BioMarin Pharmaceutical received a subpoena from the U.S. Department of Justice seeking information about the company's sponsored testing programs related to two older treatments, the drugmaker revealed in an SEC filing.
The news about the subpoena, buried on page 48 of BioMarin's recent filing, was light on details, only sharing that the DOJ had requested that the company produce "certain documents" regarding BioMarin's sponsored testing program for the drugs, Vimizim and Naglazyme.
Naglazyme is an enzyme replacement therapy approved in 2005 for the treatment of Maroteaux-Lamy Syndrome (mucopolysaccharidosis VI), a rare progressive condition that causes tissues and organs to enlarge, become inflamed and eventually atrophy. Vimizim is an enzyme replacement therapy approved in 2014 for the treatment of Morquio A Syndrome (mucopolysaccharidosis IVA) a rare condition that affects the growth of cartilage and bone.
Sponsored testing programs are clinical lab testing paid for by pharma companies. The results go back to the ordering physician but certain blinded data are shared with program sponsors. The DOJ inquiry into BioMarin's programs raises transparency questions about the broader industry practice of sponsored testing.
According to BioMarin, the company has produced documents in response to the subpoena and is cooperating fully — but the drugmaker offered no assurance that its programs will not be found to violate laws.
