Biotech Values

[DewDiligence]

MNTA – When the appellate ruling is published in the federal register, the clock begins on Amphastar’s 180-day first-to-file exclusivity.

(Because Amphastar’s Lovenox ANDA was submitted in early 2003—prior to the changes in the 180-day exclusivity regs made in Dec 2003—the old regs apply in this case. Under the old regs, the 180-day clock begins on a final action by the appellate court irrespective of whether the first-to-file company has launched its generic product.)

The timing of the appellate ruling fits in well with MNTA’s schedule. Assuming that the appellate ruling will be published in the federal register no later than June or July, the 180-day period will expire in December or January. This is around the time the MNTA expects the FDA to have ruled on the complete response letter that MNTA and Sandoz plan to submit during 3Q08.

In summary, Amphastar’s first-to-file status on generic Lovenox is very unlikely to cause any delay in a Lovenox launch from MNTA and Sandoz.