The De Facto Informative Thread to quell the paid,misaligned Bashers/Shorts
Vascepa, the drug product, is new; it didn't exist before approval. Vascepa is a description of what was granted marketing approval by the FDA; Almost all drugs have only one active ingredient; that's not news (despite what some might say). The active ingredient in Vascepa (or any drug for that matter) can be produced by anyone with some expertise in the field. The question is can it be marketed and can the company make pertinent label claims? The answer is no: only Amarin can do that The statement about production costs is groundless: where is the evidence? In any event production costs and price are determined by two different factors. Amarin has a growing patent estate around its lead product. Patent protection is critical for the success of the drug; regarding the statement about "approved API supply of any scale," this statement too is nonsense. Amarin has reported three producers of the active ingredient, with a fourth coming on line. The FDA has already carried out a pre-approval inspection of one or more of the manufacturers of the active. The clinical trial results for both Lovaza and Vascepa are a matter of public record; the clinical performance of Vascepa is superior to that of Lovaza; this point should be self evident The patent estate of Lovaza isn't news; Lovaza and Vascepa are two different drugs; Vascepa will likely have a much larger market--by a factor of four or five--than does Lovaza It should be no surprise that drugs facing upcoming competitors; it's the nature of the industry. Of course, little meaningful can be said about a drug in early clinical development. Those with experience in the industry know that drugs fail all the time. At this point, Pronova has only reported dosing studies for 4016: it's early days yet. AMR-101 was filed under a 505(b)2 NDA; Pronova is working on chemically modified fatty acids; if the company elects to file in the US, it will have to file a 505(b)1, which involves substantially more effort. It's reasonable to expect that it will take another 5 to 6 years before the company is ready to file an NDA. In the meantime, until phase III results start being made public, it's risky trying to predict what will happen to its drug.
Any of the incessant posts trying to convince you otherwise are a joke and are not worth your time reading.
Good post .
You might go on to explain that generic Lovaza ia basically a non issue .
Those who have very low LDL cholesterol may continue taking Lovaza and will benefit from the generic version ----but for most CAD ( coronary artery disease ) patients ... its all about improving our lipid profile ( including lowering TG'S ) WITHOUT raising LDL cholesterol .
The Anchor indication ( Vascepa with a statin drug ) IS the market for Vascepa ---10 x the size of the Marine indication . It address's the 200-500 TG range where Lovaza is NOT approved by the FDA , altho prescribed "off label "
Once Vascepa is FDA approved for 200-500 TG range , very few MD's will write prescriptions for Lovaza for this patient group --- doesn't matter if Lovaza is generic or not. At least thats the view of my wife ( a physicans assistant ) ---and she writes prescriptions every working day.
Lovaza ( in generic form or otherwise ) may still be used for very high TG's where pancreatitis is a concern ---- but for you typical mixed dyslipidemia patient --about 40 m of us ---where controlling LDL cholesterol is our chief concern ---- we will be taking Vascepa to reduce secondary risks associated with high TG's --- primarily in my case to eliminate the risk presented by high TG / low HDL ( Axis disorder ) identified in the Jelis trial .