Replies to post #85759 on Biotech Values

[akasidney86]

"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.

Not sure I understand this argument. It implies that applications filed under one approval pathway can somehow 'drift' off into another pathway... with no statements to that effect from either the company nor the FDA? You surely know more than I about the various routes through the maze, but to my knowledge this would be an FDA first.

[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?

[MotionMan]

MNTA: I haven't listened to the Teva cc yet. But don't you think an astute analyst and especially the ananlyst who asked the question regarding their generic lovenox anda would have asked a followup question regarding discussion of labeling with the FDA? Are analysts that out if touch with the particulars of the various pathways in particular the 505j?

[dewophile]

MNTA

the FDA definitely has grounds to deny a 505j if they feel there are differences in the API. if you get confirmation that the terms of the agreement for single generic remain in place if teva gets a 505b approval please do share

[mouton29]

<< Since a US generic drug is automatically substitutable for the corresponding branded drug, the FDA label of the generic drug is identical to the label of the corresponding branded drug.>>

Are there any uses of Lovenox that are still protected under patent or otherwise? If so, the label might exclude those even if approved as a generic. See the linked article:

http://www.mwe.com/index.cfm/fuseaction/publications.nldetail/object_id/158ffb98-bd2e-4aed-a7a3-da9be792e3ce.cfm

[drbio45]

What do you think of the chances of this scenario?

[drbio45]

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.

Have you ever been able to find out if the contractual terms in the nvs mnta partnership discusses whether a competitor receiving approval as a non substitutable generic would leave mnta's economic terms as they currently are.

[biomaven0]

considering approving Teva’s generic as a non-substitutable “branded” product

I personally consider the chances of that are close to zero. The FDA would be saying that while the drug is not actually "the same" as enox, they are nevertheless approving it without any clinical trials to prove safety and efficacy. That would be unprecedented to my knowledge.

In my calculus I see only three plausible outcomes - "yes", "no" and a prolonged "no decision." I consider the chances of an outright "no" as being fairly low, although there are certainly versions where Teva admits that they have to go back to the drawing board and we would know that there would be several years before any possible approval, so those would be tantamount to a "no."

Peter