Thursday, September 8, 2011

Genzyme lags on filling rare disease drug orders

By Julie M. Donnelly, Boston Business Journal

Genzyme Corp. is still struggling to fill orders of its rare-disease drug Fabrazyme, more than two years after a viral contamination and subsequent six week shutdown at its manufacturing plant in Allston.

In a letter to health care providers dated Aug. 25, Cambridge-based Genzyme, which is owned by French drug maker Sanofi (NYSE: SNY), apologized for failing to ship doses of the Fabry disease therapy on Aug. 1, as promised.

The letter says that as of July 25, when the letter went out promising the shipment, “all indications were that we would be able to ship Fabrazyme promptly. However, shortly after that communication we experienced an unexpected delay related to our quality release process and were not able to ship Fabrazyme as expected. Because we have a very limited inventory of Fabrazyme, we rely on each release of Fabrazyme in order to have enough medication to ship monthly allocations. Any delay in the quality release process can interfere with our ability to ship Fabrazyme.”

Genzyme said patients would receive their full doses for August in September, and that the company would update patients and doctors mid-September about when the scheduled September doses will be shipped.

Genzyme has said that FDA approval of its new plant in Framingham, expected by the end of the year, will permanently alleviate the shortage of Fabrazyme.