FDA clears ImClone's BB50 production unit

ImClone Systems, which is the subject of an agreed $6.5-billion takeover by US drug major Eli Lilly (Marketletter October 13), says that it has received approval from the Food and Drug Administration for its state-of-the-art "BB50" facility to manufacture multiple products. This approval significantly expands ImClone's total available production volume capacity for its proprietary pipeline of novel antibodies, which are now entering late-stage clinical development, the firm notes.

"This multi-product FDA-approval of BB50 significantly enhances ImClone's operational flexibility as we scale up production of our robust pipeline of proprietary antibodies for the growing number of Phase II and Phase III trials that will be commencing in the next year," said Richard Crowley, senior vice president, biopharmaceutical operations at ImClone.