Genzyme ($GENZ) swats first consent decree pitch

Genzyme ($GENZ) last week beat an end-of-November deadline for one action item dictated by its manufacturing consent decree with the FDA announced last May. It has moved the fill/finish operations of certain drugs out of its beleaguered Boston-area plant; some have been relocated to a company facility in Ireland and the rest to contractor Hospira.

The affected drugs are Cerezyme, Myozyme, Fabrazyme and Thyrogen for the U.S. market. Genzyme says in a statement that the successful relocation triggers the removal of restrictions on the marketing and distribution of Thyrogen in the U.S.

Genzyme must still relocate remaining fill/finish operations at the Allston Landing site, for products sold outside the U.S., by next August. The biotech giant has strong incentive for meeting the relocation deadlines.  By doing so, it avoids a potential "disgorgement" of 18.5 percent of profits on the affected products, on top of the $175 million disgorgement already assessed under the consent decree.

The manufacturing remediation effort is being overseen by a requisite third party, Quantic Group, which Genzyme named in March. Quantic is working on site with Genzyme throughout the operations overhaul and will remain involved for five years following its completion to the satisfaction of the FDA, reports Reuters.

Genzyme since last spring has reorganized its operations management and installed new heads of quality control and compliance as part of the remediation.

- see the Genzyme release
- here's the Reuters report

Suggested Articles

Fujifilm Diosynth Biotechnologies last year committed 10 billion yen toward its manufacturing operations. It has now kicked off one of those projects.

Popular logic says you never switch horses, or CDMOs, in the middle of the stream, but Acacia Pharma had to do that to win an FDA approval.

The FDA has found issues with the testing practices of a U.S. generics maker that had specific problems with ADHD and weight-loss drugs.