Shire ($SHPG) is voluntarily recalling three lots of its Gaucher drug Vpriv but emphasized that it does not expect any supply interruption from the recall. That is because Shire has promoted its drug's availability as an indirect selling point against a rival product from Genzyme that ran into supply issues 5 years--a problem the company has long since remedied.
Ireland-based Shire said the three lots were from a single batch and that it undertook the voluntary recall after finding stainless steel and barium sulfate particulate in a small number of vials of the injected drug. No adverse effects have been reported, but there are risks to anyone injected with the particulate, Shire said in an announcement Friday. The company said it tracked the source of the particulate back to contractor that handled the fill finish for the drug. "Shire has significant quantities of Vpriv to replace any affected product. Shire does not anticipate any disruption in supply as a result of this voluntary recall," it said in the announcement.
Gaucher disease is a painful inherited condition affecting fewer than 10,000 people in the U.S. Patients had limited treatment options before the FDA approved Genzyme's Cerezyme in 1994. But Genzyme, now owned by Sanofi ($SNY), ran into several years of supply issues when viral contamination forced the closure of a facility in 2009. It resolved those problems in 2012 with construction of a new plant, but when Shire got Vpriv approved in 2010, it made a big point of talking about redundant manufacturing and still does. When the FDA last month approved Shire's plant in Lexington, MA, as a second U.S. site for making Vpriv, it said: "Shire has always been committed to providing uninterrupted treatment for all Vpriv patients."
Doctors treating Gaucher patients have more treatment options these days. In May 2012, the FDA approved Elelyso, a new drug from partners Pfizer ($PFE) and Israel-based Protalix. The companies brought the drug to the market at a 25% discount to Cerezyme, but as Globes reported yesterday, Protalix realized only about $4.4 million in Elelyso sales last year from its distribution deal with Pfizer. It sold about $5 million worth of the drug itself in Israel. Sanofi also expects to hit the market with a new oral treatment. In December, the FDA granted 6-month priority review to the drug candidate.