ARTICLE | Company News

Non-profit wants FTC to investigate Replagal saga

July 16, 2014 12:46 AM UTC

Knowledge Ecology International sent a Shire plc (LSE:SHP; NASDAQ:SHPG) to withdraw a BLA for Replagal agalsidase alfa, effectively abandoning efforts to market the Fabry's disease drug in the U.S. According to the non-profit KEI, Shire's withdrawal of the Replagal BLA may have been part of a "possible conspiracy" with Genzyme Corp. and the Icahn School of Medicine at Mount Sinai to "segment markets globally" for the companies' competing Fabrazyme drugs.

In 2003, a U.S. district court said Replagal did not infringe a U.S. patent held by Mount Sinai covering Fabrazyme agalsidase beta from Genzyme, now part of Sanofi (Euronext:SAN; NYSE:SNY). However, in 2010 a German court said Replagal did infringe a European patent held by the school, which meant Mount Sinai could block competition for Fabrazyme in Europe but not in the U.S. Following Shire's decision to withdraw the Replagal BLA in the U.S., Mount Sinai granted Shire a license to its European patent, allowing the pharma to market Replagal in Europe. ...