Replies to post #172715 on Biotech Values

[pollyvonwog]

Anything else new from Mylan on their Copax or just the same song and dance?

[genisi]

MYL at JPM ridiculed Teva's PlosOne study, saying that what happens in healthy mice is not indicative of what happens in humans with MS and that the discrepancies cited in the paper have no clinical significance.

The authors mentioned this point in the paper in a more objective manner:

One clear caveat to any gene expression study in mice lies in the inherent differences between healthy mouse models and human MS patients. Yet, there are clear differences in biological impact of GA and generic.

This is of course basic science not clinical study but it does suggest that the generic formulation results in different activity (up and down regulation of different genes and immune cells), and if this indeed occurs in MS patients, it could lead to different clinical outcomes. Even if these data do not effect approval by the FDA, it may make docs more hesitant to prescribe Natco's formulation.