Amarin Corp Plc (AMRN)

[Biobillionair]

Oh this story just gets better and better

CDER director Janet Woodcocks set's TEVA straight. Too bad she didn't have the same consideration for Vascepa's NDA.

http://www.regulations.gov/#!documentDetail;D=FDA-2013-P-0025-0003

The drug in question was already approved in a mix, prior to it's MS approval.

Biogen Idec received NCE for Dimethyl Fumarate, after it's 505B1 application was approved. Like Icosapent Ethyl, Dimethyl Fumarate was previously approved as a "mix" in Novartis's Aliskiren Hemifumarte. The following links lead to the approvals and Pubchem sites clearly showing the compounds. I can find no FDA delay's or confusion regarding the approval of and designation of NCE for Dimethyl Fumarate.

Dimethyl Fumarate's OB Exclusivity:
http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=204063&Product_No=001&table1=OB_Rx

Dimethyl Fumarate's chemical structure can be viewed here:
http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?cid=637568&loc=ec_rcs
Aliskiren Hemifumarate's OB Exclusivity:
http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=022217&Product_No=001&table1=OB_Rx

The mix containing Biogen's Dimethyl Fumarate can be viewed here at PubChem under Novartis's Aliskiren Hemifumarate:
http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?cid=9939627&loc=ec_rcs



Vascepa and Dimethyl Fumarate share the same mix/NCE parodox:
As GSK has recently stated in the response to Crowell & Moring LLP- CP (FDA-2013-P-0148-0001), "the active ingredient (In Lovaza) is not simply the seven omega-3-acid ethyl esters, but the entire mixture", the Icosapent Ethyl should be considered a single agent separate from the mixture. Clearly CDER came to this conclusion with Biogen's Dimethyl Fumarate.
http://www.regulations.gov/#!documentDetail;D=FDA-2013-P-0148-0003