Biotech Values

[DewDiligence]

Re: MNTA “at risk” launch of 40mg Glatopa

Based on MNTA’s 1Q16 CC on 5/3/16, I expect NVS/MNTA to launch 40mg Glatopa “at risk” (assuming the 40mg ANDA has been approved by the FDA) when the Hatch-Waxman 30-month stay expires in Feb 2017, regardless of the status of the patent litigation with Teva. Although MNTA did not flat-out assert the intention to launch at-risk, such a plan is pretty easy to infer by reading between the lines.

(NVS/MNTA will not launch 40mg Glatopa if the District Court imposes a preliminary injunction against launching, but such an injunction is highly unlikely, IMO.)

Note: NVS/MNTA expect FDA tentative approval of the 40mg-Glatopa ANDA on the first review cycle (GDUFA date in 2H16) because the 40mg-Glatopa ANDA is almost identical to the already approved 20mg-Glatopa ANDA.