Additional Patients Support Clofarabine Promise; ILEX Expects FDA Decision on NDA Filing by Year End.
On December 1, 2004, the Oncologic Drugs Advisory Committee (ODAC) of the FDA recommended accelerated approval of clofarabine in children with relapsed or refractory ALL. The panel requested additional studies be conducted in AML before it could make a recommendation for approval. The FDA's decision on the approval of the clofarabine ALL indication is expected on or before the Prescription Drug User Fee Act (PDUFA) expires on December 30, 2004. The proposed branded name for clofarabine in North America is CLOLAR(TM).
"We remain encouraged by the single-agent clofarabine activity in these critically-ill children who have exhausted other treatment options," said lead investigator Sima Jeha, M.D., Director, Developmental Therapeutics, Division of Leukemia/Lymphoma, St. Jude Children's Research Hospital. "These new data continue to highlight the clinical benefit patients experienced with clofarabine, including the ability for many patients to proceed to transplant, which is their best chance for long-term survival."
Of the 103 patients, the ALL group (n=61) achieved seven CRs, five CRps and six PRs. Thirteen percent of the ALL group, or eight patients, proceeded to bone marrow or stem cell transplant following clofarabine therapy. The AML group (n=42) achieved one CRp and 10 PRs. Of these, 29 percent, or 12 patients, went to transplant.
"The need for new therapeutic options in this heavily pre-treated patient population has been a focus at ILEX," said Steve Weitman, M.D., Chief Medical Officer and pediatric oncologist.
Clofarabine was previously granted orphan drug designation for the treatment of adult and pediatric 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. If approved by the FDA, clofarabine would be the first drug to be labeled initially for pediatric leukemia in more than a decade.
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. For more information about clofarabine, please call 1-800-792-5652.
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. 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 during the fourth quarter of 2004, subject to clearance by the Federal Trade Commission and satisfaction of 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 (NASDAQ:BIVN) 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. Further information about Bioenvision can be found on the company's Web site at http://www.bioenvision.com.
This press release contains forward-looking statements, including statements about the proposed transaction between Genzyme and ILEX and the time at which the companies expect the transaction to be completed. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others, the possibility that the transaction is not completed; the possibility that the transaction may not obtain FTC clearance on terms acceptable to the companies or that the companies may be required to modify aspects of the transaction to achieve regulatory approval; the possibility that other closing conditions are not met; Genzyme's ability to successfully integrate ILEX's operations and programs with Genzyme's and the time and resources required to do so; the actual design, results and timing of preclinical and clinical studies for the companies' products and product candidates; enrollment rates for the companies' clinical trials; the actual timing and content of submissions to and decisions made by regulatory authorities regarding the companies' products and product candidates, including the receipt of marketing approval in the United States for clofarabine; the ability to manufacture sufficient quantities of products for development and commercialization activities and to do so in a timely and cost-efficient manner; the ability to attract and retain qualified sales forces; the availability and extent of reimbursement from third-party payers for the companies' products and product candidates; the scope, validity and enforceability of patents directed to, and the effect of any third-party proprietary rights on, the companies' products and product candidates; the accuracy of the companies' information concerning the markets for their respective products and product candidates, including growth projections; and the risks and uncertainties described in reports filed by ILEX and Genzyme with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation the information under the heading "Risk Factors" in the registration statement on Form S-4 filed by Genzyme with respect to the proposed transaction and under the heading "Additional Business Risks" in ILEX's Annual Report on Form 10-K for the year ending December 31, 2003. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and we undertake no obligation to update or revise the statements, risks or reasons. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
CAMPATH(R) and MABCAMPATH(R) are registered trademarks of ILEX Oncology Inc. or its subsidiaries. Genzyme(R) is a registered trademark of Genzyme Corporation. All rights reserved.
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|Date:||Dec 7, 2004|
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