Biotech Values

[DewDiligence]

NVS/MNTA’s ANDA for 40mg Copaxone has a GDUFA date during 2016, according to MNTA’s 4Q15 CC. For competitive reasons, NVS/MNTA are not disclosing the exact date.

MNTA expects to obtain (tentative) FDA approval for the 40mg-Copaxone ANDA on the first review cycle insofar as the API for 40mg Copaxone are identical to the API for 20mg Copaxone. Tentative FDA approval for generic 40mg Copaxone would then be converted to full FDA approval when the 30-month Hatch-Waxman stay on 40mg Copaxone expires on 1/28/17 (http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=020622&Product_No=003&table1=OB_Rx ).