To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Rilutek (riluzole) Now Available by Prescription for ALS URL: http://www.pslgroup.com/dg/604E.htm Doctor's Guide January 10, 1996
NEW YORK, January 10, 1996 - Rhone-Poulenc Rorer Inc. announced that Rilutek(r) is now available by prescription for people with Lou Gehrig's Disease (amyotrophic lateral sclerosis or ALS). Rilutek is the first treatment for ALS since this fatal, neurodegenerative disease was first described 127 years ago. The announcement was made at an interactive news conference that reached people with ALS, caregivers, neurologists, healthcare professionals and reporters nationwide via teleconference and the Internet. "We are very pleased that people with ALS will be able to receive Rilutek less than seven months after we filed a New Drug Application with the U.S. Food and Drug Administration," said Joseph C. Scodari, Senior Vice President, The Americas, RPR. "As the first drug to extend survival in people with ALS, Rilutek represents a significant first step for the approximately 25,000 to 30,000 people in the United States affected by the disease." Patient Support Services RPR has established two patient service programs to facilitate access to Rilutek and to assist people with ALS via comprehensive patient support services. These programs will also provide patients with long-term support in resolving insurance and reimbursement issues. The objective of both programs is to help patients gain access to Rilutek regardless of their financial status. The Rilutek Continuity Program will determine if a patient qualifies for any public or private reimbursement funds. This determination will be based on an evaluation of each patient's financial status. If a patient is not eligible for adequate public or private reimbursement funds, the Rilutek Continuity Program will refer that patient to the Rilutek Patient Assistance Program. The Rilutek Patient Assistance Program provides free Rilutek to eligible patients. The award of Rilutek depends on the applicant's financial needs. Applications and personal financial data will be reviewed by NORD (National Organization for Rare Disorders), which is administering the program. "NORD is working to help as many patients as possible gain access to the drug," said Abbey Meyers, President of NORD. "In a time of exciting breakthroughs, RPR is setting a standard for patient service and access. We're delighted to be able to assist." Rilutek will be available by prescription as a 50 milligram tablet to be administered twice daily. The treating physician is encouraged to call the Rilutek Continuity Program at 1-800 790-RTEC (7832) to obtain Rilutek for their ALS patient. The patient will have the choice of receiving the drug at home or at their local pharmacy of choice. Early Access Program A total of 3,000 people with ALS in the U.S. became eligible to receive Rilutek before FDA approval through a computerized random selection process administered by NORD under a Treatment IND (Investigational New Drug). In keeping with the program's original objectives, it will now be phased out because of the commercial availability of Rilutek. Participating patients and healthcare professionals are receiving more detailed information in a special mailing. RPR's selling price for Rilutek has been set at just under $600 per month. In establishing the price for Rilutek, RPR has taken a responsible posture which takes into account the significant research and development investment required to develop an orphan drug, but it also anticipates the future possibility that Rilutek may be used together with other therapies. "Although the patient population is relatively small, the investment required to develop Rilutek is comparable to other innovative candidates in our portfolio," said Scodari. "In setting the price, we established a lower price than many people expected, and, we remain committed to provide a comprehensive range of patient services that potentially benefit all ALS patients." ALS attacks nerve cells in the brain and spinal cord, resulting in muscle paralysis and respiratory failure. Patients generally survive three to five years after diagnosis. The outward signs of ALS are progressive weakness and deterioration of the muscles (amyotrophic), beginning in limbs, usually on one side of the body (lateral). Inside the body, the nerves controlling motor function die off after their cell bodies become hardened and shriveled (sclerosis), leaving the patient increasingly helpless. Rhone-Poulenc Rorer Inc. is a global pharmaceutical company dedicated to improving human health. CONTACT: Bob Pearson or Jim Weiss of Rhone-Poulenc Rorer Inc., 610-454-3872/ (RPR) --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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