Gentium S.p.A. Announces FDA Agrees Company's CMC Submission is Adequate for Commencing Phase III Clinical Trials with Defibroti

Gentium S.p.A. (AMEX:GNT) (the "Company") announced
today that the U.S. Food and Drug Administration (the "FDA") has
agreed that Gentium's Chemistry, Manufacturing & Controls ("CMC")
submission provides adequate characterization of Defibrotide for the
Company's planned Phase III clinical trial for the treatment of
hepatic veno-occlusive disease ("VOD") with multi-organ failure
("Severe VOD").
   Defibrotide to treat Severe VOD, which has been granted orphan
drug status by the FDA, is the Company's lead product candidate in the
U.S. An adequate CMC submission is one of the pre-requisites to
commencing Phase III clinical trials.
   Dr. Laura Ferro, Chairman and Chief Executive Officer of the
Company, said, "The FDA's acknowledgment of the adequacy of our CMC
submission for commencing Phase III clinical studies is a major
milestone in our U.S. regulatory strategy for Defibrotide to treat
Severe VOD. We are both excited and pleased to have completed this
step, and look forward to meeting with the FDA later this year to
discuss initiating our Phase III trial."

   About VOD

   VOD is a potentially devastating condition in which some of the
veins in the liver are blocked as a result of toxic cancer treatments
such as chemotherapy. We believe that the survival rate for Severe VOD
without treatment after 100 days is approximately 20%.

   About the Company

   The Company, located in Villa Guardia (Como), Italy, is a
biopharmaceutical company focused on the research, discovery and
development of drugs derived from DNA extracted from natural sources
and drugs which are synthetic oligonucleotides (molecules chemically
similar to natural DNA) to treat and prevent a variety of vascular
diseases and conditions related to cancer and cancer treatments.

   Cautionary Note Regarding Forward-Looking Statements

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statements are not historical facts but instead represent the
Company's belief regarding future results, many of which, by their
nature, are inherently uncertain and outside the Company's control. It
is possible that actual results may differ, possibly materially, from
those anticipated in these forward-looking statements. For a
discussion of some of the risks and important factors that could
affect future results, see the discussion in our Prospectus filed with
the Securities and Exchange Commission under Rule 424(b)(4) under the
caption "Risk Factors."