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Genmab, A/S
HuMax-CD4 receives U.S. orphan drug designation
September 24th, 2004
Genmab, A/S, announced that HuMax-CD4 for the treatment of Mycosis Fungoides (MF), which constitutes 75% of all cutaneous T-cell lymphomas (CTCL), has been designated an orphan drug by the U.S. Food and Drug Administration (FDA). The U.S. prevalence of MF is estimated at 16,000-20,000. Under the Orphan Drug Act, orphan drug designation gives companies access to protocol assistance to maximize the chance of success at the time of marketing authorization. Once approved by the FDA, an orphan drug is granted 7 years of market exclusivity during which time directly competitive similar products cannot normally be placed on the market. ...
Source: Food & Drug Law Weekly (2004-09-24)
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