<<To make it clear (in case someone think that I am for AMR101 as NCE), AMR101 (omega 3 fatty acid ethel ester) can not be treated as NCE because it is covered as NCE in LOVAZA. [eom]>>
Maybe short update here, because AMR101 "Patent Issue" will heat up in next weeks, and future AMR101 market protection will grossly (if not completely) depend on NCE status.
Amarin claim (10K, and it is reasonable claim): Our belief that AMR101 should be granted NCE exclusivity is based in part on precedent at FDA for granting NCE status to a previously uncharacterized active moiety, in this case, potentially ethyl-EPA, that was part of a previously approved product. It is currently unclear whether the FDA will view the ethyl-EPA in AMR101 as a previously approved active moiety in Lovaza and deny our request that AMR101 be granted new chemical entity status and the associate period of regulatory exclusivity.
Lovaza Label:
22 CLINICAL PHARMACOLOGY
23 Mechanism of Action: The mechanism of action of LOVAZA is not completely understood.
24 Potential mechanisms of action include inhibition of acyl CoA:1,2-diacylglycerol
25 acyltransferase, increased mitochondrial and peroxisomal ß-oxidation in the liver, decreased
26 lipogenesis in the liver, and increased plasma lipoprotein lipase activity. LOVAZA may reduce
27 the synthesis of triglycerides (TGs) in the liver because EPA and DHA are poor substrates for the
28 enzymes responsible for TG synthesis, and EPA and DHA inhibit esterification of other fatty
29 acids.
Label (GSK) does not explecitelly claim separate Mechanism of action of the each APIs in Lovaza, only as combination. So, ethyl-EPA can not be claimed as NCE in Lovaza product, it is not fully characterized active moiety.
Bottom line : AMR 101 will be approved and (most likely) be granted NCE. This is my current prediction, subject to change without any prior notification.
Miljenko
PS: Is this sufficient for strong marketing partner...NO IDEA! ... 5 years are "5 years"
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