Gentium Reports Third Quarter Financial Results and Clinical Update.

VILLA GUARDIA (COMO), Italy -- Gentium S.p.A. (Nasdaq:GENT) (the "Company") today reported financial results for the three and nine months ended September 30, 2006. Highlights of the third quarter of 2006 and recent weeks include:

* Publication of an independent study showing Defibrotide could prevent Veno-Occlusive Disease (VOD) associated with Infantile Osteopetrosis;

* Publication of two independent studies of Defibrotide to treat VOD in children;

* Presentation of data at the 16th European Congress of Immunology demonstrating that Defibrotide modulates immune functions of endothelial cells and its impact for transplantation and cancer therapy;

* Progress with the Phase III clinical trial in the U.S. with Defibrotide for the treatment of severe Veno-Occlusive Disease with Multiple Organ Failure (Severe VOD): this study is expected to be conducted at approximately 32 clinical centers; 18 centers are open for enrollment and nine patients have been enrolled;

* Progress with the Phase II/III clinical trial in Europe with Defibrotide for the prevention of VOD in children: 30 centers have IRB approval and 25 centers are open for patient enrollment; 56 patients have been enrolled;

* Progress with an investigator-sponsored Phase I/II study with Defibrotide for the treatment of advanced and refractory Multiple Myeloma: four centers are open; 24 patients have been enrolled, which completes enrollment for the Phase I segment of the study;

* Acceptance of 10 abstracts on Defibrotide for presentation at the Annual Meeting of the American Society of Hematology (ASH) in Orlando, Fla., December 9-12;

* Scheduling of two presentations on Defibrotide for the EuroTIDES, 7th Annual Conference on Oligonucleotides in Hamburg, Germany, December 4-5.

Clinical Highlights and Outlook

Commenting on Gentium's clinical progress, Laura Ferro, M.D., Chairman and Chief Executive Officer, said, "During the third quarter we continued to make substantial progress in advancing our clinical programs and in building our infrastructure to support these efforts. To date, our U.S. Phase III trial with Defibrotide for the treatment of VOD has 18 sites opened for enrollment, an increase of 12 sites, and nine patients are being treated. We continue to add centers and expect to have nearly all 32 clinical sites open for patient enrollment by year end. As each center needs to treat only 2-3 patients to reach accrual, we are confident that this trial will remain on track to reach full enrollment by third quarter 2007. In order to ensure the necessary support and expertise in managing this trial, we have engaged a leading contract research organization (CRO) to oversee implementation and to provide data management services.

"Our European Phase II/III trial for the prevention of VOD in pediatric patients is progressing, and we are in the process of determining our regulatory strategy for developing a combined U.S. and European Phase II/III trial for the prevention of VOD in adults," she added. "We believe a combined trial offers a better registration strategy for this indication that could save the Company time and money in bringing this potentially life-saving drug to market."

Dr. Ferro continued, "We were extremely pleased that the independent study of Defibrotide to treat multiple myeloma completed its Phase I trial, and is moving forward into the Phase II segment of the study. Data from this Phase I study will be among 10 presentations on Defibrotide at the annual ASH conference next month. These presentations, along with the two Defibrotide presentations at the EuroTides conference in December, underscore the potential therapeutic value of Defibrotide and testify to the hard work and dedication of our collaborating clinicians and Gentium's medical and scientific team," noted Dr. Ferro.

Financial Highlights

Gentium reports its financial condition and operating results using U.S. Generally Accepted Accounting Principles (GAAP). The Company's financial statements are prepared using the Euro as its functional currency. On September 30, 2006, [euro]1.00 = $1.27.

For the third quarter ended September 30, 2006 compared with the prior-year's third quarter:

* Total revenues were [euro]0.90 million, compared with [euro]0.37 million

* Operating costs and expenses were [euro]5.06 million, compared with [euro]2.69 million

* Research and development expenses, which are included in operating costs and expenses, were [euro]2.76 million, compared with [euro]1.18 million

* Operating loss was [euro]4.16 million, compared with [euro]2.32 million

* Interest income (expense), net, was [euro]0.2 million, compared with [euro]0.05 million

* Pre-tax loss was [euro]3.88 million, compared with [euro]2.18 million

* Net loss was [euro]3.88 million, compared with [euro]2.20 million

* Net loss per share was [euro]0.33, compared with [euro]0.28

For the nine months ended September 30, 2006 compared with the comparable prior-year period:

* Total revenues were [euro]3.00 million, compared with [euro]2.21 million

* Operating costs and expenses were [euro]13.42 million, compared with [euro]7.44 million

* Research and development expenses, which are included in operating costs and expenses, were [euro]6.36 million, compared with [euro]3.12 million

* Operating loss was [euro]10.41 million, compared with [euro]5.23 million

* Interest income (expense), net, was [euro]0.34 million, compared with ([euro]4.20) million

* Pre-tax loss was [euro]10.22 million, compared with [euro]9.86 million

* Net loss was [euro]10.22 million, compared with [euro]9.91 million

* Net loss per share was [euro]0.97, compared with [euro]1.62

* Cash used in operating activities was [euro]7.70 million, compared with [euro]6.69 million

* Cash and cash equivalents were [euro]21.55 million as of September 30, 2006

Dr. Ferro commented, "As we advance our clinical development programs, we expect proportionate increases in R&D and clinical and regulatory expenses to contribute to increasing losses for the balance of this year and next year. Our general and administrative expenses have increased substantially, with much of the higher expense a result of the costs of being a public company and the initiation of our Phase III VOD treatment clinical trial and Phase II/III VOD prevention trials. Our 2006 results also reflect a significant decline in interest expense due to the repayment and redemption of our Series A notes in June 2005 in conjunction with our initial public offering."

Operating Results and Trends

The fluctuation in total product sales for the three- and nine-month periods compared with the prior year is primarily the result of higher sales volume of the Company's active pharmaceutical ingredients defibrotide, urokinase and sulglicotide to our principal customer and affiliate, Sirton. Also contributing to the increase was an increase in sales and increases in third-party product sales, mainly due to the sales of sulglicotide to a Korean customer. Total product sales for the nine-month period ended September 30, 2006 increased by [euro]0.81 million, or 41%, compared with the same period in 2005.

Cost of goods sold was [euro]2.44 million for the nine-month period ended September 30, 2006, which included a [euro]182 thousand inventory reserve attributable to slow-moving inventory, compared with cost of goods sold of [euro]1.72 million for the comparable period in 2005. The increase in cost of goods sold was mainly due to increased sales volume in the nine-month period of 2006 compared to the same period in 2005.

Research and development spending increased during the three- and nine-month periods in 2006 compared with 2005, primarily due to the costs associated with the Company's Phase III trial in the U.S. for the treatment of Severe VOD, the Company's Phase II/III trial for prevention of VOD in children and preparations for the Phase II/III trial for the prevention of VOD in adults. Growth in headcount and outside services to support increased activity in our clinical trials, including clinical product production costs, contract research organization expenses and stock-based compensation expense, also contributed to increased research and development expenses.

The Company had 69 employees as of September 30, 2006, compared with 53 as of September 30, 2005. Other general and administrative expense increases were primarily the result of building corporate infrastructure, legal and public company expenses, an increase in internally provided administrative services to replace administrative services previously provided by affiliates and stock-based compensation expense. The increase in internally provided services accounted for the decrease in charges from affiliates between the periods. G&A expense includes a one-time charge of [euro]104 thousand per the absorption of the fixed portion of our production costs, not otherwise included in cost of good sold, due to the partial shut-down of the manufacturing facility in July and August for the replacement of two reactors.

Interest income (expense), net, changed primarily due to the repayment and conversion of the Company's Series A senior convertible notes in June 2005, and the higher level of invested funds compared with the prior year. For the nine months ended September 30, 2005, interest expense on the Series A notes was [euro]4.2 million, including non-cash interest expense of [euro]3.8 million from the amortization of the issue discount and debt issue cost. These notes were converted or redeemed in June 2005. Additionally, interest income increased by [euro]416 thousand from [euro]56 thousand in the period ended September 30, 2005 to [euro]472 thousand in the comparable 2006 period, as the result of a higher level of invested funds.

The Company ended the third quarter of 2006 with [euro]21.55 million in cash and cash equivalents, compared with cash and cash equivalents of [euro]12.79 million as of December 31, 2005.

About Gentium

Gentium, S.p.A., located in Como, Italy, is a biopharmaceutical company focused on the research, discovery and development of drugs to treat and prevent a variety of vascular diseases and conditions related to cancer and cancer treatments. Defibrotide, the Company's lead product candidate, is an investigational drug that has been granted Orphan Drug status and Fast Track Designation by the U.S. FDA to treat Severe VOD and Orphan Medicinal Product Designation by the European Commission both to treat and to prevent VOD.

Cautionary Note Regarding Forward-Looking Statements

This press release contains "forward-looking statements." In some cases, you can identify these statements by forward-looking words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential" or "continue," the negative of these terms and other comparable terminology. These 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 Form 20-F for the year ended December 31, 2005 under the caption "Risk Factors."

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