Biotech Values

[DewDiligence]

FDA approves AZN’s antiplatelet drug, Brilinta:

http://finance.yahoo.com/news/FDA-Approves-New-Medicine-bw-3163453236.html?x=0&.v=1

AZN finally manages to catch a break, and it’s been a long time coming! Despite a 7-1 vote in favor of approval by an FDA advisory panel in Jul 2010, the FDA issued a CRL in Dec 2010 (#msg-57939117) and AZN replied in Jan 2011. Today was the PDUFA date.

Brilinta is vying for the mantle of successor to the mega-blockbuster, Plavix (the second-largest-selling drug of all time), which will soon be generic in all countries. The competition includes LLY’s Effient, which has been a commercial bust to date (#msg-41731834). Thus, the more serious concern for AZN is generic Plavix, which managed-care companies and government buyers around the world can be expected to turn into a formidable foe. For AZN, the timing could not be worse for launching a new branded drug in this category.

Brilinta’s approval also forces NVS to make a no/no-go decision regarding Elinogrel (#msg-65364335).