ClolarTreatment for Acute Lymphoblastic Leukemia
ILEX's Clofarabine Scheduled For FDA Advisory Committee Review; ODAC to Review Pivotal Data for Pediatric Acute Leukemia
SAN ANTONIO--September 28, 2004 - ILEX(TM) Oncology, Inc. (Nasdaq:ILXO) announced today that clofarabine will be reviewed by the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) on December 1, 2004. The Company previously filed a New Drug Application (NDA) with the FDA for approval of clofarabine for the treatment of refractory or relapsed acute leukemia in children. The Prescription Drug User Fee Act (PDUFA) response date for this application is December 30, 2004.
"We look forward to the ODAC hearing," said ILEX Chief Medical Officer and pediatric oncologist, Steve Weitman, M.D. "This review is particularly important because in addition to the regulatory achievement this represents for ILEX and clofarabine, it is a key milestone for children with cancer."
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 initially for pediatric leukemia 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 pediatric and adult ALL and AML by the FDA. In the U.S., orphan drug status provides for seven years of market exclusivity for the orphan drug indication following the FDA's marketing approval. The FDA also recently granted six months of extended market exclusivity to clofarabine under the Best Pharmaceuticals for Children Act.
Clofarabine is a next generation of the drug class purine nucleoside analogs which all inhibit DNA production necessary for cancer cell growth. Bioenvision, Inc. (NASDAQ:BIVN) 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.
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 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 in the fourth quarter of 2004, 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 U.S., and is being sold by a co-development partner of Bioenvision.
Posted: September 2004
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- 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 Updates Clofarabine NDA with Encouraging Results; Additional Patient Data Resets FDA Action Date - August 24, 2004
- FDA Will Grant ILEX's Clofarabine Additional Six-Month Pediatric Exclusivity; Incentive Provides Extended Patent Protection Upon Marketing Approval - July 21, 2004
- FDA Begins Priority Review of ILEX NDA for Clofarabine in Pediatric Acute Leukemia; Filing Acceptance Indicates Start of Official Review Period - June 3, 2004
- ILEX Completes New Drug Application for Clofarabine; Filing Offers Hope to Children with Most Difficult-to-Treat Leukemias - March 31, 2004