Replies to post #109470 on Biotech Values

[oldberkeley]

OT:

Unlike Lovenox, Copaxone does not have any “junk” that needs to be characterized

Perhaps Marth is the guy who famously told the TSA agent, "Don't touch my junk."

[iwfal]

The FDA’s published guidance for what is required for approval of generic Copaxone will probably end up being taken from MNTA’s application, as was the case with Lovenox.

I don't remember seeing anything from MNTA describing in any particular detail (prior to the FDA responses) what it is that Momenta thought was important in characterizing Lovenox. That was then later parrotted by the FDA in their response to the Sanofi Citizen's Petition. I can think of several places it might have happened (e.g. in some investor conference call slides, a set of technical papers or some discussion about their work on the heparin scare) but haven't found it on their site. Do you have any pointers.

[genisi]

Unlike Lovenox, Copaxone does not have any “junk” that needs to be characterized (#msg-56267201), which makes Copaxone an easier task for MNTA to replicate, all told, than Lovenox was.

In general, polysaccharides are a lot more complex than polypeptides, but this is like stating that women are more complex than men :-)
Without going into analysis (physicochemical properties, structural signatures, polymerization/depolymerization chemistry etc), and reverse engineering of complex mixture of polysaccharides vs. complex mixture of polypeptides, two points on the "junk" issue you raised: first MNTA needs to identify and characterize every element and residue in the mixture (Lovenox or Copaxone), no matter if you call it amino acid, sugar, junk, or idit. Second, no one knows for sure that Copaxone does not have any “junk”. Being a synthetic mixture does make typical biological contaminants unlikely for example, but it does not guarantee lack of "junk". I don't think that even Prof Arnon and Prof Sela can tell which elements are clinically relevant and which (if any) are "junk" in the mixture.