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Re: biomaven0 post# 155773

Tuesday, 04/16/2013 11:42:02 AM

Tuesday, April 16, 2013 11:42:02 AM

Post# of 257250
AGN’s recent acquisition of MAPP gets off to a bad start as FDA issues CRL for Levadex:

http://www.reuters.com/article/2013/04/16/fda-allergan-migrainedrug-idUSL2N0CY14Z20130416

U.S. health regulators have declined to approve an inhaled migraine drug from Allergan Inc , citing manufacturing concerns related to the canisters used to dispense it.

…The drug, Levadex, is an inhaled version of an existing drug, dihydroergotamine, which is typically given by nasal spray or by injection at a headache center or hospital. The drug was reformatted into a more convenient form by MAP Pharmaceuticals Inc. Allergan acquired MAP in January for about $958 million [#msg-83696395].

There’s somewhat of a disconnect between AGN’s prior statement that Levadex will have peak annual sales of $500M (#msg-83735072) and AGN’s saying today that there is no need to reduce 2013 EPS guidance for the CRL.

AGN is trading down less than 1% and remains near an all-time high.

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