Biotech Values

[DewDiligence]

Re: FoB’s, partnerships, and legacy businesses

I am starting to think, MNTA is trying to negotiate with Sandoz a favorable FOB partnership (prolly much better share than the 45% contractual profit?) and it is not going anywhere. and hence the long, never ending negotiations?

I don’t think disagreement over how profits are split is what is blocking a partnership; rather, what’s blocking a partnership is MNTA’s mantra that FoB’s should be fully substitutable biogenerics rather than merely biosimilars (#msg-26837144).

So for example, if Sandoz has EPO biosimilar in the market(they have already done clinical trials) and MNTA wants to do parntership with Sandoz on EPO(presumably MNTA is getting their characterization expertise to the table and Sandoz their process expertise), Sandoz would probably not be interested or be prepared to do a deal which gives MNTA a fair share say 40%...

It’s unlikely that MNTA is interested in developing an FoB for Epogen/Aranesp, where the market will be flooded with biosimilars. (Ditto for Neupogen/Neulasta.) For MNTA, it makes more business sense to focus on FoB’s for mAbs such as those in the TNF-alpha class (#msg-59857407).

MNTA is prolly coming in and saying, hey BTW you have to maybe even throw that EPO product away(keep in mind they have made huge investment-could even be 50m), because it does not have the SAME starting material signature as RLD - Prolly that's where the strategic mis-alignment is coming in....the "legacy business".

That’s the wrong interpretation, IMO. The legacy businesses that Craig Wheeler referred to on the GS webcast are not other companies’ FoB’s, but rather their branded biologics approved via the ordinary BLA pathway. For obvious reasons, companies that have large sales from branded biologics do not want MNTA’s biogenerics to succeed.

…I heard Hospira is doing it's own generic enoxaparin, although it appears it is still early in the game in terms of it's ANDA...Does anyone here know about it?

HSP’s Lovenox ANDA is for the vial formulation only, not for the prefilled syringes (#msg-33960572, #msg-33961609). Since the vial formulation represents a minuscule portion of the US Lovenox market, HSP’s ANDA is inconsequential for MNTA, which is why no one ever talks about it.