MAP Pharmaceuticals has announced that its Phase III trial of Unit Dose Budesonide (UDB) in children with asthma did not meet its primary endpoint of disease control. In the study, 360 steroid-naive children with asthma were randomized to receive 0.25mg UDB, 0.135mg UDB or placebo twice a day over a 12 week period. An initial review of the data has not identified any serious adverse events, and patients will therefore continue to be treated in a 52 week safety study.
AstraZeneca currently markets Pulmicort Respules (budesonide), the only nebulized steroid available for the treatment of asthma in children, reaching sales of over $600m in the US in 2007. As such, UDB was expected to seriously threaten Pulmicort Respules's revenues. To negate these concerns, AstraZeneca signed an agreement with MAP Pharmaceuticals in December 2008 to jointly develop and commercialize the compound.
The expiration of the waiting period for this agreement under the Hart-Scott-Rodino Act triggered an up-front payment to MAP Pharmaceuticals of $40m on February 3, 2009. However, the additional $35m that AstraZeneca was supposed to pay upon the successful achievement of the Phase III primary endpoint is now unlikely to be handed over.
Theoretical advantages of UDB over Pulmicort Respules include a shorter nebulization time and the administration of lower doses, although the doses studied evidently did not lead to asthma control. Both companies are currently conducting further analyses of the full Phase III data to determine appropriate next steps. For AstraZeneca, the successful launch of UDB would not have entirely protected its nebulized budesonide franchise, which is also under generic threat. However, it would have at least kept the company in the game. For MAP Pharmaceuticals, given that shares fell by 40% in after-hours trading, the results could lead to more serious problems.
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