MONTVILLE, N.J. and SAN ANTONIO, Oct. 18 /PRNewswire/ -- Berlex, Inc., a U.S. affiliate of Schering AG, Germany (NYSE: SHR; FSE: SCH), and ILEX Oncology, Inc. today announced the U.S. Food and Drug Administration (FDA) has granted marketing approval for CAMPATH(R) (alemtuzumab for injection), in a new, convenient, single-dose vial.
The new formulation, containing 30 mg/mL of CAMPATH, will be three times more concentrated than the currently marketed CAMPATH ampoule (10 mg/mL). The new vial is more convenient than the ampoule because no filtering is required during preparation.
A transition to the concentrated vial will have no impact on the current two-hour IV administration of CAMPATH, and the efficacy and safety of CAMPATH (including the side effects profile) are expected to remain the same.
"This new concentrated formulation will offer increased value to health care providers by providing a more convenient way to prepare CAMPATH for administration to patients," said Craig Philips, Vice President and General Manager, Berlex Oncology.
Following the new single-dose vial launch, anticipated in December 2004, the ampoule will remain available for a short time, after which only the new vial will be available.
"We are pleased to provide health care providers and their patients a more convenient dosing formulation of CAMPATH," said ILEX CEO and President Jeffrey Buchalter.
Although the new concentrated formulation will require close attention to the dosage that is prepared, physicians can easily switch patients who are currently receiving CAMPATH from the old ampoule to the new vial without difficulty once their inventories of the ampoules are depleted. Additionally, this change will not impact the current reimbursement for CAMPATH.
The new, more-concentrated formulation of CAMPATH in vials will be available in packages of three (like the ampoule).
Schering AG, Germany, holds exclusive worldwide marketing and distribution rights to CAMPATH under an agreement with ILEX Oncology's affiliate, ILEX Pharmaceuticals, L.P. The product is marketed in the United States by Berlex, Inc. CAMPATH was launched in the United States in June 2001, and in Europe, where it is named MABCAMPATH, in August 2001 for the treatment of patients with B-cell chronic lymphocytic leukemia who have been treated with alkylating agents and who have failed fludarabine therapy. MABCAMPATH also is marketed in some countries in Asia.
For more information or for questions regarding the new CAMPATH vial, please call 888-BERLEX4.
CAMPATH is the first and only humanized monoclonal antibody approved for B-CLL and is the first product with proven efficacy in B-CLL patients who have failed both alkylating agents and fludarabine phosphate treatment. CAMPATH targets the CD52 antigen found on the surface of both cancerous and noncancerous lymphocytes, but not on the surface of cells that have the ability to mature and differentiate into new, healthy lymphocytes. This activity is called hematopoietic cell sparing, which refers to the absence of effect on the precursors of normal blood elements such as neutrophils, erythroid cells and platelets. Once CAMPATH binds to the CD52 antigen on a lymphocyte, it works to kill the cell through a variety of mechanisms that seek out and selectively destroy the malignant cells through natural processes. It also stimulates the body's natural defense mechanisms to destroy the malignant cell. These various mechanisms of action are likely responsible for the removal of malignant lymphocytes from the blood, spleen, and bone marrow after injection. Although CAMPATH has some effect in removing malignant lymphocytes that have accumulated in the lymph nodes and extranodal masses, its activity is best at clearing the bone marrow of diseased cells, thus allowing the body to replenish healthy lymphocytes.
The most commonly reported infusion-related adverse events are rigors, fever, nausea, vomiting, and hypotension. Hematologic toxicities include pancytopenia/marrow hypoplasia, anemia, thrombocytopenia, and neutropenia and should be monitored. Infections reported included sepsis, pneumonia, and opportunistic infections such as CMV, candidiasis, aspergillosis, and mucormycosis. CAMPATH is contraindicated in patients with active systemic infections, underlying immunodeficiency, or known Type 1 hypersensitivity or anaphylactic reactions to CAMPATH or any of its components.
Committed to developing novel diagnostics and therapeutics that address unmet medical needs, Berlex develops and markets diagnostic imaging agents, treatments in the areas of female healthcare, oncology and dermatology, as well as specialized therapeutics for life-threatening and disabling diseases in the fields of the central nervous and cardiovascular systems and gastroenterology. Berlex has business operations in New Jersey, California and Washington. For more information, please visit http://www.berlex.com/.
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 http://www.ilexonc.com/.
Certain statements in this press release that are neither reported financial results nor other historical information are forward-looking statements, including but not limited to, statements that are predictions of or indicate future events, trends, plans or objectives. Undue reliance should not be placed on such statements because, by their nature, they are subject to known and unknown risks and uncertainties and can be affected by other factors that could cause actual results and Schering AG's plans and objectives to differ materially from those expressed or implied in the forward-looking statements. Certain factors that may cause such differences are discussed in our Form 20-F and Form 6-K reports filed with the U.S. Securities and Exchange Commission. Schering AG undertakes no obligation to update publicly or revise any of these forward-looking statements, whether to reflect new information or future events or circumstances or otherwise.
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.
MEDIA CONTACT: INVESTOR CONTACT:
Kimberley Jordan Joanne Marion
Berlex, Inc. Berlex, Inc.
Laura Boscarino Craig Tooman/Ann Stevens
ILEX Oncology, Inc. ILEX Oncology, Inc.