Clolar
clofarabine
Treatment for Acute Lymphoblastic LeukemiaFDA Begins Priority Review of ILEX NDA for Clofarabine in Pediatric Acute Leukemia; Filing Acceptance Indicates Start of Official Review Period
SAN ANTONIO, June 3, 2004--ILEX(tm) Oncology Inc. (Nasdaq:ILXO) announced today that the U.S. Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA 21-673) for clofarabine for the treatment of refractory or relapsed acute leukemia in children. The NDA has been granted a priority review by the FDA. Clofarabine received fast-track designation in 2003. If approved, clofarabine will become the Company's second marketed product.
"We are very pleased with the FDA's decision to accept the clofarabine filing and we will work closely with the agency during this critical period," said ILEX CEO and President Jeff Buchalter.
On March 29, 2004, ILEX completed a "rolling" NDA submission for clofarabine. The application seeks marketing approval for clofarabine in refractory or relapsed acute pediatric leukemias.
Historically, cancer drugs are approved and made available for adults first and then modified for children. If approved by the FDA, clofarabine would be the first drug to be labeled for pediatric leukemia exclusively in more than a decade. Cure rates for pediatric leukemia have improved dramatically over the past several decades. However, children who do not respond to initial therapy have a very poor prognosis and long-term remissions are rare.
Clofarabine was previously granted orphan drug designation for the treatment of adult and pediatric acute lymphoblastic leukemia and acute myeloid leukemia. In the United States, orphan drug status provides for seven years of market exclusivity for the orphan drug indication following the FDA's marketing approval.
About Clofarabine
Clofarabine is a next generation of the drug class purine
nucleoside analogs which all inhibit DNA production necessary for
cancer cell growth. Bioenvision Inc. (AMEX:BIV) sub-licensed ILEX
the right to develop and market clofarabine for human cancer
indications in the United States and Canada. Bioenvision is
entitled to milestone payments tied to the development of the
compound and is entitled to royalties on North American sales. As
is its exclusive right, Bioenvision is developing clofarabine in
the rest of the world. Bioenvision originally obtained clofarabine
development and commercialization rights under patents held by
Southern Research Institute.
About ILEX
Founded in 1994 as an oncology drug development company, ILEX has a
marketed product, CAMPATH(R) in the United States and MABCAMPATH(R)
in the European Union, and is advancing an innovative and
diversified pipeline of compounds focused on the treatment of
cancer. The ILEX pipeline comprises product candidates at various
stages of clinical development, including monoclonal antibodies,
novel cytotoxic agents, angiogenesis inhibitors and signal
transduction inhibitors. Based in San Antonio, Texas, ILEX
maintains a core competency in oncology drug development. ILEX also
conducts research in angiogenesis inhibition, cell signaling,
medicinal chemistry and nuclear receptor biology at its
laboratories in Boston, Mass., and Geneva, Switzerland. In February
2004, ILEX announced its agreement to merge with Genzyme
Corporation, a global biotechnology company. The merger, subject to
ILEX stockholder approval and other customary conditions, is
expected to close in mid-2004.
Further information about ILEX can be found on the company's Web site at www.ilexonc.com.
About Bioenvision Inc.
Bioenvision's (AMEX:BIV) primary focus is the development and
distribution of compounds and technologies for the treatment of
cancer. Bioenvision has a broad pipeline of products for the
treatment of cancer, including: clofarabine (in co-development with
ILEX Oncology Inc.); Modrenal(R) (for which Bioenvision has
obtained regulatory approval for marketing in the United Kingdom
for the treatment of post-menopausal breast cancer); and other
products in clinical trials. Bioenvision also is developing
anti-infective technologies, including the OLIGON technology, an
advanced biomaterial that has been approved for certain indications
by the FDA in the United States, and is being sold by a
co-development partner of Bioenvision.
Further information about Bioenvision can be found on the company's Web site at www.bioenvision.com.
Related Articles:
Clolar Genzyme Corp. - Treatment for Leukemia in Children - December 28, 2004
FDA Advisory Committee Recommends Accelerated Clofarabine Approval for Most Common Pediatric Leukemia; FDA to Make Approval Decision by End of Year - December 1, 2004
ILEX's Clofarabine Scheduled For FDA Advisory Committee Review; ODAC to Review Pivotal Data for Pediatric Acute Leukemia - September 28, 2004
ILEX Updates Clofarabine NDA with Encouraging Results; Additional Patient Data Resets FDA Action Date - August 24, 2004
ILEX Completes New Drug Application for Clofarabine; Filing Offers Hope to Children with Most Difficult-to-Treat Leukemias - March 31, 2004
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