Our latest featured recommendation is an Italian biopharmaceutical company working on treating certain complications arising from chemotherapy, and bone marrow and stem cell transplantation therapy, notes small-cap expert Jim Oberweis Jr. in The Oberweis Report.
Gentium Spa (GENT) is focused on the development and commercialization of its leading product, defibrotide, to treat certain complications arising from chemotherapy, and bone marrow and stem cell transplantation therapy.
Defibrotide is a drug composed of a mixture of single and double-stranded DNA extracted from pig intestines.
On October 22, 2013, Gentium received marketing authorization from the European Commission to sell Defitelio (defibrotide) for the treatment of severe hepatic veno-occlusive disease (VOD) in adults and children undergoing hematopoietic stem cell transplantation therapy.
VOD is a complication in which some of the small veins in the liver are obstructed, resulting from a high-dose of chemotherapy that is given before a bone marrow transplant.
Defitelio is the first approved treatment for VOD in Europe and has received orphan status from the European Medicines Agency, which gives the company limited market exclusivity for ten years from the date of approval.
Prior to the recent European approval, and currently in the US market, the company has distributed defibrotide through a compassionate use treatment program, where patients suffering from VOD can receive the drug, as there are very few treatment alternatives.
The Gentium management team currently expects to file an NDA with the FDA sometime in the first half of 2014, and through its fast track designation, could see approval before 2014 year end.
Clients of Oberweis Asset Management own approximately 125,000 shares. These shares may be appropriate for risk-oriented investors.
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