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Portola Pharmaceuticals Inc. PTLA

"Portola Pharmaceuticals Inc is a biotechnology company focused on developing and commercializing novel therapeutics. The company focuses on areas of thrombosis, other hematologic disorders, and inflammation for patients who have limited or no approved treatment options. Portola focuses on biomarker or genetic approaches to clinical development that it believes will increase the probability of clinical, regulatory, and commercial success of first-in-class therapies. The company also uses collabo


NDAQ:PTLA - Post by User

Post by roktraderon Aug 01, 2016 12:11pm
245 Views
Post# 25100368

FDA approval is widely anticipated in the next couple weeks

FDA approval is widely anticipated in the next couple weeksWhat is an antidote to Factor Xa inhibitor? Well, again I tend to reveal my ignorance whenever I talk science but its basically an antidote to the newer variety of anticoagulant drugs like Eliquis and Xarelto (newer, that is, than the low-cost Warfarin that has been in use for a long time, with lots of well-known side effects). So if a patient is on a Factor Xa inhibitor medication to reduce coagulation, often for prevention of blood clots that could cause strokes or embolisms, such as during or after surgery, but they then have uncontrolled bleeding or internal bleeding for any reason, then they need to reverse that anticoagulant quickly but apparently they cant easily do that with existing drugs. So thats the role that Andexxa is expected to fill when it gets approved, as is widely anticipated in the next couple weeks (theyve already had FDA inspections of their initial manufacturing facilities, in addition to getting a Breakthrough Therapy designation). And thats why its pretty widely expected that it will not only be approved, but will be stocked in all hospitals and be a standard drug thats on hand in the ER even if it doesnt necessarily get used in every hospital every day. That kind of initial stock-up for a drug could bring a substantial wave of revenue, the thinking goes, though I dont know if its particularly clear what kind of sustained market there will be for the drug these antidotes are quite new, the only other one Ive seen mentioned is Praxbind, which Boehringer Ingelheim received approval for last year as an antidote to their own Pradaxa anticoagulant. I expect the hope was that having a direct antidote to Pradaxa would help that drug to compete with Eliquis and Xarelto, but I dont know whether thats working out in the marketplace (Im not trying to imply that it isnt, I just dont know Praxbind is pretty new to the marketplace and I havent seen any sales numbers, nor do I know if Pradaxa sales have changed substantially since Praxbind was released).
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