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| | | ![]() Acthar Gel Available Free of Charge Through Limited Access Program COLLEGEVILLE, Pa., March 11, 1996 -- Rhone-Poulenc Rorer Inc. (NYSE: RPR) announced today that the Company will continue to make Acthar(R) Gel (repository corticotropin injection or ACTH) available through a special Limited Access Program while it resumes normal manufacturing of the drug. Acthar Gel is broadly indicated for the treatment of a number of serious diseases. The program, which will provide Acthar Gel free of charge, will make the drug available on a limited basis to patients who have a life-threatening or serious unmet medical need. The program will continue for approximately four months after which time the drug is expected to be available nationwide via pharmacies. The program will be created by and administered through the National Organization for Rare Disorders (NORD), a federation of more than 135 not-for-profit health organizations serving people with rare disorders, and will last only until an adequate supply can be manufactured and made available through normal U.S. distribution channels. The NORD/RPR Acthar(R) Gel Limited Access Program will comply with all applicable FDA requirements. "We have been working closely with the FDA to ensure Acthar will continue to be available to these patients," said Dr. Max Talbott, Vice President, RPR Regulatory Affairs. "We share FDA's commitment to making drugs available to patients with serious unmet medical needs." The NORD/Acthar Gel Limited Access Program will have an emergency use provision so patients with life-threatening or severely debilitating conditions who do not respond to any other treatment can access Acthar Gel immediately through NORD. Other patients with less serious medical need will be selected based on a computerized random selection process administered by NORD. U.S. physicians who are interested in obtaining Acthar Gel for their patients should call 800-798-7425 to obtain an official registration form either to access the drug immediately for an emergency use situation or to enroll less serious cases in the random selection process. All patients will be selected in an unbiased manner and all patients will receive Acthar Gel through the official NORD selection process. Completed registration forms must be received by NORD no later than March 20 to be included in the initial random selection. The first selection will occur on March 22, 1996. All participants will be notified if they have been selected or if their name will be made available for the next random selection process, which is scheduled for April 5, 1996. The National Organization for Rare Disorders (NORD) is the federation of voluntary health organizations dedicated to helping people with rare (orphan) diseases and assisting the organizations that serve them. NORD is committed to the identification, treatment and cure of rare disorders through programs of education, advocacy, research and service. Rhone-Poulenc Rorer Inc. is a global pharmaceutical company dedicated to improving human health.
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