Oh my gosh golly geeeeeeeeee, where did all the garbage come from??
How can you do a study with 8,000 patients, expected to last 6 years, and get the results to the FDA before the July/Aug/Sept/Oct/Nov 2012 orange book is published?
You can't. This study must have been in the works for over a year before they enrolled the first patient.
Hogwash, everyone of you posters to this thread. Reduce-IT was not mandated by the FDA in order to receive NCE.
end of story.
I don't know if it was GSK, I speculate so, they have the most to lose. I had an email exchange followed by a phone call with the CDER Ombudsman, during the phone she stated it was a legal hold up, but couldn't go into the specifics. I rambled on about the new patents, but she wouldn't confirm or deny they were related to the delay. I requested she bring my delay concerns to the Exclusivity Board and how it effects Amarin's ability to execute it's business plan. She did relay this message, I suspect Amarin has done the same.
Hope that clears up your question.
GSK has a billion dollar market to lose 2013, no Cardiologist is going to prescribe Lovaza with the potential to raise LDL and also the new warning of atrial arythmias. I'm truely surprised GSK hasn't scooped Amarin up. I think they're #$%$ at Joe Z, and feel he was holding back on them when he sold them Reliant...LOL and didn't clue them in on pure EPA.
Sentiment: Strong Buy
Altho Joe Z has implied earlier that in the past Co's that ran outcome studies also received NCE's.....I don't think it's an absolute guarantee.
I discussed the reasons for the Outcome trial with a Cardiologist . His take was as follows ...beside the obvious benefit to the company in terms of sales if Reduce it is successful...the medical community really wanted to know if this method of reducing high TG's ( using Vascepa ) actually reduced events in the US population as opposed to just moving the lipid numbers around
He specifIcally cited Niacin . He had prescribed Niacin for years to his patients and yes Niacin reduced triglycerides in his patients .
Then the results of the Aim-High outcome trial came out and showed that taking Niacin with a statin was no different then taking the statin alone ......in terms of " events "......so this method of lowering TG's made no difference ( except for those with very high TG and very low HDL )
That's what the FDA wants to eventually know once they allow Vascepa to be prescribed to about 40m patients .....will Vascepa with a statin actually reduce events more then just the statin alone.
Thanks to the Jelis trial we have reason to be optomistic that Vascepa with a statin will reduce events more then just the statin drug alone
Yesterday at Lazaed conference--they cited Jelis study for optimism about Reduce-It study.President said--"We hope to enroll half (4000 patients) by Feb.2013 --to satisfy FDA before filing for Anchor population of 200-500 mg.triglyceride. He also said-we enrolling patents with 150 mg.trigylcerides. It seems that they are going to enough data to segment results for different levela of Trigl.
your doc also told you that reducing "markers" is a whole different can of worms that reducing health risks.
there are hundreds of study's that reduce markers, that have been proven to have ZERO medical benefits.
next time, tell the rest of the story.
The FDA requested amarin to do the outcome study REDUCE-IT.
The REDUCE-IT (Reduction of Cardiovascular Events Outcomes trial): A multi-center, prospective, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effectiveness of Vascepa as an add-on to statin therapy, in reducing the first major cardiovascular event in an high-risk patient population compared to statin therapy alone. Patients enrolled in the study have elevated triglyceride levels ( 150 mg/dL) and at least one other defined cardiovascular risk factor. The control arm of the study is comprised of patients on optimized statin therapy. The active arm of the study is comprised of patients on optimized statin therapy plus Vascepa. Entry requirements for participants in this study include elevated triglyceride levels and either coronary heart disease or risk factors for coronary heart disease. This study is being conducted internationally and Amarin anticipates utilizing more than 300 clinical sites in connection with the trial, the largest number of which will be in the United States. In December 2011, Amarin announced that the first patient was dosed in the REDUCE-IT study. The study is scheduled to be completed in approximately six years and is anticipated to include approximately 8,000 patients.
As JZ has staed before, The FDA has never requested an outcomes study and not granted NCE. With this historical trend this will weigh heavily on the NCE decision. This could have legal ramifications with the millions spent on an outcomes study...
Sentiment: Strong Buy