Genzyme shows fight in manufacturing comeback
Genzyme continues its manufacturing comeback. The company says in a recent conference call that it expects supplies of Cerezyme and Fabrazyme, manufactured at the Boston-area plant now being retooled per FDA consent decree, to increase in the coming months. However, only minimal inventory is available for both and supply could be affected by further production setbacks.
If the company delivers, it will mark another milestone in its reclamation of business lost to spiraling manufacturing problems and FDA actions in response. Among the chief recipients of Genzyme's manufacturing misfortune has been U.K.-based Shire, maker of Fabryzme alternative Replagal, which has earned pre-approval availability and then fast-track status from FDA because of the supply shortage, as reported.
Genzyme is sticking to its plan to increase Cerezyme shipments in August, says the Wall Street Journal, with expectation of quantities great enough for patients to return to normal dosing by year's end. For Fabrazyme, the goal is increased production efficiency. As an early step, the company reports that regulators have signed off on a new working cell bank.
- here's the WSJ story