In fact, Vascepa enjoys its exclusivity, though without any status granted by FDA. As a new drug product, Vascepa does deserve certain exclusivity, e.g., at least a 3y NP (new product) exclusivity. Before FDA clarifies the exclusivity status that Vascepa deserves, no one can file an ANDA on generic Vascepa.
NCE suppose to grant a 5y exclusivity. Counting on Vascepa's approval date, July 2012, an NCE status would enable an exclusivity till July 2017. However, if ANCHOR get approved on December 20, 2013, Vascepa is eligible to have a 3y NPP (new patient population) exclusivity till Dec 2016 (only 6 months shy of an NCE exclusivity). And REDUCE-IT could have another exclusivity with a brand new code and perhaps longer term due to the historical heart-benefit outcomes with trig-killeror, (many trig-killers are/were blockbusters, e.g. Tricor, Trilipix, Niaspan and Lovaza, all FDA approved without any heart-benefit outcomes).
Vascepa's NCE-delay is primarily due to GSK's Citizen Petition. Citizen Petition is a common weapon used by BP to delay whatever they don't like. Resolving a Citizen Petition is time consuming. Sometimes it takes more than ten years to resolve one case. However, Lovaza will loss patent-protection in 2016. So, GSK may withdraw its petition after that. I believe, AMRN investors should forget the NCE and focus on ANCHOR, and particularly on REDUCE-IT.
I have posted FDA's Review Docs on Vascepa. Please read those posts. I have read FDA's Review Docs on more than one dozen drug-products. I have to say that Vascepa's is the neatest, particularly dealing with safety (the most difficult part of an NDA). The Review Docs set up a key tone for the coming AdCom meeting. A positive recommendation is a given, except a minority champ of waiting fro REDUCE-IT. On Dec 11, FDA will publish its brief docs for the AdCom meeting. Usually, a summary (just like the Summary Review of the Review Docs) and a questionnaire for vote. I suppose there will be 3 voting issues
AMRN BULL BUT
" However, if ANCHOR get approved on December 20, 2013, Vascepa is eligible to have a 3y NPP (new patient population) exclusivity till Dec 2016 (only 6 months shy of an NCE exclusivity)."
THIS IS NOT TRUE, WELL KINDA, YES THEY WOULD GET 3 YRS. FOR ANCHOR INDICATION BUT THE THREE YEARS FOR MARINE WOULD START FROM JULY 2012 ENDING JULY 2015 , AGAIN I THINK IT DOESN'T MATTER AS PATENTS SHOULD HOLD UP
Upon ANCHOR data, 3 voting issues (Yes/No):
C) Approval Recommendation.
In accordance with Vascepa's Review Docs, A) and B) will have "Yes'' in almost anonymously.
Issue C) will have some votes of "waiting for REDUCE-IT" in a minority.
The safety of Vascepa was assessed in an overall Vascepa integrated database that contained information from two placebo-controlled clinical studies of patients with hypertriglyceridemia (MARINE and ANCHOR, the latter in patients on statins with TG levels 200 - 500 mg/dl) and from eight placebo-controlled clinical studies of patients with CNS disorders (e.g., Huntington's disease). There were approximately 622 patients treated with Vascepa and 309 treated with placebo from the hypertriglyceridemia trials. There were approximately 700 patients treated with Vascepa and 519 treated with placebo from the CNS clinical trials.
Dr. Iffat Chowdhmy has reviewed the safety data from the overall Vascepa integrated database. This memorandum will discuss the safety data from the two placebo-controlled trials of hypertriglyceridemic patients since these data are most relevant to the propose indication. A total of 309 patients were exposed to placebo, 312 to Vascepa 2 grams daily, and 310 to Vascepa 4 grams daily. The median number of days of dmg exposme was 84.
There was one repmied death in the hypertriglyceridemia database; a 64-year-old male died from a myocardial infarction while participating in the ANCHOR trial. He was randomized to placebo.
As pointed out by Dr. Chowdhury in her review, the incidence of nonfatal serious adverse events was 2.9% in the Vascepa pooled group and 1.6% in the placebo group. Furthermore, there was no clear association with the dose of Vascepa and the development of any serious adverse event.
Two reported adverse events occurred at least 1% more in the Vascepa pooled group than the placebo group: arthralgia and oropharyngeal pain.
While there were more reports of “bleeding- or bruising-related” adverse events in the Vascepa versus the placebo group, the non-specific nature of many of these reported events makes it difficult to determine the clinical significance of the overall numeric imbalance. For example, there were five reports of anemia in the Vascepa group versus none in the placebo group. Iron-deficiency anemia might be due to blood loss, whereas pernicious anemia would not.
There were no reports of pancreatitis in the two hypertriglyceridemia clinical trials.
There were numerically more patients on Vascepa with mild elevations of ALT (up to 2xULN) than placebo, 12.8% vs. 10.3%, respectively. One subject in the Vascepa 4 grams daily group developed an ALT 3xULN; absolute value 163 with AST within the normal range. This value was measured after the subject had completed the 12-week treatment period. There was no clinically meaningful difference between the Vascepa and placebo groups in the incidence of increases in fasting glucose levels.
From FDA's Summary Review on Vascepa NDA:
The safety of Vascepa was assessed in an overall Vascepa integrated database that contained information from two placebo-controlled clinical studies of patients with hypertriglyceridemia (MARINE and ANCHOR, the latter in patients on statins with TG levels ≥ 200 mg/dl