Biotech Values

[ThomasS]

MNTA: MS webcast: My impressions based on statements:
M-Enoxaparin
1. May be on the market Q1 2009 or sooner. MNTA refuses to project a 3-month approval timeline (as suggested by analysts and my own thoughts); they feel more comfortable guiding towards Q1, without actually "guiding." Sandoz is more aggressive in their timeline projections, due in part to their history with generics vice biosimiliar-type generics.
2. They felt back in November that their application review was finished minus the immunogenicity issue.
3. Appeals Court verdict in May; 6-month exclusivity clock starts AFTER a 6-8 week period.
4. MNTA feels very confident. They believe the a) Citizens Petition, b) Heparin contamination issue and c) even the immunogenicity issue itself, have all served to showcase MNTA's technological advantage in characterization.
5. MNTA believes their version of Lovenox will be a defacto authorized generic, fully substitutable with Lovenox at the pharmacy level.
6. When pressed, it is evident that no informed commentary can be given irt what TEVA/AMPHASTAR have going for their respective applications. My take: The FDA would be resistant to approve another Lovenox generic if not as pure as MNTA's product. Again, we have no informed opinions to go on for those other 2 applications.

Copaxone (M356)
MNTA states that they are in a "quiet period" of sorts. My take: FDA filing in 2008.

M118
1. Continued enthusiasm from an otherwise conservative CEO.
2. Partnership talks with big prospective partners continue.
3. Mentioned accelerated PIII clinical trials of large size.
4. My take: M118 PIIa results/partnership news will overshadow the Lovenox application in 2H 2008, as the market comes to grip with the potential magnitude of this product candidate. Craig made it clear that they will not give away M118 for less than it's true worth. Reminder: MNTA previously guided to end 2008 with 2 years worth of cash, i.e., end 2008 with the same amount of cash as 2008 started with. This can only be accomplished via large partnership upfront amounts and/or a M-Enoxaparin milestone. FoB partnerships are still out there, as well.

All in all, an outstanding presentation. There was a question about the NVS standstill agreement (expires 7/25), however, I don't recall the answer or non-answer.