LeukoSite, ILEX Oncology and Schering AG Sign CAMPATH(R)
24.08.1999, 18:28
Agreement Cambridge, Mass.; San Antonio and Berlin (PROTEXT) -LeukoSite, Inc. (Nasdaq: LKST), ILEX(TM) Oncology, Inc. (Nasdaq:ILXO) and Schering AG, (Dax: SCHG) today announced that they haveentered into a distribution and development agreement whichgrants Schering AG exclusive marketing and distribution rights toCAMPATH(R) in the U.S., Europe and rest of the world except Japanand East Asia, where LeukoSite and ILEX have retained rights.CAMPATH(R) (generic name awaiting final approval by the WorldHealth Organization) is a humanized monoclonal antibody in late-stage development. LeukoSite and ILEX plan to submit the finalsegment 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 chroniclymphocytic leukemia (CLL). Schering and its U.S. affiliate,Berlex Laboratories, Inc., have extensive experience andstrategic interest in CLL as the marketers of one of the leadingdrugs indicated for the treatment of patients with this disease. In the United States, Berlex, LeukoSite and ILEX will share inthe profits from the sale of CAMPATH(R). On sales made in therest of the territory, Schering AG will pay royalties equivalentto the rate of profit sharing expected in the U.S. Under terms ofthe agreement, Schering will make payments of up to $30 millionfor rights to CAMPATH(R) and for the achievement of certainregulatory milestones in CLL. LeukoSite and ILEX currently intendto use these funds to assist in the advancement of ongoingCAMPATH(R) development activity. Schering, LeukoSite and ILEX arein the planning phase of development of CAMPATH(R) for otheroncology indications and for other important non-oncologyindications. "This is an important milestone for CAMPATH(R)," saidChristopher K. Mirabelli, Ph.D., chief executive officer ofLeukoSite. "We think the Schering global organization is in thebest position to maximize sales of CAMPATH(R) and is thestrongest possible development partner for us because of itsexperience in oncology and in other therapeutic indications inwhich we intend to develop CAMPATH(R)." "Schering is ideally suited to market CAMPATH(R)," said ILEXpresident and chief executive officer Richard L. Love. "They havemade a corporate-wide commitment to improving the lives ofpatients with CLL. Because they market the only approvedtherapeutic for CLL patients who have failed alkylating agents,they have become a worldwide leader in the treatment of CLL. Themarketing of their established product along with CAMPATH(R) willallow Schering and Berlex to solidify their positions in thetreatment of hematologic malignancies." Professor Gunter Stock, a member of the Board of ExecutiveDirectors of Schering AG emphasized, "We identified CAMPATH(R) asan innovative immunotherapy for the treatment of the most commonleukemia in Western countries. With CAMPATH(R), we will expandour long established competence in oncology. We look forward tointegrating this product into our portfolio and are committed toexpanding the uses of CAMPATH(R) through further development." CLL is the most prevalent form of adult leukemia, affectingapproximately 120,000 patients in the U.S. and Europe. CLL isoften a fatal disease and is characterized by an infiltration andaccumulation of functionally immature lymphocytes in the blood,in the bone marrow and other tissues, causing bone marrowdysfunction and lymph node, liver and spleen enlargement. Currentpatient treatment may include the use of various drugs. As thereis currently no cure for this disease, most patients eventuallybecome refractory to existing drugs. So far, no therapeutic agentis on the market for CLL patients who become refractory toexisting drugs. CAMPATH(R), if approved for marketing by the FDA,could provide an important therapeutic alternative for thesepatients. CAMPATH(R), a humanized monoclonal antibody targeted to theCD52 antigen, has been tested in a recently completed pivotalPhase II clinical trial in patients with CLL refractory toexisting drugs. An independent review panel has reviewed thisdata in accordance with the National Cancer Institute'sguidelines for the diagnosis and treatment of CLL. However, thedata have not yet been reviewed by the FDA. Data from the pivotal Phase II trial have been reported andmay be accessed at either of the following URLs:http://www.ilexonc.com/news/pr/index.phtml?pr_id=53 orhttp://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 toundergo a six-month priority review under the Prescription DrugUser Fee Act. The review period begins with the submission of acompleted BLA, which is expected to occur later this year. Givenits anticipated potential to address unmet medical needs forserious or life-threatening conditions, the FDA has madeCAMPATH(R) eligible for "rolling" submission. This means the FDAwill accept and process sections of the BLA as they arecompleted. To date, the Chemistry, Manufacturing and Controls,and the Pharmacology and Toxicology sections of the BLA have beensubmitted. The Clinical section will be submitted before the endof the year. LeukoSite, Inc. is a biotechnology company developingproprietary monoclonal antibody and small molecule drugs to treatpatients with cancer and inflammatory, autoimmune and viraldiseases. LeukoSite has five drug candidates in clinicaldevelopment and nine partnered small molecule research anddevelopment 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 thoroughPR Newswire's "Company News On-Call," by calling 800-758-5804 andentering the Company's extension number 114510. LeukoSitemaintains a site on the World Wide Web at:http://www.leukosite.com ILEX Oncology, Inc. is a drug development company focusedexclusively on accelerated development of drugs for the treatmentand prevention of cancer. The company does this in two ways: byadvancing a diversified portfolio of anticancer drugs through itsILEX Products subsidiary, and, by offering drug developmentservices on a contract basis to pharmaceutical and biotechcompanies through its ILEX Oncology Services subsidiary. Thesecomplementary businesses draw from the company's corerelationships with international oncology experts, strategicalliances -- providing unparalleled access to patient recruitmentfor clinical trials, and simultaneous European and US drugdevelopment and approval capabilities. Further information about ILEX Oncology, Inc. can be found onthe World Wide Web at: http://www.ilexoncology.com Schering is a research-based pharmaceutical company. As aglobal player with innovative products Schering aims for leadingpositions in specialized markets worldwide. Schering isrepresented with more than 140 subsidiaries and affiliatedcompanies worldwide and has a workforce of over 21,800 employees.Berlex business divisions are located in Wayne and Montville, NewJersey, and Richmond, California. Group sales in 1998 amounted toover DM 6.4 billion (3.3 billion Euro), of which 85 percent wereachieved outside Germany. Schering's activities are focused onthree strategic business areas: diagnostics, gynecology andtherapeutics for disabling diseases, e.g. multiple sclerosis andoncology. With in-house R&D and an excellent R&D network withexternal partners Schering is securing innovation and a promisingproduct pipeline. Using new ideas, Schering aims to make arecognized contribution to medical progress, and strives toimprove the quality of life. http://www.schering.de. Certain statements contained herein are "forward-looking"statements (as such term is defined in the Private SecuritiesLitigation Reform Act of 1995). Because such statements includerisks and uncertainties, actual results may differ materiallyfrom those expressed or implied by such forward-lookingstatements. Factors that could cause actual results to differmaterially from those expressed or implied by such forward-looking statements include, but are not limited to, risks intechnology and product development, failure to successfullycomplete clinical trials, failure to receive market clearancefrom regulatory agencies, competitive risks and those risks anduncertainties 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: AugustineLawlor of LeukoSite, Inc., (USA) 617-621-9350; or DeborahSibley, 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 BerlexLaboratories, Inc., (USA) 973-276-2043, or Hong Chow, CorporateCommunications, 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
http://www.ilexonc.com/news/pr/index.phtml?pr_id=53
http://www.leukosite.com/ci/pr/99/6-14-99.html
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