9/10/12 No determination on regulatory exclusivity related to Vascepa™ (icosapent ethyl) Capsules expected in August Orange Book Supplement
Typically, the U.S. Food and Drug Administration (FDA) publishes a determination on the exclusivity of recently approved products in a cumulative supplement to its Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book, mid-month in the month following the drug’s approval. Vascepa was approved by the FDA in July 2012.
As previously disclosed, on August 16, 2012, the FDA communicated to Amarin Corporation plc (“Amarin”) that it had not yet made a determination with respect to the regulatory exclusivity of Vascepa and the July 2012 cumulative supplement to the Orange Book published on August 17, 2012 did not include an entry with respect to the regulatory exclusivity of Vascepa.
Based on information available to Amarin as of the filing of this report, including communication with the FDA on September 7, 2012, the FDA has not made a determination with respect to regulatory exclusivity for Vascepa. On or about September 14, 2012, the FDA is expected to publish the August 2012 cumulative supplement to the Orange Book. Based on communication with the FDA on September 7, 2012, Amarin does not anticipate that the August Orange Book Supplement will include an entry with respect to the regulatory exclusivity status of Vascepa.
Sentiment: Strong Buy
This is the problem, when LAWYERS --- not chemists or clinicians or research scientists but lawyers --- get involved.
IF, per the FDA, "Active moiety means the molecule or ion .... responsible for the physiological or pharmacological action of the drug substance,"
IF Vascepa, a SINGLE INGREDIENT molecular drug, works DIFFERENTLY from other molecules, shown in the various relevant statistical parameters needed for FDA approval for marketing --- in terms of "the physiological or pharmacological action of the drug substance" ON A SET OF SPECIFIC INDICATIONS/diseases (with Lovaza being the closest molecule to Vascepa but with Lovaza having at least THREE ACTIVE INGREDIENTS being responsible of its "physiological or pharmacological action of the drug substance")....
........ WHAT ELSE COULD POSSIBLY be making it so difficult to distinguish VASCEPA from other NCEs... other than the fact that LAWYERS are negotiating ways to cover their **s?
(a)Definitions. The following definitions of terms apply to this section:
Active moiety means the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance.
Maybe i am reading this incorrectly but it is only Amarin's OPINION, based on communication with FDA which happened on 7th, that there may not be an update in OB regarding NCE. Isnt it possible that FDA might still provide the NCE update in the OB? Nothing is still for sure. Yes chances are less but still there.
FDA could have made their determination on NCE 30 days after approval but instead, they decided to wait it out,most likely due to Joe Z and crew having a pro-active Orange Book meeting with FDA bigwigs this past June....
Management obviously informed FDA that numerous patents will be forthcoming within next few months which can only help Amarin's argument for 5 year exclusivity..
FDA could have immediately denied NCE after approval and Amarin could have appealed that decision at a later date,but at that time it would have been devastating to the stock price as we have more patents now, and more going to be allowed then we had at PDUFA time...
Dont know if we get NCE but chances are alot better now than in July..
I actually like the fact FDA is not rushing on this,I think AMRN is getting a break here as we wait for more patents to be allowed.
Why is the market reacting so negatively to this PR?
If the decision is indeed based upon the recently issued patents then it’s looking pretty good. The FDA probably just doesn’t have the time to digest all the information by Friday.
I guess we’ll have another run up leading to next month’s OB entry. And we’ll go through this all over again if it’s delayed again.
USPTO and FDA are completely different in their determinations and one does not beget the other. I wish people would just stop it w/ the NCE status, as it doesn't matter two bits (to the company).
There is no new info for FDA to digest right now. None of the allowed patents have actually issued yet. '885 will issue within days - and '889 could possibly be out by next month - though no guarantees there. FDA cannot look at the patents until they are issued and AMRN submits a from 3542. Last month they announced on the day of orange book release. This time, our Seeking Alpha article this morning may have nudged them to release the disclosure earlier. The 8-k coming out today certainly caught us by surprise.
Next month the '885 patent should be in the orange book well in advance of the supplement being released. Watch the US Pair system for "Notice of Issuance Mailed" - the electronic version of the issuance is usually sent the same or next day and AMRN will have the info they need to submit to the FDA. That is when the stock should spike in price.
Between now and September op. ex. $12.50 to $12 is where max pain says the price is going.
Very surprised on the delay and surprised how early AMRN got word from FDA, I sold some OTM calls on a small portion, at least those should be good, don't like another month and a half push out here, not sure how they handle launch in 2913 Jan and waiting for BO offers contingent on NCE. Disappointing but in a month plus won't have changed a thing to the reality of the stocks worth, short term hit I suppose