Fabrazyme

Leerink points out that the company further pushed out the timing for a full launch of both Cerezyme and Fabrazyme, meaning that the FY10 guidance is likely back-end weighted and "depends on regaining reasonable traction with Allston products and Lumizyme approval.

StreetInsider.com News Articles 2010

The biotech company, based in Cambridge, Mass., said it will begin to move the most severely affected patients in Europe to full dosages of Fabrazyme in the first quarter of this year.

Genzyme Gets Nod From FDA For Plant Sten Stovall 2012

In the quarter, Cerezyme sales more than doubled on increased shipments, while Fabrazyme sales were up 6.2% as supplies improved.

Sanofi Wins Long-Sought Biotech Deal Jeanne Whalen 2011

The plant is the sole source of Genzyme's top-selling products, Gaucher's disease treatment Cerezyme and the Fabry disease drug Fabrazyme, which are recovering from shortages that stemmed from the shutdown.

Sanofi Wins Long-Sought Biotech Deal Jeanne Whalen 2011

Genzyme has struggled with manufacturing problems, and had to cut back production of key medicines Cerezyme and Fabrazyme.

Sanofi, Genzyme May Announce Deal Wednesday Gina Chon 2011

Genzyme has been beset by manufacturing and regulatory problems since 2009, when a contamination-related shutdown of its Allston, Mass., plant caused a shortage of Genzyme's top-selling products, Fabrazyme for Fabry disease, and Cerezyme for a condition called Gaucher's disease.

Genzyme Gets Nod From FDA For Plant Sten Stovall 2012

Sanofi SA's Genzyme unit said the Food and Drug Administration has approved its new manufacturing plant in Framingham, Mass., clearing the way for production of Fabrazyme, a treatment for Fabry disease.

Genzyme Gets Nod From FDA For Plant Sten Stovall 2012

Globally, the complete return to normal supply levels of Fabrazyme will begin in the second quarter of this year, as Genzyme works to obtain all regulatory approvals needed around the world and to build inventory.

Genzyme Gets Nod From FDA For Plant Sten Stovall 2012

The new Framingham plant is dedicated to the manufacture of Fabrazyme.

Genzyme Gets Nod From FDA For Plant Sten Stovall 2012

But the continued supply shortage of Fabrazyme has meant Fabry patients are being under-treated.

Genzyme Gets Nod From FDA For Plant Sten Stovall 2012