Amgen Enbrel Rhode Island Facility To Get FDA Inspection In Early November
Executive Summary
FDA will inspect Amgen's Enbrel Rhode Island manufacturing plant in early November, Amgen said during its third quarter earnings call on Oct. 23
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FDA will inspect Amgen's Enbrel Rhode Island manufacturing plant in early November, Amgen said during its third quarter earnings call on Oct. 23. "The FDA has notified us of its intention to perform the Enbrel plant inspection in November, and we continue to believe that, assuming a reasonable review timeframe, additional supply will be available for Enbrel in the first quarter of 2003," VP-Sales & Marketing George Morrow said. "It's impossible to predict how long this next step takes," CEO Kevin Sharer said. "There are PDUFA dates which are target dates for them to respond which are sometime at the absolute end of the year, but I wouldn't hang my hat on that. We're doing our best to get ready." Amgen filed the supplemental BLA for the new Rhode Island manufacturing facility Aug. 23. The FDA inspection will involve a tour of the facility, interviews with staff, and a review of all records, followed by a post-inspection conference with Amgen management, Sharer said. During the post-inspection conference, FDA "would give a preliminary review of what they found, not a finding of whether the plant was licensable." The new plant will "double supply," Sharer said. "There are lots and lots of untreated patients out there, so the issue is get that plant approved and get out there and relaunch Enbrel and meet what is going to be a big demand." Enbrel (etanercept) has been managed via patient registry since January 2001 because of supply constraints for the rheumatoid arthritis agent (1 (Also see "Immunex Enbrel Patient Starts After Jan. 1 Will Be Via Waiting List" - Pink Sheet, 27 Nov, 2000.), p 3). Sales of Enbrel were $158 mil. in the third quarter. The quarter marked Enbrel's first as an Amgen product; the acquisition of Immunex closed on July 16. "In the third quarter, we did not activate additional patients from the prospective patient list, and due to normal patient attrition, sequential sales were lower," VP-Finance Richard Nanula said. Second quarter sales were $192 mil. Amgen previously expected Enbrel sales to be between $800 and $850 mil. for the year, but now "expects sales to be at the low end or slightly below these ranges due to continuing supply considerations," Nanula said. |