Biotech Values

[RockRat]

Oh, I see what you're getting at. That's true, but still has no bearing on the approvability. Maybe we're having a semantic issue here. Anyhow, I can find no evidence that anyone aside from Teva itself and Momenta might have what it takes. I suppose it wouldn't hurt to ask, but I still think the idea that someone else is doing this for Teva is very, very unlikely

I poked around for IP in other sources and found it circles back to Procognia. I would say most of the expertise Teva has in this area would come from there, but obviously, since the collaboration is long done, Teva is now going it alone. I remember genisi saying she had looked at this. It comes closer to what MNTA has than anything else (Hospira is conspicuously absent in this area, as is Amphastar, but maybe they have stealth partners (if so, they didn't come up in my search)?) I can find.

Here's one that has been granted since she did this:

"Polysaccharide structure and sequence determination"

http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=7,741,061.PN.&OS=PN/7,741,061&RS=PN/7,741,061

There are others, but this is the latest continuation of all of them, so I assume she has seen one of them. There are no more applications for Procognia in this field. Presumably based on that and some other digging she said:

>>My understanding is that Procognia's technique doesn't give a greater/better resolution of the glycan characterization than of HPLC or PEN-MALDI sequencing. Momenta's technique has a higher level of sequencing accuracy plus it can handle even smaller samples down into the picogram range.

Procognia's technique advantage is that no preparation or treatment of the sample is needed and it is quick relative to other methods. Hence, its best use is for the clone selection stage early in development of a new drug in cell lines and later for optimization and control of the manufacturing process conditions of that drug.

Teva ended its agreement with Procognia but I have no idea if it means that Teva will not take the former projects further to clinical trials.<<

Check out example 4 about 3/4 the way down into the app. They do seem to be claiming the ability to get complete sequences.

I don't know if there is is new info here that genisi has not seen since she made that pronouncement. It is not clear to me if this is sufficient for the FDA, either. I invite you, genisis, rkrw, Biomaven, and whoever else to take a crack at this. I would assume Teva has access to this methodology.

Now, then. You haven't answered my question: How likely do you think it is that Teva would outsource manufacturing of t-enox?

Regards, RockRat