Gentium SpA (NASDAQ:GENT)

Gentium SpA specializes in the manufacture of biopharmaceutical and medical drugs. It focuses on the development and manufacture of its primary product candidate, defibrotide, an investigational drug based on a mixture of single-stranded and double-stranded DNA extracted from pig intestines. The development of defibrotide has been focused on the treatment and prevention of a disease called hepatic veno-occlusive disease, or VOD, a condition that occurs when veins in the liver are blocked as a result of cancer treatments, such as chemotherapy or radiation, that are administered prior to stem cell transplantation. Defibrotide has been given 'orphan' status by the U.S. Food and Drug Agency and the European Medicines Agency, which means that there will be limited market exclusivity upon regulatory approval. Defibrotide has also been granted 'fast-track product' designation by the FDA for the treatment of severe VOD prior to stem cell transplantation. While there is not yet regulatory approval to market defibrotide, the company is permitted to distribute defibrotide on a pre-approval basis under a treatment Investigational New Drug protocol. Gentium was founded in 1944 and is headquartered in Como, Italy.