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Genzyme Corp. (GENZ) expects to stop rationing its rare disease treatment Fabrazyme by mid-2011, almost two years after the shortage began.
The problem stemmed from the temporary shutdown of Genzyme's Allston, Mass., plant due to a viral contamination last year. The facility is the sole source of Gaucher's disease treatment Cerezyme and Fabry disease drug Fabrazyme, and shortages of the drugs have significantly hurt Genzyme's business.
Adding to that, the efficiency of Fabrazyme production has been slower than expected since restarting the Allston plant.
Patients affected by both diseases lack specific enzymes--which the drugs replace--that break down certain types of fats, causing them to build up in the body and leading to major problems including pain, skeletal complications, organ failure and death.
For both drugs, a normal dose generally means getting the drug twice a month. Fabrazyme patients in the U.S. have received a dose every other month for the past few months, although that is increasing to a monthly dose this month.
The company previously said that current Fabrazyme allocations would remain in place for the third quarter and shipments would increase in the fourth quarter, but it provided no guidance for resumption of normal doses.
Genzyme has said that U.S. Cerezyme patients will be returning to normal doses this month with all patients around the world returning to normal in the fourth quarter.
The news comes as Genzyme has been under siege from activist investors in recent months. The company recently rejected an $18.5 billion unsolicited takeover offer from France's Sanofi-Aventis SA (SNY, SAN.FR).
The Allston plant has been plagued by problems, including numerous failed regulatory inspections and the temporary shutdown, all of which has significantly hurt Genzyme's earnings. The company recently extended the timeline for fixing the issues by a year, meaning regulatory oversight of the plant could last as many as nine years.
The problems have allowed the entrance of competitors for Cerezyme and Fabrazyme. Shire PLC (SHPGY, SHP.LN) makes Gaucher's treatment Vpriv, which is approved in the U.S. and Europe. It already sells Fabry disease drug Replagal in Europe and plans to file for U.S. approval.
Protalix BioTherapeutics Inc. (PLX) is developing a Gaucher's disease treatment with Pfizer Inc. (PFE) that is under Food and Drug Administration review.
Because of the shortages, the FDA allowed all the drugs to be used under a special protocol last year, despite not yet being approved for marketing.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; email@example.com