ItalyItaly

Gentium shares tank after liver drug is withdrawn

19.08.2011

Como – Shares in Gentium SpA lost about a third of their value on Thursday after The Italian biopharmaceutical company withdrew a marketing application for its drug Defibrotide being used against complications related to stem cell transplantation. "Given the number of issues raised by the FDA and the short deadline we have to address such issues, we felt that it was appropriate to voluntarily withdraw our NDA submission for Defibrotide," said CEO Khalid Islam. In their initial review, the FDA had raised concerns regarding the completeness of the datasets for both the treatment and prevention studies. The FDA requested that the Company conduct additional quality reviews of the original datasets and databases. The FDA also requested additional details regarding the conduct and monitoring of the trials by the independent review committee. The market didn't welcome the step. "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." Defibrotide, the Company's lead product candidate, is an investigational drug that has been granted Orphan Drug status and Fast Track Designation by both the FDA as well as the European Commission. In the first quarter 2011, defibrotide net sales as a drug of last resort was 3.86 million euros -- 76 percent of total product sales. Defibrotide is used against veno-occlusive disease (VOD), 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 transplant (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).

ItalyItaly

07.03.2012

Toscana Biomarkers S.r.l has entered the market for biomarkers with its first diagnostic kit. In late January, the company from Siena signed a licence agreement with DIESSE Ricerche S.r.l, based in Genoa. DIESSE will produce and...

ItalyItaly

07.03.2012

Italian researchers have reprogrammed neonatal cardiomyocytes into iPSCs that can re-differentiate toward CMs more efficiently than either cardiac fibroblast-derived iPS cells or even ES cells. (Cell Death Differ.,...

ItalyItaly

09.01.2012

Rome – A cold virus isolated from chimpanzees might work as an vector for human vaccines. Adenoviruses are principally suitable as vectors for vaccines for their ability to induce strong immune responses. But as most humans have...

ItalyItaly

16.12.2011

Milan/Turku – Italian drug developer Newron SpA has had a roller-coaster ride in the last few months. First Merck Serono decided to drop its stake in the company’s Parkinson’s Disease candidate salfinamide, and returned the...

ItalyItaly

15.12.2011

Genoa/Irvine – Researchers from the universities at Genoa and Irvine (US) have patented a new compound that blocks removal of the endo­cannabinoid painkiller anandamide from the synaptic space by a selective transport system....

ItalyItaly

01.10.2011

Parma/Baranzate – Chiesi Farmaceutici Spa has said it will lengthen its long-term collaboration with NiKem Research, which is focused on developing treatments within the respiratory therapeutic area. The two drug developers have...

ItalyItaly

01.10.2011

Milan/Turku – Biotie Therapies ASA’s announcement that it had signed an agreement to acquire Newron Pharma­ceuticals S.p.A. for €45m is both good and bad news for the Italian biotechnology sector. While Italy is losing one of its...

ItalyItaly

01.08.2011

Milan/London – Italy’s MolMed SpA has signed a deal with UK-based pharmaceutical giant GlaxoSmithKline to develop a production process for a gene therapy against the rare ‘bubble boy disease’. Over the next two years, GSK will...

Displaying results 1 to 10 out of 181

1-10 Next >

© 2007-2014 BIOCOM

http://www.european-biotechnology-news.com/news/messages-archive/archive-italy/article/gentium-shares-tank-after-liver-drug-is-withdrawn.html

Image Gallery

Stock list

All quotes

TOP

  • PHARMING (NL)0.53 EUR12.8%
  • BAVARIAN NORDIC (D)14.56 EUR10.3%
  • NICOX (F)2.44 EUR7.5%

FLOP

  • XENETIC BIOSCIENCES (UK)6.00 GBP-14.3%
  • GENFIT (F)22.42 EUR-8.1%
  • DEINOVE (F)12.96 EUR-5.3%

TOP

  • BIOTECH PHARMACON (N)17.50 NOK59.1%
  • WILEX (D)0.92 EUR53.3%
  • E-THERAPEUTICS (UK)28.00 GBP40.0%

FLOP

  • CYTOS (CH)0.17 CHF-93.8%
  • BIONOR PHARMA (N)2.11 NOK-44.9%
  • PROTHENA PLC (IE)28.07 USD-40.8%

TOP

  • SILENCE THERAPEUTICS (UK)256.00 GBP6221.0%
  • IXICO (UK)71.50 GBP810.8%
  • PHARMING (NL)0.53 EUR783.3%

FLOP

  • CYTOS (CH)0.17 CHF-95.8%
  • EVOCUTIS (UK)0.22 GBP-92.5%
  • AGENNIX (D)0.04 EUR-77.8%

No liability assumed, Date: 19.04.2014

Current issue

All issues

Product of the week

Products

Events

All Events

Partner-Events

München

BioVaria 2014

Frankfurt am Main

7th DVFA Life Science Conference

White Paper