Genzyme Resumes Shipments of Gaucher’s Drug from Allston Plant

12/1/09

Genzyme (NASDAQ:GENZ) says today that it has begun shipments of its best-selling drug for Gaucher’s disease made at its plant in the Allston neighborhood of Boston. There have been shortages of the drug since the firm halted production at the Allston plant in June, when viral contamination was discovered there.

The Cambridge, MA-based biotech is trying to replenish supplies of its imiglucerase (Cerezyme) and its Fabry disease treatment, agalsidase beta (Fabrazyme). The firm says that the first shipments of newly produced imiglucerase will go to the sickest Gaucher’s patients, and it expects to meet all demand for the drug by the first quarter of 2010. Yet the company hasn’t been able to ship the Fabry treatment from the Allston plant, and it doesn’t expect to be able to meet all demand for the drug before the second quarter of 2010. This means Genzyme is behind schedule in getting Allston fully up and running again. The company said in September that it would begin shipping its Fabry drug in mid-December and its Gaucher’s therapy as early as November.

Shortages of the drugs have caused Genzyme to lower sales forecasts and warn doctors to conserve current supplies to minimize interruptions in patients’ treatment regimens. Last year the company generated nearly $1.7 billion and 38 percent of its revenue from sales of the two drugs. In the Gaucher’s market, the shortages have provided an opening to Genzyme’s competitors such as Irish drug firm Shire and Israel-based Protalix Biotherapeutics to garner expedited processes to win potential approval for their rival treatments. Meantime, Genzyme continues to get hit with other setbacks, including the company’s decision to scrap development of its next-generation drug for kidney disease last month after it failed to beat its existing treatment in a clinical trial.

Robert W. Baird & Co. biotech analyst Christopher Raymond lowered his revenue forecasts for Genzyme last week, citing the series of difficulties that biotech firm has had at the Allston plant and other setbacks such as the failed development of a next-generation drug for kidney disease. Raymond projected that Shire and Protalix may garner U.S. approval of their rival Gaucher’s treatments in the first quarter of 2010 and by mid-2010, respectively. And Shire, which already markets a Fabry disease drug outside the U.S., could gain permission to sell the drug in the U.S. by middle of next year.

Genzyme didn’t say anything today about how resuming part of Allston’s production will affect its sales, but it tried to put a positive spin on the matter. “Shipping the first new product manufactured in Allston is a critical milestone in our effort to again fully meet the needs of patients with Gaucher and Fabry disease around the world,” said Henri Termeer, Genzyme’s chairman and CEO, in a statement.

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