MNTA odds and ends from Monday’s
DB webcast (in no particular order):
1. Sandoz has locked up a sufficient quantity of (uncontaminated) API to enable its generic Lovenox to supply the entire US market, and hence there will not be a supply problem even if, as hoped, Sandoz/MNTA have the only approved generic. This is relevant insofar as BAX will need to restock its own API at some point to enable a re-launch of heparin. (Heparin and Lovenox use the same API.)
2. The contaminated-heparin problem has helped MNTA, according to Craig Wheeler, in setting the approval bar for Lovenox higher than it otherwise might have been and thereby making it less likely that Teva and Amphastar will obtain approval.
3. Wheeler confirmed that the FDA sought out MNTA to help solve the contaminated-heparin problem, not the other way around.
4. Amphastar (rather then Teva) has first-to-file status on generic Lovenox in the US. This is consistent with the old first-to-file Paragraph IV rules in effect until Dec 2003, which were based merely on the ANDA filing date rather than the date when the patent(s) in question were circumvented or invalidated. (Amphastar submitted its ANDA in early 2003 and Teva submitted its ANDA in mid 2003.)
5. M118 tidbits:
--Phase-3 is expected to start in 2009. (MNTA plans to have the program partnered by then.)
--M118’s FXa vs FIIa inhibition is 1:1 at all points (i.e. the FXa and FIIa inhibition have identical PK characteristics). This enhances the consistency and predictability of the treatment response.
--For a given amount of anticoagulation, M118 has shown approximately half the bleeding risk of unfractionated heparin in preclinical and clinical studies to date.
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