Biotech Values

[DewDiligence]

MNTA 2008-2009 News Flow

[Updated for disclosures on UBS webcast.]


3Q08 (i.e. by next Tuesday): Resubmit Lovenox ANDA with immunogenicity info requested by FDA.

4Q08: Appellate court ruling on Sanofi’s request for an en banc rehearing on Lovenox patent. (There is no formal timeline for the court to act, but action in 4Q08 is likely.)

1Q09: FDA action on Lovenox ANDA.

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).

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

Mid 2009: Ink partnership deal for M118. This can occur any time after the reporting of the phase-2a data.

2H09: Start M118 phase-2b trial in ACS.

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.