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Gentium Reports First Quarter Financial Results
- The Company was cash flow positive at the end of the first quarter and expects to remain cash flows positive/neutral throughout 2010
- Revenues in line with year-end forecast
- Net loss decreased to EUR 0.03 million compared to EUR 2.97 million for the same period in 2009
Press Release Source: Gentium S.p.A On Wednesday May 26, 2010, 7:30 am EDT
VILLA GUARDIA (COMO), Italy, May 26 /PRNewswire-FirstCall/ -- Gentium S.p.A. (NASDAQ:GENT - News) (the "Company") today reported financial results for the quarter ended March 31, 2010. The Company 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 March 31, 2010, EUR 1.00 = $1.3479.
"The financial results of the first quarter of 2010 are in line with our previously announced year-end forecast. Net loss decreased from EUR 2.97 million for the three-month period ended March 31, 2009 to EUR 0.03 million for the same period in 2010," stated Salvatore Calabrese, Senior Vice-President, Finance of Gentium S.p.A. "The Company was cash flow positive, despite the one-time restructuring charges of EUR 0.95 million during the quarter."
"The demand for Defibrotide through our named-patient and cost recovery programs continues to support the need to treat and prevent veno-occlusive disease," stated Dr. Khalid Islam, Chairman and Chief Executive Officer of Gentium S.p.A. "We remain focused on completing certain preclinical and clinical studies requested by the regulatory authorities so that we can file our new drug application (NDA) for Defibrotide by the end of the second quarter 2011."
Financial Highlights
For the first quarter ended March 31, 2010 compared with the prior year's first quarter:
Total revenues were EUR 4.99 million, compared with EUR 1.01 million. Product sales for the three-month period ended March 31, 2010 were EUR 3.92 million compared to EUR 0.97 million for the same period in 2009. As of March 31, 2010, Defibrotide net sales through named-patient and cost recovery programs amounted to EUR 2.61 million, or 67% of total product sales; there were no sales of Defibrotide during same period of the prior year. As of March 31, 2010, sales of the Company's active pharmaceutical ingredients (API) amounted to 1.31 million, or 33% of total product sales, compared to EUR 0.97 million for the same period in 2009.
Operating costs and expenses, which include restructuring charges of EUR 0.95 million, were EUR 5.10 million, compared with EUR 4.16 million.
Research and development expenses, which are included in operating costs and expenses, were EUR 1.41 million, compared with EUR 1.45 million.
Operating loss was EUR 0.11 million, compared with EUR 3.14 million.
Net loss was EUR 0.03 million, compared with EUR 2.97 million.
Basic and diluted net loss per share was EUR 0.002, compared with EUR 0.20 per share.
Cash and cash equivalents were EUR 5.80 million and EUR 1.39 million as of March 31, 2010 and December 31, 2009, respectively. In February 2010, the Company received an initial payment of EUR 5.11 million ($7.0 million) from Sigma-Tau in connection with amending the existing license and supply agreement to include the commercialization of the prevention of Defibrotide in North America, Central America and South America.
Operating Results
Product sales for the three-month period ended March 31, 2010 were EUR 3.92 million compared to EUR 0.97 million for the same period in 2009, an increase of EUR 2.95 million. The increase was primarily due to the distribution of Defibrotide through the named-patient and cost recovery programs which were initiated in April 2009 and October 2009, respectively. For the three-month period ended March 31, 2010, named-patient and cost recovery programs sales amounted to EUR 2.61 million, which are net of EUR 0.39 million in service fees.
API revenues increased to EUR 1.31 million for the three-month period ended March 31, 2010 from EUR 0.97 million for the same period in 2009, reflecting the increase in volume of sales for suglicotide and urokinase.
Sales to a related party, Sirton, for the three-month period ended March 31, 2010 and 2009 represented 0% and 20% of the total product sales, respectively. The decrease in sales to a related party was due to the fact that beginning in the second quarter of 2009, the Company terminated the supply agreement with Sirton and entered into direct sales agreements with Sirton's customers in order to mitigate the risk associated with Sirton's poor financial condition.
Other revenues were EUR 1.07 million for the three-month-period ended March 31, 2010 compared to EUR 0.04 million for the same period in 2009. Fluctuation versus the prior period is primarily attributable to an increase in activities that were reimbursed from Sigma-Tau under a cost sharing arrangement with the Company, which amounted to EUR 0.18 million and EUR 0.04 million as of March 31, 2010 and 2009, respectively, and a ratable recognition of EUR 0.85 million ($1.17 million) of the EUR 5.11 million ($7.0 million) up-front payment made by Sigma-Tau in connection with the amendment of the existing license and supply agreement with the Company. The up-front payment is being recognized ratably through the second quarter of 2011, which is when the Company expects to file an NDA for Defibrotide.
Cost of goods sold was EUR 0.97 million for the three-month period ended March 31, 2010 compared to EUR 0.76 million for the same period in 2009. Cost of goods sold as a percentage of product sales was 25% for the three-month period ended March 31, 2010 compared to 78% for the same period in 2009. The percentage decrease is primarily due to higher margins on Defibrotide sold through the named-patient and cost recovery programs.
The Company incurred research and development expenses of EUR 1.41 million for the three-month period ended March 31, 2010 compared to EUR 1.45 million for the same period in 2009. Research and development expenses were primarily for the development of Defibrotide to treat and prevent VOD. The slight decrease from the comparable period in 2009 was primarily due to completion of clinical trials.
General and administrative expenses were EUR 1.39 million for the three-month period ended March 31, 2010 compared to EUR 1.63 million for the same period in 2009. The decrease was primarily due to a release of a reserve for doubtful accounts in the amount of EUR 0.09 million, lower payroll costs and a decrease in stock-based compensation expenses.
Corporate restructuring charges resulting from a strategic decision to close the Company's New York office amounted to EUR 0.95 million for the three-month period ended March 31, 2010.
Net loss was EUR 0.03 million for the three-month period ended March 31, 2010 compared to EUR 2.97 million for the same period in 2009. The difference was primarily due to increased net sales and higher margins associated with the named-patient and cost recovery programs, increase in other income and revenues (including the ratable recognition as revenue of a portion of the up-front payment made by Sigma-Tau in connection with the amendment of the existing license and supply agreement with the Company), decrease in general and administrative expenses offset by the Company's one-time restructuring charges.
The Company ended the first quarter of 2010 with EUR 5.80 million in cash and cash equivalents, compared with cash and cash equivalents of EUR 1.39 million as of December 31, 2009. The increase was mainly due to the upfront payment of EUR 5.11 million ($7.0 million) received from Sigma-Tau in connection with the amendment of the existing license and supply agreement, revenues generated from named patient and cost recovery programs, and deferment of the payment of principal debt outstanding, offset by a partial payment of the one-time restructuring charges of EUR 0.86 million ($1.14 million) for restructuring charges related to the closure of New York office and payment of outstanding payables from the prior year. For the three-month period ended March 31, 2010, the Company also benefited from a tax credit EUR 0.76 million utilized to offset the payment of an equivalent amount of social security and withholding tax and utilization of a 2009 VAT credit of EUR 0.17 million.
On the small-cap side, Italian biotech group Gentium S.p.A. /quotes/comstock/15*!gent/quotes/nls/gent (GENT 4.35, +2.06, +89.96%) saw its shares rocket 64% to $3.75.
Late Wednesday, Gentium reported that revenue for the fourth-quarter 2009 jumped to EUR 4.05 million, up from EUR 1.04 million for the previous year's period.
"For the fourth quarter 2009, we reported positive operating cash flow. We expect revenues in 2010 to be in the range of $20 - $25 million and cash flow to be positive in 2010," said Gentium's chief financial officer, Gary Gemignani, in a statement.
Gentium also announced that it hopes to file for U.S. and European approvals of its new hematology drug Defibrotide by the end of the second quarter of 2011
http://www.marketwatch.com/story/human-genome-gentium-in-spotlight-2010-04-01?siteid=yhoof
Gentium Announces Fourth Quarter and Year End 2009 Results
- Revenues increase by 78% compared with 2008
- 60% decrease in cash burn for operating activities
- Cash flow positive in Q4/2009 and expects to remain positive for 2010
- Expected revenue in 2010 to be in the range of $20 - $25 million
Press Release Source: Gentium S.p.A. On Wednesday March 31, 2010, 7:55 pm EDT
VILLA GUARDIA (COMO), Italy, March 31 /PRNewswire-FirstCall/ -- Gentium S.p.A. (Nasdaq:GENT - News) today reported financial results for the quarter and year ended December 31, 2009. The Company 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 December 31, 2009, EUR 1.00 = $1.4332.
"Total product sales rose 78 percent in 2009 resulting from the successful implementation of the named-patient program in Europe and cost recovery program in the U.S.," stated Gary Gemignani, Executive Vice President and Chief Financial Officer of Gentium S.p.A. "For the fourth quarter 2009, we reported positive operating cash flow. We expect revenues in 2010 to be in the range of $20 - $25 million and cash flow to be positive in 2010."
"We are pleased that Defibrotide was selected as one of the highlights at the American Society of Hematology (ASH) conference and more recently at European Bone Marrow Transplant (EBMT) conference," stated Dr. Khalid Islam, Chief Executive Officer of Gentium S.p.A. "We are currently completing certain preclinical and clinical studies requested by regulatory authorities and we anticipate filing for regulatory approval in the U.S. and Europe by the end of second quarter 2011. With the $7 million upfront payment in connection with our recent expansion of the license and cost sharing agreements with Sigma-Tau and substantial revenues being generated by the named-patient program, we have significantly strengthened our balance sheet."
Financial Highlights
For the fourth quarter ended December 31, 2009 compared to the prior year's fourth quarter:
Total revenues were EUR 4.05 million, compared with EUR 1.04 million
Operating costs and expenses were EUR 4.08 million, compared with EUR 4.88 million
Research and development expenses, which are included in operating costs and expenses, were EUR 0.86 million, compared with EUR 1.70 million
Operating loss was EUR 0.04 million, compared with EUR 3.84 million
Interest income/(expense), net, was EUR (0.01) million, compared with EUR 0.08 million.
Pre-tax loss was EUR 0.05 million, compared with EUR 3.45 million
Net loss was EUR 0.05 million, compared with EUR 3.45 million
Basic and diluted net loss per share was EUR 0.003, compared with EUR 0.23 per share
For the year ended December 31, 2009 compared with the prior year:
Total revenues were EUR 10.17 million, compared with EUR 7.44 million
Operating costs and expenses were EUR 14.75 million, compared with EUR 27.77 million, which included a write-down of assets of EUR 3.40 million
Research and development expenses, which are included in operating costs and expenses, were EUR 3.51 million, compared with EUR 9.57 million
Operating loss was EUR 4.58 million, compared with EUR 20.33 million, which included a write-down of EUR 3.4 million in assets
Interest income/(expense), net, was EUR (0.11) million, compared with EUR 0.25 million
Net loss was EUR 4.53 million, compared with EUR 19.90 million, which included a write-down of EUR 3.4 million in assets
Basic and diluted net loss per share was EUR 0.30 compared with EUR 1.33 per share
Cash used in operating activities was EUR 5.16 million, compared with EUR 12.78 million
Cash and cash equivalents amounted to EUR 1.39 million as of December 31, 2009
Recent Company Highlights
Gentium announced that it amended its existing License and Supply and Cost Sharing Agreements with Sigma-Tau Pharmaceuticals, Inc., to include a license for the prevention indication of Defibrotide in the Americas. Gentium will continue to own exclusive rights to Defibrotide in Europe and the rest of the world.
In March 2010, Gentium announced management and corporate restructuring changes resulting from a strategic decision to consolidate the Company's resources and operations within Italy. Mr. Gary Gemignani, Executive Vice-President and Chief Financial Officer is leaving the Company, effective today, but will provide transitional services through a consulting agreement.
The Company presented an abstract containing the final results for the Phase II/III pediatric prevention trial of Defibrotide for the prevention of VOD at the annual meetings of ASH and EBMT. In the intent to treat analysis Defibrotide demonstrated a 40% reduction in the incidence of VOD within 30 days after SCT, the primary endpoint of the study. In addition, a pre-specified analysis showed that the incidence and severity of acute graft versus host disease by day 100 in allogeneic SCT recipients was significantly reduced from 63% for the control arm to 45% for the prophylaxis arm.
Operating Results
Product sales were EUR 9.70 million for 2009 compared to EUR 5.44 million for 2008, an increase of EUR 4.26 million or 78%. The increase was primarily due to the launch in April 2009 of the named-patient program and the launch in September 2009 of the cost recovery program in the U.S. Named-patient program and cost recovery program sales, net, for the year ended December 31, 2009 amounted to EUR 4.90 million, which are net of EUR 0.79 million of service fees.
The active pharmaceutical ingredient, or API, revenues slightly decreased from EUR 4.79 million in 2008 to EUR 4.6 million, reflecting the decrease in volume of suglicotide offset by a price increase and higher sales volume of urokinase.
Sales to a related party, Sirton, for the year ended December 31, 2009 and 2008 represented 2% and 12% of the total product sales, respectively. The decrease in sales to a related party was primarily due to the fact that in the second quarter of 2009 the Company terminated the supply agreement with Sirton and entered into direct sales agreements with Sirton's customers in order to mitigate the risk associated with Sirton's poor financial condition and terminated the supply agreement with Sirton.
Other revenues were EUR 0.47 million for 2009 compared to EUR 1.99 million for 2008. The decrease versus the prior year is primarily attributable to a decrease in activities that were reimbursed from Sigma Tau under our cost sharing agreement, offset by a milestone payment from Sigma-Tau of $0.35 million for completion of the phase III clinical trial.
Cost of goods sold was EUR 4.0 million for 2009 compared to EUR 5.60 million in 2008. Cost of goods sold as a percentage of product sales, net, was 41% in 2009 compared to 103% in 2008. The percentage decrease is primarily due to higher margins on Defibrotide sold through the named-patient program and price increases in the API business. The Company fully expensed the cost of inventory in the prior year. Additionally, the higher percentage of cost of goods sold in 2008 was primarily due to the fact that product sales to a related party, Sirton, were not recognized in the amount of EUR 1.08 million due to Sirton's poor financial condition and concerns over the ability to collect such receivables.
The Company incurred research and development expenses of EUR 3.51 million in 2009 compared to EUR 9.57 million for 2008. Research and development expenses in 2009 and 2008 are net of EUR 0.85 and EUR 0.79 million, respectively, of government grants in the form of a tax credit. The decrease from the prior year is mainly due to completion of clinical trials.
General and administrative expenses were EUR 6.04 million in 2009 compared to EUR 7.67 million in 2008. In 2008, we established a reserve for doubtful in accounts in the amount of EUR 1.78 million, of which EUR 0.68 was released in 2009. Additionally, the Company had lower payroll costs due to the temporary layoffs under a special public fund used in Italy under the "Cassa Integrazione Guadagni" program and decrease in stock based compensation expenses.
In 2008, the Company recorded an impairment of EUR 3.40 million. Write-down of assets include the write-down of acquired trademarks, marketing authorizations, inventory, and the Company's patents. The trademarks and marketing authorizations have been written-down due to the expiration and non-renewal by the Company of the distribution agreement with Crinos S.p.A., which raised concern about the ability to recover the cost of these assets.
Interest income/(expense), net amounted to EUR (0.11) million and EUR 0.26 million in 2009 and 2008, respectively. The decrease in interest income/(expense), net is a result of a lower amounts of invested funds in 2009 compared to the prior period as well as a decrease in interest rates.
Net loss was EUR 4.53 million in 2009 compared to EUR 19.90 million in 2008. The difference was primarily due to increased net sales and higher margins associated with the named-patient and cost recovery programs and a decrease in development activities related to the treatment and prevention studies.
The Company ended the fourth quarter of 2009 with EUR 1.39 million in cash and cash equivalents, compared with cash and cash equivalents of EUR 11.49 million as of December 31, 2008. Absent the need to fund any additional clinical trials, management believes that the Company's cash and cash equivalents, including the upfront payment received from Sigma-Tau Pharmaceuticals, Inc. in connection with the expansion of the license agreement for Defibrotide in the Americas, together with revenues generated from its named-patient and cost recovery programs, will be sufficient to meet the Company's obligations for at least the next twelve months.
I read that and the more I read- this is very impressive! fast track FDA approval- Orphan drug status here and abroad, awarded the Van Bekkum award for best abstract and highly significant Phase II/III trial results at the conference in Italy. I like it!
Nice pop: 65 percent--2.06-3.34
Gentium Announces Defibrotide Results Highlighted at Opening Session and Symposium at EBMT Annual Meeting
Date : 03/23/2010 @ 5:00PM
Source : PR Newswire
Stock : Gentium Spa - Gentium Spa American Depositary Shares (Adss) (MM) (GENT)
Quote : 3.0001 1.1801 (64.84%) @ 7:22AM
Gentium Announces Defibrotide Results Highlighted at Opening Session and Symposium at EBMT Annual Meeting
Gentium Announces Defibrotide Results Highlighted at Opening Session and Symposium at EBMT Annual Meeting
- Utility in prevention of hepatic veno-occlusive disease and acute graft vs host disease in high risk children
- New insights into biological mechanism of action
- Subject of satellite symposium with key opinion leaders
PR Newswire
VILLA GUARDIA, Italy, March 23
VILLA GUARDIA, Italy, March 23 /PRNewswire-FirstCall/ --
Gentium S.p.A. (Nasdaq: GENT) today announced that the abstract titled, "Defibrotide prevents hepatic VOD and reduces significantly VOD-associated complications in children at high risk: final results of a prospective phase II/III multicenter study," was presented on Sunday, March 21, 2010, at the opening session of the European Blood and Marrow Transplantation (EBMT) 36th Annual Meeting in Vienna. The abstract received the esteemed Van Bekkum Award for the best abstract submitted to the physician's program. Dr. Selim Corbacioglu, Professor of Pediatrics, University of Regensburg (Germany) and Principal Investigator of the Pediatric Prevention trial, accepted the award and presented the final results of the study.
This Phase II/III, randomized, controlled study evaluated the prophylactic use of Defibrotide in pediatric stem cell transplant (SCT) patients at high risk for veno-occulsive disease (VOD). In the intent to treat analysis (ITT), which included 356 patients (180 patients in the prophylaxis arm and 176 in the control arm), Defibrotide demonstrated a 40% reduction in the incidence of VOD within 30 days after SCT, the primary endpoint of the study. VOD incidence was 20% in the control arm and 12% in the prophylaxis arm (p=0.0488 Competing Risk; p=0.0507 Kaplan-Meier). In the per-protocol analysis, the VOD incidence was 20% in the control arm and 11% in the prophylaxis arm (p=0.0225 Competing Risk; p=0.0234 Kaplan-Meier). A p-value equal to or less than 0.05 is needed to achieve statistical significance.
In addition, a pre-specified analysis showed that the incidence and severity of acute graft versus host disease (GvHD) by day 100 in allogeneic SCT recipients was significantly reduced from 63% for the control arm to 45% for the prophylaxis arm (p=0.0046 for incidence of GvHD and p=0.0034 for severity). Renal failure was reduced from 6% in the control group to 1% in the Defibrotide group (p=0.0169). With regard to safety, Defibrotide was well tolerated and no difference in adverse events was observed between the two study arms.
"The results from the study demonstrated that Defibrotide reduced the incidence of VOD in high risk pediatric patients," stated Dr. Selim Corbacioglu. "SCT patients who develop VOD, regardless of its severity and despite prompt treatment, have a mortality rate four times greater than patients without VOD. We are also very enthusiastic that Defibrotide has the potential to reduce the incidence and severity of acute GvHD, a life threatening complication, which is frequent in SCT and has limited treatment options. We believe that Defibrotide could have a future role for the prevention of GvHD."
"The Defibrotide VOD prevention study was the largest study performed in the pediatric SCT setting and its results have been included in the press conference of the EBMT," said Professor Dietger Niederwieser of University of Leipzig, Chairman of the opening session, President of the EBMT, and newly elected president of the Worldwide Network for Blood & Marrow Transplantation (WBMT). "The results of this study, which demonstrate a reduction in VOD as well as the potential beneficial effects on GvHD and renal failure, are consistent with the effects of endothelial protection and confirm the potential of Defibrotide in preventing transplant related toxicities."
"We are very encouraged by the recognition of this study by the leaders of the European hematology community," said Dr. Massimo Iacobelli, Scientific Director of Gentium. "We are fully engaged in preparing the regulatory submissions for the prevention and treatment of VOD."
Defibrotide's biological activity and mechanism of action were highlighted in a separate poster-presentation, "Defibrotide protects human microvascular endothelial cells from fludarabine-mediated pro-inflammatory and pro-apoptotic signals: a microarray (Affimetrix) analysis." This study provides new biological insights on how Defibrotide might protect endothelial cells against chemotherapy-induced activation and cell death, without affecting the antileukemic effect of fludarabine and without affecting normal endothelium.
The satellite symposium "Defibrotide for the Prevention and Treatment of Hepatic VOD following stem cell transplant," was very well attended, featuring presentations by key opinion leaders Dr. Ernst Holler (University of Regensburg); Dr. Selim Corbacioglu (University of Regensburg); Dr. Paul Richardson (Dana Farber Cancer Institute, Boston, US), and Dr. Enric Carreras (University of Barcelona). The symposium was chaired by Dr. Rob Soiffer (Dana Farber Cancer Institute, Boston, US).
About the EBMT and the Van Bekkum Award
The European Group for Blood and Marrow Transplantation (EBMT) is a European non-profit organization that was established in 1974 to allow scientists and physicians involved in clinical bone marrow transplantation to share their experience and develop cooperative studies. Representing 527 transplant centers across 57 countries in and outside of Europe, the EBMT promotes all activity aiming to improve stem cell transplantation or cellular therapy.
The Van Bekkum award is named for Dr. Dirk Van Bekkum, who is internationally recognized for his work in bone marrow transplantation; among other achievements, his laboratory was the first to identify what is now known to be graft-versus-host disease.
About the Phase II/III European Pediatric Prevention Trial
The EBMT phase II/III European pediatric prevention trial was a prospective, multi-center, open label, randomized clinical trial to evaluate the prophylactic use of Defibrotide in patients under 18 years of age who were undergoing stem cell transplantation (SCT) and were at high risk for developing hepatic Veno-Occlusive Disease (VOD). Patients randomized in the prophylaxis arm received 25 mg/kg/day of Defibrotide in four divided doses beginning at the time of conditioning and until 30 days post transplant. Patients randomized to the control arm received no VOD prophylactic therapy. Patients were permitted to receive Defibrotide as therapy if they developed VOD. The primary endpoint of the study was development of VOD within 30 days post SCT, based on the modified Seattle criteria. A blinded independent review committee of three expert hematologists confirmed the diagnosis of VOD.
About VOD
Veno-occlusive disease is a potentially life-threatening condition, which typically occurs as an important complication of stem cell transplantation. Certain high-dose conditioning regimens used as part of SCT can damage the lining cells of hepatic blood vessels and so result in VOD, a blockage of the small veins of the liver that leads to liver failure and can result in significant dysfunction in other organs such as the kidneys and lungs (so-called severe VOD). SCT is a frequently used treatment modality following high-dose chemotherapy and radiation therapy for hematologic cancers and other conditions in both adults and children. There is currently no approved agent for the treatment or prevention of VOD in the US or the EU.
About GvHD
Graft-versus-host disease (GVHD) is a complication that occurs frequently after allogeneic stem cell transplantation, where with to the blood forming cells a completely new immune system is transplanted from the donor. The differences between the donor and recipient often cause T cells (a subtype of white blood cells) from the donor to recognize the recipient's body tissues as foreign. When this happens, the newly transplanted immune system attacks the transplant recipient's body. Risk of GvHD increases with the degree of mismatch between donor and recipient.
About Gentium
Gentium S.p.A., located in Como, Italy, is a biopharmaceutical company focused on the development and manufacture of drugs to treat and prevent a variety of diseases and conditions, including vascular diseases related to cancer and cancer treatments. Defibrotide, the Company's lead product candidate, is an investigational drug that has been granted Orphan Drug status by the U.S. FDA and Orphan Medicinal Product Designation by the European Commission both to treat and to prevent VOD and Fast Track Designation by the U.S. FDA to treat 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, including with respect to the possibility of any future regulatory approval, may differ 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 filed with the Securities and Exchange Commission under the caption "Risk Factors."
Gentium S.p.A.
Gary Gemignani, +1-212-332-1666
Chief Financial Officer
ggemignani@gentium.com
The Trout Group
Marcy Nanus, +1 646-378-2927
mnanus@troutgroup.com
SOURCE Gentium S.p.A.
Biotech Stock Alert for Gentium SpA Issued by InvestorSoup
Press Release Source: InvestorSoup On Monday March 22, 2010, 6:50 am EDT
DALLAS, March 22, 2010 (GLOBE NEWSWIRE) -- InvestorSoup.com announces an investment report featuring Gentium SpA (Nasdaq:GENT - News). The report includes financial, comparative and investment analyses, and pertinent industry information you need to know to make an educated investment decision.
The full report is available at: http://www.investorsoup.com/lp/GENT
Gentium SpA (GENT) is a biopharmaceutical company focused on the development and manufacture of defibrotide, a deoxyribonucleic acid (DNA) based drug derived from pig intestines, to treat and prevent a disease called hepatic veno-occlusive disease (VOD), a condition in which some of the veins in the liver are blocked as a result of cancer treatments, such as chemotherapy or radiation treatments that are given prior to stem cell transplantation. The Company is concluding a phase III clinical trial of defibrotide to treat severe VOD in the United States, Canada and Israel.
Message Board Search for GENT: http://www.boardcentral.com/boards/GENT
In the report, the analyst notes:
"Cash, cash equivalents and short term available for sale securities as of September 30, 2009, were EUR 0.97 million compared with EUR 11.49 million as of December 31, 2008. In March 2009, the Company made a final installment payment of EUR 4.0 million related to the acquisition of marketing authorizations and trademarks for Prociclide and Noravid (previous forms of Defibrotide sold only in Italy). Net cash used in operating activities for the nine-month period ended September 30, 2009, was EUR 5.68million compared with EUR 11.09million for the same period in 2008.
"GENT recently announced management and corporate restructuring changes resulting from a strategic decision to consolidate the Company's resources and operations. Following the expansion of the license agreement with Sigma-Tau, which will provide GENT with up to $15 million in non-dilutive funding, GENT will be closing the Company's New York office and consolidating corporate activities and the executive management team within its headquarters in Italy."
To read the entire report visit: http://www.investorsoup.com/lp/GENT
InvestorSoup.com is a small-cap research and investment commentary provider. InvestorSoup.com strives to provide a balanced view of many promising small-cap companies that would otherwise fall under the radar of the typical Wall Street investor. We provide investors with an excellent first step in their research and due diligence by providing daily trading ideas, and consolidating the public information available on them. For more information on InvestorSoup.com, please visit http://www.InvestorSoup.com
IvestorSoup.com Disclosure
InvestorSoup.com is not a registered investment advisor and nothing contained in any materials should be construed as a recommendation to buy or sell any securities. InvestorSoup.com is a Web site wholly owned by BlueWave Advisors, LLC. Neither InvestorSoup nor its affiliates have a beneficial interest in the mentioned company; nor have they received compensation of any kind for any of the companies listed in this communication. Please read our report and visit our Web site, InvestorSoup.com, for complete risks and disclosures.
Contact:
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http://finance.yahoo.com/news/Biotech-Stock-Alert-for-pz-882313957.html?x=0&.v=1
Gentium Announces Defibrotide Results Highlighted at Opening Session and Symposium at EBMT Annual Meeting
- Utility in prevention of hepatic veno-occlusive disease and acute graft vs host disease in high risk children
- New insights into biological mechanism of action
- Subject of satellite symposium with key opinion leaders
Press Release Source: Gentium S.p.A. On Tuesday March 23, 2010, 5:00 pm EDT
VILLA GUARDIA, Italy, March 23 /PRNewswire-FirstCall/ -- Gentium S.p.A. (Nasdaq:GENT - News) today announced that the abstract titled, "Defibrotide prevents hepatic VOD and reduces significantly VOD-associated complications in children at high risk: final results of a prospective phase II/III multicenter study," was presented on Sunday, March 21, 2010, at the opening session of the European Blood and Marrow Transplantation (EBMT) 36th Annual Meeting in Vienna. The abstract received the esteemed Van Bekkum Award for the best abstract submitted to the physician's program. Dr. Selim Corbacioglu, Professor of Pediatrics, University of Regensburg (Germany) and Principal Investigator of the Pediatric Prevention trial, accepted the award and presented the final results of the study.
This Phase II/III, randomized, controlled study evaluated the prophylactic use of Defibrotide in pediatric stem cell transplant (SCT) patients at high risk for veno-occulsive disease (VOD). In the intent to treat analysis (ITT), which included 356 patients (180 patients in the prophylaxis arm and 176 in the control arm), Defibrotide demonstrated a 40% reduction in the incidence of VOD within 30 days after SCT, the primary endpoint of the study. VOD incidence was 20% in the control arm and 12% in the prophylaxis arm (p=0.0488 Competing Risk; p=0.0507 Kaplan-Meier). In the per-protocol analysis, the VOD incidence was 20% in the control arm and 11% in the prophylaxis arm (p=0.0225 Competing Risk; p=0.0234 Kaplan-Meier). A p-value equal to or less than 0.05 is needed to achieve statistical significance.
In addition, a pre-specified analysis showed that the incidence and severity of acute graft versus host disease (GvHD) by day 100 in allogeneic SCT recipients was significantly reduced from 63% for the control arm to 45% for the prophylaxis arm (p=0.0046 for incidence of GvHD and p=0.0034 for severity). Renal failure was reduced from 6% in the control group to 1% in the Defibrotide group (p=0.0169). With regard to safety, Defibrotide was well tolerated and no difference in adverse events was observed between the two study arms.
"The results from the study demonstrated that Defibrotide reduced the incidence of VOD in high risk pediatric patients," stated Dr. Selim Corbacioglu. "SCT patients who develop VOD, regardless of its severity and despite prompt treatment, have a mortality rate four times greater than patients without VOD. We are also very enthusiastic that Defibrotide has the potential to reduce the incidence and severity of acute GvHD, a life threatening complication, which is frequent in SCT and has limited treatment options. We believe that Defibrotide could have a future role for the prevention of GvHD."
"The Defibrotide VOD prevention study was the largest study performed in the pediatric SCT setting and its results have been included in the press conference of the EBMT," said Professor Dietger Niederwieser of University of Leipzig, Chairman of the opening session, President of the EBMT, and newly elected president of the Worldwide Network for Blood & Marrow Transplantation (WBMT). "The results of this study, which demonstrate a reduction in VOD as well as the potential beneficial effects on GvHD and renal failure, are consistent with the effects of endothelial protection and confirm the potential of Defibrotide in preventing transplant related toxicities."
"We are very encouraged by the recognition of this study by the leaders of the European hematology community," said Dr. Massimo Iacobelli, Scientific Director of Gentium. "We are fully engaged in preparing the regulatory submissions for the prevention and treatment of VOD."
Defibrotide's biological activity and mechanism of action were highlighted in a separate poster-presentation, "Defibrotide protects human microvascular endothelial cells from fludarabine-mediated pro-inflammatory and pro-apoptotic signals: a microarray (Affimetrix) analysis." This study provides new biological insights on how Defibrotide might protect endothelial cells against chemotherapy-induced activation and cell death, without affecting the antileukemic effect of fludarabine and without affecting normal endothelium.
The satellite symposium "Defibrotide for the Prevention and Treatment of Hepatic VOD following stem cell transplant," was very well attended, featuring presentations by key opinion leaders Dr. Ernst Holler (University of Regensburg); Dr. Selim Corbacioglu (University of Regensburg); Dr. Paul Richardson (Dana Farber Cancer Institute, Boston, US), and Dr. Enric Carreras (University of Barcelona
Gentium Announces an Abstract for Defibrotide in the Prevention of Hepatic VOD has been Granted the Prestigious Van Bekkum Award by the EBMT
The abstract will be presented at the opening session of the EBMT's 36th Annual Meeting
Press Release Source: Gentium S.p.A. On Friday February 5, 2010, 7:30 am
VILLA GUARDIA, Italy, Feb. 5 /PRNewswire-FirstCall/ -- Gentium S.p.A. (Nasdaq: GENT) today announced that the abstract titled, "Defibrotide prevents hepatic VOD and reduces significantly VOD-associated complications in children at high risk: final results of a prospective phase II/III multicentre study," has been awarded the Van Bekkum Award for the best abstract submitted to the physician's program for the European Group for Blood and Marrow Transplantation's (EBMT) 36th Annual Meeting, to be held in Vienna, March 21-24, 2010. The abstract will be presented by Selim Corbacioglu, MD, University of Regensburg (Germany), at the opening session of the annual meeting (Hall A) on Sunday, March 21, 2010 at 7:20 PM local time.
Defibrotide will also be featured in a satellite symposium entitled, "Defibrotide for the prevention and treatment of hepatic veno-occlusive disease following stem cell transplantation," on Sunday March 21 from 9:00 AM – 10:30 AM local time in the Austria Center, Hall G/H. A separate abstract, "Defibrotide protects human microvascular endothelial cells from fludarabine-mediated pro-inflammatory and pro-apoptotic signals: a microarray (Affimetrix) analysis," will also be presented on Tuesday, March 23 from 5:30 PM until 7:00 PM at the poster session (P 908).
About the EBMT and the Van Bekkum Award
The European Group for Blood and Marrow Transplantation (EBMT) is a European non-profit organization that was established in 1974 to allow scientists and physicians involved in clinical bone marrow transplantation to share their experience and develop cooperative studies. The Van Bekkum award is named for Dr. Dirk Van Bekkum, who is internationally recognized for his work in bone marrow transplantation; among other achievements, his laboratory was the first to identify what is now known to be graft versus host disease.
About VOD
Veno-occlusive disease is a potentially life-threatening condition, which typically occurs as an important complication of stem cell transplantation. Certain high-dose chemo-radiation therapy regimens used as part of SCT can damage the lining cells of hepatic blood vessels and so result in VOD, a blockage of the small veins of the liver that leads to liver failure and can result in significant dysfunction in other organs such as the kidneys and lungs (so-called severe VOD). SCT is a frequently used treatment modality following high-dose chemotherapy and radiation therapy for hematologic cancers and other conditions in both adults and children. There is currently no approved agent for the treatment or prevention of VOD in the US or the EU.
8:57AM Gentium announces extension of license and supply and cost sharing agreements with Sigma-Tau (GENT) 2.27 : Co announces that it has amended its existing License and Supply and Cost Sharing Agreements with Sigma-Tau Pharmaceuticals, Inc. for the development and commercialization of Defibrotide in North America, Central America and South America. Gentium will retain exclusive rights to Defibrotide in Europe and the rest of the world. In return for the amended terms, Gentium will receive an initial payment of $7,000,000 from Sigma-Tau in connection with the execution of the amended agreements. An additional payment of $6,000,000 will be due to Gentium following approval from the FDA to market Defibrotide in the US and a further $2,000,000 will be payable following the transfer of the approved NDA to Sigma-Tau. Gentium will continue to receive a 7% royalty on net sales of Defibrotide and a supply margin equal to the greater of 31% of net sales of Defibrotide or EUR50.00 per unit in the Americas.
UPDATE 1-Gentium's stem cell complication drug fails trial
Wed Aug 19, 2009 8:34am EDT
* Says defibrotide fails to meet main trial goal
* Plans to present full trial results in Dec 5-8
Aug 19 (Reuters) - Italian biopharmaceutical firm Gentium S.p.A. (GENT.O) said its experimental drug to treat veno-occlusive disease, a complication of stem cell transplantation, missed the main goal of a late-stage study.
The main goal of the trial was to measure the complete response at 100 days following stem cell transplant (SCT), compared with patients receiving the best therapy and supportive care available at the time.
Gentium's veno-occlusive disease drug, defibrotide, also failed to meet the secondary endpoint of survival rate at 100 days and six months post SCT.
"Given the outcome of the data safety monitoring board's interim review announced in November of last year, we expected that reaching the required statistical threshold for a single trial would be difficult," said Chief Financial Officer Gary Gemignani.
Gentium plans to present full results from the trial from Dec 5-8 at the American Society of Hematology Conference in New Orleans.
Gemignani also said the company plans to report final results from pediatric prevention study in the upcoming weeks.
Shares of the company closed at $3.40 Tuesday on Nasdaq.
7:32AM Gentium reports top line results from the Phase III Treatment Trial of Defibrotide for severe veno-occlusive disease (GENT) 3.40 : The co announces top-line results from a historically controlled, multicenter, open label, Phase III trial designed to evaluate the safety and efficacy of 25 mg/kg/day of Defibrotide for the treatment of severe veno-occlusive disease (sVOD) in hematopoietic stem cell transplant (SCT) patients. The results demonstrate strong trends in favor of the Defibrotide-treated patients for complete response and survival, but did not reach the protocol-specified levels of significance for the primary and secondary endpoints at 100 days. With regard to safety, adverse events were well balanced between the historical control and treatment arms. The Company plans to present full results from this trial at the American Society of Hematology Conference in New Orleans, LA, December 5-8, 2009... While the primary endpoint achieved a p-value less than 0.05 and the secondary endpoint showed a strong trend towards statistical significance, neither reached the level of significance required in the protocol for proof of efficacy with a single study.
Gentium Reports Top Line Results from the Phase III Treatment Trial of Defibrotide for Severe Veno-Occlusive Disease
Press Release
Source: Gentium S.p.A.
On Wednesday August 19, 2009, 7:30 am EDT
Companies:Gentium S.p.A
Topics:Health Care Sector
VILLA GUARDIA (COMO), Italy--(BUSINESS WIRE)--Gentium S.p.A. (NASDAQ: GENT - News) today announced top-line results from a historically controlled, multicenter, open label, Phase III trial designed to evaluate the safety and efficacy of 25 mg/kg/day of Defibrotide for the treatment of severe veno-occlusive disease (sVOD) in hematopoietic stem cell transplant (SCT) patients. The results demonstrate strong trends in favor of the Defibrotide-treated patients for complete response and survival, but did not reach the protocol-specified levels of significance for the primary and secondary endpoints at 100 days. With regard to safety, adverse events were well balanced between the historical control and treatment arms. The Company plans to present full results from this trial at the American Society of Hematology Conference in New Orleans, LA, December 5-8, 2009.
The primary endpoint of the trial was complete response at 100 days following SCT and utilized historical controls (patients who in the past received the best therapy and supportive care available at the time, but not Defibrotide) as a comparator. Secondary endpoints included survival rate at 100 days and six months post SCT. The historical control database was generated through a sequential, retrospective medical chart review, with final selection of the control group performed by an independent medical review committee (MRC). The MRC remained blinded to patient outcome data throughout the duration of the trial. Per the study protocol, data in the primary efficacy analysis were adjusted by quintiles of propensity score based on four stratification variables (allogeneic/autologous SCT, adult/pediatric, one/two+ SCTs, and ventilator/dialysis dependence) to aid in obtaining balance between the treatment and historical control arms in a non-randomized trial. As a stand-alone trial utilizing a historical control arm, the study protocol specified a p-value of less than or equal to 0.01 for the primary endpoint to achieve statistical significance, while the secondary endpoints required a p-value of less than or equal to 0.05, the more common threshold for statistical significance.
123 patients with symptoms consistent with VOD were identified and then reviewed for eligibility in the historical control arm by the MRC, with 32 cases selected as having an unequivocal diagnosis of sVOD (graft versus host disease was ruled out) and met all protocol-required entry criteria. 102 patients were enrolled in the Defibrotide treatment group and baseline characteristics were balanced between the two arms.
For the primary efficacy analysis on an intent to treat basis, 24% of patients in the Defibrotide arm compared to 9% of patients in the historical control arm achieved complete response at 100 days (p-value = 0.015). For the secondary efficacy analysis on an intent to treat basis, 38% of patients in the Defibrotide arm compared to 25% of patients in the historical control arm demonstrated survival at 100 days (p-value = 0.051). Thus, while the primary endpoint achieved a p-value less than 0.05 and the secondary endpoint showed a strong trend towards statistical significance, neither reached the level of significance required in the protocol for proof of efficacy with a single study.
“I am encouraged by the results of this trial, especially given the extremely sick patient population that was enrolled,” said Dr. Paul Richardson, Clinical Director of the Dana-Farber Cancer Institute’s Jerome Lipper Multiple Myeloma Center and principal investigator of the trial. “The data generated from this trial confirms the activity of Defibrotide seen in earlier studies, and supports the benefit of Defibrotide for the treatment of sVOD in improving complete response rates and survival, as well as its potential in less advanced stages of the disease.”
“Given the outcome of the data safety monitoring board’s interim review announced in November of last year, we expected that reaching the required statistical threshold for a single trial would be difficult,” said Gary Gemignani, Executive Vice-President and Chief Financial Officer. “We are pleased that the data are compelling and believe the results place us in a strong position to continue discussions with the FDA and others regarding next steps toward a regulatory filing. Additionally, we plan on announcing final results from our randomized, pediatric prevention study in the upcoming weeks.”
About VOD
Veno-occlusive disease is a potentially life-threatening condition, which typically occurs as an important complication of stem cell transplantation. Certain high-dose chemo-radiation therapy regimens used as part of SCT can damage the lining cells of hepatic blood vessels and so result in VOD, a blockage of the small veins of the liver that leads to liver failure and can result in significant dysfunction in other organs such as the kidneys and lungs (so-called severe VOD). SCT is a frequently used treatment modality following high-dose chemotherapy and radiation therapy for hematologic cancers and other conditions in both adults and children. There is currently no approved agent for the treatment or prevention of VOD in the U.S. or the EU.
hey surf1944, you still follow GENT ??????
GENT,sells/5000sh-buys/2000sh and pps up 27% , no reality there to me !! mm games all the way , they want volume !!!
Gentium Announces Italian Legal Proceeding
Tuesday August 26, 4:30 pm ET
VILLA GUARDIA, Italy--(BUSINESS WIRE)--Gentium S.p.A. (NASDAQ: GENT - News) (the “Company”) today announced that a legal proceeding has been commenced against the Company’s Board of Directors and Board of Statutory Auditors in the Court of Como in Italy seeking to prevent a proposed financing transaction from proceeding and alleging misconduct in connection with that transaction. The action was brought by Sigma Tau Finanziaria S.p.A. and a related entity, which together with their affiliates beneficially hold approximately 18% of the Company’s outstanding securities. The Court has scheduled an initial hearing in September on this matter and has issued an interim measure ordering that the proposed transaction not proceed.
The members of the Board of Directors and Board of Statutory Auditors will take all necessary actions in order to vigorously defend against the claims and explore appropriate legal recourse. Nevertheless, the Company remains committed to the development of Defibrotide for the benefit of patients worldwide and all of our shareholders.
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 VO
Gentium Reports First Quarter Financial Results; Provides Financial and Clinical Update
Thursday June 26, 4:30 pm ET
VILLA GUARDIA, Italy--(BUSINESS WIRE)--Gentium S.p.A. (NASDAQ: GENT - News) (the “Company”) today reported financial results for the quarter ended March 31, 2008. Highlights of the first quarter of 2008 and recent weeks through June 26, 2008, include:
--Continued updates of the ongoing Phase III clinical trial in the U.S., which is evaluating the Company's lead product, Defibrotide, as a potential treatment for patients with Veno-Occlusive Disease ("VOD") with multiple organ failure ("Severe VOD"). In January the company announced the Data Safety Monitoring Board (“DSMB”) conducted a safety analysis of Defibrotide as part of the interim analysis and concluded that there were no safety concerns. Additionally, the DSMB evaluated stratification between the prospective treatment and historical control arms and indicated that the groups appear to be balanced. However, the DSMB asked the Company to clarify and supplement certain trial data in order to complete the remainder of the interim analysis. After providing additional data, the Company announced in June that the DSMB had reconfirmed their previous finding regarding safety and patient stratification, but recommended reconfirmation of the patient enrollment criteria, and “data clean-up” as is stated in the trial protocol. The Company has concluded enrollment in the study with 86 patients in the historical control group and 101 patients in the treatment arm.
-- Progress has been made with the Company's Phase II/III clinical trial in Europe which is evaluating Defibrotide for the prevention of VOD in children. In June, the Company announced that the DSMB concluded that there were no significant safety concerns, the prophylactic treatment arm (Defibrotide) and the control arm (no drug) were well balanced, and there was no evidence of clinical futility in the trial. Furthermore, the DSMB indicated that the results to date were satisfactory and recommended that the trial continue to accrue patients. The DSMB recommended increasing total patient enrollment to 180 patients per arm from 135 patients per arm to achieve a more statistically significant benefit of Defibrotide over the control. Currently, there are 142 patients in the treatment arm and 144 patients in the control arm. Additionally, the Company announced that following discussions with the EMEA, there is the possibility of an accelerated review for Defibrotide in this indication.
Clinical Highlights and Outlook
Commenting on Gentium’s clinical progress during the quarter, Laura Ferro, M.D., Chairman and Chief Executive Officer, said, “We are working with an independent medical review committee to ensure that the proper enrollment criteria were applied when identifying historical control patients for the Defibrotide Phase III treatment trial. Additionally, we are working closely with the European clinical sites to support the recruitment of the additional patients needed for the Phase II/III pediatric prevention trial.”
Dr. Ferro continued, “We look forward to announcing top-line results from the treatment trial in the fourth quarter of 2008 and top-line results from the pediatric prevention trial in the first half of 2009. We remain encouraged that Defibrotide has the potential to not only treat Severe VOD, but also prevent its occurrence.”
Financial Highlights
The Company 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 March 31, 2008, €1.00 = $ 1.5812.
For the first quarter ended March 31, 2008 compared with the prior year’s first quarter:
* Total revenues were €2.68 million, compared with €1.25 million
* Operating costs and expenses were €7.53 million, compared with €5.42 million
* Research and development expenses, which are included in operating costs and expenses, were €3.61 million, compared with €2.74 million
* Operating loss was €4.84 million, compared with €4.16 million
* Interest income, net, was €0.1 million, compared with €0.2 million
* Pre-tax loss was €6.08 million, compared with €4.77 million
* Net loss was €6.08 million, compared with €4.77 million
* Basic and diluted net loss per share was €0.41 compared with €0.36 per share
Operating Results and Trends
The fluctuation in product sales revenues for the three month period compared with the prior-year periods is primarily due to varying demand for our products from our customers. Total product sales revenues for three months ended March 31, 2008 increased by €0.5 million, or 44%, compared with the same period in 2007. Sales to affiliates represented 30% and 77% of the total product sales in the three months ended March 31, 2008 and 2007, respectively. Sales to third parties increased to €1.20 million mainly due to higher demand for our active pharmaceutical ingredient sulglicotide in the Korean market and due to our acquisition of the Italian marketing authorization and trademarks regarding Defibrotide, which allowed the Company to sell Defibrotide directly to distributors instead of indirectly through Sirton.
Other revenues were €0.9 million for the three month period ended March 31, 2008, compared to €0.04 million in 2007. The increase is mainly attributable to the reimbursement of certain costs incurred in the Company's Phase III clinical trial of Defibrotide to treat Severe VOD under a cost-sharing agreement entered into with Sigma-Tau Inc.
Cost of goods sold was €1.42 million for the three-month period ended March 31, 2008 compared to €1.08 million in 2007. Cost of goods sold as a percentage of product sales was 81% in 2008 and 89% in 2007. The increase in margin is mainly due to changes in product mix and higher sales prices.
Research and development spending increased during the three-month period in 2008 compared with 2007, primarily due to the costs associated with the Company’s Phase III trial in the U.S. for the treatment of Severe VOD and the Company’s Phase II/III trial in Europe for the prevention of VOD. Growth in headcount and outside services to support increased activity in our clinical trials, including clinical product production costs, contract research organization expenses, regulatory activities, toxicology studies and stock-based compensation expenses also contributed to increased research and development expenses.
The Company had 87 employees as of March 31, 2008, compared with 81 as of March 31, 2007. Other general and administrative expense increases were primarily the result of increased headcount and facilities related expenses, general corporate expenses and stock based compensation expense.
Interest income, net, decreased to € 0.1 million in the three-month period ended March 31, 2008 over the same period in 2007. Interest income amounted to €0.2 million and € 0.3 million in the three months ended March 31, 2008 and 2007, respectively, a decrease of € 0.1 million. The decrease is due to a lower amount of invested funds and decrease in interest rates. Interest expense totaled € 0.1 million in both the three months ended March 31, 2008 and 2007.
The Company ended the first quarter of 2008 with €20.36 million in cash and cash equivalents, compared with cash and cash equivalents of €25.96 million as of December 31, 2007.
http://biz.yahoo.com/bw/080626/20080626006117.html?.v=1
Gentium shares fall after hours on study concerns
Thursday June 5, 5:31 pm ET
Gentium shares drop in after-hours trading on concerns over cancer drug study
NEW YORK (AP) -- Italian biopharmaceutical company Gentium SpA said Thursday it will finish a late-stage study of its drug Defibrotide without enrolling additional patients, following an independent data safety monitoring board report.
American Depository Shares plunged $1.80, or 24.3 percent, to $5.60 in after-hours trading following a 20-cent, or 2.6 percent, drop to close at $7.40 during the regular trading session.
Gentium said the safety board confirmed a prior interim analysis that there were no safety concerns and that the prospective treatment and historical control portions of the study appeared to be well-balanced. But, its latest report did cite concerns about the study data collected so far and made a recommendation to confirm the method by which it used historical patient data.
The company is studying the drug as a treatment for veno-occlusive disease in stem-cell transplant patients, a common complication occurring soon after bone marrow transplants. The study compares data from patients taking the drug with historical patient records and the board is concerned over whether the criteria properly matches.
Gentium said it is evaluating the comments and will consider them. But, it also said there are enough patients in the study currently and it plans to have data available by the end of the year.
Separately, the safety board recommended that the company continue with a European study of Defibrotide in children undergoing stem-cell transplantation. The board found no safety issues in the mid- to late-stage study.
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