(By Balaseshan) Gentium S.p.A. (NASDAQ: GENT) said it will initiate clinical development in Japan of Defibrotide to treat veno-occlusive disease (VOD), and expand named-patient program access to Asia and Japan.
The company's entry into an agreement with the National University Corporation Hamamatsu University School of Medicine (HUSM), Fukushima Medical University (FMU) and LINK Healthcare to support a clinical trial to evaluate the safety and pharmacokinetics of Defibrotide in healthy adults.
An investigational new drug application for Defibrotide to treat VOD, a potentially life-threatening condition associated with stem cell transplantation, was recently submitted to Japan's Pharmaceuticals and Medical Devices Agency (PMDA).
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Under the terms of the agreement, Gentium will provide free drug and technical support and LINK will provide administrative and logistical support for the clinical trial conducted by HUSM.
If desired outcomes are achieved following the completion of the Phase 1 clinical trial, a Phase 2 Clinical Trial will need to be completed before submitting a marketing authorization application for Defibrotide to the PMDA.
The clinical trial is supported by a Health and Labour Sciences Research Grant (2012) and is categorized by the grant program as a study to support practical drug/medical device use during the reconstruction of disaster-hit areas in Eastern Japan.
In June 2011, the company announced the appointment of Link as exclusive distributor of Defibrotide in Australia and New Zealand.
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Gentium and LINK intend to expand the distribution territories covered in their existing agreement to include Asia and Japan as LINK has recently established an operations and distribution facility in Singapore to serve the central Asian markets and purchased a business specializing in named-patient distribution in Japan.
Defibrotide 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 Commission both to treat and to prevent VOD and Fast Track Designation by the U.S. FDA to treat VOD.
GENT closed Tuesday's regular session down 1.22% at $11.36. The stock has been trading between $5.31 and $11.81 for the past 52 weeks.