Replies to post #138364 on Biotech Values

[DewDiligence]

Teva’s thrice-weekly Copaxone will be reviewed under an NDA. If approved, it could cannibalize some of the market for regular Copaxone, including the generic versions; however, thrice-weekly Copaxone will require an explicit prescription and won’t be substitutable for an Rx written for regular Copaxone.

I don't have an answer for the question in your second paragraph.

[genisi]

The thrice-weekly Copaxone formulation (GALA study) is not low volume, rather it's a stronger dose (40mg glatiramer acetate instead of 20mg). The low volume formulation tested in the SONG study got a CRL from the FDA back in Dec. 2010.

[genisi]

Teva thrice-weekly Copaxone formulation

I don't see why TEVA needs to wait for the extension study to complete prior to filing for approval. Couldn't they file & then submit the extension study data as an addendum?

I don't think TEVA needs to wait for the extension study to complete. If data are ok (and they should be), I think we'll see filing in early 2013.