The EMEA has issued US biotech firm Genzyme with a letter detailing “one major observation and several other observations” following an inspection of its Allston, Massachusetts manufacturing plant last month.
While details of the European Medicine Agencies letter (EMEA) have not been released, the news is a further blow for the facility following a number of regulatory problems over the last few months.
In March, the US Food and Drug Administration (FDA) said it had found “significant objectionable conditions” at the plant, including several deviations from current good manufacturing (cGMP) practices. The agency is due to re-inspect later this year.
The FDA’s criticism was followed in June by Genzyme’s discovery of viral contamination at the facility, which temporarily halted production of Myozyme (alglucosidase alfa), Fabrazyme (agalsidase beta) and its biggest seller Cerezyme (imiglucerase).
Manufacturing operations at Allston restarted the end of July after an extensive cleaning operation and, according to Genzyme, the first product batches will be released in November and December.
In a press statement Genzyme said the EMEA’s document contained “no critical observations” and added that it is confident the comments can be addressed in the next 15 days without interrupting manufacturing operations.
Some observers did not share Genzyme’s belief. Robert W Baird analyst Christopher Raymond told Boston.com that “While we have urged patience until now, we are surprised that there are still significant deficiencies at Allston this late in the game.”
He added that: “We are lowering our Cerezyme estimates considerably through 2012 as we now feel the odds of continued delays at Allston Landing and longer-lasting fallout from said delays are now higher.’’
Geoffrey Porges, an analyst at Sanford Bernstein, speculated that the continuing problems could have a big impact, suggesting that: “Should Genzyme’s manufacturing issues persist, the possibility of a friendly or quasi-friendly acquisition by a big pharma company definitely increases.’’
For Genzyme’s Cerezyme rivals, UK firm Shire and Israeli group Protalix BioTeherapeutics, the EMEA letter is good news. Both firms accelerated their development of alternatives to the drug this summer when Genzyme’s manufacturing problems emerged.
Concerns raised in the EMEA’s letter and the negative PR impact they have are likely to intensify Shire and Protalix’ efforts to carve out a share of the $1.24bn a year Gaucher’s disease market, regardless of whether Genzyme has to halt manufacture of Cerezyme a second time.