Marqibo
vincristine sulfate liposomes
Treatment for non-Hodgkin's LymphomaINEX and ENZON Announce ODAC Does Not Support Accelerated Approval for Cancer Drug Marqibo
VANCOUVER, British Columbia and BRIDGEWATER, N.J., December 1, 2004 -- Inex Pharmaceuticals Corporation ("INEX"; TSX: IEX) and Enzon Pharmaceuticals Inc. ("ENZON"; NASDAQ: ENZN) announced today that the Oncology Drugs Advisory Committee (ODAC) of the US Food and Drug Administration (FDA) voted unanimously against recommending accelerated approval for Marqibo (vincristine sulfate liposomes injection) as a treatment for patients with relapsed aggressive non- Hodgkin's lymphoma (NHL).
Based on this outcome, the companies believe the FDA will not grant accelerated approval for Marqibo. The FDA's decision on the New Drug Application (NDA) is expected by January 15, 2005.
"We are disappointed with the ODAC panel vote," said David Main, President and CEO of INEX. "We will take the FDA's full review into consideration to chart a new course to approval for Marqibo."
Kenneth J. Zuerblis, Executive Vice President and CFO of ENZON said, "We will work with INEX to determine the appropriate next steps for Marqibo."
About Marqibo (vincristine sulfate liposomes
injection)
Marqibo is a proprietary drug comprised of the widely used
off-patent anticancer drug vincristine encapsulated in INEX's
sphingosomal drug delivery technology. INEX's technology is
designed to provide prolonged blood circulation, tumor accumulation
and extended drug release at the cancer site. These characteristics
are intended to increase the effectiveness and reduce the side
effects of the encapsulated drug. In May 2004, the FDA accepted a
New Drug Application (NDA) seeking marketing approval of Marqibo as
a single-agent treatment for patients with relapsed aggressive
non-Hodgkin's lymphoma previously treated with at least two
combination chemotherapy regimens.
About Non-Hodgkin's Lymphoma (NHL)
NHL is the sixth-leading cause of cancer deaths in the United
States (19,400 estimated in 2004) and the fifth-leading cause of
cancer deaths in Canada (2,900 estimated in 2004), according to
estimates of the American Cancer Society and the Canadian Cancer
Society. An estimated 54,370 and 6,200 new cases will be diagnosed
in the US and Canada respectively in 2004.
About ODAC
The Oncologic Drugs Advisory Committee (ODAC) is a committee formed
by the FDA of external experts to advise the FDA in the evaluation
of marketed and investigational drugs for use in the treatment of
cancer. The Committee is comprised of a core of thirteen voting
members from the fields of general oncology, pediatric oncology,
hematologic oncology, immunologic oncology, biostatistics and other
related professions.
About INEX
INEX is a Canadian biopharmaceutical company developing and
commercializing proprietary drugs and drug delivery systems to
improve the treatment of cancer.
For further information, please visit www.inexpharm.com.
About ENZON
Enzon Pharmaceuticals Inc. is a biopharmaceutical company dedicated
to the discovery, development and commercialization of therapeutics
to treat life- threatening diseases.
For further information, please visit www.enzon.com.
Related Articles:
FDA Issues Not Approvable Letter for Marqibo - January 19, 2005
INEX and Enzon Announce Marqibo to be Reviewed by FDA's Oncologic Drugs Advisory Committee - September 27, 2004
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