Clolar
clofarabine
Treatment for Acute Lymphoblastic LeukemiaFDA Will Grant ILEX's Clofarabine Additional Six-Month Pediatric Exclusivity; Incentive Provides Extended Patent Protection Upon Marketing Approval
SAN ANTONIO, Jul 21, 2004 - ILEX(TM) Oncology Inc. (Nasdaq:ILXO) announced today that the U.S. Food and Drug Administration (FDA) will grant six months of extended market exclusivity to clofarabine under the Best Pharmaceuticals for Children Act. Clofarabine is currently under priority review by the FDA for the treatment of refractory or relapsed acute leukemia in children. If approved by the FDA, clofarabine would be the first drug to be labeled initially for pediatric leukemia in more than a decade.
"This is an important milestone for children with cancer and for the FDA because children are usually an afterthought in oncology drug development," said Children's Cause for Advocacy President, Susan L. Weiner, Ph.D. "Hopefully this good news will set a precedent for other companies to make children with cancer a priority in their drug development plans."
The Best Pharmaceuticals for Children Act offers extended market exclusivity to drug developers as an incentive to increase therapeutic research in children.
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
ILEX Oncology Inc. is an oncology drug development company with a
marketed product, CAMPATH(R) in the United States and MABCAMPATH(R)
in the European Union, as well as a pipeline of investigational
compounds focused on the treatment of cancer. ILEX maintains a core
competency in oncology drug development in San Antonio, Texas. ILEX
also conducts research in angiogenesis inhibition, cell signaling,
medical chemistry and nuclear receptor biology at its laboratories
in Boston, Mass., and Geneva, Switzerland. In February 2004, ILEX
entered into an agreement and plan of merger with Genzyme(R)
Corporation, a leading global biotechnology company. The merger is
expected to close this summer, but remains subject to clearance by
the Federal Trade Commission and other customary closing
conditions. 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
New Drug Applications Archive
2007: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2006: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2005: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2004: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
