T. Weisel Lowers Axcan Pharma to 'Peer Perform'

The FDA says Axcan's ulcer drug is still not approvable, due to ongoing deficiencies at one of its manufacturing sites

Thomas Weisel downgraded Axcan Pharma (AXCA ) to peer perform from outperform.

The FDA says a re-submitted new drug application for Axcan's ulcer drug Helicide is "still not approvable." Analyst Donald Ellis says ongoing manufacturing issues at an Italian manufacturer are still present. Given that the manufacturer is currently being liquidated, Axcan doesn't expect the issues to be resolved, and has selected a German manufacturer. Axcan will meet with the FDA to determine the next steps in the approval process.

Ellis cut the 75 cents fiscal 2004 (Sept) earnings per share estimate to 71 cents. He notes management stated a near-term acquisition may result in fiscal 2005 revenue exceeding $250 million. Ellis says he'll re-evaluate the company after considering the merits of an acquisition. He cut the $18 target to $14, based on slowing growth of Axcan's base business and increased reliance on product acquisitions.

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