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| |  FDA Approves Campath (Alemtuzumab) New Single-Use Vial New, Concentrated Formulation Allows More Convenient Dosage Preparation MONTVILLE, NJ and SAN ANTONIO, TX -- October 18, 2004 -- Berlex, Inc., a U.S. affiliate of Schering AG, Germany (NYSE: SHR; FSE: SCH), and ILEX Oncology, Inc. (Nasdaq: ILXO) today announced the U.S. Food and Drug Administration (FDA) has granted marketing approval for Campath® (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. About Campath 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.
Campath® and MABCampath® are registered trademarks of ILEX Oncology, Inc. or its subsidiaries. Genzyme® is a registered trademark of Genzyme Corporation. All rights reserved.
SOURCE: Berlex, Inc.
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