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Genzyme Tissue Repair, Diacrin Announce Orphan Drug Designations Source: PR Newswire CAMBRIDGE, Mass., Jan. 8 /PRNewswire/ via Individual Inc. -- The U.S. Food and Drug Administration has granted orphan drug designation for two new experimental therapies, NeuroCell(TM)-PD for advanced Parkinson's disease and NeuroCell(TM)-HD for Huntington's disease, Diacrin Inc. (Nasdaq: DCRN) and Genzyme Corp.'s Tissue Repair Division (Nasdaq: GENZL) announced today. The FDA Office of Orphan Drug Products granted two orphan drug designations for each therapy. Each received a designation for use of the product with antibody pretreatment to prevent rejection and a designation for use without pretreatment. Both therapies involve transplanted porcine neural cells. The Orphan Drug Act provides incentives to manufacturers to develop and market drugs for disorders affecting fewer than 200,000 people in the United States. The first developer to receive FDA marketing approval for a designated orphan drug is entitled to a seven-year exclusive marketing period in the United States. The NeuroCell-PD designations cover all advanced patients. In late stage Parkinson's disease patients, disease progression has diminished the effectiveness of conventional medications. These people experience greater disability than people in the early stages of the disease. Genzyme Tissue Repair and Diacrin estimate the population of people with advanced Parkinson's disease ranges from 115,000 to 155,000 in the United States. The NeuroCell-HD designations include all Huntington's disease patients. There are approximately 25,000 such patients in the United States. In September 1996, Genzyme Tissue Repair and Diacrin announced the formation of a 50-50 joint venture to pursue development and commercialization of NeuroCell-PD and NeuroCell-HD. Both products are in phase I clinical trials, funded by the joint venture, at major medical centers. Patient enrollment in the NeuroCell-PD trial was completed in the fourth quarter of 1996. The companies are seeking approval from the FDA to start a pivotal trial this year. Successful completion of a pivotal trial could lead directly to the filing of an application for marketing approval. Diacrin develops and produces transplantable porcine cells for the treatment of intractable human diseases characterized by cell dysfunction or cell death. Product candidates in preclinical development include NeuroCell(TM)-FE for focal epilepsy, NeuroCell(TM)-CD for cognitive disorders, HepatoCell(TM) for liver failure and hypercholesterolemia, and CardioCell(TM) for repair of damaged heart muscle. Genzyme Tissue Repair is a leading developer of biological products for the treatment of cartilage damage, severe burns, chronic skin ulcers, and neurodegenerative diseases. It is a division of Genzyme Corp. and has its own common stock intended to reflect the division's value and track its performance. This news release contains forwarding-looking statements about the potential market sizes for NeuroCell-PD and NeuroCell-HD and the planned start of a pivotal trial of NeuroCell-PD. Actual market sizes may differ depending on the accuracy of the company's information about the prevalence of Huntington's disease and the prevalence of advanced Parkinson's disease. The planned timing of a pivotal trial of NeuroCell-PD may change depending on the results of the phase I study and the timing and content of decisions made by the FDA. Genzyme's news releases are on the World Wide Web at http: //www.genzyme.com. They are also available from Genzyme's fax-on-demand service at 1-800-436-1443 within the United States or 1-201-521-1080 outside the United States. SOURCE Genzyme Tissue Repair /CONTACT: Thomas H. Fraser, Ph.D., President and CEO of Diacrin, 617-242-9100, or Cheryl Greenhouse (media), 617-252-7785 or Kristin Nally (investors), 617-252-7815, both of Genzyme/ (GENZL DCRN) CO: Genzyme Tissue Repair; Genzyme Corporation; Diacrin Inc. ST: Massachusetts IN: MTC SU: PDT SB -- NEW011 -- 0118 01/08/97 09:18 EST http://www.prnewswire.com [01-08-97 at 12:00 EST, PR Newswire]