Replies to post #79501 on Biotech Values

[PSA declining]

MNTA: Is there any way to determine what the chances that if/when the FDA approves a generic Lovenox, M-Enoxaparin would be the only one approved for a significant amount of time?

I had read an article back a few years that Amphastar's product had significant differences in mass spectrometry compared to Lovenox. I think that was back in 2005.

What testing does the company do to determine equivalency? Mass spec, chromatography, and or NMR?

I'm hoping we get a response from the FDA soon. Not sure how long Teva will take to catch up, if they even can.

From listening to the Goldman presentation, I think Craig Wheeler said they believe they still have a significant lead over their competition with their technology, know-how and trade secrets.

[dewophile]

"Heparin per se has very low immunogenicity (it’s not a protein), and hence any immunogenicity that might be caused by a heparin-based drug would likely stem from impurities in the manufacturing process"

in vivo heparin can be immunogenic (heparin-induced thrombocytopenia is an immune-medated side effect)