CPMP Recommends Approval of Taxotere(R) to Treat Advanced Non-Small-Cell Lung Cancer in the European Union

COLLEGEVILLE, Pa., and ANTONY, France (PROTEXT) - Rhone-Poulenc Rorer (RPR), the global pharmaceutical subsidiary ofRhone-Poulenc S.A. (NYSE: RP), announced that the Committee forProprietary Medicinal Products (CPMP) recommended approval ofTaxotere(R) (docetaxel) in the 15 Member States of the EuropeanUnion* for the treatment of patients with locally advanced ormetastatic non-small-cell lung cancer (NSCLC) after failure ofprior chemotherapy. The CPMP is the scientific committee of theEuropean Agency for the Evaluation of Medicinal Products (EMEA). This favorable CPMP opinion now has to be endorsed by theEuropean Commission before Taxotere receives final marketingauthorization in this indication. Up to now, Taxotere wasapproved in the European Union for the treatment of locallyadvanced or metastatic breast cancer after failure of priorchemotherapy, including an anthracycline or an alkylating agent. "The clinical trial data we presented clearly led to theCommittee's favorable opinion for the use of Taxotere in theEuropean Union to treat advanced non-small-cell lung cancer,"said Gary T. Shearman, Ph.D., Senior Vice President,Pharmaceutical Drug Development, and Deputy Head of Research andDevelopment at RPR. "This is a major step toward making Taxotereavailable to an underserved patient population with few treatmentoptions." The favorable opinion of the CPMP was based on the results oftwo Phase III, multicenter studies involving patients withadvanced non-small-cell lung cancer whose disease had progressedon prior chemotherapy. In a pivotal Phase III trial, 204 patients whose disease hadfailed to respond to platinum-based chemotherapy received either75 mg/m2 or 100 mg/m2 of Taxotere given as a one-hour infusion onday one and repeated every three weeks, or best supportive care(BSC). BSC refers to measures aimed at maintaining patientcomfort, including nutritional support and control of symptoms,such as nausea, vomiting, pain and shortness of breath. In patients treated with Taxotere at 75 mg/m2, overallsurvival (median is 9 months versus 4.6 months) and time toprogression (median is 12.3 weeks versus 7 weeks) weresignificantly longer compared to patients receiving BSC. The one-year survival rate was also significantly longer, in patientstreated with Taxotere at 75 mg/m2 (40 percent) versus BSC (16percent). "Historically, patients with recurrent or resistant non-small-cell lung cancer are a very challenging population with a poorsurvival rate," said Francis Shepherd, MD, Professor of Medicineat the University of Toronto, and the Princess Margaret Hospital,Toronto, Ontario, Canada, and primary investigator of the trial."We are greatly encouraged by the results we have seen withTaxotere." Patient quality-of-life (QOL) was assessed using severaltools, including the Lung Cancer Symptom Scale (LCSS) and theEuropean Organization for the Research and Treatment of Cancer(EORTC) QOL questionnaire. The analysis showed that patientstreated with Taxotere used less radiotherapy and symptom-relieving medications and had less weight loss. The QOLevaluation also showed that patients treated with Taxotere hadless pain and fatigue and more appetite. In the second multicenter Phase III trial, 373 patients withadvanced NSCLC who were resistant to platinum-based chemotherapyreceived either treatment with Taxotere 75 mg/m2 or 100 mg/m2,every three weeks, or treatment with either vinorelbine, 30 mg/m2weekly, or ifosfamide, 2 gm/m2 daily for three days every threeweeks. The study found that the one-year survival rate inpatients treated with 75 mg/m2 of Taxotere was 32%, compared to19% in patients treated with either vinorelbine or ifosfamide. About Taxotere Taxotere, a drug in the taxane class of chemotherapeuticagents, inhibits cancer cell division by essentially "freezing"the cell's internal skeleton, which is comprised of microtubules.Microtubules assemble and disassemble during a cell cycle.Taxotere promotes their assembly and blocks their disassembly,thereby preventing cancer cells from dividing, which results incancer cell death. Common side effects associated with Taxotere may include lowblood cell counts, fluid retention, hypersensitivity, nausea anddiarrhea. A premedication regimen with corticosteroids isrecommended in order to prevent or reduce hypersensitivity andfluid retention. Taxotere is not an appropriate therapy for somepatients with severe liver impairment. To date, Taxotere is approved for the treatment of advancedNSCLC in more than 40 other countries. Taxotere also is approvedin more than 80 countries, including the European Union and theUnited States, to treat advanced breast cancer after failure ofprior chemotherapy. Taxotere is not yet approved in the UnitedStates for the treatment of non-small-cell lung cancer. About Lung Cancer Attributed primarily to smoking and tobacco use, lung canceris the second leading cause of cancer-related deaths worldwide.Although the incidence of lung cancer in men has leveled off, theincidence in women continues to increase. Among women, lungcancer now exceeds breast cancer as the number one cause ofcancer-related deaths. Non-small-cell lung cancer is the most common type of lungcancer, accounting for 80 percent of all cases. At present,patients with advanced NSCLC have relatively limited treatmentoptions. Only 25 percent of patients have tumors that areoperable. The majority of patients are treated with radiationtherapy and/or chemotherapy, and best supportive care. Rhone-Poulenc Rorer is a global pharmaceutical companydedicated to improving human health. Rhone-Poulenc S.A. (NYSE:RP), is a leading life sciences company, growing throughinnovations in human, plant and animal health. With sales in 1998of FF86.8 billion (U.S. $14.8 billion; Euros 13.2 billion),Rhone-Poulenc employs 65,000 people in 160 countries worldwide.The RPR Internet website is at http://www.rp-rorer.com. *Austria, Belgium, Denmark, Finland, France, Germany, Greece,Ireland, Italy, Luxembourg, The Netherlands, Portugal, Spain,Sweden and the United Kingdom. NOTE: The "2" in "75 mg/m2", "100 mg/m2", "30 mg/m2" and "2gm/m2" is superscript. ots Original Text Service: Rhone-PoulencRorer Internet: http://www.newsaktuell.de Contact: Terri Pedoneof Rhone-Poulenc Rorer (US), 610-454-8284, or Sophie Langlois ofRhone-Poulenc Rorer (France), 33 1 55 71 72 63 Web site:http://www.rp-rorer.com

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