NeoRx Corp. announced Tuesday that it has started a limitedclinical trial requested by FDA to qualify Boehringer IngelheimInternational GmbH (BI) as the manufacturer of its Oncotracsmall cell lung cancer imaging agent to stage patients with thisdisease.
NeoRx entered into a strategic alliance with BI in September1992, by which BI would become the manufacturer of NeoRx'smonoclonal antibody-based OncoTrac cancer imaging products.BI purchased $8 million worth of NeoRx stock (NASDAQ:NERX)at the time, and agreed to pay the Seattle company anadditional $3.6 million when it files with the FDA equivalencydata to qualify BI as the manufacturer.
NeoRx expects to file the results of this multicenter trial withFDA during the third quarter of this year.
"We believe qualifying BI's wholly owned subsidiary, KarlThomae GmbH, as the manufacturer of OncoTrac is the last stepnecessary to gain marketing approval in the U.S.," said PaulAbrams, NeoRx's president and chief executive officer.
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