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DewDiligence

01/23/13 9:08 PM

#155775 RE: biomaven0 #155773

AGN figures whatever Levadex sales they get from PCP’s are a bonus—they will focus on neuros and pain specialists. However, Levadex is probably the closest AGN has come to having a primary care drug, so they are going to construct an enhanced salesforce to detail Levadex and Botox/migraine.
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DewDiligence

04/16/13 11:42 AM

#159933 RE: biomaven0 #155773

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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DewDiligence

06/30/14 6:53 PM

#179950 RE: biomaven0 #155773

AGN—[Peak annual Semprana sales of $500M is] probably higher than I would have guessed given that insurers will likely be cautious covering this drug.

Given the three CRLs issued for this drug (the third one announced today), we may never find out what the true market potential is.