Manufacturing remediation chugs along at Genzyme, which anticipates some supply constraints of Gaucher-disease treatment Cerezyme before the supply outlook improves in February. Operating under a consent decree with the FDA, the now-Sanofi ($SNY) division says it anticipates Cerezyme shortages through January.
Behind the shortages is a reduction in Cerezyme output earlier this year at the troubled Allston, MA, facility and manufacturing timeline adjustments, says spokesperson Lori Gorski in an email. Cerezyme productivity has since returned to expected levels.
"We continue to make improvements with the goal of creating stable long-term supply. We are in the process of plant validation for our new Framingham facility, and anticipate completing regulatory approval processes that will allow us to ship Fabrazyme made in Framingham in the first quarter of 2012," Gorski says.
Approval of the Framingham plant will allow Genzyme to boost Cerezyme production at the Allston facility, which currently produces both Cerezyme and Fabrazyme, a treatment for Fabry disease.
The update provides context for comments made last week by Brian Abrahams, senior analyst at Wells Fargo Securities, for Protalix BioTherapeutics ($PLX), which is nearing the marketing finishing line with its Gaucher disease treatment. The comments appear in "Flash Reports" that were sent to FiercePharma Manufacturing. Abrahams cited Genzyme's ongoing manufacturing remediation as a reason for his positive outlook on Protalix.
He said in a note to analysts that Protalix should "add more patients, who could potentially roll over to commercial therapy upon approval to the taliglucerase program."
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