MAP Pharmaceuticals announced yesterday (7/9/09) that AstraZeneca has ended its collaboration on unit dose budesonide (UDB). This past February, MAP reported that the Phase 3 study had failed to reach its primary endpoints. Apparently, further analysis failed to support continued development of UDB.
We seldom see failed 505(b)(2) development projects. This case is interesting because it paired MAP with the innovator (arguably making this a 505(b)(1) since MAP may have had full right of reference to the underlying data). We usually advise clients that seeking a new indication is the highest risk for a 505(b)(2) project, yet, in this case, the active is already approved for treating asthma. By ending its collaboration, AstraZeneca apparently decided further investments weren’t warranted. Formulation issues, trial design, evaporating market potential or shifting corporate priorities can be some of the causes of decisions to end collaboration.
Fortunately for MAP, its other product candidate appears to be on track. We recently commented on the successful completion of Phase 3 for its orally inhaled dihydroergotamine.