Bio,
Always appreciate your hard work. I've been working on this same issue of NCE and put more credance on it than possibly many here. I think it is very important in the future negotiations with Big Pharma as well as overall perception that funds have for our company. I however agree that the long term value of our company with or without NCE is the ability of our patents to hold up are the true protection. I came to a similar conclusion about 2 weeks ago that the FDA is preparing for a decision to be made. I've got pages of info but here are just a few of my finds that support your findings. A DISCLAIMER HOWEVER THAT I HAVE NO CLUE WHEN WE GET NCE BECAUSE I DO NOT KNOW WHAT "NEEDS TO BE IN PLACE" BEFORE THEY CAN OFFICIALLY GIVE IT TO US.
Introduction section of the summary review notice how they differentiate the names in this section
Introduction and Regulatory review:
Vascepa (icosapent ethyl) is a highly purified ethyl ester of eicosapentaenoic acid (EPA;
20:5 n-3) derived from fish oil. Its molecular formula is C22H34O2 and its molecular
weight is 330.51. Its structural formula is:
The drug product, AMR101 Capsule, is a one gram, light-yellow oblong shaped soft
gelatin capsule filled with pale yellow liquid
NOTICE THAT WE HAVE BOTH A DIFFEENT CHEMICAL FORMULA AND MOLECULAR WT NOW: C20-H30-O2 and MW of 302.
Page 140 of 144
Applicant is requesting 5 years of exclusivity: “Vasecpa does not contain the same active
moiety as in any drug product approved under FDC Act § 505(b) and therefore Vascepa
is eligible for five-year NCE exclusivity.”
This statement was from us and not the FDA
1. Single active ingredient product.
Has FDA previously approved under section 505 of the Act any drug product containing the same
active moiety as the drug under consideration? Answer "yes" if the active moiety (including other
esterified forms, salts, complexes, chelates or clathrates) has been previously approved, but this
particular form of the active moiety, e.g., this particular ester or salt (including salts with hydrogen
or coordination bonding) or other non-covalent derivative (such as a complex, chelate, or clathrate)
has not been approved. Answer "no" if the compound requires metabolic conversion (other than
deesterification of an esterified form of the drug) to produce an already approved active moiety.
***Determination of whether this application qualifies for 3 or 5 years of exclusivity was not
finalized by the goal date. The final decision will be made post-approval and this form will be
completed at that time.*** YES NO
If "yes," identify the approved drug product(s) containing the active moiety, and, if known, the NDA
NOTICE THAT IT SAYS 3 OR 5 YEAR EXCLUSIVITY. IT IS THAT WE GET EITHER 5 OR 3. IT IS PURE NONSENSE TO CONSIDER THAT WE WILL NOT AT LEAST GET NME (WHICH IMO IS NOT A POSSIBILITY AFTER MY RESEARCH).
FDA Preliminary Response: Under 505(s) of the FD&C Act, all new chemical entities must
either be discussed at an Advisory Committee Meeting or a justification provided as to why
it will not be discussed. A final decision on whether AMR101 is a new chemical entity has
not been made.
Meeting Discussion: The firm pressed for a more definitive response given the limited resources
of the company. The sponsor was informed that, based on what is known about the compound at
this time, and in our opinion it was less likely that AMR101 would go to an Advisory
Committee. Final decision on the question of an Advisory Committee would be made after
submission of the NDA.
Initially the FDA did not see the value of an Advisory Committee and did not think it was necessary. After meeting with us, they saw that they had misunderstood the situation. Our drug has now gone to the advisory committee. Also examine those who were present in the meeting (posted on Stocktwits). It will make more sense.
From the MAPP documents
It is CDER’s responsibility to determine whether the name of a drug product that contains an active ingredient that is a salt should include the name of the active moiety or the name of the active ingredient (salt). CDER anticipates that most drug products containing active ingredients that are salts will be named using the active moiety.
Notice the language. Very important. What is our Active Moeity? What is Lovaza's active moeity? Since we have been given separate AMs and certainly not the same chemical name. No doubt in my mind that we get NCE. What the factor is holding it up however I do not know. I do not believe it is tied with Anchor. If you read the Therapeutic Category from your posts, it is clear that we are listed as cardiovascular (antiplatelet) whereas Lovaza is listed as antilipemic.
Take this for what its worth. Just one crazy investor's thoughts:-). Gotta run
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