Replies to post #198389 on Biotech Values

[DewDiligence]

Reuters plugs PTLA’s Andexanet Alfa (currently under FDA review):

http://finance.yahoo.com/news/blood-thinner-antidote-help-doctors-120001705.html

[DewDiligence]

PTLA-BMY/PFE ink Andexanet Alfa commercialization deal for Japanese market:

http://finance.yahoo.com/news/portola-pharmaceuticals-enters-licensing-agreements-115500159.html

Under the terms of the agreement with Bristol-Myers Squibb and Pfizer, Portola will receive an upfront payment of $15 million and is eligible to receive potential regulatory and sales-based milestone payments totaling $90 million, as well as double-digit royalties based on andexanet alfa net sales in Japan. Bristol-Myers Squibb and Pfizer will be responsible for all development and regulatory activities for andexanet alfa in Japan and for commercializing the drug in Japan…

BMY and PFE share the worldwide commercial rights to Eliquis, one of the FXa inhibitors that PTLA’s Andexanet Alfa reverses.

[DewDiligence]

PTLA’s PDUFA date for Andexanet Alfa is 8/17/16 (with priority review):

http://finance.yahoo.com/news/portola-pharmaceuticals-announces-biologics-license-224217932.html

This BLA seeks FDA accelerated approval based on the surrogate endpoint of FXa reversal. A single-arm phase-4 trial is already in progress to show that Andexanet Alfa can safely restore hemostasis in patients with major, including life-threatening, bleeding (#msg-109888826).