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Re: DewDiligence post# 109470

Sunday, 11/28/2010 6:51:35 AM

Sunday, November 28, 2010 6:51:35 AM

Post# of 252444

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 smile
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.

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