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Gentium shares tank after liver drug is withdrawn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).

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