Biotech Values

[mcbio]

Re: MNTA TEVA (labeling)

If Bill Marth’s comments are taken at face value, one might infer that the FDA is considering approving Teva’s generic as a non-substitutable “branded” product—as though Teva’s application had been reviewed by the FDA under the 505b2 NDA pathway rather than the 505j ANDA pathway.

The above scenario raises the possibility of an asymmetric outcome that would be highly bullish for MNTA: NVS/MNTA’s ANDA is approved as a full-fledged substitutable generic while Teva’s ANDA is approved as a non-substitutable “branded” generic. Under this scenario, I’m pretty sure the contractual terms of the NVS-MNTA partnership would treat Teva’s product as not being a second generic Lovenox, and hence MNTA would enjoy the favorable economic terms of the single-generic case.

I very much hope your asymmetric outcome turns out to be true as I am long MNTA. However, we have no way of knowing whether or not MNTA is going through the same type of labeling discussions with the FDA, correct?