LeukoSite, ILEX Oncology and Schering AG Sign CAMPATH(R)

LeukoSite, Inc. (Nasdaq: LKST), ILEX(TM) Oncology, Inc. (Nasdaq: ILXO) and Schering AG, (Dax: SCHG) today announced that they have entered into a distribution and development agreement which grants Schering AG exclusive marketing and distribution rights to CAMPATH(R) in the U.S., Europe and rest of the world except Japan and East Asia, where LeukoSite and ILEX have retained rights. CAMPATH(R) (generic name awaiting final approval by the World Health Organization) is a humanized monoclonal antibody in late- stage development. LeukoSite and ILEX plan to submit the final segment of the Biologics License Application (BLA) for CAMPATH(R) with the U.S. Food and Drug Administration (FDA) later this year. CAMPATH(R), if determined to be safe and effective by the FDA, may offer a new treatment option for patients with chronic lymphocytic leukemia (CLL). Schering and its U.S. affiliate, Berlex Laboratories, Inc., have extensive experience and strategic interest in CLL as the marketers of one of the leading drugs indicated for the treatment of patients with this disease. In the United States, Berlex, LeukoSite and ILEX will share in the profits from the sale of CAMPATH(R). On sales made in the rest of the territory, Schering AG will pay royalties equivalent to the rate of profit sharing expected in the U.S. Under terms of the agreement, Schering will make payments of up to $30 million for rights to CAMPATH(R) and for the achievement of certain regulatory milestones in CLL. LeukoSite and ILEX currently intend to use these funds to assist in the advancement of ongoing CAMPATH(R) development activity. Schering, LeukoSite and ILEX are in the planning phase of development of CAMPATH(R) for other oncology indications and for other important non-oncology indications. "This is an important milestone for CAMPATH(R)," said Christopher K. Mirabelli, Ph.D., chief executive officer of LeukoSite. "We think the Schering global organization is in the best position to maximize sales of CAMPATH(R) and is the strongest possible development partner for us because of its experience in oncology and in other therapeutic indications in which we intend to develop CAMPATH(R)." "Schering is ideally suited to market CAMPATH(R)," said ILEX president and chief executive officer Richard L. Love. "They have made a corporate-wide commitment to improving the lives of patients with CLL. Because they market the only approved therapeutic for CLL patients who have failed alkylating agents, they have become a worldwide leader in the treatment of CLL. The marketing of their established product along with CAMPATH(R) will allow Schering and Berlex to solidify their positions in the treatment of hematologic malignancies." Professor Gunter Stock, a member of the Board of Executive Directors of Schering AG emphasized, "We identified CAMPATH(R) as an innovative immunotherapy for the treatment of the most common leukemia in Western countries. With CAMPATH(R), we will expand our long established competence in oncology. We look forward to integrating this product into our portfolio and are committed to expanding the uses of CAMPATH(R) through further development." CLL is the most prevalent form of adult leukemia, affecting approximately 120,000 patients in the U.S. and Europe. CLL is often a fatal disease and is characterized by an infiltration and accumulation of functionally immature lymphocytes in the blood, in the bone marrow and other tissues, causing bone marrow dysfunction and lymph node, liver and spleen enlargement. Current patient treatment may include the use of various drugs. As there is currently no cure for this disease, most patients eventually become refractory to existing drugs. So far, no therapeutic agent is on the market for CLL patients who become refractory to existing drugs. CAMPATH(R), if approved for marketing by the FDA, could provide an important therapeutic alternative for these patients. CAMPATH(R), a humanized monoclonal antibody targeted to the CD52 antigen, has been tested in a recently completed pivotal Phase II clinical trial in patients with CLL refractory to existing drugs. An independent review panel has reviewed this data in accordance with the National Cancer Institute's guidelines for the diagnosis and treatment of CLL. However, the data have not yet been reviewed by the FDA. Data from the pivotal Phase II trial have been reported and may be accessed at either of the following URLs: http://www.ilexonc.com/news/pr/index.phtml?pr_id=53 or http://www.leukosite.com/ci/pr/99/6-14-99.html. CAMPATH(R), licensed by LeukoSite and ILEX from BTG plc, received "fast track" designation from the FDA and is expected to undergo a six-month priority review under the Prescription Drug User Fee Act. The review period begins with the submission of a completed BLA, which is expected to occur later this year. Given its anticipated potential to address unmet medical needs for serious or life-threatening conditions, the FDA has made CAMPATH(R) eligible for "rolling" submission. This means the FDA will accept and process sections of the BLA as they are completed. To date, the Chemistry, Manufacturing and Controls, and the Pharmacology and Toxicology sections of the BLA have been submitted. The Clinical section will be submitted before the end of the year. LeukoSite, Inc. is a biotechnology company developing proprietary monoclonal antibody and small molecule drugs to treat patients with cancer and inflammatory, autoimmune and viral diseases. LeukoSite has five drug candidates in clinical development and nine partnered small molecule research and development programs. LeukoSite is collaborating with Warner- Lambert Co., Roche Bioscience, Kyowa Hakko Kogyo Co., Ltd., Genentech, Inc. and MorphoSys AG. News releases issued by LeukoSite, Inc. are available thorough PR Newswire's "Company News On-Call," by calling 800-758-5804 and entering the Company's extension number 114510. LeukoSite maintains a site on the World Wide Web at: http://www.leukosite.com ILEX Oncology, Inc. is a drug development company focused exclusively on accelerated development of drugs for the treatment and prevention of cancer. The company does this in two ways: by advancing a diversified portfolio of anticancer drugs through its ILEX Products subsidiary, and, by offering drug development services on a contract basis to pharmaceutical and biotech companies through its ILEX Oncology Services subsidiary. These complementary businesses draw from the company's core relationships with international oncology experts, strategic alliances -- providing unparalleled access to patient recruitment for clinical trials, and simultaneous European and US drug development and approval capabilities. Further information about ILEX Oncology, Inc. can be found on the World Wide Web at: http://www.ilexoncology.com Schering is a research-based pharmaceutical company. As a global player with innovative products Schering aims for leading positions in specialized markets worldwide. Schering is represented with more than 140 subsidiaries and affiliated companies worldwide and has a workforce of over 21,800 employees. Berlex business divisions are located in Wayne and Montville, New Jersey, and Richmond, California. Group sales in 1998 amounted to over DM 6.4 billion (3.3 billion Euro), of which 85 percent were achieved outside Germany. Schering's activities are focused on three strategic business areas: diagnostics, gynecology and therapeutics for disabling diseases, e.g. multiple sclerosis and oncology. With in-house R&D and an excellent R&D network with external partners Schering is securing innovation and a promising product pipeline. Using new ideas, Schering aims to make a recognized contribution to medical progress, and strives to improve the quality of life. http://www.schering.de. Certain statements contained herein are "forward-looking" statements (as such term is defined in the Private Securities Litigation Reform Act of 1995). Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward- looking statements include, but are not limited to, risks in technology and product development, failure to successfully complete clinical trials, failure to receive market clearance from regulatory agencies, competitive risks and those risks and uncertainties discussed in filings made by ILEX Oncology, Inc. and, LeukoSite, Inc. with the Securities and Exchange Commission. The companies disclaim any obligation to update these forward- looking statements. ots Original Text Service: ILEX Oncology, Inc. Internet: http://www.newsaktuell.de Contact: Augustine Lawlor of LeukoSite, Inc., (USA) 617-621-9350; or Deborah Sibley, Marketing & Professional Communications (USA) 210-949- 8287, or Ann Stevens, Investor Relations, (USA) 210-949-8230, both of ILEX Oncology, Inc.; or Wendy Neininger of Berlex Laboratories, Inc., (USA) 973-276-2043, or Hong Chow, Corporate Communications, Investor Relations, +49-30-468-12838, or Pia- Maria Gorner, Corporate Communications, Business Media, +49-30- 468-15296, or Frank Richtersmeier, Corporate Communications, Scientific Media, +49-30-468-17661, all of Schering AG Web site: http://www.ilexonc.com





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