BioMarin has provided documents to the U.S. Department of Justice in response to a subpoena which requested information on the company’s government-sponsored testing programs for enzyme replacement therapies Vimizim and Naglazyme.
The California biotech revealed the subpoena in a 10-K annual report that it filed on Monday.
Both medicines are for the rare genetic condition mucopolysaccharidosis, a lysosomal storage disorder. Vimizim (elosulfase alfa) treats the Type IVA (Morquio A syndrome) version of the condition and has been on the market for 10 years. Naglazyme (galsulfase) treats Type VI (Maroteaux-Lamy syndrome) and was approved in 2005.
"We have produced documents in response to the subpoena and are cooperating fully, but there is no assurance that such sponsored testing programs, or our other operations or programs, will not be found to violate" certain U.S. laws, the company said in the filing.
The company warned that it may be required to pay penalties, be under increased government scrutiny or be suspended from participating in government healthcare programs if it is found in violation of privacy or data protection laws.
“This does not relate to the safety and efficacy of Vimizim and Naglazyme,” a BioMarin spokesperson said in an emailed statement. “While we have produced documents in response to the subpoena and are cooperating fully, we are still in early stages in responding to the subpoena and we currently cannot comment on any specific details.”
The news made little impact on BioMarin's shares as their price has dropped by less than 1% since Monday morning.
Both programs in question are for drugs that are among BioMarin’s best sellers. Vimizim generated sales of $701 million last year, while Naglazyme delivered $420 million in revenue. The duo combined for 46% of the company’s overall revenue last year of $2.42 billion.