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Ongoing supply problems for Genzyme’s Cerezyme
Article | 19 September 2011
US biotech Genzyme, now a subsidiary of French drug major Sanofi (Euronext: SAN), says it will have only limited supplies of its Gaucher disease drug Cerezyme (imiglucerase, injection) available for the next four months starting October.
In a letter to US health care providers, published by the National Gaucher Foundation, Genzyme said the shortage was caused by "a temporary decrease in Cerezyme yields," coupled with "changes to our product release processes and procedures".
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The company has had problems with supplies of Cerezyme, as well as its Fabry disease drug Fabrazyme (agalsidase beta) for patients worldwide, as a result of earlier manufacturing issues since June 2009 (The Pharma Letters passim). The Genzyme problems have benefited Ireland-headquartered Shire, as it has resulted in switching to the company’s Replagal (agalsidase alfa) from Fabrazyme and to Vpriv (velaglucerase alfa) from Cerezyme.
Adjustments to individual treatment plans
Changes to Cerezyme availability will be felt globally, the letter stated, adding that delays in shipments will likely affect patients and some adjustment to individual treatment plans may be necessary. For the USA from October through January, Genzyme expects to provide:
• one full dose (equivalent to the currently prescribed dose) per month for patients aged 19 years and older currently treated with Cerezyme; and
• two full doses per month for patients aged 18 years and younger and for Type 2/3 patients currently treated with Cerezyme.
Genzyme will confirm shipping availability each month. Given current improvements to productivity and progress with the firm’s manufacturing recovery, Genzyme currently anticipates an improving Cerezyme supply outlook from February 2012 forward.
In order to support the current level of patient demand, Cerezyme is made available as it is produced, which does not allow the build-up of inventory, the company explained. “Operating with little or no inventory means changes like these in our manufacturing plans can impact supply. Over the past four years there has been significant investment in a new manufacturing facility to produce Fabrazyme in Framingham, Massachusetts. We are in the process of plant validation and currently anticipate completing regulatory approval processes that will allow us to ship product in the first part of 2012. This is a critical step as it will allow us to improve Cerezyme production at the Allston facility which is producing both Cerezyme and Fabrazyme today,” said Genzyme’s letter.