Replies to post #54801 on Biotech Values

[DewDiligence]

Re: Mircera

>We also know that amgen is running into safety problems etc. with these products. What would happen if we found out that cera did not have these common problems just like the similar to the vioxx and celebrex story. The patents in question are more in the manufacturing phase than the patient stage. Could Amgen be forced to allow cera come to market and be paid a percentage?<

I don’t think so. The relative merit of the two drugs from a medical standpoint would seem to be a separate issue from the patent litigation.

[DewDiligence]

MNTA – The FDA approval of Mircera could be construed as a small positive sign for the Lovenox ANDA.

How so? Well, it shows that the FDA does not necessarily sit on an application just because there’s a blocking patent that runs for several more years.

Of course, it’s easier for the FDA to stall an ANDA than a BLA or NDA, but they have manifold ways of stalling any kind of application when they really want to. Hence, the Mircera approval suggests that the FDA may be willing to approve MNTA’s Lovenox ANDA—provided they are eventually satisfied on the immunogenicity issue—even if the Lovenox patent appeal is still pending.

Not exactly a strong inference, but every little but helps :-)