Biotech Values

[DewDiligence]

Re: Other Lovenox ANDA’s

>Have other companies already tried to get their generic versions of Lovenox approved, but were shot down by the FDA?<

Amphastar and Teva submitted separate ANDA’s for Lovenox in 2003; neither has yet been approved. On MNTA’s CC three days ago, CEO Craig Wheeler stated that the FDA told him over the phone that these other ANDA’s will also be required to demonstrate non-immunogenicity.

Why haven’t investors heard anything about the generic-Lovenox ANDA’s from these companies?

For Teva, a change in status of this program does not meet the threshold of materiality for disclosure to investors and hence we won’t hear anything from Teva unless the news is positive.

Amphastar is a private company and it need not disclose anything. Amphastar’s partner is WPI, which had this to say about Lovenox on Tuesday: #msg-24335230.

I doubt that investors will hear anything more about the Amphastar ANDA unless the news is positive.