Interim efficacy analysis showed negative results.

La Jolla Pharmaceutical lost almost 89% of its value after it said that it was stopping development of Phase III lupus nephritis drug. Biomarin, which just last month paid $15 million up front to license the therapy, dropped about 4%.


The Independent Data Monitoring Board’s first interim analysis of Riquent®  determined that continuing the study was futile. La Jolla and Biomarin say that they will unblind the data and evaluate all of the clinical results including secondary endpoints such as SLE (systemic lupus erythematosus) disease activity indices and proteinuria.


Riquent was La Jolla’s only clinical-stage compound. Previous efforts in Phase III trials also failed, with efficacy endpoints not being met. Yet, Biomarin and La Jolla were both optimistic about the most recent study. Still, BioMarin CEO, Jean-Jacques Bienaime, was careful to structure the deal with La Jolla, which had the potential value of $273.5 million, in such a way that payments would be made only if certain milestones were achieved. Bienaime thus points out that Biomarin has spent only $15 million, the initial fee, on this drug, “a relatively modest amount for a late Phase III asset addressing a large market opportunity.”


 



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