MNTA has some great technology. Including the proprietary software that has been described here. In addition they have shown that they have the necessary assays up and running to rapidly characterize heparin. However this does not exclude other analytical chemists from doing the same thing with less stellar technology. Now that the FDA has said what they want to see all the companies have a chance to work toward those metrics. My view is that all the companies have NMR and MS instruments capable of characterizing these samples. MNTA may be better at it but that doesn't mean that other companies can't develop enough expertise to meet the requirements of the FDA. The financial incentive is large for them to do so.
MNTA has published some of their methods.
In the Nature Biothech. article they state in their conclusions which I posted earlier:
"This study also provides a set of screening methods that could be used to monitor the heparin supply and ensure the absence of oversulfated chondroitin sulfate contamination. For example, using the structural information presented here, it is now possible to (i) design reference standards that ensure accuracy, quantification and specificity of analysis for a given analytical method and (ii) devise an experimental protocol to clearly define the nature and extent, if any, of contamination in a given lot of heparin. Finally, the ramifications of these findings extend beyond scientific considerations and include clinical and health policy issues."
I could probably do the NMR analysis of heparin with the information given in this article. It is a bit of rocket science but there are rocket scientists in the Teva labs too. Can they do it as elegantly as MNTA. Probably no. Can they do well enough for the guidance the FDA sets. It depends on the guidance but I am thinking they can do it.
I would be happy to be wrong as I own MNTA shares but am betting on more share price appreciation from a M118 partnership than Lovenox generics.
Of course I have been waiting for GTCB to sign a partnership for about a year now. It maybe that neither "ship" comes in.
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