Biotech Values

[DewDiligence]

MNTA 2008-2009 News Flow

[Updated for disclosures on 2Q08 CC.]


3Q08: Appellate court ruling on Sanofi’s request for an en banc rehearing on Lovenox patent.

3Q08: Resubmit Lovenox ANDA with immunogenicity info requested by FDA.

1Q09: FDA action on Lovenox ANDA (assuming resubmission of ANDA in 3Q08).

1H09: Possible US launch of generic Lovenox (assuming FDA approval). The launch can occur after Amphastar’s 180-day exclusivity runs out; the clock begins on a final resolution on the patent rehearing (see above).

1Q09/2Q09: Report M118 phase-2a data in stable angina.

2Q09: Start M118 phase-2b trial in PCI.

2Q09: Ink partnership deal for M118. This can occur any time after the reporting of the phase-2a data.

2008-2009: Announcements re follow-on biologics programs.

2009-2010: Possible FDA action on Copaxone ANDA. There is no formal review schedule. Although the FDA is barred from granting final approval of the ANDA before the statutory 30-month stay expires, the FDA is allowed to take other actions during this period including tentative approval, non-approval, or a request for more information.


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