Fabrazyme agalsidase beta regulatory update
The Dutch Minister of Health, Welfare and Sport said that manufacturers of drugs for Fabry's and Pompe's diseases should negotiate with the ministry to reduce the price of the Orphan drugs. The minister told the Dutch House of Representatives last week that the drugs are provisionally being reimbursed in 2013 and that a "satisfactory outcome of these negotiations is essential for the continuation of the reimbursement of these Orphan drugs."
Sanofi's Genzyme Corp. unit - which markets Fabrazyme agalsidase beta for Fabry's and Myozyme/Lumizyme alglucosidase alfa for Pompe's - said negotiations will start "in the coming months" and are slated to be completed by mid-year. Genzyme said the ministry has not communicated when any new prices would be applied. Genzyme declined to disclose details, including the prices or current level of reimbursement in the Netherlands for the drugs. Shire, which markets Replagal agalsidase alfa for Fabry's, could not be reached for comment. ...