Replies to post #81843 on Biotech Values

[tony111]

Its a positive for MNTA since now FDA will not be making any unprecedented decision as the congress passes the biogeneric bill.

[DewDiligence]

What would the effect on MNTA be if the proposals to grant 12 year data exclusivity were enacted?

The data-exclusivity period in the FoB bills that may finally be passed by Congress have little if any effect on MNTA, especially in the short run.

MNTA has only one program involving an FoB: the one in collaboration with NVS for the undisclosed protein called M178 (#msg-34383144, #msg-37325602).

Lovenox and Copaxone are not biologics; generic versions of Lovenox and Copaxone in the US will not be governed by FoB legislation, but rather by the existing ANDA process.

Moreover, the data-exclusivity provision in proposed FoB legislation is getting much more attention than it deserves. FoB data exclusivity comes into play only when someone wants to market a generic version of a biologic that lacks US patent protection.