Shire received approval from the EMA for its second manufacturing facility in the USA for its Fabry's Disease drug, Replagel. It will be the first product made at the plant, and if things go well will be followed by Shire's Gaucher drug, Vpriv, next year. Both drugs were afforded better opportunity to penetrate the market due to Genzyme's serious problems in supplying their versions of these drugs, Fabrazyme and Cerezyme respectively. Replagel's sales grew 81% last year and reached $351 million. The 200,000 square foot facility is claimed to be the world's largest based on disposable manufacturing technology. See InPharm article.
Novo Nordisk also announced that it will be spending 1 billion Danish kroner to build a new factory in Denmark for making biologicals like hemophilia drugs and growth hormones. The expansion was planned to keep up with demand on current product plus provide additional capacity for new products in the pipeline. The packaging portion of the facility is expected on-line by 2013 with the manufacturing areas coming on-line in 2015. See PharmaNews.
Posted by Bruce Lehr June 28th 2011.