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Tuesday, May 28, 2013 7:27:49 AM
It's all about EPA levels when related to CV outcomes....period.
4 Grams Vascepa Cmax= 366 mcg/ml; Cmin= 231 mcg/ml
Page 37 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S)
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000ClinPharmR.pdf
What Omthera have?
200 mcg/ml steady state EPA
http://www.omthera.com/pdf/OmtheraJPMorganPresentationJan-10-2012.pdf page 16
Vascepa 4 grams
89 mcg/ml RBC EPA levels
Omthera
Page 18, unknown level but they do admit it's import;)
http://www.omthera.com/pdf/OmtheraJPMorganPresentationJan-10-2012.pdf
IP protection: 1 application
http://assignments.uspto.gov/assignments/q?db=pat&qt=asne&reel=&frame=&pat=&pub=&asnr=&asnri=&asne=Omthera+&asnei=&asns=
13/620,312 METHODS AND COMPOSITIONS FOR TREATING, REVERSING, INHIBITING OR PREVENTING RESISTANCE TO ANTIPLATELET THERAPY 385452-004US (117199)
Congrats AZN...;)
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