) announced that the European Medicines Agency's (EMA) Committee
for Medicinal Products for Human Use (CHMP) recently rendered a
negative opinion on its pipeline candidate defibrotide.
Gentium is looking to get the candidate approved for treating
and preventing hepatic veno-occlusive disease (VOD) in adults and
children. The condition appears in patients undergoing
hematopoietic stem cell transplantation therapy. VOD refers to a
rare but serious deficiency. The disorder results in damage to
the small blood vessels in the liver due to high doses of
chemotherapy and radiation received by the patient before
undergoing a stem cell transplant. We note that currently there
are no approved therapies to treat VOD.
Gentium intends to appeal against the negative opinion issued
by the CHMP and request the body to its adverse stance. The
company believes that the benefits associated with the candidate
outweigh the risks involved.
Moreover, defibrotide was recommended by the European Group
for Blood and Marrow Transplantation (EBMT)as the sole option to
treat VOD patients. EBMT is the largest professional body in the
haematopoietic stem cell transplantation space. The body,
which boasts of more than 4,200 members in 570 transplant centers
in 57 countries across the globe, has expressed concern over the
negative opinion issued by the CHMP regarding the approval of
defibrotide in Europe.
According to the procedure laid down by the EMA regarding
appeal, Gentium has to request for a re-examination of the CHMP
opinion within 15 days of its receipt of the same. Moreover,
Gentium can submit the grounds for appeal within 60 days.
The CHMP can review its initial opinion within a further 60
days. Under the EMA appeal procedure, Gentium has to request for
re-examination of the CHMP's opinion on the basis of the initial
data submitted. The company can submit a fresh application in the
EU in the event of its appeal being unsuccessful.
Gentium carries a Zacks Rank #3 (Hold).
Osiris Therapeutics, Inc.
) look more attractive in the pharma space. All three stocks
carry a Zacks Rank #1 (Strong Buy).
ATHERSYS INC (ATHX): Free Stock Analysis
CYTOKINETCS INC (CYTK): Free Stock Analysis
GENTIUM SPA-ADR (GENT): Free Stock Analysis
OSIRIS THERAPTC (OSIR): Free Stock Analysis
To read this article on Zacks.com click here.