Biotech Values

[DewDiligence]

Re: MNTA and competitors for generic Lovenox

>Are Teva and Amphastar two separate competitors or just one joint entity?<

They are separate. Amphastar has enlisted WPI to handle commercialization (subject to FDA approval, of course).

>If they're separate, what do we know about Teva's generic and any reasons why it would be unlikely to receive approval?<

We don’t know anything about it except that Teva acknowledged replying to an FDA request for information pertaining to immunogenicity. The status of Teva’s ANDA is perhaps the biggest uncertainty for MNTA investors and is arguably the main reason the valuation is as low as it is.

>Are the FDA decisions for Teva, Amphastar, and MNTA's generic drugs for Lovenox all mutually exclusive in terms of timing or are the decisions expected to be known around the same time for all three?<

The decisions are independent of one another—in theory. However, it’s reasonable to presume that the FDA will rule first on the application from Amphastar because Amphastar is the first filer and the 180-day exclusivity clock started ticking on 10/2/08. If the FDA acts on the applications from MNA/Sandoz and Teva without acting on the one from Amphastar, it will be reasonable to interpret such an outcome as a rejection of the application from Amphastar.

>…which company is first expected to get an FDA decision and is there any idea of timing in 2009?<

There is no way to know whether the FDA will act first on MNTA/Sandoz, act first on Teva, or act on both at the same time. The absolute timing of an FDA action is also not known. MNTA and NVS are on record that they expect to be able to launch in 2009 (subject to approval); to my knowledge, Teva has not given any guidance on timing.