. The ruling by the regulator will give the lipid-lowering treatment five years of patent protection until July 2017.
While the timeline may seem short, the start of the exclusivity is taken from FDA approval of Vascepa, which occurred in July 2012. More importantly, the group is now entitled to the statutory 30-month stay from competition after a potential generic challenge is filed. This could in effect extend Vascepa’s exclusive time on the market to 2020, representing more valuable selling time for a product that has so far disappointed.
Investors greeted the news from the FDA by sending Amarin’s shares up by 12% yesterday to $2.08.
Let the good times roll
The NCE decision is the latest bit of much needed positive news for the Irish-domiciled biotech company. In March, it announced it had won its first amendment case allowing it to promote off-label use of Vascepa outside of the approved indication of severe hypertriglyceridaemia in people with triglyceride levels of over 500mg/dl, a very limited patient population.
To date, sales of Vascepa have failed to reach anywhere near the blockbuster status that was forecast for it at launch. In 2015, the product’s reported revenues were just $81m, which represented almost 100% of Amarin’s total revenues.
Forecast sales for 2018 are also an unimpressive $253m, down from the lofty-looking $1.6bn forecast in 2013.
So being able to prescribe to the much bigger mixed dyslipidaemia population, albeit off-label, is a boon for the struggling group, which only has one other pipeline product.
The real charm
While the news from the FDA represents an important milestone, allowing five years of market exclusivity irrespective of the validity of Vascepa’s patents, the real turning point in Amarin’s fortunes will be the outcome of the Reduce-IT trial looking at cardiovascular outcomes.
This study represents the group’s best chance of formally extending Vascepa’s label into the much larger mixed dyslipidaemia population. Analysts at Jefferies predict that sales of Vascepa could reach $2.9bn by 2030, with $391m coming from sales in severe hypertriglyceridaemia and $2.5bn from mixed dyslipidaemia.
Reduce-IT is an 8,000 patient double-blind study evaluating the efficacy and safety of Vascepa in combination with statins versus statins alone in reducing long-term cardiovascular events in high-risk patients with mixed dyslipidaemia. The primary endpoint is the reduction in a mixture of cardiovascular events, including cardiovascular death, stroke, heart attack and hospitalizations.
An interim efficacy and safety analysis of 60% of events is expected as early as September and if positive will be an important catalyst for Amarin shares.
Money matters
The interim readout could also provide the opportunity for Amarin to raise much-needed funds. The group currently owes about $300m in outstanding loans, with the first loan call due in January 2019, which has acted as another drag on the share price.
However, those banking on or hoping for positive news at the end of the year should remember, as Jefferies analysts point out, the relationship between lowering triglycerides and reducing cardiovascular events is not as firmly established as the advantages of lowering low-density lipid cholesterol, and Reduce-IT’s is therefore a much riskier endpoint.
So while Amarin may have scored another victory, the outcome of the larger battle is still very much in the balance.
viralic
Forumer storico
Io sono dentro $AMRN da ieri, in seguito a questa news: Amarin Announces FDA New Chemical Entity Market Exclusivity Determination for Vascepa(R) (icosapent ethyl) Capsules (NASDAQ:AMRN), anche se non ne comprendo appieno la portata, se qualcuno vuole commentare ne sarei felice
Scusa , volevo rispondere a te ma ho sbagliato post e ho citato Cloaca ...mi scuso con gli interessati.
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