surf1944
11 years ago
7:04AM Gentium: Interim results from Gentium's treatment IND for Defibrotide -- 35% of patients achieved a complete response (CR) and 55% survived to day 100 (D+100) (GENT) 56.79 : Co announced that additional data on Defibrotide were presented this week at the 55th Annual Meeting and Exposition of the American Society of Hematology at the Ernst N. Morial Convention Center in New Orleans, LA, Dec 7-10, 2013.
Professor Paul G. Richardson, RJ Corman Professor of Medicine, Clinical Director Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute Harvard Medical School, Boston, MA (USA) reported, in an oral presentation, the updated results from the ongoing Treatment IND Expanded Access Protocol, a large prospective study on the use of Defibrotide in the treatment of Hepatic Veno-Occlusive Disease in hematopoietic stem cell transplant patients, (abstract # 700). This updated interim analysis was based on 470 patients with VOD, enrolled between Dec 2007 and Dec 2012 at 75 centers across the United States. 425 patients had undergone hematopoietic stem cell transplant and of those patients, 35% of patients achieved a complete response (CR) and 55% survived to day 100 (D+100).
Additional findings were as follows: In the subgroup of 284 HSCT patients with severe VOD, 29% achieved a CR and 48% survived to day 100. In the sub-group of 141 HSCT patients with non-severe VOD, 47% achieved a CR and 69 % survived to D+100. In the subgroup of 45 patients who had VOD following chemotherapy but no HSCT, 40% achieved a CR and 62% survived to D+100. Delayed initiation of Defibrotide treatment (more than 2 days after VOD diagnosis) resulted in reduced CR (25% versus 39%, p=0.0052) and survival (38% versus 61%, p=0.0001) compared to early administration (within 2 days from VOD diagnosis).
surf1944
11 years ago
7:02AM Gentium announces successful completion of Defibrotide Phase 1 study in Japan; no serious adverse events were noted (GENT) 47.92 : Co announced that the medical team from the Phase 1 Trial Unit of the Translational Research Center at the National University Corporation, Hamamatsu University School of Medicine, Fukushima Medical University has successfully completed the phase 1 clinical study to evaluate the Safety and Pharmacokinetics of Defibrotide (DF) in Healthy Adults. This Investigator led clinical trial was adopted as a Health and Labour Sciences Research Grant in 2012 for Practical Use of Medical Technology. The primary objective of the study was to evaluate the safety and pharmacokinetics of defibrotide in healthy Japanese adult subjects. The secondary objective was to evaluate the effect of defibrotide on the coagulation and fibrinolytic systems in vivo. Two dose levels (3 mg/kg and 6.25 mg/kg, termed Cohort 1 and Cohort 2, respectively) were evaluated, each cohort consisted of 10 subjects (8 subjects were given DF, 2 were given placebo).
All 20 subjects completed the protocol defined treatment and there were no premature discontinuations. No serious adverse events were noted and only one mild, transient and reversible adverse event observed. Moreover, no clinically significant changes were observed in laboratory test results in any of the dosing groups.
surf1944
12 years ago
6:30AM Gentium to request re-examination of CHMP opinion on Defibrotide (GENT) 7.70 : Co announced that it has requested a re-examination of the negative opinion adopted, by the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP"), on March 22nd, regarding the Marketing Authorisation submitted for Defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy. In accordance with European regulations, the Company has 60 days to submit grounds for appeal and the CHMP has further 60 days to consider a revision of the initial opinion. The appeal involves a re-examination of the original MAA and must be based on the data already submitted. Notwithstanding the CHMP's negative opinion, Gentium remains convinced of the favourable benefit/risk profile of Defibrotide, which is the only option recommended by the European Group for Blood and Marrow Transplantation for the treatment VOD.
surf1944
12 years ago
8:34AM Gentium receives negative opinion from the CHMP on Defibrotide for the treatment and prevention of VOD (GENT) 8.13 : Co announced that it has been informed by the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") that it has adopted a negative opinion, recommending the refusal of the marketing authorization for Defibrotide to treat and prevent hepatic veno-occlusive disease ("VOD") in adults and children undergoing hematopoietic stem cell transplantation therapy. Gentium remains convinced of the favourable benefit/risk profile of Defibrotide, which is the only option recommended by the European Group for Blood and Marrow Transplantation for the treatment VOD, an unmet medical need where no agents are currently approved. In accordance with European regulations, the Company plans to appeal the EMA's decision and request a re-examination of the CHMP opinion. EU patients will continue to have access to Defibrotide, under a named patient program where available.
surf1944
12 years ago
7:01AM Gentium provides update on the review of Defibrotide Marketing Authorization; co expects an opinion recommending against approval of the Marketing Authorization Application for Defibrotide (GENT) 11.93 : Co had presented an oral explanation at the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") as part of its Marketing Authorization Application ("MAA") for Defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy. Following the oral explanation, based on preliminary feedback from the EMA's CHMP, the co expects an opinion recommending against approval of the MAA for Defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy. While not a final decision, the Company considers it unlikely that this position will change before the formal vote is undertaken next month. If a formal negative recommendation is issued, and depending upon the nature of the objections, the Company may appeal such negative decision.
surf1944
12 years ago
7:01AM Gentium reports results from its treatment IND for Defibrotide Presented at the American Society of Hematology Annual Meeting; In the subgroup of HSCT patients with sVOD, 26% achieved a CR and 45% survived to day 100 (GENT) 11.80 : Co announced that additional data from ongoing trials of Defibrotide were presented this week at the 54th Annual Meeting and Exposition of the American Society of Hematology (ASH) held at the Georgia World Congress Center in Atlanta, Georgia. Dr. Paul Richardson, Clinical Director of the Dana-Farber Cancer Institute, Boston, MA (USA), reported in an oral presentation the updated results of a large prospective study on the use of Defibrotide in the treatment of Hepatic Veno-Occlusive Disease (VOD) in hematopoietic stem cell transplant patients, from the ongoing Treatment IND Expanded Access Protocol.
The interim analysis was based on 333 patients with severe veno-occlusive disease (sVOD) and multi-organ failure (MOF), enrolled between December 2007 and September 2011 at 68 centers across the United States. 305 patients had undergone hematopoietic stem cell transplant (HSCT) and of those patients, 30% of patients achieved a complete response (CR) and 50% survived to day 100 (D+100). Additional findings were as follows:
In the subgroup of HSCT patients with sVOD, 26% achieved a CR and 45% survived to day 100. In patients with non-severe VOD, 39% achieved a CR and 65 % survived to D+100.
In the Treatment IND, 155 patients matched the entry criteria for the original Phase 3 trial and comparison to the Phase 3 historical controls showed a statistically improved outcome in CR (29% vs 9%, p=0.0019) and D+100 survival (49% vs 25%, p=0.0016)
Delayed initiation of Defibrotide treatment (>2 days, versus a delay of <2 days) following VOD diagnosis resulted in reduced CR (20% versus 34%, p=0.0195) and survival (37% versus 56%, p=0.0118). CR rate and D+100 survival for the 69 patients with non-severe VOD were 42% and 62%, respectively.
Children younger than 16 years old had higher CR rates than adults (33% vs 26%, p=0.187) and survival (56% vs 44%, p=0.277).
surf1944
12 years ago
Gentium Provides Update on the Review of Defibrotide Marketing Authorization Application
GlobeNewswirePress Release: Gentium S.p.A. – 1 hour 1 minute
VILLA GUARDIA, Italy, Sept. 26, 2012 (GLOBE NEWSWIRE) -- Gentium S.p.A. (GENT) (the "Company") today announced that, following the Company's presentation of Oral Explanations to the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") on September 19, 2012, the CHMP has decided to adopt a second List of Outstanding Issues ("LoOI") relating to the Company's Marketing Authorization Application ("MAA") for Defibrotide to treat and prevent hepatic veno-occlusive disease (VOD) in adults and children undergoing haematopoietic stem cell transplantation therapy. Defibrotide was designated as an orphan drug product in the European Union on July 29, 2004 for the treatment and prevention of VOD.
Dr. Khalid Islam, Chairman and CEO of the Company, commented that "Gentium is committed to obtaining approval of this potentially life-saving treatment for VOD, a condition with a mortality rate of greater than 80% and for which there is currently no approved treatment."
The Company continues to engage in an ongoing dialogue with the rapporteurs in the final stages of the application review process. The Company expects the CHMP to render a final decision on the Defibrotide MAA in the coming months.
About the EMA Review Process:
More information can be obtained from the EMA website www.ema.europa.eu.
About VOD
Veno-occlusive disease (VOD) is a potentially life-threatening condition, which typically occurs as a significant complication of stem cell transplantation. Certain high-dose conditioning regimens used as part of stem cell transplantation can damage the lining cells of hepatic blood vessels and result in VOD, a blockage of the small veins in 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). Stem cell transplantation is a frequently used treatment modality following high-dose chemotherapy and radiation therapy for hematologic cancers and other conditions in both adults and children. At present there is no approved agent for the treatment or prevention of VOD in the United States or the European Union.
surf1944
12 years ago
I believe the stock could best $2 level after Krystexxa EU approval this year. If the drug fails to gain approval, I believe we will see the stock back under $1.
3. Gentium (GENT), 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. Food and Drug Administration (FDA) and Orphan Medicinal Product Designation by the European Medicines Agency, both to treat and to prevent VOD, as well as Fast Track Designation by the U.S. FDA to treat VOD.
(click to enlarge)
Upcoming EMA catalyst
The company announced on June 21 that it has submitted its responses to the Day 180 List of Outstanding Issues (LoOIs) received from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) with respect to the company's Marketing Authorization Application (MAA) for Defibrotide to treat and prevent hepatic veno-occlusive disease (VOD) in adults and children undergoing haematopoietic stem cell transplantation therapy. Gentium expects to receive an opinion from the CHMP regarding the approval of Defibrotide during the third quarter of 2012.
Veno-occlusive disease is a potentially life-threatening condition, which typically occurs as a significant complication of stem cell transplantation. Certain high-dose conditioning regimens used as part of stem cell transplantation can damage the lining cells of hepatic blood vessels and result in VOD, a blockage of the small veins in 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). Stem cell transplantation is a frequently used treatment modality following high-dose chemotherapy and radiation therapy for hematologic cancers and other conditions in both adults and children. At present there is no approved agent for the treatment or prevention of VOD in the United States or the European Union.
Financials
The company reported the first-quarter financial results on May 17 with the following highlights:
Revenue $7.5 million
Net loss $1.2 million
Cash $14.2 million
Salvatore Calabrese, SVP & Chief Financial Officer of Gentium commented on May 17:
"We are pleased to report that Defibrotide usage increased by 28% compared to the prior-year period. The company continues to be cash flow positive despite higher expenditures incurred with activities related to expansion of the company's commercial infrastructure and the hiring of contract research organizations and scientific and regulatory consultants to assist and support the FDA and EMA regulatory approval processes."
http://seekingalpha.com/article/832691-5-pharmaceutical-companies-with-ema-or-mhra-catalysts-this-year?source=yahoo
trade2much
13 years ago
GENT CHMP news today
Gentium Receives Day 180 List of Outstanding Issues From the CHMP for Defibrotide MAA
Print
Alert
Gentium Spa - Ads Represents Ordinary Shares (MM) (NASDAQ:GENT)
Intraday Stock Chart
Today : Friday 4 May 2012
Click Here for more Gentium Spa - Ads Represents Ordinary Shares (MM) Charts.
Gentium S.p.A. (Nasdaq:GENT) (the "Company") announced today that it has received the Day 180 List of Outstanding Issues (the "LoOIs") from the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") in connection with the Company's Marketing Authorization Application (MAA) for Defibrotide to treat and prevent hepatic veno-occlusive disease (VOD) in adults and children undergoing haematopoietic stem cell transplantation therapy.
The Company plans to submit its responses to the LoOls within 60 days, in line with the regulatory timetable. If the written responses satisfy the issues raised in the LoOIs and the CHMP does not require further explanation or clarification, a recommendation on the approval of Defibrotide could be made as early as the third quarter of 2012. If oral explanations are required, a clock stop may be imposed. The CHMP is expected to reach its final opinion no later than Day 210, based on the EMA review process timeline.
"We believe we have made good progress in working with the E.U. Rapporteurs to address the issues raised in their Day 120 List of Questions," said Dr. Khalid Islam, Chairman & Chief Executive Officer of the Company. "We plan to continue working closely with the EMA towards the approval of Defibrotide and to resolve any remaining open issues."
About the EMA Review Process:
EMA guidelines permit companies in receipt of LoOIs to respond within one month. More information can be obtained from the EMA website www.ema.europa.eu.
About VOD
Veno-occlusive disease (VOD) is a potentially life-threatening condition, which typically occurs as a significant complication of stem cell transplantation. Certain high-dose conditioning regimens used as part of stem cell transplantation can damage the lining cells of hepatic blood vessels and result in VOD, a blockage of the small veins in 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). Stem cell transplantation is a frequently used treatment modality following high-dose chemotherapy and radiation therapy for hematologic cancers and other conditions in both adults and children. At present there is no approved agent for the treatment or prevention of VOD in the United States or the European Union.
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. Food and Drug Administration (FDA) and Orphan Medicinal Product Designation by the European Medicines Agency, both to treat and to prevent VOD, as well as Fast Track Designation by the U.S. FDA to treat VOD.
The Gentium S.p.A. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=12669
surf1944
13 years ago
7:51AM On The Wires (WIRES) :Gentium (GENT) announced the appointment of PharmaSwiss, a division of Valeant Pharmaceuticals International (VRX) as the exclusive distributor of Defibrotide for 10 years in Albania, Bosnia, Bulgaria, Croatia, Cyprus, Czech Republic, Greece, Hungary, Macedonia, Montenegro, Poland, Romania, Serbia, Slovenia and Slovakia.
mlkrborn
13 years ago
Up $1.50 t0 $7.10..
Gentium Appoints Swedish Orphan Biovitrum AB as Exclusive Distributor of Defibrotide in Nordic and Baltic Territories
Press Release: Gentium S.p.A. – Mon, Jan 9, 2012 7:30 AM EST
Companies:
* Gentium S.p.A
* Swedish Orphan Biovitrum AB
RELATED QUOTES
Symbol Price Change
GENT 7.10 +1.38
VILLA GUARDIA (COMO), Italy, Jan. 9, 2012 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT - News) announced the appointment of the Swedish Orphan Biovitrum A.B., (Sobi) (Stockholm:SOBI.ST - News) as the exclusive distributor of Defibrotide in the following territories: Sweden, Denmark, Norway, Iceland, Finland, Latvia, Lithuania and Estonia. Under the terms of the agreement, which is valid for 10 years, Sobi will be responsible for managing named-patient requests and achieving price and reimbursement approvals in these territories. Following regulatory approval to market Defibrotide, if any, Sobi will be responsible for sales, marketing and local medical affairs activities in the territories.
Commenting on the appointment of Sobi, Adrian Haigh, Senior Vice President of Commercial Operations at Gentium S.p.A. said, "We are pleased to have established a long-term relationship with Sobi for the Nordic and Baltic territories, which is consistent with our overall commercial strategy to partner with strong local distributors. Sobi has unparalleled experience in managing orphan drugs and an established expertise in the area of stem cell transplantation."
"We are looking forward to the partnership with Gentium and the growth potential that Defibrotide will add to our specialty distribution portfolio. In addition, Defibrotide has a strong strategic fit with our current hematology portfolio, in particular with Kepivance(R), targeting patients undergoing stem-cell transplantation," said Anders Edvell, VP, Marketing & Sales at Sobi.
About VOD
Veno-occlusive disease is a potentially life-threatening condition, which typically occurs as a significant complication of stem cell transplantation. Certain high-dose conditioning regimens used as part of stem cell transplantation 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 Defibrotide
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). The efficacy of Defibrotide to treat hepatic VOD in HSCT patients is supported by data from a multi-center Phase 3 historically controlled trial, evaluating Defibrotide for the treatment of severe VOD (patients with VOD and multi-organ failure), a Phase 2 dose finding study, and interim data reported from the ongoing Phase 3 expanded access U.S. Treatment IND program in patients with severe hepatic VOD. Additional data include a Phase 3 randomized controlled study of Defibrotide in the prevention of hepatic VOD in pediatric HSCT patients. Defibrotide has generally been well-tolerated in the clinical setting, and results in more than 1,300 patients to date have shown that generally Defibrotide does not appear to increase the risk of complications in HSCT patients.
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. Gentium submitted the MAA for Defibrotide to the EMA in May 2011 and the CHMP issued the 120 day List of Questions in September 2011. Gentium anticipates responding to these questions during the first quarter of 2012. The CHMP review of the MAA will resume with Day 121 on receipt of Gentium's responses.
About Swedish Orphan Biovitrum (Sobi)
Swedish Orphan Biovitrum (Sobi) is a leading integrated biopharmaceutical company dedicated to bringing innovative therapies and services to improve the health of rare disease patients and their families. The company has three business lines: a core product portfolio including 5 proprietary medicines in the core therapeutic areas of Inflammation and Genetics & Metabolism, a Specialty Distribution Portfolio of 50 marketed products, and a GMP biologics facility. Sobi has three protein therapy projects in late stage clinical development -- Kiobrina, an enzyme replacement therapy to prevent growth restriction of prematurity in infants, and long acting coagulation factors 8 and 9 for Hemophilia A and B in collaboration with Biogen Idec. In 2010 Sobi had revenues of SEK 1.9 billion and 500 employees. The share (Stockholm:SOBI.ST - News) is listed on OMX NASDAQ Stockholm. More information is available at www.sobi.com.
surf1944
13 years ago
October 20, 2011 07:36 EDT Gentium provides update on MAA process for defibrotide in Europe
Gentium provided an update on the European Marketing Authorization Application for Defibrotide, the MAA, to treat and prevent hepatic veno-occlusive disease, VOD, in adults and children undergoing haematopoietic stem-cell transplantation therapy. The Company has received and reviewed the Day 120 List of Questions (LoQs) from the European Medicines Agency's (the "EMA") Committee for Medical Products for Human Use (the "CHMP") and anticipates that it will submit its responses by the end of December. (GENT)
mlkrborn
13 years ago
Gentium Reports First Half 2011 Financial Results
Related Quotes
Symbol Price Change
GENT 6.45 0.00
Press Release Source: Gentium S.p.A. On Tuesday September 20, 2011, 7:00 am EDT
* Cash flow positive and stronger cash position
* Defibrotide product sales increased by 25%
* Net income of EUR 2.67 million (US$ 3.85 million) for the first half of 2011
* Decrease in API revenues related to a health authority imposed price adjustment; revised product sales guidance for 2011 to EUR 21-23 million
VILLA GUARDIA (COMO), Italy, Sept. 20, 2011 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT - News) (the "Company") today reported financial results for the first half of 2011 and the quarter ended June 30, 2011. The Company reports its financial 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 June 30, 2011, EUR 1.00 = $1.44.
"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.A. "Additionally, we have continued to be cash flow positive and profitable during the first half of 2011, and have decreased our long-term debt while investing in the establishment of our European sales infrastructure. We confirm our previously reported projection that Defibrotide product sales for 2011 are expected to increase 25%-30% over 2010, but due in large part to lower API revenues, we are revising our 2011 product sales forecast to be in the range of EUR 21-23 million instead of EUR 23--25 million as originally projected."
"We are delighted that the number of clinics using Defibrotide through the expanded access and named-patients programs has increased since the beginning of the year, and we have entered into new local distribution agreements with several specialized regional partners that will initially distribute Defibrotide through these programs," stated Dr. Khalid Islam, Chairman and Chief Executive Officer of Gentium S.p.A. "Our Marketing Authorization Application (MAA) for Defibrotide was accepted by the European Medicines Agency (EMA) and we expect to receive any questions on the application shortly. With regard to the United States, we recently announced that we voluntarily withdrew our New Drug Application (NDA) for Defibrotide with the U.S. Food and Drug Administration (FDA) in order to conduct additional quality reviews on our original datasets and databases. An independent clinical research organization specialized in this area has been engaged to review all the datasets and identify the issues. Once that process is complete, we intend to prepare a remediation plan and discuss it with the FDA to determine if it satisfactorily addresses the Agency's concerns."
mlkrborn
13 years ago
GENT $6.00 Gentium shares tumble after co withdraws liver drug
By Shravya Jain
Thu Aug 18, 2011 10:40am EDT
(Reuters) - Shares of Gentium SpA (GENT.O) fell as much as 30 percent on Thursday, a day after it withdrew a marketing application for its experimental treatment for life-threatening complications related to stem cell transplantation.
"We have lost confidence in management's abilities to successfully navigate the regulatory and commercial paths for Defibrotide, the company's sole proprietary drug candidate," ThinkEquity analyst Mani Mohindru wrote in a note and downgraded the company's stock to "sell" from "buy."
Gentium is testing defibrotide as both preventive and acute treatment options for veno-occlusive disease, a condition in which small veins of the liver are blocked, in stem cell transplant patients.
The U.S. Food and Drug Administration raised concerns about the completeness of the datasets for both the treatment and prevention studies.
Mohindru said she had been expecting the issues to be debated by an advisory panel.
"Contrary to our expectations, the clinical deficiencies were apparently so serious, that the FDA did not even want to spend time to review the entire application," she wrote.
However, Wedbush Securities analyst Gregory Wade said he was confident in the drug's ability to get approved both in the United States and Europe and would be an aggressive buyer of the company's shares based on weakness.
He cut the price target on the stock by $2 to $14.
He said the product remained the standard of care both in the United States and Europe and that hasn't changed.
In the first quarter, defibrotide net sales to patients who have unsuccessfully used all alternate treatment options was 3.86 million euros -- 76 percent of total product sales.
"While there may be a bump in the road to approval, it is not really affecting the business of the company in the near-term at least," he said.
The Italian company's shares were trading down 29 percent at $6.22 on Thursday morning on Nasdaq.
(Reporting by Shravya Jain in Bangalore; Editing by Joyjeet Das)
surf1944
13 years ago
Gentium announces NDA submission for Defibrotide
theflyonthewall
On Wednesday July 6, 2011, 7:35 am EDT
Gentium S.p.A. announced that it has submitted a New Drug Application, NDA, to the United States Food and Drug Administration, FDA, for Defibrotide for the treatment of hepatic veno-occlusive disease, VOD, in adults and children undergoing hematopoietic stem-cell transplantation, HSCT.
Trade smarter, not harder: Unleash your inner pro with our toolkit and live discussions.
Ask ADVFN Intelligence (AI)
Renee
11 years ago
Big_Money_Upward
11 years ago
Penny Roger$
13 years ago
ghmm
13 years ago
Hot Features
Premium
