Genzyme posts loss after inventory write-off
pharmafile | August 12, 2010 | News story | Manufacturing and Production, Sales and Marketing |Â Â Genzyme, manufacturing complianceÂ
Genzyme has had to write off an additional tranche of product that does not meet quality standards, forcing it to revise its second-quarter financial results and driving the firm into a second-quarter loss.
The US biotech, which Sanofi-Aventis is currently angling to purchase, has also said it will take longer than expected to get its troubled Allston Landing manufacturing facility up to code.
Genzyme revealed in a Securities & Exchange (SEC) filing yesterday that it has discarded a further $6.5 million-worth of product that failed to meet quality control specifications, in addition to the $21.9 million of product wastage reported in its July 21 second-quarter results statement.
The decision means that Genzyme has now posted a net loss for the second quarter of $3.8 million, compared with net income of $23,000.
The drugs involved in the latest disposal are Cerezyme (imiglucerase) for Gaucher disease, Fabrazyme (agalsidase beta) for Fabry disease, Thyrogen (thyrotropin alfa for injection) for thyroid cancer and cholesterol lowerer Cholestagel (colesevelam).
A spokesman for the company told Reuters that the quality issues were unrelated to the ongoing compliance problems at Allston Landing, which remains shut down after contamination incidents and other transgressions.
Meanwhile, Genzyme has also revealed that its remediation plan for the Allston Landing facility looks set to take longer than anticipated, with the estimated completion now expected in three to four years’ time.
Previously, the company had said it expected to complete the programme in two to three years, according to a Bloomberg report.
Genzyme has already paid a fine of around $175 million because of the quality issues at Allston Landing, and in May submitted a remediation plan to the US regulator the FDA.
That plan indicated that fill and finish activities for Cerezyme and Fabrazyme should be shifted to other manufacturing plants by 28 November.
The continuing quality concerns could now play into Sanofi-Aventis’ hands during the acquisition negotiation process.
Phil Taylor
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