Genzyme Says Cerezyme Sales Fell 70%, But Allston Plant Production Is On Track
This article was originally published in The Pink Sheet Daily
Executive Summary
Troubled by viral contamination problems at its enzyme-replacement therapy manufacturing site, Genzyme maintains full-scale production will resume by first-quarter 2010.
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In Brief
Further delay for Prevnar 13: FDA has not yet completed its review of Pfizer's Prevnar 13 vaccine for pneumococcal disease and therefore the review will continue beyond the Dec. 30 user fee deadline. It's not clear how much longer the review will take and there was no explanation for the delay, but there was no indication that additional information was sought, according to the drug maker's Dec. 30 statement. The vaccine is under priority review and FDA already used its one-time extension of the user fee period to move the original action date of Sept. 30 to the December date, after additional manufacturing data was submitted. An FDA advisory committee voted 10 to 1 on Nov. 18 to recommend the product, although the panel did not endorse a broad claim for otitis media (1"The Pink Sheet," Nov. 23, 2009). European marketing authorization was granted on Dec. 11
In Brief
Further delay for Prevnar 13: FDA has not yet completed its review of Pfizer's Prevnar 13 vaccine for pneumococcal disease and therefore the review will continue beyond the Dec. 30 user fee deadline. It's not clear how much longer the review will take and there was no explanation for the delay, but there was no indication that additional information was sought, according to the drug maker's Dec. 30 statement. The vaccine is under priority review and FDA already used its one-time extension of the user fee period to move the original action date of Sept. 30 to the December date, after additional manufacturing data was submitted. An FDA advisory committee voted 10 to 1 on Nov. 18 to recommend the product, although the panel did not endorse a broad claim for otitis media (1"The Pink Sheet," Nov. 23, 2009). European marketing authorization was granted on Dec. 11
Business And Finance, In Brief
Coming off Cerezyme sales decrease, Genzyme reduces earnings per share guidance: Having announced a 70 percent decline in sales of the Gaucher disease drug Cerezyme (imiglucerase) during its third-quarter 2009 earnings call Oct. 21, Genzyme reduced its earnings-per-share guidance for the year (1"The Pink Sheet" DAILY, Oct. 21, 2009). The big biotech said it expects non-GAAP earnings per share to come in at roughly $2.26 for the year, down from prior guidance for EPS of between $2.35 and $2.90 per share. Genzyme attributed the reduction to the costs from remediation of its Allston Landing, Mass., manufacturing plant, the decision to discard and write off some of the in-process Cerezyme material on hand at the time of the Allston shutdown, and management of customer-level inventories related to its oncology transaction with Bayer. While overall revenue for the quarter was down roughly $100 million, the company reported an earnings increase in its cardiometabolic and renal drugs franchise, as combined sales of dialysis drugs Renvela (sevelamer carbonate) and Renagel (severlamer hydrochloride) rose nearly $11 million, year over year, to $181.7 million