Amylin: FDA Reports Issues in Plant, New Byetta Pending Approval

by Scott Wu | March 12, 2010 at 05:24 pm

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Amylin FDA Report Found Issues in Ohio Plant, Once-weekly Byetta Pending Approval

An FDA report was released on Friday indicating that Amylin Pharmaceuticals' manufacturing plant in Ohio had shortcomings. The Food and Drug Administration listed 10 observations. The FDA visited Amylin's West Chester plant in Ohio in December 2009. Amylin and Eli Lilly and Co are expecting the approval of a new version of diabetes drug Byetta.

The timing of the FDA report is sensitive. Amylin is expecting the decision for the approval of the new once-weekly version of Byetta this Friday.

In the report, one of the observation made by FDA was that "procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed."

Amylin Chief Executive Daneil Bradbury had said back in January that they could address the issues by the review deadline for Byetta. "We've addressed these findings in previous public statements, indicating that we believe these observations are addressable," said an Amylin spokesperson.

Industry analyst Thomas Wei warned against reading too much into the timing of the FDA report.

The FDA report notes the inspection findings are "observations, and do not represent a final agency determination regarding your compliance."

Jefferies & Co analyst Thomas Wei said he would caution against reading into the timing of the posting of the inspection report as it relates to the decision on the new form of Byetta.

Amylin's shares fell by 4.39% to $20.26 after the release of the FDA report. On the other hand, Eli Lilly and Co stayed strong rising 0.11% to $35.93.

Byetta had sales of $797 million last year. Currently, patients need to take the injection twice a day. The new version pending for FDA approval would require patients to be treated only once a week.