Boston Business Journal -- Genzyme Corp. (Nasdaq: GENZ) has announced that new problems at its beleaguered Allston plant will further aggravate a shortage of its drug Fabrazyme, to treat the rare genetic disorder, Fabry disease.
Patients, some of whom have been receiving only half of their usual doses, may now have to skip or delay a dose of the drug over the next few months, Genzyme said.
In a message to patients, the Cambridge, Mass.-based biotechnology company said that a problem with the last step of the manufacturing process, called fill/finish, where the medicine is put into vials and labeled, has caused a batch of medicine to be rejected. The news comes as the company is still trying to recover from a shortage of the product that began almost two years ago, after the Allston plant was closed for six weeks during the summer of 2009, following the discovery of a virus.
Fill/finish problems have long plagued Genzyme, and a serious enforcement action by the U.S. Food and Drug Administration last year, called a Consent Decree, ordered the company to cease all fill/finish operations in Allston. Genzyme has to date transferred most of those functions to a contract manufacturer, and said it will send all Fabrazyme fill/finish work to the contractor from here on out.
Genzyme told patients that the company is still on track to return to normal dosing of the drug during the second half of 2011, when a new facility in Framingham, Mass. is expected to be approved by the FDA.
Genzyme’s shares were trading at $75.60 in afternoon trading Wednesday, down slightly from $75.66 at the previous close. Genzyme agreed to be bought by French drug maker Sanofi-Aventis Feb. 16 for $20.1 billion.