Defibrotide

Defibrotide, the Company's lead product candidate, is an investigational drug that has been granted Orphan Drug status by the U.S.

unknown title 2011

Defibrotide net sales through named-patient and cost recovery programs were EUR 4.37 million, or 77% of total product sales, compared to EUR 3.99 million or 65%.

unknown title 2011

Completion of pre-clinical and clinical studies for Defibrotide.

unknown title 2011

"We are pleased to report that Defibrotide product sales increased 25% compared with the prior-year period," stated Salvatore Calabrese, Senior Vice President and Chief Financial Officer of Gentium S.p.

unknown title 2011

Voluntarily withdrew the NDA for Defibrotide following correspondence from the FDA identifying potential "refusal to file" issues regarding the completeness of the datasets and requesting additional quality reviews and further details regarding the trials.

unknown title 2011

Defibrotide sales through the named-patient and cost recovery programs have a higher margin compared to the sales of the Company's other active pharmaceuticals ingredients.

unknown title 2011

Dr McDonough also commented on the new distribution agreement with the Italian company Gentium regarding Defibrotide in the Nordic and Baltic regions announced yesterday by Gentium.

Reuters: Press Release 2012

Defibrotide has the potential to become the first drug approved for the prevention and treatment of hepatic veno-occlusive disease (VOD) a serious and potentially fatal complication of hematopoietic stem-cell transplantation (HSCT).

Reuters: Press Release 2012

The variance was primarily due to the increased distribution of Defibrotide through the named-patient and cost recovery programs.

unknown title 2011

The percentage decrease is primarily due to a different composition of product mix with proportionately increased sales of Defibrotide, which represent 76% of the product sales compared to 66% for the prior-year period.

unknown title 2011