Unfortunately for patients with Alzheimer's disease, it was recently reported that the first of the two U.S. bapineuzumab trials did not meet its endpoint. This was the trial studying patients with an allele known as ApoE4, and for which (inaudible) was held, based on various analyses of the Phase-II Bapi data, that shows better results in its non-ApoE4 carriers.
On Tuesday of this week, Pfizer disclosed that analysis is underway of the second U.S. Phase-III trial studying Alzheimer's patients, who do not carry the ApoE4 allele. Pfizer said during its earnings call, that these data will be presented in September. It is also possible if Pfizer, and or J&J will take a top line release of this data, sooner than that.
With respect to solanezumab, Lilly has stated that the data from its two Phase 3 trials will be disclosed in the second half of 2012, with many expecting some disclosure at one or both of the Alzheimer conferences at the beginning and end of October. Lilly has disclosed that it has enrolled apoE4 and non-apoE4 carriers in its trials and that it intends to stratify such patients in its statistical analysis. We have no information on the number of apoE4 and non-apoE4 carriers in their trials.
To be clear, most Wall Street analysts attach a low probability of success to either the BAPI or SOLA trials, but also agree that each would be a several $1 billion blockbuster drug integrate to meet its product profile in the Phase 3 trials and be approved.In early July, we entered into a transaction with Merus Labs and before discussing the specifics of the transaction, it may be useful to review on slide number four why are we considering such transactions. Read the rest of this transcript for free on seekingalpha.com
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