GENENTECH <GENE> FILES SUIT AGAINST FDA
Genentech Inc said it filed
a suit against the Food and Drug Administration in the U.S.
District Court for the District of Columbia over an unresolved
issue relating to genetically engineered human growth hormone.
    At issue, said Genentech, is whether Eli Lilly and Co's
<ELI> recombinant human growth hormone and its new recombinant
growth hormone, are the same drug. Both drugs are under review
by the FDA.
    Since 1985, Genentech has been marketing Protropin, a
recombinant human growth hormone for treating abnormally short
children.
    The biotechnology concern said it has the right to seven
years of exclusive marketing for Protropin, granted orphan drug
status by the FDA. Orphan drugs are a special category of drugs
that are used to treat rare diseases.
    Genentech said the suit seeks clarification of what
constitutes a drug under the standards of the orphan Drug Act.
It suggested that without the "clarification," companies that
develop orphan drugs may not recover development costs during
the period of marketing exclusivity.
    It said Lilly's growth hormone and its new growth hormone
differ slightly, and are produced by different processes.
 Reuter
