Ireland's Jazz Pharmaceuticals ($JAZZ) is betting $1 billion that Italian biotech Gentium ($GENT) and its orphan treatment Defitelio can sustain their momentum, buying the company to get its hands on a drug for a rare liver disease.
In an all-cash deal, Jazz gets a drug with a long history of regulatory back-and-forth that finally culminated in a European approval in October. Defitelio, which treats the vein-blocking hepatic veno-occlusive disease, endured an initial rejection at the hands of the European Medicines Agency, and a 2011 FDA rebuke led Gentium to pull its U.S. application for the drug, never refiling.
But Jazz believes it has a winner on its hands, and CEO Bruce Cozadd said his company is prepared to hit the ground running with Defitelio overseas and pursue new indications for the drug, including one for graft-versus-host disease.
"Because Defitelio is already approved in the EU, the acquisition would add a new orphan product that has potential for short- and long-term revenue generation, high growth and expansion of our multi-national commercial platform," Cozadd said in a statement.
Whether Defitelio has any future in the U.S. is unclear, and Gentium's initial retreat came after the agency raised serious concerns about the completeness and quality of its data, asking for more details about how its trials were conducted and monitored.
- read the announcement (PDF)