Why was M178 dropped? It’s hard to say for sure because NVS/MNTA never disclosed what M178 was other than to say that:
• it was a compound NVS was already working on when the companies inked their 2006 collaboration; and
• it was a glycoprotein.
That M178 was a glycoprotein—rather than a polypeptide such as Copaxone or a sugar mixture such as Lovenox—had a lot to do with NVS’ decision, IMO.
Because Copaxone and Lovenox are regulated by the FDA as small molecules, they have the potential to be launched in the US as fully substitutable generics with negligible sales and marketing expenses.
But M178, as a glycoprotein, did not qualify for FDA approval under the ANDA pathway and hence its approvability would have been subject to Congress’ passing enabling FoB legislation. Moreover, an eventual FDA approval of M178 would have required an aggressive marketing commitment to produce meaningful sales if the FDA had designated it as non-substitutable for the branded counterpart.
The need for an aggressive marketing commitment kills the attractiveness of the FoB business model for all but the largest-selling biologics, and M178 may not have had sufficient upside to be worth the trouble.
“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”
