Here's what CELG says in their 10-K:
As a result of our own applications and designations acquired from the CMCC, we now have Orphan Drug designations from the FDA for THALOMID(Reg. TM) covering primary brain malignancies, HIV-associated wasting syndrome, severe Recurrent Aphthous Stomatitis, or RAS, clinical manifestations of mycobacterial infections caused by mycobacterium tuberculosis and non-tuberculous mycobacteria, ENL, multiple myeloma, Crohn's disease and Kaposi's sarcoma. If the FDA approves any of these indications for THALOMID(Reg. TM), we will be granted a seven-year period of exclusivity during which time the FDA is prohibited, except under certain conditions, from approving another version of thalidomide for the approved indication. In November 2001, we were also granted European Orphan Drug status for THALOMID(Reg. TM) in multiple myeloma and ENL. In addition, patents related to S.T.E.P.S.(Reg. TM) provide additional protection as the S.T.E.P.S.(Reg. TM) program is included in the THALOMID(Reg. TM) label.
Note that, strange as it seems, the STEPS patent is actually listed in the Orange Book.
See also:
fdli.org
Peter |
