Biotech Values

[DewDiligence]

Has anyone here heard of AZD0837? If you haven’t, poor DD is not at fault. To the contrary, AZD0837 has been perhaps the lowest-profile big-drug candidate from Big Pharma.

What is it? AZD0837 is an oral direct thrombin inhibitor (DTI) that is similar to Exanta but supposedly less toxic. And therein lies the reason that AZN has kept 0837 under wraps: Exanta was one of AZN’s biggest failures and one of the highest-profile failures ever for Big Pharma.

The news (from AZN’s 2Q08 CC yesterday) is that AZD0837 is finally entering phase-3 following a two-year delay during which AZN perfected the formulation to allow for qD dosing.

AZN is taking a high-risk approach by going after the large addressable market in AF/stroke prevention right off the bat rather than first testing 0837 in orthopedic indications as is customary for DTI’s and FXa inhibitors.

The drug that AZD0837 most closely resembles is Pradaxa from BI, which was recently approved in Europe (#msg-27956748).