) recently announced that it is seeking a re-examination of the
negative opinion issued on defibrotide by the European Medicines
Agency's (EMA) Committee for Medicinal Products for Human Use
The CHMP had issued the negative opinion in Mar 2013.
Gentium is looking to get the candidate approved for treating
and preventing hepatic veno-occlusive disease (VOD) in adults and
children undergoing hematopoietic stem cell transplantation
therapy. We note that currently there are no approved therapies
to treat VOD in the US and EU.
We note that defibrotide was recommended by the European Group
for Blood and Marrow Transplantation (EBMT) as the sole option to
treat VOD patients. The EBMT has also expressed concern over the
negative opinion issued by the CHMP regarding the approval of
defibrotide in Europe.
The CHMP will review its initial opinion within 60 days and a
final recommendation will available by the end of Jul 2013.
The regulatory proceedings for defibrotide were also far from
smooth in the US. Defibrotide was granted fast-track designation
by the US Food and Drug Administration (FDA). In Jul 2011, a New
Drug Application (NDA) was filed with the FDA for defibrotide for
the treatment of VOD.
As the FDA found many potential "Refuse to File" issues with
the candidate, Gentium voluntarily withdrew its NDA in Aug 2011.
Since then, Gentiumhas been working on it and expects to resubmit
the NDA in 2013.
Gentium currently carries a Zacks Rank #3 (Hold).Currently,
Salix Pharmaceuticals Ltd.
) look well positioned with a Zacks Rank #1 (Strong Buy).
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