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Biotech / Medical : Momenta Pharmaceuticals Inc.
MNTA 52.480.0%Oct 2 5:00 PM EST
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To: Biotech Jim who wrote (2447)8/27/2010 1:05:11 PM
From: Biomaven  Read Replies (2) of 3027
 
Looking at those five properties in terms of the copaxone issue:

(1) equivalence of physicochemical properties, such as molecular weight distribution and overall chemical
composition;

presumably an easy-to-meet test for copaxone generics.

(2) equivalence of heparin source material

not applicable

(3) equivalence in disaccharide building blocks, fragment mapping, and sequence of oligosaccharide species

the counterpart test here will be the critical factor

(4) equivalence of in vitro biological and biochemical assay results;

don't know how they can find a counterpart except for some simple PK-type stuff

(5) equivalence of in vivo pharmacodynamic profile based upon measurements of in vivo anti- Xa and anti-IIa profiles

no obvious counterpart. With copaxone you are dealing with the drug's interactions with the immune system which is an altogether different ballpark than the clotting system.

So based on my limited understanding of this stuff, the counterpart to (3) will be critical. The fact that (4) and (5) are not helpful in characterizing sameness puts considerably added weight on (3).

I'm guessing that the counterpart to (3) will have to include criteria like the distribution of the optical properties of all the molecules in the mixture.

Peter
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