(By Balachander) Gentium S.p.A. (NASDAQ: GENT) tumbled nearly 39 percent in premarket trading on Wednesday after the Italian biopharmaceutical company provided an update on the review of marketing authorization for its lead product candidate to treat hepatic veno-occlusive disease (VOD).
Gentium said it expects an opinion recommending against approval of the Marketing Authorization Application for Defibrotide from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).
"While not a final decision, the company considers it unlikely that this position will change before the formal vote is undertaken next month," the company said. "If a formal negative recommendation is issued, and depending upon the nature of the objections, the company may appeal such negative decision."
VOD is a disease of the liver in which the small vessels are destroyed. This can occur following liver transplantation but also as an adverse reaction to certain medicines. VOD typically occurs as a significant complication of stem cell transplantation.
Currently, there is no approved agent to treat or prevent VOD in the United States or the European Union. Orphan designation of Defibrotide was granted in the United States for the treatment of hepatic VOD.
"We will work closely with the CHMP to address the Committee's concerns and remain confident of the favorable benefit/risk profile of Defibrotide, which is the only option recommended by the European Group for Blood and Marrow Transplantation for the treatment of VOD," Gentium said.
ADRs of GENT, which have been trading in the 52-week range of $7.70 to $12.84, ended at $11.93 on Wednesday.