Genzyme EVP Sandra Poole said her plant at Allston Landing was ready for the inspectors. Well, maybe not quite ready. When European regulators made their visit, they identified one "major" deficiency and several less-serious problems. The company said in a statement that it would respond within 15 days with "a plan and timetable for addressing the observations."
The manufacturing issues weren't serious enough to force another production halt, spokesman Bo Piela told Reuters. But the company didn't provide any details about just what those issues were. And analysts told the newspaper that they're worried by the EMEA's findings. Historically, less than 10 percent of EMEA's observations on inspection have been classified as "major," Christopher Raymond at Robert W. Baird told the news service.
"While we have urged patience until now, we are surprised that there are still significant deficiencies at Allston this late in the game,'' Raymond said. "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.''
Genzyme was forced to shut down the plant after it was contaminated with a virus. The company cleaned up the plant and restarted production a little over a month ago. But that wasn't fast enough to prevent shortages of Genzyme's drugs for Gaucher disease (Cerezyme) and Fabry disease (Fabrazyme). The company had been hoping to release its first new batches in November and December.