Eurand NV, a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies, announced that its raw material supplier has filed its response to questions relating to the Drug Master File (DMF) raised by the US Food and Drug Administration (FDA) for EUR-1008 (Zentase), an innovative pancreatic enzyme replacement product (PEP). This filing is in addition to the response that Eurand submitted in August 2008 to the FDA's questions relating to the manufacture of EUR-1008 in its June 2008 approvable letter.
"We are pleased that our raw material supplier has completed its response to the FDA's questions on the DMF," said Gearoid Faherty, chairman and chief executive officer. He noted that the FDA recently held an advisory committee meeting for another PEP and that Eurand's raw material supplier had taken note of the panel's recommendations in preparing its reply to the FDA's questions but that Eurand was unsure what, if any, impact the committee's proposed recommendations for that product might have on review or timing of the review of the NDA for EUR-1008.
Separately, the company announced that late-stage negotiations are continuing for a European partner for EUR-1008, and it expects to finalize a distribution agreement in early 2009.
Eurand's lead product candidate, EUR-1008 (Zentase), is an innovatively formulated pancreatic enzyme product that is being developed for the treatment of exocrine pancreatic insufficiency, a condition associated with cystic fibrosis, chronic pancreatitis and other diseases.