THE GUARENTEED REASON WE GET NCE...AFTER ALOT OF RESEARCH
Just to preface....I am a physician and have extensive knowledge of medicine and some background in organic chemistry and bio-chem....but by no means a specialist in chemistry or laws surrounding NCE. I have been on the edge to sell my sharesbecause previously I was pretty sure that we would not get the NCE...but this is what I just found after weeks of research...
the proof is all in he labels, look at loveza and vascepa:
-loveza is a mixture of EPA cis and trans isomers + DHA. For those that don't know what an isomer is, they same chemical makeup....but MIRROR IMAGES of each other. The common argument on here is that " Vascepa is pure EPA, without the DHA and so we should get NCE." By strict definition of the FDA, this will not get us NCE. But we will get it and I will tell you why...once again it is all in the label
- Vascepa is ethyl all-cis-5,8,11,14,17-icosapentaenoate (CC'd directly from the label). This is the trans MIRROR IMAGE. Remember, lovveza is a mixture of cis and trans........
THIS IS WHY WE WILL GET NCE (and before I found this an hour ago, I thought it would not get NCE)
** Joe Z. was very smart when he developed this drug. He knew the FDA NCE statues I will copy and paste below and he knew that if he used both isomers of EPA he would not get NCE. But he isolated the cis isomer of EPA....this is one of his guarded trade secrets, as isomers are not easy to separate!
By doing this as seen below it qualifies for NCE. I am sure quite a bit of money was spent separating these isomers, it would have been simplier and much less costly to just use the racemic mixture. So why didn't he use the racemic mixture.....it would save bundles of $$$$$$?
Because in 1997 the FDA passed the FDA Revitalization Act "FDARA". There is ABSOLUTELY no other reason to seperate them and use only the cis isomer in Vascepa, it is just not cost effective. You see, the FDARA 264 in 1997 replaced the Hatch-Waxman Act which originally said ' FDA will consider wether a drug contains a previously approved active moiety on a case-by-case basis. FDA notes that a single enantiomer of a previously approved active moiety and is therefore not considered a new chemical entity.'
Because of FDARA 264 this is how it currently stands:
**Here is the direct quote from the FDA below (FDARA 264), this addendum to the Hatch-Waxman Act
specifically....FDARA 264 amended FDC Act to add 505(t)--"certain drugs containing single enantiomers"--to provide that:
...if an application is submitted under 505 (b) for such non-racemic drug containing as an active ingredient a single enantiomer that is contained in a racemic drug approved in another application under 505(b), the applicant may, in the application for such non-racemic drug, elect to have the single enantiomer not be considered the same active ingredient as that contained in the approved racemic drug.....
Thus, if a single enantiomer is not considered to be the same active ingredient as that contained , FDA may consider it to be a new chemical entitiy eligible for 5 year exclusivity!!!!!
Here is the best part....if you google fdara 264 and pull up the law book and sec 264, this expires oct 1st 2012 unless congress reauthorizes it. "application must be submitted between date of enactment and oct 1 2012'....want to guess why Joe Z. wanted to push the NCE application through in August (which he did)....
The senate passed this FDARA provision in order to put to bed a 1997 FDA notice in which the Agency requested comment on whether granting a 5 year period of exclusivity to enantiomers of previously approved racemates would encourage medically significant innovation.